title: Commission Implementing Regulation (EU) 2019/1976 of 25 November 2019 authorising the placing on the market of Phenylcapsaicin as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

text:
                  29.11.2019

                  EN

                  Official Journal of the European Union

                  L 308/40

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1976
         of 25 November 2019
         authorising the placing on the market of Phenylcapsaicin as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (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 of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

                     (2)

                     Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

                     (3)

                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on updating the Union list.

                     (4)

                     On 7 February 2018, the company aXichem AB (‘the applicant’) made a request to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place Phenylcapsaicin obtained by chemical synthesis on the Union market as a novel food. The application concerns the use of Phenylcapsaicin in foods for special medical purposes as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (3) excluding those intended for infants young children and children under the age of 11 years, and in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4) intended for the general population above the age of 11 years.

                     (5)

                     The Applicant also submitted a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application, namely, an in vivo absorption, distribution, metabolism, and excretion (‘ADME’) study with Phenylcapsaicin in rats (5), an in vivo ADME study with Capsaicin in rats (6), a bacterial reverse mutation test with Phenylcapsaicin (7), an in vitro mammalian cell micronucleus test with Phenylcapsaicin (8), a 90-day oral toxicity study in Wistar rats with Phenylcapsaicin (9), and a TRPV1 activation test using the HEK293 cell line with Phenylcapsaicin and Capsaicin (10).

                     (6)

                     On 27 August 2018, the Commission consulted the European Food Safety Authority (‘the Authority’), asking it to carry out an assessment of Phenylcapsaicin as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283.

                     (7)

                     On 15 May 2019, the Authority adopted its scientific opinion ‘Safety of Phenylcapsaicin as a novel food pursuant to Regulation (EU) 2015/2283’ (11). That scientific opinion is in accordance with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (8)

                     In its opinion, the Authority concluded that Phenylcapsaicin is safe under the proposed conditions of use. Therefore the scientific opinion gives sufficient grounds to establish that Phenylcapsaicin, under the proposed uses and uses levels, when used in foods for special medical purposes excluding those intended for infants, young children, and children under the age of 11 years, and when used in food supplements intended for the general population above the age of 11 years, complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (9)

                     In its opinion on Phenylcapsaicin, the Authority considered that the data from the in vivo ADME study with Phenylcapsaicin in rats, the in vivo ADME study with Capsaicin in rats, the bacterial reverse mutation test with Phenylcapsaicin, the in vitro mammalian cell micronucleus tests with Phenylcapsaicin, the 90-day oral toxicity study in rats with Phenylcapsaicin, and the TRPV1 activation test using the HEK293 cell line with Phenylcapsaicin and Capsaicin served as a basis to establish the safety of the novel food. Therefore, it is considered that the conclusions on the safety of Phenylcapsaicin could not have been reached without the data from the report of these studies.

                     (10)

                     Following the receipt of the Authority’s opinion, the Commission requested the Applicant to further clarify the justification provided with regard to their proprietary data from the in vivo ADME study with Phenylcapsaicin in rats, the in vivo ADME study with Capsaicin in rats, the bacterial reverse mutation test with Phenylcapsaicin, the in vitro mammalian cell micronucleus tests with Phenylcapsaicin, the 90-day oral toxicity study in rats with Phenylcapsaicin, and the TRPV1 activation test using the HEK293 cell line with Phenylcapsaicin and Capsaicin, and to clarify their claim to an exclusive right of reference to these reports and studies, as referred to in Article 26(2) of Regulation (EU) 2015/2283.

                     (11)

                     The Applicant declared that, at the time the application was submitted, they held proprietary and exclusive rights of reference to the study under national law and that therefore third parties could not lawfully access or use those studies.

                     (12)

                     The Commission assessed all the information provided by the Applicant and considered that the Applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the data from the studies contained in the Applicant’s file which served as a basis for the Authority’s conclusion establishing the safety of the novel food and the safety of Phenylcapsaicin, and without which the novel food could not have been assessed by the Authority, should not be used by the Authority for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation. As a consequence, the placing on the market within the Union of the novel food authorised by this Regulation should be restricted to the Applicant for a period of five years.

                     (13)

                     However, restricting the authorisation of Phenylcapsaicin and of the reference to the studies contained in the Applicant’s file for the sole use of the Applicant does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on lawfully obtained information supporting the authorisation under this Regulation.

                     (14)

                     Directive 2002/46/EC lays down requirements on food supplements. The use of Phenylcapsaicin should be authorised without prejudice to that Directive.

                     (15)

                     Regulation (EU) No 609/2013 lays down requirements on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control. The use of Phenylcapsaicin should be authorised without prejudice to that Regulation.

                     (16)

                     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

               1.   Phenylcapsaicin as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

               2.   For a period of five years from the date of entry into force of this Regulation only the Applicant:

                           Company: aXichem AB;

                           Address: Södergatan 26, SE 211 34, Malmö, Sweden,

                     is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 or with the agreement of aXichem AB.

               3.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

               4.   The authorisation provided for in this Article shall be without prejudice to the provisions of Regulation (EU) No 609/2013 and to the provisions of Directive 2002/46/EC.

