title: Commission Implementing Regulation (EU) 2021/1166 of 15 July 2021 amending Implementing Regulation (EU) 2019/947 as regards postponing the date of application for standard scenarios for operations executed in or beyond the visual line of sight (Text with EEA relevance)

text:
                  16.7.2021

                  EN

                  Official Journal of the European Union

                  L 253/49

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1166
         of 15 July 2021
         amending Implementing Regulation (EU) 2019/947 as regards postponing the date of application for standard scenarios for operations executed in or beyond the visual line of sight
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 216/2008 and (EC) No 552/2004 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (1), and in particular Article 57 thereof,
         Whereas:

                     (1)

                     Pursuant to Article 23(4) of Commission Implementing Regulation (EU) 2019/947 (2), as from 2 December 2021, Member States may only accept declarations made by UAS operators in accordance with Article 5(5) of that Implementing Regulation for an operation complying with one of the two standard scenarios set out in Appendix 1 to the Annex of that Implementing Regulation.

                     (2)

                     Harmonized standards are considered by UAS manufacturers as an important instrument to enable them to place compliant UAS on the market.

                     (3)

                     However, some of the harmonised standards addressing the requirements applicable to UAS of classes C5 and C6 will not be available by 2 December 2021.

                     (4)

                     It is therefore necessary to postpone the date of application in order to ensure that the harmonised standards addressing the requirements applicable to UAS of classes C5 and C6 are available before Member States may only accept declarations for operations compliant with the standard scenarios established by Appendix 1 to the Annex of Implementing Regulation (EU) 2019/947. Until then Member States should be able to accept declarations made by UAS operators in accordance with Article 5(5) of that Implementing Regulation, based on national standard scenarios or equivalent.

                     (5)

                     The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 127 of Regulation (EU) 2018/1139,

               HAS ADOPTED THIS REGULATION:

            Article 1
            In Article 23 of Implementing Regulation (EU) 2019/947, paragraphs 2, 3 and 4 are replaced by the following:

                  ‘2.   Article 5(5) shall apply from 3 December 2023.

                  3.   Point (2)(g) of point UAS.OPEN.060 of the Annex and point (1)(l) of point UAS.SPEC.050 of the Annex shall apply from 1 July 2022.

                  4.   Without prejudice to Article 21(1), until 2 December 2023 Member States may accept declarations made by UAS operators in accordance with Article 5(5), based on national standard scenarios or equivalent, if those national scenarios meet the requirements of point UAS.SPEC.020 of the Annex.
                  Such declarations shall cease to be valid from 2 December 2025.’

            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, 15 July 2021

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 212, 22.8.2018, p. 1.

            (2)  Commission Implementing Regulation (EU) 2019/947 of 24 May 2019 on the rules and procedures for the operation of unmanned aircraft (OJ L 152, 11.6.2019, p. 45).


title: Commission Implementing Regulation (EU) 2021/1373 of 12 August 2021 entering a name in the register of protected designations of origin and protected geographical indications ‘Jászsági nyári szarvasgomba’ (PGI)

text:
                  19.8.2021

                  EN

                  Official Journal of the European Union

                  L 296/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1373
         of 12 August 2021
         entering a name in the register of protected designations of origin and protected geographical indications
         ‘Jászsági nyári szarvasgomba’ (PGI)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Hungary’s application to register the name ‘Jászsági nyári szarvasgomba’ was published in the Official Journal of the European Union (2).

                     (2)

                     As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Jászsági nyári szarvasgomba’ should therefore be entered in the register,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘Jászsági nyári szarvasgomba’ (PGI) is hereby entered in the register.
            The name specified in the first paragraph denotes a product in Class 1.6. – Fruit, vegetables and cereals, fresh or processed, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

            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, 12 August 2021.

                  For the Commission

                  On behalf of the President

               Janusz WOJCIECHOWSKI

                  Member of the Commission

            (1)  OJ L 343, 14.12.2012, p. 1.

            (2)  OJ C 149, 27.4.2021, p. 11.

            (3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).


title: Commission Implementing Regulation (EU) 2021/1377 of 19 August 2021 authorising the change of the conditions of use of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae 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:
                  20.8.2021

                  EN

                  Official Journal of the European Union

                  L 297/20

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1377
         of 19 August 2021
         authorising the change of the conditions of use of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae 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 of the European Parliament and of the Council 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 the updating of the Union list.

                     (4)

                     The novel food ‘Astaxanthin-rich oleoresin from Haematococcus pluvialis algae’ has been authorised pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3) for use in food supplements intended for the general population, as defined in Directive 2002/46/EC of the European Parliament and of the Council (4). The maximum authorised levels of the astaxanthin-rich oleoresin from Haematococcus pluvialis algae for the general population is currently 40-80 mg per day of oleoresin, resulting in ≤ 8,0 mg astaxanthin per day.

                     (5)

                     At the time of the establishment of the Union list of authorised novel foods in 2017, the Commission considered that, based on previous two opinions (5)
                        , (6) of 2014 of the European Food Safety Authority (‘the Authority’), one on the use of astaxanthin in feed additives as defined in Regulation (EC) No 1831/2003 of the European Parliament and the Council (7) on feed additives for animal nutrition, that established an Acceptable Daily Intake (‘ADI’) of 0,034 mg/kg body weight per day for astaxanthin, and one on the safety of astaxanthin as a novel food ingredient, the intake of astaxanthin from food supplements containing the maximum authorised use levels of up to 8,0 mg per day, may exceed the ADI and may not be in accordance with the conditions set out in Article 7 of Regulation (EU) 2015/2283. The Commission considered that the Union list should be amended to adjust the authorised levels of astaxanthin in light of the 2014 Authority opinions.

