title: Commission Implementing Regulation (EU) 2021/1043 of 24 June 2021 on the extension of the transitional provisions related to own funds requirements for exposures to central counterparties set out in Regulation (EU) No 575/2013 of the European Parliament and of the Council (Text with EEA relevance)

text:
                  25.6.2021

                  EN

                  Official Journal of the European Union

                  L 225/52

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1043
         of 24 June 2021
         on the extension of the transitional provisions related to own funds requirements for exposures to central counterparties set out in Regulation (EU) No 575/2013 of the European Parliament and of the Council
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (1), and in particular Article 497(3) thereof,
         Whereas:

                     (1)

                     In order to avoid disruption to international financial markets and to prevent penalising institutions established in the Union by subjecting them to higher own funds requirements during the processes of recognition of existing third-country central counterparties (CCPs), Article 497(1) of Regulation (EU) No 575/2013 established a transitional period during which institutions may treat exposures to those third-country CCPs as exposures to qualifying CCPs.

                     (2)

                     For third-country CCPs that submitted their application for recognition in accordance with Article 25(6) of Regulation (EU) No 648/2012 of the European Parliament and of the Council (2) before 27 June 2019, specifically all third-country CCPs still awaiting recognition by the European Securities and Markets Authority (ESMA), the transitional period is set to expire on 28 June 2021.

                     (3)

                     The Commission has not yet adopted decisions in accordance with Article 25(6) of Regulation (EU) No 648/2012 for some of the jurisdictions in which those third-country CCPs are established. Such decisions are a prerequisite for ESMA to recognise third-country CCPs. Since those decisions will not be adopted by 28 June 2021, ESMA will not be able to complete by that date the recognition procedures for the third-country CCPs awaiting recognition.

                     (4)

                     If the transitional period is not extended, institutions established in the Union, or their subsidiaries established outside the Union, having exposures to those third-country CCPs, will be required to increase their own funds for those exposures significantly. This could potentially lead to the withdrawal of those institutions as direct participants in those CCPs or, at least temporarily, to the cessation of the provision of clearing services to those institutions’ clients, and thus cause severe disruption in the markets in which those CCPs operate. Therefore, it is necessary to extend the transitional provision in Article 497(1), point (b)(iii) of Regulation (EU) No 575/2013 by 12 months, until 28 June 2022.

                     (5)

                     The extension of the transitional provision would leave time for the Commission to finalise its equivalence assessments in accordance with Article 25(6) of Regulation (EU) No 648/2012 and to adopt equivalence decisions where conditions thereof are met. It would also leave time for ESMA to recognise the third-country CCPs concerned. Where a positive equivalence decision would not be adopted by the Commission, an extension would leave time for institutions to properly prepare for the end of the transitional period provided for in Article 497(1) of Regulation (EU) No 575/2013.

                     (6)

                     This Regulation should apply from the first day after the expiry of the existing transitional period.

                     (7)

                     The measures provided for in this Regulation are in accordance with the opinion of the European Banking Committee,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The transitional period referred to in Article 497(1), point (b)(iii), of Regulation (EU) No 575/2013 is extended until 28 June 2022.

            Article 2
            This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
            It shall apply from 29 June 2021.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 24 June 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 176, 27.6.2013, p. 1.

            (2)  Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (OJ L 201, 27.7.2012, p. 1).


title: Commission Implementing Regulation (EU) 2021/1044 of 22 June 2021 granting a Union authorisation for the single biocidal product ‘Pesguard® Gel’ (Text with EEA relevance)

text:
                  25.6.2021

                  EN

                  Official Journal of the European Union

                  L 225/54

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1044
         of 22 June 2021
         granting a Union authorisation for the single biocidal product ‘Pesguard® Gel’
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the first subparagraph of Article 44(5) thereof,
         Whereas:

                     (1)

                     On 21 September 2016, Sumitomo Chemical Agro Europe SAS submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a single biocidal product named ‘Pesguard® Gel’ of product-type 18, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-HS027052-37 in the Register for Biocidal Products.

                     (2)

                     ‘Pesguard® Gel’ contains pyriproxyfen and clothianidin, as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.

                     (3)

                     On 31 March 2020, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

                     (4)

                     On 13 October 2020, the Agency submitted to the Commission an opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Pesguard® Gel’ and the final assessment report on the single biocidal product in accordance with Article 44(3) of Regulation (EU) No 528/2012.

                     (5)

                     The opinion concludes that ‘Pesguard® Gel’ is a biocidal product, that it is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012 and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.

                     (6)

                     On 26 October 2020, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

                     (7)

                     The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Pesguard® Gel’.

                     (8)

                     According to the opinion of the Agency, as regards the non-active substances cis CTAC and dichloromethane contained in ‘Pesguard® Gel’, it was not possible to conclude whether they meet the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (3) within the period for the evaluation of the application. Further examination of cis CTAC and dichloromethane should therefore take place. If it is concluded that either cis CTAC or dichloromethane or both are considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for ‘Pesguard® Gel’ in accordance with Article 48 of Regulation (EU) No 528/2012.

                     (9)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

               HAS ADOPTED THIS REGULATION:

            Article 1
            A Union authorisation with authorisation number EU-0024951-0000 is granted to Sumitomo Chemical Agro Europe SAS for the making available on the market and use of the single biocidal product ‘Pesguard® Gel’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
            The Union authorisation is valid from 15 July 2021 until 30 June 2031.

            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, 22 June 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 167, 27.6.2012, p. 1.

