title: Commission Implementing Regulation (EU) 2021/566 of 30 March 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly ‘S. griseoviridis’), Trichoderma asperellum (formerly ‘T. harzianum’) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly ‘T. harzianum’) strain T11, Trichoderma gamsii (formerly ‘T. viride’) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram (Text with EEA relevance)

text:
                  7.4.2021

                  EN

                  Official Journal of the European Union

                  L 118/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/566
         of 30 March 2021
         amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly ‘S. griseoviridis’), Trichoderma asperellum (formerly ‘T. harzianum’) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly ‘T. harzianum’) strain T11, Trichoderma gamsii (formerly ‘T. viride’) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram
         (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 the first paragraph of Article 17 thereof,
         Whereas:

                     (1)

                     Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

                     (2)

                     Commission Implementing Regulation (EU) 2020/421 (3) extended the approval period of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad,Streptomyces K61 (formerly ‘S. griseoviridis’), Trichoderma asperellum (formerly ‘T. harzianum’) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly ‘T. harzianum’) strain T11, Trichoderma gamsii (formerly ‘T. viride’) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram until 30 April 2021.

                     (3)

                     Applications for the renewal of the approval of those substances were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (4).

                     (4)

                     Due to the fact that the assessment of those substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

                     (5)

                     In addition, an extension of the approval period is required for the active substances cyprodinil, dichlorprop-P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, pyrimethanil, spinosad, triclopyr, trinexapac, triticonazole and ziram also to provide the time necessary to carry out an assessment relating to endocrine disrupting properties of those active substances in accordance with the procedure set out in Articles 13 and 14 of Implementing Regulation (EU) No 844/2012.

                     (6)

                     As regards cases where the Commission is to adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission is to set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission is to adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

                     (7)

                     Implementing Regulation (EU) No 540/2011 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) No 540/2011 is amended in accordance with 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, 30 March 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 309, 24.11.2009, p. 1.

            (2)  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).

            (3)  Commission Implementing Regulation (EU) 2020/421 of 18 March 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, Lecanicillium muscarium (formerly ‘Verticillium lecanii’) strain Ve6, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, Phlebiopsis gigantea strains FOC PG 410.3, VRA 1835 and VRA 1984, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly ‘S. griseoviridis’), Trichoderma asperellum (formerly ‘T. harzianum’) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly ‘T. harzianum’) strains IMI 206040 and T11, Trichoderma gamsii (formerly ‘T. viride’) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram (OJ L 84, 20.3.2020, p. 7).

            (4)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

            ANNEX
            Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                        (1)

                        in the sixth column, expiration of approval, of row 74, Ziram, the date is replaced by ‘30 April 2022’;

                        (2)

                        in the sixth column, expiration of approval, of row 89, Pseudomonas chlororaphis strain MA 342, the date is replaced by ‘30 April 2022’;

                        (3)

                        in the sixth column, expiration of approval, of row 90, Mepanipyrim, the date is replaced by ‘30 April 2022’;

                        (4)

                        in the sixth column, expiration of approval, of row 123, Clodinafop, the date is replaced by ‘30 April 2022’;

                        (5)

                        in the sixth column, expiration of approval, of row 124, Pirimicarb, the date is replaced by ‘30 April 2022’;

                        (6)

                        in the sixth column, expiration of approval, of row 125, Rimsulfuron, the date is replaced by ‘30 April 2022’;

                        (7)

                        in the sixth column, expiration of approval, of row 127, Triticonazole, the date is replaced by ‘30 April 2022’;

                        (8)

                        in the sixth column, expiration of approval, of row 129, Clopyralid, the date is replaced by ‘30 April 2022’;

                        (9)

                        in the sixth column, expiration of approval, of row 130, Cyprodinil, the date is replaced by ‘30 April 2022’;

                        (10)

                        in the sixth column, expiration of approval, of row 131, Fosetyl, the date is replaced by ‘30 April 2022’;

                        (11)

                        in the sixth column, expiration of approval, of row 132, Trinexapac, the date is replaced by ‘30 April 2022’;

