title: Commission Implementing Regulation (EU) 2020/1763 of 25 November 2020 approving formaldehyde as an existing active substance for use in biocidal products of product-types 2 and 3 (Text with EEA relevance)

text:
                  26.11.2020

                  EN

                  Official Journal of the European Union

                  L 397/17

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1763
         of 25 November 2020
         approving formaldehyde as an existing active substance for use in biocidal products of product-types 2 and 3
         (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 lists includes formaldehyde.

                     (2)

                     Formaldehyde has been evaluated for use in biocidal products of product-type 2, private area and public health area disinfectants and other biocidal products, and product-type 3, veterinary hygiene biocidal products, as described in Annex V to Directive 98/8/EC of the European Parliament and of the Council (3), which correspond respectively to product-types 2 and 3 as described in Annex V to Regulation (EU) No 528/2012.

                     (3)

                     The evaluating competent authority of Germany submitted the assessment reports together with its conclusions to the Commission on 29 July 2013.

                     (4)

                     In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency (4) (the ‘Agency’) were adopted on 10 December 2019 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

                     (5)

                     It can be derived from Article 90(2) of Regulation (EU) No 528/2012 that substances for which the Member States’ evaluation has been completed by 1 September 2013 should be evaluated in accordance with the provisions of Directive 98/8/EC.

                     (6)

                     According to the opinions of the Agency, biocidal products of product-types 2 and 3 containing formaldehyde may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain specifications and conditions concerning their use are complied with.

                     (7)

                     It is therefore appropriate to approve formaldehyde for use in biocidal products of product-types 2 and 3, subject to compliance with certain specifications and conditions.

                     (8)

                     The opinions of the Agency conclude that formaldehyde meets the criteria for classification as carcinogen category 1B in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5).

                     (9)

                     Since formaldehyde should be approved under the terms of Directive 98/8/EC, taking into account that property, the period of approval should be considerably shorter than 10 years, in accordance with the latest practice established under that Directive. In addition, since formaldehyde has benefitted from the transitional period provided for in Article 89 of Regulation (EU) No 528/2012 since 14 May 2000 and has been under peer review since 29 July 2013, and with the view to examine at Union level as soon as possible in the context of a potential renewal of approval whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied for formaldehyde, the period of approval should be three years.

                     (10)

                     Furthermore, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the competent authorities of the Member States should evaluate whether the conditions of Article 5(2) of that Regulation can be satisfied in their territories in order to decide whether a biocidal product containing formaldehyde can be authorised.

                     (11)

                     For the purposes of Article 23 of Regulation (EU) No 528/2012, formaldehyde meets the conditions laid down in point (a) of Article 10(1) of that Regulation and should therefore be considered a candidate for substitution. The competent authorities of the Member States should therefore perform a comparative assessment as part of the evaluation of an application for authorisation or for renewal of authorisation of a biocidal product containing formaldehyde.

                     (12)

                     Since, as concluded by the Agency, formaldehyde meets the criteria for classification as carcinogen category 1B and as skin sensitiser category 1 in accordance with Annex I to Regulation (EC) No 1272/2008, treated articles treated with or incorporating formaldehyde should be appropriately labelled when placed on the market.

                     (13)

                     This Regulation does not affect the application of Union law in the area of health and safety at work, in particular Council Directives 89/391/EEC (6) and 98/24/EC (7), and Directive 2004/37/EC of the European Parliament and of the Council (8).

                     (14)

                     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.

                     (15)

                     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
            Formaldehyde is approved as an active substance for use in biocidal products of product-types 2 and 3, 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, 25 November 2020.

                  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 (BPC) opinion on the application for approval of the active substance Formaldehyde, Product type: 2, ECHA/BPC/232/2019, adopted on 10 December 2019; Biocidal Products Committee (BPC) opinion on the application for approval of the active substance Formaldehyde, Product type: 3, ECHA/BPC/233/2019, adopted on 10 December 2019.

            (5)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

            (6)  Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1).

            (7)  Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).

            (8)  Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50).

            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

                        Formaldehyde

                        IUPAC Name:
                        Methanal
                        EC No: 200-001-8
                        CAS No: 50-00-0

                        25–55,5 % formaldehyde in aqueous solution (minimum purity 87,5 % w/w with regard to formaldehyde)

                        1 February 2022

                        31 January 2025

                        2

                        Formaldehyde is considered a candidate for substitution in accordance with point (a) of Article 10(1) of Regulation (EU) No 528/2012.
                        The authorisations of biocidal products are subject to the following conditions:

                                    1.

                                    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. In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied.

                                    2.

                                    Products shall only be authorised for use in Member States where at least one of the conditions set in Article 5(2) of Regulation (EU) No 528/2012 is met.

                                    3.

                                    In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:

                                                (i)

                                                professional users for products used for disinfection by mopping and wiping of surfaces;

                                                (ii)

                                                secondary exposure of the general public and children;

                                                (iii)

                                                the aquatic environment for products used for room disinfection by fumigation in epidemic cases.

