title: Commission Implementing Regulation (EU) 2019/533 of 28 March 2019 concerning a coordinated multiannual control programme of the Union for 2020, 2021 and 2022 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (Text with EEA relevance.)

text:
                  29.3.2019

                  EN

                  Official Journal of the European Union

                  L 88/28

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/533
         of 28 March 2019
         concerning a coordinated multiannual control programme of the Union for 2020, 2021 and 2022 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin
         (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 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 (1), in particular Article 29(2) thereof,
         Whereas:

                     (1)

                     By Commission Regulation (EC) No 1213/2008 (2) a first coordinated multiannual Community control programme, covering the years 2009, 2010 and 2011, was established. That programme continued under consecutive Commission Regulations. The latest one was Commission Implementing Regulation (EU) 2018/555 (3).

                     (2)

                     Thirty to forty foodstuffs constitute the major components of the diet in the Union. Since pesticide uses show significant changes over a period of three years, pesticides should be monitored in those foodstuffs over a series of three-year cycles to allow consumer exposure and the application of Union legislation to be assessed.

                     (3)

                     The European Food Safety Authority (‘the Authority’), submitted a scientific report on a design assessment of the pesticide monitoring programme. It concluded that an MRL exceedance rate above 1 % could be estimated with a margin of error of 0,75 % by selecting 683 sample units for a minimum of 32 different food items (4). Collection of those samples should be apportioned among Member States according to population numbers, with a minimum of 12 samples per product and per year.

                     (4)

                     Analytical results from the previous official control programmes of the Union have been taken into account to ensure that the range of pesticides covered by the control programme is representative for the pesticides used.

                     (5)

                     Guidance concerning ‘Analytical quality control and validation procedures for pesticide residues analysis in food and feed’ is published on the Commission website (5).

                     (6)

                     Where the residue definition of a pesticide includes other active substances, metabolites and/or breakdown or reaction products, those compounds should be reported separately as far as they are measured individually (6).

                     (7)

                     Implementing measures, such as the Standard Sample Description (SSD) for submitting results of pesticide residues analysis, relating to the submission of information by Member States have been agreed by Member States, the Commission and the Authority.

                     (8)

                     For the sampling procedures, Commission Directive 2002/63/EC (7), which incorporates the sampling methods and procedures recommended by the Codex Alimentarius Commission, should apply.

                     (9)

                     It is necessary to assess whether maximum residue levels for food for infants and young children provided for in Article 10 of Commission Directive 2006/141/EC (8) and Article 7 of Commission Directive 2006/125/EC (9) are respected, taking into account only the residue definitions as they are set out in Regulation (EC) No 396/2005.

                     (10)

                     As regards single residue methods, Member States may be able to meet their obligations of analysis by having recourse to official laboratories already having the validated methods required.

                     (11)

                     Member States should submit by 31 August of each year the information concerning the previous calendar year.

                     (12)

                     In order to avoid any confusion due to an overlap between consecutive multiannual programmes, Implementing Regulation (EU) 2018/555 should be repealed in the interest of legal certainty. It should, however, continue to apply to samples tested in 2019.

                     (13)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Member States shall, during the years 2020, 2021 and 2022, take and analyse samples for the pesticide/product combinations, as set out in Annex I.
            The number of samples of each product, including foods for infants and young children and products originating from organic farming, shall be as set out in Annex II.

            Article 2

               1.   The lot to be sampled shall be chosen randomly.
               The sampling procedure, including the number of units, shall comply with Directive 2002/63/EC.

               2.   All samples, including those of foods intended for infants and young children and products originating from organic farming, shall be analysed for the pesticides set out in Annex I in accordance with the residue definitions set out in Regulation (EC) No 396/2005.

               3.   For foods intended for infants and young children, samples shall be evaluated on the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers, taking into account the MRLs set out in Directives 2006/125/EC and 2006/141/EC. Where such foods can be consumed both as sold and as reconstituted, the results shall be reported on the non-reconstituted product as sold.

            Article 3
            Member States shall submit the results of the analysis of samples tested in 2020, 2021 and 2022 by 31 August 2021, 2022 and 2023 respectively. Those results shall be submitted in the electronic reporting format as set out by EFSA.
            Where the residue definition of a pesticide includes more than one compound (active substance and/or metabolite or breakdown or reaction product), Member States shall report the analysis results in accordance with the full residue definition. In addition, the results of all analytes that are part of the residue definition shall be submitted separately, as far as they are measured individually.

            Article 4
            Implementing Regulation (EU) 2018/555 is repealed.
            However, as regards samples tested in 2019, it shall continue to apply until 1 September 2020.

            Article 5
            This Regulation shall enter into force on 1 January 2020.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 28 March 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 70, 16.3.2005, p. 1.

            (2)  Commission Regulation (EC) No 1213/2008 of 5 December 2008 concerning a coordinated multiannual Community control programme for 2009, 2010 and 2011 to ensure compliance with maximum residue levels of and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (OJ L 328, 6.12.2008, p. 9).

            (3)  Commission Implementing Regulation (EU) 2018/555 of 9 April 2018 concerning a coordinated multiannual control programme of the Union for 2019, 2020 and 2021 to ensure compliance with maximum levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (OJ L 92, 10.4.2018, p. 6).

            (4)  European Food Safety Authority; pesticide monitoring program: design assessment. EFSA Journal 2015;13(2):4005.

            (5)  Document No. SANTE/11813/2017. https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_wrkdoc_2017-11813.pdf in its most recent version.

            (6)  SANCO/12574/2014, Working Document on the summing up of LOQs in case of complex residue definitions.

            (7)  Commission Directive 2002/63/EC of 11 July 2002 establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC (OJ L 187, 16.7.2002, p. 30).