                     (6)

                     The Commission also became aware of new scientific evidence in 2017, submitted by business operators during the public consultation of the draft Implementing Regulation establishing the Union list of authorised novel foods, pointing to a considerably higher ADI for astaxanthin than the one previously established by the Authority. In addition, evidence submitted during the same public consultation demonstrated that there already existed a considerable intake of astaxanthin from the normal diet as it is naturally present in some fish and crustaceans.

                     (7)

                     On 27 February 2018, the Commission, in accordance with Article 29(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (8) requested the Authority to deliver an opinion on the safety of astaxanthin when used as a novel food in food supplements at levels of up to 8,0 mg/day, taking into account the overall cumulative intake of astaxanthin from all food sources.

                     (8)

                     On 18 December 2019, the Authority adopted its scientific opinion ‘Safety of astaxanthin for its use as a novel food in food supplements’ (9).

                     (9)

                     In its scientific opinion, the Authority concluded that on the basis of the new evidence, the ADI for astaxanthin is 0,2 mg/kg body weight per day. Taking into account the astaxanthin ADI and the intake of astaxanthin from the normal diet, the Authority concluded that the intake of the maximum currently authorised levels of up to 8,0 mg/day astaxanthin from food supplements containing astaxanthin-rich oleoresin from Haematococcus pluvialis algae is safe for adults and adolescents above 14 years old.

                     (10)

                     A clear designation of the novel food and a labelling requirement should be laid down for food supplements containing astaxanthin-rich oleoresin from Haematococcus pluvialis algae in order ensure that those food supplements are not consumed by children and adolescents aged less than 14 years of age.

                     (11)

                     The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

                     (12)

                     Evidence form the market place seems to indicate that although food supplements containing ≤ 8,0 mg astaxanthin are currently authorised for the general population, in practice they are not used by children and adolsescents but are almost exclusively used by the adult population. In order to limit the administrative burden and to provide business operators with sufficient time to adjust their practices to comply with the requirements of this Regulation, transitional periods should be laid down to cover food supplements containing ≤ 8,0 mg astaxanthin which have been placed on the market or dispatched from third countries for the Union and are intended for the general population, before the date of entry into force of this Regulation. Those transitional measures should take into account the safety of consumers by providing them the information about the appropriate use in line with the requirements of this Regulation.

                     (13)

                     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.   The entry in the Union list of authorised novel foods, as provided for in Article 6 of Regulation (EU) 2015/2283 and included in Implementing Regulation (EU) 2017/2470, referring to the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae, is amended as specified in the Annex to this Regulation.

               2.   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.

            Article 2

               1.   Food supplements containing ≤ 8,0 mg astaxanthin intended for the general population which were lawfully placed on the market before the date of entry into force of this Regulation, may be marketed until their date of minimum durability or use by date.

               2.   Foods supplements containing ≤ 8,0 mg astaxanthin intended for the general population imported into the Union may be marketed until their date of minimum durability or use by date where the importer of such food can demonstrate that they were dispatched from the third country concerned and were on their way to the Union before the date of entry into force of this Regulation.

               3.   The food business operators should provide a notice for the food supplements referred to in paragraph 1 to be displayed at the place of sale informing them that those food supplements should not be consumed by infants, children and adolescents below the age of 14 years.

            Article 3
            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, 19 August 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (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 (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).

            (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)  EFSA Journal 2014;12(6):3724.

            (6)  EFSA Journal 2014; 12(7):3757.

            (7)  Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).

            (8)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

            (9)  EFSA Panel on Nutrition, Novel Foods and Food Allergens, Scientific Opinion on the safety of astaxanthin as a novel food in food supplements. EFSA Journal 2020;18(2):5993.

            ANNEX
            In the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘Astaxanthin-rich oleoresin from Haematococcus pluvialis algae’ in Table 1 (Authorised novel foods) is replaced by the following:

                           ‘Authorised novel food

                              Conditions under which the novel food may be used

                              Additional specific labelling requirements

                              Other requirements

                           ‘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-rich oleoresin from Haematococcus pluvialis algae’
                           The labelling of food supplements containing Astaxanthin-rich oleoresin from Haematococcus pluvialis algae shall bear a statement that they should not be consumed by infants, children, and adolescents younger than 14 years.’

                           Food Supplements as defined in Directive 2002/46/EC, excluding infants, young children, children, and adolescents younger than14 years

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


title: Commission Implementing Regulation (EU) 2021/1378 of 19 August 2021 laying down certain rules concerning the certificate issued to operators, groups of operators and exporters in third countries involved in the imports of organic and in-conversion products into the Union and establishing the list of recognised control authorities and control bodies in accordance with Regulation (EU) 2018/848 of the European Parliament and of the Council (Text with EEA relevance)

text:
                  20.8.2021

                  EN

                  Official Journal of the European Union

                  L 297/24

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1378
         of 19 August 2021
         laying down certain rules concerning the certificate issued to operators, groups of operators and exporters in third countries involved in the imports of organic and in-conversion products into the Union and establishing the list of recognised control authorities and control bodies in accordance with Regulation (EU) 2018/848 of the European Parliament and of the Council
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (1), and in particular Articles 45(4) and 46(1) thereof,
         Whereas:

                     (1)

                     In accordance with point (b)(i) of Article 45(1) of Regulation (EU) 2018/848, a product may be imported from a third country for the purpose of placing that product on the market within the Union as an organic product or as in-conversion product, if operators and groups of operators, including exporters in the third country concerned, have been subject to controls by control authorities or control bodies recognised in accordance with Article 46 of that Regulation, and those authorities or bodies have provided all such operators, groups of operators and exporters with a certificate confirming that they comply with Regulation (EU) 2018/848.