            (2)  ECHA opinion of 8 October 2020 on the Union authorisation of the biocidal product ‘Pesguard® Gel’ (ECHA/BPC/269/2020), https://echa.europa.eu/it/opinions-on-union-authorisation

            (3)  Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).

            ANNEX

               Summary of product characteristics for a biocidal product

            Pesguard® Gel
            Product type 18 – Insecticides, acaricides and products to control other arthropods (Pest control)
            Authorisation number: EU-0024951-0000
            R4BP asset number: EU-0024951-0000
            1.   ADMINISTRATIVE INFORMATION

            1.1.   Trade name(s) of the product

                        Trade name(s)

                        Pesguard® Gel

                  1.2.   Authorisation holder

                        Name and address of the authorisation holder

                        Name

                        Sumitomo Chemical Agro Europe SAS

                        Address

                        Parc d’Affaires de Crécy 10A, rue de la Voie Lactée, 69370 Saint Didier au Mont d’Or, France

                        Authorisation number

                        EU-0024951-0000

                           R4BP asset number

                        EU-0024951-0000

                        Date of the authorisation

                        15 July 2021

                        Expiry date of the authorisation

                        30 June 2031

                  1.3.   Manufacturer(s) of the product

                        Name of manufacturer

                        McLaughlin Gormley King Company (MGK)

                        Address of manufacturer

                        8810 10th Avenue North, MN 55427 Minneapolis United States

                        Location of manufacturing sites

                        McLaughlin Gormley King Company, 4001  Peavey Road, MN 55318 Chaska United States

                  1.4.   Manufacturer(s) of the active substance(s)

                        Active substance

                        (E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidine (Clothianidin)

                        Name of manufacturer

                        Sumitomo Chemical Co. Ltd

                        Address of manufacturer

                        27-1, Shinkawa 2-chome, Chuo-ku, 104-8260 Tokyo Japan

                        Location of manufacturing sites

                        Sumitomo Chemical Company LTD, Oita Works, 2200, Tsurusaki, Oita City„ 870-0106 Oita Japan

                        Active substance

                        pyriproxyfen

                        Name of manufacturer

                        Sumitomo Chemical Co. Ltd

                        Address of manufacturer

                        27-1, Shinkawa 2-chome, Chuo-ku, 104-8260 Tokyo Japan

                        Location of manufacturing sites

                        Sumitomo Chemical Company LTD, Misawa Works, Aza-Sabishirotaira, Oaza-Misawa, Misawa„ 033-0022 Aomori Japan

                  2.   PRODUCT COMPOSITION AND FORMULATION

            2.1.   Qualitative and quantitative information on the composition of the product

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Clothianidin

                        (E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidine

                        Active Substance

                        210880-92-5

                        433-460-1

                        0,526

                        pyriproxyfen

                        4-phenoxyphenyl (RS)-2-(2- pyridyloxy)propyl ether

                        Active Substance

                        95737-68-1

                        429-800-1

                        0,515

                        Acetic acid

                        Ethanoic acid

                        Non-active substance

                        64-19-7

                        200-580-7

                        0,3

                        Potassium sorbate

                        potassium (E,E)-hexa-2,4-dienoate

                        Non-active substance

                        24634-61-5

                        246-376-1

                        0,5

                  2.2.   Type of formulation

            RB – Bait (ready for use)
            3.   HAZARD AND PRECAUTIONARY STATEMENTS

                        Hazard statements

                        May cause an allergic skin reaction.
                        Very toxic to aquatic life with long lasting effects.

                        Precautionary statements

                        IF ON SKIN:Wash with plenty of water.
                        If skin irritation or rash occurs: Get medical advice.
                        Wear protective gloves.
                        Avoid release to the environment.
                        Dispose of container in accordance with local regulations.
                        Collect spillage.

                  4.   AUTHORISED USE(S)

            4.1.   Use description

               Table 1. Use # 1 – Professional Use – RTU Bait

                        Product type

                        PT18 – Insecticides, acaricides and products to control other arthropods (Pest control)

                        Where relevant, an exact description of the authorised use

                        Insecticide

                        Target organism(s) (including development stage)

                        Scientific name: Blattella germanica
                        Common name: German cockroach
                        Development stage: Nymphs
                        Scientific name: Blattella germanica
                        Common name: German cockroach
                        Development stage: Adults
                        Scientific name: Supella longipalpa
                        Common name: Brown-banded cockroach
                        Development stage: Nymphs
                        Scientific name: Supella longipalpa
                        Common name: Brown-banded cockroach
                        Development stage: Adults
                        Scientific name: Blatta orientalis
                        Common name: Oriental Cockroach
                        Development stage: Nymphs
                        Scientific name: Blatta orientalis
                        Common name: Oriental Cockroach
                        Development stage: Adults
                        Scientific name: Periplaneta americana
                        Common name: American Cockroach
                        Development stage: Nymphs
                        Scientific name: Periplaneta americana
                        Common name: American Cockroach
                        Development stage: Adults

                        Field(s) of use

                        Indoor
                        In cracks and crevices, or in concealed locations inaccessible to humans or domestic animals: behind refrigerators cupboards and shelves, under kitchen appliances, in electrical control boxes, voids and ducting and under bathroom fixtures etc.