            Article 2
            The studies and reports contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the Applicant as fulfilling the requirements laid down in Article 26(2) of Regulation (EC) No 2015/2283, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of aXichem AB.

            Article 3
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

            Article 4
            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, 25 November 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  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).

            (3)  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).

            (4)  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).

            (5)  Feng et al. 2012a (unpublished).

            (6)  Feng et al. 2012b (unpublished).

            (7)  Schreib 2015 (unpublished).

            (8)  Donath 2016 (unpublished).

            (9)  Stiller 2016 (unpublished).

            (10)  Yang and Dong, 2015 (unpublished).

            (11)  EFSA Journal 2019;17(6):5718.

            ANNEX
            The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

                        (1)

                        In Table 1 (Authorised novel foods), the following entry is inserted in alphabetical order:

                                       Authorised novel food

                                       Conditions under which the novel food may be used

                                       Additional specific labelling requirements

                                       Other requirements

                                       Data protection

                                    ‘Phenylcapsaicin

                                          Specified food category

                                          Maximum levels

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

                                    Authorised on 19 December 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: aXichem AB, Södergatan 26, SE 211 34, Malmö Sweden. During the period of data protection, the novel food phenylcapsaicin is authorised for placing on the market within the Union only by aXichem AB, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of aXichem AB.’

                                    Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants, young children and children under the age of 11 years

                                    2,5 mg/day

                                    Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding children under the age of 11 years

                                    2,5 mg/day

                        (2)

                        In Table 2 (Specifications), the following entry is inserted in alphabetical order:

                                       Authorised Novel Food

                                       Specification

                                    ‘Phenylcapsaicin

                                       Description/Definition:

                                    Phenylcapsaicin (N-[(4-hydroxy-3-methoxyphenyl)methyl]-7-phenylhept-6-ynamide, C21H23NO3, CAS no: 848127-67-3), is synthesized chemically via a two step synthesis process involving in a first step the production of the acetylenic acid intermediate through a reaction of phenyl acetylene with a carboxylic acid derivative, and in a second step a series of reactions of the acetylenic acid intermediate with vanillylamine derivative to produce phenylcapsaicin.

                                       Characteristics/Composition:

                                    Purity (% of dry matter): ≥ 98 %
                                    Moisture: ≤ 0,5 %
                                    Total synthesis related production by-products: ≤ 1,0 %

                                       N,N-dimethyl formamide: ≤ 880 mg/kg
                                    Dichloromethane: ≤ 600 mg/kg
                                    Dimethoxyethane: ≤ 100 mg/kg
                                    Ethyl acetate: ≤ 0,5 %
                                    Other solvents: ≤ 0,5 %

                                       Heavy metals:

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

                                       Microbiological criteria:

                                    Total plate count: ≤ 10 CFU/g
                                    Coliforms: ≤ 10 CFU/g

                                       Escherichia coli: Negative/10 g

                                       Salmonella sp.: Negative/10 g
                                    Yeast and mould: ≤ 10 CFU/g
                                    CFU: Colony Forming Units’


title: Commission Implementing Regulation (EU) 2019/1977 of 26 November 2019 concerning the authorisation of phenylmethanethiol, benzyl methyl sulfide, sec-pentylthiophene, tridec-2-enal, 12-methyltridecanal, 2,5-dimethylphenol, hexa-2(trans),4(trans)-dienal and 2-ethyl-4-hydroxy-5-methyl-3(2H)-furanone as feed additives for cats and dogs (Text with EEA relevance)

text:
                  29.11.2019

                  EN

                  Official Journal of the European Union

                  L 308/45

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1977
         of 26 November 2019
         concerning the authorisation of phenylmethanethiol, benzyl methyl sulfide, sec-pentylthiophene, tridec-2-enal, 12-methyltridecanal, 2,5-dimethylphenol, hexa-2(trans),4(trans)-dienal and 2-ethyl-4-hydroxy-5-methyl-3(2H)-furanone as feed additives for cats and dogs
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

                     (2)

                     Phenylmethanethiol, benzyl methyl sulfide, sec-pentylthiophene, tridec-2-enal, 12-methyltridecanal, 2,5-dimethylphenol, hexa-2(trans),4(trans)-dienal and 2-ethyl-4-hydroxy-5-methyl-3(2H)-furanone (‘the substances concerned’) were authorised as feed additives for cats and dogs without a time limit in accordance with Directive 70/524/EEC. Those feed additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

                     (3)