                     (2)

                     In order to give effect to point (b)(i) of Article 45(1) of Regulation (EU) 2018/848, the content of the certificate referred to in that provision should be specified, as well as the technical means by which it is to be issued.

                     (3)

                     In addition, for the purposes of point (b)(i) of Article 45(1) of Regulation (EU) 2018/848, it is appropriate to establish in this Regulation the list of recognised control authorities and control bodies that are competent to carry out those controls and to issue that certificate in third countries.

                     (4)

                     In the interest of clarity and legal certainty, this Regulation should apply from the date of application of Regulation (EU) 2018/848.

                     (5)

                     The measures provided for in this Regulation are in accordance with the opinion of the Organic Production Committee,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Certificate for operators, groups of operators and exporters in third countries
            Control authorities and control bodies that have been recognised in accordance with Article 46(1) of Regulation (EU) 2018/848 shall provide operators, groups of operators and exporters in third countries that have been subject to the controls referred to in point (b)(i) of Article 45(1) of that Regulation with a certificate confirming that such operators, groups of operators and exporters comply with Regulation (EU) 2018/848 (‘the certificate’).
            The certificate shall:

                        (a)

                        be issued in electronic form, in accordance with the model set out in Annex I to this Regulation, and by using the electronic Trade Control and Expert System (TRACES) referred to in point (36) of Article 2 of Commission Implementing Regulation (EU) 2019/1715 (2);

                        (b)

                        allow the identification of:

                                    (i)

                                    the operator, group of operators or exporter covered by the certificate, including the list of members of a group of operators;

                                    (ii)

                                    the category of products covered by the certificate, classified in the same way as provided for in Article 35(7) of Regulation (EU) 2018/848; and

                                    (iii)

                                    its period of validity;

                        (c)

                        certify that the activity of the operator, group of operators or exporter complies with Regulation (EU) 2018/848; and

                        (d)

                        be updated whenever changes occur concerning the data included in it.

            Article 2
            List of recognised control authorities and control bodies

               1.   The list of control authorities and control bodies recognised in accordance with Article 46(1) of Regulation (EU) 2018/848 is set out in Annex II to this Regulation. The list shall contain the following information on each recognised control authority or control body:

                           (a)

                           the name and code number of the control authority or control body;

                           (b)

                           the product categories, as set out in Article 35(7) of Regulation (EU) 2018/848, for each third country;

                           (c)

                           the third countries in which the product categories have their origin, provided that those third countries are not already covered for the product category or product concerned by an agreement on trade in organic products in accordance with Article 47 of Regulation (EU) 2018/848 or through an equivalence recognition in accordance with Article 48 of that Regulation;

                           (d)

                           the duration of the recognition; and

                           (e)

                           the exceptions to the recognition, where appropriate.

                              2.   Detailed information relating to the mailing address, website address and email contact point of the control authority or control body, as well as the name of the accreditation body granting the accreditation in accordance with point (d) of Article 46(2) of Regulation (EU) 2018/848, shall be publicly available via the Commission organic farming website.

            Article 3
            Entry into force and application
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 January 2022.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 19 August 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 150, 14.6.2018, p. 1.

            (2)  Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the information management system for official controls and its system components (the IMSOC Regulation) (OJ L 261, 14.10.2019, p. 37).

            ANNEX I
            MODEL OF THE CERTIFICATE

               CERTIFICATE FOR OPERATORS, GROUPS OF OPERATORS AND EXPORTERS IN THIRD COUNTRIES FOR PRODUCTS TO BE IMPORTED INTO THE EUROPEAN UNION AS ORGANIC PRODUCTS OR IN-CONVERSION PRODUCTS

               Part I: Mandatory elements

                                    1.

                                    Document number

                                    2.

                                    (choose as appropriate)

                                                •

                                                Operator

                                                •

                                                Group of operators – see point 10

                                                •

                                                Exporter

                                    3.

                                    Name and address of the operator, group of operators or exporter:

                                    4.

                                    Name, address and code number of the control authority or control body of the operator, group of operators or exporter:

                                    5.

                                    Activity or activities of the operator, group of operators or exporter (choose as appropriate):

                                    •

                                    Production

                                    •

                                    Preparation

                                    •

                                    Distribution

                                    •

                                    Storing

                                    •

                                    Import

                                    •

                                    Export

                                    6.

                                    Category or categories of products as referred to in Article 35(7) of Regulation (EU) 2018/848 of the European Parliament and of the Council (1) and production methods (choose as appropriate):

                                    (a)

                                    unprocessed plants and plant products, including seeds and other plant reproductive material
                                    Production method:

                                                ☐

                                                organic production excluding during the conversion period

                                                ☐

                                                production during the conversion period

                                                ☐

                                                organic production with non-organic production

                                    (b)

                                    livestock and unprocessed livestock products
                                    Production method:

                                                ☐

                                                organic production excluding during the conversion period

                                                ☐

                                                production during the conversion period

                                                ☐

                                                organic production with non-organic production

                                    (c)

                                    algae and unprocessed aquaculture products
                                    Production method:

                                                ☐

                                                organic production excluding during the conversion period

                                                ☐

                                                production during the conversion period

                                                ☐

                                                organic production with non-organic production

                                    (d)

                                    processed agricultural products, including aquaculture products, for use as food
                                    Production method:

                                                ☐

                                                production of organic products

                                                ☐

                                                production of in-conversion products

                                                ☐

                                                organic production with non-organic production

                                    (e)

                                    feed
                                    Production method:

                                                ☐

                                                production of organic products

                                                ☐

                                                production of in-conversion products

                                                ☐

                                                organic production with non-organic production

                                    (f)

                                    wine
                                    Production method:

                                                ☐

                                                production of organic products

                                                ☐

                                                production of in-conversion products

                                                ☐

                                                organic production with non-organic production

                                    (g)

                                    other products listed in Annex I to Regulation (EU) 2018/848 or not covered by the previous categories
                                    Production method:

                                                ☐

                                                production of organic products

                                                ☐

                                                production of in-conversion products

                                                ☐

                                                organic production with non-organic production

                                    7.