            (8)  Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, p. 1).

            (9)  Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (OJ L 339, 6.12.2006, p. 16).

            ANNEX I
            Part A: Products of plant origin
                (1)
               to be sampled in 2020, 2021 and 2022.

                        2020

                        2021

                        2022

                        (a)

                        (b)

                        (c)

                        Oranges (2)

                        Table grapes (2)

                        Apples (2)

                        Pears (2)

                        Bananas (2)

                        Strawberries (2)

                        Kiwi fruits (2)

                        Grapefruits (2)

                        Peaches, including nectarines and similar hybrids (2)

                        Cauliflowers (2)

                        Aubergines (2)

                        Wine (red or white) made from grapes. (If no specific processing factors for wine are available, Member States are requested to report the wine processing factors used in the ‘National Summary report’)

                        Onions (2)

                        Broccoli (2)

                        Lettuces (2)

                        Carrots (2)

                        Melons (2)

                        Head cabbages (2)

                        Potatoes (2)

                        Cultivated fungi (2)

                        Tomatoes (2)

                        Beans (dried) (2)

                        Sweet peppers/bell peppers (2)

                        Spinaches (2)

                        Rye grain (3)

                        Wheat grain (3)

                        Oat grain (3)
                            (4)

                        Brown rice (husked rice), defined as rice after the removal of the hull from paddy rice (5)

                        Virgin olive oil (If no specific oil processing factor is available, Member States are requested to report the processing factors used in the ‘National Summary report’)

                        Barley grain (3)
                            (6)

            Part B: Products of animal origin (1) to be sampled in 2020, 2021 and 2022.

                        2020

                        2021

                        2022

                        (f)

                        (d)

                        (e)

                        Poultry fat (2) (7)

                        Bovine fat (2) (7)

                        Cow's milk (8)

                        Bovine Liver (2)

                        Chicken eggs (2) (9)

                        Swine fat (2) (7)

            Part C: Pesticide/product combinations to be monitored in/on products of plant origin

                        2020

                        2021

                        2022

                        Remarks

                        2,4-D

                        (a)

                        (b)

                        (c)

                        It shall only be analysed in and on oranges, cauliflowers, brown rice and dried beans in 2020; in and on grapefruits, table grapes, aubergines and broccoli in 2021; in and on lettuces, spinaches and tomatoes in 2022.

                        2-Phenylphenol

                        (a)

                        (b)

                        (c)

                        Abamectin

                        (a)

                        (b)

                        (c)

                        Acephate

                        (a)

                        (b)

                        (c)

                        Acetamiprid

                        (a)

                        (b)

                        (c)

                        Acrinathrin

                        (a)

                        (b)

                        (c)

                        Aldicarb

                        (a)

                        (b)

                        (c)

                        Aldrin and dieldrin

                        (a)

                        (b)

                        (c)

                        Ametoctradin

                        (a)

                        (b)

                        (c)

                        Azinphos-methyl

                        (a)

                        (b)

                        (c)

                        Azoxystrobin

                        (a)

                        (b)

                        (c)

                        Bifenthrin

                        (a)

                        (b)

                        (c)

                        Biphenyl

                        (a)

                        (b)

                        (c)

                        Bitertanol

                        (a)

                        (b)

                        (c)

                        Boscalid

                        (a)

                        (b)

                        (c)

                        Bromide ion

                        (a)

                        (b)

                        (c)

                        It shall only be analysed in and on brown rice in 2020; in and on sweet peppers in 2021; in and on lettuces and tomatoes in 2022.

                        Bromopropylate

                        (a)

                        (b)

                        (c)

                        Bupirimate

                        (a)

                        (b)

                        (c)

                        Buprofezin

                        (a)

                        (b)

                        (c)

                        Captan

                        (a)

                        (b)

                        (c)

                        Carbaryl

                        (a)

                        (b)

                        (c)

                        Carbendazim and benomyl

                        (a)

                        (b)

                        (c)

                        Carbofuran

                        (a)

                        (b)

                        (c)

                        Chlorantraniliprole

                        (a)

                        (b)

                        (c)

                        Chlorfenapyr

                        (a)

                        (b)

                        (c)

                        Chlormequat

                        (a)

                        (b)

                        (c)

                        It shall only be analysed in and on carrots, pears, rye and brown rice in 2020; in and on aubergines, table grapes, cultivated fungi and wheat in 2021; in and on tomatoes and oat in 2022.

                        Chlorothalonil

                        (a)

                        (b)

                        (c)

                        Chlorpropham

                        (a)

                        (b)

                        (c)

                        Chlorpyrifos

                        (a)

                        (b)

                        (c)

                        Chlorpyrifos-methyl

                        (a)

                        (b)

                        (c)

                        Clofentezine

                        (a)

                        (b)

                        (c)

                        It shall be analysed in and on all listed commodities except cereals.

                        Clothianidin

                        (a)

                        (b)

                        (c)

                        Cyazofamid

                        (a)

                        (b)

                        (c)

                        Cyflufenamid

                        (a)

                        (b)

                        (c)

                        Cyfluthrin

                        (a)

                        (b)

                        (c)

                        Cymoxanil

                        (a)

                        (b)

                        (c)

                        Cypermethrin

                        (a)

                        (b)

                        (c)

                        Cyproconazole

                        (a)

                        (b)

                        (c)

                        Cyprodinil

                        (a)

                        (b)

                        (c)

                        Cyromazine

                        (a)

                        (b)

                        (c)

                        It shall only be analysed in and on potatoes, onions and carrots in 2020; in and on aubergines, sweet peppers, melons and cultivated fungi in 2021; in and on lettuces and tomatoes in 2022.

