title: Commission Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods (Text with EEA relevance)

text:
                  24.7.2018

                  EN

                  Official Journal of the European Union

                  L 187/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1023
         of 23 July 2018
         correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 8 thereof,
         Whereas:

                     (1)

                     Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission is to establish, by 1 January 2018, the Union list of novel foods authorised or notified under Regulation (EC) No 258/97 of the European Parliament and of the Council (2).

                     (2)

                     The Union list of novel foods authorised or notified under Regulation (EC) No 258/97 was established by Commission Implementing Regulation (EU) 2017/2470 (3).

                     (3)

                     Pursuant to Article 36 of Regulation (EU) 2015/2283, the new novel food Regulation applies from 1 January 2018. A number of products were authorised or notified under Regulation (EC) No 258/97 during the period between the Standing Committee vote on the Union list on 6 December 2017 and the date of application of Regulation (EU) 2015/2283 on 1 January 2018. These products should therefore be included in the Union list established through Implementing Regulation (EU) 2017/2470.

                     (4)

                     On 19 December 2017, the company Demethra Biotech S.r.l. notified the Commission that it placed the novel food ‘Echinacea purpurea extract from cell cultures’ on the Union market pursuant to Article 5 of Regulation (EC) No 258/97. This novel food was not included in the Union list. Therefore, a new entry should be added to Tables 1 and 2 of the Annex to Implementing Regulation (EU) 2017/2470.

                     (5)

                     On 21 and 22 December 2017, two companies, DuPont Nutrition & Biosciences ApS and FrieslandCampina Nederland BV, notified the Commission that they placed the novel food ‘2'-Fucosyllactose (microbial source)’ on the Union market pursuant to Article 5 of Regulation (EC) No 258/97. ‘2'-Fucosyllactose (microbial source)’ was already included in the Annex to Implementing Regulation (EU) 2017/2470. Those new notifications modify the numerical values of several parameters listed in the specifications of this novel food and therefore, the entry ‘2'-Fucosyllactose (microbial source)’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 should be corrected accordingly.

                     (6)

                     On 20 December 2017, the company c-LEcta GmbH notified the Commission that it placed the novel food ‘Trehalose’ on the Union market pursuant to Article 5 of Regulation (EC) No 258/97. ‘Trehalose’ was included in the Annex to Implementing Regulation (EU) 2017/2470. That new notification concerns a new source of trehalose, sucrose. Therefore, the specifications of the entry ‘Trehalose’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 should be corrected accordingly.

                     (7)

                     After the publication of Implementing Regulation (EU) 2017/2470, a number of errors or omissions were noted concerning the specifications or the conditions of use of a number of authorised novel foods. Therefore, the Union list established in the Annex to Implementing Regulation (EU) 2017/2470 should be corrected.

                     (8)

                     The novel food ‘L-Alanyl-L-Glutamine’ was authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The category ‘Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen’ was erroneously omitted. Therefore, a correction adding ‘Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen’ as allowed food category in the entry ‘L-Alanyl-L-Glutamine’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

                     (9)

                     The novel food ‘Glucosamine HCl’ was authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The food category ‘Milk-based drinks and similar products intended for young children’ was added erroneously and should be deleted from this entry. A correction in the entry ‘Glucosamine HCl’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is therefore necessary.

                     (10)

                     The novel food ‘Lacto-N-neotetraose’ was authorised under certain conditions of use and maximum levels by Commission Implementing Decision (EU) 2016/375 (4). The wording ‘at concentrations up to 1,2 g/l’ was added erroneously and should be removed from the food category ‘Milk-based drinks and similar products intended for young children’ for this novel food. Therefore, a correction of the entry ‘Lacto-N-neotetraose’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

                     (11)

                     The novel food ‘Spermidine-rich wheat germ extract (Triticum aestivum)’ was authorised under certain conditions of use for ‘adult population excluding pregnant and lactating women’ pursuant to Article 5 of Regulation (EC) No 258/97. However, the exclusion of pregnant and lactating women erroneously did not feature in the Union list. In consequence, the correction of the entry ‘Spermidine-rich wheat germ extract (Triticum aestivum)’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

                     (12)

                     The novel food ‘Antarctic Krill oil from Euphausia superba’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 erroneously omitted the following requirement, which should be added: ‘Oxidative stability: all food products containing Antarctic Krill oil from Euphausia superba should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC)’. Therefore, a correction of this entry in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

                     (13)

                     The novel food ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’ was authorised under certain conditions of use by the Finnish competent authorities (5). The specifications erroneously added the following requirement: ‘Oxidative stability: all food products containing Antarctic Krill oil rich in phospholipids from Euphausia superba should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC)’. This requirement should be removed. Therefore, a correction of the entry ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

                     (14)

                     The novel food ‘Chia seeds (Salvia hispanica)’ was initially authorised under certain conditions of use by Commission Decision 2009/827/EC (6). The specifications erroneously added the following requirement: ‘(EU: carbohydrates are available = sugar + starch)’. This requirement should be removed. Therefore, a correction of the entry ‘Chia seeds (Salvia hispanica)’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

                     (15)

                     The novel food ‘Chitosan extract from fungi (Agaricus bisporus; Aspergillus niger)’ was initially authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The specifications erroneously added the following requirement: ‘Fat binding capacity 800 x 9 w/wet weight): pass’. This requirement should be replaced by ‘Fat binding capacity 800 x (w/w wet weight): pass’. Therefore, a correction of the entry ‘Chitosan extract from fungi (Agaricus bisporus; Aspergillus niger)’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

                     (16)

                     The novel food ‘Citicoline’ was authorised under certain conditions of use by Commission Implementing Decision 2014/423/EU (7). In Table 2 of the Annex to Implementing Regulation (EU) 2017/2470, the specifications of the novel food ‘Citicoline’ refer to citicoline produced via either a synthetic or a microbial process. After the publication of that Regulation, it became clear that microbial process for the production of citicoline, also involved synthetic process. Thus, the specifications concerning ‘Citicoline’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 should be corrected to include only the microbial production process.

                     (17)

                     The novel food ‘Echinacea angustifolia extract from cell cultures’ was initially authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The specifications erroneously omitted the wording ‘description/definition’. Therefore, a correction of the entry ‘Echinacea angustifolia extract from cell cultures’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

                     (18)

                     The novel food ‘Galacto-oligosaccharide’ is included in the Union list established by Implementing Regulation (EU) 2017/2470. The following microbial sources Pichia pastoris, Kluyveromyces lactis, Sporobolomyces singularis and Papiliotrema terrestris of the enzyme ‘β-galactosidase’ were erroneously omitted in the specifications. Therefore, these sources of β-galactosidase should be added to the entry ‘Galacto-oligosaccharide’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470.

                     (19)

                     The novel food ‘Vitamin K2 (menaquinone)’ was initially authorised under certain conditions of use by Commission Decision 2009/345/EC (8). The chemical definition of Vitamin K2 was added to ‘specifications of microbiologically produced vitamin K2 (menaquinone-7)’ but erroneously not added to ‘specifications of synthetic vitamin K2 (menaquinone-7)’. Therefore, a correction of the entry ‘Vitamin K2 (menaquinone)’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

                     (20)

                     The novel food ‘Yeast beta-glucans’ was authorised under certain conditions of use by Commission Implementing Decision 2011/762/EU (9). In the specifications, ‘Microbiological data’ and ‘heavy metals’ erroneously refer to the three forms of Yeast beta-glucans instead of to the form ‘Insoluble in water but dispersible in many liquid matrices’. Therefore, a correction of the entry ‘Yeast beta-glucans’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

                     (21)

                     The novel food ‘Phytosterols/phytostanols’ was authorised under certain conditions of use by Commission Decision 2004/333/EC (10). On 14 April 2016, the company BASF SE Human Nutrition, ENS/HR notified the Commission that it placed the novel food ‘Phytosterols/phytostanols’ on the Union market in the category ‘Food supplement’ pursuant to Article 5 of Regulation (EC) No 258/97. The category ‘Food supplement’ was erroneously omitted. Therefore, a correction adding ‘Food supplement’ as allowed food category in the entry ‘Phytosterols/phytostanols’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

                     (22)

                     The novel food ‘Arachidonic acid-rich oil from the fungus Mortierella alpina’ was authorised under certain conditions of use by Commission Decision 2008/968/EC (11). The following non-genetically modified strain ‘CBS 210.32’ of the fungus Mortierella alpina was erroneously not included in the specifications. Therefore, this strain should be added to the entry ‘Arachidonic acid-rich oil from the fungus Mortierella alpina’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470.

                     (23)

                     The novel food ‘Epigallocatechin gallate as a purified extract from green tea leaves (Camellia sinensis)’ was initially authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The food category ‘Foods fortified in accordance with Regulation (EC) No 1925/2006’ was added erroneously and should be deleted from this entry. Furthermore, a correction adding ‘Foods’ to ‘food supplements as defined in Directive 2002/46/EC’ as the allowed food category in the entry ‘Epigallocatechin gallate as a purified extract from green tea leaves (Camellia sinensis)’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

                     (24)

                     The novel food ‘Lycopene from tomatoes’ was authorised under certain conditions of use pursuant to Article 5 of Regulation (EC) No 258/97. The food category ‘Food supplement’ was omitted erroneously and should be added to this entry. Therefore, a correction adding ‘Food supplement’ as allowed food category in the entry ‘Lycopene from tomatoes’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

                     (25)

                     In addition, after the publication of Implementing Regulation (EU) 2017/2470, several typographical errors have been identified in the Annex. While such typographic errors are usually corrected by a corrigendum, for the sake of clarity for economic operators and enforcement authorities, the correction of those typographical errors should be included in this correcting act.

                     (26)

                     Given the number of corrections, it is appropriate to replace the whole Annex to Implementing Regulation (EU) 2017/2470.

                     (27)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The Annex to Implementing Regulation (EU) 2017/2470 is replaced by the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 23 July 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 327, 11.12.2015, p. 1.

            (2)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

            (3)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

            (4)  Commission Implementing Decision (EU) 2016/375 of 11 March 2016 authorising the placing on the market of lacto-N-neotetraose as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 70, 16.3.2016, p. 22).

            (5)  Letter of 8 May 2015 (https://ec.europa.eu/food/sites/food/files/safety/docs/novel-food_authorisation_2015_auth-letter_krill-oil_en.pdf)

            (6)  Commission Decision 2009/827/EC of 13 October 2009 authorising the placing on the market of Chia seed (Salvia hispanica) as novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 294, 11.11.2009, p. 14).

            (7)  Commission Implementing Decision 2014/423/EU of 1 July 2014 authorising the placing on the market of citicoline as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 196, 3.7.2014, p. 24).

            (8)  Commission Decision 2009/345/EC of 22 April 2009 authorising the placing on the market of Vitamin K2 (menaquinone) from Bacillus subtilis natto as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 105, 25.4.2009, p. 16).

            (9)  Commission Implementing Decision 2011/762/EU of 24 November 2011 authorising the placing on the market of yeast beta-glucans as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 313, 26.11.2011, p. 41).

            (10)  Commission Decision 2004/333/EC of 31 March 2004 authorising the placing on the market of yellow fat spreads, salad dressings, milk type products, fermented milk type products, soya drinks and cheese type products with added phytosterols/phytostanols as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 105, 14.4.2004, p. 40).

            (11)  Commission Decision 2008/968/EC of 12 December 2008 authorising the placing on the market of arachidonic acid-rich oil from Mortierella alpina as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 344, 20.12.2008, p. 123).

            ANNEX

               UNION LIST OF NOVEL FOODS

               Content of the list

                        1.

                        The Union list shall consist of Tables 1 and 2.

                        2.

                        Table 1 includes the authorised novel foods and contains the following information:

                                    Column 1

                                    :

                                    Authorised novel food

                                    Column 2

                                    :

                                    Conditions under which the novel food may be used. This column is further subdivided into two: Specified food category and Maximum levels

                                    Column 3

                                    :

                                    Additional specific labelling requirements

                                    Column 4

                                    :

                                    Other requirements

                        3.

                        Table 2 includes the specifications on novel foods and contains the following information:

                                    Column 1

                                    :

                                    Authorised novel food

                                    Column 2

                                    :

                                    Specifications

               Table 1: Authorised novel foods

                        Authorised novel food

                        Conditions under which the novel food may be used

                        Additional specific labelling requirements

                        Other requirements

                              N-Acetyl-D-neuraminic acid

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘N-acetyl-D-neuraminic acid’
                        Food supplements containing N-acetyl-D-neuraminic acid shall bear a statement that the food supplement should not be given to infants, young children and children under 10 years of age where they consume breast milk or other foods with added N-acetyl-D-neuraminic acid within the same twenty four hour period.

                        Infant and follow-on formulae as defined by Regulation (EU) No 609/2013 (1)

                        0,05 g/L of reconstituted formula

                        Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013

                        0,05 g/kg for solid foods

                        Foods for special medical purposes for infants and young children as defined by Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than the maximum levels specified for the category mentioned in the table corresponding to the products.

                        Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013

                        0,2 g/L (drinks)
                        1,7 g/kg (bars)

                        Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 (2)

                        1,25 g/kg

                        Unflavoured pasteurised and sterilised (including UHT) milk-based products

                        0,05 g/L

                        Unflavoured fermented milk-based products, heat treated after fermentation, flavoured fermented milk products including heat-treated products

                        0,05 g/L (beverages)
                        0,4 g/kg (solids)

                        Dairy analogues, including beverage whiteners

                        0,05 g/L (beverages)
                        0,25 g/kg (solids)

                        Cereal bars

                        0,5 g/kg

                        Table top sweeteners

                        8,3 g/kg

                        Fruit and vegetable-based drinks

                        0,05 g/L

                        Flavoured drinks

                        0,05 g/L

                        Speciality coffee, tea, herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions

                        0,2 g/kg

                        Food Supplements as defined in Directive 2002/46/EC (3)

                        300 mg/day for general population older than 10 years
                        55 mg/day for infants
                        130 mg/day for young children
                        250 mg/day for children between 3 to 10 years of age

                              Adansonia digitata (Baobab) dried fruit pulp

                        Not specified

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Baobab fruit pulp’

                              Ajuga reptans extract from cell cultures

                           Specified food category

                           Maximum levels

                        Food Supplements as defined in Directive 2002/46/EC

                        In line with normal use in food supplements of a similar extract of the flowering aerial parts of Ajuga reptans

                           L-Alanyl-L-Glutamine

                           Specified food category

                           Maximum levels

                        Food Supplements as defined in Directive 2002/46/EC

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013 excluding foods for infants and young children

                        Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

                           Algal oil from the microalgae Ulkenia sp.

                           Specified food category

                           Maximum levels of DHA

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the micro-algae Ulkenia sp.’

                        Bakery products (breads, rolls and sweet biscuits)

                        200 mg/100 g

                        Cereal bars

                        500 mg/100 g

                        Non-alcoholic beverages (including milk based beverages)

                        60 mg/100 ml

                              Allanblackia seed oil

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Allanblackia seed oil’

                        Yellow fat spreads and cream based spreads

                        20 g/100 g

                              Aloe macroclada Baker leaf extract

                           Specified food category

                           Maximum levels

                        Food Supplements as defined in Directive 2002/46/EC

                        In line with normal use in food supplements of the similar gel derived from Aloe vera (L.) Burm.

                           Antarctic Krill oil from Euphausia superba

                           Specified food category

                           Maximum levels of combined DHA and EPA

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lipid extract from the crustacean Antarctic Krill (Euphausia superba)’

                        Dairy products except milk-based drinks

                        200 mg/100 g or for cheese products 600 mg/100 g

                        Dairy analogues except drinks

                        200 mg/100 g or for analogues to cheese products 600 mg/100 g

                        Non-alcoholic beverages
                        Milk-based drinks
                        Dairy analogue drinks

                        80 mg/100 ml

                        Spreadable fat and dressings

                        600 mg/100 g

                        Cooking fats

                        360 mg/100 ml

                        Breakfast cereals

                        500 mg/100 g

                        Bakery products (breads, rolls and sweet biscuits)

                        200 mg/100 g

                        Nutrition bars/cereal bars

                        500 mg/100 g

                        Food Supplements as defined in Directive 2002/46/EC

                        3 000  mg/day for the general population
                        450 mg/day for pregnant and lactating women

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the persons for whom the products are intended

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

                        250 mg/meal

                        Processed cereal-based food and baby food intended for infants and young children covered by Regulation (EU) No 609/2013

                        200 mg/100 ml

                        Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

                        Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

                           Antarctic Krill oil rich in phospholipids from Euphausia superba

                           Specified food category

                           Maximum levels of combined DHA and EPA

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lipid extract from the crustacean Antarctic Krill (Euphausia superba)’

                        Dairy products except milk-based drinks

                        200 mg/100 g or for cheese products 600 mg/100 g

                        Dairy analogues except drinks

                        200 mg/100 g or for analogues to cheese products 600 mg/100 g

                        Non-alcoholic beverages
                        Milk-based drinks
                        Dairy analogue drinks

                        80 mg/100 ml

                        Spreadable fat and dressings

                        600 mg/100 g

                        Cooking fats

                        360 mg/100 ml

                        Breakfast cereals

                        500 mg/100 g

                        Bakery products (breads, rolls and sweet biscuits)

                        200 mg/100 g

                        Nutrition bars/cereal bars

                        500 mg/100 g

                        Food Supplements as defined in Directive 2002/46/EC

                        3 000  mg/day for the general population
                        450 mg/day for pregnant and lactating women

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the persons for whom the products are intended

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

                        250 mg/meal

                        Processed cereal-based food and baby food intended for infants and young children covered by Regulation (EU) No 609/2013

                        200 mg/100 ml

                        Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

                        Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

                           Arachidonic acid-rich oil from the fungus Mortierella alpina

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from Mortierella alpina’ or ‘Mortierella alpina oil’

                        Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

                        In accordance with Regulation (EU) No 609/2013

                        Foods for special medical purposes for premature infants as defined in Regulation (EU) No 609/2013

                        In accordance with Regulation (EU) No 609/2013

                           Argan oil from Argania spinosa

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Argan oil’ and if used as seasoning ‘Vegetable oil only for seasoning’ shall be mentioned on the label

                        As seasonings

                        Not specified

                        Food Supplements as defined in Directive 2002/46/EC

                        In line with normal food use of vegetable oils

                           Astaxanthin-rich oleoresin from Haematococcus pluvialis algae

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Astaxanthin’

                        Food Supplements as defined in Directive 2002/46/EC

                        40-80 mg/day of oleoresin, resulting in ≤ 8 mg astaxanthin per day

                           Basil seeds (Ocimum basilicum)

                           Specified food category

                           Maximum levels

                        Fruit juice and fruit/vegetable blend beverages

                        3 g/200 ml for addition of whole basil seeds (Ocimum basilicum)

                           Fermented black bean extract

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fermented black bean (Soya) extract’’ or ‘Fermented Soya extract’

                        Food Supplements as defined in Directive 2002/46/EC

                        4,5 g/day

                           Bovine lactoferrin

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’

                        Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 (ready to drink)

                        100 mg/100 ml

                        Foods on dairy basis intended for young children (ready to eat/drink)

                        200 mg/100 g

                        Processed cereal food (solid)

                        670 mg/100 g

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        Depending on the needs of the individual up to 3 g/day

                        Beverages based on milk

                        200 mg/100 g

                        Powdered drink mixes based on milk (ready to drink)

                        330 mg/100 g

                        Beverages based on fermented milk (including yoghurt drinks)

                        50 mg/100 g

                        Non-alcoholic drinks

                        120 mg/100 g

                        Products based on yoghurt

                        80 mg/100 g

                        Products based on cheese

                        2 000  mg/100 g

                        Ice cream

                        130 mg/100 g

                        Cakes and pastries

                        1 000  mg/100 g

                        Candies

                        750 mg/100 g

                        Chewing gum

                        3 000  mg/100 g

                              Buglossoides arvensis seed oil

                           Specified food category

                           Maximum levels of stearidonic acid (STA)

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined Buglossoides oil’

                        Dairy products and analogues

                        250 mg/100 g

                        75 mg/100 g for drinks

                        Cheese and cheese products

                        750 mg/100 g

                        Butter and other fat and oil emulsions including spreads (not for cooking or frying purposes)

                        750 mg/100 g

                        Breakfast cereals

                        625 mg/100 g

                        Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

                        500 mg/day

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013, excluding foods for special medical purposes intended for infants and young children

                        In accordance with the particular nutritional requirements of the persons for whom the products are intended

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

                        250 mg/meal

                              Calanus finmarchicus oil

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘oil from Calanus finmarchicus (crustacean)’

                        Food supplements as defined in Directive 2002/46/EC

                        2,3 g/day

                           Chewing gum base (monomethoxypolyethylene glycol)

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Gum base (including 1,3-butadiene, 2-methyl-homopolymer, maleated, esters with polyethylene glycol mono-Me ether)’ or ‘Gum base (including CAS No: 1246080-53-4)’

                        Chewing gum

                        8  %

                           Chewing gum base (Methyl vinyl ether-maleic anhydride copolymer)

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Gum base (including methyl vinyl ether-maleic anhydride copolymer)’ or ‘Gum base (including CAS No 9011-16-9)’

                        Chewing gum

                        2  %

                           Chia oil from Salvia hispanica

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chia oil (Salvia hispanica)’

                        Fats and oils

                        10  %

                        Pure chia oil

                        2 g/day

                        Food Supplements as defined in Directive 2002/46/EC

                        2 g/day

                           Chia seeds (Salvia hispanica)

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chia seeds (Salvia hispanica)’

                                    2.

                                    Pre-packaged Chia (Salvia hispanica) seeds shall carry additional labelling to inform the consumer that the daily intake is no more than 15 g.

                        Bread products

                        5 % (whole or ground chia seeds)

                        Baked products

                        10 % whole chia seeds

                        Breakfast cereals

                        10 % whole chia seeds

                        Fruit, nut and seed mixes

                        10 % whole chia seeds

                        Fruit juice and fruit/vegetable blend beverages

                        15 g/day for addition of whole, mashed or ground chia seeds

                        Pre-packaged Chia seed as such

                        15 g/day whole chia seeds

                        Fruit spreads

                        1 % whole chia seeds

                        Yoghurt

                        1,3 g whole chia seeds per 100 g of yoghurt or 4,3 g whole chia seeds per 330 g of yoghurt (portion)

                        Sterilised ready to eat meals based on cereal grains, pseudocereals grains and/or pulses

                        5 % whole chia seeds

                           Chitin-glucan from Aspergillus niger

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chitin-glucan from Aspergillus niger’

                        Food Supplements as defined in Directive 2002/46/EC

                        5 g/day

                           Chitin-glucan complex from Fomes fomentarius

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chitin-glucan from Fomes fomentarius’

                        Food Supplements as defined in Directive 2002/46/EC

                        5 g/day

                           Chitosan extract from fungi (Agaricus bisporus; Aspergillus niger)

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chitosan extract from Agaricus bisporus’ or ‘Chitosan extract from Aspergillus niger’

                        Food Supplements as defined in Directive 2002/46/EC

                        In line with normal use in food supplements of chitosan from crustaceans

                           Chondroitin sulphate

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chondroitin sulphate derived from microbial fermentation and sulphation’

                        Food supplements as defined in Directive 2002/46/EC for adult population, excluding pregnant and lactating women

                        1 200  mg/day

                           Chromium Picolinate

                           Specified food category

                           Maximum levels of total chromium

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chromium Picolinate’

                        Foods covered by Regulation (EU) No 609/2013

                        250 μg/day

                        Foods fortified in accordance with Regulation (EC) No 1925/2006 (4)

                              Cistus incanus L. Pandalis herb

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Cistus incanus L. Pandalis herb’

                        Herbal infusions

                        Intended daily intake: 3 g herbs/day (2 cups/day)

                           Citicoline

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Citicoline’

                                    2.

                                    The labelling of foods containing citicoline shall bear a statement that the product is not intended to be consumed by children

                        Food Supplements as defined in Directive 2002/46/EC

                        500 mg/day

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        250 mg per serving and a maximum daily consumption level of 1 000  mg

                              Clostridium butyricum

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Clostridium butyricum MIYAIRI 588 (CBM 588)’ or ‘Clostridium butyricum (CBM 588)’

                        Food Supplements as defined in Directive 2002/46/EC

                        1,35 × 108 CFU/day

                           Extract of defatted cocoa powder

                           Specified food category

                           Maximum levels

                        Consumers shall be instructed not to consume more than 600 mg polyphenols corresponding to 1,1 g of extract of defatted cocoa powder per day

                        Nutrition bars

                        1 g/day and 300 mg polyphenols corresponding to not more than 550 mg of extract of defatted cocoa powder in one portion of food (or food supplement)

                        Milk based beverages

                        Any other foods (including food supplements as defined in Directive 2002/46/EC) which have become established vehicles for functional ingredients and which are typically positioned for consumption by health conscious adults

                           Low fat cocoa extract

                           Specified food category

                           Maximum levels

                        Consumers shall be instructed not to consume more than 600 mg of cocoa flavanols per day

                        Foods including food supplements as defined in Directive 2002/46/EC

                        730 mg per serving and around 1,2 g/day

                           Coriander seed oil from Coriandrum sativum

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Coriander seed oil’

                        Food Supplements as defined in Directive 2002/46/EC

                        600 mg/day

                              Crataegus pinnatifida dried fruit

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Crataegus pinnatifida dried fruit’

                        Herbal infusions

                        In line with normal food use of Crataegus laevigata

                        Jams and jellies in accordance with Directive 2001/113/EC (5)

                        Compotes

                           α-cyclodextrin

                        Not specified

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Alpha-cyclodextrin’ or ‘α-cyclodextrin’

                           γ-cyclodextrin

                        Not specified

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Gamma-Cyclodextrin’ or ‘γ-Cyclodextrin’

                           Dextran preparation produced by Leuconostoc mesenteroides

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Dextran’

                        Bakery products

                        5  %

                           Diacylglycerol oil of plant origin

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Diacylglycerol oil of plant origin (at least 80 % diacylglycerols)’

                        Cooking oils

                        Fat spreads

                        Salad dressings

                        Mayonnaise

                        Meal replacement for weight control (as drinks)

                        Bakery products

                        Yoghurt type products

                           Dihydrocapsiate (DHC)

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Dihydrocapsiate’

                                    2.