                                    Directory of products:

                        Name of the product and/or Combined Nomenclature (CN) code as referred to in Council Regulation (EEC) No 2658/87 (2) for products within the scope of Regulation (EU) 2018/848

                                    ☐

                                    Organic

                                    ☐

                                    In-conversion

                        This document has been issued in accordance with Commission Implementing Regulation (EU) 2021/1378 (3) to certify that the operator, group of operators or exporter (choose as appropriate) complies with Regulation (EU) 2018/848.

                                    8.

                                    Date, place

                              Name and signature on behalf of the issuing control authority or control body:

                                    9.

                                    Certificate valid from………. [insert date] to..………[insert date]

                        10.

                        List of members of the group of operators as defined in Article 36 of Regulation (EU) 2018/848

                                    Name of member

                                    Address or other form of member identification

               Part II: Specific optional elements

            One or more elements to be completed if so decided by the control authority or control body that issues the certificate to the operator, group of operators or exporter in accordance with Implementing Regulation (EU) 2021/1378

                        1.

                        Quantity of products

                                    Name of the product and/or CN code as referred to in Regulation (EEC) No 2658/87 for products within the scope of Regulation (EU) 2018/848.

                                    ☐ Organic
                                    ☐ In-conversion

                                    Quantity estimated in kilograms, litres or, where relevant, in number of units.

                        2.

                        Information on the land

                                    Name of the product

                                    ☐ Organic
                                    ☐ In-conversion
                                    ☐ Non-organic

                                    Surface in hectares

                        3.

                        List of premises or units where the activity is performed by the operator or group of operators

                                    Address or geolocation

                                    Description of the activity or activities as referred to in point 5 of part I

                        4.

                        Information on the activity or activities carried out by the operator or group of operators and whether the activity is, or the activities are performed for their own purpose or as a subcontractor carrying out the activity or activities for another operator, while the subcontractor remains responsible for the activity or activities performed

                                    Description of the activity or activities as referred to in point 5 of part I

                                    ☐ Carrying out activity/activities for own purpose
                                    ☐ Carrying out activity/activities as a subcontractor for another operator, while the subcontractor remains responsible for the activity or activities performed

                        5.

                        Information on the activity or activities carried out by the subcontracted third party

                                    Description of the activity or activities as referred to in point 5 of part I

                                    ☐ Operator or group of operators remains responsible
                                    ☐ Subcontracted third party is responsible

                        6.

                        List of subcontractors carrying out an activity or activities for the operator or group of operators for which the operator or group of operators remains responsible as regards organic production and for which it has not transferred that responsibility to the subcontractor

                                    Name and address

                                    Description of the activity or activities as referred to in point 5 of part I

                        7.

                        Information on the accreditation of the control body in accordance with point (d) of Article 46(2) of Regulation (EU) 2018/848

                                    (a)

                                    name of the accreditation body;

                                    (b)

                                    hyperlink to the accreditation certificate.

                        8.

                        Other information

               (1)  Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).

               (2)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256 7.9.1987, p. 1).

               (3)  Commission Implementing Regulation (EU) 2021/1378 of 19 August 2021 laying down certain rules concerning the certificate issued to operators, groups of operators and exporters in third countries involved in the imports of organic products into the Union and establishing the list of recognised control authorities and control bodies in accordance with Regulation (EU) 2018/848 of the European Parliament and of the Council (OJ L 297, 20.8.2021, p. 24).

            ANNEX II
            List of control authorities and control bodies recognised in accordance with Article 46 of Regulation (EU) 2018/848
            For the purposes of this Annex, the product categories are designated by the following codes:

                        A

                        :

                        unprocessed plants and plant products, including seeds and other plant reproductive material;

                        B

                        :

                        livestock and unprocessed livestock products;

                        C

                        :

                        algae and unprocessed aquaculture products;

                        D

                        :

                        processed agricultural products, including aquaculture products, for use as food;

                        E

                        :

                        feed;

                        F

                        :

                        wine;

                        G

                        :

                        other products listed in Annex I to Regulation (EU) 2018/848 or not covered by the previous categories.

                  Information relating to the mailing address, website address and email contact point of the control authority or control body, as well as the name of the accreditation body granting its accreditation, can be found on the Commission organic farming website.
            Name of the control authority or control body:

                        1.

                        Code numbers, third countries and product categories concerned

                                    Code number

                                    Third country

                                    Category of products

                                    XX-BIO-XXX

                                    A

                                    B

                                    C

                                    D

                                    E

                                    F

                                    G

                        2.

                        Duration of the recognition:

                        3.

                        Exceptions:


title: Commission Implementing Regulation (EU) 2021/1974 of 12 November 2021 authorising the placing on the market of dried fruits of Synsepalum dulcificum 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:
                  15.11.2021

                  EN

                  Official Journal of the European Union

                  L 402/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1974
         of 12 November 2021
         authorising the placing on the market of dried fruits of Synsepalum dulcificum 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 of the European Parliament and of the Council 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)

                     On 14 November 2018, the company Medicinal Gardens S.L. (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place dried fruits of Synsepalum dulcificum on the Union market as a novel food. The application requested for dried fruits of Synsepalum dulcificum to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3) at the maximum intake level of 0,9 g/day, the target population being the general adult population with the exception of pregnant and lactating women.