                              The placing on the market of treated articles is subject to the following condition that the person responsible for the placing on the market of a treated article treated with or incorporating formaldehyde shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

                        3

                        Formaldehyde is considered a candidate for substitution in accordance with point (a) of Article 10(1) of Regulation (EU) No 528/2012.
                        The authorisations of biocidal products are subject to the following conditions:

                                    1.

                                    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. In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied.

                                    2.

                                    Products shall only be authorised for use in Member States where at least one of the conditions set in Article 5(2) of Regulation (EU) No 528/2012 is met.

                                    3.

                                    In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:

                                                (i)

                                                professional users for products used for disinfection by spraying of animal housing and of vehicles in epidemic cases;

                                                (ii)

                                                secondary exposure of the general public;

                                                (iii)

                                                surface water, sediment, soil and groundwater following use of products for disinfection of vehicles and disinfection of animal’s feet by bathing or dipping.

                                    4.

                                    For products that may lead to residues in food or feed, it shall be verified whether new maximum residue levels (MRLs) need to be set or the existing MRLs need to be amended 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), and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

                              The placing on the market of treated articles is subject to the condition that the person responsible for the placing on the market of a treated article treated with or incorporating formaldehyde shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

               (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).


title: Commission Implementing Regulation (EU) 2020/1764 of 25 November 2020 concerning the authorisation of disodium 5'-inosinate produced by fermentation with Corynebacterium stationis KCCM 80161 as a feed additive for all animal species (Text with EEA relevance)

text:
                  26.11.2020

                  EN

                  Official Journal of the European Union

                  L 397/21

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1764
         of 25 November 2020
         concerning the authorisation of disodium 5'-inosinate produced by fermentation with Corynebacterium stationis KCCM 80161 as a feed additive for all animal species
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of disodium 5'-inosinate produced by fermentation with Corynebacterium stationis KCCM 80161. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     This application concerns the authorisation of disodium 5'-inosinate produced by fermentation with Corynebacterium stationis KCCM 80161 as a feed additive for all animal species. The applicant requested this additive to be classified in the additive category ‘sensory additives’.

                     (4)

                     The applicant requested the feed additive to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking. Therefore, the use of disodium 5'‐inosinate produced by fermentation with Corynebacterium stationis KCCM 80161 in water for drinking should not be allowed. The fact that the additive is not authorised for use as a flavouring in water for drinking does not preclude its use in compound feed administered via water.

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 7 May 2020 (2) that, under the proposed conditions of use, disodium 5'‐inosinate produced by fermentation with Corynebacterium stationis KCCM 80161 does not have adverse effects on animal health, consumer health or the environment. The Authority concluded in the opinion that the additive is not toxic by inhalation, not irritant to skin or eyes and is not a dermal sensitiser. The Authority also concluded that the effect of disodium 5'-inosinate produced by fermentation with Corynebacterium stationis KCCM 80161 to increase the taste of food is well proven, and therefore, no further demonstration of its efficacy in feed is necessary. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (6)

                     The assessment of disodium 5'-inosinate produced by fermentation with Corynebacterium stationis KCCM 80161 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of disodium 5'-inosinate produced by fermentation with Corynebacterium stationis KCCM 80161 should be authorised as specified in the Annex to this Regulation.

                     (7)

                     Restrictions and conditions should be provided for to allow better control. In particular, a recommended content should be indicated on the label of the feed additive. Where such content is exceeded, certain information should be indicated on the label of premixtures.

                     (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 substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that 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, 25 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2020;18(5):6140.

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

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

                           Category: Sensory additives

                           Functional group: Flavouring compounds

                        2b631i

                        -

                        Disodium 5'-inosinate

                           Additive composition

                        Disodium 5'-inosinate

                           Characterisation of the active substance

                        Disodium 5'-inosinate
                        Produced by fermentation with Corynebacterium stationis (KCCM 80161)
                        Purity: ≥ 97 % (% assay)
                        Chemical formula: C10H11N4Na2O8P·7.5H2O
                        CAS number 4691-65-0

                           Method of analysis
                            (1)

                        For the identification of disodium 5'-inosinate in the feed additive: FAO JECFA monographs ‘disodium 5'-inosinate’ and ‘disodium 5′-ribonucleotides’.
                        For the determination of disodium 5'-inosinate (IMP) in the feed additive and flavouring premixtures: high performance liquid chromatography coupled to UV detection (HPLC-UV)

                        All animal species

                        -

                        -

                        -

                                    1.

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

                                    2.

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

                                    3.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance alone or in combination with other authorised disodium 5′-ribonucleotides shall be: 50 mg/kg of complete feedingstuff with a moisture content of 12 % ’.

                                    4.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 50 mg/kg.