                        Application method(s)

                        Bait application
                        A ready to use (RTU) insecticidal gel bait for the control of cockroaches in public hygiene

                        Application rate(s) and frequency

                        Pesguard® Gel should be applied as a number of spots of approximately 4 mm diameter (each spot comprising approximately 0,032 g of bait).
                        In cases of severe infestation, where larger cockroach species are present (B. orientalis or P. americana), in areas that are particularly dirty or cluttered or where alternative sources of food cannot be entirely eliminated the higher application rate (e.g. 2 instead of 1 spot per m2 in case of a light infestation) should be used.

                                    •

                                    Light infestation 1 – 2 (0,032 – 0,064 g) spots per m2

                                    •

                                    Medium infestation 3 – 6 (0,096 – 0,192 g) spots per m2

                                    •

                                    Heavy infestation 6 – 10 (0,192 – 0,320 g) spots per m2

                              The maximum number of annual applications is 11.

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        30 g Polypropylene (PP) syringe
                        Screw top cap High Density Poly Ethylene (HDPE)

                  4.1.1.   Use-specific instructions for use

            See the general directions for use.
            4.1.2.   Use-specific risk mitigation measures

            See the general directions for use.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See the general directions for use.
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See the general directions for use.
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See the general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (1)

            5.1.   Instructions for use

            Always read the label or leaflet before use and respect/follow all the instructions provided.
            Do not expose bait drops to sunlight or heat (e.g. radiator).
            The pre-filled plastic reservoir containing Pesguard® Gel is intended for use with the plunger provided or a specific bait application device common to the pest control industry. Refer to the manufacturer’s instructions for directions on the use of the applicator.
            Inject the bait into cracks and crevices, void spaces, or in concealed locations inaccessible to humans or domestic animals where insects may live, feed and breed. Such areas are generally warm/damp and dark (behind refrigerators, cupboards and shelves, under kitchen appliances, in electrical control boxes, voids and ducting and under bathroom fixtures etc.). Inspection or trapping to confirm infestation is recommended prior to treatment. Ensure that any alternative food sources are removed and concentrate the bait placements as individual spots at cockroach activity sites. The product should not be applied to areas accessible to children and pets.
            Do not apply Pesguard® Gel where it will come into contact with water or in areas that are routinely cleaned. Typically cockroaches will die a few hours after a single feed on Pesguard® Gel. In infested premises, dead cockroaches will normally be seen within 24 hours of treatment.
            Remove the cap from the nozzle, touch the top to the surface to be treated, and push down on the plunger. Replace the cap on the dispenser after treatment is completed.
            The bait will adhere to non-greasy or non-dusty surfaces and will remain pliable and palatable to cockroaches as long as it is visibly present.
            Treated area’s should be visually inspected after 1-2 weeks. Where initial infestation was heavy a second Pesguard® Gel application may be required if the first treatment has been consumed and live cockroaches are still present.
            A second visual inspection of bait placements is recommended 2-4 weeks after the initial treatment. Reapply when bait is no longer visibly present, according to the level of infestation (light, medium or heavy). Replace bait before it is completely consumed to keep cockroaches from returning.
            Inform the registration holder if the treatment is ineffective.
            Spills and residues containing the product need to be removed as chemical waste.
            Care should be taken to avoid depositing gel onto exposed surfaces. If gel contacts an exposed surface, remove gel with a paper towel and clean the area with disposable wet wipes.
            During follow-up visits, inspect bait placements and re-apply when necessary.
            Do not place bait in locations that are routinely washed, as bait will be removed by washing. Do not use this product in or on electrical equipment where a possibility of shock hazard exists. Avoid contact with textiles and clothing, as bait may stain.
            5.2.   Risk mitigation measures

            Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).
            Do not apply bait in areas where repellent insecticides have been used without thoroughly cleaning the surface with disposable wet tissue. Do not apply repellent insecticides after application of the bait.
            Do not apply directly on or near food, feed or drinks, or on surfaces or utensils likely to be in direct contact with food, feed, drinks and animals.
            Spills and residues containing the product must be removed as chemical waste.
            Avoid placing gel on fabrics or carpets since it may stain some absorbent materials. To prevent staining, exposed bait should be cleaned up immediately with disposable wet wipes.
            Cleaning materials must be disposed of as to solid waste.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            This biocidal product contains clothianidin, which is dangerous to bees.

               Description of first aid measures

            Skin contact: Remove contaminated clothing immediately and wash skin with soap and water. Get medical attention if irritation persists after washing.
            Eye contact: If symptoms occur, rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.
            Ingestion: If swallowed: If symptons occur call a POISON CENTRE or a doctor.
            If inhaled: not applicable.

               Most important symptoms and effects, both acute and delayed

            Eyes: May cause temporary eye irritation.

               Emergency measures to protect the environment

            Avoid release of the product to the environment.
            5.4.   Instructions for safe disposal of the product and its packaging

            Only pass on empty containers/packaging for recycling.
            Disposal of this packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Protect from frost. Store away from direct sunlight.
            Shelf life: 2 years.
            6.   OTHER INFORMATION

               (1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.


title: Commission Implementing Regulation (EU) 2021/1045 of 24 June 2021 approving didecyldimethyl ammonium chloride as an active substance for use in biocidal products of product-types 3 and 4 (Text with EEA relevance)

text:
                  25.6.2021

                  EN

                  Official Journal of the European Union

                  L 225/62

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1045
         of 24 June 2021
         approving didecyldimethyl ammonium chloride as an active substance for use in biocidal products of product-types 3 and 4
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,
         Whereas:

                     (1)

                     Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes didecyldimethyl ammonium chloride (DDAC) to be renamed for the purposes of this Regulation as didecyldimethyl ammonium chloride as a result of its evaluation.