                     In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the substances concerned for cats and dogs, requesting those feed additives to be classified in the additive category ‛sensory additives’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 February 2019 (3) that, under the proposed conditions of use, the substances concerned do not have adverse effects on animal health or the environment. It also concluded that hazards for users have been identified. The applicant as required produced a safety data sheet for each compound where hazards for users have been identified. No studies to assess the safety for the user were submitted. Therefore, the EFSA cannot conclude on the safety for the users when handling the additives. The hazards described in the safety data sheet are, in particular, hazards for skin and eye contact were recognised for 2,5-dimethylphenol, 12-methyltridecanal, hexa-2(trans),4(trans)-dienal, phenylmethanethiol, benzyl methyl sulfide, 2-ethyl-4-hydroxy-5-methyl-3(2H)-furanone and sec-pentylthiophene. Hazard for respiratory exposure was recognised for 12-methyltridecanal, benzyl methyl sulfide and 2-pentylthiophene. In the absence of data, the Authority could not conclude on the risk for the users. Therefore, the Commission considers that appropriate protective measures should be taken to prevent effects on human health, in particular as regards the users of the feed additive. For non-food-producing animals Commission Regulation (EC) No 429/2008 (4), exempted additives intended for those animals from the environmental assessment as they do not have a significant environmental effect. Pets are not raised in large groups of animals so their effect on the environment is considered not significant. The Authority further concluded that since the substances concerned are used in food as flavourings and their function in feed is the same as that in food, no further demonstration of efficacy in feed is necessary.

                     (5)

                     The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (6)

                     Restrictions and conditions should be provided for to allow for a better control. For the substances concerned recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures. and in the labelling compound feeds and feed materials.

                     (7)

                     The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied for the use in feed. Accordingly, the use of those feed additives should be authorised as specified in the Annex to this Regulation.

                     (8)

                     Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

                     (9)

                     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
            Authorisation
            The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in the Annex.

            Article 2
            Transitional Measures

               1.   The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 19 December 2019 in accordance with the rules applicable before 19 December 2019 may continue to be placed on the market and used until 19 June 2020.

               2.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 19 December 2021 in accordance with the rules applicable before 19 December 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for cats and dogs.

            Article 3
            Entry into Force
            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, 26 November 2019.

                  For the Commission

                  The President

               Jean- Claude JUNCKER

            (1)  OJ L 268, 18.10.2003, p. 29.

            (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

            (3)  EFSA Journal 2019;17(3):5649.

            (4)  Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1).

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

                        mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

                           Category: Sensory additives. Functional group: Flavouring compounds

                        2b5169

                        -

                        12-Methyltridecanal

                           Additive composition:

                        12-Methyltridecanal

                           Characterisation of the active substance:

                        12-Methyltridecanal
                        Produced by chemical synthesis
                        Purity: min. 97 %
                        Chemical formula: C14H28O
                        CAS number: 75853-49-5
                        FLAVIS: 05.169

                           Method of analysis
                            (1):
                        For the determination of
                        12-methyltridecanal
                        in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                        Cats and dogs

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture.

                                    2.

                                    In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment shall be indicated.

                                    3.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,5 mg/kg’

                                    4.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,5 mg/kg.

                                    5.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                        19.12.2029

                        2b5057

                        -

                        Hexa-2(trans),4(trans)-dienal

                           Additive composition:

                        Hexa-2(trans),4(trans)-dienal

                           Characterisation of the active substance:

                        Hexa-2(trans),4(trans)-dienal
                        Produced by chemical synthesis
                        Purity: min. 97 %
                        Chemical formula: C6H8O
                        CAS number: 142-83-6
                        FLAVIS: 05.057

                           Method of analysis
                            (1):
                        For the determination of hexa-2(trans),4(trans)-dienal in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                        Cats and dogs

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture.

                                    2.

                                    In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment shall be indicated.

                                    3.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1,5 mg/kg’

                                    4.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 1,5 mg/kg.

                                    5.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection safety glasses and gloves.

                        19.12.2029

                        2b5078

                        -

                        Tridec-2-enal

                           Additive composition:

                        Tridec-2-enal

                           Characterisation of the active substance:

                        Tridec-2-enal
                        Produced by chemical synthesis
                        Purity: min. 92 %
                        Chemical formula: C13H24O
                        CAS number: 7774-82-5
                        FLAVIS: 05.078

                           Method of analysis
                            (1):
                        For the determination of tridec-2-enal in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                        Cats and dogs

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture.

                                    2.

                                    In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment shall be indicated.

                                    3.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,5 mg/kg’

                                    4.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,5 mg/kg.

                                    5.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                        19.12.2029

                        2b13084

                        2-Ethyl-4-hydroxy-5-methyl-3 (2H)-furanone

                           Additive composition:

                        2-Ethyl-4-hydroxy-5-methyl-3 (2H)-furanone

                           Characterisation of the active substance:

                        2-Ethyl-4-hydroxy-5-methyl-3 (2H)-furanone
                        Produced by chemical synthesis
                        Purity: min. 97 %
                        Chemical formula: C7H10O3

                        CAS number: 27538-09-6
                        FLAVIS: 13.084

                           Method of analysis
                            (1):
                        For the determination of
                        2-ethyl-4-hydroxy-5-methyl-3 (2H)-furanone in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                        Cats and dogs

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture.

                                    2.

                                    In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment shall be indicated.

                                    3.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 2,25 mg/kg’

                                    4.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 2,25 mg/kg.

                                    5.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                        19.12.2029

                        2b12005

                        -

                        Phenylmethanethiol

                           Additive composition:

                        Phenylmethanethiol

                           Characterisation of the active substance:

                        Phenylmethanethiol
                        Produced by chemical synthesis
                        Purity: min. 99 %
                        Chemical formula: C7H8S
                        CAS number: 100-53-8
                        FLAVIS: 12.005

                           Method of analysis
                            (1):
                        For the determination of phenylmethanethiol in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                        Cats and dogs

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture.