                                    Food supplements containing synthetic dihydrocapsiate will be labelled as ‘not intended for children up to 4.5 years’

                        Cereal bars

                        9 mg/100 g

                        Biscuits, cookies and crackers

                        9 mg/100 g

                        Rice based snacks

                        12 mg/100 g

                        Carbonated drinks, dilutable drinks, fruit juice based beverages

                        1,5 mg/100 ml

                        Vegetable drinks

                        2 mg/100 ml

                        Coffee based drinks, tea based drinks

                        1,5 mg/100 ml

                        Flavoured water — still

                        1 mg/100 ml

                        Precooked oatmeal cereal

                        2,5 mg/100 g

                        Other cereals

                        4,5 mg/100 g

                        Ice cream, dairy desserts

                        4 mg/100 g

                        Pudding mixes (ready to eat)

                        2 mg/100 g

                        Products based on yoghurt

                        2 mg/100 g

                        Chocolate confectionery

                        7,5 mg/100 g

                        Hard candy

                        27 mg/100 g

                        Sugar-free gum

                        115 mg/100 g

                        Whitener/creamer

                        40 mg/100 g

                        Sweeteners

                        200 mg/100 g

                        Soup (ready to eat)

                        1,1 mg/100 g

                        Salad dressing

                        16 mg/100 g

                        Vegetable protein

                        5 mg/100 g

                        Ready to eat meals

                        3 mg/meal

                        Meal replacements for weight control

                        3 mg/meal

                        Meal replacement for weight control (as drinks)

                        1 mg/100 ml

                        Food Supplements as defined in Directive 2002/46/EC

                        3 mg/single intake
                        9 mg/day

                        Non-alcoholic powdered drink mixes

                        14,5 mg/kg equivalent to 1,5 mg/100 ml

                           Dried extract of Lippia citriodora from cell cultures

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried extract of Lippia citriodora from cell cultures HTN®Vb’

                        Food Supplements as defined in Directive 2002/46/EC

                        In line with normal use in food supplements of a similar extract from the leaves of Lippia citriodora

                              Echinacea angustifolia extract from cell cultures

                           Specified food category

                           Maximum levels

                        Food Supplements as defined in Directive 2002/46/EC

                        In line with normal use in food supplements of a similar extract from the root of Echinacea angustifolia

                              Echinacea purpurea extract from cell cultures

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried extract of Echinacea purpurea from cell cultures HTN®Vb’

                        Food Supplements as defined in Directive 2002/46/EC

                        In line with normal use in food supplements of a similar extract from florets within the flower head of Echinacea purpurea

                              Echium plantagineum oil

                           Specified food category

                           Maximum levels of stearidonic acid (STA)

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined echium oil’

                        Milk-based products and drinkable yoghurt products delivered in a single dose

                        250 mg/100 g; 75 mg/100 g for drinks

                        Cheese preparations

                        750 mg/100 g

                        Spreadable fat and dressings

                        750 mg/100 g

                        Breakfast cereals

                        625 mg/100 g

                        Food supplements as defined in Directive 2002/46/EC

                        500 mg/day

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the persons for whom the products are intended

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

                        250 mg/meal

                           Epigallocatechin gallate as a purified extract from green tea leaves (Camellia sinensis)

                           Specified food category

                           Maximum levels

                        The labelling shall bear a statement that consumers should not consume more than 300 mg of extract per day

                        Foods including food supplements as defined in Directive 2002/46/EC

                        150 mg of extract in one portion of food or food supplement

                           L-ergothioneine

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘L-ergothioneine’

                        Food supplements as defined in Directive 2002/46/EC

                        30 mg/day for general population (excluding pregnant and lactating women)
                        20 mg/day for children older than 3 years

                           Ferric Sodium EDTA

                           Specified food category

                           Maximum levels (expressed as anhydrous EDTA)

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ferric Sodium EDTA’

                        Food supplements as defined in Directive 2002/46/EC

                        18 mg/day for children
                        75 mg/day for adults

                        Foods covered by Regulation (EU) No 609/2013

                        12 mg/100 g

                        Foods fortified in accordance with Regulation (EC) No 1925/2006

                           Ferrous ammonium phosphate

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ferrous ammonium phosphate’

                        Food supplements as defined in Directive 2002/46/EC

                        To be used in compliance with Directive 2002/46/EC, Regulation (EU) No 609/2013 and/or Regulation (EC) No 1925/2006

                        Foods covered by Regulation (EU) No 609/2013

                        Foods fortified in accordance with Regulation (EC) No 1925/2006

                           Fish peptides from Sardinops sagax

                           Specified food category

                           Maximum levels fish peptide product

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish (Sardinops sagax) peptides’

                        Foods based on yoghurt, yoghurt drinks, fermented milk products, and powdered milk

                        0,48 g/100 g (ready to eat/drink)

                        Flavoured water, and vegetable-based drinks

                        0,3 g/100 g (ready to drink)

                        Breakfast cereals

                        2 g/100 g

                        Soups, stews and soup powders

                        0,3 g/100 g (ready to eat)

                           Flavonoids from Glycyrrhiza glabra

                           Specified food category

                           Maximum levels of flavonoids from Glycyrrhiza glabra

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Flavonoids from Glycyrrhiza glabra L.’

                                    2.

                                    The labelling of the foods where the product was added as a novel food ingredient shall bear a statement that:

                                                (a)

                                                the product should not be consumed by pregnant and breast feeding women, children and young adolescents; and

                                                (b)

                                                people taking prescription drugs should only consume the product under medical supervision;

                                                (c)

                                                a maximum of 120 mg of flavonoids per day should be consumed.

                                    3.

                                    The amount of flavonoids in the final food shall be indicated on the labelling of the food containing it.

                        Beverages containing flavonoids shall be presented to the final consumer as single portions.

                        Beverages based on milk

                        120 mg/day

                        Beverages based on yoghurt

                        Beverages based on fruit or vegetables

                        Food Supplements as defined in Directive 2002/46/EC

                        120 mg/day

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

                        120 mg/day

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        120 mg/day

                           Fucoidan extract from the seaweed Fucus vesiculosus

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fucoidan extract from seaweed Fucus vesiculosus’.

                        Foods including food supplements as defined in Directive 2002/46/EC for the general population

                        250 mg/day

                           Fucoidan extract from the seaweed Undaria pinnatifida

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fucoidan extract from seaweed Undaria pinnatifida’

                        Foods including food supplements as defined in Directive 2002/46/EC for the general population

                        250 mg/day

                           2′-Fucosyllactose

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘2′-fucosyllactose’.

                                    2.

                                    The labelling of food supplements containing 2′-fucosyllactose shall bear a statement that the supplements should not be used if other foods with added 2′-fucosyllactose are consumed the same day.

                                    3.

                                    The labelling of food supplements containing 2′-fucosyllactose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added 2′-fucosyllactose are consumed the same day.

                        Unflavoured pasteurised and sterilised (including UHT) milk-based products

                        1,2 g/l

                        Unflavoured fermented milk-based products

                        1,2 g/l beverages

                        19,2 g/kg products other than beverages

                        Flavoured fermented milk-based products including heat-treated products

                        1,2 g/l beverages

                        19,2 g/kg products other than beverages

                        Dairy analogues, including beverage whiteners

                        1,2 g/l beverages

                        12 g/kg for products other than beverages

                        400 g/kg for whitener

                        Cereal bars

                        12 g/kg

                        Table-top sweeteners

                        200 g/kg

                        Infant formula as defined in Regulation (EU) No 609/2013

                        1,2 g/l alone or in combination with up to 0,6 g/l of lacto-N-neotetraose at a ratio of 2:1 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

                        Follow-on formula as defined in Regulation (EU) No 609/2013

                        1,2 g/l alone or in combination with up to 0,6 g/l of lacto-N-neotetraose at a ratio of 2:1 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

                        Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013

                        12 g/kg for products other than beverages

                        1,2 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer

                        Milk-based drinks and similar products intended for young children

                        1,2 g/l for milk-based drinks and similar products added alone or in combination with up to 0,6 g/l lacto-N-neotetraose, at a ratio of 2:1 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the persons for whom the products are intended

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

                        4,8 g/l for drinks

                        40 g/kg for bars

                        Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

                        60 g/kg

                        Flavoured drinks

                        1,2 g/l

                        Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products

                        9,6 g/l — the maximum level refers to the products ready to use

                        Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants

                        3,0 g/day for general population

                        1,2 g/day for young children

                           Galacto-oligosaccharide

                           Specified food category

                           Maximum levels (expressed as ratio kg galacto-oligosaccharide/kg final food)

                        Food Supplements as defined in Directive 2002/46/EC

                        0,333

                        Milk

                        0,020

                        Milk drinks

                        0,030

                        Meal replacement for weight control (as drinks)

                        0,020

                        Dairy analogue drinks

                        0,020

                        Yoghurt

                        0,033

                        Dairy based deserts

                        0,043

                        Frozen dairy deserts

                        0,043

                        Fruit drinks and energy drinks

                        0,021

                        Infant meal replacement drinks

                        0,012

                        Baby juice

                        0,025

                        Baby yogurt drink

                        0,024

                        Baby desert

                        0,027

                        Baby snack

                        0,143

                        Baby cereals

                        0,027

                        Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

                        0,013

                        Juice

                        0,021

                        Fruit pie fillings

                        0,059

                        Fruit preparations

                        0,125

                        Bars

                        0,125

                        Cereals

                        0,125

                        Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

                        0,008

                           Glucosamine HCl

                           Specified food category

                           Maximum levels

                        Food Supplements as defined in Directive 2002/46/EC

                        In line with normal food use of glucosamine from shell fish

                        Foods covered by Regulation (EU) No 609/2013

                        Meal replacement for weight control

                        Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

                        Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

                           Glucosamine sulphate KCl

                           Specified food category

                           Maximum levels

                        Food Supplements as defined in Directive 2002/46/EC

                        In line with normal food use of glucosamine from shell fish

                           Glucosamine sulphate NaCl

                           Specified food category

                           Maximum levels

                        Food Supplements as defined in Directive 2002/46/EC

                        In line with normal food use of glucosamine from shell fish

                           Guar Gum

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Guar Gum’.

                                    2.

                                    A specific mention of the possible risks of digestive discomfort linked to the exposure of children aged under 8 to guar gum must be visible on the label of any foodstuffs containing it.
                                    For example, ‘Excessive consumption of these products may cause digestive discomfort, especially for children under 8 years of age’.

                                    3.

                                    In the case of products with two compartments containing dairy and cereal products respectively, the instructions for use must clearly specify the need to mix the cereal and the dairy product before consumption, in order to take into account the potential risk of gastro-intestinal obstruction.

                        Fresh dairy products such as yogurts, fermented milks, fresh cheeses and other dairy-based desserts.

                        1,5 g/100 g

                        Fruit or vegetable-based liquid foodstuffs (of the ‘smoothie’ variety)

                        1,8 g/100 g

                        Fruit or vegetable-based compotes

                        3,25 g/100 g

                        Cereals accompanied by a dairy product, in packaging containing two compartments

                        10 g/100 g in the cereals
                        None in the accompanying dairy product
                        1 g/100 g in the product when ready to eat

                           Heat-treated milk products fermented with Bacteroides xylanisolvens

                           Specified food category

                           Maximum levels

                        Fermented milk products (in liquid, semi-liquid and spray-dried powder forms)

                           Hydroxytyrosol

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the food products containing it shall be ‘hydroxytyrosol’.
                        The labelling of the food products containing hydroxytyrosol shall bear the following statements:

                                    (a)

                                    This food product should not be consumed by children under the age of three years, pregnant women, and lactating women;

                                    (b)

                                    This food product should not be used for cooking, baking or frying’

                        Fish and vegetable oils, (except olive oils and olive pomace oils as defined in Part VIII of Annex VII of Regulation (EU) No 1308/2013 (6)), placed as such on the market

                        0,215 g/kg

                        Spreadable fats as defined in Part VII of Annex VII of Regulation (EU) No 1308/2013, placed as such on the market

                        0,175 g/kg

                           Ice Structuring Protein type III HPLC 12

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ice Structuring Protein’

                        Edible ices

                        0,01  %

                           Aqueous extracts of dried leaves of Ilex guayusa

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Extracts of dried leaves of Ilex guayusa’

                        Herbal infusions

                        In line with normal use in herbal infusions and food supplements of a similar aqueous extract of dried leaves of Ilex paraguariensis

                        Food Supplements as defined in Directive 2002/46/EC

                           Isomalto-oligosaccharide

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Isomaltooligosaccharide’.

                                    2.

                                    Foods containing the novel ingredient must be labelled as ‘a source of glucose’.

                        Energy-Reduced Soft Drinks

                        6,5  %

                        Energy Drinks

                        5,0  %

                        Foods intended to meet the expenditure of intense muscular efforts, especially for sportsmen (including isotonic drinks)

                        6,5  %

                        Fruit Juices

                        5  %

                        Processed Vegetables and Vegetable Juices

                        5  %

                        Other Soft Drinks

                        5  %

                        Cereals Bars

                        10  %

                        Cookies, Biscuits

                        20  %

                        Breakfast Cereal Bars

                        25  %

                        Hard Candies

                        97  %

                        Soft Candies/Chocolate Bars

                        25  %

                        Meal replacement for weight control (as bars or milk based)

                        20  %

                           Isomaltulose

                        Not specified

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Isomaltulose’.

                                    2.

                                    The designation of the novel food on the labelling shall be accompanied by indication that the ‘Isomaltulose is a source of glucose and fructose’.

                           Lactitol

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the food supplements containing it shall be ‘Lactitol’

                        Food Supplements as defined in Directive 2002/46/EC (capsules or tablets) intended for the adult population

                        20 g/day

                           Lacto-N-neotetraose

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘lacto-N-neotetraose’.

                                    2.

                                    The labelling of food supplements containing lacto-N-neotetraose shall bear a statement that the supplements should not be used if other foods with added lacto-N-neotetraose are consumed the same day.

                                    3.

                                    The labelling of food supplements containing lacto-N-neotetraose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added lacto-N-neotetraose are consumed the same day.

                        Unflavoured pasteurised and sterilised (including UHT) milk-based products

                        0,6 g/l

                        Unflavoured fermented milk-based products

                        0,6 g/l for beverages
                        9,6 g/kg for products other than beverages

                        Flavoured fermented milk-based products including heat-treated products

                        0,6 g/l for beverages
                        9,6 g/kg for products other than beverages

                        Dairy analogues, including beverage whiteners

                        0,6 g/l for beverages
                        6 g/kg for products other than beverages
                        200 g/kg for whitener

                        Cereal bars

                        6 g/kg

                        Table-top sweeteners

                        100 g/kg

                        Infant formula as defined in Regulation (EU) No 609/2013

                        0,6 g/l in combination with up to 1,2 g/l of 2′-fucosyllactose at a ratio of 1:2 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

                        Follow-on formula as defined in Regulation (EU) No 609/2013

                        0,6 g/l in combination with up to 1,2 g/l of 2′-fucosyllactose at a ratio of 1:2 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

                        Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013

                        6 g/kg for products other than beverages
                        0,6 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer

                        Milk-based drinks and similar products intended for young children

                        0,6 g/l for milk-based drinks and similar products added alone or in combination with 2′-fucosyllactose, at a ratio of 1:2 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the persons for whom the products are intended

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

                        2,4 g/l for drinks
                        20 g/kg for bars

                        Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

                        30 g/kg

                        Flavoured drinks

                        0,6 g/l

                        Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products

                        4,8 g/l — the maximum level refers to the products ready to use

                        Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants

                        1,5 g/day for general population
                        0,6 g/day for young children

                           Lucerne leaf extract from Medicago sativa

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lucerne (Medicago sativa) protein’ or ‘Alfalfa (Medicago sativa) protein’.

                        Food supplements as defined in Directive 2002/46/EC

                        10 g/day

                           Lycopene

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’

                        Fruit/vegetable juice-based drinks (including concentrates)

                        2,5 mg/100 g

                        Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

                        2,5 mg/100 g

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

                        8 mg/meal

                        Breakfast cereals

                        5 mg/100 g

                        Fats and dressings

                        10 mg/100 g

                        Soups other than tomato soups

                        1 mg/100 g

                        Bread (including crispy breads)

                        3 mg/100 g

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the persons for whom the products are intended

                        Food supplements as defined in Directive 2002/46/EC

                        15 mg/day

                           Lycopene from Blakeslea trispora

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’

                        Fruit/vegetable juice-based drinks (including concentrates)

                        2,5 mg/100 g

                        Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

                        2,5 mg/100 g

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

                        8 mg/meal

                        Breakfast cereals

                        5 mg/100 g

                        Fats and dressings

                        10 mg/100 g

                        Soups other than tomato soups

                        1 mg/100 g

                        Bread (including crispy breads)

                        3 mg/100 g

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the persons for whom the products are intended

                        Food supplements as defined in Directive 2002/46/EC

                        15 mg/day

                           Lycopene from tomatoes

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’

                        Fruit/vegetable juice-based drinks (including concentrates)

                        2,5 mg/100 g

                        Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

                        2,5 mg/100 g

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

                        8 mg/meal

                        Breakfast cereals

                        5 mg/100 g

                        Fats and dressings

                        10 mg/100 g

                        Soups other than tomato soups

                        1 mg/100 g

                        Bread (including crispy breads)

                        3 mg/100 g

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the persons for whom the products are intended

                        Food supplements as defined in Directive 2002/46/EC

                        15 mg/day

                           Lycopene oleoresin from tomatoes

                           Specified food category

                           Maximum levels of lycopene

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene oleoresin from tomatoes’

                        Fruit/vegetable juice-based drinks (including concentrates)

                        2,5 mg/100 g

                        Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

                        2,5 mg/100 g

                        Total diet replacement for weight control covered by Regulation (EU) No 609/2013 and meal replacements for weight control

                        8 mg/meal

                        Breakfast cereals

                        5 mg/100 g

                        Fats and dressings

                        10 mg/100 g

                        Soups other than tomato soups

                        1 mg/100 g

                        Bread (including crispy breads)

                        3 mg/100 g

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the persons for whom the products are intended

                           Magnesium citrate malate

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Magnesium citrate malate’

                        Food Supplements as defined in Directive 2002/46/EC

                           Magnolia Bark Extract

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Magnolia Bark Extract’

                        Mints (confectionary products)

                        0,2 % for breath freshening purposes. Based on a 0,2 % maximum incorporation level and a maximum gum/mint size of 1,5 g each, each gum or mint serving will contain no more than 3 mg of magnolia bark extract.

                        Chewing gum

                           Maize-germ oil high in unsaponifiable matter

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Maize-germ oil extract’

                        Food Supplements as defined in Directive 2002/46/EC

                        2 g/day

                        Chewing gum

                        2  %

                           Methylcellulose

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Methylcellulose’

                        Methylcellulose is not to be used in foods specially prepared for young children

                        Edible ices

                        2  %

                        Flavoured drinks

                        Flavoured or unflavoured fermented milk products

                        Cold desserts (dairy, fat, fruit, cereal, egg-based products)

                        Fruit preparations (pulps, purees or compotes)

                        Soups and broths

                           (6S)-5-methyltetrahydrofolic acid, glucosamine salt

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘(6S)-5-methyltetrahydrofolic acid, glucosamine salt’ or ‘5MTHF-glucosamine’

                        Food Supplements as defined in Directive 2002/46/EC as a source of folate

                           Monomethylsilanetriol (Organic Silicon)

                           Specified food category

                           Maximum levels of silicon

                        The designation of the novel food on the labelling of the food supplements containing it shall be ‘Organic silicon (monomethylsilanetriol)’

                        Food Supplements as defined in Directive 2002/46/EC for adult population (in liquid form)

                        10,40 mg/day

                           Mycelial extract from Shiitake mushroom (Lentinula edodes)

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘extract from the mushroom Lentinula edodes’ or ‘extract from Shiitake mushroom’

                        Bread products

                        2 ml/100 g

                        Soft drinks

                        0,5 ml/100 ml

                        Ready prepared meals

                        2,5 ml per meal

                        Foods based on yoghurt

                        1,5 ml/100 ml

                        Food supplements as defined in Directive 2002/46/EC

                        2,5 ml per day dose

                           Noni fruit juice (Morinda citrifolia)

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Noni juice’ or ‘Juice of Morinda citrifolia’

                        Pasteurised fruit and fruit nectar based drinks

                        30 ml with one serving (up to 100 % noni juice)
                        or
                        20 ml twice a day, not more than 40 ml per day

                           Noni fruit juice powder (Morinda citrifolia)

                        Food supplements as defined in Directive 2002/46/EC

                        6,6 g/day (equivalent to 30 ml of noni juice)

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Noni juice powder’ or ‘Juice powder of Morinda citrifolia’

                           Noni fruit puree and concentrate (Morinda citrifolia)

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be:
                        For fruit puree:
                        ‘Morinda citrifolia fruit puree’ or ‘Noni fruit puree’
                        For fruit concentrate:
                        ‘Morinda citrifolia fruit concentrate’ or ‘Noni fruit concentrate’

                        Fruit puree

                        Candy/confectionery

                        45 g/100 g

                        Cereal bars

                        53 g/100 g

                        Powdered nutritional drink mixes (dry weight)

                        53 g/100 g

                        Carbonated beverages

                        11 g/100 g

                        Ice cream & sorbet

                        31 g/100 g

                        Yoghurt

                        12 g/100 g

                        Biscuits

                        53 g/100 g

                        Buns, cakes and pastries

                        53 g/100 g

                        Breakfast cereals (wholegrain)

                        88 g/100 g

                        Jams and jellies in accordance with Directive 2001/113/EC

                        133 g/100 g
                        Based on pre-processing quantity to produce final 100 g product

                        Sweet spreads, fillings and icings

                        31 g/100 g

                        Savoury sauces, pickles, gravies and condiments

                        88 g/100 g

                        Food Supplements as defined in Directive 2002/46/EC

                        26 g/day

                        Fruit concentrate

                        Candy/Confectionery

                        10 g/100 g

                        Cereal bars

                        12 g/100 g

                        Powdered nutritional drink mixes (dry weight)

                        12 g/100 g

                        Carbonated beverages

                        3 g/100 g

                        Ice cream & sorbet

                        7 g/100 g

                        Yoghurt

                        3 g/100 g

                        Biscuits

                        12 g/100 g

                        Buns, cakes and pastries

                        12 g/100 g

                        Breakfast cereals (wholegrain)

                        20 g/100 g

                        Jams and jellies in accordance with Directive 2001/113/EC

                        30 g/100 g

                        Sweet spreads, fillings and icings

                        7 g/100 g

                        Savoury sauces, pickles, gravies and condiments

                        20 g/100 g

                        Food Supplements as defined in Directive 2002/46/EC

                        6 g/day

                           Noni leaves (Morinda citrifolia)

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Noni leaves’ or ‘leaves of Morinda citrifolia’.

                                    2.

                                    Instructions shall be given to the consumer that a cup of infusion should not be prepared with more than 1 g of dried and roasted leaves of Morinda citrifolia.

                        For the preparation of infusions

                        A cup of infusion to be consumed shall not be prepared with more than 1 g of dried and roasted leaves of Morinda citrifolia

                           Noni fruit powder (Morinda citrifolia)

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Morinda citrifolia fruit powder’ or ‘Noni fruit powder’

                        Food Supplements as defined in Directive 2002/46/EC

                        2,4 g per/day

                              Odontella aurita microalgae

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Odontella aurita microalgae’

                        Flavoured pasta

                        1,5  %

                        Fish soups

                        1  %

                        Marine terrines

                        0,5  %

                        Broth preparations

                        1  %

                        Crackers

                        1,5  %

                        Frozen breaded fish

                        1,5  %

                           Oil enriched with phytosterols/phytostanols

                           Specified food category

                           Maximum levels of phytosterols/ phytostanols

                        In accordance with Annex III.5 to Regulation (EU) No 1169/2011

                        Spreadable fats as defined in Annex VII, Part VII and Appendix II, points B and C of Regulation (EU) No 1308/2013, and excluding cooking and frying fats and spreads based on butter or other animal fat

                                    1.