                     (2)

                     Didecyldimethyl ammonium chloride has been evaluated for use in biocidal products of product-type 3, veterinary hygiene biocidal products and product-type 4, food and feed area disinfectants, as defined in Annex V to Directive 98/8/EC of the European Parliament and of the Council (3), which correspond respectively to product-types 3 and 4 as defined in Annex V to Regulation (EU) No 528/2012.

                     (3)

                     Italy was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions to the Commission on 10 September 2012.

                     (4)

                     In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the Biocidal Products Committee adopted the opinions of the European Chemicals Agency (4) (‘the Agency’) on 6 October 2020, having regard to the conclusions of the evaluating competent authority.

                     (5)

                     According to those opinions, biocidal products of product-types 3 and 4 containing didecyldimethyl ammonium chloride may be expected to satisfy the requirements laid down in Article 5(1)(b), (c) and (d) of Directive 98/8/EC, provided that certain specifications and conditions concerning their use are complied with.

                     (6)

                     Taking into account the opinions of the Agency, it is appropriate to approve didecyldimethyl ammonium chloride as an active substance for use in biocidal products of product-types 3 and 4 subject to compliance with certain specifications and conditions.

                     (7)

                     A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

                     (8)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Didecyldimethyl ammonium chloride is approved as an active substance for use in biocidal products of product-types 3 and 4 subject to the specifications and conditions set out in the Annex.

            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, 24 June 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 167, 27.6.2012, p. 1.

            (2)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

            (3)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

            (4)  Biocidal Products Committee Opinions on the applications for approval of the active substance didecyldimethylammonium chloride; Product-types: 3 and 4; ECHA/BPC/265/2020 and ECHA/BPC/266/2020, adopted on 6 October 2020.

            ANNEX

                        Common Name

                        IUPAC Name
                        Identification Numbers

                        Minimum degree of purity of the active substance  (1)

                        Date of approval

                        Expiry date of approval

                        Product type

                        Specific conditions

                        Didecyldimethyl ammonium chloride

                        IUPAC name: N,N-Didecyl-N,N-dimethylammonium chloride
                        EC No: 230-525-2
                        CAS No: 7173-51-5

                        Minimum purity of the active substance evaluated: 908 g/kg dry weight

                        1 November 2022

                        31 October 2032

                        3

                        The authorisation of biocidal products is subject to the following conditions:

                                    (a)

                                    The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.

                                    (b)

                                    In the light of the outcome of the risk assessment for the uses assessed, the product assessment shall pay particular attention to:

                                                (1)

                                                professional users;

                                                (2)

                                                sediment and soil following disinfection of vehicles used for animal transport and disinfection in hatcheries after fogging treatment.

                                    (c)

                                    For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residues levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (2) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (3) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

                        4

                        The authorisation of biocidal products is subject to the following conditions:

                                    (a)

                                    The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.

                                    (b)

                                    In the light of the outcome of the risk assessment for the used assessed, the product assessment shall pay particular attention to:

                                                (1)

                                                professional users;

                                                (2)

                                                sediment and soil following disinfection in slaughterhouses and butcheries.

                                    (c)

                                    For products that may lead to residues in food or feed, the need to set new or to amend existing MRLs in accordance with Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

                                    (d)

                                    Didecyldimethyl ammonium chloride shall not be incorporated in materials and articles intended to come into contact with food falling within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council (4), unless the Commission has established specific limits on the migration of didecyldimethyl ammonium chloride into food or it has been established pursuant to that Regulation that such limits are not necessary.

               (1)  The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.

               (2)  Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

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

               (4)  Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).


title: Commission Implementing Regulation (EU) 2021/1046 of 23 June 2021 amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin

text:
                  25.6.2021

                  EN

                  Official Journal of the European Union

                  L 225/66

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1046
         of 23 June 2021
         amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 183(b) thereof,
         Having regard to Regulation (EU) No 510/2014 of the European Parliament and of the Council of 16 April 2014 laying down the trade arrangements applicable to certain goods resulting from the processing of agricultural products and repealing Council Regulations (EC) No 1216/2009 and (EC) No 614/2009 (2), and in particular Article 5(6)(a) thereof,
         Whereas:

                     (1)

                     Commission Regulation (EC) No 1484/95 (3) lays down detailed rules for implementing the system of additional import duties and fixes representative prices in the poultrymeat and egg sectors and for egg albumin.

                     (2)

                     Regular monitoring of the data used to determine representative prices for poultrymeat and egg products and for egg albumin shows that the representative import prices for certain products should be amended to take account of variations in price according to origin.

                     (3)

                     Regulation (EC) No 1484/95 should therefore be amended accordingly.

                     (4)

                     Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EC) No 1484/95 is replaced by the text set out in the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 23 June 2021.

                  For the Commission,

                  On behalf of the President,

               Wolfgang BURTSCHER

                  Director-General

                  Directorate-General for Agriculture and Rural Development

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

            (2)  OJ L 150, 20.5.2014, p. 1.

            (3)  Commission Regulation (EC) No 1484/95 of 28 June 1995 laying down detailed rules for implementing the system of additional import duties and fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and repealing Regulation No 163/67/EEC (OJ L 145, 29.6.1995, p. 47).