                                    2.

                                    In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment shall be indicated.

                                    3.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg’

                                    4.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 mg/kg.

                                    5.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                        19.12.2029

                        2b12077

                        -

                        Benzyl methyl sulfide

                           Additive composition:

                        Benzyl methyl sulfide

                           Characterisation of the active substance:

                        Benzyl methyl sulfide
                        Produced by chemical synthesis
                        Purity: min. 99 %
                        Chemical formula: C8H10S
                        CAS number: 766-92-7
                        FLAVIS: 12.077

                           Method of analysis
                            (1):
                        For the determination of benzyl methyl sulfide in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                        Cats and dogs

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture.

                                    2.

                                    In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment shall be indicated.

                                    3.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg’

                                    4.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,05 mg/kg.

                                    5.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                        19.12.2029

                        2b4019

                        -

                        2,5-Dimethylphenol

                           Additive composition:

                        2,5-Dimethylphenol

                           Characterisation of the active substance:

                        2,5-Dimethylphenol
                        Produced by chemical synthesis
                        Purity: min. 99 %
                        Chemical formula: C8H10O
                        CAS number: 95-87-4
                        FLAVIS: 04.019

                           Method of analysis
                            (1):
                        For the determination of
                        2,5-dimethylphenol in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                        Cats and dogs

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture.

                                    2.

                                    In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment shall be indicated.

                                    3.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 1 mg/kg’

                                    4.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 1 mg/kg.

                                    5.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                        19.12.2029

                        2b15096

                        -

                        sec-Pentylthiophene

                           Additive composition:

                        sec-Pentylthiophene

                           Characterisation of the active substance:

                        sec-Pentylthiophene
                        Produced by chemical synthesis
                        Purity: min. 98 %
                        Chemical formula: C9H14S
                        CAS number: 4861-58-9
                        FLAVIS: 15.096

                           Method of analysis
                            (1):
                        For the determination of sec-
                        -pentylthiophene in the feed additive and in feed flavouring premixtures:
                        Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                        Cats and dogs

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture.

                                    2.

                                    In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment shall be indicated.

                                    3.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,1 mg/kg’

                                    4.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 0,1 mg/kg.

                                    5.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

                        19.12.2029

               (1)  Details of the methods of analysis are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.


title: Commission implementing Regulation (EU) 2019/1979 of 26 November 2019 authorising the placing on the market of 2'-Fucosyllactose/Difucosyllactose mixture as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

text:
                  29.11.2019

                  EN

                  Official Journal of the European Union

                  L 308/62

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1979
         of 26 November 2019
         authorising the placing on the market of 2'-Fucosyllactose/Difucosyllactose mixture as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (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 of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

                     (2)

                     Pursuant to Article 8 of Regulation (EU) 2015/2283 Commission Implementing Regulation (EU) 2017/2470 (2) was adopted, which establishes a Union list of authorised novel foods.

                     (3)

                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on updating the Union list.

                     (4)

                     On 30 April 2018, the company Glycom A/S (‘the Applicant’) made a request to the Commission within the meaning of Article 10(1) of Regulation (EU) 2015/2283 to place 2'-Fucosyllactose/Difucosyllactose mixture (‘2'-FL/DFL’), obtained by microbial fermentation with a genetically modified strain of Escherichia coli strain K12 DH1, on the Union market as a novel food. The Applicant requested for 2'-FL/DFL to be used in unflavoured pasteurised and unflavoured sterilised milk products, flavoured and unflavoured fermented milk based products including heat-treated products, cereal bars, flavoured drinks, infant formula and follow-on formula and processed cereal-based food and baby food for infants and young children, foods for special medical purposes, and total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (3), and in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4) intended for the general population excluding infants.

                     (5)

                     On 30 April 2018, the Applicant also made a request to the Commission for protection of proprietary data for a number of studies submitted in support of the application, namely, the proprietary analytical reports on the structure comparison via nuclear magnetic resonance (‘NMR’) of 2'-fucosyllactose and of difucosyllactose produced by bacterial fermentation with 2'-fucosyllactose and difucosyllactose naturally present in human milk (5), the detailed characterisation data on the production bacterial strains and their certificates (6), (7), the specifications for the raw materials and processing aids (8), the certificates of analyses of the various 2'-FL/DFL batches (9), the analytical methods and validation reports (10), the 2'-FL/DFL stability reports (11), the laboratory accreditation certificates (12), the 2'-FL/DFL intake assessment reports (13), the summary table of the statistically significant observations in the toxicity studies (14), a bacterial reverse mutation test with 2'-FL/DFL (15), an in vitro mammalian cell micronucleus test with 2'-FL/DFL (16), a 14-day oral toxicity study in the neonatal rat with 2'-FL/DFL (17), a 90-day oral toxicity study in the neonatal rat with 2'-FL/DFL (18), a bacterial reverse mutation test with 2'-Fucosyllactose (‘2'-FL’) (19) two in vitro mammalian cell micronucleus tests with 2'-FL (20), (21), and a 90-day oral toxicity study in the neonatal rat with 2'-FL (22).

