The reg. EU 2022/1644 integrates the reg. EU 2017/625 'with specific prescriptions on the execution of official controls, on the use of authorized and non-authorised pharmacologically active substances and on the relative residues.(1)
Official controls on veterinary drugs (EU reg. 2019/6. See note 2) are thus subject to uniform rules, in turn supplemented by the 'uniform practical arrangements for implementation' referred to in the following reg. EU 2022/1646.
The new rules, in force since 15 December 2022, define the criteria to be followed in the multiannual national control and surveillance plans. By putting an end to the 'transitional' measures introduced a quarter of a century ago (Directive 96/23/EC).
1) Official controls on veterinary drugs, reg. EU 2022/1644
Regulation (EU) 2022/1644 establishes the criteria of:
- sampling and analysis of pharmacologically active substances (banned, unauthorized and authorised) and their residues in food-producing animals (Annex I),
- selection of specific combinations of substance groups and product groups for the purpose of national risk-based production control plans (Annex II),
- sampling strategy for risk-based national production control plans in the Member States (Annex III),
- randomized national production surveillance plans, selection of specific combinations of product substance groups (Annex IV),
- sampling, strategy to be followed in the randomized national production surveillance plans in the Member States (Annex V),
- risk-based imports from third countries. Criteria for the selection of specific combinations of substance groups and product groups for the purpose of national control plans (Annex VI),
- risk analysis on imports from third countries and relative sampling strategy to be followed in the national control plans (Annex VII).
2) Multi-annual national control plan (MANCP) and risk analysis
The reg. EU 2017/625 (Official Controls Regulation, OCR), as already in force reg. EC 882/04, requires Member States to carry out official controls on the basis of the multiannual national control plan (multi-annual national control plan, MANCP) as well as risk analysis and its evaluation (3,4).
The regulations EU 2022/1644 and 2022/1646 (5) define the criteria to be followed in the elaboration of risk-based national plans and randomized national surveillance plans relating to official controls on the use of pharmacologically active substances (veterinary drugs, feed additives ) and their residues.
3) Groups of active substances
The national plans surveillance for the search for residues or pharmacologically active substances must consider two groups of substances:
- group A. Pharmacologically active substances prohibited or not authorized in food-producing animals (substances with hormonal and thyrostatic action and ß-agonist substances whose use is prohibited; substances not authorized for use in feed of food-producing animals),
- Group B. Pharmacologically active substances authorized for use in food-producing animals (antimicrobials; insecticides, fungicides, anthelmintics and other antiparasitic agents; tranquilizers; non-steroidal anti-inflammatory drugs, corticosteroids and glucocorticoids; other pharmacologically active substances, coccidiostats and histomonostats) .
3.1) Criteria for combining groups of specific substances. Group A
Identification of the combination criteria of substances and species, products and matrices included in the control plans is a key element of the risk assessment for the purpose of the national control plan.
Criteria identified for Group A of substances concern:
a) the combination of substances in animal foodstuffs,
b) the selection of specific substances for control (frequency of detection of cases of non-compliance, availability of suitable laboratory methods and analytical standards),
c) the selection of animals and products of animal origin (taking into account the results of controls on the use of specific pharmacologically active substances, the presence of injection sites, the veterinary history of the animals and health certificates.
3.2) Group B
Group B substances instead they must be subjected to checks on the basis of combination criteria that consider:
a) selection of specific substances for control purposes. Having also regard to the information on the distribution of the medicinal product, the national register of authorized active substances, the maximum residue limits of active substances and feed additives,
b) selection of groups of substances and animals and products of animal origin. Also having regard to:
– marketing authorizations for veterinary medicinal products and additives containing active substances for specific animal species,
– information on the frequency of use of substances belonging to specific substance categories and on antimicrobial resistance rates, or
– the frequency of detection of cases of non-compliance.
4) Sampling strategy
The sampling strategy for the control of combinations of substances and products, pursuant to reg. EU 2022/1646, must be included in the MANCP (multi-annual national control plan) on production, always based on risk analysis. The reg. EU 2022/1644 establishes the sampling criteria, which must be carried out:
- at variable intervals, equally distributed over the entire year or production period considered,
- at or around slaughter, capture or collection, as well as at all stages of the life cycle of the animals.