                        Deltamethrin

                        (a)

                        (b)

                        (c)

                        Diazinon

                        (a)

                        (b)

                        (c)

                        Dichlorvos

                        (a)

                        (b)

                        (c)

                        Dicloran

                        (a)

                        (b)

                        (c)

                        Dicofol

                        (a)

                        (b)

                        (c)

                        It shall be analysed in and on all listed commodities except cereals.

                        Diethofencarb

                        (a)

                        (b)

                        (c)

                        Difenoconazole

                        (a)

                        (b)

                        (c)

                        Diflubenzuron

                        (a)

                        (b)

                        (c)

                        Dimethoate

                        (a)

                        (b)

                        (c)

                        Dimethomorph

                        (a)

                        (b)

                        (c)

                        Diniconazole

                        (a)

                        (b)

                        (c)

                        Diphenylamine

                        (a)

                        (b)

                        (c)

                        Dithianon

                        (a)

                        (b)

                        (c)

                        It shall only be analysed in and on pears and brown rice in 2020; in and on table grapes in 2021; in and on apples and peaches in 2022.

                        Dithiocarbamates

                        (a)

                        (b)

                        (c)

                        It shall be analysed in and on all listed commodities except broccoli, cauliflowers, head cabbages, olive oil, wine and onions.

                        Dodine

                        (a)

                        (b)

                        (c)

                        Emamectin benzoate B1a, expressed as emamectin

                        (a)

                        (b)

                        (c)

                        Endosulfan

                        (a)

                        (b)

                        (c)

                        Epoxiconazole

                        (a)

                        (b)

                        (c)

                        Ethephon

                        (a)

                        (b)

                        (c)

                        It shall only be analysed in and on oranges and pears in 2020; in and on sweet peppers, wheat and table grapes in 2021; in and on apples, peaches, tomatoes and wine in 2022.

                        Ethion

                        (a)

                        (b)

                        (c)

                        Ethirimol

                        (a)

                        (b)

                        (c)

                        It shall be analysed in and on all listed commodities except cereals.

                        Etofenprox

                        (a)

                        (b)

                        (c)

                        Etoxazole

                        (a)

                        (b)

                        (c)

                        Famoxadone

                        (a)

                        (b)

                        (c)

                        Fenamidone

                        (a)

                        (b)

                        (c)

                        Fenamiphos

                        (a)

                        (b)

                        (c)

                        Fenarimol

                        (a)

                        (b)

                        (c)

                        It shall be analysed in and on all listed commodities except cereals.

                        Fenazaquin

                        (a)

                        (b)

                        (c)

                        It shall be analysed in and on all listed commodities except cereals.

                        Fenbuconazole

                        (a)

                        (b)

                        (c)

                        Fenbutatin oxide

                        (a)

                        (b)

                        (c)

                        It shall only be analysed in and on oranges and pears in 2020; in and on aubergines, grapefruits, sweet peppers and table grapes in 2021; in and on apples, strawberries, peaches, tomatoes and wine in 2022.

                        Fenhexamid

                        (a)

                        (b)

                        (c)

                        Fenitrothion

                        (a)

                        (b)

                        (c)

                        Fenoxycarb

                        (a)

                        (b)

                        (c)

                        Fenpropathrin

                        (a)

                        (b)

                        (c)

                        Fenpropidin

                        (a)

                        (b)

                        (c)

                        Fenpropimorph

                        (a)

                        (b)

                        (c)

                        Fenpyrazamine

                        (a)

                        (b)

                        (c)

                        Fenpyroximate

                        (a)

                        (b)

                        (c)

                        Fenthion

                        (a)

                        (b)

                        (c)

                        Fenvalerate

                        (a)

                        (b)

                        (c)

                        Fipronil

                        (a)

                        (b)

                        (c)

                        Flonicamid

                        (a)

                        (b)

                        (c)

                        Fluazifop-P

                        (a)

                        (b)

                        (c)

                        It shall only be analysed in and on cauliflowers, dried beans, potatoes and carrots in 2020; in and on aubergines, broccoli, sweet peppers and wheat in 2021; in and on strawberries, head cabbages, lettuces, spinaches and tomatoes in 2022.

                        Flubendiamide

                        (a)

                        (b)

                        (c)

                        Fludioxonil

                        (a)

                        (b)

                        (c)

                        Flufenoxuron

                        (a)

                        (b)

                        (c)

                        Fluopicolide

                        (a)

                        (b)

                        (c)

                        Fluopyram

                        (a)

                        (b)

                        (c)

                        Fluquinconazole

                        (a)

                        (b)

                        (c)

                        Flusilazole

                        (a)

                        (b)

                        (c)

                        Flutriafol

                        (a)

                        (b)

                        (c)

                        Fluxapyroxad

                        (a)

                        (b)

                        (c)

                        Folpet

                        (a)

                        (b)

                        (c)

                        Formetanate

                        (a)

                        (b)

                        (c)

                        Fosthiazate

                        (a)

                        (b)

                        (c)

                        Glyphosate

                        (a)

                        (b)

                        (c)

                        Haloxyfop including haloxyfop-P

                        (a)

                        (b)

                        (c)

                        It shall only be analysed in and on dried beans in 2020; in and on broccoli, grapefruits, sweet peppers and wheat in 2021; in and on strawberries and head cabbages in 2022.

                        Hexaconazole

                        (a)

                        (b)

                        (c)

                        Hexythiazox

                        (a)

                        (b)

                        (c)

                        It shall be analysed in and on all listed commodities except cereals.