                     (4)

                     The applicant also made a request to the Commission for the protection of proprietary scientific data for a number of studies submitted in support of the application, namely compositional studies (4), acute oral toxicity study in rats (5), bacterial reverse mutation tests (6), in vivo mammalian erythrocyte micronucleus test (7), in vitro mammalian cell micronucleus test (8), 90-day repeated dose oral toxicity study with a 14-day recovery period (9), and a sensory study (10).

                     (5)

                     In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 25 March 2019, asking it to provide a scientific opinion by carrying out a safety assessment for dried fruits of Synsepalum dulcificum as a novel food.

                     (6)

                     On 27 April 2021, the Authority adopted a scientific opinion on the safety of dried fruits of Synsepalum dulcificum as a novel food (11), in accordance with Article 11 of Regulation (EU) 2015/2283.

                     (7)

                     In its opinion, the Authority did not establish the safety of dried fruits of Synsepalum dulcificum used in food supplements intended for adults at the maximum intake level of 0,9 g/day as proposed by the applicant because the intake would exceed the level which is considered safe (10 mg/kg bw per day). However, the Authority concluded that dried fruits of Synsepalum dulcificum is safe for adults when added to food supplements at a maximum daily dose of 0,7 g/day which corresponds to the safe level of intake for an adult person with a default body weight of 70 kg. Therefore, the opinion of the Authority gives sufficient grounds to establish that dried fruits of Synsepalum dulcificum at a maximum daily dose of 0,7 g/day complies with Article 7, points (a) and (b) and Article 12(1) of Regulation (EU) 2015/2283.

                     (8)

                     The Authority in its opinion, using a weight of evidence approach on the basis of in silico protein sequence homology analyses between miraculin and the peanut proteins, and the results of a preliminary in vitro enzyme-linked immunosorbent assay (‘ELISA’) screening experiment, identified a potential for cross-reactivity between dried fruits of Synsepalum dulcificum and peanuts. However, additional in vivo experimental or epidemiological evidence normally needed to confirm or exclude the likelihood that the identified potential cross-reactivity may manifest itself in real life, is lacking. Taking the lack of such evidence together with the available in vitro data showing that miraculin will be rapidly and completely broken down after ingestion, the Commission considers that at present the potential of dried fruits of Synsepalum dulcificum to cause cross-reactivity to peanuts is unlikely to manifest itself in real life and consequently no specific labelling requirement should be included in the Union list of authorised novel foods in this regard.

                     (9)

                     In its opinion, the Authority noted that its conclusion on the safety of the novel food was based on the compositional studies, the acute oral toxicity study in rats, the two bacterial reverse mutation tests, the in vivo mammalian erythrocyte micronucleus test, the in vitro mammalian cell micronucleus test, and the 90-day repeated dose oral toxicity study with a 14-day recovery period. It also noted that it could not have reached that conclusion without the data from the unpublished reports of the studies contained in the applicant’s file.

                     (10)

                     The Commission requested the applicant to further clarify the justification provided with regard to their proprietary scientific claim over those studies and to clarify their claim to an exclusive right of reference to those studies, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

                     (11)

                     The applicant declared that they held proprietary and exclusive right of reference to the compositional studies, the acute oral toxicity study in rats, the two bacterial reverse mutation tests, the in vivo mammalian erythrocyte micronucleus test, the in vitro mammalian cell micronucleus test, and the 90-day repeated dose oral toxicity study with a 14-day recovery period at the time they submitted the application and that therefore third parties cannot lawfully access, use or refer to 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 specific studies on the compositional studies, the acute oral toxicity study in rats, the two bacterial reverse mutation tests, the in vivo mammalian erythrocyte micronucleus test, the in vitro mammalian cell micronucleus test, and the 90-day repeated dose oral toxicity study with a 14-day recovery period, contained in the applicant’s file, on which the Authority based its conclusion on the safety of the novel food and without which it could not have assessed the novel food, should not be used for the benefit of any subsequent applicant for a period of 5 years from the date of entry into force of this Regulation. Accordingly, only the applicant should be authorised to place dried fruits of Synsepalum dulcificum on the market within the Union during that period.

                     (13)

                     However, restricting the authorisation of dried fruits of Synsepalum dulcificum and 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 an authorisation.

                     (14)

                     The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

                     (15)

                     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.   Dried fruits of Synsepalum dulcificum, 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 5 years from 5 December 2021, only the initial applicant,
               Company: Medicinal Gardens S.L.;
               Address: Marqués de Urquijo 47, 1° D, Office 1, Madrid, 28008, Spain,
               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 of this Regulation or with the agreement of Medicinal Gardens S.L.

               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.

            Article 2
            The studies contained in the application file on the basis of which the novel food referred to in Article 1 have been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of 5 years from 5 December 2021 without the agreement of Medicinal Gardens S.L.

            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, 12 November 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (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)  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)  Medicinal Gardens S.L., 2017-20 (unpublished)

            (5)  Medicinal Gardens S.L. Study No. IF-81517 (unpublished, 2018c)

            (6)  Medicinal Gardens S.L. Study No. IF-74616 (unpublished, 2018a) and Study No 20229053 (unpublished, 2020a)

            (7)  Medicinal Gardens S.L. Study No. IF-74516 (unpublished, 2018b)

            (8)  Medicinal Gardens S.L. Study code: 20/020-013C (unpublished, 2020b)

            (9)  Medicinal Gardens S.L. Study No 73416 (unpublished, 2018d)

            (10)  Medicinal Gardens S.L. Sensory study with healthy young adults (unpublished, 2018)

            (11)  Safety of dried fruits of Synsepalum dulcificum as a novel food pursuant to Regulation (EU) 2015/2283; EFSA Journal 2021;19(6):6600

            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:

                                    Authorised novel food

                                    Conditions under which the novel food may be used

                                    Additional specific labelling requirements

                                    Other requirements

                                    Data protection

                                    ‘Synsepalum dulcificum dried fruits

                                    Specified food category

                                    Maximum levels

                                                1.