If specified In analytical results, samples taken from injection sites can be useful for monitoring illegal drug use. Apart from these hypotheses, it is necessary to avoid multiple samplings and respect the selection criteria and frequency of sampling.
4.1) Selection criteria and sampling frequency
The authorities of the veterinary services must comply with the selection criteria and the frequency of sampling on animals and products established for each food business operator, slaughterhouses and cutting plants, milk production establishments, establishments for the production and placing on the market of products of aquaculture, honey and egg production, egg packing centres.
4.2) Specificity of sampling for controls on groups of substances
The samplingsthe following are some specificities, in relation to the groups of substances subject to official controls:
- for group A, the sampling must detect illicit treatments with prohibited or unauthorized substances. With attention to animals where there is a greater probability of illicit treatments. On-farm sampling must consider drinking water and animal feed, as well as non-edible materials,
- for group B, only edible fabrics and/or products can be considered, to verify their compliance with the maximum residue limits. Also in this case, having regard to the tissues and/or products of animal origin which (based on the risk analysis) present a greater probability of non-compliance.
5) National randomized surveillance plans
The national plans randomized surveillance in turn must in turn follow differentiated criteria in relation to the two groups of substances:
- group A. The samples to be taken must consist of a combination of substance groups and product groups, in addition to what is foreseen in the national risk-based production control plans,
- group B. Checks of combinations of substance groups and product groups should be performed on the largest number of pharmacologically active substances.
The maximum limits of residues of pharmacologically active substances in foods of animal origin are indicated in reg. EU 37/2010. (6) Feed additives are in turn regulated by reg. CE 1831/2003. (7)
5.1) Randomized surveillance plans, sampling strategy
The surveillance it is also subject to a rendomised sampling strategy, to be included in the national plans. Sampling, in this case aleatory (random), must be performed at or close to slaughtering (or collection) and be representative of production/consumption. With the specificities that pertain to the two groups of substances:
(A) Sampling must take place during the production process of food-producing animals and unprocessed animal products. On live animals and the most suitable matrices,
B) sampling must be performed only on fresh or frozen meat, edible offal, eggs, milk and honey, which have not undergone further processing or mixing. Also on different substance categories, to ensure appropriate sample sizes.
7) Notification of national plans to Brussels
National control plans risk-based and randomized surveillance ones must be sent by 31 March each year to the European Commission, which evaluates them and expresses comments within the following four months.
Member States they can in any case maintain the control plans already prepared without needing to update them. provided that they justify their decisions with regard to the reservations expressed by Brussels.
Dario Dongo and Giulia Pietrollini
Footnotes to the story
(1) EU Reg. 2022/1644 which supplements the reg. EU 2017/625 with specific requirements for the execution of official controls on the use of pharmacologically active substances authorized as veterinary medicinal products or as feed additives, and their residues, and on the use of prohibited or unauthorized pharmacologically active substances and their residues https://eur-lex.europa.eu/legal-content/IT/TXT/?qid=1672994494881&uri=CELEX%3A32022R1644
(2) Dario Dongo, Giulia Torre. Antibiotic resistance, veterinary medicines and animal welfare. The ABC of the new rules. GIFT (Great Italian Food Trade). 22.1.20
(3) Dario Dongo, Giulia Torre. Official public controls, EU regulation 2017/625 is underway. GIFT (Great Italian Food Trade)... 18.12.19
(4) Dario Dongo, Giulia Pietrollini. Official controls, European Commission guidelines on reg. EU 2017/625. GIFT (Great Italian Food Trade). 2.1.23
(5) EU Reg. 2022/1646, on uniform practical arrangements for the performance of official controls as regards the use of pharmacologically active substances authorized as veterinary medicinal products or as feed additives, and their residues, and the use of prohibited or unauthorized pharmacologically active substances and their residues, the specific content of the multi-annual national control plans and the specific arrangements for drawing them up https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=CELEX%3A32022R1646&qid=1673006114153
(6) EU Reg. 37/2010, concerning pharmacologically active substances and their classification with regard to maximum residue limits in food of animal origin. Consolidated text as at 9.5.22 on Eur-Lex https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=CELEX%3A32010R0037&qid=1673009397365
(7) EC Reg. 1831/2003, on additives intended for animal feed. Consolidated text as at 27.3.21 on Eur-Lex https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=CELEX%3A32003R1831&qid=1673009982667
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