                                    The products containing the novel food ingredient shall be presented in such a manner that they can be easily divided into portions that contain either a maximum of 3 g (in case of one portion per day) or a maximum of 1 g (in case of three portions per day) of added phytosterols/phytostanols.

                                    2.

                                    The amount of phytosterols/phytostanols added to a container of beverages shall not exceed 3 g.

                                    3.

                                    Salad dressings, mayonnaise and spicy sauces shall be packed as single portions.

                        Milk based products, such as products based on semi-skimmed and skimmed milk products, possibly with the addition of fruits and/or cereals, products based on fermented milk such as yoghurt and cheese based products (fat content ≤ 12 g per 100 g), where possibly the milk fat has been reduced and the fat or protein has been partly or fully replaced by vegetable fat or protein

                        Soya drinks

                        Salad dressings, mayonnaise and spicy sauces

                           Oil extracted from squids

                           Specified food category

                           Maximum levels of DHA and EPA combined

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’.

                        Dairy products except milk-based beverages

                        200 mg/100 g or for cheese products 600 mg/100 g

                        Dairy analogues except drinks

                        200 mg/100 g or for analogues to cheese products 600 mg/100 g

                        Spreadable fat and dressings

                        600 mg/100 g

                        Breakfast cereals

                        500 mg/100 g

                        Bakery products (breads and bread rolls)

                        200 mg/100 g

                        Cereal bars

                        500 mg/100 g

                        Non-alcoholic beverages (including milk-based beverages)

                        60 mg/100 ml

                        Food Supplements as defined in Directive 2002/46/EC

                        3 000  mg/day for general population
                        450 mg/day for pregnant and lactating women

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the persons for whom the products intended

                        Total diet replacement for weight control defined in Regulation (EU) No 609/2013 and meal replacements for weight control

                        200 mg/meal

                           Pasteurised fruit-based preparations produced using high-pressure treatment

                           Specified food category

                           Maximum levels

                        The wording ‘pasteurised by high-pressure treatment’ shall be displayed next to the name of the fruit preparations as such and in any product in which it is used

                        Types of fruit:
                        apple, apricot, banana, blackberry, blueberry, cherry, coconut, fig, grape, grapefruit, mandarin, mango, melon, peach, pear, pineapple, prune, raspberry, rhubarb, strawberry

                           Phosphated maize starch

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Phosphated maize starch’

                        Baked bakery products

                        15  %

                        Pasta

                        Breakfast cereals

                        Cereal bars

                           Phosphatidylserine from fish phospholipids

                           Specified food category

                           Maximum levels of phosphatidylserine

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish phosphatidylserine’

                        Beverages based on yoghurt

                        50 mg/100 ml

                        Powders based on milk powders

                        3 500  mg/100 g (equivalent to 40 mg/100 ml ready to drink)

                        Foods based on yoghurt

                        80 mg/100 g

                        Cereal bars

                        350 mg/100 g

                        Chocolate based confectionary

                        200 mg/100 g

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In compliance with Regulation (EU) No 609/2013

                        Food supplements as defined in Directive 2002/46/EC

                        300 mg/day

                           Phosphatidylserine from soya phospholipids

                           Specified food category

                           Maximum levels of phosphatidylserine

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Soya phosphatidylserine’

                        Beverages based on yoghurt

                        50 mg/100 ml

                        Powders based on milk powder

                        3,5 g/100 g (equivalent to 40 mg/100 ml ready to drink)

                        Foods based on yoghurt

                        80 mg/100 g

                        Cereal bars

                        350 mg/100 g

                        Chocolate based confectionary

                        200 mg/100 g

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In compliance with Regulation (EU) No 609/2013

                           Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid

                           Specified food category

                           Maximum levels of phosphatidylserine

                        The designation of the novel food on the labelling of the foodstuffs containing shall be ‘Soy phosphatidylserine and phosphatidic acid’

                        The product is not intended to be marketed to pregnant or breast-feeding women

                        Breakfast cereals

                        80 mg/100 g

                        Cereal bars

                        350 mg/100 g

                        Foods based on yogurt

                        80 mg/100 g

                        Soy-based yogurt-like products

                        80 mg/100 g

                        Yogurt based-drinks

                        50 mg/100 g

                        Soy-based yogurt-like drinks

                        50 mg/100 g

                        Powders based on milk powder

                        3,5 g/100 g (equivalent to 40 mg/100 ml ready-to drink)

                        Food Supplements as defined in Directive 2002/46/EC

                        800 mg/day

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In compliance with Regulation (EU) No 609/2013

                           Phospholipides from egg yolk

                           Specified food category

                           Maximum levels

                        Not specified

                           Phytoglycogen

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Phytoglycogen’

                        Processed foods

                        25  %

                           Phytosterols/phytostanols

                           Specified food category

                           Maximum levels

                        In accordance with Annex III.5 of Regulation (EU) No 1169/2011

                        Rice drinks

                                    1.

                                    They shall be presented in such a manner that they can be easily divided into portions that contain either a maximum of 3 g (in case of 1 portion/day) or a maximum of 1 g (in case of 3 portions/day) of added phytosterols/phytostanols.
                                    The amount of phytosterols/phytostanols added to a container of beverages shall not exceed 3 g.
                                    Salad dressings, mayonnaise and spicy sauces shall be packed as single portions

                        Rye bread with flour containing ≥ 50 % rye (wholemeal rye flour, whole or cracked rye kernels and rye flakes) and ≤ 30 % wheat; and with ≤ 4 % added sugar but no fat added.

                        Salad dressings, mayonnaise and spicy sauces.

                        Soya drink

                        Milk type products, such as semi-skimmed and skimmed milk type products, possibly with the addition of fruits and/or cereals, where possibly the milk fat has been reduced, or where milk fat and/or protein has been partly or fully replaced by vegetable fat and/or protein.

                        Products based on fermented milk such as yoghurt and cheese type products (fat content < 12 % per 100 g), where possibly the milk fat has been reduced, or where milk fat and/or protein has been partly or fully replaced by vegetable fat and/or protein

                        Spreadable fats as defined in Annex VII, Part VII and Appendix II, points B and C of Regulation (EU) No 1308/2013, and excluding cooking and frying fats and spreads based on butter or other animal fat.

                        Food Supplements as defined in Directive 2002/46/EC

                        3 g/day

                           Plum kernel oil

                           Specified food category

                           Maximum levels

                        For frying and as seasoning

                        In line with normal food use of vegetable oils

                           Potato proteins (coagulated) and hydrolysates thereof

                        Not specified

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Potato protein’

                           Prolyl oligopeptidase (enzyme preparation)

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Prolyl oligopeptidase’

                        Food Supplements as defined in Directive 2002/46/EC for general adult population

                        120 PPU/day (2,7 g of enzyme preparation/day) (2 × 106 PPI/day)
                        PPU – Prolyl Peptidase Units or Proline Protease Units
                        PPI – Protease Picomole International

                           Protein extract from pig kidneys

                           Specified food category

                           Maximum levels

                        Food Supplements as defined in Directive 2002/46/EC

                        3 capsules/day; equalizing 12,6 mg pig kidney extract a day
                        Diamine oxidase (DAO) content: 0,9 mg/day (3 capsules with a content of DAO of 0,3 mg/capsule)

                        Food for special medical purposes as defined in Regulation (EU) No 609/2013

                           Rapeseed oil high in unsaponifiable matter

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rapeseed oil extract’

                        Food Supplements as defined in Directive 2002/46/EC

                        1,5 g per portion recommended for daily consumption

                           Rapeseed Protein

                        As a vegetable protein source in foods except in infant formula and follow-on formula

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rapeseed protein’.

                                    2.

                                    Any foodstuff containing ‘rapeseed protein’ shall bear a statement that this ingredient may cause allergic reaction to consumers who are allergic to mustard and products thereof. Where relevant, this statement shall appear in close proximity to the list of ingredients.

                           Trans-resveratrol

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the food supplements containing it shall be ‘Trans-resveratrol’.

                                    2.

                                    The labelling of food supplements containing trans-resveratrol shall bear a statement that people using medicines should only consume the product under medical supervision.

                        Food Supplements as defined in Directive 2002/46/EC for adult population (capsule or tablet form)

                        150 mg/day

                           Trans-resveratrol (microbial source)

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the food supplements containing it shall be ‘Trans-resveratrol’.

                                    2.

                                    The labelling of food supplements containing trans-resveratrol shall bear a statement that people using medicines should only consume the product under medical supervision.

                        Food supplements as defined in Directive 2002/46/EC

                        In line with normal use in food supplements of resveratrol extracted from Japanese knotweed (Fallopia japonica)

                           Rooster comb extract

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rooster comb extract’ or ‘Cockerel comb extract’

                        Milk-based drinks

                        40 mg/100 g or mg/100 ml

                        Milk based fermented drinks

                        80 mg/100 g or mg/100 ml

                        Yoghurt-type products

                        65 mg/100 g or mg/100 ml

                           Fromage frais

                        110 mg/100 g or mg/100 ml

                           Sacha inchi oil from Plukenetia volubilis

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sacha inchi oil (Plukenetia volubilis)’

                        As for linseed oil

                        In line with normal food use of linseed oil

                           Salatrims

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘reduced energy fat (salatrims)’.

                                    2.

                                    There shall be a statement that excessive consumption may lead to gastro-intestinal disturbance.

                                    3.

                                    There shall be a statement that the products are not intended for use by children.

                        Bakery products and confectionary

                              Schizochytrium sp. oil rich in DHA and EPA

                           Specified food category

                           Maximum levels of DHA and EPA combined:

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’

                        Food Supplements as defined in Directive 2002/46/EC for adult population excluding pregnant and lactating women

                        3 000  mg/day

                        Food Supplements as defined in Directive 2002/46/EC for pregnant and lactating women

                        450 mg/day

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the persons for whom the products are intended

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

                        250 mg/meal

                        Milk-based drinks and similar products intended for young children

                        200 mg/100 g

                        Processed cereal based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013

                        Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

                        Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

                        Bakery Products (Breads, Rolls and Sweet Biscuits)

                        200 mg/100 g

                        Breakfast Cereals

                        500 mg/100 g

                        Cooking Fats

                        360 mg/100 g

                        Dairy Analogues except drinks

                        600 mg/100 g for cheese; 200 mg/100 g for soy and imitation milk products (excluding drinks)

                        Dairy Products except milk-based drinks

                        600 mg/100 g for cheese; 200 mg/100 g for milk products (including milk, fromage frais and yoghurt products; excluding drinks)

                        Non-alcoholic Beverages (including dairy analogue and milk-based drinks)

                        80 mg/100 g

                        Cereal/Nutrition Bars

                        500 mg/100 g

                        Spreadable Fats and Dressings

                        600 mg/100 g

                              Schizochytrium sp. (ATCC PTA-9695) oil

                           Specified food category

                           Maximum levels of DHA

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp. (ATCC PTA-9695)’

                        Dairy products except milk-based drinks

                        200 mg/100 g or for cheese products 600 mg/100 g

                        Dairy analogues except drinks

                        200 mg/100 g or for analogues to cheese products 600 mg/100 g

                        Spreadable fats and dressings

                        600 mg/100 g

                        Breakfast cereals

                        500 mg/100 g

                        Food Supplements as defined in Directive 2002/46/EC

                        250 mg DHA/day for general population

                        450 mg DHA/day for pregnant and lactating women

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

                        250 mg/meal

                        Milk-based drinks and similar products intended for young children

                        200 mg/100 g

                        Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

                        Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the persons for whom the products are intended

                        Bakery products (breads,rolls, and, sweet biscuits)

                        200 mg/100 g

                        Cereal bars

                        500 mg/100 g

                        Cooking fats

                        360 mg/100 g

                        Non-alcoholic beverages (including dairy analogue and milk-based drinks)

                        80 mg/100 ml

                        Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

                        In accordance with Regulation (EU) No 609/2013

                        Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013

                        200 mg/100 g

                              Schizochytrium sp. oil

                           Specified food category

                           Maximum levels of DHA

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’

                        Dairy products except milk-based drinks

                        200 mg/100 g or for cheese products 600 mg/100 g

                        Dairy analogues except drinks

                        200 mg/100 g or for analogues to cheese products 600 mg/100 g

                        Spreadable fats and dressings

                        600 mg/100 g

                        Breakfast cereals

                        500 mg/100 g

                        Food Supplements as defined in Directive 2002/46/EC

                        250 mg DHA/day for general population

                        450 mg DHA/day for pregnant and lactating women

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

                        250 mg/meal

                        Milk-based drinks and similar products intended for young children

                        200 mg/100 g

                        Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013

                        Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

                        Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the persons for whom the products are intended

                        Bakery products (breads, rolls and sweet biscuits)

                        200 mg/100 g

                        Cereal bars

                        500 mg/100 g

                        Cooking fats

                        360 mg/100 g

                        Non-alcoholic beverages (including dairy analogue and milk-based drinks)

                        80 mg/100 ml

                              Schizochytrium sp. (T18) oil

                           Specified food category

                           Maximum levels of DHA

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’

                        Dairy products except milk-based drinks

                        200 mg/100 g or for cheese products 600 mg/100 g

                        Dairy analogues except drinks

                        200 mg/100 g or for analogues to cheese products 600 mg/100 g

                        Spreadable fats and dressings

                        600 mg/100 g

                        Breakfast cereals

                        500 mg/100 g

                        Food Supplements as defined in Directive 2002/46/EC

                        250 mg DHA/day for general population

                        450 mg DHA/day for pregnant and lactating women

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

                        250 mg/meal

                        Milk-based drinks and similar products intended for young children

                        200 mg/100 g

                        Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

                        Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

                        Foods for special medical purposes as defined in Regulation (EU) No 609/2013

                        In accordance with the particular nutritional requirements of the persons for whom the products are intended

                        Bakery products (breads, rolls and, sweet biscuits)

                        200 mg/100 g

                        Cereal bars

                        500 mg/100 g

                        Cooking fats

                        360 mg/100 g

                        Non-alcoholic beverages (including dairy analogue and milk-based drinks)

                        80 mg/100 ml

                        Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

                        In accordance with Regulation (EU) No 609/2013

                        Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013

                        200 mg/100 g

                           Fermented soybean extract

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fermented soybean extract’.

                                    2.

                                    The labelling of food supplements containing fermented soybean extract shall bear a statement that persons taking medication should only consume the product under medical supervision.

                        Food Supplements as defined in Directive 2002/46/EC (capsules, tablets or powder form) intended for the adult population, excluding pregnant and lactating women

                        100 mg/day

                           Spermidine-rich wheat germ extract (Triticum aestivum)

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the food supplements containing it shall be ‘spermidine-rich wheat germ extract’

                        Food Supplements as defined in Directive 2002/46/EC intended for the adult population, excluding pregnant and lactating women

                        Equivalent of max. 6 mg/day spermidine

                           Sucromalt

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sucromalt’.

                                    2.

                                    The designation of the novel food on the labelling shall be accompanied by indication that the product is a source of glucose and fructose.

                        Not specified

                           Sugar cane fibre

                           Specified food category

                           Maximum levels

                        Bread

                        8  %

                        Bakery goods

                        5  %

                        Meat and muscle products

                        3  %

                        Seasonings and spices

                        3  %

                        Grated cheeses

                        2  %

                        Special diet foods

                        5  %

                        Sauces

                        2  %

                        Beverages

                        5  %

                           Sunflower oil extract

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sunflower oil extract’

                        Food Supplements as defined in Directive 2002/46/EC

                        1,1 g/day

                           Dried Tetraselmis chuii microalgae

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Dried microalgae Tetraselmis chuii’ or ‘Dried microalgae T. chuii’
                        Food supplements containing dried microalgae Tetraselmis chuii shall bear the following statement: ‘Contains negligible amounts of iodine’

                        Sauces

                        20 % or 250mg/day

                        Special salts

                        1  %

                        Condiment

                        250 mg/day

                        Food Supplements as defined in Directive 2002/46/EC

                        250 mg/day

                              Therapon barcoo/Scortum

                        Intended use identical to that of the salmon, namely the preparation of culinary fish products and dishes, including cooked, raw, smoked and baked fish products

                           D-Tagatose

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘D-Tagatose’.

                                    2.

                                    The labelling of any product where the level of D-Tagatose exceeds 15 g per serving and all beverages containing greater than 1 % D-Tagatose (as consumed) shall bear a statement ‘excessive consumption may produce laxative effects’.

                        Not specified

                           Taxifolin-rich extract

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘taxifolin-rich extract’.

                        Food Supplements as defined in Directive 2002/46/EC intended for the general population, excluding infants, young children, children and adolescents younger than 14 years

                        100 mg/day

                           Trehalose

                           Specified food category

                           Maximum levels

                                    1.

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Trehalose’ and shall be displayed on the labelling of the product as such or in the list of ingredients of foodstuffs containing it.

                                    2.

                                    The designation of the novel food on the labelling shall be accompanied by indication that the ‘Trehalose is a source of glucose’.

                        Not specified

                           UV-treated mushrooms (Agaricus bisporus)

                           Specified food category

                           Maximum levels of vitamin D2

                        Mushrooms (Agaricus bisporus)

                        10 μg of vitamin D2/100 g fresh weight

                                    1.

                                    The designation on the label of the novel food as such or of the foodstuffs containing it shall be ‘UV-treated mushrooms (Agaricus bisporus)’.

                                    2.

                                    The designation on the label of the novel food as such or of the foodstuffs containing it shall be accompanied by indication that a ‘controlled light treatment was used to increase vitamin D levels’ or ‘UV treatment was used to increase vitamin D2 levels’.

                           UV-treated baker’s yeast (Saccharomyces cerevisiae)

                           Specified food category

                           Maximum levels of vitamin D2

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Vitamin D yeast’ or ‘Vitamin D2 yeast’

                        Yeast-leavened breads and rolls

                        5 μg of vitamin D2/100 g

                        Yeast-leavened fine bakery wares

                        5 μg of vitamin D2/100 g

                        Food Supplements as defined in Directive 2002/46/EC

                        5 μg of vitamin D2/day

                           UV-treated bread

                           Specified food category

                           Maximum levels of vitamin D2

                        The designation on the label of the novel food shall be accompanied by ‘contains vitamin D produced by UV-treatment’

                        Yeast leavened bread and rolls (without toppings)

                        3 μg vitamin D2/100 g

                           UV-treated milk

                           Specified food category

                           Maximum levels of vitamin D3

                                    1.

                                    The designation on the label of the novel food shall be ‘UV-treated’.

                                    2.

                                    Where UV-treated milk contains an amount of vitamin D that is considered significant in accordance with Point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011 of the European Parliament and of the Council, the designation for the labelling shall be accompanied by ‘contains vitamin D produced by UV-treatment’ or ‘milk containing vitamin D resulting from UV-treatment’.

                        Pasteurised whole milk as defined in Regulation (EU) No 1308/2013 to be consumed as such

                        5-32 μg/kg for general population excluding infants

                        Pasteurised semi-skimmed milk as defined in Regulation (EU) No 1308/2013 to be consumed as such

                        1-15 μg/kg for general population excluding infants

                           Vitamin K2 (menaquinone)

                        To be used in compliance with Directive 2002/46/EC, Regulation (EU) No 609/2013 and/or Regulation (EC) No 1925/2006

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Menaquinone’ or ‘Vitamin K2’

                           Wheat bran extract

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Wheat bran extract’

                        The ‘Wheat Bran Extract’ may not be introduced onto the market as a food supplement or food supplement ingredient. Nor may it be added to infant formula.

                        Beer and substitutes

                        0,4 g/100 g

                        Ready to eat cereals

                        9 g/100 g

                        Dairy products

                        2,4 g/100 g

                        Fruit and vegetable juices

                        0,6 g/100 g

                        Soft drinks

                        0,6 g/100 g

                        Meat preparations

                        2 g/100 g

                           Yeast beta-glucans

                           Specified food category

                           Maximum levels of pure beta-glucans from yeast (Saccharomyces cervisiae)

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’

                        Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

                        1,275 g/day for children older than 12 years and general adult population
                        0,675 g/day for children younger than 12 years

                        Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

                        1,275 g/day

                        Food for special medical purposes as defined in Regulation (EU) No 609/2013, excluding food for special medical purposes intended for infants and young children

                        1,275 g/day

                        Beverages based on fruit and/or vegetable juices including concentrate and dehydrated juices

                        1,3 g/kg

                        Fruit-flavoured drinks

                        0,8 g/kg

                        Cocoa beverages preparation powder

                        38,3 g/kg (powder)

                        Other beverages

                        0,8 g/kg (ready to drink)

                        7 g/kg (powder)

                        Cereal bars

                        6 g/kg

                        Breakfast cereals

                        15,3 g/kg

                        Wholegrain and high fibre instant hot breakfast cereals

                        1,5 g/kg

                        Cookie-type biscuits

                        6,7 g/kg

                        Cracker-type biscuits

                        6,7 g/kg

                        Milk based beverages

                        3,8 g/kg

                        Fermented milk products

                        3,8 g/kg

                        Milk product analogues

                        3,8 g/kg

                        Dried milk/milk powder

                        25,5 g/kg

                        Soups and soup mixes

                        0,9 g/kg (ready to eat)

                        1,8 g/kg (condensed)

                        6,3 g/kg (powder)

                        Chocolate and confectionery

                        4 g/kg

                        Protein bars and powders

                        19,1 g/kg

                        Jam, marmalade and other fruit spreads

                        11,3 g/kg

                           Zeaxanthin

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘synthetic zeaxanthin’

                        Food Supplements as defined in Directive 2002/46/EC

                        2 mg/day

                           Zinc L-pidolate

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Zinc L-pidolate’

                        Foods covered by Regulation (EU) No 609/2013

                        3 g/day

                        Milk based drinks and similar products intended for young children

                        Meal replacement for weight control

                        Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

                        Food bearing statement on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

                        Food Supplements as defined in Directive 2002/46/EC

               Table 2: Specifications

                        Authorised Novel Food

                        Specifications

                              N-Acetyl-D-neuraminic acid

                           Description:

                           N-Acetyl-D-neuraminic acid is a white to off-white crystalline powder

                           Definition:

                           Chemical name:

                        IUPAC names:

                           N-Acetyl-D-neuraminic acid (dihydrate)
                        5-Acetamido-3,5-dideoxy-D-glycero-D-galacto-non-2-ulopyranosonic acid (dihydrate)
                        Synonyms:
                        Sialic acid (dihydrate)

                           Chemical formula:

                        C11H19NO9 (acid)
                        C11H23NO11 (C11H19NO9 * 2H2O) (dihydrate)

                           Molecular mass:

                        309,3 Da (acid)
                        345,3 (309,3 + 36,0) (dihydrate)

                           CAS No.:

                        131-48-6 (free acid)
                        50795-27-2 (dihydrate)

                           Specifications:

                        Description: white to off-white crystalline powder
                        pH (20 °C, 5 % solution): 1,7 – 2,5

                           N-Acetyl-D-neuraminic acid (dihydrate): > 97,0 %
                        Water (dihydrate calculates to 10,4 %): ≤ 12,5 % (w/w)
                        Ash, sulphated: < 0,2 % (w/w)
                        Acetic acid (as free acid and/or sodium acetate): < 0,5 % (w/w)

                           Heavy Metals:

                        Iron: < 20,0 mg/kg
                        Lead: < 0,1 mg/kg
                        Residual proteins: < 0,01 % (w/w)

                           Residual solvents:

                        2-Propanol: < 0,1 % (w/w)
                        Acetone: < 0,1 % (w/w)
                        Ethyl acetate: < 0,1 % (w/w)

                           Microbiological criteria:

                           Salmonella: Absence in 25 g
                        Aerobic mesophilic total count:< 500 CFU/g
                        Enterobacteriaceae: Absence in 10 g

                           Cronobacter (Enterobacter) sakazakii: Absence in 10 g

                           Listeria monocytogenes: Absence in 25 g

                           Bacillus cereus: < 50 CFU/g
                        Yeasts: < 10 CFU/g
                        Moulds: < 10 CFU/g
                        Residual endotoxins: < 10 EU/mg
                        CFU: Colony Forming Units; EU: Endotoxin Units.

                              Adansonia digitata (Baobab) dried fruit pulp

                           Description/Definition:

                        The Baobab (Adansonia digitata) fruits are harvested from trees. The hard shells are cracked open and the pulp is separated from the seeds and the shell. This is milled, separated into coarse and fine lots (particle size 3 to 600 μ) and then packaged.

                           Typical nutritional components:

                        Moisture (loss on drying) (g/100 g): 4,5-13,7
                        Protein (g/100 g): 1,8-9,3
                        Fat (g/100 g): 0-1,6
                        Total carbohydrate (g/100 g): 76,3-89,5
                        Total sugars (as glucose): 15,2-36,5
                        Sodium (mg/100 g): 0,1-25,2

                           Analytical specifications:

                        Foreign matter: Not more than 0,2 %
                        Moisture (loss on drying) (g/100 g): 4,5-13,7
                        Ash (g/100 g): 3,8-6,6

                              Ajuga reptans extract from cell cultures

                           Description/Definition:

                        Hydroalcoholic extract from Ajuga reptans L. tissue cultures which is substantially equivalent to extracts from flowering aerial parts of Ajuga reptans obtained by traditional cultures.

