title: Commission Implementing Regulation (EU) 2022/159 of 4 February 2022 approving the low-risk active substance Bacillus amyloliquefaciens strain IT-45 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

text:
                  7.2.2022

                  EN

                  Official Journal of the European Union

                  L 26/7

         COMMISSION IMPLEMENTING REGULATION (EU) 2022/159
         of 4 February 2022
         approving the low-risk active substance Bacillus amyloliquefaciens strain IT-45 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011
         (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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) in conjunction with Article 22(1) thereof,
         Whereas:

                     (1)

                     In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Danstar Ferment AG and Comercial Quimica Masso submitted to France, on 26 June 2017, an application for the approval of the active substance Bacillus amyloliquefaciens strain IT-45.

                     (2)

                     In accordance with Article 9(3) of that Regulation, France, as rapporteur Member State, notified the applicants, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 1 December 2017 of the admissibility of the application.

                     (3)

                     On 15 May 2019, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, concluding that the active substance Bacillus amyloliquefaciens strain IT-45 could be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

                     (4)

                     In accordance with Article 12(3) of Regulation (EC) No 1107/2009, the Authority also set a time limit for the applicants to supply additional information to the Member States, the Commission and the Authority

                     (5)

                     In its Conclusion, communicated to the applicants, the Member States and the Commission, following a peer review of the pesticide risk assessment pursuant to Article 12 (2) of Regulation (EC) No 1107/2009, the Authority held that the active substance Bacillus amyloliquefaciens strain IT-45 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public (2).

                     (6)

                     On 21-22 October 2021, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed its review report on the active substance Bacillus amyloliquefaciens strain IT-45 and a draft of this Regulation regarding Bacillus amyloliquefaciens strain IT-45.

                     (7)

                     The applicants were given the possibility to submit comments on the review report.

                     (8)

                     It has been established with respect to one representative use of at least one plant protection product containing the active substance, as examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

                     (9)

                     Since the Commission considers that Bacillus amyloliquefaciens strain IT-45 is a low-risk active substance, pursuant to Article 22 of Regulation (EC) No 1107/2009, and since plant protection products containing that substance may be expected to pose only a low risk to human and animal health and the environment, it may be approved for up to 15 years. No critical area of concerns were identified for humans, animals and the environment.

                     (10)

                        Bacillus amyloliquefaciens strain IT-45 is a microorganism, which also fulfils the conditions established by Article 22 (2) of Regulation (EC) No 1107/2009, in conjunction with point 5.2. of Annex II to that Regulation. It is therefore appropriate to approve Bacillus amyloliquefaciens strain IT-45 as a low-risk substance.

                     (11)

                     In accordance with Article 13(4) of Regulation (EC) No 1107/2009, Commission Implementing Regulation (EU) No 540/2011 (3) should therefore be amended accordingly.

                     (12)

                     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
            Approval of the active substance
            The active substance Bacillus amyloliquefaciens strain IT-45, as specified in Annex I, is approved

            Article 2
            Amendments to Implementing Regulation (EU) No 540/2011
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

            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, 4 February 2022.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

            (2)  Conclusion on the Peer review of the pesticide risk assessment of the active substance Bacillus amyloliquefaciens strain IT-45. EFSA Journal 2021;19(5):6594 https://doi.org/10.2903/j.efsa.2021.6594.

            (3)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                           Bacillus amyloliquefaciens

                        IT-45

                        n.a.

                        The nominal content of Bacillus amyloliquefaciens IT-45 in the technical product and formulation is: minimum: 2 x 1013 CFU/kg, maximum: 6 x 1014 CFU/kg.
                        No relevant impurities

                        27 February 2022

                        27 February 2037

                        For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus amyloliquefaciens IT-45 shall be taken into account.

               (1)  Further details on the identity and the specification of the active substance are provided in the review report.

            ANNEX II
            In Part D of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                           No.

                           Common Name, Identification Numbers

                           IUPAC Name

                           Purity (1)

                           Date of approval

                           Expiration of approval

                           Specific provisions

                           ‘35

                              Bacillus amyloliquefaciens IT-45

                           n.a.

                           The nominal content of Bacillus amyloliquefaciens IT-45 in the technical product and formulation is: minimum: 2 x 1013 CFU/kg, maximum: 6 x 1014 CFU/kg.
                           No relevant impurities

                           27 February 2022

                           27 February 2037

                           For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus amyloliquefaciens IT-45 shall be taken into account.