                        16.12.2030

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


title: Commission Implementing Regulation (EU) 2020/1767 of 20 November 2020 entering a name in the register of protected designations of origin and protected geographical indications ‘Rucola della Piana del Sele’ (PGI)

text:
                  27.11.2020

                  EN

                  Official Journal of the European Union

                  L 398/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1767
         of 20 November 2020
         entering a name in the register of protected designations of origin and protected geographical indications ‘Rucola della Piana del Sele’ (PGI)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Italy’s application to register the name ‘Rucola della Piana del Sele’ was published in the Official Journal of the European Union (2).

                     (2)

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

               HAS ADOPTED THIS REGULATION:

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

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 20 November 2020.

                  For the Commission,

                  On behalf of the President,

               Janusz WOJCIECHOWSKI

                  Member of the Commission

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

            (2)  OJ C 254, 3.8.2020, p. 17.

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


title: Commission Implementing Regulation (EU) 2020/1768 of 25 November 2020 amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin

text:
                  27.11.2020

                  EN

                  Official Journal of the European Union

                  L 398/2

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1768
         of 25 November 2020
         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, 25 November 2020.

                  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

                                 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

                                 175,9

                                 42

                                 AR

                                 145,6

                                 57

                                 BR

                                 245

                                 17

                                 CL

                                 192,8

                                 34

                                 TH

                                 1602 32 11

                                 Preparations of fowls of the species Gallus domesticus, uncooked

                                 167,3

                                 41

                                 BR

               ’

               (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) 2020/1770 of 26 November 2020 on types and species of plants for planting not exempted from the traceability code requirement for plant passports under Regulation (EU) 2016/2031 of the European Parliament and of the Council and repealing Commission Directive 92/105/EEC

text:
                  27.11.2020

                  EN

                  Official Journal of the European Union

                  L 398/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1770
         of 26 November 2020
         on types and species of plants for planting not exempted from the traceability code requirement for plant passports under Regulation (EU) 2016/2031 of the European Parliament and of the Council and repealing Commission Directive 92/105/EEC
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (1), and in particular Article 83(3) thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2016/2031 lays down rules concerning the content and the format of the plant passport required for movement within the Union territory, and into and within protected zones, of certain plants, plant products and other objects.

                     (2)

                     Τhe plant passport for movement within the Union territory includes a traceability code, except for certain plants for planting being ready for the sale to final users. That exception does not apply to types and species of plants for planting to be listed by the Commission.

                     (3)

                     Certain plants for planting are subject to Union measures adopted pursuant to Article 28 or Article 30 of Regulation (EU) 2016/2031 for specific pests. Some of these plants for planting, in particular those that are known to be more likely infested or infected with those specific pests or that have been intercepted on the internal market because of their infestation or infection with those specific pests, may contribute to spreading those pests within the Union, and thus increase a potential of those pests to cause a major and long-term negative impact on those plants for planting.

                     (4)

                     Certain plants for planting originating within the Union are subject to special requirements specified in respect of certain Union quarantine pests according to Article 41(2) of Regulation (EU) 2016/2031 and Article 8(2) of Commission Implementing Regulation (EU) 2019/2072 (2). Those plants for planting may contribute to spreading those pests within the Union, and thus increase a potential of those pests to cause a major and long-term negative impact on those plants for planting.

                     (5)

                     Certain of those plants for planting have been intercepted, while moving within the Union, for hosting Union quarantine pests.

                     (6)

                     It is therefore appropriate to require a traceability code for all cases of plant passports issued for those plants for planting, in order to enhance rapid traceability of those plants.

                     (7)

                     Regulation (EU) 2016/2031, Commission Implementing Regulation (EU) 2017/2313 (3) and this Regulation establish a set of new rules concerning the use and content of plant passports. For this reason, Commission Directive 92/105/EEC (4) becomes obsolete and should be repealed.

                     (8)

                     In order for the professional operators and the competent authorities to have adequate time to adapt to those requirements, this Regulation should apply from 31 December 2021.

                     (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
            Types and species of plants for planting not exempted from the traceability code requirement for plant passports
            The exemption from the traceability code requirement for plant passports for movement within the Union territory as provided for in the second subparagraph of Article 83(2) of Regulation (EU) 2016/2031 shall not apply to the types and species of plants for planting listed in the Annex to this Regulation.

            Article 2
            Repeal of Directive 92/105/EEC
            Directive 92/105/EEC is repealed.

            Article 3
            Entry into force and date of application
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 31 December 2021.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 26 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 317, 23.11.2016, p. 4.

            (2)  Commission Implementing Regulation (EU) 2019/2072 of 28 November 2019 establishing uniform conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament and the Council, as regards protective measures against pests of plants, and repealing Commission Regulation (EC) No 690/2008 and amending Commission Implementing Regulation (EU) 2018/2019 (OJ L 319, 10.12.2019, p. 1).

            (3)  Commission Implementing Regulation (EU) 2017/2313 of 13 December 2017 setting out the format specifications of the plant passport for movement within the Union territory and the plant passport for introduction into, and movement within, a protected zone (OJ L 331, 14.12.2017, p. 44).