                        Imazalil

                        (a)

                        (b)

                        (c)

                        Imidacloprid

                        (a)

                        (b)

                        (c)

                        Indoxacarb

                        (a)

                        (b)

                        (c)

                        Iprodione

                        (a)

                        (b)

                        (c)

                        Iprovalicarb

                        (a)

                        (b)

                        (c)

                        Isocarbophos

                        (a)

                        (b)

                        (c)

                        Isoprothiolane

                        (a)

                        It shall only be analysed in and on brown rice in 2020. The substance is not to be analysed in or on any product in 2021 and 2022.

                        Kresoxim-methyl

                        (a)

                        (b)

                        (c)

                        Lambda-cyhalothrin

                        (a)

                        (b)

                        (c)

                        Linuron

                        (a)

                        (b)

                        (c)

                        Lufenuron

                        (a)

                        (b)

                        (c)

                        Malathion

                        (a)

                        (b)

                        (c)

                        Mandipropamid

                        (a)

                        (b)

                        (c)

                        Mepanipyrim

                        (a)

                        (b)

                        (c)

                        Mepiquat

                        (a)

                        (b)

                        (c)

                        It shall only be analysed in and on pears, rye and brown rice in 2020; in and on cultivated fungi and wheat in 2021; in and on barley and oat in 2022.

                        Metalaxyl and metalaxyl-M

                        (a)

                        (b)

                        (c)

                        Methamidophos

                        (a)

                        (b)

                        (c)

                        Methidathion

                        (a)

                        (b)

                        (c)

                        Methiocarb

                        (a)

                        (b)

                        (c)

                        Methomyl

                        (a)

                        (b)

                        (c)

                        Methoxyfenozide

                        (a)

                        (b)

                        (c)

                        Metrafenone

                        (a)

                        (b)

                        (c)

                        Monocrotophos

                        (a)

                        (b)

                        (c)

                        Myclobutanil

                        (a)

                        (b)

                        (c)

                        Omethoate

                        (a)

                        (b)

                        (c)

                        Oxadixyl

                        (a)

                        (b)

                        (c)

                        Oxamyl

                        (a)

                        (b)

                        (c)

                        Oxydemeton-methyl

                        (a)

                        (b)

                        (c)

                        Paclobutrazole

                        (a)

                        (b)

                        (c)

                        Parathion methyl

                        (a)

                        (b)

                        (c)

                        Penconazole

                        (a)

                        (b)

                        (c)

                        Pencycuron

                        (a)

                        (b)

                        (c)

                        Pendimethalin

                        (a)

                        (b)

                        (c)

                        Permethrin

                        (a)

                        (b)

                        (c)

                        Phosmet

                        (a)

                        (b)

                        (c)

                        Pirimicarb

                        (a)

                        (b)

                        (c)

                        Pirimiphos-methyl

                        (a)

                        (b)

                        (c)

                        Procymidone

                        (a)

                        (b)

                        (c)

                        Profenofos

                        (a)

                        (b)

                        (c)

                        Propamocarb

                        (a)

                        (b)

                        (c)

                        It shall be only analysed in and on carrots, cauliflowers, onions and potatoes in 2020; in and on table grapes, melons, aubergines, broccoli, sweet peppers and wheat in 2021; in and on strawberries, head cabbages, spinaches, lettuces, tomatoes and barley in 2022.

                        Propargite

                        (a)

                        (b)

                        (c)

                        Propiconazole

                        (a)

                        (b)

                        (c)

                        Propyzamide

                        (a)

                        (b)

                        (c)

                        Proquinazid

                        (a)

                        (b)

                        (c)

                        Prosulfocarb

                        (a)

                        (b)

                        (c)

                        Prothioconazole

                        (a)

                        (b)

                        (c)

                        It shall be only analysed in and on carrots, onions, rye and brown rice in 2020; in and on sweet peppers and wheat in 2021; in and on head cabbages, lettuces, tomatoes, oat and barley in 2022.

                        Pymetrozine

                        (b)

                        (c)

                        The substance is not to be analysed in or on any product in 2020; it shall only be analysed in and on aubergines, melons and sweet peppers in 2021; in and on head cabbages, lettuces, strawberries, spinaches and tomatoes in 2022.

                        Pyraclostrobin

                        (a)

                        (b)

                        (c)

                        Pyridaben

                        (a)

                        (b)

                        (c)

                        Pyrimethanil

                        (a)

                        (b)

                        (c)

                        Pyriproxyfen

                        (a)

                        (b)

                        (c)

                        Quinoxyfen

                        (a)

                        (b)

                        (c)

                        Spinosad

                        (a)

                        (b)

                        (c)

                        Spirodiclofen

                        (a)

                        (b)

                        (c)

                        Spiromesifen

                        (a)

                        (b)

                        (c)

                        Spiroxamine

                        (a)

                        (b)

                        (c)

                        Spirotetramat

                        (a)

                        (b)

                        (c)

                        Tau-Fluvalinate

                        (a)

                        (b)

                        (c)

                        Tebuconazole

                        (a)

                        (b)

                        (c)

                        Tebufenozide

                        (a)

                        (b)

                        (c)

                        Tebufenpyrad

                        (a)

                        (b)

                        (c)

                        It shall be analysed in and on all listed commodities except cereals.

                        Teflubenzuron

                        (a)

                        (b)

                        (c)

                        Tefluthrin

                        (a)

                        (b)

                        (c)

                        Terbuthylazine

                        (a)

                        (b)

                        (c)

                        Tetraconazole

                        (a)

                        (b)

                        (c)

                        Tetradifon

                        (a)

                        (b)

                        (c)

                        It shall be analysed in and on all listed commodities except cereals.