               (1)  Further details on the identity and the specification of the active substance are provided in the review report.’


title: Commission Implementing Regulation (EU) 2022/160 of 4 February 2022 laying down uniform minimum frequencies of certain official controls to verify compliance with Union animal health requirements in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council and repealing Regulations (EC) No 1082/2003 and (EC) No 1505/2006 (Text with EEA relevance)

text:
                  7.2.2022

                  EN

                  Official Journal of the European Union

                  L 26/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2022/160
         of 4 February 2022
         laying down uniform minimum frequencies of certain official controls to verify compliance with Union animal health requirements in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council and repealing Regulations (EC) No 1082/2003 and (EC) No 1505/2006
         (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 20, paragraph 3, first subparagraph, point (a), thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2017/625 lays down general rules for official controls performed by the competent authority for the verification of compliance with rules in a number of areas, including animal health, on a risk basis and with appropriate frequencies. That Regulation also lays down methods and techniques for official controls, which include, among others, inspections of premises, animals and goods under the control of operators.

                     (2)

                     Regulation (EU) 2017/625 provides for uniform practical arrangements for the performance of official controls regarding uniform minimum frequencies of official controls to be laid down, where necessary to respond to specific hazards and risks to animal health and to verify compliance with disease prevention and control measures.

                     (3)

                     Before the entry into application of Regulation (EU) 2016/429 of the European Parliament and of the Council (2), a number of legal acts on animal health laid down rules for minimum frequencies for official controls, in particular inspections. Regulation (EU) 2016/429 repealed those legal acts with effect from 21 April 2021.

                     (4)

                     Commission Delegated Regulation (EU) 2019/2035 (3) lays down requirements for approval, among others, of hatcheries and establishments keeping poultry, establishments for assembly operations for ungulates and poultry, assembly centres of dogs, cats and ferrets, animal shelters for dogs, cats and ferrets, control posts, environmentally isolated production establishments for bumble bees, quarantine establishments and confined establishments of terrestrial animals.

                     (5)

                     Commission Delegated Regulation (EU) 2020/686 (4) lays down requirements for approval of germinal product establishments for bovine, porcine, ovine, caprine and equine animals from which germinal products of those animals may be moved to another Member State.

                     (6)

                     Commission Delegated Regulation (EU) 2020/691 (5) lays down requirements for approval of certain aquaculture establishments and groups of aquaculture establishments keeping aquatic animals posing a significant animal health risk.

                     (7)

                     It is important that the competent authority verifies by way of regular official controls, in particular by way of inspections referred to in Article 14, point (b), of Regulation (EU) 2017/625, that the animals and germinal products are continued to be kept and produced under the uniform approval conditions for establishments, that are intended to mitigate risks and hazards associated with diseases listed in Regulation (EU) 2016/429 and with emerging diseases. To respond to those uniform hazards and risks to human and animal health posed by those diseases, uniform minimum frequencies for inspections in certain approved establishments should be laid down in this Regulation.

                     (8)

                     For approved germinal product establishments any uniform minimum frequency for inspections should take into account the non-seasonal nature of collecting semen of bovine and porcine animals.

                     (9)

                     Any uniform minimum frequency for inspections in certain approved aquaculture establishments and approved groups of aquaculture establishments should take into account the risk ranking of that establishment or group of establishments in accordance with Commission Delegated Regulation (EU) 2020/689 (6).

                     (10)

                     As regards identification and registration of certain animals, Commission Regulations (EC) No 1082/2003 (7) and Commission Regulation (EC) No 1505/2006 (8) lay down the minimum level of controls or checks to be carried out in establishments keeping bovine, ovine and caprine animals each year as well as the number of animals to be inspected in each of those establishment.

                     (11)

                     Delegated Regulation (EU) 2019/2035 also lays down detailed requirements for the identification and registration of bovine, ovine and caprine animals to ensure their traceability.