                        (12)

                        in the sixth column, expiration of approval, of row 133, Dichlorprop-P, the date is replaced by ‘30 April 2022’;

                        (13)

                        in the sixth column, expiration of approval, of row 134, Metconazole, the date is replaced by ‘30 April 2022’;

                        (14)

                        in the sixth column, expiration of approval, of row 135, Pyrimethanil, the date is replaced by ‘30 April 2022’;

                        (15)

                        in the sixth column, expiration of approval, of row 136, Triclopyr, the date is replaced by ‘30 April 2022’;

                        (16)

                        in the sixth column, expiration of approval, of row 137, Metrafenone, the date is replaced by ‘30 April 2022’;

                        (17)

                        in the sixth column, expiration of approval, of row 138, Bacillus subtilis (Cohn 1872) strain QST 713, the date is replaced by ‘30 April 2022’;

                        (18)

                        in the sixth column, expiration of approval, of row 139, Spinosad, the date is replaced by ‘30 April 2022’;

                        (19)

                        in the sixth column, expiration of approval, of row 193, Bacillus thuringiensis subsp. Aizawai strain ABTS-1857 and strain GC-91, the date is replaced by ‘30 April 2022’;

                        (20)

                        in the sixth column, expiration of approval, of row 194, Bacillus thuringiensis subsp. israeliensis (serotype H-14) strain AM65-52, the date is replaced by ‘30 April 2022’;

                        (21)

                        in the sixth column, expiration of approval, of row 195, Bacillus thuringiensis subsp. kurstaki strain ABTS 351, strain PB 54, strain SA 11, strain SA 12, strain EG 2348, the date is replaced by ‘30 April 2022’;

                        (22)

                        in the sixth column, expiration of approval, of row 197, Beauveria bassiana strain ATCC 74040, strain GHA, the date is replaced by ‘30 April 2022’;

                        (23)

                        in the sixth column, expiration of approval, of row 198, Cydia pomonella Granulovirus (CpGV), the date is replaced by ‘30 April 2022’;

                        (24)

                        in the sixth column, expiration of approval, of row 200, Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) strain BIPESCO 5/ F52, the date is replaced by ‘30 April 2022’;

                        (25)

                        in the sixth column, expiration of approval, of row 202, Pythium oligandrum strain M1, the date is replaced by ‘30 April 2022’;

                        (26)

                        in the sixth column, expiration of approval, of row 203, Streptomyces K61 (formerly S. griseoviridis) strain K61, the date is replaced by ‘30 April 2022’;

                        (27)

                        in the sixth column, expiration of approval, of row 204, Trichoderma atroviride (formerly T. harzianum) strain T11, the date is replaced by ‘30 April 2022’;

                        (28)

                        in the sixth column, expiration of approval, of row 206, Trichoderma harzianum Rifai strain T-22, stain ITEM 908, the date is replaced by ‘30 April 2022’;

                        (29)

                        in the sixth column, expiration of approval, of row 207, Trichoderma asperellum (formerly T. harzianum) strain ICC012, strain T25, strain TV1, the date is replaced by ‘30 April 2022’;

                        (30)

                        in the sixth column, expiration of approval, of row 208, Trichoderma gamsii (formerly T. viride) strain ICC080, the date is replaced by ‘30 April 2022’;

                        (31)

                        in the sixth column, expiration of approval, of row 210, Abamectin, the date is replaced by ‘30 April 2022’;

                        (32)

                        in the sixth column, expiration of approval, of row 213, Fenpyroximate, the date is replaced by ‘30 April 2022’.


title: Commission Implementing Regulation (EU) 2021/567 of 6 April 2021 approving the low-risk active substance aqueous extract from the germinated seeds of sweet Lupinus albus 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:
                  7.4.2021

                  EN

                  Official Journal of the European Union

                  L 118/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/567
         of 6 April 2021
         approving the low-risk active substance aqueous extract from the germinated seeds of sweet Lupinus albus 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, CEV SA submitted to the Netherlands on 7 June 2016 an application for the approval of the active substance aqueous extract from the germinated seeds of sweet Lupinus albus.