                           L-Alanyl-L-Glutamine

                           Description/Definition:

                        L-Alanyl-L-Glutamine is produced by fermentation with a genetically modified strain of Escherichia coli. During the fermentation process, the ingredient is secreted into the growth medium from which it is subsequently separated and purified to a concentration of > 98 %.
                        Appearance: White crystalline powder
                        Purity: > 98 %
                        Infrared spectroscopy: Conformity with ref. standard
                        Appearance of solution: Colourless and clear
                        Assay (dry basis): 98-102 %
                        Related substances (each): ≤ 0,2 %
                        Residue on ignition: ≤ 0,1 %
                        Loss on drying: ≤ 0,5 %
                        Optical rotation: +9,0 - +11,0o

                        pH (1 %; H2O): 5,0-6,0
                        Ammonium (NH4): ≤ 0,020 %
                        Chloride (Cl): ≤ 0,020 %
                        Sulphate (SO4): ≤ 0,020 %

                           Microbiological criteria:

                           Escherichia coli: Absence/g

                           Algal oil from the microalgae Ulkenia sp.

                           Description/Definition:

                        Oil from the micro-algae Ulkenia sp.
                        Acid value: ≤ 0,5 mg KOH/g
                        Peroxide value (PV): ≤ 5,0 meq/kg oil
                        Moisture and volatiles: ≤ 0,05 %
                        Unsaponifiables: ≤ 4,5 %
                        Trans-fatty acids: ≤ 1,0 %
                        DHA content: ≥ 32 %

                              Allanblackia seed oil

                           Description/Definition:

                           Allanblackia seed oil is obtained from the seeds of the allanblackia species: A. floribunda (synonymous with A. parviflora) and A. stuhlmannii.

                           Composition of fatty acids:

                        Lauric acid (C12:0): < 1,0 %
                        Myristic acid (C14:0): < 1,0 %
                        Palmitic acid (C16:0): < 2,0 %
                        Palmitoleic acid (C16:1): < 1,0 %
                        Stearic acid (C18:0): 45-58 %
                        Oleic acid (C18:1): 40-51 %
                        Linoleic acid (C18:2): < 1,0 %
                        γ-Linolenic acid (C18:3): < 1,0 %
                        Arachidic acid (C20:0): < 1,0 %
                        Free fatty acids: max 0,1 %

                           Characteristics:

                        Trans fatty acids: max 0,5 %
                        Peroxide value (PV): max 0,8 meq/kg
                        Iodine value: < 46 g/100 g
                        Unsaponifiable matter: max 1,0 %
                        Saponification value: 185-198 mg KOH/g

                              Aloe macroclada Baker leaf extract

                           Description/Definition:

                        Powdered gel extract derived from the leaves of Aloe macroclada Baker which is substantially equivalent to the same gel derived from Aloe vera (L.) Burm.f. leaves.
                        Ash: 25 %
                        Dietary fibres: 28,6 %
                        Fat: 2,7 %
                        Moisture: 4,7 %
                        Polysaccharides: 9,5 %
                        Protein: 1,63 %
                        Glucose: 8,9 %

                           Antarctic Krill oil from Euphausia superba

                           Description/Definition:

                        To produce lipid extract from Antarctic Krill (Euphausia superba) deep-frozen crushed krill or dried krill meal is subjected to lipid extraction with an approved extraction solvent (under Directive 2009/32/EC). Proteins and krill material are removed from the lipid extract by filtration. The extraction solvents and residual water are removed by evaporation.
                        Saponification value: ≤ 230 mg KOH/g
                        Peroxide value (PV): ≤ 3 meq O 2/kg oil
                        Oxidative stability: All food products containing Antarctic Krill oil from Euphausia superba should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC).
                        Moisture and volatiles: ≤ 3 % or 0,6 expressed as water activity at 25 °C
                        Phospholipids: 35-50 %
                        Trans-fatty acids: ≤ 1 %
                        EPA (eicosapentaenoic acid): ≥ 9 %
                        DHA (docosahexaenoic acid): ≥ 5 %

                           Antarctic Krill oil rich in phospholipids from Euphausia superba

                           Description/Definition:

                        Oil rich in phospholipids is produced from Antarctic krill (Euphausia superba) by repeated solvent washings with an approved solvent (under Directive 2009/32/EC) to increase phospholipid content of the oil. Solvents are removed from the final product by evaporation.
                        Saponification value: ≤ 230 mg KOH/g
                        Peroxide value (PV): ≤ 3 meq O2/kg oil
                        Moisture and volatiles: ≤ 3 % or 0,6 expressed as water activity at 25 °C
                        Phospholipids: ≥ 60 %
                        Trans-fatty acids: ≤ 1 %
                        EPA (eicosapentaenoic acid): ≥ 9 %
                        DHA (docosahexaenoic acid): ≥ 5 %

                           Arachidonic acid-rich oil from the fungus Mortierella alpina

                           Description/Definition:

                        The clear yellow arachidonic acid-rich oil is obtained by fermentation of the non-genetically modified strains IS-4, I49-N18, FJRK-MA01 and CBS 210.32 of the fungus Mortierella alpina using a suitable liquid. The oil is then extracted from the biomass and purified.
                        Arachidonic acid: ≥ 40 % by weight of the total fatty acid content
                        Free fatty acids: ≤ 0,45 % of the total fatty acid content
                        Trans fatty acids: ≤ 0,5 % of the total fatty acid content
                        Unsaponifiable matter: ≤ 1,5 %
                        Peroxide value (PV): ≤ 5 meq/kg
                        Anisidin value: ≤ 20
                        Acid value: ≤ 1,0 KOH/g
                        Moisture: ≤ 0,5 %

                           Argan oil from Argania spinosa

                           Description/Definition:

                        Argan oil is the oil obtained by cold pressing of the almond like kernels of the fruits of Argania spinosa (L.) Skeels. Kernels may be roasted prior to pressing, but with no direct contact with a flame.

                           Composition:

                        Palmitic acid (C16:0): 12-15 %
                        Stearic acid (C18:0): 5-7 %
                        Oleic acid (C18:1): 43-50 %
                        Linoleic acid (C18:2): 29-36 %
                        Unsaponifiable matter: 0,3-2 %
                        Total sterols: 100-500 mg/100 g
                        Total tocopherols: 16-90 mg/100 g
                        Oleic acidity: 0,2-1,5 %
                        Peroxide value (PV): < 10 meq O2/kg

                           Astaxanthin-rich oleoresin from Haematococcus pluvialis algae

                           Description/Definition:

                        Astaxanthin is a carotenoid produced by Haematococcus pluvialis algae. Production methods for the growth of the algae are variable; using either closed systems exposed to sunlight or strictly controlled illuminated light; alternatively open ponds may be used. The algal cells are harvested and dried; the oleoresin is extracted using either super critical CO2 or a solvent (ethyl acetate). The Astaxanthin is diluted and standardized to 2,5 %, 5,0 %, 7,0 %, 10 %, 15 % or 20 % using olive oil, safflower oil, Sunflower oil or MCT (Medium Chain Triglycerides).

                           Composition of the Oleoresin:

                        Fat: 42,2- 99 %
                        Protein: 0,3-4,4 %
                        Carbohydrate: 0-52,8 %
                        Fibre: < 1,0 %
                        Ash: 0,0-4,2 %
                        Specification of Carotenoids w/w%
                        Total Astaxanthins: 2,9-11,1 %
                        9-cis-astaxanthin: 0,3-17,3 %
                        13-cis-astaxanthin: 0,2-7,0 %
                        Astaxanthin monoesters: 79,8-91,5 %
                        Astaxanthin diesters: 0,16-19,0 %
                        Β-Carotene: 0,01-0,3 %
                        Lutein: 0-1,8 %
                        Canthaxanthin: 0-1,30 %

                           Microbiological criteria:

                        Total aerobic bacteria: < 3 000  CFU/g
                        Yeast and Moulds: < 100 CFU/g
                        Coliforms: < 10 CFU/g

                           E. coli: Negative

                           Salmonella: Negative

                           Staphylococcus: Negative

                           Basil seeds (Ocimum basilicum)

                           Description/Definition:

                        Basil (Ocimum basilicum L.) belongs to the family ‘Lamiaceae’ within the order ‘Lamiales’. Post-harvest the seeds are cleaned mechanically. Flowers, leaves and other parts of the plant are removed. Highest level of purity of Basil seeds has to be ensured by filtering (optical, mechanical). Production process of fruit juice and fruit/vegetable blend beverages containing Basil seeds (Ocimum basilicum L.) includes seed pre-hydration and pasteurisation steps. Microbiological controls and monitoring systems are in place.
                        Dry Matter: 94,1 %
                        Protein: 20,7 %
                        Fat: 24,4 %
                        Carbohydrate: 1,7 %
                        Dietary Fibre: 40,5 % (Method: AOAC 958,29)
                        Ash: 6,78 %

                           Fermented black bean extract

                           Description/Definition:

                        Fermented black bean extract (Touchi extract) is a fine light-brown protein-rich powder obtained by water extraction of small soybeans (Glycine max (L.) Merr.) fermented with Aspergillus oryzae. The extract contains an α-glucosidase inhibitor.

                           Characteristics:

                        Fat: ≤ 1,0 %
                        Protein: ≥ 55 %
                        Water: ≤ 7,0 %
                        Ash: ≤ 10 %
                        Carbohydrate: ≥ 20 %
                        α-glucosidase inhibitory activity: IC50 min 0,025 mg/ml
                        Soy isoflavone: ≤ 0,3 g/100 g

                           Bovine lactoferrin

                           Description/Definition:

                        Bovine lactoferrin is a protein that occurs naturally in cows’ milk. It is an iron-binding glycoprotein of approximately 77 kDa and consists of a single polypeptide chain of 689 amino acids.
                        Production process: Bovine lactoferrin is isolated from skimmed milk or cheese whey via ion exchange and subsequent ultra-filtration steps. Finally, it is dried by freeze drying or spraying and the large particles are sieved out. It is a virtually odourless, light pinkish powder.

                           Physical-Chemical properties of Bovine lactoferrin:

                        Moisture: < 4,5 %
                        Ash: < 1,5 %
                        Arsenic: < 2,0 mg/kg
                        Iron: < 350 mg/kg
                        Protein: > 93 %
                        of which bovine lactoferrin: > 95 %
                        of which other proteins: < 5,0 %
                        pH (2 % solution, 20 °C): 5,2-7,2
                        Solubility (2 % solution, 20 °C): complete

                              Buglossoides arvensis seed oil

                           Description/Definition:

                        Refined Buglossoides oil is extracted from the seeds of Buglossoides arvensis (L.) I.M.Johnst
                        Alpha-linolenic acid: ≥ 35 % w/w of total fatty acids
                        Stearidonic acid: ≥ 15 % w/w of total fatty acids
                        Linoleic acid: ≥ 8,0 % w/w of total fatty acids
                        Trans fatty acids: ≤ 2,0 % w/w of total fatty acids
                        Acid value: ≤ 0,6 mg KOH/g
                        Peroxide value (PV): ≤ 5,0 meq O2/kg
                        Unsaponifiable content: ≤ 2,0 %
                        Protein content (total nitrogen): ≤ 10 μg/ml
                        Pyrrolizidine alkaloids: Not detectable with a detection limit of 4,0 μg/kg

                              Calanus finmarchicus oil

                           Description/Definition:

                        The novel food is ruby coloured, slightly viscous oil with a slight shellfish odour extracted from the crustacean (marine zooplankton) Calanus finmarchicus. The ingredient consists primarily of wax esters (> 85 %) with minor amounts of triglycerides and other neutral lipids.

                           Specifications:

                        Water: < 1,0 %
                        Wax esters: > 85 %
                        Total fatty acids: > 46 %
                        Eicosapentaenoic acid (EPA): > 3,0 %
                        Docosahexaenoic acid (DHA): > 4,0 %
                        Total fatty alcohols: > 28 %
                        C20:1 n-9 fatty alcohol: > 9,0 %
                        C22:1 n-11 fatty alcohol: > 12 %
                        Trans fatty acids: < 1,0 %
                        Astaxanthinesters: < 0,1 %
                        Peroxide value (PV): < 3,0 meq. O2/kg

                           Chewing gum base (monomethoxypolyethylene glycol)

                           Description/Definition:

                        The novel food ingredient is a synthetic polymer (Patent number WO2006016179). It consists of branched polymers of monomethoxypolyethylene glycol (MPEG) grafted onto polyisoprene-graft-maleic anhydride (PIP-g-MA), and unreacted MPEG (less than 35 % by weight).
                        White to off-white colour.
                        CAS No.: 1246080-53-4

                           Characteristics:

                        Moisture: < 5,0 %
                        Aluminium: < 3,0 mg/kg
                        Lithium: < 0,5 mg/kg
                        Nickel: < 0,5 mg/kg
                        Residual anhydride: < 15 μmol/g
                        Polydispersity index: < 1,4
                        Isoprene: < 0,05 mg/kg
                        Ethylene oxide: < 0,2 mg/kg
                        Free maleic anhydride: < 0,1 %
                        Total oligomeres (less than 1 000  Dalton): ≤ 50 mg/kg
                        Ethylene glycol: < 200 mg/kg
                        Diethylene glycol: < 30 mg/kg
                        Monoethylene glycol methyl ether: < 3,0 mg/kg
                        Diethylene glycol methyl ether: < 4,0 mg/kg
                        Triethylene glycol methyl ether: < 7,0 mg/kg
                        1,4-Dioxane: < 2,0 mg/kg
                        Formaldehyde: < 10 mg/kg

                           Chewing gum base (Methyl vinyl ether-maleic anhydride copolymer)

                           Description/Definition:

                        Methyl vinyl ether-maleic anhydride copolymer is an anhydrous copolymer of methyl vinyl ether and maleic anhydride.
                        Free-flowing, white to white-off powder
                        CAS No: 9011-16-9

                           Purity:

                        Assay value: At least 99,5 % in dry matter
                        Specific viscosity (1 % MEK): 2-10
                        Residual methyl vinyl ether: ≤ 150 ppm
                        Residual maleic anhydride: ≤ 250 ppm
                        Acetaldehyde: ≤ 500 ppm
                        Methanol: ≤ 500 ppm
                        Dilauroyl peroxide: ≤ 15 ppm
                        Total heavy metals: ≤ 10 ppm

                           Microbiological criteria:

                        Total aerobic plate count: ≤ 500 CFU/g
                        Mould/yeast: ≤ 500 CFU/g

                           Escherichia coli: Negative to test

                           Salmonella: Negative to test

                           Staphylococcus aureus: Negative to test

                           Pseudomonas aeruginosa: Negative to test

                           Chia oil from Salvia hispanica

                           Description/Definition:

                        Chia oil is produced from Chia (Salvia hispanica L.) seeds (99,9 % pure) by cold pressing. No solvents are used and, once pressed, the oil is held in decantation tanks and a filtration process employed to remove impurities. It can also be produced by extraction with supercritical CO2.

                           Production process:

                        Produced by cold pressing. No solvents are used and, once pressed, the oil is held in decantation tanks and a filtration process employed to remove impurities.
                        Acidity expressed as oleic acid: ≤ 2,0 %
                        Peroxide value (PV): ≤ 10 meq/kg
                        Insoluble impurities: ≤ 0,05 %
                        Alpha linolenic acid: ≥ 60 %
                        Linoleic acid: 15-20 %

                           Chia seeds (Salvia hispanica)

                           Description/Definition:

                        Chia (Salvia hispanica L.) is a summer annual herbaceous plant belonging to the Labiatae family. Post-harvest the seeds are cleaned mechanically. Flowers, leaves and other parts of the plant are removed.
                        Dry matter: 90-97 %
                        Protein: 15-26 %
                        Fat: 18-39 %
                        Carbohydrate (*): 18-43 %
                        Crude Fibre(**): 18-43 %
                        Ash: 3-7 %

                                    (*)

                                    Carbohydrates include the fibre value

                                    (**)

                                    Crude fibre is the part of fibre made mainly of indigestible cellulose, pentosans and lignin

                           Production process:

                        Production process of fruit juices and fruit juice blends beverages, containing Chia seeds, includes seed pre-hydration and pasteurisation steps. Microbiological controls and monitoring systems are in place.

                           Chitin-glucan from Aspergillus niger

                           Description/Definition:

                        Chitin-glucan is obtained from the mycelium of Aspergillus niger; it is a slightly yellow, odourless, free-flowing powder. It has a dry matter content of 90 % or more.
                        Chitin-glucan is composed largely of two polysaccharides:

                                    —

                                    chitin, composed of repeating units of N-acetyl-D-glucosamine (CAS No: 1398-61-4),

                                    —

                                    beta (1, 3)-glucan, composed of repeating units of D-glucose (CAS No: 9041-22-9).

                              Loss on drying: ≤ 10 %
                        Chitin-glucan: ≥ 90 %
                        Ratio of chitin to glucan: 30:70 to 60:40
                        Ash: ≤ 3,0 %
                        Lipids: ≤ 1,0 %
                        Proteins: ≤ 6,0 %

                           Chitin-glucan complex from Fomes fomentarius

                           Description/Definition:

                        Chitin-glucan complex is obtained from the cell walls of the fruit bodies of the fungus Fomes fomentarius. It consists primarily of two polysaccharides:

                                    —

                                    Chitin, composed of repeating units of N-acetyl-D-glucosamine (CAS No: 1398-61-4);

                                    —

                                    Beta-(1,3)(1,6)-D-glucan, composed of repeating units of D-glucose (CAS No: 9041-22-9).

                              The production process consists of several steps, including: cleaning, reduction in size and grinding, softening in water and heating in an alkaline solution, washing, drying. No hydrolysis is applied during the production process.
                        Appearance: Powder, odourless, flavourless, brown

                           Purity:

                        Moisture: ≤ 15 %
                        Ash: ≤ 3,0 %
                        Chitin-glucan: ≥ 90 %
                        Ratio of chitin to glucan: 70:20
                        Total carbohydrates, excluding glucans: ≤ 0,1 %
                        Proteins: ≤ 2,0 %
                        Lipids: ≤ 1,0 %
                        Melanins: ≤ 8,3 %
                        Additives: None
                        pH: 6,7-7,5

                           Heavy metals:

                        Lead (ppm): ≤ 1,00
                        Cadmium (ppm): ≤ 1,00
                        Mercury (ppm): ≤ 0,03
                        Arsenic (ppm): ≤ 0,20

                           Microbiological criteria:

                        Total mesophilic bacteria: ≤ 103/g
                        Yeast and moulds: ≤ 103/g
                        Coliforms at 30 °C: ≤ 103/g

                           E. coli: ≤ 10/g

                           Salmonella and other pathogenic bacteria: Absence/25 g

                           Chitosan extract from fungi (Agaricus bisporus; Aspergillus niger)

                           Description/Definition:

                        The chitosan extract (containing mainly poly(D-glucosamine)) is obtained from stems of Agaricus bisporus or from the mycelium of Aspergillus niger.
                        The patented production process consists of several steps, including: extraction and deacetylation (hydrolysis) in alkaline medium, solubilisation in acidic medium, precipitation in alkaline medium, washing and drying.
                        Synonym: Poly(D-glucosamine)
                        Chitosan CAS number: 9012-76-4
                        Chitosan formula: (C6H11NO4)n

                        Appearance: fine free-flowing powder
                        Aspect: Off –white to slightly brownish
                        Odour: Odourless

                           Purity:

                        Chitosan content (% w/w dry weight):≥ 85
                        Glucan content (% w/w dry weight): ≤ 15
                        Loss on drying (% w/w dry weight): ≤ 10
                        Viscosity (1 % in 1 % acetic acid): 1-15
                        Degree of acetylation (in % mol/wet weight): 0-30
                        Viscosity (1 % in 1 % acetic acid) (mPa.s): 1-14 for chitosan from Aspergillus niger; 12-25 for chitin from Agaricus bisporus

                        Ash (% w/w dry weight): ≤ 3,0
                        Proteins (% w/w dry weight): ≤ 2,0
                        Particle size: > 100 nm
                        Tapped density (g/cm3): 0,7-1,0
                        Fat binding capacity 800 × (w/w wet weight): pass

                           Heavy metals:

                        Mercury (ppm): ≤ 0,1
                        Lead (ppm): ≤ 1,0
                        Arsenic (ppm): ≤ 1,0
                        Cadmium (ppm): ≤ 0,5

                           Microbiological criteria:

                        Aerobic count (CFU/g): ≤ 103

                        Yeast and mould count (CFU/g): ≤ 103

                           Escherichia coli (CFU/g): ≤ 10
                        Enterobacteriaceae (CFU/g): ≤ 10

                           Salmonella: Absence/25g

                           Listeria monocytogenes: Absence/25g

                           Chondroitin sulphate

                           Description/Definition:

                        Chondroitin sulphate (sodium salt) is a biosynthetic product. It is obtained by chemical sulphation of chondroitin derived from fermentation by the bacterium Escherichia coli O5:K4:H4 strain U1-41 (ATCC 23502).
                        Chondroitin sulphate (sodium salt) (% dry basis): 95-105
                        MWw (weight avg.) (kDa): 5-12
                        MWn (number avg.) (kDa): 4-11
                        Dispersity (wh/w0,05): ≤ 0,7
                        Sulphation pattern (ΔDi-6S) (%): ≤ 85
                        Loss on drying (%) (105 °C to constant weight): ≤ 10,0
                        Residue on ignition (% dry basis): 20-30
                        Protein (% dry basis): ≤ 0,5
                        Endotoxins (EU/mg): ≤ 100
                        Total organic impurities (mg/kg): ≤ 50

                           Chromium Picolinate

                           Description/Definition:

                        Chromium picolinate is a reddish free-flowing powder, slightly soluble in water at pH 7. The salt is also soluble in polar organic solvents.
                        Chemical name: tris(2pyridinecarboxylato-N,O)chromium(III) or 2-pyridinecarboxylic acid chromium(III) salt
                        CAS No.: 14639-25-9
                        Chemical formula: Cr(C6H4NO2)3

                        Chemical characteristics:
                        Chromium Picolinate: ≥ 95 %
                        Chromium (III): 12-13 %
                        Chromium (VI): not detected
                        Water: ≤ 4,0 %

                              Cistus incanus L. Pandalis herb

                           Description:

                           Cistus incanus L. Pandalis herb; species belonging to the Cistaceae family and native to the Mediterranean region, Chalkidiki Peninsula.

                           Composition:

                        Moisture: 9–10 g/100 g herbs
                        Protein: 6,1 g/100 g herbs
                        Fat: 1,6 g/100 g herbs
                        Carbohydrates: 50,1 g/100 g herbs
                        Fiber: 27,1 g/100 g herbs
                        Minerals: 4,4 g/100 g herbs
                        Sodium: 0,18 g
                        Potassium: 0,75 g
                        Magnesium: 0,24 g
                        Calcium: 1,0 g
                        Iron: 65 mg
                        Vitamin B1: 3,0 μg
                        Vitamin B2: 30 μg
                        Vitamin B6: 54 μg
                        Vitamin C: 28 mg
                        Vitamin A: less than 0,1 mg
                        Vitamin E: 40–50 mg
                        Alpha-Tocopherol: 20–50 mg
                        Beta and Gamma-Tocopherols: 2–15 mg
                        Delta-Tocopherol: 0,1–2 mg

                           Citicoline

                           Description/Definition:

                        Citicoline is produced by a microbial process.
                        Citicoline is composed of cytosine, ribose, pyrophosphate and choline.
                        White crystalline powder
                        Chemical name: Choline cytidine 5′-pyrophosphate, Cytidine 5′-(trihydrogen diphosphate) P’-[2-(trimethylammonio)ethyl]ester inner salt
                        Chemical formula: C14H26N4O11P2

                        Molecular weight: 488,32 g/mol
                        CAS No.: 987-78-0
                        pH (sample solution of 1 %): 2,5-3,5

                           Purity:

                        Assay value: ≥ 98 % of dry matter
                        Loss on drying (100 °C for 4 hours): ≤ 5,0 %
                        Ammonium: ≤ 0,05 %
                        Arsenic: Not more than 2 ppm
                        Free phosphoric acids: ≤ 0,1 %
                        5′-Cytidylic acid: ≤ 1,0 %

                           Microbiological criteria:

                        Total plate count: ≤ 103 CFU/g
                        Yeast and moulds: ≤ 102 CFU/g

                           Escherichia coli: Absence in 1 g

                              Clostridium butyricum

                           Description/Definition:

                           Clostridium butyricum (CBM-588) is a Gram-positive, spore-forming, obligate anaerobic, non-pathogenic, non-genetically modified bacterium. Depository number FERM BP-2789

                           Microbiological criteria:

                        Total viable aerobic count: ≤ 103 CFU/g

                           Escherichia coli: Not detected in 1 g

                           Staphylococcus aureus: Not detected in 1 g

                           Pseudomonas aeruginosa: Not detected in 1 g
                        Yeast and moulds: ≤ 102 CFU/g

                           Extract of defatted cocoa powder

                        Cocoa (Theobroma cacao L.) Extract
                        Appearance: Dark brown powder free of visible impurities
                        Physical and chemical properties:
                        Polyphenol content: Min 55,0 % GAE
                        Theobromine content: Max 10,0 %
                        Ash content: Max 5,0 %
                        Moisture content: Max 8,0 %
                        Bulk density: 0,40-0,55 g/cm3

                        pH: 5,0-6,5
                        Residual solvent: Max 500 ppm

                           Low fat cocoa extract

                        Low fat Cocoa (Theobroma cacao L.) extract
                        Appearance: Dark red to purple powder
                        Cocoa extract, concentrate: Min 99 %
                        Silicon dioxide (technological aid): Max 1,0 %
                        Cocoa flavanols: Min. 300 mg/g

                                    —

                                    Epicatechin: Min. 45 mg/g

                              Loss on drying: Max. 5,0 %

                           Coriander seed oil from Coriandrum sativum

                           Description/Definition:

                        Coriander seed oil is an oil containing glycerides of fatty acids that is produced from the seeds of the coriander plant Coriandrum sativum L.
                        Slight yellow colour, bland taste
                        CAS No.: 8008-52-4
                        Composition of fatty acids:
                        Palmitic acid (C16:0): 2-5 %
                        Stearic acid (C18:0): < 1,5 %
                        Petroselinic acid (cis-C18:1(n-12)): 60-75 %
                        Oleic acid (cis-C18:1 (n-9)): 8-15 %
                        Linoleic acid (C18:2): 12-19 %
                        α-Linolenic acid (C18:3): < 1,0 %
                        Trans fatty acids: ≤ 1,0 %

                           Purity:

                        Refractive index (20 °C): 1,466-1,474
                        Acid value: ≤ 2,5 mg KOH/g
                        Peroxide value (PV): ≤ 5,0 meq/kg
                        Iodine value: 88-110 units
                        Saponification value: 186-200 mg KOH/g
                        Unsaponifiable matter: ≤ 15 g/kg

                              Crataegus pinnatifida dried fruit

                           Description/Definition:

                        Dried fruits of Crataegus pinnatifida species belonging to the Rosaceae family and native to north China and Korea.