            ANNEX

                     ‘ANNEX I

                                 CN code

                                 Description of goods

                                 Representative price
                                 (EUR/100 kg)

                                 Security under Article 3
                                 (EUR/100 kg)

                                 Origin (1)

                                 0207 14 10

                                 Fowls of the species Gallus domesticus, boneless cuts, frozen

                                 170,6
                                 154,9
                                 192,2

                                 45
                                 53
                                 34

                                 AR
                                 BR
                                 TH

               (1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7).’


title: Commission Implementing Regulation (EU) 2021/1053 of 25 June 2021 repealing the definitive anti-dumping duties on imports of certain seamless pipes and tubes of iron or steel originating in the People’s Republic of China imposed by Implementing Regulation (EU) 2015/2272

text:
                  28.6.2021

                  EN

                  Official Journal of the European Union

                  L 227/35

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1053
         of 25 June 2021
         repealing the definitive anti-dumping duties on imports of certain seamless pipes and tubes of iron or steel originating in the People’s Republic of China imposed by Implementing Regulation (EU) 2015/2272
         THE EUROPEAN COMMISSION,
         Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1), and in particular Article 14(1) thereof,
         Whereas:

                     (1)

                     Following an anti-dumping investigation in accordance with Article 5 of Council Regulation (EC) No 1225/2009 (2), on 6 October 2009, pursuant to Council Regulation (EC) No 926/2009 (3), a definitive anti-dumping duty was imposed on imports of certain seamless pipes and tubes of iron or steel originating in the People’s Republic of China. The measures took the form ad valorem duty rates: 17,7 % for Shandong Luxing Steel Pipe Co. Ltd); 27,2 % for other cooperating companies and 39,2 % for all other companies.

                     (2)

                     Following an expiry review investigation in accordance with Article 11(2) of Regulation (EC) No 1225/2009, on 8 December 2015, pursuant to Commission Implementing Regulation (EU) 2015/2272, definitive anti-dumping measures were imposed for a further five years (4).

                     (3)

                     On 29 January 2014, in its judgement of case T-528/09, the General Court annulled Regulation (EC) No 926/2009 in so far as the exports of products produced by Hubei Xinyegang Steel Co. Ltd (‘Hubei’) were concerned (5). This judgement was appealed by the Council.

                     (4)

                     By judgment of 7 April 2016 in the joined cases C-186/14 P and C-193/14 P, the Court of Justice (ECJ) upheld the findings of the General Court and confirmed the annulment of the measures insofar as the exporting producer Hubei was concerned (6).

                     (5)

                     On 9 December 2020, the anti-dumping measures imposed by Implementing Regulation (EU) 2015/2272 expired (7).

                     (6)

                     On 4 February 2021, the ECJ ruled in case C-324/19, on a request for a preliminary ruling under Article 267 TFEU from the Finanzgericht Hamburg, that Regulation (EC) No 926/2009 is invalid (‘the Judgment’) (8).

                     (7)

                     According to Article 266 of the Treaty on the Functioning of the European Union, the Union institutions are obliged to take the necessary steps to comply with the Court’s judgments.

                     (8)

                     In case C-324/19, the Judgment had the effect of invalidating the original measures erga omnes and ex-tunc. That means the judgment is applicable to all parties and that Regulation (EC) No 926/2009 is considered invalid from the day it entered into force.

                     (9)

                     In addition, given the original measure had been extended in 2015, the Judgment also had an indirect impact on Regulation (EU) 2015/2272. This is because, according to the ECJ case law, a ‘prolonging regulation is invalid to the same extent as the definitive regulation’ (9). Furthermore, compliance with the rule of equivalence of form requires that the anti-dumping measures imposed by Implementing Regulation (EU) 2015/2272 should be repealed by means of a Commission regulation (10).

                     (10)

                     As a result of the Judgment declaring Regulation (EC) No 926/2009 is invalid in its entirety, the anti-dumping duties imposed by Implementing Regulation (EU) 2015/2272 should also be repealed ex tunc. Furthermore, any definitive duty paid pursuant to Implementing Regulation (EU) 2015/2272 may be repaid or remitted in accordance with the applicable customs legislation. It follows, in particular, that the operator which has paid those duties is able, in principle, to claim their repayment only if and in so far as the three-year period laid down for that purpose in Article 121(1)(a) of the Union Customs Code (11) has not expired. The fact that Regulation (EC) No 926/2009 has been declared invalid (including with erga omnes effect) would not represent an unforeseeable circumstance or force majeure allowing for an extension of this period under second subparagraph of Article 121(1) of the Union Customs Code. (12)

                     (11)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 15(1) of the basic Regulation,

               HAS ADOPTED THIS REGULATION:

            Article 1

               1.   The anti-dumping duties on imports of certain seamless pipes and tubes of iron or steel originating in the People’s Republic of China imposed by Implementing Regulation (EU) 2015/2272 are repealed as from 9 December 2015.

               2.   Any definitive duty paid pursuant to Implementing Regulation (EU) 2015/2272 shall be repaid or remitted in accordance with the applicable customs legislation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 25 June 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 176, 30.6.2016, p. 21.

            (2)  Council Regulation (EC) No 1225/2009 of 30 November 2009 on protection against dumped imports from countries not members of the European Community (OJ L 343, 22.12.2009, p. 51).

            (3)  Council Regulation (EC) No 926/2009 of 24 September 2009 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of certain seamless pipes and tubes of iron or steel originating in the People’s Republic of China (OJ L 262, 6.10.2009, p. 19).

            (4)  Commission Implementing Regulation (EU) 2015/2272 of 7 December 2015 imposing a definitive anti-dumping duty on imports of certain seamless pipes and tubes of iron or steel originating in the People’s Republic of China following an expiry review pursuant to Article 11(2) of Council Regulation (EC) No 1225/2009 (OJ L 322, 8.12.2015, p. 21).