            (4)  Commission Directive 92/105/EEC of 3 December 1992 establishing a degree of standardization for plant passports to be used for the movement of certain plants, plant products or other objects within the Community, and establishing the detailed procedures related to the issuing of such plant passports and the conditions and detailed procedures for their replacement (OJ L 4, 8.1.1993, p. 22).

            ANNEX
            Types and species of plants for planting not exempted from the traceability code requirement for plant passports
            Plants for planting, other than seeds, of:

                        —

                           Citrus,

                        —

                           Coffea,

                        —

                           Lavandula dentata L.,

                        —

                           Nerium oleander L.,

                        —

                           Olea europea L.,

                        —

                           Polygala myrtifolia L.,

                        —

                           Prunus dulcis (Mill.) D.A.Webb,

                        —

                           Solanum tuberosum L.


title: Commission Implementing Regulation (EU) 2020/1771 of 26 November 2020 approving reaction mass of peracetic acid (PAA) and peroxyoctanoic acid (POOA) as an existing active substance for use in biocidal products of product-types 2, 3 and 4 (Text with EEA relevance)

text:
                  27.11.2020

                  EN

                  Official Journal of the European Union

                  L 398/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1771
         of 26 November 2020
         approving reaction mass of peracetic acid (PAA) and peroxyoctanoic acid (POOA) as an existing active substance for use in biocidal products of product-types 2, 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 peroxyoctanoic acid, to be renamed reaction mass of peracetic acid and peroxyoctanoic acid, as the result of its evaluation.

                     (2)

                     Reaction mass of peracetic acid and peroxyoctanoic acid has been evaluated for use in biocidal products of product-type 2, disinfectants and algaecides not intended for direct application to humans or animals, product-type 3, veterinary hygiene, and product-type 4, food and feed area, as described in Annex V to Regulation (EU) No 528/2012.

                     (3)

                     France was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions to the European Chemicals Agency (‘the Agency’) on 2 January 2019.

                     (4)

                     In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the Biocidal Products Committee adopted the opinions of the Agency (3) on 4 March 2020, having regard to the conclusions of the evaluating competent authority.

                     (5)

                     According to those opinions, biocidal products of product-types 2, 3 and 4 containing reaction mass of peracetic acid and peroxyoctanoic acid may be expected to meet the criteria laid down in point (b) of Article 19(1) of Regulation (EU) No 528/2012, 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 reaction mass of peracetic acid and peroxyoctanoic acid for use in biocidal products of product-types 2, 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
            Reaction mass of peracetic acid and peroxyoctanoic acid is approved as an active substance for use in biocidal products of product-types 2, 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, 26 November 2020.

                  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)  Biocidal Products Committee Opinions on the application for approval of the active substance reaction mass of peracetic acid (PAA) and peroxyoctanoic acid (POOA); Product type: 2, 3 and 4; ECHA/BPC/242, 243 and 244, adopted on 4 March 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

                        Reaction mass of peracetic acid (PAA) and peroxyoctanoic acid (POOA)

                        IUPAC name: Reaction mass of peracetic acid (PAA) and peroxyoctanoic acid (POOA)
                        EC No: 201-186-8 and 450-280-7
                        CAS No: 79-21-0 and 33734-57-5

                        The minimum purity of the active substance is not relevant as the active substance is a double equilibrium using hydrogen peroxide, acetic acid and octanoic acid as starting materials. The specifications correspond to a range of concentration.

                        1 April 2022

                        31 March 2032

                        2

                        The authorisations of biocidal products are 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 assessment of the active substance.

                                    (b)

                                    In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users.

                        Components

                        Specifications range content (%w/w)

                        Active substance

                        Peracetic acid

                        1,8–13,9

                        Active substance

                        Peroxyoctanoic acid

                        0,15–2,42

                        Relevant impurity

                        Hydrogn peroxyde

                        1,1–25,45

                        Relevant impurity

                        Acetic acid

                        5,74–51

                        3

                        The authorisations of biocidal products are 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 assessment of the active substance.

                                    (b)

                                    In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users.

                        Relevant impurity

                        Octanoic acid

                        1,63–9,03

                        4

                        The authorisations of biocidal products are 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 assessment of the active substance.

                                    (b)

                                    Products containing reaction mass of peracetic acid and peroxyoctanoic acid shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council (2), unless the Commission has established specific limits on the migration of reaction mass of peracetic acid and peroxyoctanoic acid into food or it has established] in accordance with that Regulation that such limits are not necessary.

                                    (c)

                                    In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users.

               (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 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) 2020/1772 of 26 November 2020 amending Implementing Regulation (EU) 2017/2469 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance)

text:
                  27.11.2020

                  EN

                  Official Journal of the European Union

                  L 398/13

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1772
         of 26 November 2020
         amending Implementing Regulation (EU) 2017/2469 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 13 and Article 35(3) thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2015/2283 lays down rules for the placing on the market and use of novel foods in the Union.