                                                The designation of the novel food on the labelling of food supplements containing it shall be ‘dried Synsepalum dulcificum fruits’

                                                2.

                                                The labelling of food supplements containing Synsepalum dulcificum dried fruits shall bear a statement that this food supplement should be consumed by adults only excluding pregnant and lactating women.

                                    Authorised on 5 December 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: Medicinal Gardens S.L. Marqués de Urquijo 47, 1° D, Office 1, Madrid, 28008, Spain.
                                    During the period of data protection, the novel food is authorised for placing on the market within the Union only by Medicinal Gardens S.L. unless a subsequent applicant obtains authorisation for that 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 Medicinal Gardens S.L.
                                    End date of the data protection: 5 December 2026.’

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

                                    0,7 g/day

                        (2)

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

                                    Authorised Novel Food

                                    Specification

                                    ‘
                                          Synsepalum dulcificum dried fruits

                                       Description/Definition:

                                    The novel food is lyophilised pulp and skin of pitted fruits of Synsepalum dulcificum (Schumach. & Thonn.) Daniell that belongs to the Sapotaceae family. The resulting dried cake is milled into a powder.

                                       Characteristics/Composition:

                                    Moisture (g/100 g): < 6
                                    Ash (g/100 g): 3,5-8,5
                                    Total carbohydrates (g/100 g): 70-87
                                    Sugars (g/100 g): 50-75
                                    Fibre (g/100 g): 1-6,5
                                    Total protein (g/100 g): 3,5-6,0
                                    Miraculin (*1) (g/100 g): 1,5-2,5
                                    Total fat (g/100 g): 0,50-3,50

                                       Microbiological criteria:

                                    Total aerobic colony count: < 104 CFU (*2)/g

                                       Bacillus cereus (presumptive): < 100 CFU/g
                                    Sulfite-reducing Clostridia: ≤ 30 CFU/g
                                    Total Enterobacteriaceae: < 100 CFU/g
                                    Yeasts and moulds: < 500 CFU/g

                                       Pesticides:

                                    Pesticide levels in accordance with Code number 0820990 (‘others’ in the group of fruit spices) set out in Regulation (EC) No 396/2005 (1)

               (*1)  Miraculin is part of the total protein content.

               (*2)  CFU: colony forming units.

               (1)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).’


title: Commission Implementing Regulation (EU) 2021/1975 of 12 November 2021 authorising the placing on the market of frozen, dried and powder forms of Locusta migratoria 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:
                  15.11.2021

                  EN

                  Official Journal of the European Union

                  L 402/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1975
         of 12 November 2021
         authorising the placing on the market of frozen, dried and powder forms of Locusta migratoria 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 of the European Parliament and of the Council 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)

                     On 28 December 2018, the company Fair Insects BV (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place frozen, dried and powder (ground) forms of Locusta migratoria (migratory locust) on the Union market as a novel food. The applicant requested for frozen, dried and powder forms of Locusta migratoria to be used in the form of snack, and as a food ingredient in a number of food products for the general population.

                     (4)

                     The applicant also made a request to the Commission for the protection of proprietary scientific data for a number of data submitted in support of the application, namely a description of the production process (3), analytical data on the composition (4), analytical data on contaminants (5), stability and microbiological status, data on the novel food sales (6), an intake assessment (7), protein digestibility and the Digestible Indispensable Amino Acid Score (8), the solubility and sterility tests on dried Locusta migratoria conducted prior to the genotoxicity studies which indicated that no genotoxicity testing was possible (9), and a cytotoxicity study (10).

                     (5)

                     In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 9 July 2019, asking it to provide a scientific opinion by carrying out an assessment of the safety of frozen, dried and powder forms of Locusta migratoria as a novel food.

                     (6)

                     On 25 May 2021, the Authority adopted a scientific opinion on the safety of frozen, dried and powder forms of Locusta migratoria as a novel food (11), in accordance with Article 11 of Regulation (EU) 2015/2283.

                     (7)

                     In its opinion, the Authority concluded that frozen, dried and powder forms of Locusta migratoria are safe under the proposed uses and use levels. Therefore, the opinion of the Authority gives sufficient grounds to establish that frozen, dried and powder forms of Locusta migratoria under the assessed conditions of use comply with Article 12(1) of Regulation (EU) 2015/2283.

                     (8)

                     In that opinion, the Authority also concluded on the basis of limited published evidence on food allergies related to insects in general, which equivocally linked the consumption of Locusta migratoria to a number of anaphylaxis events, and on the basis of evidence demonstrating that Locusta migratoria contains a number of potentially allergenic proteins, that the consumption of this novel food may trigger sensitisation to Locusta migratoria proteins. The Authority also recommended carrying out further research on the allergenicity of Locusta migratoria.

                     (9)

                     In order to address the Authority’s recommendation, the Commission is currently exploring the ways to carry out the necessary research on the allergenicity of Locusta migratoria. Until the data generated by the research is assessed by the Authority, and considering that, to date, only few allergic cases caused by Locusta migratoria (12) have been reported according to data available to the insect industry, and that the evidence on the allergenicity potential associated with the consumption of Locusta migratoria is equivocal, the Commission considers that no specific labelling requirements concerning the potential of Locusta migratoria to cause primary sensitization should be included in the Union list of authorised novel foods.