                     (12)

                     Bovine, ovine or caprine animals that are not identified or registered in accordance with the requirements laid down in Delegated Regulation (EU) 2019/2035 may play a role in spreading diseases listed in Regulation (EU) 2016/429 and in emerging diseases. To mitigate that uniform hazard and risk to human and animal health, to regularly verify compliance of operators with the requirements laid down in Delegated Regulation (EU) 2019/2035 and to ensure the uniform implementation of Regulation (EU) 2017/625, uniform minimum frequencies for inspections during the performance of official controls on identification and registration of bovine, ovine, and caprine animals should be laid down.

                     (13)

                     Delegated Regulation (EU) 2019/2035 did not explicitly repeal Regulations (EC) No 1082/2003 and (EC) No 1505/2006. To ensure legal certainty, this Regulation should repeal those Regulations.

                     (14)

                     The rules laid down in this Regulation should apply to the United Kingdom in respect of Northern Ireland, in accordance with Article 5(4) of the Protocol on Ireland/Northern Ireland to the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community in conjunction with Annex 2 to that Protocol.

                     (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
            Subject matter and scope
            This Regulation lays down uniform minimum frequencies for official controls, in particular, inspections of animals and germinal products, and the conditions under which they are kept or produced in the following establishments:

                        (a)

                        approved establishments for kept terrestrial animals and hatching eggs referred to in Article 1(1), point (a), of Delegated Regulation (EU) 2019/2035;

                        (b)

                        approved germinal product establishments referred to in Article 3 of Delegated Regulation (EU) 2020/686;

                        (c)

                        certain aquaculture establishments approved pursuant to Article 176(1), of Regulation (EU) 2016/429 and groups of aquaculture establishments approved pursuant to Article 177, of that Regulation;

                        (d)

                        registered establishments for kept terrestrial animals referred to in Article 1(1) point (a), of Delegated Regulation (EU) 2019/2035 that keep bovine, ovine or caprine animals.

            Article 2
            Definitions
            For the purposes of this Regulation, the following definitions laid down in Regulation (EU) 2016/429, in Delegated Regulation (EU) 2019/2035, Delegated Regulation (EU) 2020/686, Delegated Regulation (EU) 2020/688 (9) and Delegated Regulation (EU) 2020/990 (10) shall apply:

                        (a)

                        ‘establishment’ as defined in Article 4, point (27), of Regulation (EU) 2016/429;

                        (b)

                        ‘hatchery’ as defined in Article 4, point (47), of Regulation (EU) 2016/429;

                        (c)

                        ‘assembly operation’ as defined in Article 4, point (49), of Regulation (EU) 2016/429;

                        (d)

                        ‘assembly centre of dogs, cats and ferrets’ as defined in Article 2, point (7), of Delegated Regulation (EU) 2019/2035;

                        (e)

                        ‘animal shelter’ as defined in Article 2, point (8), of Delegated Regulation (EU) 2019/2035;

                        (f)

                        ‘control post’ as defined in Article 2, point (9), of Delegated Regulation (EU) 2019/2035;

                        (g)

                        ‘environmentally isolated production establishment’ as defined in Article 2, point (10), of Delegated Regulation (EU) 2019/2035;

                        (h)

                        ‘approved quarantine establishment’ as defined in Article 3, point (9), of Delegated Regulation (EU) 2020/688;

                        (i)

                        ‘confined establishment’ as defined in Article 4, point (48), of Regulation (EU) 2016/429;

                        (j)

                        ‘approved germinal product establishment’ as defined in Article 2, point (2), of Delegated Regulation (EU) 2020/686;

                        (k)

                        ‘approved aquaculture establishment’ as defined in Article 2, point (10), of Delegated Regulation (EU) 2020/990;

                        (l)

                        ‘approved group of aquaculture establishments’ as defined in Article 2, point (11), of Delegated Regulation (EU) 2020/990.

            Article 3
            Uniform minimum frequency of inspections in certain approved establishments
            The competent authorities of Member States (11) shall perform at least once every calendar year, official controls on, in particular inspections of, animals and hatching eggs and the conditions under which those animals and hatching eggs are kept or produced in the following types of establishments on its territory that have obtained approval from the competent authority:

                        (a)

                        hatcheries and establishments keeping poultry;

                        (b)

                        establishments for assembly operations for ungulates and poultry;

                        (c)

                        assembly centres of dogs, cats and ferrets;

                        (d)

                        animal shelters for dogs, cats and ferrets;

                        (e)

                        control posts;

                        (f)

                        environmentally isolated production establishments for bumble bees;

                        (g)

                        approved quarantine establishments;

                        (h)

                        confined establishments.