                     (2)

                     Commission Implementing Regulation (EU) 2017/2469 (2) lays down administrative and scientific requirements for applications referred to in Article 10(1) of Regulation (EU) 2015/2283.

                     (3)

                     Regulation (EU) 2019/1381 of the European Parliament and the Council (3) amended Regulation (EC) No 178/2002 (4) and Regulation (EU) 2015/2283. Those amendments are aimed at strengthening the transparency and the sustainability of the EU risk assessment in all areas of the food chain where the European Food Safety Authority (‘the Authority’) delivers a scientific risk assessment, including in the area of novel foods.

                     (4)

                     As regards the placing on the market of novel foods, the amendments to Regulation (EC) No 178/2002 introduced new provisions concerning amongst other issues: general pre-submission advice by the staff of the Authority at the request of a potential applicant and the obligation to notify studies commissioned or carried out by business operators to support an application and the consequences of non-compliance with that obligation. It also introduced provisions on the public disclosure by the Authority of all scientific data, studies and other information supporting applications, with the exception of confidential information, early on in the risk assessment process, followed up by a consultation of third parties. The amendments also set out specific procedural requirements for the submission of confidentiality requests and the assessment thereof by the Authority in relation to the information submitted by an applicant, where the Commission requests the opinion of the Authority.

                     (5)

                     Regulation (EU) 2019/1381 also amended Regulation (EU) 2015/2283 to include provisions ensuring consistency with the adaptations of Regulation (EC) No 178/2002 and taking into account sectoral specificities with respect to confidential information.

                     (6)

                     Given the scope and application of all those amendments, Implementing Regulation (EU) 2017/2469 should be adjusted to accommodate the changes as regards the content, drafting and presentation of applications referred to in Article 10 of Regulation (EU) 2015/2283, the arrangements for verifying the validity of applications, and the information to be included in the opinion of the Authority. In particular, Implementing Regulation (EU) 2017/2469 should make reference to the standard data formats and require that applications provide information demonstrating compliance with the notification requirement laid down in Article 32b of Regulation (EC) No 178/2002. It should also clarify that the assessment of compliance with the notification requirement forms part of the verification of the validity of an application.

                     (7)

                     Furthermore, taking into account the fact that the Authority is responsible for managing the database of studies in accordance with Article 32b of Regulation (EC) No 178/2002, it should also be made possible for the Commission to consult the Authority as part of the verification of the validity of applications to ascertaining that the application fulfils the relevant requirements that are laid down in that Article.

                     (8)

                     Where public consultations are performed during the risk assessment in accordance with Article 32c(2) of Regulation (EC) No 178/2002, the opinion of the Authority should also include the results of those consultations, in line with the transparency requirements to which the Authority is subject.

                     (9)

                     This Regulation should apply from 27 March 2021 and to applications submitted as of that date, which is the date of application of Regulation (EU) 2019/1381.

                     (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
            Amendments to Implementing Regulation (EU) 2017/2469
            Implementing Regulation (EU) 2017/2469 is amended as follows:

                        (1)

                        Article 3 is amended as follows:

                                    (a)

                                    paragraph 1 is replaced by the following:

                                       ‘1.   An application shall consist of the following:

                                                   (a)

                                                   a cover letter;

                                                   (b)

                                                   a technical dossier;

                                                   (c)

                                                   a summary of the dossier.

                                             Prior to the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the application shall be submitted through the electronic submission system provided by the Commission, in an electronic format allowing for the downloading, printing and searching of documents. After the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the application shall be submitted through the electronic submission system provided by the Commission in accordance with those standard data formats.’;

                                    (b)

                                    paragraph 5 is replaced by the following:

                                       ‘5.   In addition to the information referred to in points (a), (b) and (e) of Article 10(2) of Regulation (EU) 2015/2283, the summary of the dossier referred to in paragraph 1(c) of this Article shall set out the reasons why the use of the novel food complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283. The summary of the dossier shall not contain any information subject to a request for confidential treatment pursuant to Article 23 of Regulation (EU) 2015/2283 and Article 39a of Regulation (EC) No 178/2002.’;

                        (2)

                        Article 4 is replaced by the following:

                           ‘Article 4
                           Administrative data requirements
                           In addition to the information set out in Article 10(2) of Regulation (EU) 2015/2283, the application shall include the following administrative data:

                                       (a)

                                       the name(s) of the manufacturer(s) of the novel food, if different than the applicant’s, address and contact details;

                                       (b)

                                       the name, address and contact details of the person responsible for the dossier authorised to communicate on behalf of the applicant with the Commission and the Authority;

                                       (c)

                                       the date of submission of the dossier;

                                       (d)

                                       a table of contents of the dossier;

                                       (e)

                                       a detailed list of documents annexed to the dossier, including references to titles, volumes and pages;