            (5)  Judgment of 29 January 2014, Hubei Xinyegang Steel v Council, T-528/09, ECLI:EU:T:2014:35.

            (6)  Judgment of 7 April 2016, ArcelorMittal Tubular Products Ostrava a.s. and Others v Hubei Xinyegang Steel Co. Ltd and Council of the European Union v Hubei Xinyegang Steel Co. Ltd, joined cases C-186/14 P and C-193/14 P.

            (7)  OJ C 424, 8.12.2020, p. 32.

            (8)  Judgment of 4 February 2021, Eurocylinder systems AG v Hauptzollamt Hamburg-Stadt, C-324/19, EU:C:2021:94.

            (9)  Judgment of 4 February 2016, C & J Clark International Ltd v The Commissioners for Her Majesty’s Revenue & Customs and Puma SE v Hauptzollamt Nürnberg, joined cases C-659/13 and C-34/14, EU:C: 2016:74, paragraphs 175 to 177.

            (10)  Judgment of 18 October 2018, ArcelorMittal Tubular Products Ostrava a.s. and Others v European Commission, T-364/16, EU:T:2018:696.

            (11)  Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1).

            (12)  See, in particular judgement of 4 February 2016 in C & J Clark International Ltd v The Commissioners for Her Majesty’s Revenue & Customs and Puma SE v Hauptzollamt Nürnberg, joined cases C-659/13 and C-34/14, EU:C:2016:74, paragraphs 186-194; judgement of 14 June 2012, Compagnie internationale pour la vente à distance (CIVAD) SA v Receveur des douanes de Roubaix and Others, C-533/10, EU:C:2012:347, paragraphs 16-35; and judgement of 18 January 2017, Wortmann KG Internationale Schuhproduktionen v Hauptzollamt Bielefeld, C-365/15, EU:C:2017:19, paragraph 34.


title: Commission Implementing Regulation (EU) 2021/1063 of 28 June 2021 approving alkyl (C12-16) dimethylbenzyl ammonium chloride as an active substance for use in biocidal products of product-types 3 and 4 (Text with EEA relevance)

text:
                  29.6.2021

                  EN

                  Official Journal of the European Union

                  L 229/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1063
         of 28 June 2021
         approving alkyl (C12-16) dimethylbenzyl ammonium chloride as an active substance for use in biocidal products of product-types 3 and 4
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,
         Whereas:

                     (1)

                     Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) to be renamed for the purposes of this Regulation as alkyl (C12-16) dimethylbenzyl ammonium chloride as a result of its evaluation.

                     (2)

                     Alkyl (C12-16) dimethylbenzyl ammonium chloride has been evaluated for use in biocidal products of product-type 3, veterinary hygiene biocidal products and product-type 4, food and feed area disinfectants, as defined in Annex V to Directive 98/8/EC of the European Parliament and of the Council (3), which correspond respectively to product-types 3 and 4 as defined in Annex V to Regulation (EU) No 528/2012.

                     (3)

                     Italy was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions to the Commission on 10 September 2012.

                     (4)

                     In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the Biocidal Products Committee adopted the opinions of the European Chemical Agency (4) (‘the Agency’) on 6 October 2020, having regard to the conclusions of the evaluating competent authority.

                     (5)

                     According to those opinions, biocidal products of product-types 3 and 4 containing alkyl (C12-16) dimethylbenzyl ammonium chloride may be expected to satisfy the requirements laid down in Article 5(1)(b), (c) and (d) of Directive 98/8/EC, provided that certain specifications and conditions concerning their use are complied with.

                     (6)

                     Taking into account the opinions of the Agency, it is appropriate to approve alkyl (C12-16) dimethylbenzyl ammonium chloride as an active substance for use in biocidal products of product-types 3 and 4, subject to compliance with certain specifications and conditions.

                     (7)

                     A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

                     (8)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Alkyl (C12-16) dimethylbenzyl ammonium chloride is approved as an active substance for use in biocidal products of product-types 3 and 4 subject to the specifications and conditions set out in the Annex.

            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, 28 June 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 167, 27.6.2012, p. 1.

            (2)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

            (3)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

            (4)  Biocidal Products Committee Opinions on the applications for approval of the active substance alkyl(C12-16) dimethylbenzyl ammonium chloride; Product types: 3 and 4; ECHA/BPC/267/2020 and ECHA/BPC/268/2020, adopted on 6 October 2020.

            ANNEX

                        Common Name

                        IUPAC Name
                        Identification Numbers

                        Minimum degree of purity of the active substance (1)

                        Date of approval

                        Expiry date of approval

                        Product type

                        Specific conditions

                        Alkyl (C12-16) dimethylbenzyl ammonium chloride

                        IUPAC name: not applicable
                        EC No: 270-325-2
                        CAS No: 68424-85-1

                        Minimum purity of the active substance evaluated: 972 g/kg dry weight

                        1 November 2022

                        31 October 2032

                        3

                        The authorisation of biocidal products is subject to the following conditions:

                                    (a)

                                    The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.

                                    (b)

                                    In the light of the outcome of the risk assessment for the uses assessed, the product assessment shall pay particular attention to:

                                                (1)

                                                professional users;

                                                (2)

                                                sediment following disinfection of vehicles used for animal transport and disinfection in hatcheries after fogging treatment;

                                                (3)

                                                soil following disinfection of vehicles used for animal transport, footwear disinfection and disinfection in hatcheries after fogging treatment.

