EN Official Journal of the European Union L 115/2

COMMISSION IMPLEMENTING REGULATION (EU) 2016/662

of 1 April 2016

concerning a coordinated multiannual control programme of the Union for 2017, 2018 and 2019 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) 2015/595 (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 3 years, pesticides should be monitored in those foodstuffs over a series of 3-year cycles to allow consumer exposure and the application of Union legislation to be assessed.

(3) The European Food Safety Authority, hereinafter ‘the Authority’, submitted a scientific report on a design assessment of the pesticide monitoring program. 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 minimum 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, breakdown or reaction products, those compounds should be reported separately as far as they are measured individually.

(7) Implementing measures, such as the Standard Sample Description (SSD) (6) (7) 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 European Food Safety Authority.

(8) For the sampling procedures, Commission Directive 2002/63/EC (8), 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 (9) and Article 7 of Commission Directive 2006/125/EC (10) 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) 2015/595 should be repealed in the interest of legal certainty. It should, however, continue to apply to samples tested in 2016.

(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 2017, 2018 and 2019, 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, 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 2017, 2018 and 2019 by 31 August 2018, 2019 and 2020 respectively. Those results shall be submitted in accordance with the Standard Sample Description (SSD).

Where the residue definition of a pesticide includes more than one compound (active substance, metabolite and/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) 2015/595 is repealed.

However, it shall continue to apply to samples tested in 2016.

Article 5

This Regulation shall enter into force on 1 January 2017.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 1 April 2016. 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) 2015/595 of 15 April 2015 concerning a coordinated multiannual control programme of the Union for 2016, 2017 and 2018 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 99, 16.4.2015, p. 7).

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

(5) Document No. SANTE/11945/2015 http://ec.europa.eu/food/plant/docs/plant_pesticides_mrl_guidelines_wrkdoc_11945_en.pdf in its most recent version.

(6) Standard sample description for food and feed (EFSA Journal 2010; 8(1): 1457).

(7) Use of the EFSA Standard Sample Description for the reporting of data on the control of pesticide residues in food and feed according to Regulation (EC) No 396/2005 (EFSA Journal 2014; 12(1):3545).

(8) 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).

(9) 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).

