Commission Implementing Regulation (EU) 2022/932 of 9 June 2022 on uniform practical arrangements for the performance of official controls as regards contaminants in food, on specific additional content of multi-annual national control plans and specific additional arrangements for their preparation (Text with EEA relevance)

17.6.2022 EN Official Journal of the European Union L 162/13 COMMISSION IMPLEMENTING REGULATION (EU) 2022/932 of 9 June 2022 on uniform practical arrangements for the performance of official controls as regards contaminants in food, on specific additional content of multi-annual national control plans and specific additional arrangements for their preparation (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 2017on 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 Article 19(3)(a) and (b) thereof, Whereas: (1) Regulation (EU) 2017/625 lays down rules for the performance of official controls and other official activities by the competent authorities of the Member States for verifying compliance with Union legislation in the area of food and food safety. Article 109 of that Regulation provides for an obligation for Member States to ensure that official controls are performed by the competent authorities on the basis of a multi-annual national control plan (‘MANCP’). Regulation (EU) 2017/625 furthermore specifies the general content of the MANCP, requires Member States to provide in their MANCP official controls on contaminants in food and, in this regard, empowers the Commission to lay down specific additional content of the MANCP and specific additional arrangements for its preparation, as well as a uniform minimum frequency of official controls, having regard to the hazards and risks related to substances referred to in Article 19(1) of that Regulation. (2) Regulation (EU) 2017/625 repealed Council Directive 96/23/EC(2), which provided measures to monitor certain substances, including contaminants, in live animals and products of animal origin and specifically set requirements for Member States’ monitoring plans for the detection of residues or substances within its scope. However, Regulation (EU) 2017/625 does not incorporate all the measures contained in that Directive or in the acts adopted by the Commission on its basis. Therefore, in order to ensure a smooth transition, Regulation (EU) 2017/625 provided that competent authorities were to continue to perform the official controls in accordance with the Annexes to Directive 96/23/EC until 14 December 2022or until the date of application of the corresponding rules to be adopted by the Commission. This Regulation, together with Commission Delegated Regulation (EU) 2022/ 931(3), aims therefore at ensuring continuity of the rules of Directive 96/23/EC concerning the content of the MANCP and its preparation, as well as the minimum frequency of official controls, as regards contaminants in food, within the framework of Regulation (EU) 2017/625. (1) OJ L 95, 7.4.2017, p. 1. (2) Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p. 10). (3) Commission Delegated Regulation (EU) 2022/931 of 23 March 2022 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council by laying down rules for the performance of official controls as regards contaminants in food (see page 7 of this Official Journal).L 162/14 EN Official Journal of the European Union 17.6.2022 (3) In light of the specific provisions for official controls of food of animal origin entering the Union from third countries set out by Article 47 of Regulation (EU) 2017/625, it is appropriate to require Member States to include in their MANCPs two different plans for the control of contaminants in food, one for such food of animal origin entering the Union and another one for any other food placed on the Union market. (4) The plan for food of animal origin entering the Union should include the official controls on all such food intended to be placed on the Union market, but also official controls on fishery products which are to be carried out on vessels when these call at a port in a Member State, in accordance with Article 68 of Commission Implementing Regulation (EU) 2019/627(4), since those vessels are to be considered as similar to border control points, irrespective of flag. (5) The plan for food placed on the Union market should concern any other food, namely, each Member State’s domestic food production, food introduced from other Member States, and food of non-animal origin entering the Union. It should also concern composite products within the meaning of Commission Delegated Regulation (EU) 2019/625(5), even those entering the Union from third countries since some of those products do not have to be controlled at border control points in accordance with Regulation (EU) 2017/625. (6) In addition to the rules on the combinations of contaminants or contaminant groups and commodity groups of the samples to be taken by Member States and the sampling strategy including criteria that they are to use for defining the content of their plans and the performance of the related official controls laid down in Delegated Regulation (EU) 2022/931, minimum control frequencies should be laid down in this Regulation for each of the plans, in order to ensure