                        Thiabendazole

                        (a)

                        (b)

                        (c)

                        Thiacloprid

                        (a)

                        (b)

                        (c)

                        Thiamethoxam

                        (a)

                        (b)

                        (c)

                        Thiophanate-methyl

                        (a)

                        (b)

                        (c)

                        Tolclofos-methyl

                        (a)

                        (b)

                        (c)

                        Triadimefon

                        (a)

                        (b)

                        (c)

                        Triadimenol

                        (a)

                        (b)

                        (c)

                        Thiodicarb

                        (a)

                        (b)

                        (c)

                        Triazophos

                        (a)

                        (b)

                        (c)

                        Tricyclazole

                        (a)

                        (b)

                        (c)

                        It shall only be analysed in and on rice.

                        Trifloxystrobin

                        (a)

                        (b)

                        (c)

                        Triflumuron

                        (a)

                        (b)

                        (c)

                        Vinclozolin

                        (a)

                        (b)

                        (c)

            Part D: Pesticide/product combinations to be monitored in/on products of animal origin

                        2020

                        2021

                        2022

                        Remarks

                        Aldrin and dieldrin

                        (f)

                        (d)

                        (e)

                        Bifenthrin

                        (f)

                        (d)

                        (e)

                        Chlordane

                        (f)

                        (d)

                        (e)

                        Chlorpyrifos

                        (f)

                        (d)

                        (e)

                        Chlorpyrifos-methyl

                        (f)

                        (d)

                        (e)

                        Cypermethrin

                        (f)

                        (d)

                        (e)

                        DDT

                        (f)

                        (d)

                        (e)

                        Deltamethrin

                        (f)

                        (d)

                        (e)

                        Diazinon

                        (f)

                        (d)

                        (e)

                        Endosulfan

                        (f)

                        (d)

                        (e)

                        Famoxadone

                        (f)

                        (d)

                        (e)

                        Fenvalerate

                        (f)

                        (d)

                        (e)

                        Fipronil

                        (f)

                        (d)

                        (e)

                        Glyphosate

                        (f)

                        (d)

                        (e)

                        Heptachlor

                        (f)

                        (d)

                        (e)

                        Hexachlorobenzene

                        (f)

                        (d)

                        (e)

                        Hexachlorcyclohexan (HCH, Alpha-Isomer)

                        (f)

                        (d)

                        (e)

                        Hexachlorcyclohexan (HCH, Beta-Isomer)

                        (f)

                        (d)

                        (e)

                        Indoxacarb

                        (e)

                        It shall only be analysed in and on milk in 2022.

                        Lindane

                        (f)

                        (d)

                        (e)

                        Methoxychlor

                        (f)

                        (d)

                        (e)

                        Parathion

                        (f)

                        (d)

                        (e)

                        Permethrin

                        (f)

                        (d)

                        (e)

                        Pirimiphos-methyl

                        (f)

                        (d)

                        (e)

               (1)  For the raw commodities to be analysed, the parts of the products to which MRLs apply shall be analysed for the main product of the group or subgroup as listed in Part A of Annex I to Regulation (EC) No 396/2005 unless stated otherwise.

               (2)  Unprocessed products shall be analysed. In case of products sampled in frozen state, a processing factor shall be reported, if applicable.

               (3)  If no sufficient samples of rye, wheat, oat or barley grains are available, also rye, wheat, oat or barley whole grain flour can be analysed and a processing factor shall be reported.

               (4)  If no sufficient samples of oat grains are available, the part of the required sample number for oat grains that could not be taken, can be added to the sample number for barley grains, resulting in a reduced sample number for oat grains and a proportionately increased sample number for barley grains.

               (5)  Where appropriate, also polished rice grain can be analysed. It shall be reported to EFSA whether polished or husked rice was analysed. If polished rice was analysed, a processing factor shall be reported.

               (6)  If no sufficient samples of barley grains are available, the part of the required sample number for barley grains that could not be taken, can be added to the sample number for oat grains, resulting in a reduced sample number for barley grains and a proportionately increased sample number for oat grains.

               (7)  Meat may also be sampled according to Table 3 of the Annex to Directive 2002/63/EC.

               (8)  Fresh (unprocessed) milk shall be analysed, including frozen, pasteurised, heated, sterilised or filtrated milk.

               (9)  Whole eggs without the shell shall be analysed.

            ANNEX II

               Number of samples referred to in Article 1

                        (1)

                        The number of samples to be taken for each commodity and analysed for the pesticides listed in Annex I by each Member State is set out in the table in point (5).

                        (2)

                        In addition to the samples required in accordance with the table in point (5), in 2020 each Member State shall take and analyse five samples of infant formulae and five samples of follow-on formulae.
                        In addition to the samples required in accordance with that table, in 2021 each Member State shall take and analyse ten samples of processed cereal-based baby food.
                        In addition to the samples required in accordance with that table, in 2022 each Member State shall take and analyse ten samples of foods for infants and young children other than infant formulae, follow-on formulae and processed cereal-based baby food.

                        (3)

                        In accordance with the table in point (5), samples from commodities originating from organic farming shall, where available, be taken in proportion to the market share of those commodities in each Member State, with a minimum of 1.

                        (4)

                        Member States using multi-residue methods may use qualitative screening methods on up to 15 % of the samples to be taken and analysed in accordance with the table in point (5). Where a Member State uses qualitative screening methods, it shall analyse the remaining number of samples by quantitative multi-residue methods.
                        Where the results of qualitative screening are positive, Member States shall use a usual target method to quantify the findings.