                     (10)

                     The Authority in its opinion also considered that the consumption of frozen, dried and powder forms of Locusta migratoria may cause allergic reactions in persons that are allergic to crustaceans, molluscs and mites. Furthermore, the Authority noted that additional allergens may end up in the novel food, if these allergens are present in the substrate fed to insects. Therefore, it is appropriate that frozen, dried and powder forms of Locusta migratoria made available to the consumer as such and foods containing them are appropriately labelled following the requirements in accordance with Article 9 of Regulation (EU) 2015/2283.

                     (11)

                     In its opinion, the Authority noted that its conclusion on the safety of the novel food was based on a number of data submitted in support of the application, namely a description of the production process, analytical data on the composition, analytical data on contaminants, stability and microbiological status, data on the novel food sales, an intake assessment, protein digestibility and Digestible Indispensable Amino Acid Score, the solubility and sterility tests on dried Locusta migratoria conducted prior to the genotoxicity studies which indicated that no genotoxicity testing was possible, and a cytotoxicity study. It also noted that it could not have reached that conclusion without the data from the unpublished reports of those studies contained in the applicant’s file.

                     (12)

                     The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those studies and to clarify their claim to an exclusive right of reference to those data, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

                     (13)

                     The applicant declared that they held proprietary and exclusive right of reference to description of the production process, analytical data on the composition, analytical data on contaminants, stability and microbiological status, data on the novel food sales, intake assessment, data on protein digestibility and the Digestible Indispensable Amino Acid Score, the solubility and sterility tests on dried Locusta migratoria conducted prior to the genotoxicity studies which indicated that no genotoxicity testing was possible, and cytotoxicity study, at the time they submitted the application and that therefore third parties cannot lawfully access, use or refer to those studies.

                     (14)

                     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 specific studies on description of the production process, analytical data on the composition, analytical data on contaminants, stability and microbiological status, data on the novel food sales, intake assessment, protein digestibility and Digestible Indispensable Amino Acid Score, the solubility and sterility tests on dried Locusta migratoria conducted prior to the genotoxicity studies which indicated that no genotoxicity testing was possible, and cytotoxicity study, contained in the applicant’s file, on which the Authority based its conclusion on the safety of the novel food and without which it could not have assessed the novel food, should 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. Accordingly, only the applicant should be authorised to place frozen, dried and powder forms of Locusta migratoria on the market within the Union during that period.

                     (15)

                     However, restricting the authorisation of frozen, dried and powder forms of Locusta migratoria and 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 an authorisation.

                     (16)

                     The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

                     (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.   Frozen, dried and powder forms of Locusta migratoria, 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 5 December 2021, only the initial applicant,
               Company: Fair Insects BV;
               Address: Industriestraat 3, 5107 NC Dongen, the Netherlands,
               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 Fair Insects BV.

               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.

            Article 2
            The data contained in the application file on the basis of which the novel food referred to in Article 1 have been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of five years from 5 December 2021 without the agreement of Fair Insects BV.

            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, 12 November 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (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)  Fair Insects BV. 2019 (unpublished).

            (4)  Fair Insects BV. 2019 (unpublished).

            (5)  Fair Insects BV. 2019 (unpublished).

            (6)  Fair Insects BV. 2018 (unpublished).

            (7)  Fair Insects BV. 2019 (unpublished).

            (8)  Fair Insects BV. Digestibility of protein from Locusta migratoria during transit through the dynamic in vitro gastrointestinal model. Study report V21246/01 (unpublished, 2018).

            (9)  Fair Insects BV. Solubility and sterility test on dried Locusta migratoria prior to the genotoxicity studies (unpublished, 2018).

            (10)  Fair Insects BV. Cellular toxicity of aqueous extracts from Locusta migratoria (unpublished, 2018).

            (11)  Safety of frozen and dried formulations from migratory locust (Locusta migratoria) as a novel food pursuant to Regulation (EU) 2015/2283; EFSA Journal 2021;19(7):6667.

            (12)  Locusta migratoria is marketed in a number of Member States under the transitional measures laid down in Article 35(2) of Regulation (EU) 2015/2283. According to the applicant, dried and frozen locusts have been sold in the Dutch market since 2016.

            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:

                                       Authorised novel food

                                       Conditions under which the novel food may be used

                                       Additional specific labelling requirements

                                       Other requirements

                                       Data protection

                                    ‘Frozen, dried and powder forms of Locusta migratoria (migratory locust)

                                       Specified food category

                                       Maximum levels (g/100 g)

                                       (marketed as such or reconstituted according to the instructions)

                                                1.

                                                The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘frozen Locusta migratoria (migratory locust)’, ‘dried/powder Locusta migratoria (migratory locust)’, ‘Whole Locusta migratoria (migratory locust) powder’ depending on the form used.

                                                2.

                                                The labelling of the foodstuffs containing frozen dried or powder forms of Locusta migratoria (migratory locust) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, molluscs and products thereof, and to mites.

                                          This statement shall appear in close proximity to the list of ingredients.

                                    Authorised on 5.12.2021.
                                    This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: Fair Insects BV, Industriestraat 3, 5107 NC Dongen, the Netherlands.
                                    During the period of data protection, the novel food is authorised for placing on the market within the Union only by Fair Insects BV, unless a subsequent applicant obtains authorisation for that 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 Fair Insects BV.
                                    End date of the data protection: 5.12.2026.’