                     (6)

                     On 29 June 2018, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of 2'-FL/DFL as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283.

                     (7)

                     On 15 May 2019, the Authority adopted its scientific opinion ‘Safety of 2'-Fucosyllactose/Difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283’ (23). That scientific opinion is in accordance with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (8)

                     In its opinion, the Authority concluded that 2'-FL/DFL is safe under the proposed conditions of use for the proposed target population. Therefore that scientific opinion gives sufficient grounds to establish that 2'-FL/DFL, when used in unflavoured pasteurised and unflavoured sterilised milk products, flavoured and unflavoured fermented milk based products including heat treated products, cereal bars, flavoured drinks, infant formula and follow-on formula and processed cereal-based food and baby food for infants and young children, foods for special medical purposes, and total diet replacement foods for weight control, and in food supplements intended for the general population, excluding infants, complies with the requirements of Article 12(1) of Regulation (EU) 2015/2283.

                     (9)

                     In its opinion, the Authority considered that the data from the analytical NMR reports on the structure comparison of 2'-fucosyllactose and of difucosyllactose produced by bacterial fermentation with 2'-fucosyllactose and difucosyllactose naturally present in human milk, the detailed characterisation data on the production bacterial strains, the specifications for the raw materials and processing aids, the certificates of analyses of the various 2'-FL/DFL batches, the bacterial reverse mutation test with 2'-FL/DFL, the in vitro mammalian cell micronucleus test with 2'-FL/DFL, the 90-day oral toxicity study in the neonatal rat with 2'-FL/DFL, and the summary table of the statistically significant observations in the 90-day toxicity study, served as a basis to establish the safety of the novel food. Therefore, it is considered that the conclusions on the safety of 2'-FL/DFL could not have been reached without the data from the reports of these studies.

                     (10)

                     Following the receipt of the Authority’s considerations, the Commission requested the Applicant to further clarify the justification provided with regard to their proprietary analytical NMR reports on the structure comparison of 2'-fucosyllactose and of difucosyllactose produced by bacterial fermentation with 2'-fucosyllactose and difucosyllactose naturally present in human milk, the detailed characterisation data on the production bacterial strains, the specifications for the raw materials and processing aids, the certificates of analyses of the various 2'-FL/DFL batches, the bacterial reverse mutation test with 2'-FL/DFL, the in vitro mammalian cell micronucleus test with 2'-FL/DFL, the 90-day oral toxicity study in the neonatal rat with 2'-FL/DFL, and the summary table of the statistically significant observations in the 90-day toxicity study, and to clarify their claim to an exclusive right of reference to those reports and studies, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

                     (11)

                     The Applicant declared that, at the time the application was made, they held proprietary and exclusive rights of reference to the studies under national law and that therefore third parties could not lawfully access or use these studies.

                     (12)

                     The Commission assessed all the information provided by the Applicant and considered that the Applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore the data from the studies contained in the Applicant’s file which served as a basis for the Authority to establish the safety of the novel food and to reach its conclusions on the safety of 2'-FL/DFL, and without which the novel food could not have been assessed by the Authority, should not be used by the Authority for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of 2'-FL/DFL should be restricted to the Applicant for that period.

                     (13)

                     However, restricting the authorisation of 2'-FL/DFL and of the reference to the studies contained in the Applicant’s file for the sole use of the Applicant, does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such authorisation under Regulation (EU) 2015/2283.

                     (14)

                     The use of 2'-FL/DFL should be authorised without prejudice to Regulation (EU) No 609/2013 laying down requirements on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control.

                     (15)

                     The use of 2'-FL/DFL should also be authorised without prejudice to Directive 2002/46/EC laying down requirements on food supplements.

                     (16)

                     The use of 2'-FL/DFL should be authorised without prejudice to Regulation (EU) No 1308/2013 of the European Parliament and Council of 17 December 2013 establishing a common organisation of the markets in agricultural products (24) laying down requirements for agricultural products, in particular on milk and milk products.

                     (17)

                     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

               1.   2'-FL/DFL as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

               2.   For a period of five years from the date of entry into force of this Regulation only the initial Applicant:

                           Company: Glycom A/S;

                           Address: Kogle Allé 4, DK-2970 Hørsholm, Denmark,

                     is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 to this Regulation or with the agreement of Glycom A/S.

               3.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

               4.   The authorisation provided for in this Article shall be without prejudice to the provisions of Regulation (EU) No 609/2013, of Directive 2002/46/EC, and Regulation (EU) No 1308/2013.

            Article 2
            The studies and reports contained in the application file on the basis of which 2'-FL/DFL has been assessed by the Authority, claimed by the Applicant as fulfilling the requirements laid down in Article 26(2) of Regulation (EC) 2015/2283, shall not be used for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Glycom A/S.

            Article 3
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

            Article 4
            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, 26 November 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  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).

            (3)  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).

            (4)  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).

            (5)  Glycom 2018 (unpublished).

            (6)  Glycom 2018 (unpublished).