                                    (c)

                                    For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (2) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (3) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

                        4

                        The authorisation of biocidal products is subject to the following conditions:

                                    (a)

                                    The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.

                                    (b)

                                    In the light of the outcome of the risk assessment for the uses assessed, the product assessment shall pay particular attention to:

                                                (1)

                                                professional users;

                                                (2)

                                                sediment and soil following disinfection in slaughterhouses and butcheries.

                                    (c)

                                    For products that may lead to residues in food or feed, the need to set new or to amend existing MRLs in accordance with Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

                                    (d)

                                    Alkyl (C12-16) dimethylbenzyl ammonium chloride shall not be incorporated in materials and articles intended to come into contact with food falling within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council (4), unless the Commission has established specific limits on the migration of alkyl (C12-16) dimethylbenzyl ammonium chloride into food or it has been established pursuant to that Regulation that such limits are not necessary.

               (1)  The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.

               (2)  Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

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

               (4)  Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).


title: Commission Implementing Regulation (EU) 2021/1064 of 28 June 2021 amending Implementing Regulation (EU) 2021/520 with regard to the configuration of the animal identification code for the traceability of certain kept terrestrial animals for the United Kingdom in respect of Northern Ireland (Text with EEA relevance)

text:
                  29.6.2021

                  EN

                  Official Journal of the European Union

                  L 229/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1064
         of 28 June 2021
         amending Implementing Regulation (EU) 2021/520 with regard to the configuration of the animal identification code for the traceability of certain kept terrestrial animals for the United Kingdom in respect of Northern Ireland
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         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’) (1), and in particular Article 120(1) and Article 120(2), points (c), (d) and (f), thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2016/429 lays down rules for the prevention and control of animal diseases that are transmissible to animals or humans. Part IV, Title I, Chapters 1 and 2 of that Regulation provide the rules for establishments keeping terrestrial animals and hatcheries, and for the traceability of certain kept terrestrial animals and hatching eggs within the Union. Regulation (EU) 2016/429 also empowers the Commission to adopt rules to supplement certain non-essential elements of that Regulation by means of delegated acts.

                     (2)

                     Commission Delegated Regulation (EU) 2019/2035 (2) supplements Regulation (EU) 2016/429 by providing the rules for registered and approved establishments for kept terrestrial animals and hatching eggs, and for the traceability of certain kept terrestrial animals and hatching eggs. Part III of that Delegated Regulation includes rules for the traceability of kept terrestrial animals, and more specifically Part III, Titles I and II , lay down rules for the traceability of kept bovine, ovine and caprine animals.

                     (3)

                     To ensure the uniform application in the Union of the traceability rules laid down in Regulation (EU) 2016/429 and Delegated Regulation (EU) 2019/2035, implementing rules on the traceability of certain kept terrestrial animals are laid down in Commission Implementing Regulation (EU) 2021/520 (3).

                     (4)

                     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, Regulation (EU) 2016/429, as well as the Commission acts based on it, 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. Consequently, the rules laid down in Implementing Regulation (EU) 2021/520 apply in the United Kingdom in respect of Northern Ireland. For the sake of clarity, it is appropriate to refer to the Withdrawal Agreement in Article 1 of that Implementing Regulation.

                     (5)

                     In addition, Article 12, point (a) of Implementing Regulation (EU) 2021/520 lays down rules for the configuration of the identification code of kept bovine, ovine, caprine, camelid and cervid animals. The first element of the identification code is the country code of the Member State where the means of identification was first applied to the animals, in the format of either the two-letter code in accordance with International Organization for Standardization (ISO) standard 3166-1 alpha-2, except for Greece, for which the two-letter code ‘EL’ is to be used, or the three-digit country code in accordance with ISO standard 3166-1 numeric. Since there are no subdivisions for the United Kingdom in respect of Northern Ireland in the ISO standards referred to in Article 12 of Regulation (EU) 2021/520, that Regulation should be amended so as to lay down which country code should be the first element of the identification code of kept bovine, ovine, caprine, camelid and cervid animals identified in that region of the United Kingdom.

                     (6)

                     Annex I to Commission Implementing Regulation (EU) 2020/1470 (4) sets out the nomenclature of countries and territories for the European Statistics on international trade in goods, and it lays down that ‘XI’ is the two-letter code to be used if the United Kingdom in respect of Northern Ireland needs to be distinguished according to the conditions laid down in the relevant Union provisions. That code should therefore be referred to in Article 12(a)(i) of Implementing Regulation (EU) 2021/520 for the United Kingdom in respect of Northern Ireland.

                     (7)

                     Furthermore, a corresponding three-digit code has not been defined for use when the United Kingdom in respect of Northern Ireland needs to be distinguished. The three-digit code ‘899’ is not assigned in the ISO standard 3166-1 numeric. That code should therefore be referred to in Article 12(a)(ii) of Implementing Regulation (EU) 2021/520 for the United Kingdom in respect of Northern Ireland.

                     (8)

                     Implementing Regulation (EU) 2021/520 should therefore be amended accordingly.