                           Composition:

                        Dry matter: 80 %
                        Carbohydrates: 55 g/kg fresh weight
                        Fructose: 26,5–29,3 g/100 g
                        Glucose: 25,5–28,1 g/100 g
                        Vitamin C: 29,1 mg/100 g fresh weight
                        Sodium: 2,9 g/100 g fresh weight
                        Compotes are products obtained by thermal processing of the edible part of one or several species of fruits, whole or in pieces, sieved or not, without significant concentration. Sugars, water, cider, spices and lemon juice may be used.

                           α-cyclodextrin

                           Description/Definition:

                        A non-reducing cyclic saccharide consisting of six α-1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase (CGTase, EC 2.4.1.19) on hydrolyzed starch. Recovery and purification of α-cyclodextrin may be carried out using one of the following procedures: precipitation of a complex of α-cyclodextrin with 1-decanol, dissolution in water at elevated temperature and re-precipitation, steam-stripping of the complexant, and crystallisation of α-cyclodextrin from the solution; or chromatography with ion-exchange or gel filtration followed by crystallisation of α-cyclodextrin from the purified mother liquor; or membrane separation methods such as ultra-filtration and reverse osmosis: Description: Virtually odourless, white or almost white crystalline solid.
                        Synonyms: α-cyclodextrin, α-dextrin, cyclohexaamylose, cyclomaltohexaose, α-cycloamylase
                        Chemical name: Cyclohexaamylose
                        CAS No.: 10016-20-3
                        Chemical formula: (C6H10O5)6

                        Formula weight: 972,85
                        Assay: ≥ 98 % (dry basis)

                           Identification:

                        Melting range: Decomposes above 278 °C
                        Solubility: Freely soluble in water; very slightly soluble in ethanol
                        Specific rotation: [α]D
                           25: Between +145o and +151o (1 % solution)
                        Chromatography: The retention time for the major peak in a liquid chromatogram of the sample corresponds to that for α-cyclodextrin in a chromatogram of reference α-cyclodextrin (available from Consortium für Elektrochemische Industrie GmbH, München, Germany or Wacker Biochem Group, Adrian, MI, USA) using the conditions described in the METHOD OF ASSAY

                           Purity:

                        Water: ≤ 11 % (Karl Fischer Method)
                        Residual complexant: ≤ 20 mg/kg
                        (1-decanol)
                        Reducing substances: ≤ 0,5 % (as glucose)
                        Sulphated ash: ≤ 0,1 %
                        Lead: ≤ 0,5 mg/kg

                           Method of assay:

                        Determine by liquid chromatography using the following conditions:
                        Sample solution: Weigh accurately about 100 mg of test sample into a 10 ml volumetric flask and add 8 ml of deionised water. Dissolve the sample completely using an ultra-sonification bath (10-15 min) and dilute to the mark with purified deionised water. Filter through a 0,45-micrometer filter
                        Reference solution: Weigh accurately about 100 mg of α-cyclodextrin into a 10 ml volumetric flask and add 8 ml of deionised water. Dissolve the sample completely using an ultra-sonification bath and dilute to the mark with purified deionised water.
                        Chromatography: Liquid chromatograph equipped with a refractive index detector and an integrating recorder.
                        Column and packing: Nucleosil-100-NH2 (10 μm) (Macherey & Nagel Co. Düren, Germany) or similar
                        Length: 250 mm
                        Diameter: 4 mm
                        Temperature: 40 °C
                        Mobile phase: acetonitrile/water (67/33, v/v)
                        Flow rate: 2,0 ml/min
                        Injection volume: 10 μl
                        Procedure: Inject the sample solution into the chromatograph, record the chromatogram, and measure the area of the α-CD peak. Calculate the percentage of α-cyclodextrin in the test sample as follows:
                        % α-cyclodextrin (dry basis) = 100 × (AS/AR) (WR/WS)
                        where
                        AS and AR are the areas of the peaks due to α-cyclodextrin for the sample solution and reference solution, respectively.
                        WS and WR are the weights (mg) of the test sample and reference α-cyclodextrin, respectively, after correcting for water content.

                           γ-cyclodextrin

                           Description/Definition:

                        A non-reducing cyclic saccharide consisting of eight α-1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase (CGTase, EC 2.4.1.19) on hydrolysed starch. Recovery and purification of γ-cyclodextrin may be carried out by precipitation of a complex of γ-cyclodextrin with 8-cyclohexadecen-1-one, dissolution of the complex with water and n-decane, steam-stripping of the aqueous phase and recovery of gamma-CD from the solution by crystallisation.
                        Virtually odourless, white or almost white crystalline solid
                        Synonyms: γ-cyclodextrin, γ-dextrin, cyclooctaamylose, cyclomaltooctaose, γ-cycloamylase
                        Chemical name: Cyclooctaamylose
                        CAS number: 17465-86-0
                        Chemical formula: (C6H10O5)8

                        Assay: ≥ 98 % (dry basis)

                           Identification:

                        Melting range: Decomposes above 285 °C
                        Solubility: Freely soluble in water; very slightly soluble in ethanol
                        Specific rotation: [α]D
                           25: between + 174o and + 180o (1 % solution)

                           Purity:

                        Water: ≤ 11 %
                        Residual complexant (8-cyclohexadecen-1-one (CHDC)): ≤ 4 mg/kg
                        Residual solvent (n-decane): ≤ 6mg/kg
                        Reducing substances: ≤ 0,5 % (as glucose)
                        Sulphated ash: ≤ 0,1 %

                           Dextran preparation produced by Leuconostoc mesenteroides

                                    1.

                                       Powdered form:

                                    Carbohydrates: 60 % with: (Dextran: 50 %, Mannitol: 0,5 %, Fructose: 0,3 %, Leucrose: 9,2 %)
                                    Protein: 6,5 %
                                    Lipid: 0,5 %
                                    Lactic acid: 10 %
                                    Ethanol: traces
                                    Ash: 13 %
                                    Moisture: 10 %

                                    2.

                                       Liquid form:

                                    Carbohydrates: 12 % with: (Dextran: 6,9 %, Mannitol: 1,1 %, Fructose: 1,9 %, Leucrose: 2,2 %)
                                    Protein: 2,0 %
                                    Lipid: 0,1 %
                                    Lactic acid: 2,0 %
                                    Ethanol: 0,5 %
                                    Ash: 3,4 %
                                    Moisture: 80 %

                           Diacylglycerol oil of plant origin

                           Description/Definition:

                        Manufactured from glycerol and fatty acids derived from edible vegetable oils, in particular from soybean oil (Glycine max) or rapeseed oil (Brassica campestris, Brassica napus) using a specific enzyme.

                           Acylglycerol Distribution:

                        Diacylglycerols (DAG): ≥ 80 %
                        1,3-Diacylglycerols (1,3-DAG): ≥ 50 %
                        Triacylglycerols (TAG): ≤ 20 %
                        Monoacylglycerols (MAG): ≤ 5,0 %

                           Fatty Acid Composition (MAG, DAG, TAG):

                        Oleic acid (C18:1): 20-65 %
                        Linoleic acid (C18:2): 15-65 %
                        Linolenic acid (C18:3): ≤ 15 %
                        Saturated fatty acids: ≤ 10 %

                           Others:

                        Acid value: ≤ 0,5 mg KOH/g
                        Moisture and volatile: ≤ 0,1 %
                        Peroxide value (PV): ≤ 1,0 meq/kg
                        Unsaponifiables: ≤ 2,0 %
                        Trans fatty acids≤ 1,0 %
                        MAG = monoacylglycerols, DAG = diacylglycerols, TAG = triacylglycerols

                           Dihydrocapsiate (DHC)

                           Description/Definition:

                        Dihydrocapsiate is synthesised by enzyme-catalysed esterification of vanillyl alcohol and 8-methylnonanoic acid. Following the esterification dihydrocapsiate is extracted with n-hexane.
                        Viscous to colourless to yellow liquid
                        Chemical formula: C18 H28 O4

                        CAS No: 205687-03-2

                           Physical-chemical properties:

                        Dihydrocapsiate: > 94 %
                        8-Methylnonanoic acid: < 6,0 %
                        Vanillyl acohol: < 1,0 %
                        Other synthesis related substances: < 2,0 %

                           Dried extract of Lippia citriodora from cell cultures

                           Description/Definition:

                        Dried extract of Lippia citriodora (Palau) Kunth from cell cultures HTN®Vb.

                              Echinacea angustifolia extract from cell cultures

                           Description/Definition:

                        Extract of the roots of Echinacea angustifolia obtained from plant tissue culture which is substantially equivalent to a root extract from Echinacea angustifolia obtained in ethanol-water titrated to 4 % echinacoside.

                              Echinacea purpurea extract from cell cultures

                           Description/Definition:

                        Dried extract of Echinacea purpurea from cell cultures HTN®Vb

                              Echium plantagineum oil

                           Description/Definition:

                        Echium oil is the pale yellow product obtained by refining oil extracted from the seeds of Echium plantagineum L. Stearidonic acid: ≥ 10 % w/w of total fatty acids
                        Trans fatty acids: ≤ 2,0 % (w/w of total fatty acids)
                        Acid value: ≤ 0,6 mg KOH/g
                        Peroxide value (PV): ≤ 5,0 meq O2/kg
                        Unsaponifiable content: ≤ 2,0 %
                        Protein content (total nitrogen): ≤ 20 μg/ml
                        Pyrrolizidine alkaloids: Not detectable with a detection limit 4,0 μg/kg

                           Epigallocatechin gallate as a purified extract from green tea leaves (Camellia sinensis)

                           Description/Definition:

                        A highly purified extract from the leaves of green tea (Camellia sinensis (L.) Kuntze) in the form of a fine, off-white to pale pink powder. It is composed of a minimum of 90 % epigallo-catechin gallate (EGCG), and has a melting point between approx. 210 and 215 °C
                        Appearance: off-white to pale pink powder
                        Chemical name: polyphenol (-) epigallocatechin-3-gallate
                        Synonyms: epigallocatechin gallate (EGCG)
                        CAS No.: 989-51-5
                        INCI name: epigallocatechin gallate
                        Molecular mass: 458,4 g/mol
                        Loss on drying: max 5,0 %

                           Heavy metals:

                        Arsenic: max 3,0 ppm
                        Lead: max 5,0 ppm

                           Assay:

                        Min. 94 % EGCG (on dry material)
                        max. 0,1 % caffeine
                        Solubility: EGCG is fairly soluble in water, ethanol, methanol and acetone

                           L-ergothioneine

                           Definition

                        Chemical name (IUPAC): (2S)-3-(2-thioxo-2,3-dihydro-1H-imidazol-4-yl)-2-(trimethylammonio)-Propanoate
                        Chemical formula: C9H15N3O2S
                        Molecular mass: 229,3 Da
                        CAS No.: 497-30-3

                           Parameter

                           Specification

                           Method

                        Appearance

                        White powder

                        Visual

                        Optical rotation

                        [α]D ≥ (+) 122° (c = 1, H2O)a)

                        Polarimetry

                        Chemical purity

                        ≥ 99,5 %
                        ≥ 99,0 %

                        HPLC [Eur. Ph. 2,2.29]
                        1H-NMR

                        Identification

                        Compliant with the structure
                        C: 47,14 ± 0,4 %
                        H: 6,59 ± 0,4 %
                        N: 18,32 ± 0,4 %

                        1H-NMR
                        Elemental analysis

                        Total residual solvents
                        (methanol, ethyl acetate, isopropanol, ethanol)

                        [Eur. Ph. 01/2008:50400]
                        < 1 000  ppm

                        Gas chromatography
                        [Eur. Ph. 01/2008:20424]

                        Loss on drying

                        Internal standard < 0,5 %

                        [Eur. Ph. 01/2008:20232]

                        Impurities

                        < 0,8 %

                        HPLC/GPC or 1H-NMR

                           Heavy metals
                           b) c)

                        Lead

                        < 3,0 ppm

                        ICP/AES

                        Cadmium

                        < 1,0 ppm

                        (Pb, Cd)

                        Mercury

                        < 0,1 ppm

                        Atomic fluorescence (Hg)

                           Microbiological specifications
                           b)

                        Total viable aerobic count (TVAC)

                        ≤ 1 x 103 CFU/g

                        [Eur. Ph. 01/2011:50104]

                        Total yeast and mould count (TYMC)

                        ≤ 1 x 102 CFU/g

                           Escherichia coli

                        Absence in 1 g

                        Eur. Ph.: European Pharmacopoeia; 1H-NMR: proton nuclear magnetic resonance; HPLC: high-performance liquid chromatography; GPC: gel permeation chromatography; ICP/AES: Inductively coupled plasma atomic emission spectroscopy;
                        CFU: colony-forming units.

                                    a)

                                    Lit. [α]D = (+) 126,6o (c = 1, H2O)

                                    b)

                                    Analyses conducted on each batch

                                    c)

                                    Maximum levels in accordance with Regulation (EC) No 1881/2006

                           Ferric Sodium EDTA

                           Description/Definition:

                        Ferric Sodium EDTA (ethylenediaminetetraacetic acid) is an odourless free-flowing, yellow to brown powder with a chemical purity of more than 99 % (w/w). It is freely soluble in water.
                        Chemical formula: C10H12FeN2NaO8 * 3H2O
                        Chemical characteristics:
                        pH of 1 % solution: 3,5-5,5
                        Iron: 12,5-13,5 %
                        Sodium: 5,5 %
                        Water: 12,8 %
                        Organic matter (CHNO): 68,4 %
                        EDTA: 65,5-70,5 %
                        Water insoluble matter: ≤ 0,1 %
                        Nitrilo-triacetic acid: ≤ 0,1 %

                           Ferrous ammonium phosphate

                           Description/Definition:

                        Ferrous ammonium phosphate is a grey/green fine powder, practically insoluble in water and soluble in dilute mineral acids.
                        CAS No.: 10101-60-7
                        Chemical formula: FeNH4PO4

                        Chemical characteristics:
                        pH of 5 % suspension in water: 6,8-7,8
                        Iron (total): ≥ 28 %
                        Iron (II): 22-30 % (w/w)
                        Iron (III): ≤ 7,0 % (w/w)
                        Ammonia: 5-9 % (w/w)
                        Water: ≤ 3,0 %

                           Fish peptides from Sardinops sagax

                           Description/Definition:

                        The novel food ingredient is a peptide mixture, which is obtained by an alkaline protease-catalysed hydrolysis of fish (Sardinops sagax) muscle, subsequent isolation of the peptide fraction by column chromatography, concentration under vacuum and spray drying.
                        Yellowish white powder
                        Peptides (1) (short chain peptides, dipeptides and tripeptides with a molecular weight of less than 2 kDa): ≥ 85 g/100 g
                        Val-Tyr (dipeptide): 0,1-0,16 g/100 g
                        Ash: ≤ 10 g/100 g
                        Moisture: ≤ 8 g/100 g

                                    (1)

                                    Kjeldahl method

                           Flavonoids from Glycyrrhiza glabra

                           Description/Definition:

                        Flavonoids derived from the roots or rootstock of Glycyrrhiza glabra L. are extracted with ethanol followed by further extraction of this ethanolic extract with medium-chain triglycerides. It is a dark-brown coloured liquid, containing 2,5 % to 3,5 % of glabridin.
                        Moisture: < 0,5 %
                        Ash: < 0,1 %
                        Peroxide value (PV): < 0,5 meq/kg
                        Glabridin: 2,5-3,5 % of fat
                        Glycyrrhizinic acid: < 0,005 %
                        Fat including polyphenol-type substances: ≥ 99 %
                        Protein: < 0,1 %
                        Carbohydrates: not detectable

                           Fucoidan extract from the seaweed Fucus vesiculosus

                           Description/Definition:

                        Fucoidan from the seaweed Fucus vesiculosus is extracted using aqueous extraction in acidic solution and filtration processes without the use of organic solvents. The resulting extract is concentrated and dried to yield the fucoidan extract with the following specifications:
                        Off-white to brown powder
                        Odour and Taste: Bland odour and taste
                        Moisture: < 10 % (105 °C for 2 hours)
                        pH value: 4,0-7,0 (1 % suspension at 25 °C)

                           Heavy metals:

                        Arsenic (inorganic): < 1,0 ppm
                        Cadmium: < 3,0 ppm
                        Lead: < 2,0 ppm
                        Mercury: < 1,0 ppm

                           Microbiological criteria:

                        Total aerobic microbial count: < 10 000  CFU/g
                        Yeast and mould count: < 100 CFU/g
                        Total enterobacteria count: Absence/g

                           Escherichia coli: Absence/g

                           Salmonella: Absence/10 g

                           Staphylococcus aureus: Absence/g
                        Composition of the two permitted types of extracts, based on the level of fucoidan:

                           Extract 1:

                        Fucoidan: 75-95 %
                        Alginate: 2,0-5,5 %
                        Polyphloroglucinol: 0,5-15 %
                        Mannitol: 1-5 %
                        Natural salts/Free Minerals: 0,5-2,5 %
                        Other carbohydrates: 0,5-1,0 %
                        Protein: 2,0-2,5 %

                           Extract 2:

                        Fucoidan: 60-65 %
                        Alginate: 3,0-6,0 %
                        Polyphloroglucinol: 20-30 %
                        Mannitol: < 1,0 %
                        Natural salts/Free Minerals: 0,5-2,0 %
                        Other carbohydrates: 0,5-2,0 %
                        Protein: 2,0-2,5 %

                           Fucoidan extract from the seaweed Undaria pinnatifida

                           Description/Definition:

                        Fucoidan from seaweed Undaria pinnatifida is extracted using aqueous extraction in acidic solution and filtration processes without the use of organic solvents. The resulting extract is concentrated and dried to yield the fucoidan extract with the following specifications:
                        Off-white to brown powder
                        Odour and Taste: Bland odour and taste
                        Moisture: < 10 % (105 °C for 2 hours)
                        pH value: 4,0-7,0 (1 % suspension at 25 °C)

                           Heavy metals:

                        Arsenic (inorganic): < 1,0 ppm
                        Cadmium: < 3,0 ppm
                        Lead: < 2,0 ppm
                        Mercury: < 1,0 ppm

                           Microbiology:

                        Total aerobic microbial count: < 10 000  CFU/g
                        Yeast and mould count: < 100 CFU/g
                        Total enterobacteria count: Absence/g

                           Escherichia coli: Absence/g

                           Salmonella: Absence/10 g

                           Staphylococcus aureus: Absence/g
                        Composition of the two permitted types of extracts, based on the level of fucoidan:

                           Extract 1:

                        Fucoidan: 75-95 %
                        Alginate: 2,0-6,5 %
                        Polyphloroglucinol: 0,5-3,0 %
                        Mannitol: 1-10 %
                        Natural salts/Free Minerals: 0,5-1,0 %
                        Other carbohydrates: 0,5-2,0 %
                        Protein: 2,0-2,5 %

                           Extract 2:

                        Fucoidan: 50-55 %
                        Alginate: 2,0-4,0 %
                        Polyphloroglucinol: 1,0-3,0 %
                        Mannitol: 25-35 %
                        Natural salts/Free Minerals: 8-10 %
                        Other carbohydrates: 0,5-2,0 %
                        Protein: 1,0-1,5 %

                           2′-Fucosyllactose

                           (synthetic)

                           Definition:

                        Chemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)- D-glucopyranose
                        Chemical formula: C18H32O15

                        CAS No: 41263-94-9
                        Molecular weight: 488,44 g/mol

                           Description:

                        2′-fucosyllactose is a white to off-white powder that is produced by a chemical synthesis process.

                           Purity:

                        2'-Fucosyllactose: ≥ 95 %
                        D-Lactose: ≤ 1,0 w/w %
                        L-Fucose: ≤ 1,0 w/w %
                        Difucosyl- D-lactose isomers: ≤ 1,0 w/w %
                        2′-Fucosyl- D-lactulose: ≤ 0,6 w/w %
                        pH (20 °C, 5 % solution): 3,2-7,0
                        Water (%): ≤ 9,0 %
                        Ash, sulphated: ≤ 0,2 %
                        Acetic acid: ≤ 0,3 %
                        Residual solvents (methanol, 2-propanol, methyl acetate, acetone): ≤ 50,0 mg/kg singly, ≤ 200,0 mg/kg in combination
                        Residual proteins: ≤ 0,01 %

                           Heavy Metals:

                        Palladium: ≤ 0,1 mg/kg
                        Nickel: ≤ 3,0 mg/kg

                           Microbiological criteria:

                        Aerobic mesophilic bacteria total count: ≤ 500 CFU/g
                        Yeasts and Moulds: ≤ 10 CFU/g
                        Residual endotoxins: ≤ 10 EU/mg

                           2'-Fucosyllactose

                           (microbial source)

                           Definition:

                        Chemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose
                        Chemical formula: C18H32O15

                        CAS No: 41263-94-9
                        Molecular weight: 488,44 g/mol

                           Source:

                        Genetically modified strain of Escherichia coli K-12

                           Source:

                        Genetically modified strain of Escherichia coli BL21

                           Description:

                        2′-Fucosyllactose is a white to off-white powder that is produced by a microbial process.

                           Purity:

                        2'-Fucosyllactose: ≥ 90 %
                        D-Lactose: ≤ 3,0 %
                        L-Fucose: ≤ 2,0
                        Difucosyl-D-lactose: ≤ 2,0 %
                        2′-Fucosyl-D-lactulose: ≤ 1,0 %
                        pH (20 °C, 5 % solution): 3,0-7,5
                        Water: ≤ 9,0 %
                        Sulphated ash: ≤ 2,0 %
                        Acetic acid: ≤ 1,0 %
                        Residual proteins: ≤ 0,01 %

                           Microbiological criteria:

                        Aerobic mesophilic bacteria total count: ≤ 3 000  CFU/g
                        Yeasts: ≤ 100 CFU/g
                        Moulds: ≤ 100 CFU/g
                        Endotoxins: ≤ 10 EU/mg

                           Description:

                        2′-Fucosyllactose is a white to off white powder and the liquid concentrate (45 % ± 5 % w/v) aqueous solution is a colourless to slight yellow clear aqueous solution. 2'-Fucosyllactose is produced by a microbiological process.