                        (5)

                        Minimum number of samples per Member State per commodity:

                                    Member State

                                    Samples

                                    Member State

                                    Samples

                                    BE

                                    12

                                    LU

                                    12

                                    BG

                                    12

                                    HU

                                    12

                                    CZ

                                    12

                                    MT

                                    12

                                    DK

                                    12

                                    NL

                                    18

                                    DE

                                    97

                                    AT

                                    12

                                    EE

                                    12

                                    PL

                                    47

                                    EL

                                    12

                                    PT

                                    12

                                    ES

                                    50

                                    RO

                                    20

                                    FR

                                    71

                                    SI

                                    12

                                    IE

                                    12

                                    SK

                                    12

                                    IT

                                    69

                                    FI

                                    12

                                    CY

                                    12

                                    SE

                                    12

                                    LV

                                    12

                                    UK

                                    71

                                    LT

                                    12

                                    HR

                                    12

                                    TOTAL NUMBER OF SAMPLES: 683


title: Commission Implementing Regulation (EU) 2019/585 of 11 April 2019 amending Regulation (EU) No 206/2010 as regards the inclusion of the United Kingdom of Great Britain and Northern Ireland and certain of its Crown Dependencies in the lists of third countries, territories or parts thereof authorised for the introduction into the Union of certain animals and fresh meat (Text with EEA relevance.)

text:
                  11.4.2019

                  EN

                  Official Journal of the European Union

                  LI 100/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/585
         of 11 April 2019
         amending Regulation (EU) No 206/2010 as regards the inclusion of the United Kingdom of Great Britain and Northern Ireland and certain of its Crown Dependencies in the lists of third countries, territories or parts thereof authorised for the introduction into the Union of certain animals and fresh meat
         (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(2)(a) thereof,
         Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (2), and in particular points (1) and (4) of Article 8 thereof,
         Having regard to Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC (3), and in particular Article 3(1) thereof,
         Whereas:

                     (1)

                     On 29 March 2017, the United Kingdom submitted the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union (TEU). On 22 March 2019, the European Council adopted Decision (EU) 2019/476 (4) extending the period under Article 50(3) TEU in agreement with the United Kingdom. In accordance with that Decision, in the event that the Withdrawal Agreement is not approved by the House of Commons by 29 March 2019 at the latest, the period provided for in Article 50(3) TEU is extended until 12 April 2019. As the Withdrawal Agreement has not been approved by 29 March 2019, Union law will cease to apply to and in the United Kingdom from 13 April 2019 (‘the withdrawal date’).

                     (2)

                     Commission Regulation (EU) No 206/2010 (5) lays down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements. It provides that consignments of ungulates, and fresh meat of those animals intended for human consumption, are only to be introduced into the Union from third countries if they comply with the conditions laid down in that Regulation.

                     (3)

                     The United Kingdom of Great Britain and Northern Ireland has provided the necessary guarantees for that country and certain of its Crown Dependencies to comply with the conditions laid down in Regulation (EU) No 206/2010 for the introduction into the Union of consignments of ungulates, other than equidae, and fresh meat of ungulates including that of equidae, from the withdrawal date by continuing to comply with Union legislation for an initial period of at least nine months.

                     (4)

                     Therefore, taking into account these specific guarantees provided by the United Kingdom of Great Britain and Northern Ireland, and in order to avoid any unnecessary disruption to trade after the withdrawal date, the United Kingdom and certain of its Crown Dependencies, should be included in the lists of third countries, territories and parts thereof set out in Part 1 of Annex I and in Part 1 of Annex II to Regulation (EU) No 206/2010 authorised for the introduction into the Union of consignments of ungulates, other than equidae, and fresh meat of ungulates including that of equidae.

                     (5)

                     Annexes I and II to Regulation (EU) No 206/2010 should therefore be amended accordingly.

                     (6)

                     This Regulation should apply from 13 April 2019, unless Union law continues to apply to and in the United Kingdom of Great Britain and Northern Ireland on that date.

                     (7)

                     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
            Annexes I and II to Regulation (EU) No 206/2010 are amended in accordance with the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
            It shall apply from 13 April 2019.
            However, it shall not apply if Union law continues to apply to and in the United Kingdom of Great Britain and Northern Ireland on that date.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 11 April 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

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

            (3)  OJ L 139, 30.4.2004, p. 321.

            (4)  European Council Decision (EU) 2019/476 taken in agreement with the United Kingdom of 22 March 2019 extending the period under Article 50(3)TEU (OJ L 80 I, 22.3.2019, p. 1).

            (5)  Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (OJ L 73, 20.3.2010, p. 1).

            ANNEX
            Regulation (EU) No 206/2010 is amended as follows:

                        (1)

                        In Part 1 of Annex I to Regulation (EU) No 206/2010:

                                    (a)

                                    the following lines are inserted after the entry for Chile:

                                                ‘GB-United Kingdom of Great Britain and Northern Ireland

                                                GB-0

                                                Whole country

                                                GB-1

                                                England, Wales and Northern Ireland

                                                BOV-X, BOV-Y, OVI-X, OVI-Y POR-X, POR-Y, RUM, SUI

                                                   III, IVa, V, IX

                                                GB-2

                                                Scotland

                                                BOV-X, BOV-Y, OVI-X, OVI-Y POR-X, POR-Y, RUM, SUI

                                                   II, III, IVa, V, IX

                                                GG-Guernsey

                                                GG-0

                                                Whole country

                                                BOV-X, BOV-Y, OVI-X, OVI-Y POR-X, POR-Y, RUM, SUI

                                                   V, IX’

                                    (b)

                                    the following line is inserted after the entry for Iceland:

                                                ‘JE-Jersey

                                                JE-0

                                                Whole country

                                                BOV-X, BOV-Y, OVI-X, OVI-Y POR-X, POR-Y, RUM, SUI

                                                   IVa, V, IX’

                        (2)

                        In Part 1 of Annex II to Regulation (EU) No 206/2010:

                                    (a)

                                    the following lines are inserted after the entry for Falkland Islands:

                                                ‘GB- United Kingdom of Great Britain and Northern Ireland

                                                GB-0

                                                Whole country

                                                BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW

                                                GG-Guernsey

                                                GG-0

                                                Whole country

                                                BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW’

                                    (b)

                                    the following line is inserted after the entry for Iceland:

                                                ‘JE-Jersey

                                                JE-0

                                                Whole country

                                                BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW’


title: Commission Implementing Regulation (EU) 2019/1137 of 3 July 2019 renewing the approval of the active substance dimethenamid-P in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

text:
                  4.7.2019

                  EN

                  Official Journal of the European Union

                  L 180/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1137
         of 3 July 2019
         renewing the approval of the active substance dimethenamid-P in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) thereof,
         Whereas:

                     (1)

                     Commission Directive 2003/84/EC (2) included dimethenamid-P as an active substance in Annex I to Council Directive 91/414/EEC (3).