                                       (f)

                                       where the applicant submits, in accordance with Article 23 of Regulation (EU) 2015/2283, a request to treat as confidential certain parts of the information of the dossier, including supplementary information, a list of the parts to be treated as confidential accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree;

                                       (g)

                                       where the production process contains confidential data, a non-confidential summary of the production process;

                                       (h)

                                       separately included information and explanations substantiating the existence of the applicant’s right of reference to the proprietary scientific evidence or scientific data in accordance with Article 26 of Regulation (EU) 2015/2283;

                                       (i)

                                       a list of the studies submitted to support the application, including information demonstrating compliance with Article 32b of Regulation (EC) No 178/2002.’;

                        (3)

                        Article 6 is replaced by the following:

                           ‘Article 6
                           Verification of the validity of an application

                              1.   On receipt of an application, the Commission shall, without delay verify whether the application falls within the scope of Regulation (EU) 2015/2283 and whether the application fulfils the requirements set out in Article 10(2) of that Regulation, Articles 3 to 5 of this Regulation and in Article 32b of Regulation (EC) No 178/2002.

                              2.   The Commission may consult the Authority on whether the application fulfils the relevant requirements referred to in paragraph 1. The Authority shall provide the Commission with its views within a period of 30 working days.

                              3.   The Commission may request additional information from the applicant as regards the validity of the application and inform the applicant of the period within which that information has to be provided.

                              4.   By way of derogation from paragraph 1 of this Article, and without prejudice to Article 10(2) of Regulation (EU) 2015/2283 and to Article 32b(4) and (5) of Regulation (EC) No 178/2002, an application may be considered valid even if it does not contain all the elements required under Articles 3 to 5 of this Regulation, provided that the applicant has submitted appropriate justification for each missing element.

                              5.   The Commission shall inform the applicant, the Member States and the Authority whether the application is considered valid or not. Where the application is not considered valid, the Commission shall indicate the reasons for that finding.’;

                        (4)

                        in Article 7(1), the following point (n) is added:

                                    ‘(n)

                                    the results of consultations performed during the risk assessment process in accordance with Article 32c(2) of Regulation (EC) No 178/2002.’;

                        (5)

                        Annex I is replaced in accordance with the Annex to this Regulation;

                        (6)

                        Annex II is deleted.

            Article 2
            Entry into force and application
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 27 March 2021 and to applications submitted to the Commission from that date.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 26 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 64).

            (3)  Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and the sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (OJ L 231, 6.9.2019, p. 1).

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

            ANNEX

                     ‘ANNEX
                     Template cover letter accompanying an application for novel food
                     EUROPEAN COMMISSION
                     Directorate-General
                     Directorate
                     Unit
                     Date: …
                     Subject: Application for authorisation of a novel food in accordance with Regulation (EU) 2015/2283

                        (Please indicate clearly by ticking one of the boxes)

                                 ☐

                                 Application for an authorisation of a new novel food.

                                 ☐

                                 Application for adding, removing or changing the conditions of use of an already authorised novel food. Please provide a reference to that authorisation.

                                 ☐

                                 Application for adding, removing or changing the specifications of an already authorised novel food. Please provide a reference to that authorisation.

                                 ☐

                                 Application for adding, removing or changing additional specific labelling requirements of an already authorised novel food. Please provide a reference to that authorisation.

                                 ☐

                                 Application for adding, removing or changing post market monitoring requirements of an already authorised novel food. Please provide a reference to that authorisation.

                           The Applicant(s) or their Representative(s) in the Union
                     (name(s), address(es)…)
                     …
                     …
                     …
                     submit(s) this application in order to update the Union list on novel foods.
                     Identity of the novel food (Please provide information on the identity of the novel food depending on the category(ies) under which the novel food falls):
                     …
                     …
                     Confidentiality. Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283:

                                 ☐

                                 Yes

                                 ☐

                                 No

                           Data Protection (*1). Where appropriate, state whether the application includes a request for the protection of proprietary data according to Article 26 of Regulation (EU) 2015/2283:

                                 ☐

                                 Yes

                                 ☐

                                 No

                           Food categories, conditions of use and labelling requirements

                                 Food category

                                 Specific conditions of use

                                 Additional specific labelling requirement

                           Yours sincerely,
                     Signature …
                     Enclosures:

                                 ☐

                                 Complete dossier

                                 ☐

                                 Summary of the dossier (non-confidential)

                                 ☐

                                 List of the parts of the dossier requested to be treated as confidential, accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree

                                 ☐

                                 Information supporting the protection of proprietary data relating to the novel food application

                                 ☐

                                 Copy of administrative data of applicant(s)

                                 ☐

                                 List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002

               ’

               (*1)  Applicant should specify the part(s) of the application which include(s) proprietary data for which protection is requested, clearly stating section(s) and page number(s). Applicant should provide verifiable justification/declaration for the proprietary claim.