that controls are carried out in all products at least to a certain extent throughout the Union. However, in order to ensure proportionality, those minimum annual control frequencies should be set, depending on the products, by reference to Member States’ production data and to Member States’ population size, but with a reasonable minimum amount, and to number of imported consignments. For the same reason, and, in particular, in order to avoid excessive burden and costs, it is appropriate to allow Member States to not perform official controls on certain contaminant/commodity combinations annually, provided that the MANCPs justifies this choice. As regards, in particular, imported consignments, food products imported from third countries listed in Annex II to Commission Implementing Regulation (EU) 2019/2129(6), with which the Union has concluded agreements of equivalence for physical checks, should not be counted against the number of imported consignments as Member States must carry out their controls at a frequency rate, as provided in those agreements. (7) In order to ensure a comprehensive content of the MANCPs on the presence of contaminants in food, the information that Member States are to include in their MANCPs regarding the choices they have made in their plans should be defined. (8) For ensuring a uniform implementation of this Regulation, it is appropriate to require Member States to submit their control plans for evaluation to the Commission on annual basis and to provide a procedure for that evaluation. (9) Data collected by the Member States through official controls on the presence of contaminants in food must also be transmitted to the European Food Safety Authority (‘EFSA’) in accordance with Article 33 of Regulation (EC) No 178/2002 of the European Parliament and of the Council(7). In order to allow for the monitoring of recent occurrence data, all Member States should submit data on a regular basis and by the same date. (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). (5) Commission Delegated Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption (OJ L 131, 17.5.2019, p. 18). (6) Commission Implementing Regulation (EU) 2019/2129 of 25 November 2019 establishing rules for the uniform application of frequency rates for identity checks and physical checks on certain consignments of animals and goods entering the Union (OJ L 321, 12.12.2019, p. 122). (7) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).17.6.2022 EN Official Journal of the European Union L 162/15 (10) Article 150(1) of the Regulation (EU) 2017/625 lays down a transitional period obliging Member States to perform official controls in accordance with Directive 96/23/EC until 14 December 2022. Article 19(1) of Regulation (EU) 2017/625 provides that official controls to verify compliance with the rules on food and food safety as well as feed and feed safety shall include official controls on relevant substances including substances to be used in food contact materials, contaminants, non-authorised, prohibited and undesirable substances whose use or presence on crops or animals or to produce or process food or feed may result in residues of those substances in food or feed. However, since the last monitoring plans adopted by Member States under Directive 96/23/EC will apply to the year 2022, and thus beyond 14 December 2022, it is appropriate that this Regulation applies from 1 January 2023. (11) 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: CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject matter and scope This Regulation lays down uniform practical arrangements for the performance of official controls on the presence of contaminants in food, regarding: (a) the annual uniform minimum frequency of these official controls; and (b) specific arrangements and specific content for the Member States’ MANCPs, in addition to those laid down in Article 110 of Regulation (EU) 2017/625. Article 2 Definitions For the purposes of this Regulation, the definitions laid down in Council Regulation (EEC) No 315/93(8), Regulation (EC) No 178/2002, Regulation (EC) No 852/2004 of the European Parliament and of the Council(9), Regulation (EC) No 853/2004 of the European Parliament and of the Council(10), Regulation (EC) No 396/2005 of the European Parliament and of the Council(11), Commission Recommendation 2013/165/EU(12), Commission Regulation (EU) 2017/644(13)and Commission Regulation (EU) 2017/2158(14)shall apply. (8) Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, p. 1). (9) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1). (10) 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). (11) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1). (12) Commission Recommendation 2013/165/EU of 27 March 2013 on the presence of T-2 and HT-2 toxin in cereals and cereal products (OJ L 91, 3.4.2013, p. 12). (13) Commission Regulation (EU) 2017/644 of 5 April 2017 laying down methods of sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and non-dioxin-like PCBs in certain foodstuffs and repealing Regulation (EU) No 589/2014 (OJ L 92, 6.4.2017, p. 9). (14) Commission Regulation (EU) 2017/2158 of 20 November 2017 establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food (OJ L 304, 21.11.2017, p. 24).L 162/16 EN Official Journal of the European Union 17.6.2022 CHAPTER II CONTENT OF THE MANCP Article 3 General provisions Member States shall ensure that the part of the MANCP concerning the performance of official controls on the presence of contaminants in food includes the following: (a) a ‘control plan for food placed on the Union market’ as provided for in Article 4; and (b) a ‘control plan for food of animal origin entering the Union’ as provided for in Article 5. Article 4 Control plan for food placed on the Union market 1. Member States shall prepare a control plan concerning the presence of the contaminants or contaminant groups on food placed on the Union market, other than food of animal origin entering the Union. This plan shall cover official controls on each Member State’s domestic food production, food introduced from other Member States, food of non- animal origin entering the Union, and composite products, even those entering the Union from third countries. 2. The control plan for food placed on the Union market shall set out: (a) the list of combinations of contaminants or contaminant groups and commodity groups to be controlled as decided by the Member State in accordance with Annex I to Delegated Regulation (EU) 2022/931; (b) the sampling strategy as decided by the Member State in accordance with Annex II to Delegated Regulation (EU) 2022/ 931; and (c) the actual control frequencies as decided by the Member State taking into account the annual minimum control frequencies laid down in Annex I. 3. Member States may include in the control plans information on the controls as regards the combinations of contaminants or contaminant groups and commodity groups for which national maximum levels or other regulatory levels are established by national legislation. Article 5 Control plan for food of animal origin entering the Union 1. Member States shall prepare a control plan concerning the presence of the contaminants or contaminant groups in food of animal origin entering the Union and intended for placing on the Union market. This plan shall cover the official controls on food of animal origin entering the Union and intended to be placed on the Union market and on fishery products which are to be carried out on vessels when these call at a port in a Member State. 2. The control plan for food of animal origin entering the Union shall set out: (a) the list of combinations of contaminants or contaminant groups and commodity groups to be controlled as decided by the Member State in accordance with Annex I to Delegated Regulation (EU) 2022/931; (b) the sampling strategy as decided by the Member State in accordance with Annex II to Delegated Regulation (EU) 2022/ 931; and (c) the actual control frequencies as decided by the Member State taking into account the annual minimum frequencies laid down in Annex II.17.6.2022 EN Official Journal of the European Union L 162/17 3. Member States may include in the control plans information on the controls as regards the combinations of contaminants or contaminant groups and commodity groups for which national maximum levels or other regulatory levels are established by national legislation. Article 6 Common requirements for the control plans The control plans referred to in Article 3 shall, in addition, specify: (a) a justification for selected combinations of contaminants or contaminant groups and commodity groups, including an explanation on how the criteria listed in Annex I to Delegated Regulation (EU) 2022/931 were taken into account, even if no changes were made compared to the plan of the previous year; (b) in case a plan provides that official controls of certain combinations of contaminants or contaminant groups and commodity groups are not performed annually but within a certain time period, a justification of that decision; and (c) information about the competent authority/authorities responsible for the implementation of the plans. CHAPTER III SUBMISSION AND EVALUATION OF THE CONTROL PLANS AND SUBMISSION OF DATA BY THE MEMBER STATES Article 7 Submission and evaluation of the control plans By 31 March of each year, the Member States shall submit the control plans referred to in Article 3 for the current year electronically to the Commission. The Commission shall evaluate the control plans on the basis of this Regulation and Delegated Regulation (EU) 2022/931 and shall communicate its evaluation to each Member State, where needed. The Member States shall consider the Commission’s comments when implementing their control plans and when preparing the next submission of their plans pursuant to this Article. However, where the Commission identifies a major non-compliance of a plan, it may request the concerned Member State to submit an updated plan at an earlier date than 31 March of the following year. Where a Member State decides not to update its control plans based on the Commission’s comments, it shall justify its position. Article 8 Submission of data by the Member States By 30 June, the Member States shall transmit to the European Food Safety Authority (‘EFSA’) all data gathered under the control plans referred to in Article 3.L 162/18 EN Official Journal of the European Union 17.6.2022 CHAPTER IV GENERAL PROVISIONS Article 9 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2023. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 9 June 2022. For the Commission The President Ursula VON DER LEYEN17.6.2022 EN Official Journal of the European Union L 162/19 ANNEX I Minimum control frequency per Member State in the control plan for food placed on the Union market 1. Food of animal origin (a) Member States shall comply with the following minimum control frequencies in the control plan for food placed on the Union market: Control frequency Unprocessed bovine meat (including Minimum 0,02 % of the total number of slaughtered animals edible offal) Unprocessed ovine and caprine meat Minimum 0,004 % of the total number of slaughtered animals (including edible offal) Unprocessed porcine meat (including Minimum 0,003 % of the total number of slaughtered animals edible offal) Unprocessed equine meat (including The number of samples is to be determined by each Member State edible offal) according to the level of production and the problems identified Unprocessed poultry meat (including For each category of poultry considered (broiler chickens, spent hens, edible offal) turkeys and other poultry) minimum 1 sample per 3 000 tonnes of annual production (deadweight) Unprocessed meat from other farmed The number of samples is to be determined by each Member State terrestrial animals(*)(including edible according to the level of production and the problems identified offal) Raw bovine milk Minimum 1 sample per 110 000tonnes of annual production of milk Raw ovine and caprine milk The number of samples is to be determined by each Member State according to the level of production and the problems identified Fresh hen eggs and other eggs Minimum 1 sample per 3 700tonnes of annual production of eggs Honey Minimum 1 sample per 1 300tonnes of annual production Unprocessed fishery products(**) Minimum 1 sample per 700 tonnes of annual production of aquaculture (excluding crustaceans) for the first 60 000 tonnes of production and then 1 sample for each additional 2 000tonnes For wild caught fishery products, the number of samples is to be determined by each Member State according to the level of production and the problems identified Crustaceans and bivalve molluscs The number of samples is to be determined by each Member State according to the level of production and the problems identified Animal and marine fats and oils The number of samples is to be determined by each Member State according to the level of production and the problems identified Processed products of animal origin(***) The number of samples is to be determined by each Member State according to the level of production and the problems identified (*) Other farmed terrestrial animals as defined in entry 1017000 of Annex I, part A, to Regulation (EC) No 396/2005. (**) Fishery products as defined in Regulation (EC) No 853/2004. (***) Processed products as defined in Regulation (EC) No 852/2004.L 162/20 EN Official Journal of the European Union 17.6.2022 (b) Member States shall annually perform controls on ‘metals’ in minimum 10 % of the samples taken for each commodity group in accordance to the table of this Annex with the exception of the commodity groups ‘crustaceans and bivalve molluscs’, ‘animal and marine fats and oils’ and ‘processed products of animal origin’. (c) Member States shall annually perform controls on ‘mycotoxins’ in minimum 10 % of the samples taken for the commodity group ‘raw bovine milk’ and ‘raw ovine and caprine milk’ in accordance to the table of this Annex. (d) Within the commodity group ‘unprocessed bovine, ovine and caprine meat (including edible offal)’, Member States shall take samples from all species, taking into account their relative production volume. (e) Within the commodity group ‘unprocessed poultry meat (including edible offal)’, Member States shall take samples from all species, taking into account their relative production volume. (f) For the determination of the number of samples for fishery products and bivalve molluscs, Member States shall also take into account the geographical aspects, landing/production volumes and specific contamination patterns in the areas from which they are harvested. (g) For calculating the minimum control frequencies, Member States shall use the most recent production data available, at least from previous or at maximum from penultimate year, adjusted, if relevant, to reflect known evolutions in production since the data were made available. (h) In case the control frequency calculated in accordance with this Annex would represent less than five samples per year, sampling may be carried out once per two years. (i) In case that, within a three years period, the production corresponding to a minimum of one sample is not reached, Member States shall analyse a minimum of two samples once per three years provided that production takes place for that product in their territory. (j) Samples taken for the purposes of other control plans relevant for analysis on contaminants (e.g. on pharmacologically active substances and residues thereof, on pesticide residues), may also be used for controls on contaminants provided that the requirements concerning the controls