                     (2)

                     Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

                     (3)

                     The approval of the active substance dimethenamid-P, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2019.

                     (4)

                     An application for the renewal of the approval of the active substance dimethenamid-P was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

                     (5)

                     The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

                     (6)

                     The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 11 August 2016.

                     (7)

                     The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

                     (8)

                     On 12 April 2018, the Authority communicated to the Commission its conclusion (6) on whether dimethenamid-P can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report and the Regulation proposal regarding dimethenamid-P to the Standing Committee on Plants, Animals, Food and Feed on 24 January 2019.

                     (9)

                     As regards the criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (7), the conclusion of the Authority indicates that, based on the scientific evidence, it is highly unlikely that dimethenamid-P is an endocrine disrupter and that no additional studies are considered necessary to be carried out. Thus, the Commission concludes that dimethenamid-P is not to be considered as having endocrine disrupting properties.

                     (10)

                     The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the draft renewal report. The applicant submitted its comments, and the Commission has carefully examined them.

                     (11)

                     It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance dimethenamid-P that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to renew the approval of dimethenamid-P.

                     (12)

                     The risk assessment for the renewal of the approval of the active substance dimethenamid-P is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing dimethenamid-P may be authorised.

                     (13)

                     In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 of that Regulation and in the light of current scientific and technical knowledge, it is, however, necessary to provide for certain conditions. It is, in particular, appropriate to require further confirmatory information as regards the effects of water treatment processes on the nature of residues present in drinking water and to recommend Member States to pay attention to the protection of operators and workers, of groundwater, of aquatic organisms and small herbivorous mammals in the framework of any authorisations to be granted, as appropriate.

                     (14)

                     In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

                     (15)

                     Commission Implementing Regulation (EU) 2018/1262 (8) extended the approval period of dimethenamid-P to 31 October 2019 in order to allow the renewal process to be completed before the expiry of the approval of that active substance. Given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply from 1 September 2019.

                     (16)

                     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
            Renewal of the approval of active substance
            The approval of the active substance dimethenamid-P, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

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

            Article 3
            Entry into force 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 1 September 2019.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 3 July 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Directive 2003/84/EC of 25 September 2003 amending Council Directive 91/414/EEC to include flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam as active substances (OJ L 247, 30.9.2003, p. 20).

            (3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

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

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

            (6)  EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk assessment of the active substance dimethenamid-P, EFSA Journal 2018;16(4):5211.

            (7)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).

            (8)  Commission Implementing Regulation (EU) 2018/1262 of 20 September 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, clomazone, cypermethrin, daminozide, deltamethrin, dimethenamid-p, diuron, fludioxonil, flufenacet, flurtamone, fosthiazate, indoxacarb, MCPA, MCPB, prosulfocarb, thiophanate-methyl and tribenuron (OJ L 238, 21.9.2018, p. 62).

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                        Dimethenamid-P
                        CAS No 163515-14-8
                        CIPAC No 638

                        (S)-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy1-methylethyl)acetamide

                        ≥ 930 g/kg
                        The following impurity is of toxicological concern and must not exceed the following level in the technical material:
                        1,1,1,2-Tetrachloroethane (TCE): ≤ 1,0 g/kg

                        1 September 2019

                        31 August 2034

                        For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on dimethenamid-P, and in particular Appendices I and II thereto, shall be taken into account.
                        In this overall assessment Member States shall pay particular attention to:

                                    —

                                    the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment;

                                    —

                                    the protection of groundwater, in particular regarding the metabolites of dimethenamid-P;

                                    —

                                    the protection of aquatic organisms and small herbivorous mammals.

                              Conditions of use shall include risk mitigation measures, where appropriate.
                        The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water.
                        The applicant shall submit the requested information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

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

            ANNEX II
            The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                        (1)

                        in Part A, entry 67 on dimethenamid-P is deleted;

                        (2)

                        in Part B, the following entry is added:

                                    No

                                    Common Name, Identification Numbers

                                    IUPAC Name

                                    Purity (1)

                                    Date of approval

                                    Expiration of approval

                                    Specific provisions

                                    ‘137

                                    Dimethenamid-P
                                    CAS No 163515-14-8
                                    CIPAC No 638

                                    (S)-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy1-methylethyl)acetamide

                                    ≥ 930 g/kg
                                    The following impurity is of toxicological concern and must not exceed the following level in the technical material:
                                    1,1,1,2-Tetrachloroethane (TCE): ≤ 1,0 g/kg

                                    1 September 2019

                                    31 August 2034

                                    For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on dimethenamid-P, and in particular Appendices I and II thereto, shall be taken into account.
                                    In this overall assessment Member States shall pay particular attention to:

                                                —

                                                the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment;

                                                —

                                                the protection of groundwater, in particular regarding the metabolites of dimethenamid-P;

                                                —

                                                the protection of aquatic organisms and small herbivorous mammals.