            Article 4
            Uniform minimum frequency of inspections in approved germinal product establishments
            The competent authorities of the Member States shall perform official controls on, and in particular, inspections of, germinal products, except hatching eggs, and the conditions under which those germinal products are produced every calendar year in the following types of establishments on its territory that have obtained approval from the competent authority:

                        (a)

                        at least twice every calendar year, semen collection centres for bovine and porcine animals;

                        (b)

                        at least once every calendar year:

                                    (i)

                                    semen collection centres for ovine, caprine and equine animals;

                                    (ii)

                                    embryo collection or production teams;

                                    (iii)

                                    germinal product processing establishments;

                                    (iv)

                                    germinal product storage centres.

            Article 5
            Uniform minimum frequency of inspections in certain approved aquaculture establishments and in certain approved groups of aquaculture establishments
            The competent authority of a Member State shall perform official controls on, and in particular, inspections of, aquaculture animals and the conditions under which those animals are kept in certain approved aquaculture establishments and approved groups of aquaculture establishments on its territory. Those official controls shall take into account the risk ranking of the approved aquaculture establishment or the approved group of aquaculture establishments determined by the competent authority pursuant to Part 1, Chapter 1, point 1.2, of Annex VI to Delegated Regulation (EU) 2020/689 or the risk ranking of the establishments in dependent compartments referred to in Article 73(3), point (b), of that Regulation, as follows:

                        (a)

                        high-risk establishments shall be inspected at least once every calendar year;

                        (b)

                        medium-risk establishments shall be inspected at least once every two calendar years;

                        (c)

                        low-risk establishments shall be inspected at least once every three calendar years.

            Article 6
            Uniform minimum frequency of inspections in establishments keeping bovine, ovine and caprine animals
            The competent authority of a Member State shall perform official controls on, and in particular, inspections of, the identification and registration of bovine, ovine and caprine animals every calendar year in at least 3 % of establishments on its territory keeping those animals.

            Article 7
            Repeals

               1.   Regulations (EC) No 1082/2003 and (EC) No 1505/2006 are repealed.

               2.   References to the repealed Regulations shall be construed as references to this Regulation and shall be read in accordance with the correlation table in the Annex.

            Article 8
            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, 4 February 2022.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (Animal Health Law) (OJ L 084 31.3.2016, p. 1).

            (3)  Commission Delegated Regulation (EU) 2019/2035 of 28 June 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs (OJ L 314, 5.12.2019, p. 115).

            (4)  Commission Delegated Regulation (EU) 2020/686 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain kept terrestrial animals (OJ L 174, 3.6.2020, p. 1).

            (5)  Commission Delegated Regulation (EU) 2020/691 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of Council as regards rules for aquaculture establishments and transporters of aquatic animals (OJ L 174, 3.6.2020, p. 345).

            (6)  Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (OJ L 174, 3.6.2020, p. 211).

            (7)  Commission Regulation (EC) No 1082/2003 of 23 June 2003 laying down detailed rules for the implementation of Regulation (EC) No 1760/2000 of the European Parliament and of the Council as regards the minimum level of controls to be carried out in the framework of the system for the identification and registration of bovine animals (OJ L 156, 25.6.2003, p. 9).

            (8)  Commission Regulation (EC) No 1505/2006 of 11 October 2006 implementing Council Regulation (EC) No 21/2004 as regards the minimum level of checks to be carried out in relation to the identification and registration of ovine and caprine animals (OJ L 280, 12.10.2006, p. 3).

            (9)  Commission Delegated Regulation (EU) 2020/688 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs (OJ L 174, 3.6.2020, p. 140).

            (10)  Commission Delegated Regulation (EU) 2020/990 of 28 April 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health and certification requirements for movements within the Union of aquatic animals and products of animal origin from aquatic animals (OJ L 221, 10.7.2020, p. 42).

            (11)  In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Regulation references to ‘Member States’ include the United Kingdom in respect of Northern Ireland.