                     (2)

                     In accordance with Article 9(3) of Regulation (EC) No 1107/2009, the Netherlands, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) of the admissibility of the application on 18 January 2017.

                     (3)

                     On 1 April 2019, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

                     (4)

                     The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of that Regulation, it requested that the applicant supplies additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report on 3 March 2020.

                     (5)

                     On 19 June 2020, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance aqueous extract from the germinated seeds of sweet Lupinus albus 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.

                     (6)

                     On 23 October 2020, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed a review report and a draft regulation regarding aqueous extract from the germinated seeds of sweet Lupinus albus.

                     (7)

                     The applicant was given the possibility to submit comments on the review report.

                     (8)

                     It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were 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)

                     The Commission further considers that aqueous extract from the germinated seeds of sweet Lupinus albus is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Aqueous extract from the germinated seeds of sweet Lupinus albus is not a substance of concern and it fulfils the conditions set out in point 5.1 of Annex II to Regulation (EC) No 1107/2009.

                     (10)

                     It is therefore appropriate to approve aqueous extract from the germinated seeds of sweet Lupinus albus.

                     (11)

                     In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to include certain conditions and restrictions. It is in particular appropriate to require further confirmatory information.

                     (12)

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

                     (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
            Approval of the active substance
            The active substance aqueous extract from the germinated seeds of sweet Lupinus albus, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

            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, 6 April 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 309, 24.11.2009, p. 1.

            (2)  EFSA (European Food Safety Authority), 2020. Conclusion on the peer review of the pesticide risk assessment of the active substance Aqueous extract from the germinated seeds of sweet Lupinus albus; EFSA Journal 2020;18(7):6190, 45 pp.; https://doi:10.2903/j.efsa.2020.6190. Available online: www.efsa.europa.eu.

            (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

                        Aqueous extract from the germinated seeds of sweet Lupinus albus

                           CAS No:

                        Not available for the extract

                           BLAD protein: 1219521-95-5

                        CIPAC No:
                        Not allocated

                        Not applicable

                        The minimum purity is not relevant for the extract.
                        BLAD protein content: 195 – 210 g/kg.
                        The following relevant impurities (of toxicological, ecotoxicological and/or environmental concern) in the active substance as manufactured were identified:
                        Total quinolizidine alkaloids (QA):
                        (lupanine, 13α-OH-lupanine, 13α-angeloyloxylupanine, lupinine, albine, angustofoline, 13α-tigloyloxylupanine, α-isolupanine, tetrahydrohombifoline, multiflorine, sparteine)
                        Maximum content: provisionally set at 0,05 g/kg

                        27 April 2021

                        27 April 2036

                        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 aqueous extract from the germinated seeds of sweet Lupinus albus, and in particular Appendices I and II thereto, shall be taken into account.
                        In this overall assessment, Member States shall pay particular attention to the necessary labelling instructions concerning the measures to address foaming and stability of dilutions of the formulation.
                        The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                    1.

                                    the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification; and

                                    2.

                                    in particular, the maximum content of the quinolizidine alkaloids (lupanine, 13α-OH-lupanine, 13α-angeloyloxylupanine, lupinine, albine, angustofoline, 13α-tigloyloxylupanine, α-isolupanine, tetrahydrohombifoline, multiflorine, sparteine).

                              The applicant shall submit the information referred in points 1 and 2 by 27 October 2021.