                     (9)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Implementing Regulation (EU) 2021/520 is amended as follows:

                        (1)

                        in Article 1, the introductory phrase is replaced by the following:
                        ‘This Regulation lays down rules for Member States (*1) concerning:

                           (*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 Regulation, references to Member States or to the Union include the United Kingdom in respect of Northern Ireland.’;"

                        (2)

                        in Article 12, point (a) is replaced by the following:

                                    ‘(a)

                                    the first element of the identification code shall be the country code of the Member State where the means of identification was first applied to the animals, in the format of either:

                                                (i)

                                                the two-letter code in accordance with ISO standard 3166-1 alpha-2, except for Greece, for which the two-letter code ‘EL’ shall be used, and for the United Kingdom in respect of Northern Ireland, for which the two-letter code ‘XI’ shall be used; or

                                                (ii)

                                                the three-digit country code in accordance with ISO standard 3166-1 numeric, except for the United Kingdom in respect of Northern Ireland, for which ‘899’ shall be used;’.

            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, 28 June 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  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).

            (3)  Commission Implementing Regulation (EU) 2021/520 of 24 March 2021 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council with regard to the traceability of certain kept terrestrial animals (OJ L 104, 25.3.2021, p. 39).

            (4)  Commission Implementing Regulation (EU) 2020/1470 of 12 October 2020 on the nomenclature of countries and territories for the European statistics on international trade in goods and on the geographical breakdown for other business statistics (OJ L 334, 13.10.2020, p. 2).


title: Commission Implementing Regulation (EU) 2021/1071 of 29 June 2021 amending Implementing Regulation (EU) 2021/442 and Implementing Regulation (EU) 2021/521 related to the mechanism making certain products subject to the production of an export authorisation

text:
                  30.6.2021

                  EN

                  Official Journal of the European Union

                  L 230/28

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1071
         of 29 June 2021
         amending Implementing Regulation (EU) 2021/442 and Implementing Regulation (EU) 2021/521 related to the mechanism making certain products subject to the production of an export authorisation
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/479 of the European Parliament and of the Council of 11 March 2015 on common rules for exports (1), and in particular Article 6 thereof,
         Whereas:

                     (1)

                     On 30 January 2021, the Commission adopted Implementing Regulation (EU) 2021/111 (2) making the exportation of COVID-19 vaccines as well as active substances, including master and working cell banks, used to manufacture these vaccines, subject to the production of an export authorisation, pursuant to Article 5 of Regulation (EU) 2015/479, for a period of six weeks. Hereafter, on 12 March 2021, the Commission adopted Implementing Regulation (EU) 2021/442 (3) making the exportation of the same products subject to an export authorisation until 30 June 2021, pursuant to Article 6 of Regulation (EU) 2015/479.

                     (2)

                     On 24 March 2021, the Commission adopted Implementing Regulation (EU) 2021/521 (4) introducing as an additional factor when considering granting an export authorisation, the need to assess whether such authorisation does not pose a threat to the security of supply within the Union of the goods covered by Implementing Regulation (EU) 2021/442. By the same Regulation, the Commission decided on a temporary suspension of the exemption of certain destination countries from the scope of Implementing Regulation (EU) 2021/442.

                     (3)

                     Commission Implementing Regulation (EU) 2021/521 was adopted pursuant to Article 5 of Regulation (EU) 2015/479 and applied for a period of six weeks. The measures introduced by that Regulation were subsequently extended until 30 June 2021 by Commission Implementing Regulation (EU) 2021/734 (5).

                     (4)

                     Vaccine production capacity in the Union has stepped up in the meantime, resulting in an increase of deliveries of COVID-19 vaccine doses in the Union. This led to an acceleration of the vaccination campaign in the Union.

                     (5)

                     This vaccination campaign is however still on-going and uncertainties remain, in particular with the emergence of new variants of the COVID-19 virus. There is therefore a continuing need for transparency of export deliveries and Union supplies.

                     (6)

                     The risk that exports would threaten either the execution of the Advance Purchase Agreements between the Union and the vaccine manufacturers or the security of Union supplies of COVID-19 vaccines and their active substances also still persists.

                     (7)

                     Measures introduced by Implementing Regulation (EU) 2021/442 and Implementing Regulation (EU) 2021/521 should therefore continue to apply until 30 September 2021. Those Regulations should therefore be amended accordingly.

                     (8)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 3(1) of Regulation (EU) 2015/479,

               HAS ADOPTED THIS REGULATION:

            Article 1
            In Article 4 of Implementing Regulation (EU) 2021/442, the second paragraph is replaced by the following:

               ‘It shall apply until 30 September 2021.’.

            Article 2
            In Article 3 of Implementing Regulation (EU) 2021/521, the second paragraph is replaced by the following:

               ‘It shall apply until 30 September 2021.’.

            Article 3
            This Regulation shall enter into force on 1 July 2021.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 29 June 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 83, 27.3.2015, p. 34.

            (2)  Commission Implementing Regulation (EU) 2021/111 of 29 January 2021 making the exportation of certain products subject to the production of an export authorisation (OJ L 31 I, 30.1.2021, p. 1).

            (3)  Commission Implementing Regulation (EU) 2021/442 of 11 March 2021 making the exportation of certain products subject to the production of an export authorisation (OJ L 85, 12.3.2021, p. 190).

            (4)  Commission Implementing Regulation (EU) 2021/521 of 24 March 2021 making specific arrangements to the mechanism making the exportation of certain products subject to the production of an export authorisation (OJ L 104, 25.3.2021, p. 52).

            (5)  Commission Implementing Regulation (EU) 2021/734 of 5 May 2021 amending Implementing Regulation (EU) 2021/521 making specific arrangements to the mechanism making certain products subject to the production of an export authorisation (OJ L 158, 6.5.2021, p. 13).