            ANNEX
            Correlation tables referred to in Article 7(2)
            1.   Regulation (EC) No 1082/2003

                        Regulation (EC) No 1082/2003

                        This Regulation

                        Article 1

                        -

                        Article 2(1)

                        Article 6

                        Article 2(2)

                        -

                        Article 2(3)

                        -

                        Article 2(4)

                        -

                        Article 2(5)

                        -

                        Article 2(6)

                        -

                        Article 3

                        -

                        Article 4

                        -

                        Article 5

                        -

                        Annex I

                        -

                  2.   Regulation (EC) No 1505/2006

                        Regulation (EC) No 1505/2006

                        This Regulation

                        Article 1

                        -

                        Article 2

                        -

                        Article 3

                        -

                        Article 4

                        -

                        Article 5(1), first subparagraph

                        Article 6

                        Article 5(1), second subparagraph

                        -

                        Article 5(2), first subparagraph

                        -

                        Article 5(2), second subparagraph

                        -

                        Article 6

                        -

                        Article 7

                        -

                        Annex

                        -


title: Commission Implementing Regulation (EU) 2022/158 of 4 February 2022 amending Implementing Regulation (EU) 2020/1641 regarding imports of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods for human consumption from the United States of America (Text with EEA relevance)

text:
                  7.2.2022

                  EN

                  Official Journal of the European Union

                  L 26/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2022/158
         of 4 February 2022
         amending Implementing Regulation (EU) 2020/1641 regarding imports of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods for human consumption from the United States of America
         (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 129(1) thereof,
         Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (2), and in particular Article 238(3) thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2017/625 lays down general rules for the performance of official controls to verify compliance with rules aimed at preventing, eliminating or reducing, to acceptable levels, the risks to which humans and animals are exposed either directly or through the environment.

                     (2)

                     In particular, Regulation (EU) 2017/625 lays down general conditions for the entry into the Union of animals and goods from third countries or regions thereof, including food intended for human consumption. Article 129 of Regulation (EU) 2017/625 empowers the Commission to recognise that measures applied by third countries, or regions thereof, are equivalent to the requirements laid down in certain rules referred to in Article 1(2) of that Regulation, if the third countries offer objective proof in this respect. It also empowers the Commission to set out the conditions governing the entry into the Union of such animals and goods from such third countries or regions thereof, in particular with regard to the nature and content of the official certificates or attestations that are to accompany those commodities.

                     (3)

                     In accordance with Commission Implementing Regulation (EU) 2020/1641 (3), the measures applied in the States of Massachusetts and Washington of the United States for the protection of public health in relation to the production and placing on the market of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption are equivalent to the requirements laid down in rules as regards food safety referred to in Article 1(2)(a) of Regulation (EU) 2017/625.

                     (4)

                     Implementing Regulation (EU) 2020/1641 establishes a model official certificate for imports from the United States of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption. The model official certificate requires an official inspector to certify that the measures applied to the production and placing on the market of those commodities are equivalent to the requirements laid down in rules as regards food safety referred to in Article 1(2)(a) of Regulation (EU) 2017/625.

                     (5)

                     In line with the measures agreed with the department of the Food and Drug Administration of the United States responsible for the export to the Union of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption, the model official certificate established in Implementing Regulation (EU) 2020/1641 should be adapted to the appropriate format for the export to the Union of those commodities. In particular, the model official certificate should inform about the date of departure of the consignments. Furthermore, information should be provided on whether the commodities are certified for human consumption or for the final consumer.

                     (6)

                     In addition to the public health requirements of the model official certificate established in Implementing Regulation (EU) 2020/1641, live bivalve molluscs of species listed in Commission Implementing Regulation (EU) 2018/1882 (4), which are intended for human consumption, and products of animal origin from those molluscs, which are intended for further processing in the Union before human consumption, should enter the Union only if they are accompanied by an official certificate that includes the appropriate animal health attestations. Consequently, in order to fulfil animal health requirements that provide guarantees equivalent to those provided for in Union legislation, the model official certificate should include the general animal health requirements for entry into the Union, as set out in Article 6(1), points (a) and (b), Articles 6(2) and 7(1) and Article 8 of Commission Delegated Regulation (EU) 2020/692 (5), and the specific animal health requirements for entry into the Union of those commodities as set out in Article 167, points (a), (c)(ii), (c)(iii) and (d), and Article 169(1) and (2) of Delegated Regulation (EU) 2020/692.

                     (7)

                     Implementing Regulation (EU) 2020/1641 should therefore be amended accordingly.