               (1)  Further details on identity and specification of 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

                           ‘28

                           Aqueous extract from the germinated seeds of sweet Lupinus albus

                              CAS No:

                           Not available for the extract

                              BLAD protein: 1219521-95-5

                           CIPAC No:
                           Not allocated

                           Not applicable

                           The minimum purity is not relevant for the extract.
                           BLAD protein content: 195 – 210 g/kg.
                           The following relevant impurities (of toxicological, ecotoxicological and/or environmental concern) in the active substance as manufactured were identified:
                           Total quinolizidine alkaloids (QA):
                           (lupanine, 13α-OH-lupanine, 13α-angeloyloxylupanine, lupinine, albine, angustofoline, 13α-tigloyloxylupanine, α-isolupanine, tetrahydrohombifoline, multiflorine, sparteine)
                           Maximum content: provisionally set at 0,05 g/kg

                           27 April 2021

                           27 April 2036

                           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 aqueous extract from the germinated seeds of sweet Lupinus albus, and in particular Appendices I and II thereto, shall be taken into account.
                           In this overall assessment, Member States shall pay particular attention to the necessary labelling instructions concerning the measures to address foaming and stability of dilutions of the formulation.
                           The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                       1.

                                       the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification; and

                                       2.

                                       in particular on the maximum content of the quinolizidine alkaloids (lupanine, 13α-OH-lupanine, 13α-angeloyloxylupanine, lupinine, albine, angustofoline, 13α-tigloyloxylupanine, α-isolupanine, tetrahydrohombifoline, multiflorine, sparteine).

                                 The applicant shall submit the information referred in points 1 and 2 by 27 October 2021.’

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


title: Commission Implementing Regulation (EU) 2021/568 of 6 April 2021 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for the United Kingdom in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into and transit through the Union in relation to highly pathogenic avian influenza (Text with EEA relevance)

text:
                  7.4.2021

                  EN

                  Official Journal of the European Union

                  L 118/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/568
         of 6 April 2021
         amending Annex I to Regulation (EC) No 798/2008 as regards the entry for the United Kingdom in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into and transit through the Union in relation to highly pathogenic avian influenza
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (1), and in particular the introductory phrase of Article 8, the first subparagraph of paragraph 1 of Article 8, paragraph 4 of Article 8 and Article 9(4) thereof,
         Having regard to Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (2), and in particular Articles 23(1), 24(2) and 25(2) thereof,
         Whereas:

                     (1)

                     Commission Regulation (EC) No 798/2008 (3) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry and poultry products (‘the commodities’). It provides that the commodities are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I thereto.

                     (2)

                     Regulation (EC) No 798/2008 also lays down the conditions for a third country, territory, zone or compartment to be considered as free from highly pathogenic avian influenza (HPAI).

                     (3)

                     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 (Withdrawal Agreement), and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, Directives 2002/99/EC and 2009/158/EC, as well as the Commission acts based on them, apply to and in the United Kingdom in respect of Northern Ireland after the end of the transition period provided for in the Withdrawal Agreement.

                     (4)

                     Therefore, the United Kingdom, excluding Northern Ireland, is listed in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country from which imports into and transit through the Union of certain poultry commodities are authorised from certain parts of its territory depending on the presence of HPAI. That regionalisation of the United Kingdom is set out in Part 1 of Annex I to Regulation (EC) No 798/2008, as amended by Commission Implementing Regulation (EU) 2021/256 (4).

                     (5)

                     On 29 March 2021, the United Kingdom confirmed the presence of HPAI of subtype H5N8 in a poultry holding in East Staffordshire.

                     (6)

                     The veterinary authorities of the United Kingdom placed a 10 km control zone around the affected holding and implemented a stamping-out policy in order to control the presence of HPAI and limit the spread of that disease. Furthermore, the veterinary authorities of the United Kingdom confirmed that they immediately suspended issuing veterinary certificates for consignments of commodities intended for export to the Union from the whole of the territory of the United Kingdom, excluding Northern Ireland.

                     (7)

                     The United Kingdom has submitted information to the Commission on the epidemiological situation on its territory and the measures it has taken to prevent the further spread of HPAI which has now been evaluated by the Commission. On the basis of that evaluation, it is appropriate to place restrictions on the introduction into the Union of commodities from the area the veterinary authorities of the United Kingdom have placed under restrictions due to the current HPAI outbreak in East Staffordshire.

                     (8)

                     The entry for the United Kingdom in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 should, therefore, be amended to take account of the current epidemiological situation in that third country.