(10) 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 2017, 2018 and 2019 2017 2018 2019 (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, a default factor of 1 may be applied. 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) Husked rice grain (5) Virgin olive oil (If no specific oil processing factor is available, a default factor of 5 may be applied for fat soluble substances, taking into account an olive oil production standard yield of 20 % of the olive harvest; for non-fat soluble substances a default oil processing factor of 1 may be used. 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 (7) to be sampled in 2017, 2018 and 2019 2017 2018 2019 (f) (d) (e) Poultry fat (8) Bovine fat (8) Cow's milk (9) Sheep fat (8) Chicken eggs (8) (10) Swine fat (8) Part C: Pesticide/product combinations to be monitored in/on products of plant origin 2017 2018 2019 Remarks 2,4-D (a) (b) (c) It shall only be analysed in and on oranges, cauliflowers, rice grain and dried beans in 2017; in and on grapefruits, table grapes, aubergines and broccoli in 2018; in and on lettuces, spinaches and tomatoes in 2019. 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) 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 rice grain in 2017; in and on sweet peppers in 2018; in and on lettuces and tomatoes in 2019. 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 grain and rice grain in 2017; in and on aubergines, table grapes, cultivated fungi and wheat grain in 2018; in and on tomatoes and oat grain in 2019. 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 for all listed commodities except cereals. Clothianidin (a) (b) (c) Also see thiamethoxam. 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 2017; in and on aubergines, sweet peppers, melons and cultivated fungi in 2018; in and on lettuces and tomatoes and in 2019. Deltamethrin (a) (b) (c) Diazinon (a) (b) (c) Dichlorvos (a) (b) (c) Dicloran (a) (b) (c) Dicofol (a) (b) (c) It shall be analysed for 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 rice grain in 2017; in and on table grapes in 2018; in and on apples and peaches in 2019. 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) Endosulfan (a) (b) (c) EPN (a) (b) (c) Epoxiconazole (a) (b) (c) Ethephon (a) (b) (c) It shall only be analysed in and on oranges and pears in 2017; in and on sweet peppers, wheat grain and table grapes in 2018; in and on apples, peaches, tomatoes and wine in 2019. Ethion (a) (b) (c) Ethirimol (a) (b) (c) It shall be analysed in and on all listed commodities except cereals. Etofenprox (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 2017; in and on aubergines, grapefruits, sweet peppers and table grapes in 2018; in and on apples, strawberries, peaches, tomatoes and wine in 2019. Fenhexamid (a) (b) (c) Fenitrothion (a) (b) (c) Fenoxycarb (a) (b) (c) Fenpropathrin (a) (b) (c) Fenpropidin (a) (b) (c) Fenpropimorph (a) (b) (c) Fenpyroximate (a) (b) (c) Fenthion (a) (b) (c) Fenvalerate (a) (b) (c) Fipronil (a) (b) (c) Flonicamid (a) (b) (c) It shall only be analysed in and on potatoes, pears, rice grain and rye grain in 2017; in and on aubergines, table grapes, grapefruits, melons, sweet peppers and wheat grain in 2018; in and on apples, peaches, spinaches, lettuces, tomatoes, oat grain and barley grain in 2019. Fludioxonil (a) (b) (c) Flufenoxuron (a) (b) (c) Fluazifop-P-butyl (a) (b) (c) It shall only be analysed in and on cauliflowers, dried beans, potatoes and carrots in 2017; in and on aubergines, broccoli, sweet peppers and wheat grain in 2018; in and on strawberries, head cabbages, lettuces, spinaches and tomatoes in 2019. Flubendiamide (a) (b) (c) Fluopyram (a) (b) (c) Fluquinconazole (a) (b) (c) Flusilazole (a) (b) (c) Flutriafol (a) (b) (c) Folpet (a) (b) (c) Formetanate (a) (b) (c) Fosthiazate (a) (b) (c) Glyphosate (a) (b) (c) It shall only be analysed in and on pears, oranges and rye grain in 2017; in and on table grapes and wheat grain in 2018; in and on apples, peaches, wine, barley grain and oat grain in 2019. Haloxyfop including haloxyfop-P (b) (c) It shall only be analysed in and on broccoli, grapefruits, sweet pepper and wheat grain in 2018; in and on strawberries and head cabbages in 2019. The substance is not to be analysed in or on any product in 2017. Hexaconazole (a) (b) (c) Hexythiazox (a) (b) (c) It shall be analysed for 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 rice grain in 2017. The substance is not to be analysed in or on any product in 2018 and 2019. 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 grain and rice grain in 2017; in and on cultivated fungi, and wheat grain in 2018; in and on barley grain and oat grain in 2019. Metalaxyl and metalaxyl-M (a) (b) (c) Methamidophos (a) (b) (c) Methidathion (a) (b) (c) Methiocarb (a) (b) (c) Methomyl and thiodicarb (a) (b) (c) Methoxyfenozide (a) (b) (c) Monocrotophos (a) (b) (c) Myclobutanil (a) (b) (c) Oxadixyl (a) (b) (c) Oxamyl (a) (b) (c) Oxydemeton-methyl (a) (b) (c) Paclobutrazole (a) (b) (c) Parathion (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 2017; in and on table grapes, melons, aubergines, broccoli, sweet peppers and wheat grain in 2018; in and on strawberries, head cabbages, spinaches, lettuces, tomatoes and barley grain in 2019. Propargite (a) (b) (c) Propiconazole (a) (b) (c) Propyzamide (a) (b) (c) Pymetrozine (b) (c) It shall only be analysed in and on aubergines, melons and sweet peppers in 2018; in and on head cabbages, lettuces, strawberries, spinaches and tomatoes in 2019. The substance is not to be analysed in or on any product in 2017. 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) 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) Tolylfluanid (a) (b) (c) It shall be analysed in and on all listed commodities except cereals. Triadimefon and triadimenol (a) (b) (c) Triazophos (a) (b) (c) 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 2017 2018 2019 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) 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 milk in 2019. 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 Reg. (EU) No 752/2014 unless stated otherwise. (2) Unprocessed products (including frozen products) shall be analysed. (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. If no specific processing factors are available, a default factor of 1 may be applied. (4) If no sufficient samples of oat grain are available, the part of the required sample number for oat grain that could not be taken, can be added to the sample number for barley grain, resulting in a reduced sample number for oat grain and a proportionately increased sample number for barley grain. (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. If no specific processing factors are available, a default factor of 0,5 may be applied. (6) If no sufficient samples of barley grain are available, the part of the required sample number for barley grain that could not be taken, can be added to the sample number for oat grain, resulting in a reduced sample number for barley grain and a proportionately increased sample number for oat grain. (7) 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 Reg. (EU) No 752/2014 unless stated otherwise. (8) Unprocessed products (including frozen products) shall be analysed. (9) Fresh (unprocessed) milk shall be analysed, including frozen, pasteurised, heated, sterilised or filtrated milk. (10) Whole eggs without the shell shall be analysed.