title: Commission Implementing Regulation (EU) 2020/1777 of 27 November 2020 amending Implementing Regulation (EU) 2018/659 on the conditions for the entry into the Union of live equidae and of semen, ova and embryos of equidae (Text with EEA relevance)

text:
                  30.11.2020

                  EN

                  Official Journal of the European Union

                  L 399/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1777
         of 27 November 2020
         amending Implementing Regulation (EU) 2018/659 on the conditions for the entry into the Union of live equidae and of semen, ova and embryos of equidae
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (1), and in particular Article 17(3) thereof,
         Having regard to Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and importation from third countries of equidae (2), and in particular Article 12(1), (4) and (5), Article 13(2), Article 16 and Article 19(a) and (b) thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) 2018/659 (3) lays down the conditions for entry into the Union of equidae and of semen, ova and embryos of equidae. It sets out the list of third countries from where Member States are to authorise the entry of equidae and of semen, ova and embryos of animals of the equine species, and specifies the animal health and veterinary certification conditions for such entries.

                     (2)

                     Directive 2009/156/EC lays down the animal health requirements governing imports of equidae from third countries into the Union. It provides that imports of equidae into the Union are only authorised from third countries or parts of the territory thereof which have been free from glanders (Burkholderia mallei) for a period of at least six months.

                     (3)

                     On 25 July 2019, Kuwait informed the Commission of two cases of glanders (Burkholderia mallei) in registered horses kept in pre-export quarantine for dispatch to the Union. Kuwait has immediately suspended the export of registered horses to the Union and taken the necessary surveillance and control measures. The entry of registered horses from Kuwait into the Union was therefore suspended by adoption of Commission Implementing Regulation (EU) 2019/2147 (4). On 8 September 2019, three more horses in the same farm were confirmed positive for glanders by complement fixation test (CFT) carried out in the World Organisation for Animal Health (OIE) Regional Reference Laboratory. On 23 June 2020, Kuwait informed the Commission that on 30 April 2020 it had completed an active clinical and serological survey, including testing for glanders of 7 914 horses carried out with negative results in an OIE Regional Reference Laboratory.

                     (4)

                     Kuwait has thus demonstrated that it has remained free of glanders since the last case was detected on 8 September 2019. As a consequence, temporary admission of registered horses, re-entry of registered horses after temporary export and imports of registered horses as well as transit of equidae from Kuwait should be authorised. It is therefore appropriate to amend the entry for Kuwait in Annex I to Implementing Regulation (EU) 2018/659.

                     (5)

                     On 25 December 2019, Turkey notified through the Animal Disease Notification System, that a case of glanders was confirmed on 4 December 2019 in a horse on the Büyükada Island, Province of Istanbul, Turkey. The entry into the Union of equidae and of germinal products of equidae from Turkey was suspended for a period of at least 6 months by adoption of Commission Implementing Regulation (EU) 2020/581 (5).

                     (6)

                     Turkey has provided information documenting that the Provinces of Ankara, Edirne, Istanbul, Izmir, Kirklareli and Tekirdag have remained free of glanders for more than six months since the outbreak on the Büyükada Island was notified on 25 December 2019. That country has furthermore implemented measures to reduce the risk of introduction of glanders into those provinces. As a consequence, temporary admission of registered horses, re-entry of registered horses after temporary export and imports of registered horses as well as transit of equidae from the Provinces of Ankara, Edirne, Istanbul, Izmir, Kirklareli and Tekirdag should be authorised. It is therefore appropriate to amend the entry for Turkey in Annex I to Implementing Regulation (EU) 2018/659.

                     (7)

                     Implementing Regulation (EU) 2018/659 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
            Annex I to Implementing Regulation (EU) 2018/659 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, 27 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 268, 14.9.1992, p. 54.

            (2)  OJ L 192, 23.7.2010, p. 1.

            (3)  Commission Implementing Regulation (EU) 2018/659 of 12 April 2018 on the conditions for the entry into the Union of live equidae and of semen, ova and embryos of equidae (OJ L 110, 30.4.2018, p. 1).

            (4)  Commission Implementing Regulation (EU) 2019/2147 of 28 November 2019 amending and correcting Implementing Regulation (EU) 2018/659 on the conditions for the entry into the Union of live equidae and of semen, ova and embryos of equidae (OJ L 325, 16.12.2019, p. 99).

            (5)  Commission Implementing Regulation (EU) 2020/581 of 27 April 2020 amending Implementing Regulation (EU) 2018/659 on the conditions for the entry into the Union of live equidae and of semen, ova and embryos of equidae (OJ L 133, 28.4.2020, p. 52).