                     (9)

                     Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

                     (10)

                     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
            Part 1 of Annex I to Regulation (EC) No 798/2008 is amended in accordance with the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 6 April 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 18, 23.1.2003, p. 11.

            (2)  OJ L 343, 22.12.2009, p. 74.

            (3)  Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1).

            (4)  Commission Implementing Regulation (EU) 2021/256 of 18 February 2021 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for the United Kingdom in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into and transit through the Union in relation to highly pathogenic avian influenza (OJ L 58, 19.2.2021, p. 36).

            ANNEX
            In Part 1 of Annex I to Regulation (EC) No 798/2008, the entry for the United Kingdom is replaced by the following:

                           ‘GB - United Kingdom (*1)

                           GB-0

                           Whole country

                           SPF

                           EP, E

                           GB-1

                           The whole country of the United Kingdom, excluding area GB-2

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N

                           A

                           WGM

                           POU, RAT

                           N

                           GB-2

                           The territory of the United Kingdom corresponding to:

                           GB-2.1

                           North Yorkshire County:
                           The area contained within a circle of a radius of 10 km, centered on WGS84 dec. coordinates N54.30 and W1.47

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           1.1.2021

                           6.1.2021

                           A

                           WGM

                           P2

                           1.1.2021

                           6.1.2021

                           POU, RAT

                           N
                           P2

                           1.1.2021

                           6.1.2021

                           GB-2.2

                           North Yorkshire County:
                           The area contained within a circle of a radius of 10 km, centered on WGS84 dec. coordinates N54.29 and W1.45

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           1.1.2021

                           8.1.2021

                           A

                           WGM

                           P2

                           1.1.2021

                           8.1.2021

                           POU, RAT

                           N
                           P2

                           1.1.2021

                           8.1.2021

                           GB-2.3

                           Norfolk County:
                           The area contained within a circle of a radius of 10 km, centered on WGS84 dec. coordinates N52.49 and E0.95

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           1.1.2021

                           10.1.2021

                           A

                           WGM

                           P2

                           1.1.2021

                           10.1.2021

                           POU, RAT

                           N
                           P2

                           1.1.2021

                           10.1.2021

                           GB-2.4

                           Norfolk County:
                           The area contained within a circle of a radius of 10 km, centered on WGS84 dec. coordinates N52.72 and E0.15

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           1.1.2021

                           11.1.2021

                           A

                           WGM

                           P2

                           1.1.2021

                           11.1.2021

                           POU, RAT

                           N
                           P2

                           1.1.2021

                           11.1.2021

                           GB-2.5

                           Derbyshire County:
                           The area contained within a circle of a radius of 10 km, centered on WGS84 dec. coordinates N52.93 and W1.57

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           1.1.2021

                           17.1.2021

                           A

                           WGM

                           P2

                           1.1.2021

                           17.1.2021

                           POU, RAT

                           N
                           P2

                           1.1.2021

                           17.1.2021

                           GB-2.6

                           North Yorkshire County:
                           The area contained within a circle of a radius of 10 km, centered on WGS84 dec. coordinates N54.37 and W2.16

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           1.1.2021

                           19.1.2021

                           A

                           WGM

                           P2

                           1.1.2021

                           19.1.2021

                           POU, RAT

                           N
                           P2

                           1.1.2021

                           19.1.2021

                           GB-2.7

                           Orkney Islands:
                           The area contained within a circle of a radius of 10 km, centered on WGS84 dec. coordinates N59.28 and W2.44

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           1.1.2021

                           20.1.2021

                           A

                           WGM

                           P2

                           1.1.2021

                           20.1.2021

                           POU, RAT

                           N
                           P2

                           1.1.2021

                           20.1.2021

                           GB-2.8

                           Dorset County:
                           The area contained within a circle of a radius of 10 km, centered on WGS84 dec. coordinates N51.06 and W2.27

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           1.1.2021

                           20.1.2021

                           A

                           WGM

                           P2

                           1.1.2021

                           20.1.2021

                           POU, RAT

                           N
                           P2

                           1.1.2021

                           20.1.2021

                           GB-2.9

                           Norfolk County:
                           The area contained within a circle of a radius of 10 km, centered on WGS84 dec. coordinates N52.52 and E0.96