                                          Conditions of use shall include risk mitigation measures, where appropriate.
                                    The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water.
                                    The applicant shall submit the requested information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

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


title: Commission Implementing Regulation (EU) 2019/1139 of 3 July 2019 amending Regulation (EC) No 2074/2005 as regards official controls on food of animal origin in relation to requirements concerning food chain information and fishery products and to the reference to recognised testing methods for marine biotoxins and to testing methods for raw milk and heat-treated cow's milk (Text with EEA relevance.)

text:
                  4.7.2019

                  EN

                  Official Journal of the European Union

                  L 180/12

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1139
         of 3 July 2019
         amending Regulation (EC) No 2074/2005 as regards official controls on food of animal origin in relation to requirements concerning food chain information and fishery products and to the reference to recognised testing methods for marine biotoxins and to testing methods for raw milk and heat-treated cow's milk
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (1), and in particular point (f) of the first subparagraph of Article 18(8) thereof,
         After consulting the Committee on Plants, Animals, Food and Feed,
         Whereas:

                     (1)

                     Regulation (EU) 2017/625 lays down rules for the official controls and other official activities performed by the competent authorities of the Member States to verify compliance with Union legislation, inter alia, in the area of food safety at all stages of production, processing and distribution. In particular, it provides for official controls in relation to products of animal origin intended for human consumption.

                     (2)

                     Commission Regulation (EC) No 2074/2005 (2) lays down implementing measures for certain products under, inter alia, Regulation (EC) No 853/2004 of the European Parliament and of the Council (3). These include live bivalve molluscs, raw milk and heat-treated cow's milk.

                     (3)

                     Commission Implementing Regulation (EU) 2019/627 (4) amends Regulation (EC) No 2074/2005 as regards official controls. That Regulation sets out, that as regards requirements concerning food chain information, Section II and the Appendix in Annex I to Regulation (EC) No 2074/2005 are deleted and that as regards requirements concerning fishery products, Section II in Annex II to Regulation (EC) No 2074/2005 is deleted.

                     (4)

                     Regulation (EC) No 853/2004 requires the slaughterhouse operator to request, receive, check and act upon food chain information for all animals, other than wild game, sent or intended to be sent to the slaughterhouse. In addition, he should make sure the food chain information provides all the details required under Regulation (EC) No 853/2004.

                     (5)

                     Regulation (EC) No 853/2004 sets out the requirements governing parasite checks during handling of fishery products on shore and on board vessels. It is up to food business operators to carry out their own checks at all stages in the production of fishery products in accordance with the rules in Chapter V(D) of Section VIII of Annex III to Regulation (EC) No 853/2004 so that fish which are obviously infested with parasites are not released for human consumption. The adoption of detailed rules relating to visual inspections calls for the concepts of visible parasites and visual inspection to be defined and the type and frequency of the observations to be determined.

                     (6)

                     Implementing Regulation (EU) 2019/627 lays down rules on uniform practical arrangements for the performance of official controls on food of animal origin. That Regulation sets out, in its Annex V, the recognised testing methods for the detection of marine biotoxins in live bivalve molluscs to be used by the competent authorities for the purpose of official controls. Furthermore, it sets out, in its Annex III, the testing methods for raw milk and heat-treated cow's milk to be used by the competent authorities for the purpose of official controls. Regulation (EC) No 853/2004 requires food business operators to carry out their own checks at all stages in the production to ensure that live bivalve molluscs, raw milk and heat-treated cow's milk comply with the hygiene rules for food of animal origin laid down in that Regulation. To ensure a high level of consumer protection with regard to food safety, Regulation (EC) No 2074/2005 should therefore include an obligation for food business operators to use the same recognised testing methods for marine biotoxins and testing methods for raw milk and heat-treated cow's milk as the competent authorities are to use in accordance with Implementing Regulation (EU) 2019/627.

                     (7)

                     Regulation (EC) No 2074/2005 should therefore be amended accordingly.

                     (8)

                     As Regulation (EU) 2017/625 applies with effect from 14 December 2019, this Regulation should apply from the same date.

                     (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
            Regulation (EC) No 2074/2005 is amended as follows:

                        (1)

                        Article 1 is replaced by the following:

                           ‘Article 1
                           Requirements concerning food chain information for the purpose of Regulation (EC) No 853/2004
                           Requirements concerning food chain information as referred to in Section III of Annex II to Regulation (EC) No 853/2004 are set out in Annex I to this Regulation.’

                        (2)

                        Article 2 is replaced by the following:

                           ‘Article 2
                           Requirements concerning fishery products for the purpose of Regulation (EC) No 853/2004
                           Requirements concerning fishery products as referred to in Article 11(9) of Regulation (EC) No 853/2004 are set out in Annex II to this Regulation.’

                        (3)

                        Article 3 is replaced by the following:

                           ‘Article 3
                           Recognised testing methods for marine biotoxins for the purpose of Regulation (EC) No 853/2004
                           The recognised testing methods for detecting marine biotoxins as referred to in Article 11(4) of Regulation (EC) No 853/2004 are as set out in Annex V to Implementing Regulation (EU) 2019/627.’

                        (4)

                        Article 6a is replaced by the following:

                           ‘Article 6a
                           Testing methods for raw milk and heat-treated cow's milk
                           The analytical methods set out in Annex III to Implementing Regulation (EU) 2019/627 shall be used by food business operators to check compliance with the limits set out in Part III of Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004 and to ensure appropriate application of a pasteurisation process to dairy products as referred to in Part II of Chapter II of Section IX of Annex III to that 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.
            It shall apply from 14 December 2019.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 3 July 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (OJ L 338, 22.12.2005, p. 27).

            (3)  Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55)

            (4)  Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council and amending Commission Regulation (EC) No 2074/2005 as regards official controls (OJ L 131, 17.5.2019, p. 51).