                           Purity:

                        2'-Fucosyllactose: ≥ 90 %
                        Lactose: ≤ 5,0 %
                        Fucose: ≤ 3,0 %
                        3-Fucosyllactose: ≤ 5,0 %
                        Fucosylgalactose: ≤ 3,0 %
                        Difucosyllactose: ≤ 5,0 %
                        Glucose: ≤ 3,0 %
                        Galactose: ≤ 3,0 %
                        Water: ≤ 9,0 % (powder)
                        Ash, sulphated: ≤ 0,5 % (powder and liquid)
                        Residual proteins: ≤ 0,01 % (powder and liquid)

                           Heavy Metals:

                        Lead: ≤ 0,02 mg/kg (powder and liquid);
                        Arsenic: ≤ 0,2 mg/kg (powder and liquid)
                        Cadmium: ≤ 0,1 mg/kg (powder and liquid)
                        Mercury: ≤ 0,5 mg/kg (powder and liquid)

                           Microbiological criteria:

                        Total plate count: ≤ 104 CFU/g (powder), ≤ 5 000  CFU/g (liquid)
                        Yeasts and Moulds: ≤ 100 CFU/g (powder); ≤ 50 CFU/g (liquid)
                        Enterobacteriaceae/Coliforms: absence in 11g (powder and liquid)

                           Salmonella: negative/100 g (powder), negative/200 ml (liquid)

                           Cronobacter: negative/100 g (powder), negative/200 ml (liquid)
                        Endotoxins: ≤ 100 EU/g (powder), ≤ 100 EU/ml (liquid)
                        Aflatoxin M1: ≤ 0,025 μg/kg (powder and liquid)

                           Galacto-oligosaccharide

                           Description/Definition:

                           Galacto-oligosaccharide is produced from milk lactose by an enzymatic process using β-galactosidases from Aspergillus oryzae, Bifidobacterium bifidum, Pichia pastoris, Sporobolomyces singularis, Kluyveromyces lactis, Bacillus circulans, and Papiliotrema terrestris
                           .
                        GOS: min 46 % Dry Matter (DM)
                        Lactose: max 40 % DM
                        Glucose: max 27 % DM
                        Galactose: min 0,8 % DM
                        Ash: max 4,0 % DM
                        Protein: max 4,5 % DM
                        Nitrite: max. 2 mg/kg

                           Glucosamine HCl from Aspergillus niger and genetically modified strain of E. coli K-12

                        White crystalline odourless powder
                        Molecular formula: C6H13NO5 · HCl
                        Relative molecular mass: 215,63 g/mol
                        D-Glucosamine HCl 98,0-102,0 % of reference standard (HPLC)
                        Specific rotation + 70,0o - + 73,0o

                           Glucosamine sulphate KCl from Aspergillus niger and genetically modified strain of E. coli K-12

                        White crystalline odourless powder
                        Molecular formula: (C6H14NO5)2SO4 · 2KCl
                        Relative molecular mass: 605,52 g/mol
                        D-Glucosamine Sulphate 2KCl 98,0-102,0 % of reference standard (HPLC)
                        Specific Rotation +50,0o to +52,0o

                           Glucosamine sulphate NaCl from Aspergillus niger and genetically modified strain of E. coli K-12

                        White crystalline odourless powder
                        Molecular formula: (C6H14NO5)2SO4 · 2NaCl
                        Relative molecular mass: 573,31 g/mol
                        D-Glucosamine HCl: 98-102 % of reference standard (HPLC)
                        Specific Optical Rotation: +52o - +54o

                           Guar Gum

                           Description/Definition:

                        Native guar gum is the ground endosperm of seeds from natural strains of guar Cyamopsis tetragonolobus L. Taub. (Leguminosae family). It consists of a high molecular weight polysaccharide, primarily composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as a galactomannan (galactomannan content not less than 75 %).
                        Appearance: White to yellowish powder
                        Molecular weight: Between 50 000  – 8 000 000  Daltons
                        CAS number: 9000-30-0
                        Einecs Number: 232-536-8
                        Purity: As specified by Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (7) & by Commission Implementing Regulation (EU) 2015/175 of 5 February 2015 laying down special conditions applicable to the import of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins (8).

                           Physico-chemical properties:

                           Powder

                        Shelf-life: 2 years
                        Colour: White
                        Odour: Light
                        Average diameter of particles: 60-70μm
                        Moisture: Max 15 %
                        Viscosity * at 1 hour —
                        Viscosity * at 2 hours: Min 3 600  mPa.s
                        Viscosity * at 24 hours: Min 4 000  mPa.s
                        Solubility: Soluble in hot and cold water
                        pH for 10g/L, at 25 °C - 6-7,5

                           Flakes

                        Useful life: 1 year
                        Colour: White/off white with absence or minimal presence of black spots
                        Odour: Light
                        Average diameter of particles: 1-10 mm
                        Moisture: Max 15 %
                        Viscosity * at 1 hour: Min 3 000  mPa.s
                        Viscosity * at 2 hours —
                        Viscosity * at 24 hours —
                        Solubility — Soluble in hot and cold water
                        pH for 10g/L, at 25 °C - 5-7,5

                                    (*)

                                    The measurements of viscosity are carried out under the following conditions: 1 %, 25 °C, 20 rpm

                           Heat-treated milk products fermented with Bacteroides xylanisolvens

                           Description/Definition:

                        Heat-treated fermented milk products are produced with Bacteroides xylanisolvens (DSM 23964) as starter culture.
                        Semi-skimmed milk (between 1,5 % and 1,8 % fat) or skimmed milk (0,5 % fat or less) is pasteurised or ultra-heat-treated before starting the fermentation with Bacteroides xylanisolvens (DSM 23964). The resulting fermented milk product is homogenised and then heat-treated to inactivate Bacteroides xylanisolvens (DSM 23964). The final product does not contain viable cells of Bacteroides xylanisolvens (DSM 23964)(1).

                                    (1)

                                    Modified DIN EN ISO 21528-2.

                           Hydroxytyrosol

                           Description/Definition:

                        Hydroxytyrosol is a pale yellow viscous liquid obtained by chemical synthesis
                        Molecular formula: C8H10O3

                        Molecular weight: 154,6 g/mol
                        CAS No: 10597-60-1
                        Moisture ≤ 0,4 %
                        Odour: Characteristic
                        Taste: Slightly bitter
                        Solubility (water): Miscible with water
                        pH: 3,5-4,5
                        Refractive Index: 1,571-1,575

                           Purity:

                        Hydroxytyrosol: ≥ 99 %
                        Acetic acid: ≤ 0,4 %
                        Hydroxytyrosol acetate: ≤ 0,3 %
                        Sum of homovanillic acid, iso-homovanilic acid, and 3-methoxy-4hydroxyphenylglycol: ≤ 0,3 %

                           Heavy Metals

                        Lead: ≤ 0,03 mg/kg
                        Cadmium: ≤ 0,01 mg/kg
                        Mercury: ≤ 0,01 mg/kg

                           Residual Solvents

                        Ethyl acetate: ≤ 25,0 mg/kg
                        Isopropanol: ≤ 2,50 mg/kg
                        Methanol: ≤ 2,00 mg/kg
                        Tetrahydrofuran: ≤ 0,01 mg/kg

                           Ice Structuring Protein type III HPLC 12

                           Description/Definition:

                        The Ice Structuring Protein (ISP) preparation is a light-brown liquid produced by submerged fermentation of a genetically-modified strain of food-grade baker’s yeast (Saccharomyces cerevisiae) in which a synthetic gene for the ISP has been inserted into the yeast’s genome. The protein is expressed and secreted into the growth medium where it is separated from the yeast cells by micro-filtration and concentrated by ultra-filtration. As a result, the yeast cells are not transferred into the ISP preparation as such or under an altered form. The ISP preparation consists of native ISP, glycosylated ISP and proteins and peptides from the yeast and sugars as well as acids and salts commonly found in food. The concentrate is stabilised with 10 mM citric acid buffer.
                        Assay: ≥ 5 g/l active ISP
                        pH: 2,5-3,5
                        Ash: ≤ 2,0 %
                        DNA: Not detectable

                           Aqueous extract of dried leaves of Ilex guayusa

                           Description/Definition:

                        Dark brown liquid. Aqueous extracts of dried leaves of Ilex guayusa.

                           Composition:

                        Protein: < 0,1 g/100 ml
                        Fat: < 0,1 g/100 ml
                        Carbohydrate: 0,2–0,3 g/100 ml
                        Total sugars: < 0,2 g/100 ml
                        Caffeine: 19,8–57,7 mg/100 ml
                        Theobromine: 0,14–2,0 mg/100 ml
                        Chlorogenic acids: 9,9–72,4 mg/100ml

                           Isomalto-oligosaccharide

                           Powder:

                        Solubility (water) (%): > 99
                        Glucose (% dry basis): ≤ 5,0
                        Isomaltose + DP3 to DP9 (% dry basis): ≥ 90
                        Moisture (%): ≤ 4,0
                        Sulphated ash(g/100 g): ≤ 0,3

                           Heavy metals:

                        Lead (mg/kg): ≤ 0,5
                        Arsenic (mg/kg): ≤ 0,5

                           Syrup:

                        Dried solids (g/100 g): > 75
                        Glucose (% dry basis): ≤ 5,0
                        Isomaltose + DP3 to DP9 (% dry basis): ≥ 90
                        pH: 4 - 6
                        Sulphated ash(g/100 g): ≤ 0,3

                           Heavy metals:

                        Lead (mg/kg): ≤ 0,5
                        Arsenic (mg/kg): ≤ 0,5

                           Isomaltulose

                           Description/Definition:

                        A reducing disaccharide that consists of one glucose and one fructose moiety linked by an alpha-1,6-glycosidic bond. It is obtained from sucrose by an enzymatic process. The commercial product is the monohydrate. Appearance: Virtually odourless, white or almost white crystals with a sweet taste
                        Chemical name: 6-O-α-D-glucopyranosyl-D-fructofuranose, monohydrate
                        CAS No.: 13718-94-0
                        Chemical formula: C12H22O11 · H2O
                        Structural formula

                        Formula weight: 360,3 (monohydrate)

                           Purity:

                        Assay: ≥ 98 % on the dry basis
                        Loss on drying: ≤ 6,5 % (60 °C, 5 hours)

                           Heavy metals:

                        Lead: ≤ 0,1 mg/kg
                        Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in FNP 5(1), ‘Instrumental methods’

                                    (1)

                                    Food and Nutrition Paper 5 Rev. 2 — Guide to specifications for general notices, general analytical techniques, identification tests, test solutions and other reference materials (JECFA), 1991, 322 pp., English, ISBN 92-5-102991-1.

                           Lactitol

                           Description/Definition:

                        Crystalline powder or colourless solution manufactured via catalytic hydrogenation of lactose. Crystalline products occur in anhydrous, monohydrate and dihydrate forms. Nickel is used as a catalyst.
                        Chemical name: 4-O-β-D-Galactopyranosyl-D-glucitol
                        Chemical formula: C12H24O11

                        Molecular weight: 344,31 g/mol
                        CAS No: 585-86-4

                           Purity:

                        Solubility (in water): Very soluble in water
                        Specific rotation [α]D
                           20 = + 13o to + 16o

                        Assay: ≥ 95 % d.b (d.b — expressed on the dry weight basis)
                        Water: ≤ 10,5 %
                        Other polyols: ≤ 2,5 % d.b
                        Reducing sugars: ≤ 0,2 % d.b
                        Chlorides: ≤ 100 mg/kg d.b
                        Sulphates: ≤ 200 mg/kg d.b
                        Sulphated ash: ≤ 0,1 % d.b
                        Nickel: ≤ 2,0 mg/kg d.b
                        Arsenic: ≤ 3,0 mg/kg d.b
                        Lead: ≤ 1,0 mg/kg d.b

                           Lacto-N-neotetraose

                           (synthetic)

                           Definition:

                        Chemical name: β-D-Galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)- D-glucopyranose
                        Chemical formula: C26H45NO21

                        CAS No: 13007-32-4
                        Molecular weight: 707,63 g/mol

                           Description:

                        Lacto-N-neotetraose is a white to off-white powder. Produced by a chemical synthesis process and is isolated by crystallisation.

                           Purity:

                        Assay (water free): ≥ 96 %
                        D-Lactose: ≤ 1,0 %
                        Lacto-N-triose II: ≤ 0,3 %
                        Lacto-N-neotetraose fructose isomer: ≤ 0,6 %
                        pH (20 °C, 5 % solution): 5,0-7,0
                        Water: ≤ 9,0 %
                        Ash, sulphated: ≤ 0,4 %
                        Acetic acid: ≤ 0,3 %
                        Residual solvents (methanol, 2-propanol, methyl acetate, acetone): ≤ 50 mg/kg singly, ≤ 200 mg/kg in combination
                        Residual proteins: ≤ 0,01 %
                        Palladium: ≤ 0,1 mg/kg
                        Nickel: ≤ 3,0 mg/kg

                           Microbiological criteria:

                        Aerobic mesophilic bacteria total count: ≤ 500 CFU/g
                        Yeasts: ≤ 10 CFU/g
                        Moulds: ≤ 10 CFU/g
                        Residual endotoxins: ≤ 10 EU/mg

                           Lacto-N-neotetraose

                           (microbial source)

                           Definition:

                        Chemical name: β-D-Galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose
                        Chemical formula: C26H45NO21

                        CAS No: 13007-32-4
                        Molecular weight: 707,63 g/mol

                           Source:

                        Genetically modified strain of Escherichia coli K-12

                           Description:

                        Lacto-N-neotetraose is a white to off-white powder that is produced by a microbiological process. Lacto-N-neotetraose is isolated by crystallisation.

                           Purity:

                        Assay (water free): ≥ 92 %
                        D-Lactose: ≤ 3,0 %
                        Lacto-N-triose II: ≤ 3,0 %

                           para-Lacto-N-neohexaose: ≤ 3,0 %
                        Lacto-N-neotetraose fructose isomer: ≤ 1,0 %
                        pH (20 °C, 5 % solution): 4,0-7,0
                        Water: ≤ 9,0 %
                        Ash, sulphated: ≤ 0,4 %
                        Residual solvents (methanol): ≤ 100 mg/kg
                        Residual proteins: ≤ 0,01 %

                           Microbiological criteria:

                        Aerobic mesophilic bacteria total count: ≤ 500 CFU/g
                        Yeasts: ≤ 10 CFU/g
                        Moulds: ≤ 10 CFU/g
                        Residual endotoxins: ≤ 10 EU/mg

                           Lucerne leaf extract from Medicago sativa

                           Description/Definition:

                        The Lucerne (Medicago sativa L.) is processed within 2 hours after harvest. It is chopped and crushed. By passing through an oleaginous-type press, the Lucerne provides a fibrous residue and press juice (10 % of dry matter). The dry matter of this juice contains about 35 % of crude protein. The press juice (pH 5,8-6,2) is neutralised. Preheating and vapour injection allows coagulation of proteins associated with carotenoid and chlorophyll pigments. The protein precipitate is separated by centrifugation and thereafter dried. After adding ascorbic acid the Lucerne protein concentrate is granulated and stored in inert gas or in cold storage.

                           Composition:

                        Protein: 45-60 %
                        Fat: 9-11 %
                        Free carbohydrates (soluble fibre): 1-2 %
                        Polysaccharides (insoluble fibre): 11-15 %
                        including cellulose: 2-3 %
                        Minerals: 8-13 %
                        Saponins: ≤ 1,4 %
                        Isoflavones: ≤ 350 mg/kg
                        Coumestrol: ≤ 100 mg/kg
                        Phytates: ≤ 200 mg/kg
                        L-canavanine: ≤ 4,5 mg/kg

                           Lycopene

                           Description/Definition:

                        Synthetic lycopene is produced by the Wittig condensation of synthetic intermediates commonly used in the production of other carotenoids used in food. Synthetic lycopene consists of ≥ 96 % lycopene and minor quantities of other related carotenoid components. Lycopene is presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Antioxidative protection has to be assured.
                        Chemical name: Lycopene
                        CAS No.: 502-65-8 (all-trans lycopene)
                        Chemical formula: C40H56

                        Formula weight: 536,85 Da

                           Lycopene from Blakeslea trispora

                           Description/Definition:

                        The purified lycopene from Blakeslea trispora consists of ≥ 95 % lycopene and ≤ 5 % other carotenoids. It is presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Anti-oxidative protection has to be assured.
                        Chemical name: Lycopene
                        CAS No.: 502-65-8 (all trans lycopene)
                        Chemical formula: C40H56

                        Formula weight: 536,85 Da

                           Lycopene from tomatoes

                           Description/Definition:

                        The purified lycopene from tomatoes (Lycopersicon esculantum L.) consists of ≥ 95 % lycopene and ≤ 5 % other carotenoids. It is presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Anti-oxidative protection has to be assured.
                        Chemical name: Lycopene
                        CAS No.: 502-65-8 (all trans lycopene)
                        Chemical formula: C40H56

                        Formula weight: 536,85 Da

                           Lycopene oleoresin from tomatoes

                           Description/Definition:

                        Lycopene oleoresin from tomatoes is obtained by solvent extraction of ripe tomatoes (Lycopersicon esculentum Mill.) with subsequent removal of the solvent. It is a red to dark brown viscous, clear liquid.
                        Total lycopene: 5-15 %
                        Thereof trans-lycopene: 90-95 %
                        Total carotenoids (calculated as lycopene): 6,5-16,5 %
                        Other carotenoids: 1,75 %
                        (Phytoene/phytofluene/β-carotene): (0,5-0,75/0,4-0,65/0,2-0,35 %)
                        Total tocopherols: 1,5-3,0 %
                        Unsaponifiable matter: 13-20 %
                        Total fatty acids: 60-75 %
                        Water (Karl Fischer): ≤ 0,5 %

                           Magnesium citrate malate

                           Description/Definition:

                        Magnesium citrate malate is a white to yellowish-white, amorphous powder.
                        Chemical formula: Mg5(C6H5O7)2(C4H4O5)2

                        Chemical name: Pentamagnesium di-(2-hydroxybutanedioate)-di-(2- hydroxypropane-1,2,3-tricarboxylate)
                        CAS No.: 1259381-40-2
                        Molecular weight: 763,99 Daltons (anhydrous)
                        Solubility: Freely soluble in water (about 20 g in 100 ml)
                        Description of the physical state: Amorphous powder
                        Assay magnesium: 12,0-15,0 %
                        Loss on drying (120 °C/4 hours): ≤ 15 %
                        Colour (solid): White to yellowish-white
                        Colour (20 % aqueous solution): Colourless to yellowish
                        Appearance (20 % aqueous solution): Clear solution
                        pH (20 % aqueous solution): Approx. 6,0

                           Impurities:

                        Chloride: ≤ 0,05 %
                        Sulphate: ≤ 0,05 %
                        Arsenic: ≤ 3,0 ppm
                        Lead: ≤ 2,0 ppm
                        Cadmium: ≤ 1 ppm
                        Mercury: ≤ 0,1 ppm

                           Magnolia Bark Extract

                           Description/Definition:

                        Magnolia bark extract is obtained from the bark of the plant Magnolia officinalis L. and produced with supercritical carbon dioxide. The bark is washed and oven dried to reduce moisture content before being crushed and extracted with supercritical carbon dioxide. The extract is dissolved in medical-grade ethanol and re-crystallised to yield magnolia bark extract.
                        Magnolia bark extract is mainly composed of two phenolic compounds, magnolol and honokiol.
                        Appearance: Light brownish powder

                           Purity:

                        Magnolol: ≥ 85,2 %
                        Honokiol: ≥ 0,5 %
                        Magnolol & Honokiol: ≥ 94 %
                        Total Eudesmol: ≤ 2 %
                        Moisture: 0,50 %

                           Heavy metals:

                        Arsenic (ppm): ≤ 0,5
                        Lead (ppm): ≤ 0,5
                        Methyl eugenol (ppm): ≤ 10
                        Tubocurarine (ppm): ≤ 2,0
                        Total Alkaloid (ppm): ≤ 100

                           Maize-germ oil high in unsaponifiable matter

                           Description/Definition:

                        Maize-germ oil high in unsaponifiable matter is produced by vacuum distillation and it is different from refined maize-germ oil in the concentration of the unsaponifiable fraction (1,2 g in refined maize-germ oil and 10 g in ‘maize-germ oil high in unsaponifiable matter’).

                           Purity:

                        Unsaponifiable matter: > 9,0 g/100 g
                        Tocopherols: ≥ 1,3 g/100 g
                        α-tocopherol (%): 10-25 %
                        β-tocopherol (%): < 3,0 %
                        γ-tocopherol (%): 68-89 %
                        δ-tocopherol (%): < 7,0 %
                        Sterols, triterpenic alcohols, methylsterols: > 6,5 g/100 g
                        Fatty acids in triglycerides:
                        palmitic acid: 10,0-20,0 %
                        stearic acid: < 3,3 %
                        oleic acid: 20,0-42,2 %
                        linoleic acid: 34,0-65,6 %
                        linolenic acid: < 2,0 %
                        Acid value: ≤ 6,0 mg KOH/g
                        Peroxide value (PV): ≤ 10 mEq O2/kg

                           Heavy metals:

                        Iron (Fe): < 1 500  μg/kg
                        Copper (Cu): < 100 μg/kg

                           Impurities:

                        Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: < 2 μg/kg
                        Treatment with active carbon is required to ensure that polycyclic aromatic hydrocarbons (PAH) are not enriched in the production of ‘maize-germ oil high in unsaponifiable matter’

                           Methylcellulose

                           Description/Definition:

                        Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups.
                        Chemical name: Methyl ether of cellulose
                        Chemical formula: The polymers contain substituted anhydroglucose units with the following general formula:
                        C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the following:

                                    —

                                    H

                                    —

                                    CH3 or

                                    —

                                    CH2CH3

                              Molecular weight: Macromolecules: from about 20 000  (n about 100) up to about 380 000  g/mol (n about 2 000 )
                        Assay: Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)
                        Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder.
                        Solubility: Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol, ether and chloroform. Soluble in glacial acetic acid.

                           Purity:

                        Loss on drying: ≤ 10 % (105 °C, 3 hours)
                        Sulphated Ash: ≤ 1,5 % determined at 800 ± 25 °C
                        pH: ≥ 5,0 and ≤ 8,0 (1 % colloidal solution)

                           Heavy metals:

                        Arsenic: ≤ 3,0 mg/kg
                        Lead: ≤ 2,0 mg/kg
                        Mercury: ≤ 1,0 mg/kg
                        Cadmium: ≤ 1,0 mg/kg

                           (6S)-5-methyltetrahydrofolic acid, glucosamine salt

                           Description/Definition:

                        Chemical name: N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic acid, glucosamine salt
                        Chemical formula: C32H51N9O16

                        Molecular weight: 817,80 g/mol (anhydrous)
                        CAS No.: 1181972-37-1
                        Appearance: Creamy to light-brown powder

                           Purity:

                        Diastereoisomeric purity: At least 99 % of (6S)-5-methyltetrahydrofolic acid
                        Glucosamine assay: 34-46 % in dry basis
                        5-Methyltetrahydrofolic acid assay: 54-59 % in dry basis
                        Water: ≤ 8,0 %

                           Heavy metals:

                        Lead: ≤ 2,0 ppm
                        Cadmium: ≤ 1,0 ppm
                        Mercury: ≤ 0,1 ppm
                        Arsenic: ≤ 2,0 ppm
                        Boron: ≤ 10 ppm

                           Microbiological criteria:

                        Total aerobic microbial count: ≤ 100 CFU/g
                        Yeasts and moulds: ≤ 100 CFU/g

                           Escherichia coli: Absence in 10g

                           Monomethylsilanetriol (Organic Silicon)

                           Description/Definition:

                        Chemical name: Silanetriol, 1-methyl-
                        Chemical formula: CH6O3Si
                        Molecular weight: 94,14 g/mol
                        CAS No: 2445-53-6

                           Purity:

                        Organic Silicon (monomethylsilanetriol) preparation (aqueous solution):
                        Acidity (pH): 6,4-6,8
                        Silicon: 100-150 mg Si/l

                           Heavy metals:

                        Lead: ≤ 1,0 μg/l
                        Mercury: ≤ 1,0 μg/l
                        Cadmium: ≤ 1,0 μg/l
                        Arsenic: ≤ 3,0 μg/l

                           Solvents:

                        Methanol: ≤ 5,0 mg/kg (residual presence)

                           Mycelial extract from Shiitake mushroom (Lentinula edodes)

                           Description/Definition:

                        The novel food ingredient is a sterile aqueous extract obtained from the mycelium of Lentinula edodes cultivated in a submerged fermentation. It is a light brown, slightly turbid liquid.
                        Lentinan is a β-(1-3) β-(1-6)-D-glucan which has a molecular weight of approximately 5 × 105 Daltons, a degree of branching of 2/5 and a triple helical tertiary structure.

                           Purity/Composition of the mycelial extract from Lentinula edodes:

                        Moisture: 98 %
                        Dry matter: 2 %
                        Free glucose: < 20 mg/ml
                        Total protein(1): < 0,1 mg/ml
                        N-containing constituents(2): < 10 mg/ml
                        Lentinan: 0,8 – 1,2 mg/ml\

                                    (1)

                                    Bradford method

                                    (2)

                                    Kjeldahl method

                           Noni fruit juice (Morinda citrifolia)

                           Description/Definition:

                        Noni fruits (fruits of Morinda citrifolia L.) are pressed. The obtained juice is pasteurised. An optional fermentation step before or after the pressing may occur.
                        Rubiadin: ≤ 10 μg/kg
                        Lucidin: ≤ 10 μg/kg

                           Noni fruit juice powder (Morinda citrifolia)

                           Description/Definition:

                        Seeds and skin of the sun-dried fruits of Morinda citrifolia are separated. The obtained pulp is filtered to separate juice from the flesh. Desiccation of the produced juice occurs in one or two ways:
                        Either by atomisation using maize maltodextrins, this mixture is obtained by keeping the rates of inflow of the juice and maltodextrins constant
                        Or by zeodratation or drying and then mixing with an excipient, this process allows the juice to be dried initially and then mixed with maltodextrins (same amount as used in atomisation).