            ANNEX
            In Annex I to Implementing Regulation (EU) 2018/659, the list of third countries and parts of the territory of third countries from which the entry into the Union of consignments of equidae and of semen, ova and embryos of equidae is authorised, is amended as follows:

                        (a)

                        the entry for Kuwait is replaced by the following:

                                    ‘KW

                                    Kuwait

                                    KW-0

                                    Whole country

                                    E

                                    X

                                    X

                                    X

                                    —

                                    —

                                    —

                                    —

                                    —

                                    —

                                    X

                                    ’

                        (b)

                        the entry for Turkey is replaced by the following:

                                    ‘TR

                                    Turkey

                                    TR-0

                                    Whole country

                                    —

                                    —

                                    —

                                    —

                                    —

                                    —

                                    —

                                    —

                                    —

                                    —

                                    —

                                    TR-1

                                    Provinces of Ankara, Edirne, Istanbul, Izmir, Kirklareli and Tekirdag

                                    E

                                    X

                                    X

                                    X

                                    —

                                    —

                                    —

                                    —

                                    —

                                    —

                                    X

                                    ’


title: Commission Implementing Regulation (EU) 2020/1795 of 30 November 2020 concerning the authorisation of iron chelate of lysine and glutamic acid as a feed additive for all animal species (Text with EEA relevance)

text:
                  1.12.2020

                  EN

                  Official Journal of the European Union

                  L 402/27

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1795
         of 30 November 2020
         concerning the authorisation of iron chelate of lysine and glutamic acid as a feed additive for all animal species
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of iron chelate of lysine and glutamic acid. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

                     (3)

                     That application concerns the authorisation of iron chelate of lysine and glutamic acid as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 4 July 2019 (2) and 25 May 2020 (3) that, under the proposed conditions of use, iron chelate of lysine and glutamic acid does not have an adverse effect on animal health and consumer safety. It also concluded that the additive is an eye irritant, skin and respiratory sensitizer, and stated a risk for the users of the additive upon inhalation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that that the additive does not pose an additional risk for the environment compared to other authorised compounds of iron and that it is an efficacious source of iron for all animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of the additive shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are, subject to the relevant protective measures for the users of the additive, satisfied. Accordingly, the use of the additive should be authorised.

                     (6)

                     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 substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition subject to the conditions laid down in that 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, 30 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2019;17(7):5792.

            (3)  EFSA Journal 18(6):6164.

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

                        Content of element (Fe) in mg/kg of complete feed with a moisture content of 12 %

                           Category of nutritional additives. Functional group: compounds of trace elements

                        3b111

                        -

                        Iron chelate of lysine and glutamic acid

                           Additive composition

                        Mixture of chelates of iron with lysine and chelates of iron with glutamic acid in a ratio of 1:1 as a powder with

                                    an iron content between 15 and 16 %,

                                    a lysine content between 19 and 21 %,

                                    a glutamic acid content between 18,5 and 21,5 % and

                                    a maximum of 3 % moisture

                        All animal species

                        -

                        -

                        Ovine: 500 (total (2))
                        Bovines and poultry: 450 (total (2))
                        Piglets up to one week before weaning: 250 mg/day (total (2))
                        Pet animals: 600 (total (2))
                        Other species: 750 (total (2))

                                    1.

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

                                    2.

                                    Iron chelate of lysine and glutamic acid may be placed on the market and used as an additive consisting of a preparation.

                                    3.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing protection.

                        21.12.2030

                           Characterisation of the active substances

                        Chemical formulas:
                        Iron-2,6-diaminohexanoic acid, chloride and hydrogen sulfate salt:
                        C6H17ClFeN2O7S
                        Iron-2-aminopentanedioic acid, sodium and hydrogen sulfate salt:
                        C5H12FeNNaO10S

                           Analytical methods
                            (1)

                        For the quantification of the lysine and glutamic acid content in the feed additive:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

                              For proving the chelated structure of the feed additive:

                                    —

                                    mid-infrared (IR) spectrometry together with the determination of the content of the trace element and lysine and glutamic acid in the feed additive

                              For the quantification of total iron in the feed additive:

                                    —

                                    Atomic Absorption Spectrometry, AAS (EN ISO 6869); or

                                    —

                                    Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510); or

                                    —

                                    Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (EN 15621).

                              For the quantification of total iron in premixtures:

                                    —

                                    Atomic Absorption Spectrometry, AAS (EN ISO 6869); or

                                    —

                                    Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510); or

                                    —

                                    Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (EN 15621); or

                                    —

                                    Inductively Coupled Plasma – Mass Spectrometry, ICP-MS (EN 17053).

                              For the quantification of total iron in feed materials and compound feed:

                                    —

                                    Atomic Absorption Spectrometry, AAS (Commission Regulation (EC) No 152/2009, Annex IV-C) or

                                    —

                                    Atomic Absorption Spectrometry, AAS (EN ISO 6869) or

                                    —

                                    Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510) or

                                    —

                                    Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (EN 15621) or

                                    —

                                    Inductively Coupled Plasma – Mass Spectrometry, ICP-MS (EN 17053).

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

               (2)  The amount of inert iron is not to be taken into consideration for the calculation of the total iron content of the feed.