            (7)  Glycom/DSMZ 2018 (unpublished).

            (8)  Glycom 2018 (unpublished).

            (9)  Glycom 2018 (unpublished).

            (10)  Glycom 2018 (unpublished).

            (11)  Glycom 2018 (unpublished).

            (12)  Glycom 2018 (unpublished).

            (13)  Glycom 2018 (unpublished).

            (14)  Flaxmer 2018 (unpublished) and Philips K. R., N. Baldwin, B. Lynch, J. Flaxmer, A. Šoltésová, M. H. Mikš, C. H. Röhrig. 2018. Safety evaluation of the human-identical milk oligosaccharides 2'-fucosyllactose and difucosyllactose. Food and Chemical Toxicology 120:552-565.

            (15)  Šoltésová, 2017 (unpublished) and Philips et al. 2018. Food and Chemical Toxicology 120:552-565.

            (16)  Gilby 2017 (unpublished) and Philips et al. 2018. Food and Chemical Toxicology 120:552-565.

            (17)  Flaxmer 2017 (unpublished) and Philips et al. 2018. Food and Chemical Toxicology 120:552-565.

            (18)  Flaxmer 2018 (unpublished) and Philips et al. 2018. Food and Chemical Toxicology 120:552-565.

            (19)  Verspeek-Rip 2015 (unpublished).

            (20)  Verbaan 2015a (unpublished).

            (21)  Verbaan 2015b (unpublished).

            (22)  Penard 2015 (unpublished).

            (23)  EFSA Journal 2019;17(6):5717.

            (24)  OJ L 347, 20.12.2013, p. 671.

            ANNEX
            The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

                        (1)

                        in Table 1 (Authorised novel foods), the following entry is inserted in alphabetical order:

                                       Authorised novel food

                                       Conditions under which the novel food may be used

                                       Additional specific labelling requirements

                                       Other requirements

                                       Data Protection

                                    ‘2'-Fucosyllactose/Difucosyllactose mixture (‘2'-FL/DFL’)

                                       (microbial source)

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be “2'-Fucosyllactose/Difucosyllactose mixture”.
                                    The labelling of food supplements containing the 2'-Fucosyllactose/Difucosyllactose mixture shall bear a statement that they should not be used if breast milk or other foods containing added 2'-Fucosyllactose and/or Difucosyllactose are consumed the same day.

                                    Authorised on 19.12.2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 2'-Fucosyllactose/Difucosyllactose mixture is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.
                                    End date of the data protection: 19.12.2024.’

                                    Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products

                                    2,0 g/L

                                    Unflavoured fermented milk-based products

                                    2,0 g/L (beverages)
                                    20 g/kg (products other than beverages)

                                    Flavoured fermented milk-based products including heat-treated products

                                    2,0 g/L (beverages)
                                    20 g/kg (products other than beverages)

                                    Beverages (flavoured drinks)

                                    2,0 g/L

                                    Cereal bars

                                    20 g/kg

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

                                    1,6 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

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

                                    1,2 g/L 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 under Regulation (EU) No 609/2013

                                    1,2 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
                                    10 g/kg for products other than beverages

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

                                    4,0 g/L (beverages)
                                    40 g/kg (products other than beverages)

                                    Food for special medical purposes as defined under 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 intended for the general population excluding infants

                                    4,0 g/day

                        (2)

                        in Table 2 (Specifications), the following entry is inserted in alphabetical order:

                                       Authorised Novel Food

                                       Specification

                                    ‘2'-Fucosyllactose/Difucosyllactose mixture (‘2'-FL/DFL’)

                                       (microbial source)

                                       Description/Definition:

                                    2'-Fucosyllactose/Difucosyllactose mixture is a purified, white to off-white amorphous powder that is produced by a microbial process. After purification, the 2'-Fucosyllactose/Difucosyllactose mixture is isolated by spray drying.

                                       Source: Genetically modified strain of Escherichia coli strain K-12 DH1

                                       Characteristics/Composition

                                    Appearance: White to off white powder or agglomerates
                                    Sum of 2'-Fucosyllactose, Difucosyllactose, Lactose and Fucose (% of dry matter): ≥ 92,0 % (w/w)
                                    Sum of 2'-fucosyllactose and difucosyllactose (% of dry matter): ≥ 85,0 % (w/w)
                                    2'-Fucosyllactose (% of dry matter): ≥ 75,0 % (w/w)
                                    Difucosyllactose (% of dry matter): ≥ 5,0 % (w/w)
                                    D-Lactose: ≤ 10,0 % (w/w)
                                    L-Fucose: ≤ 1,0 % (w/w)
                                    2'-Fucosyl-D-lactulose: ≤ 2,0 % (w/w)
                                    Sum of other carbohydrates (*1): ≤ 6,0 % (w/w)
                                    Moisture: ≤ 6,0 % (w/w)
                                    Ash, sulfated: ≤ 0,8 % (w/w)
                                    pH (20 °C, 5 % solution): 4,0-6,0
                                    Residual protein: ≤ 0,01 % (w/w)

                                       Microbiological criteria:

                                    Aerobic mesophilic bacteria total plate count: ≤ 1000 CFU/g

                                       Enterobacteriaceae: ≤ 10 CFU/g

                                       Salmonella sp.: Negative/25 g
                                    Yeast: ≤ 100 CFU/g
                                    Mould: ≤ 100 CFU/g
                                    Residual endotoxins: ≤ 10 EU/mg
                                    CFU: Colony Forming Units; EU: Endotoxin Units

               (*1)  3'-Fucosyllactose, 2'-Fucosyl-galactose, Glucose, Galactose, Mannitol, Sorbitol, Galactitol, Trihexose, Allo-lactose and other structurally related carbohydrates.’


title: Commission Implementing Regulation (EU) 2019/1981 of 28 November 2019 amending Implementing Regulation (EU) 2019/626 as regards lists of third countries and regions thereof authorised for the entry into the European Union of snails, gelatine and collagen, and insects intended for human consumption (Text with EEA relevance)

text:
                  29.11.2019

                  EN

                  Official Journal of the European Union

                  L 308/72

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1981
         of 28 November 2019
         amending Implementing Regulation (EU) 2019/626 as regards lists of third countries and regions thereof authorised for the entry into the European Union of snails, gelatine and collagen, and insects intended for human consumption
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (1), and in particular Article 127(2) thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2017/625 lays down rules for official controls and other control activities performed by the competent authorities of the Member States in order to verify compliance with Union legislation in the area of, among others, food safety at all stages of the production, processing and distribution process. In particular, it provides that certain animals and goods are only to enter the Union from a third country or region thereof which appears on a list drawn up by the Commission for that purpose.

                     (2)

                     Commission Delegated Regulation (EU) 2019/625 (2) supplements Regulation (EU) 2017/625 as regards the requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption from third countries or regions thereof in order to ensure that they comply with the relevant requirements established by the rules referred to in Article 1(2)(a) of Regulation (EU) 2017/625 or with requirements recognised to be at least equivalent. Article 3 of Delegated Regulation (EU) 2019/625 lays down rules regarding certain animals and goods that are required to come only from third countries or regions thereof included in the list referred to in Article 126(2)(a) of Regulation (EU) 2017/625. Requirements to be included in the list are laid down in Article 4 of Delegated Regulation (EU) 2019/625, in addition to the more general requirements for inclusion laid down in Article 127(3) of Regulation (EU) 2017/625.

                     (3)

                     Commission Implementing Regulation (EU) 2019/626 (3) lays down or refers to lists of third countries or regions thereof authorised for the entry into the Union of consignments of certain animals and goods intended for human consumption to ensure compliance with the food safety requirements laid down in Article 4 of Delegated Regulation (EU) 2019/625 and Article 127(3) of Regulation (EU) 2017/625. Implementing Regulation (EU) 2019/626 applies from 14 December 2019.

                     (4)

                     Article 12 of Implementing Regulation (EU) 2019/626 authorises the entry into the Union of consignments of snails, as defined in point 6.2 of Annex I to Regulation (EC) No 853/2004 (4), under certain conditions, provided that such consignments come from the third countries or regions thereof listed in Annex III to Implementing Regulation (EU) 2019/626.

                     (5)

                     In accordance with Article 6(1)(a) of Regulation (EC) No 853/2004, products of animal origin, including other species of snails intended for human consumption, may be imported in the Union only if the third country or regions thereof appear on a list laid down in Implementing Regulation (EU) 2019/626.

                     (6)

                     Pending such listing in accordance with Regulation (EU) 2019/626, imports of such snails are allowed in accordance with Article 3 of Commission Regulation (EU) 2017/185 (5), which provides a derogation concerning public health requirements for imports of products of animal origin laid down in Article 6(1) of Regulation (EC) No 853/2004 and which applies until 31 December 2020. It is appropriate to include these species of snails in the list of third countries and regions thereof, laid down in Annex III to Implementing Regulation (EU) 2019/626 to avoid any trade disruption after 31 December 2020.

                     (7)

                     On 31 January 2019, Armenia requested to be included in the list of third countries from which Member States are to authorise the import to the Union of snails intended for human consumption. Armenia provided guarantees on compliance with the requirements laid down in Article 127(3) of Regulation (EU) 2017/625 and Article 4 of Delegated Regulation (EU) 2019/625, to be authorised for the entry into the Union of snails. Armenia should therefore be included in the list of third countries and regions thereof authorised for the entry into the Union of snails, set out in Annex III of Implementing Regulation (EU) 2019/626.

                     (8)

                     Article 14 of Implementing Regulation (EU) 2019/626 refers to lists of third countries and regions thereof authorised for the entry into the Union of gelatine and collagen. Article 14 restricts the entry into the Union of gelatine and collagen derived from bovine, ovine, caprine, porcine and equine animals, and from poultry, only to third countries or regions thereof authorised for the entry into the Union of fresh meat of certain species of ungulates and poultry meat.

                     (9)

                     Article 14 further restricts the entry into the Union of such gelatine and collagen based on animal health restrictions applicable to fresh meat. The latter restrictions are not appropriate because the production process of gelatine and collagen excludes the presence of such animal health hazards. Therefore, a less strict approach should be applied for the entry into the Union of gelatine and collagen from third countries or regions thereof, only based on compliance with the requirements for the entry into the Union of animal and goods laid down in Regulation (EU) 2017/625 and Delegated Regulation (EU) 2019/625.