                           Noni fruit puree and concentrate (Morinda citrifolia)

                           Description/Definition:

                        The fruits of Morinda citrifolia are harvested by hand. Seeds and skin may be separated mechanically from the pureed fruits. After pasteurisation, the puree is packaged in aseptic containers and stored under cold conditions.

                           Morinda citrifolia concentrate is prepared from M. citrifolia puree by treatment with pectinolytic enzymes (50– 60 °C for 1-2 h). Then the puree is heated to inactivate the pectinases and then immediately cooled. The juice is separated in a decanter centrifuge. Afterwards the juice is collected and pasteurised, prior to being concentrated in a vacuum evaporator from a brix of 6 to 8 to a brix of 49 to 51 in the final concentrate.

                           Composition:

                           Puree:

                        Moisture: 89-93 %
                        Protein: < 0,6 g/100 g
                        Fat: ≤ 0,4 g/100 g
                        Ash: < 1,0 g/100 g
                        Total carbohydrates: 5-10 g/100 g
                        Fructose: 0,5-3,82 g/100 g
                        Glucose: 0,5-3,14 g/100 g
                        Dietary fibre: < 0,5-3 g/100 g
                        5,15-dimethylmorindol (1): ≤ 0,254 μg/ml
                        Lucidin (1): Not detectable
                        Alizarin (1): Not detectable
                        Rubiadin (1): Not detectable

                           Concentrate:

                        Moisture: 48-53 %
                        Protein: 3-3,5 g/100 g
                        Fat: < 0,04 g/100 g
                        Ash: 4,5-5,0 g/100 g
                        Total carbohydrates: 37-45 g/100 g
                        Fructose: 9-11 g/100 g
                        Glucose: 9-11 g/100 g
                        Dietary fibre: 1,5-5,0 g/100 g
                        5,15-dimethylmorindol (1): ≤ 0,254 μg/ml

                                    (1)

                                    By an HPLC-UV method developed and validated for the analysis of anthraquinones in Morinda citrifolia puree and concentrate. Limits of detection: 2,5 ng/ml (5,15 dimethylmorindol); 50,0 ng/ml (lucidin); 6,3 ng/ml (alizarin) and 62,5 ng/ml (rubiadin).

                           Noni leaves (Morinda citrifolia)

                           Description/Definition:

                        After cutting, the leaves of Morinda citrifolia are subject to drying and roasting steps. The product has a particle size ranging from broken leaves to coarse powder with fines. It is of greenish brown to brown colour.

                           Purity/Composition:

                        Moisture: < 5,2 %
                        Protein: 17- 20 %
                        Carbohydrate: 55-65 %
                        Ash: 10-13 %
                        Fat: 4-9 %
                        Oxalic acid: < 0,14 %
                        Tannic acid: < 2,7 %
                        5,15-dimethylmorindol: < 47 mg/kg
                        Rubiadin: non detectable, ≤ 10 μg/kg
                        Lucidin: non detectable, ≤ 10 μg/kg

                           Noni fruit powder (Morinda citrifolia)

                           Description/Definition:

                        Noni fruit powder is made from pulped noni (Morinda citrifolia L.) fruits by freeze-drying. Fruits are pulped and seeds are removed. After freeze-drying during which water is removed from noni fruits, the remaining noni pulp is milled to a powder and encapsulated.

                           Purity/Composition

                        Moisture: 5,3-9 %
                        Protein: 3,8-4,8 g/100 g
                        Fat: 1-2 g/100 g
                        Ash: 4,6-5,7 g/100 g
                        Total carbohydrates: 80-85 g/100 g
                        Fructose: 20,4-22,5 g/100 g
                        Glucose: 22-25 g/100 g
                        Dietary fibre: 15,4-24,5 g/100 g
                        5,15-dimethylmorindol (1): ≤ 2,0 μg/ml

                                    (1)

                                    By an HPLC-UV method developed and validated for the analysis of anthraquinones in Morinda citrifolia fruit powder. Limits of detection: 2,5 ng/ml (5,15 dimethylmorindol)

                              Odontella aurita microalgae

                        Silicon: 3,3 %
                        Crystalline silica: max 0,1-0,3 % as impurity

                           Oil enriched with phytosterols/phytostanols

                           Description/Definition:

                        Oil enriched with phytosterols/phytostanols is composed of an oil fraction and a phytosterol fraction.

                           Acylglycerol Distribution:

                        Free fatty acids (expressed as oleic acid): ≤ 2,0 %
                        Monoacylglycerols (MAG): ≤ 10 %
                        Diacylglycerols (DAG): ≤ 25 %
                        Triacylglycerols (TAG): Making up the balance

                           Phytosterol fraction:

                        β-sitosterol: ≤ 80 %
                        β-sitostanol: ≤ 15 %
                        campesterol: ≤ 40 %
                        campestanol: ≤ 5,0 %
                        stigmasterol: ≤ 30 %
                        brassicasterol ≤ 3,0 %
                        other sterols/stanols: ≤ 3,0 %

                           Others:

                        Moisture and volatile: ≤ 0,5 %
                        Peroxide value (PV): < 5,0 meq/kg
                        Trans fatty acids: ≤ 1 %
                        Contamination/Purity (GC-FID or equivalent method) of phytosterols/phytostanols:
                        Phytosterols and phytostanols extracted from sources other than vegetable oil suitable for food have to be free of contaminants, best ensured by a purity of more than 99 %.

                           Oil extracted from squids

                        Acid value: ≤ 0,5 KOH/g oil
                        Peroxide value (PV): ≤ 5 meq O2/kg oil
                        p-Anisidine value: ≤ 20
                        Cold test at 0 °C: ≤ 3 hours
                        Moisture: ≤ 0,1 % (w/w)
                        Unsaponifiable matter: ≤ 5,0 %
                        Trans fatty acids: ≤ 1,0 %
                        Docosahexaeonic acid: ≥ 20 %
                        Eicosapentaenoic acid: ≥ 10 %

                           Pasteurised fruit-based preparations produced using high-pressure treatment

                           Parameter

                           Target

                           Comments

                        Fruit storage before high-pressure treatment

                        Minimum 15 days at – 20 °C

                        Fruit harvested and stored in conjunction with good/hygienic agricultural and manufacturing practices

                        Fruit added

                        40 % to 60 % of thawed fruit

                        Fruit homogenised and added to other ingredients

                        pH

                        3,2 to 4,2

                           o Brix

                        7 to 42

                        Assured by added sugars

                        aw

                        < 0,95

                        Assured by added sugars

                        Final storage

                        60 days maximum at + 5 °C maximum

                        Equivalent to storage regimen for conventionally processed product

                           Phosphated maize starch

                           Description/Definition:

                        Phosphated maize starch (phosphated distarch phosphate) is a chemically modified resistant starch derived from high amylose starch by combining chemical treatments to create phosphate cross-links between carbohydrate residues and esterified hydroxyl groups.
                        The novel food ingredient is a white or nearly white powder.
                        CAS No: 11120-02-8
                        Chemical formula: (C6H10O5)n [(C6H9O5)2PO2H]x [(C6H9O5)PO3H2]y
                        n = number of glucose units; x, y = degrees of substitution
                        The chemical characteristics of phosphated distarch phosphate:
                        Loss on drying: 10-14 %
                        pH: 4,5-7,5
                        Dietary fibre: ≥ 70 %
                        Starch: 7-14 %
                        Protein: ≤ 0,8 %
                        Lipids: ≤ 0,8 %
                        Residual bound phosphorus: ≤ 0,4 % (as phosphorus) ‘high amylose maize’ as source

                           Phosphatidylserine from fish phospholipids

                           Description/Definition:

                        The novel food ingredient is yellow to brown powder. Phosphatidylserine is obtained from fish phospholipids by an enzymatic transphosphorylation with the amino acid L-serine.

                           Specification of the phosphatidylserine product manufactured from fish phospholipids:

                        Moisture: < 5,0 %
                        Phospholipids: ≥ 75 %
                        Phosphatidylserine: ≥ 35 %
                        Glycerides: < 4,0 %
                        Free L-serine: < 1,0 %
                        Tocopherols: < 0,5 % (1)
                        Peroxide value (PV): < 5,0 meq O2/kg

                                    (1)

                                    Tocopherols may be added as antioxidants according to Commission Regulation (EU) No 1129/2011

                           Phosphatidylserine from soya phospholipids

                           Description/Definition:

                        The novel food ingredient is off-white to light yellow powder. It is also available in liquid form with a clear brown to orange colour. The liquid form contains medium chain triacylglycerides (MCT) as a carrier. It contains lower levels of Phosphatidylserine due to the fact that it includes significant amounts of oil (MCT).
                        Phosphatidylserine from soya phospholipids is obtained through enzymatic transphosphatidylation of high-phosphatidylcholine soybean lecithin with the amino acid L-serine. Phosphatidylserine consists of a glycerophosphate skeleton conjugated with two fatty acids and L-serine via a phosphodiester linkage.

                           Characteristics of Phosphatidylserine from soya phospholipids:

                           Powder form:

                        Moisture: < 2,0 %
                        Phospholipids: ≥ 85 %
                        Phosphatidylserine: ≥ 61 %
                        Glycerides: < 2,0 %
                        free L-serine: < 1,0 %
                        Tocopherols: < 0,3 %
                        Phytosterols: < 0,2 %

                           Liquid form:

                        Moisture: < 2,0 %
                        Phospholipids: ≥ 25 %
                        Phosphatidylserine: ≥ 20 %
                        Glycerides: not applicable
                        free L-serine: < 1,0 %
                        Tocopherols: < 0,3 %
                        Phytosterols: < 0,2 %

                           Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid

                           Description/Definition:

                        The product is manufactured through enzymatic conversion of soy lecithin. The phospholipid product is a highly concentrated, yellow-brown powder form of phosphatidylserine and phosphatidic acid at an equal level.

                           Specification of the product:

                        Moisture: ≤ 2,0 %
                        Total phospholipids: ≥ 70 %
                        Phosphatidylserine: ≥ 20 %
                        Phosphatidic acid: ≥ 20 %
                        Glycerides: ≤ 1,0 %
                        Free L-serine: ≤ 1,0 %
                        Tocopherols: ≤ 0,3 %
                        Phytosterols: ≤ 2,0 %
                        Silicon dioxide is used with a maximum content of 1,0 %

                           Phospholipides from egg yolk

                        85 % and 100 % pure Phospholipides from egg yolk

                           Phytoglycogen

                           Description: White to off-white powder which is an odourless, colourless, flavourless polysaccharide derived from non-GM sweet corn using conventional food processing techniques

                           Definition: Glucose polymer (C6H12O6)n with linear linkages of α(1 – 4) glycosidic bonds branched every 8 to 12 glucose units by α(1 – 6) glycosidic bonds

                           Specifications:

                        Carbohydrates: 97 %
                        Sugars: 0,5 %
                        Fibre: 0,8 %
                        Fat: 0,2 %
                        Protein: 0,6 %

                           Phytosterols/phytostanols

                           Description/Definition:

                        Phytosterols and phytostanols are sterols and stanols that are extracted from plants and may be presented as free sterols and stanols or esterified with food grade fatty acids.

                           Composition (with GC-FID or equivalent method):
                        β-sitosterol: < 81 %
                        β-sitostanol: < 35 %
                        campesterol: < 40 %
                        campestanol: < 15 %
                        stigmasterol: < 30 %
                        brassicasterol: < 3,0 %
                        other sterols/stanols: < 3,0 %

                           Contamination/Purity (GC-FID or equivalent method):
                        Phytosterols and phytostanols extracted from sources other than vegetable oil suitable for food have to be free of contaminants, best ensured by a purity of more than 99 % of the phytosterol/phytostanol ingredient.

                           Plum kernel oil

                           Description/Definition:

                        Plum kernel oil is a vegetable oil obtained by cold pressing of plum (Prunus domestica) kernels.

                           Composition:

                        Oleic acid (C18:1): 68 %
                        Linoleic acid (C18:2): 23 %
                        γ-Tocopherol:80 % of total tocopherols
                        β-Sitosterol: 80-90 % of total sterols
                        Triolein: 40-55 % of triglycerides
                        Cyanhydric acid: maximum 5 mg/kg oil

                           Potato proteins (coagulated) and hydrolysates thereof

                        Dry substance: ≥ 800 mg/g
                        Protein (N * 6,25): ≥ 600 mg/g (dry substance)
                        Ash: ≤ 400 mg/g (dry substance)
                        Glycoalkaloid (total): ≤ 150 mg/kg
                        Lysinoalanine (total): ≤ 500 mg/kg
                        Lysinoalanine (free): ≤ 10 mg/kg

                           Prolyl oligopeptidase (enzyme preparation)

                           Specification of the enzyme:

                        Systematic name: Prolyl oligopeptidase
                        Synonyms: Prolyl endopeptidase, proline-specific endopeptidase, endoprolylpeptidase
                        Molecular weight: 66 kDa
                        Enzyme Commission number: EC 3.4.21.26
                        CAS number: 72162-84-6
                        Source: A genetically modified strain of Aspergillus niger (GEP-44)

                           Description: Prolyl oligopeptidase is available as an enzyme preparation containing approximately 30 % maltodextrin.

                           Specifications of the enzyme preparation of prolyl oligopeptidase:

                        Activity: > 580 000  PPI(1)/g (> 34,8 PPU(2)/g)
                        Appearance: Microgranulate
                        Colour: Off-white to orange yellowish. The colour may change from batch to batch
                        Dry Matter: > 94 %
                        Gluten: < 20 ppm

                           Heavy metals:

                        Lead: ≤ 1,0 mg/kg
                        Arsenic: ≤ 1,0 mg/kg
                        Cadmium: ≤ 0,5 mg/kg
                        Mercury: ≤ 0,1 mg/kg

                           Microbiological criteria:

                        Total aerobic plate count: ≤ 103 CFU/g
                        Total yeasts and moulds: ≤ 102 CFU/g
                        Sulphite reducing anaerobes: ≤ 30 CFU/g

                           Enterobacteriaceae: < 10 CFU/g

                           Salmonella: Absence in 25 g

                           Escherichia coli: Absence in 25 g

                           Staphylococcus aureus: Absence in 10 g

                           Pseudomonas aeruginosa: Absence in 10 g

                           Listeria monocytogenes: Absence in 25 g
                        Antimicrobial activity: Absent
                        Mycotoxins: Below limits of detection: Aflatoxin B1, B2, G1, G2 (< 0,25 μg/kg), total Aflatoxins (< 2,0 μg/kg), Ochratoxin A (< 0,20 μg/kg), T-2 Toxin (< 5 μg/kg), Zearalenone (< 2,5 μg/kg), Fumonisin B1 and B2 (< 2,5 μg/kg)

                                    (1)

                                    PPI – Protease Picomole International

                                    (2)

                                    PPU – Prolyl Peptidase Units or Proline Protease Units

                           Protein extract from pig kidneys

                           Description/Definition:

                        The protein extract is obtained from homogenised pig kidneys through a combination of salt precipitation and high speed centrifugation. The obtained precipitate contains essentially proteins with 7 % of the enzyme diamine oxidase (enzyme nomenclature E.C. 1.4.3.22) and is resuspended in a physiologic buffer system. The obtained pig kidney extract is formulated as encapsulated enteric coated pellets to reach the active sites of digestion.
                        Basic Product:
                        Specification: pig kidney protein excerpt with natural content of Diamin oxidase (DAO):
                        Physical condition: liquid
                        Colour: brownish
                        Appearance: slightly turbid solution
                        pH value: 6,4-6,8
                        Enzymatic activity: > 2 677  kHDU DAO/ml (DAO REA (DAO Radioextractionassay))

                           Microbiological criteria:

                           Brachyspira spp.: negative (Real Time PCR)

                           Listeria monocytogenes: negative (Real Time PCR)

                           Staphylococcus aureus: < 100 CFU/g
                        Influenza A: negative (Reverse Transcription Real Time PCR)

                           Escherichia coli: < 10 CFU/g
                        Total aerobic microbiological count: < 105 CFU/g
                        Yeasts/moulds count: < 105 CFU/g

                           Salmonella: Absence/10g
                        Bile salt resistant enterobacteriaceae: < 104 CFU/g

                           Final product:

                        Specification pig kidney protein excerpt with natural content of DAO (E.C. 1.4.3.22) in an enteric coated formulation:
                        Physical condition: solid
                        Colour: yellow gray
                        Appearance: micropellets
                        Enzymatic activity: 110-220 kHDU DAO/g pellet (DAO REA (DAO Radioextractionassay))
                        Acid stability 15 min 0,1M HCl followed by 60 min Borat pH = 9,0: > 68 kHDU DAO/g pellet (DAO REA (DAO Radioextractionassay))
                        Humidity: < 10 %

                           Staphylococcus aureus: < 100 CFU/g

                           Escherichia coli: < 10 CFU/g
                        Total aerobic microbiological count: < 104 CFU/g
                        Total combined yeasts/moulds count: < 103 CFU/g

                           Salmonella: Absence/10g
                        Bile salt resistant enterobacteriaceae: < 102 CFU/g

                           Rapeseed oil high in unsaponifiable matter

                           Description/Definition:

                        Rapeseed oil high in unsaponifiable matter’ is produced by vacuum distillation and it is different from refined rapeseed oil in the concentration of the unsaponifiable fraction (1 g in refined rapeseed oil and 9 g in ‘rapeseed oil high in unsaponifiable matter’). There is a minor reduction of triglycerides containing monounsaturated and polyunsaturated fatty acids.

                           Purity:

                        Unsaponifiable matter: > 7,0 g/100 g
                        Tocopherols: > 0,8 g/100 g
                        α-tocopherol (%): 30-50 %
                        γ-tocopherol (%): 50-70 %
                        δ-tocopherol (%): < 6,0 %
                        Sterols, triterpenic alcohols, methylsterols: > 5,0 g/100 g

                           Fatty acids in triglycerides:

                        palmitic acid: 3-8 %
                        stearic acid: 0,8-2,5 %
                        oleic acid: 50-70 %
                        linoleic acid: 15-28 %
                        linolenic acid: 6-14 %
                        erucic acid: < 2,0 %
                        Acid value: ≤ 6,0 mg KOH/g
                        Peroxide value (PV): ≤ 10 mEq O2/kg

                           Heavy metals:

                        Iron (Fe): < 1 000  μg/kg
                        Copper (Cu): < 100 μg/kg

                           Impurities:

                        Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: < 2 μg/kg
                        Treatment with active carbon is required to ensure that polycyclic aromatic hydrocarbons (PAH) are not enriched in the production of ‘rapeseed oil high in unsaponifiable matter.

                           Rapeseed Protein

                           Definition:

                        Rapeseed protein is an aqueous protein-rich extract from rapeseed press cake originating from non-genetically modified Brassica napus L. and Brassica rapa L.

                           Description:

                        White to off-white, spray dried powder
                        Total protein: ≥ 90 %
                        Soluble protein: ≥ 85 %
                        Moisture: ≤ 7,0 %
                        Carbohydrates: ≤ 7,0 %
                        Fat: ≤ 2,0 %
                        Ash: ≤ 4,0 %
                        Fibre: ≤ 0,5 %
                        Total glucosinolates: ≤ 1 mmol/kg

                           Purity:

                        Total phytate: ≤ 1,5 %
                        Lead: ≤ 0,5 mg/kg

                           Microbiological criteria:

                        Yeast and mould count: ≤ 100 CFU/g
                        Aerobic bacteria count: ≤ 10 000  CFU/g
                        Total coliform count: ≤ 10 CFU/g

                           Escherichia coli: Absence in 10 g

                           Salmonella: Absence in 25 g

                           Trans-resveratrol

                           Description/Definition:

                           Synthetic
                           Trans-resveratrol is off-white to beige crystals.
                        Chemical name: 5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diol
                        Chemical formula: C14H12O3

                        Molecular weight: 228,25 Da
                        CAS No: 501-36-0

                           Purity:

                           Trans-resveratrol: ≥ 98 %-99 %
                        Total by-products (related substances): ≤ 0,5 %
                        Any single related substance: ≤ 0,1 %
                        Sulphated ash: ≤ 0,1 %
                        Loss on drying: ≤ 0,5 %

                           Heavy metals:

                        Lead: ≤ 1,0 ppm
                        Mercury: ≤ 0,1 ppm
                        Arsenic: ≤ 1,0 ppm

                           Impurities:

                        Diisopropylamine: ≤ 50 mg/kg

                              Microbial source
                           : A genetically modified strain of Saccharomyces cerevisiae

                        Appearance: Off-white to slight yellow powder
                        Particle size: 100 % less than 62,23 μm
                        Trans-resveratrol content: Min. 98 % w/w (dry weight basis)
                        Ash: Max. 0,5 % w/w
                        Moisture: Max. 3 % w/w

                           Rooster comb extract

                           Description/Definition:

                        Rooster comb extract is obtained from Gallus gallus by enzymatic hydrolysis of rooster comb and by subsequent filtration, concentration and precipitation steps. The principal constituents of rooster comb extract are the glycosaminoglycans hyaluronic acid, chondroitin sulphate A and dermatan sulphate (chondroitin sulphate B). White or almost white hygroscopic powder.
                        Hyaluronic acid: 60-80 %
                        Chondroitin sulphate A: ≤ 5,0 %
                        Dermatan sulphate (chondroitin sulphate B): ≤ 25 %
                        pH: 5,0-8,5

                           Purity:

                        Chlorides: ≤ 1,0 %
                        Nitrogen: ≤ 8,0 %
                        Loss on drying: (105 °C for 6 hours): ≤ 10 %

                           Heavy metals:

                        Mercury: ≤ 0,1 mg/kg
                        Arsenic: ≤ 1,0 mg/kg
                        Cadmium: ≤ 1,0 mg/kg
                        Chromium: ≤ 10 mg/kg
                        Lead: ≤ 0,5 mg/kg

                           Microbiological criteria:

                        Total viable aerobic count: ≤ 102 CFU/g

                           Escherichia coli: Absence in 1 g

                           Salmonella: Absence in 1 g

                           Staphylococcus aureus: Absence in 1 g

                           Pseudomonas aeruginosa: Absence in 1g

                           Sacha Inchi oil from Plukenetia volubilis

                           Description/Definition:

                        Sacha inchi oil is a 100 % cold pressed vegetable oil obtained from the seeds of Plukenetia volubiis L. It is a transparent, fluid (liquid) and shiny oil at room temperature. It has a fruity, light, green vegetable taste without undesirable flavours.
                        Aspect, limpidity, shine, colour: Fluid at room temperature, clean, shiny yellow gold
                        Odour and taste: Fruity, vegetable without non acceptable taste or odour

                           Purity:

                        Water and Volatiles: < 0,2 g/100 g
                        Impurities insoluble in hexane: < 0,05 g/100 g
                        Oleic acidity: < 2,0 g/100 g
                        Peroxide value (PV): < 15 meq O2/kg
                        Trans fatty acids: < 1,0 g/100 g
                        Total unsaturated fatty acids: > 90 %
                        Omega 3 alpha linolenic acid (ALA): > 45 %
                        Saturated fatty acids: < 10 %
                        No trans fatty acids (< 0,5 %)
                        No erucic acid (< 0,2 %)
                        More than 50 % of tri-linolenin and di-linolenin-triglycerides
                        Phytosterols composition and level
                        No cholesterol (< 5,0 mg/100 g)

                           Salatrims

                           Description/Definition:

                        Salatrim is the internationally recognised acronym for (short and long chain acyl triglyceride molecules). Salatrim is prepared by non-enzymatic inter-esterification of triacetin, tripropionin, tributyrin, or their mixtures with hydrogenated canola, soybean, cottonseed, or sunflower oil. Description: Clear, slightly amber liquid to a light coloured waxy solid at room temperature. Free of particulate matter and of foreign or rancid odour.
                        Glycerol ester disribution:
                        Triacylglycerols: > 87 %
                        Diacylglycerols: ≤ 10 %
                        Monoacylglycerols: ≤ 2,0 %
                        Fatty acid composition:
                        MOLE % LCFA (long chain fatty acids): 33-70 %
                        MOLE % SCFA (short chain fatty acids): 30-67 %
                        Saturated long chain fatty acids: < 70 % by weight
                        Trans fatty acids: ≤ 1,0 %
                        Free fatty acids as oleic acid: ≤ 0,5 %
                        Triacylglycerol profile:
                        Triesters (short/long of 0,5 to 2,0): ≥ 90 %
                        Triesters (short/long = 0): ≤ 10 %
                        Unsaponifiable material: ≤ 1,0 %
                        Moisture: ≤ 0,3 %
                        Ash: ≤ 0,1 %
                        Colour: ≤ 3,5 Red (Lovibond)
                        Peroxide value (PV): ≤ 2,0 Meq/Kg

                              Schizochytrium sp. oil rich in DHA and EPA

                        Acid value: ≤ 0,5 mg KOH/g
                        Peroxide value (PV): ≤ 5,0 meq/kg oil
                        Oxidative stability: All food products containing Schizochytrium sp. oil rich in DHA and EPA should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC)
                        Moisture and volatiles: ≤ 0,05 %
                        Unsaponifiables: ≤ 4,5 %
                        Trans-fatty acids: ≤ 1 %
                        DHA content: ≥ 22,5 %
                        EPA content: ≥ 10 %

                              Schizochytrium sp. (ATCC PTA-9695) oil

                        Peroxide value (PV): ≤ 5,0 meq/kg oil
                        Unsaponifiables: ≤ 3,5 %
                        Trans-fatty acids: ≤ 2,0 %
                        Free fatty acids: ≤ 0,4 %
                        Docosapentaenoic acid (DPA) n-6: ≤ 7,5 %
                        DHA content: ≥ 35 %

                              Schizochytrium sp. oil

                        Acid value: ≤ 0,5 mg KOH/g
                        Peroxide value (PV): ≤ 5,0 meq/kg oil
                        Moisture and volatiles: ≤ 0,05 %
                        Unsaponifiables: ≤ 4,5 %
                        Trans-fatty acids: ≤ 1,0 %
                        DHA content: ≥ 32,0 %

                              Schizochytrium sp. (T18) oil

                        Acid value: ≤ 0,5 mg KOH/g
                        Peroxide value (PV): ≤ 5,0 meq/kg oil
                        Moisture and volatiles: ≤ 0,05 %
                        Unsaponifiables: ≤ 3,5 %
                        Trans-fatty acids: ≤ 2,0 %
                        Free fatty acids: ≤ 0,4 %
                        DHA content: ≥ 35 %

                           Fermented soybean extract

                           Description/Definition:

                        Fermented soybean extract is an odourless milk-white coloured powder. It is comprised of 30 % fermented soybean extract powder and 70 % resistant dextrin (as carrier) from corn-starch, which is added during the processing. Vitamin K2 is removed during the manufacturing process.
                        Fermented soybean extract contains nattokinase isolated from natto, a foodstuff produced by the fermentation of non-genetically modified soybeans (Glycine max (L.)) with a selected strain of Bacillus subtilis var. natto.
                        Nattokinase activity: 20 000  -28 000  Fibrin degradation unit/g(1)
                        Identity: Confirmable
                        Condition: No offensive taste or smell
                        Loss on drying: ≤ 10 %
                        Vitamin K2: ≤ 0,1 mg/kg

                           Heavy metals:

                        Lead: ≤ 5,0 mg/kg
                        Arsenic: ≤ 3,0 mg/kg

                           Microbiological criteria:

                        Total viable aerobic count: ≤ 103 CFU(3)/g
                        Yeast and mould: ≤ 102 CFU/g
                        Coliforms: ≤ 30 CFU/g
                        Spore-forming bacteria: ≤ 10 CFU/g

                           Escherichia coli: Absence/25 g

                           Salmonella: Absence/25 g

                           Listeria: Absence/25 g

                                    (1)

                                    Assay method as described by Takaoka et al. (2010).