on contaminants are complied with. 2. Food of non-animal origin(1) Member States shall at least take 100 to 2 000samples per year depending on their population size. However, where it is necessary on account of the risk, more samples shall be taken to ensure controls remain effective. Sampling shall be representative for the different contaminants, which may be present in different products on the Member State’s market, taking into account also different contaminant patterns in products originating from different regions and the different numbers and sizes of food business operators. (1) For the purpose of this Regulation, the criteria relevant for food of non-animal origin shall be applied for composite products.17.6.2022 EN Official Journal of the European Union L 162/21 ANNEX II Minimum control frequency per Member State in the control plan for food of animal origin entering the Union The Member States shall comply with the minimum control frequency as set out in the table below. Controls carried out under Articles 47(1)(d) (reinforced checks) and 47(1)(e) (safeguard measures) of Regulation (EU) 2017/625, shall not be counted towards achieving the minimum control frequencies of this Annex. Controls carried out under the established emergency measures and the intensified official controls, on the basis of Article 53 of Regulation (EC) No 178/2002 and of Article 65(4) of Regulation (EU) 2017/625, shall not be counted towards achieving the minimum control frequencies of this Annex. Controls of food products from certain third countries listed in Annex II to Regulation (EU) 2019/2129, with which the Union has concluded agreements of equivalence for physical checks, shall not be counted towards achieving the minimum control frequencies of this Annex. For the controls of fishery products carried out in accordance with Article 68 of Regulation (EU) 2019/627, the Member States shall take into account the geographical aspects, landing/production volumes and specific contamination patterns in the areas from which they are harvested. Control frequency Bovine (includes meat, minced meat, mechanically separated meat, edible offal, Minimum 1 % of the imported meat preparations and meat products) consignments Ovine/caprine (includes meat, minced meat, mechanically separated meat, edible Minimum 1 % of the imported offal, meat preparations and meat products) consignments Porcine (includes meat, minced meat, mechanically separated meat, edible offal, Minimum 1 % of the imported meat preparations and meat products) consignments Equine (includes meat, minced meat, mechanically separated meat, edible offal, Minimum 1 % of the imported meat preparations and meat products) consignments Poultry (includes meat, minced meat, edible offal, meat preparations and meat Minimum 1 % of the imported products) consignments Meat from other farmed terrestrial animals(*)(includes meat, minced meat, edible Minimum 1 % of the imported offal, meat preparations and meat products) consignments Milk (includes raw milk, dairy products, colostrum and colostrum-based products Minimum 1 % of the imported of all species) consignments Eggs (includes eggs and egg products from all bird species) Minimum 1 % of the imported consignments Honey (includes honey and other apiculture products) Minimum 1 % of the imported consignments Unprocessed fishery products(**)excluding crustaceans Minimum 1 % of the imported consignments Crustaceans and bivalve molluscs (includes muscle meat and muscle meat products) Minimum 1 % of the imported consignments Unprocessed animal and marine fats and oils(***) Minimum 1 % of the imported consignments (*) Other farmed terrestrial animals as defined in entry 1017000 of Annex I, part A, to Regulation (EC) No 396/2005. (**) Fishery products as defined in Regulation (EC) No 853/2004. (***) Processed products as defined in Regulation (EC) No 852/2004.L 162/22 EN Official Journal of the European Union 17.6.2022 Additional provisions: 1. The control frequency for other processed products of food of animal origin, such as gelatine and collagen, shall be determined by each Member State taking into account the number of imported consignments and the problems identified. 2. For the calculation of the minimum control frequencies listed in this Annex, Member States shall use the most recent data of the number of consignments entering the Union through their border control posts, at least from previous or at maximum from penultimate year. 3. In case the number of consignments of food entering the Union and intended for placing on the Union market is lower than the number of consignments corresponding to one sample, Member States may perform the sampling once per two or three years. In case the number of consignments imported over a three years period is lower than the number of consignments corresponding to one sample, Member States shall take at least one sample once per three years. 4. Samples taken for the purposes of other control plans relevant for analysis on contaminants (e.g. on pharmacologically active substances and residues thereof, on pesticide residues, etc.) may also be used for controls on contaminants provided that the requirements concerning the controls on contaminants are complied with.