                                       Frozen

                                       Dried or

                                       Powder

                                    Frozen, dried and powder forms of Locusta migratoria

                                    Processed potato products; legumes-based dishes and pasta-based products

                                    15

                                    5

                                    Meat analogues

                                    80

                                    50

                                    Soups and concentrated soups

                                    15

                                    5

                                    Canned/jarred legumes and vegetables

                                    20

                                    15

                                    Salads

                                    15

                                    5

                                    Beer-like beverages, Alcoholic drink mixes

                                    2

                                    2

                                    Chocolate confectionery

                                    30

                                    10

                                    Nuts, oilseeds and chickpeas

                                    20

                                    Frozen fermented milk-based products

                                    15

                                    5

                                    Sausages

                                    30

                                    10

                        (2)

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

                                       Authorised Novel Food

                                       Specifications

                                    ‘Frozen, dried and powder forms of Locusta migratoria (migratory locust)

                                       Description/Definition:

                                    The novel food consists of the frozen, dried and powder forms of migratory locust. The term ‘migratory locust’ refers to the adult of Locusta migratoria, an insect species that belongs to the Acrididae family (subfamily Locustinae).
                                    The novel food is intended to be marketed in three different forms, namely: (i) thermally processed and frozen L. migratoria (LM frozen); (ii) thermally processed and freeze-dried L. migratoria (LM dried), and (iii) thermally processed freeze-dried and ground whole L. migratoria (whole LM powder). The LM dried may be marketed as such or in powder.
                                    For LM frozen and LM dried, legs and wings must be removed to reduce the risk of intestinal constipation that could be possibly caused by ingestion of the large spines on the insect tibia. The whole LM powder is obtained via mechanical grinding of the insect with legs and wings, and sieving to reduce particle size below 1 mm.
                                    A minimum 24 hours fasting period is required before killing the insects by freezing, to allow the adults to discard their bowel content.

                                       Parameters

                                       LM frozen

                                       LM dried

                                       Whole LM powder

                                       Characteristics/Composition

                                    Ash (% w/w)

                                    0,6 -1,0

                                    2,0 -3,1

                                    1,8 -1,9

                                    Moisture (% w/w)

                                    67 -73

                                    ≤ 5

                                    ≤ 5

                                    Crude protein (N × 6,25 ) (% w/w)

                                    11 -21

                                    43 -53

                                    50  – 60

                                    Fat (% w/w)

                                    7 -13

                                    31 -41

                                    31 -41

                                    Saturated fatty acids (% fat)

                                    35 -43

                                    35 -43

                                    35 -43

                                    Digestible carbohydrates (% w/w)

                                    0,1 -2,0

                                    0,1 -2,0

                                    1,0 -3,5

                                        (*1)Dietary fibre (% w/w)

                                    1,5 -3,5

                                    5,5 -9,0

                                    5,5 -9,0

                                    Chitin (% w/w)

                                    1,7 -2,4

                                    6,4 -10,4

                                    10,5 -13,9

                                    Peroxide value (Meq O2 /kg fat)

                                    ≤ 5

                                    ≤ 5

                                    ≤ 5

                                       Contaminants

                                    Lead (mg/kg)

                                    ≤ 0,07

                                    ≤ 0,07

                                    ≤ 0,07

                                    Cadmium (mg/kg)

                                    ≤ 0,05

                                    ≤ 0,05

                                    ≤ 0,05

                                    Aflatoxins (Sum of B1, B2, G1, G2) (μg/kg)

                                    ≤ 4

                                    ≤ 4

                                    ≤ 4

                                    Aflatoxin B1 (μg/kg)

                                    ≤ 2

                                    ≤ 2

                                    ≤ 2

                                    Deoxynivalenol (μg/kg)

                                    ≤ 200

                                    ≤ 200

                                    ≤ 200

                                    Ochratoxin A (μg/kg)

                                    ≤ 1

                                    ≤ 1

                                    ≤ 1

                                    Sum of dioxins and dioxins-like PCBs UB ( (*2)WHO2005 PCDD/F-PCB-TEQ) (pg/g fat)

                                    ≤ 1,2

                                    ≤ 1,2

                                    ≤ 1,2

                                       Microbiological criteria

                                    Total aerobic colony count ( (*3)CFU/g)

                                    ≤ 10 5

                                    ≤ 10 5

                                    ≤ 10 5

                                    Enterobacteriaceae (presumptive) (CFU/g)

                                    ≤ 100

                                    ≤ 100

                                    ≤ 100

                                       Escherichia coli (CFU/g)

                                    ≤ 50

                                    ≤ 50

                                    ≤ 50

                                       Listeria monocytogenes

                                    Not detected in 25 g

                                    Not detected in 25 g

                                    Not detected in 25 g

                                       Salmonella spp.

                                    Not detected in 25 g

                                    Not detected in 25 g

                                    Not detected in 25 g

                                       Bacillus cereus (presumptive) (CFU/g)

                                    ≤ 100

                                    ≤ 100

                                    ≤ 100

                                    Coagulase positive Staphylococci (CFU/g

                                    ≤ 100

                                    ≤ 100

                                    ≤ 100

                                       Sulfite-reducing Anaerobes (CFU/g)

                                    ≤ 30

                                    ≤ 30

                                    ≤ 30

                                    Yeasts and moulds (CFU/g)

                                    ≤ 100

                                    ≤ 100

                                    ≤ 100

               (*1)  Dietary fibre may not include chitin due to different analytical methods.

               (*2)  Upper bound sum of polychlorinated dibenzo-para-dioxins (PCDDs)-polychlorinated dibenzofurans (PCDFs) and dioxin-like polychlorinated biphenyls (PCBs) expressed as World Health Organization toxic equivalent (using WHO-TEFs of 2005)).

               (*3)  CFU: colony forming units’.