                           Spermidine-rich wheat germ extract (Triticum aestivum)

                           Description/Definition:

                        Spermidine-rich wheat germ extract is obtained from non-fermented, non-sprouting wheat germs (Triticum aestivum) by the process of solid-liquid extraction targeting specifically, but not exclusively polyamines.
                        Spermidine: 0,8-2,4 mg/g
                        Spermine: 0,4-1,2 mg/g
                        Spermidine trichloride < 0,1 μg/g
                        Putrescine: < 0,3 mg/g
                        Cadaverine: < 0,1 μg/g

                           Mycotoxins:

                        Aflatoxins (total): < 0,4 μg/kg

                           Microbiological criteria:

                        Total aerobic bacteria: < 10 000  CFU/g
                        Yeast and moulds: < 100 CFU/g

                           Escherichia coli: < 10 CFU/g

                           Salmonella: Absence/25g

                           Listeria monocytogenes: Absence/25g

                           Sucromalt

                           Description/Definition:

                        Sucromalt is a complex mixture of saccharides which is produced from sucrose and a starch hydrolysate by means of an enzymatic reaction. In this process, glucose units are attached to saccharides from the starch hydrolysate by means of an enzyme produced by the bacterium Leuconostoc citreum or by means of a recombinant strain of the production organism Bacillus licheniformis. The resulting oligosaccharides are characterised by the presence of α-(1→6) and α-(l→3) glycosidic compounds. The overall product is syrup, in addition to these oligosaccharides, contains mainly fructose but also the disaccharide leucrose and other disaccharides.
                        Total solids: 75-80 %
                        Moisture: 20-25 %
                        Sulphatase: Max 0,05 %
                        pH: 3,5-6,0
                        Conductivity < 200 (30 %)
                        Nitrogen < 10 ppm
                        Fructose: 35-45 % d.w.
                        Leucrose: 7-15 % d.w.
                        Other disaccharides: Mах 3 %
                        Higher saccharides: 40-60 % d.w

                           Sugar cane fibre

                           Description/Definition:

                        Sugar Cane Fibre is derived from the dry cell wall or fibrous residue remaining after expression or extraction of sugar juice from sugar cane, of the Saccharum genotype. It consists primarily of cellulose and hemicellulose.
                        The production process consists of several steps, including: chipping, alkaline digestion, removal of lignins and other non-cellulosic components, bleaching of purified fibres, acid washing and neutralization.
                        Moisture: ≤ 7,0 %
                        Ash: ≤ 0,3 %
                        Total Dietary Fibre (AOAC) dry basis (all insoluble): ≥ 95 %
                        of which: Hemicellulose (20-25 %) and cellulose (70-75 %)
                        Silica (ppm): ≤ 200
                        Protein: 0,0 %
                        Fat: Trace
                        pH: 4-7

                           Heavy metals:

                        Mercury (ppm): ≤ 0,1
                        Lead (ppm): ≤ 1,0
                        Arsenic (ppm): ≤ 1,0
                        Cadmium (ppm): ≤ 0,1

                           Microbiological criteria:

                        Yeast and moulds (CFU/g): ≤ 1 000

                           Salmonella: Absence

                           Listeria monocytogenes: Absence

                           Sunflower oil extract

                           Description/Definition:

                        The sunflower extract is obtained by a concentration factor of 10 of the unsaponifiable fraction of refined sunflower oil extracted from the seeds of the sunflower, Helianthus Annuus L.

                           Composition:

                        Oleic acid (C18:1): 20 %
                        Linoleic acid (C18:2): 70 %
                        Unsaponifiable matter: 8,0 %
                        Phytosterols: 5,5 %
                        Tocopherols: 1,1 %

                           Dried Tetraselmis chuii microalgae

                           Description/Definition:

                        The dried product is obtained from the marine microalgae Tetraselmis chuii, belonging to the Chlorodendraceae family, cultivated in sterile sea water in closed photobioreactors insulated from the outside air.

                           Purity/Composition:

                        Identified by means of nuclear marker rDNA 18 S (sequence analysed no less than 1 600  base pairs) in the National Centre for Biotechnology information (NCBI) database: Not less than 99,9 %
                        Humidity: ≤ 7,0 %
                        Proteins: 35-40 %
                        Ashes: 14-16 %
                        Carbohydrates: 30-32 %
                        Fibre: 2-3 %
                        Fat: 5-8 %
                        Saturated fatty acids: 29-31 % of total fatty acids
                        Monounsaturated fatty acids: 21-24 % of total fatty acids
                        Polyunsaturated fatty acids: 44-49 % of total fatty acids
                        Iodine: ≤ 15 mg/kg

                              Therapon barcoo/Scortum

                           Description/Definition:

                        Scortum/Therapon barcoo is a species of fish in the family Terapontidae. It is an endemic fresh water species from Australia. It is now reared in fish farms.
                        Taxonomic Identification: Class: Actinopterygii > order: Perciformes > family: Terapontidae > genus: Therapon or Scortum barcoo

                        Composition of fish flesh:
                        Protein (%): 18-25
                        Moisture (%): 65-75
                        Ash (%): 0,5-2,0
                        Energy (KJ/Kg): 6000-11500
                        Carbohydrates (%): 0,0
                        Fat (%): 5-15
                        Fatty acids (mg FA/g fillet):
                        Σ PUFA n-3: 1,2-20,0
                        Σ PUFA n-6: 0,3-2,0
                        PUFA n-3/n-6: 1,5-15,0
                        Total omega 3 acids: 1,6-40,0
                        Total omega 6 acids: 2,6-10,0

                           D-Tagatose

                           Description/Definition:

                        Tagatose is produced by isomerization of galactose by means of chemical or enzymatic conversion, or by epimerization of fructose by means of enzymatic conversion. These are single-step conversions.
                        Appearance: White or almost white crystals
                        Chemical name: D-tagatose
                        Synonym: D-lyxo-Hexulose
                        CAS number: 87-81-0
                        Chemical formula: C6H12O6

                        Formula weight: 180,16 (g/mol)

                           Purity:

                        Assay: ≥ 98 % on a dry weight basis
                        Loss on drying: ≤ 0,5 % (102 °C, 2 hours)
                        Specific Rotation: [α]D
                           20: – 4 to – 5,6o (1 % aqueous solution)(1)
                        Melting range: 133– 137 °C

                           Heavy metals:

                        Lead: ≤ 1,0 mg/kg(*)

                                    (*)

                                    Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in FNP 5. ‘Instrumental methods’(1).

                                    (1)

                                    Food and nutrition paper 5 Rev 2 – Guide to specifications for general notices, general analytical techniques, identification tests, test solutions and other reference materials (JECFA) 1991, 307 p.; English – ISBN 92-5-102991-1

                           Taxifolin-rich extract

                           Description:

                        Taxifolin-rich extract from the wood of Dahurian Larch (Larix gmelinii (Rupr.) Rupr) is a white to pale-yellow powder that crystallizes from hot aqueous solutions.

                           Definition:

                        Chemical name: [(2R,3R)-2-(3,4 dihydroxyphenyl)-3,5,7-trihydroxy-2,3-dihydrochromen-4-one, also called (+) trans (2R,3R)- dihydroquercetin]
                        Chemical formula: C15H12O7

                        Molecular mass: 304,25 Da
                        CAS No: 480-18-2

                           Specifications:

                           Physical parameter

                        Moisture: ≤ 10 %

                           Compound analysis

                        Taxifolin (m/m): ≥ 90,0 % of the dry weight

                              Heavy Metals, Pesticide

                        Lead: ≤ 0,5 mg/kg
                        Arsenic: ≤ 0,02 mg/kg
                        Cadmium: ≤ 0,5 mg/kg
                        Mercury: ≤ 0,1 mg/kg
                        Dichlorodiphenyltrichloroethane (DDT): ≤ 0,05 mg/kg

                              Residual solvents

                        Ethanol: < 5 000  mg/kg

                              Microbiological criteria

                        Total Plate Count (TPC): ≤ 104 CFU/g
                        Enterobacteria: ≤ 100/g
                        Yeast and Mould : ≤ 100 CFU/g

                           Escherichia coli: Absence/1 g

                           Salmonella: Absence/10 g

                           Staphylococcus aureus: Absence/1 g

                           Pseudomonas: Absence/1g

                           Usual range of components of the Taxifolin-rich extract (as per dry substance)

                           Extract component

                           Content, usual observed range (%)

                        Taxifolin

                        90 – 93

                        Aromadendrin

                        2,5 – 3,5

                        Eriodictyol

                        0,1 – 0,3

                        Quercetin

                        0,3 – 0,5

                        Naringenin

                        0,2 – 0,3

                        Kaempferol

                        0,01 – 0,1

                        Pinocembrin

                        0,05 – 0,12

                        Unidentified flavonoids

                        1 – 3

                        Water(*)

                        1,5

                                    (*)

                                    Taxifolin in its hydrated form and during the drying process is a crystal. This results on the inclusion of water of crystallisation in a quantity of 1,5 %.

                           Trehalose

                           Description/Definition:

                        A non-reducing disaccharide that consists of two glucose moieties linkes by an α-1,1-glucosidic bond. It is obtained from liquefied starch or from sucrose by a multistep enzymatic process. The commercial product is the dihydrate. Virtually odourless, white or almost white crystals with a sweet taste
                        Synonyms: α,α-trehalose
                        Chemical name: α-D-glucopyranosyl-α-D-glucopyranoside, dihydrate
                        CAS No.: 6138-23-4 (dihydrate)
                        Chemical formula: C12H22O11 · 2H2O (dihydrate)
                        Formula weight: 378,33 (dihydrate)
                        Assay: ≥ 98 % on the dry basis
                        Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in FNP 5 (1), ‘Instrumental methods’

                           Method of assay:

                        Principle: trehalose is identified by liquid chromatography and quantified by comparison to a reference standard containing standard trehalose
                        Preparation of sample solution: weigh accurately about 3 g of dry sample into a 100 ml volumetric flask and add about 80 ml of purified, deionised water. Bring sample to complete dissolution and dilute to mark with purified deionised water. Filter through a 0,45 micron filter
                        Preparation of standard solution: dissolve accurately weighed quantities of dry standard reference trehalose in water to obtain a solution having known concentration of about 30 mg of trehalose per ml.
                        Apparatus: liquid chromatography equipped with a refractive index detector and integrating recorder
                        Conditions:
                        Column: Shodex Ionpack KS-801 (Showa Denko Co.) or equivalent

                                    —

                                    length: 300 mm

                                    —

                                    diameter: 10 mm

                                    —

                                    temperature: 50 °C

                              Mobile phase: water
                        flow rate: 0,4 ml/min
                        Injection volume: 8 μl
                        Procedure: inject separately equal volumes of the sample solution and the standard solution into the chromatograph.
                        Record the chromatograms and measure the size of response of the trehalose peak
                        Calculate the quantity, in mg, of trehalose in 1 ml of the sample solution by the following formula:
                        % trehalose = 100 × (RU/RS) (WS/WU)
                        where

                                    RS

                                    =

                                    peak area of trehalose in the standard preparation

                                    RU

                                    =

                                    peak area of trehalose in the sample preparation

                                    WS

                                    =

                                    weight in mg of trehalose in the standard preparation

                                    WU

                                    =

                                    weight of dry sample in mg

                           Characteristics:

                        Identification:
                        Solubility: Freely soluble in water, very slightly soluble in ethanol
                        Specific rotation: [α]D
                           20 = +179o (5 % aqueous solution, dihydrate), +199o (5 % aqueous solution, anhydrous substance)
                        Melting point: 97 °C (dihydrate)

                           Purity:

                        Loss on drying: ≤ 1,5 % (60 °C, 5h)
                        Total ash: ≤ 0,05 %

                           Heavy metals:

                        Lead: ≤ 1,0 mg/kg

                           UV treated mushrooms (Agaricus bisporus)

                           Description/Definition:

                        Commercially grown Agaricus bisporus to which UV light treatment is applied to harvested mushrooms.
                        UV radiation: a process of radiation in ultraviolet light within the wavelength of 200-800 nm.

                           Vitamin D2:

                        Chemical name: (3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol
                        Synonym: Ergocalciferol
                        CAS No: 50-14-6
                        Molecular weight: 396,65 g/mol

                           Contents:

                        Vitamin D2 in the final product: 5-10 μg/100 g fresh weight at the expiration of shelf life

                           UV-treated baker’s yeast (Saccharomyces cerevisiae)

                           Description/Definition:

                        Baker’s yeast (Saccharomyces cerevisiae) is treated with ultraviolet light to induce the conversion of ergosterol to vitamin D2 (ergocalciferol). Vitamin D2 content in the yeast concentrate varies between 1 800 000 -3 500 000  IU vitamin D/100 g (450-875 μg/g).
                        Tan-coloured, free-flowing granules

                           Vitamin D2:

                        Chemical name: (5Z,7E,22E)-3S-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol
                        Synonym: Ergocalciferol
                        CAS No.: 50-14-6
                        Molecular weight: 396,65 g/mol

                           Microbiological criteria for the yeast concentrate:

                        Coliforms: ≤ 103/g

                           Escherichia coli: ≤ 10/g

                           Salmonella: Absence in 25g

                           UV-treated bread

                           Description/Definition:

                        UV-treated bread is yeast leavened bread and rolls (without toppings) to which a treatment with ultraviolet radiation is applied after baking in order to convert ergosterol to vitamin D2 (ergocalciferol).
                        UV radiation: A process of radiation in ultraviolet light within the wavelength of 240-315 nm for maximum of 5 seconds with energy input of 10-50 mJ/cm2.

                           Vitamin D2:

                        Chemical name: (5Z,7E,22E)-3S-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol
                        Synonym: Ergocalciferol
                        CAS No: 50-14-6
                        Molecular weight: 396,65 g/mol

                           Contents:

                        Vitamin D2 (ergocalciferol) in the final product: 0,75-3 μg/100 g(1)
                        Yeast in dough: 1-5 g/100 g (2)

                                    (1)

                                    EN 12821, 2009, European Standard.

                                    (2)

                                    Recipe calculation.

                           UV-treated milk

                           Description/Definition:

                        UV-treated milk is cow’s milk (whole and semi-skimmed) to which a treatment with ultraviolet (UV) radiation via turbulent flow is applied after pasteurisation. The treatment of the pasteurised milk with UV radiation results in an increase in the vitamin D3 (cholecalciferol) concentrations by conversion of 7-dehydrocholesterol to vitamin D3.
                        UV radiation: A process of radiation in ultraviolet light within the wavelength of 200-310 nm with energy input of 1 045  J/l.

                           Vitamin D3:

                        Chemical name: (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol
                        Synonym: Cholecalciferol
                        CAS No: 67-97-0
                        Molecular weight: 384,6377 g/mol

                           Contents:

                        Vitamin D3 in the final product:
                        Whole milk(1)0,5-3,2 μg/100 g(2)
                        Semi-skimmed milk(1): 0,1–1,5 μg/100 g(2)

                                    (1)

                                    As defined by Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671).

                                    (2)

                                    HPLC

                           Vitamin K2 (menaquinone)

                        This novel food is produced by a synthetic or microbiological process.
                        Vitamin K2 (2-methyl-3-all-trans-polyprenyl-1,4-naphthoquinones), or the menaquinone series, is a group of prenylated naphthoquinone derivatives. The number of isoprene residues, where 1 isoprene unit consists of 5 carbons comprising the side chain, is used to characterise the menaquinone homologues containing primarily MK-7 and to a smaller extent MK-6.
                        Vitamin K2 (menaquinones) series with menaquinone-7 (MK-7)(n = 6) being C46H64O2, menaquinone-6 (MK-6)(n = 5) being C41H56O2 and menaquinone-4 (MK-4)(n = 3) being C31H40O2.
                        Chemical Name: (all-E)-2-(3,7,11,15,19,23,27-Heptamethyl-2,6,10,14,18,22,26-octacosaheptaenyl)-3-methyl-1,4-naphtalenedione
                        CAS Number: 2124-57-4
                        Molecular formula: C46H64O2

                        Molecular weight: 649 g/mol

                              Specification of synthetic Vitamin K2 (menaquinone-7)

                        Appearance: Yellow powder
                        Purity: Max 6,0 % cis-isomer, max 2,0 % other impurities
                        Content: 97-102 % Menaquinone-7 (including at least 92 % all-trans Menaquinone-7)

                              Specifications of microbiologically produced Vitamin K2 (menaquinone-7)

                        Source: Bacillus subtilis spp. natto and Bacillus licheniformis

                        Appearance: Yellow powder or oil suspension

                           Wheat bran extract

                           Description/Definition:

                        White crystalline powder obtained by enzymatic extraction from Triticum aestivum L. bran, rich in arabinoxylan oligosaccharides
                        Dry matter: Min. 94 %
                        Arabinoxylan oligosaccharides: Min 70 % of dry matter
                        Average degree of polymerisation of arabinoxylan oligosaccharides: 3-8
                        Ferulic acid (bound to arabinoxylan oligosaccharides): 1-3 % of dry matter
                        Total poly/oligosaccharides: Min 90 %
                        Protein: Max 2 % of dry matter
                        Ash: Max 2 % of dry matter

                           Microbiological parameters:

                        Mesophilic bacteria – total count: Max 10 000/g
                        Yeasts: Max 100/g
                        Fungi: Max 100/g

                           Salmonella: Absence in 25g

                           Bacillus cereus: Max 1000/g

                           Clostridium perfringens: Max 1000/g

                           Yeast beta-glucans

                           Description/Definition:

                        Beta-glucans are complex, high molecular mass (100–200 kDa) polysaccharides, found in the cell wall of many yeasts and cereals.
                        The chemical name for ‘yeast beta-glucans’ is (1-3),(1-6)-ß-D-glucans.
                        Beta-glucans consist of a backbone of ß-1-3-linked glucose residues that are branched by ß-1-6-linkages, to which chitin and mannoproteins are linked by ß-1-4-bonds.
                        Beta-glucans are isolated from yeast Saccharomyces cerevisiae.
                        The tertiary structure of the glucan cell wall of Saccharomyces cerevisiae consists of chains of ß-1,3-linked glucose residues, branched by ß-1,6-linkages, forming a backbone to which are linked chitin via ß-1,4- bonds, ß-1,6-glucans and some mannoproteins.
                        This novel food is available in three different forms: soluble, insoluble and insoluble in water, but dispersible in many liquid matrices.

                           Chemical characteristics yeast (Saccharomyces cerevisiae) beta-glucans:

                           Soluble form:

                        Total carbohydrates: > 75 %
                        Beta-glucans (1,3/1,6): > 75 %
                        Ash: < 4,0 %
                        Moisture: < 8,0 %
                        Protein: < 3,5 %
                        Fat: < 10 %

                           Insoluble form:

                        Total carbohydrates: > 70 %
                        Beta-glucans (1,3/1,6): > 70 %
                        Ash: ≤ 12 %
                        Moisture: < 8,0 %
                        Protein: < 10 %
                        Fat: < 20 %

                           Insoluble in water, but dispersible in many liquid matrices:

                        (1,3)-(1,6)-ß-D-Glucans: > 80 %
                        Ash: < 2,0 %
                        Moisture: < 6,0 %
                        Protein: < 4,0 %
                        Total fat: < 3,0 %

                           Microbiological data for insoluble in water, but dispersible in many liquid matrices:

                        Total plate count: < 1 000  CFU/g
                        Enterobacteriaceae: < 100 CFU/g
                        Total coliforms: < 10 CFU/g
                        Yeast: < 25 CFU/g
                        Mould: < 25 CFU/g

                           Salmonella: Absence in 25 g

                           Escherichia coli: Absence in 1 g

                           Bacillus cereus: < 100 CFU/g

                           Staphylococcus aureus: Absence in 1 g

                           Heavy metals for insoluble in water, but dispersible in many liquid matrices:

                        Lead: < 0,2 mg/g
                        Arsenic: < 0,2 mg/g
                        Mercury: < 0,1 mg/g
                        Cadmium: < 0,1 mg/g

                           Zeaxanthin

                           Description/Definition:

                        Zeaxanthin is a naturally occurring xanthophyll pigment, it is an oxygenated carotenoid.
                        The synthetic zeaxanthin is presented either as a spray-dried powder of gelatin or starch base (‘beadlets’) with added α-tocopherol and ascorbyl palmitate or as a corn oil suspension with added α-tocopherol. Synthetic zeaxanthin is produced by a multi-step chemical synthesis from smaller molecules.
                        Orange-red crystalline powder with little or no odour.
                        Chemical formula: C40H56O2

                        CAS No: 144-68-3
                        Molecular weight: 568,9 daltons

                           Physical-chemical properties:

                        Loss on drying: < 0,2 %

                           All-trans zeaxanthin: > 96 %
                        Cis-zeaxanthin: < 2,0 %
                        Other carotenoids: < 1,5 %
                        Triphenylphosphine oxid (CAS No 791-28-6): < 50 mg/kg

                           Zinc L-pidolate

                           Description/Definition:

                        Zinc L-pidolate is a white to off-white powder, with characteristic odour.
                        International non-proprietary name (INN): L-pyroglutamic acid, Zinc salt
                        Synonyms: Zinc 5-oxoproline, Zinc pyroglutamate, Zinc pyrrolidone carboxylate, Zinc PCA, L-Zinc pidolate
                        CAS No.: 15454-75-8
                        Molecular formula: (C5 H6 NO3)2 Zn
                        Relative anhydrous molecular mass: 321,4
                        Appearance: White to slightly white powder

                           Purity:

                        Zinc L-pidolate (purity): ≥ 98 %
                        pH (10 % aqueous sol.): 5,0-6,0
                        Specific rotation: 19,6o- 22,8o

                        Water: ≤ 10,0 %
                        Glutamic acid: < 2,0 %

                           Heavy metals:

                        Lead: ≤ 3,0 ppm
                        Arsenic: ≤ 2,0 ppm
                        Cadmium: ≤ 1,0 ppm
                        Mercury: ≤ 0,1 ppm

                           Microbiological criteria:

                        Total viable mesophilic count: ≤ 1 000  CFU/g
                        Yeasts and moulds: ≤ 100 CFU/g
                        Pathogen: Absence

               (1)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

               (2)  Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food (OJ L 228, 31.7.2014, p. 5).

               (3)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

               (4)  Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26).

               (5)  Council Directive 2001/113/EC of 20 December 2001 relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumption (OJ L 10, 12.1.2002, p. 67).

               (6)  Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulation (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) 1234/2007 (OJ L 347, 20.12.2013, p. 671).

               (7)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

               (8)  Commission Implementing Regulation (EU) 2015/175 of 5 February 2015 laying down special conditions applicable to the import of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins (OJ L 30, 6.2.2015, p. 10).