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           1.1.2021

                           23.1.2021

                           A

                           WGM

                           P2

                           1.1.2021

                           23.1.2021

                           POU, RAT

                           N
                           P2

                           1.1.2021

                           23.1.2021

                           GB-2.10

                           Norfolk County:
                           The area contained within a circle of a radius of 10 km, centered on WGS84 dec. coordinates N52.52 and E0.95

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           1.1.2021

                           28.1.2021

                           A

                           WGM

                           P2

                           1.1.2021

                           28.1.2021

                           POU, RAT

                           N
                           P2

                           1.1.2021

                           28.1.2021

                           GB-2.11

                           Norfolk County:
                           The area contained within a circle of a radius of 10.4 km, centered on WGS84 dec. coordinates N52.53 and E0.66

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           1.1.2021

                           7.2.2021

                           A

                           WGM

                           P2

                           1.1.2021

                           7.2.2021

                           POU, RAT

                           N
                           P2

                           1.1.2021

                           7.2.2021

                           GB-2.12

                           Devon County:
                           The area contained within a circle of a radius of 10 km, centred on WGS84 dec. coordinates N50.70 and W3.36

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           1.1.2021

                           31.1.2021

                           A

                           WGM

                           P2

                           1.1.2021

                           31.1.2021

                           POU, RAT

                           N
                           P2

                           1.1.2021

                           31.1.2021

                           GB-2.13

                           Near Amlwch, Isle of Anglesey, Wales:
                           The area contained within a circle of a radius of 10 km, centred on WGS84 dec. coordinates N53.38 and W4.30

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           27.1.2021

                           A

                           WGM

                           P2

                           27.1.2021

                           POU, RAT

                           N
                           P2

                           27.1.2021

                           GB-2.14

                           Near Redcar, Redcar and Cleveland, England:
                           The area contained within a circle of a radius of 10km, centred on WGS84 dec, coordinates N54.57 and W1.07

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           8.2.2021

                           A

                           WGM

                           P2

                           8.2.2021

                           POU, RAT

                           N
                           P2

                           8.2.2021

                           GB-2.15

                           Glenrothes, Fife, Scotland:
                           The area contained within a circle of a radius of 10km, centred on WGS84 dec, coordinates N56.23 and W3.02

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           12.2.2021

                           A

                           WGM

                           P2

                           12.2.2021

                           POU, RAT

                           N
                           P2

                           12.2.2021

                           GB-2.16

                           Staffordshire county, Derbyshire county:
                           The area contained with a circle of a radius of 10km, centred on WGS84 dec, coordinates N52.99 and W1.85

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           N
                           P2

                           29.3.2021

                           A

                           WGM

                           P2

                           29.3.2021

                           POU, RAT

                           N
                           P2

                           29.3.2021

               (*1)  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 Annex references to the United Kingdom do not include Northern Ireland.’.


title: Commission Implementing Regulation (EU) 2019/1852 of 30 October 2019 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications Gall del Penedès (PGI)

text:
                  6.11.2019

                  EN

                  Official Journal of the European Union

                  L 285/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1852
         of 30 October 2019
         approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications ‘Gall del Penedès’ (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 the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Spain’s application for the approval of amendments to the specification for the protected geographical indication ‘Gall del Penedès’, registered under Commission Implementing Regulation (EU) 2016/929 (2).

                     (2)

                     Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

                     (3)

                     As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Gall del Penedès’ (PGI) are hereby approved.

            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, 30 October 2019.

                  For the Commission,

                  On behalf of the President,

               Phil HOGAN

                  Member of the Commission

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

            (2)  Commission Implementing Regulation (EU) 2016/929 of 1 June 2016 entering a name in the register of protected designations of origin and protected geographical indications (Gall del Penedès (PGI)) (OJ L 155, 14.6.2016, p. 7).

            (3)  OJ C 217, 28.6.2019, p. 10.