                     (10)

                     Article 20 of Implementing Regulation (EU) 2019/626 refers to a list of third countries and regions thereof authorised for the entry into the Union of insects. This Article refers to third countries and regions thereof from which insects have been authorised in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council (6) and listed in Commission Implementing Regulation (EU) 2017/2470 (7). However, Article 20 of Implementing Regulation (EU) 2019/626 does not provide to specifically identify the third countries and regions thereof that have such authorisation. It is therefore appropriate to refer to a concrete list of third countries and regions thereof authorised for the entry into the Union of these insects in a specific Annex to Implementing Regulation (EU) 2019/626. Third countries and regions thereof should only be authorised for the entry into the Union of insects and listed if they provide sufficient guarantees that they comply with the requirements laid down in Article 127(3) of Regulation (EU) 2017/625 and Article 4 of Delegated Regulation (EU) 2019/625.

                     (11)

                     On 8 October 2019, Canada provided sufficient guarantees to be authorised for the entry into the Union of insects.

                     (12)

                     On 28 August 2019, Switzerland provided sufficient guarantees to be authorised for the entry into the Union of insects.

                     (13)

                     On 11 September 2019, South Korea provided sufficient guarantees to be authorised for the entry into the Union of insects.

                     (14)

                     Canada, Switzerland and South Korea should therefore be listed as authorised for the entry into the Union of insects and Article 20 of Implementing Regulation (EU) 2019/626 should be amended accordingly.

                     (15)

                     As Implementing Regulation (EU) 2019/626 applies with effect from 14 December 2019, this Regulation should also apply from that date in order to avoid any trade disruption in particular on the entry into the Union of consignments of gelatine and collagen.

                     (16)

                     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
            Implementing Regulation (EU) 2019/626 is amended as follows:

                        (1)

                        in Article 2, point 17 is replaced by the following:

                                    ‘(17)

                                    “snails” means snails as defined in point 6.2 of Annex I to Regulation (EC) No 853/2004 and any other species of snails of the family of Helicidae, Hygromiidae or Sphincterochilidae, intended for human consumption;’;

                        (2)

                        Article 12 is replaced by the following:

                           ‘Article 12
                           List of third countries or regions thereof authorised for the entry into the Union of snails
                           Consignments of snails intended for human consumption shall only be authorised for the entry into the Union if they come from third countries or regions thereof that are listed in Annex III to this Regulation.’;

                        (3)

                        in Article 14, paragraphs 1 and 2 are replaced by the following:

                                    ‘1.

                                    Consignments of gelatine and collagen derived from bovine, ovine, caprine, porcine and equine animals, intended for human consumption shall only be authorised for the entry into the Union if they come from the third countries listed in column 1 of Part 1 of Annex II to Regulation (EU) No 206/2010 or from South Korea, Malaysia, Pakistan or Taiwan.

                                    2.

                                    Consignments of gelatine and collagen derived from poultry intended for human consumption shall only be authorised for the entry into the Union if they come from the third countries listed in column 1 of the table in Part 1 of Annex I to Regulation (EC) No 798/2008, or from Taiwan.’;

                        (4)

                        Article 20 is replaced by the following:

                           ‘Article 20
                           Third countries or regions thereof authorised for the entry into the Union of insects
                           Consignments of insects intended for human consumption shall only be authorised for the entry into the Union if such foods have originated in and been consigned from a third country or region thereof, listed in Annex IIIa to this Regulation.’;

                        (5)

                        the Annexes are amended in accordance with the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
            It shall apply from 14 December 2019.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 28 November 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 95, 7.4.2017, p. 1.

            (2)  Commission Delegated Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption (OJ L 131, 17.5.2019, p. 18).

            (3)  Commission Implementing Regulation (EU) 2019/626 of 5 March 2019 concerning lists of third countries and regions thereof authorised for the entry into the European Union of certain animals and goods intended for human consumption, amending Implementing Regulation (EU) 2016/759 as regards these lists (OJ L 131, 17.5.2019, p. 31).

            (4)  Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).

            (5)  Commission Regulation (EU) 2017/185 of 2 February 2017 laying down transitional measures for the application of certain provisions of Regulations (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and of the Council (OJ L 29, 3.2.2017, p. 21).

            (6)  Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 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 (OJ L 327, 11.12.2015, p. 1).

            (7)  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).

            ANNEX
            The Annexes to Regulation (EU) 2019/626 are amended as follows:

                        (1)

                        in Annex III, the following entry is inserted between the entry for Albania and the entry for Angola:

                                    ‘AM

                                    Armenia’

                        (2)

                        the following Annex IIIa is inserted:

                  ‘ANNEX IIIa

                     List of third countries or regions thereof from which entry into the Union of insects is permitted, referred to in Article 20

                              Country ISO code

                              Third country or regions thereof

                              Remarks

                              CA

                              Canada

                              CH

                              Switzerland

                              KR

                              South Korea’