                     (8)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The Annex to Implementing Regulation (EU) 2020/1641 is replaced by the text set out in the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 4 February 2022.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  OJ L 84, 31.3.2016, p. 1.

            (3)  Commission Implementing Regulation (EU) 2020/1641 of 5 November 2020 regarding imports of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods for human consumption from the United States of America (OJ L 370, 6.11.2020, p. 4).

            (4)  Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21).

            (5)  Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, p. 379).

            ANNEX
            MODEL OFFICIAL CERTIFICATE FOR THE ENTRY INTO THE UNION OF LIVE, CHILLED, FROZEN OR PROCESSED BIVALVE MOLLUSCS, ECHINODERMS, TUNICATES AND MARINE GASTROPODS INTENDED FOR HUMAN CONSUMPTION FROM THE UNITED STATES OF AMERICA

                           United States (US)

                           Veterinary certificate to EU

                        Part II: Certification

                                    II.

                                    Health information

                                    II.a.

                                    Certificate reference number

                        II.b.

                                    II.1.

                                    Public health attestation for live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption
                                    I, the undersigned hereby certify that:

                                                —

                                                The herein described products comply with and were produced in accordance with relevant US standards and requirements of the US molluscan shellfish regulatory control program.

                                                —

                                                The herein described products are labelled as not destined to be immersed or in contact with any EU water

                                                —

                                                All foreign-sourced shellfish material used in these products originates from third countries/establishments/growing areas approved to export live bivalve molluscs to the EU.

                                    (1) (2)[II.2.

                                    Animal health attestation for live bivalve molluscs
                                    (3)
                                    of listed species intended for human consumption,
                                    I, the undersigned official veterinarian, hereby certify that the aquatic animals referred to in Box I.18 of Part I meet:

                                                II.2.1.

                                                the general animal health requirements for entry into the Union, which are set out in Article 6(1), in points (a)(4), and (b), Articles 6(2) and 7(1) and Article 8 of Commission Delegated Regulation (EU) 2020/692 (1);

                                                II.2.2.

                                                the specific animal health requirements for entry into the Union of the commodities to which this certificate applies, which are set out in Article 167, points (a), (c)(ii), (c)(iii) and (d), and Article 169(1) and (2) of Delegated Regulation (EU) 2020/692.]

                           Notes

                        n accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland / Northern Ireland in conjunction with Annex 2 to that Protocol, references to the European Union in this certificate include the United Kingdom in respect of Northern Ireland.

                        Part I:

                                    —

                                    Box reference I.8: Region of origin: state of US harvest and code of approved production area.

                              Part II:

                                    (1)

                                    Part II.2. of this certificate applies only to the following commodities of live bivalve molluscs intended for human consumption:

                                                (a)

                                                molluscs of listed species transported without water which are packaged and labelled for human consumption in accordance with the specific requirements for those animals as set out in Regulation (EC) No 853/2004 of the European Parliament and of the Council (2) and which are no longer able to survive as living animals if returned to the aquatic environment;

                                                (b)

                                                molluscs of listed species transported without water which are intended for human consumption without further processing, provided they are packaged for retail sale in compliance with the requirements for such packaging as set out in Regulation (EC) No 853/2004;

                                                (c)

                                                molluscs of listed species transported without water which are packaged and labelled for human consumption in accordance with the specific requirements for those animals as set out in Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing.

                                    (2)

                                    Part II.2 does not apply, and should be deleted when the consignment consists of wild aquatic animals which are landed from fishing vessels.

                                    (3)

                                    Species listed in columns 3 and 4 of the table in the Annex to Commission Implementing Regulation (EU) 2018/1882 (3). Species listed in column 4 of that table shall only be regarded as vectors under the conditions set out in Article 171(1) of Delegated Regulation (EU) 2020/692.

                                    (4)

                                    Where disease is relevant and reportable.

                                    (5)

                                    To be signed by:

                                                —

                                                an official veterinarian when the animal health attestation of part II.2 is completed;

                                                —

                                                a certifying officer or an official veterinarian when the animal health attestation in part II.2 is deleted.

                        [Official veterinarian](5) / [Certifying officer](5)

                        Name (in capitals)_______________________________
                        Qualification and title_______________________________
                        Date_______________________________
                        Signature_______________________________
                        Stamp

               (1)  Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, p. 379).

               (2)  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).

               (3)  Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21).