Reg. EU 2022/1644 supplements reg. EU 2017/625 ‘with specific requirements on the performance of official controls, the use of authorized and unauthorized pharmacologically active substances and their residues.’ (1)
Official controls on veterinary drugs (reg. EU 2019/6. See footnote 2) are thus subject to uniform rules, which in turn are supplemented by the ‘uniform practical modalities of implementation‘ in the subsequent reg. EU 2022/1646.
The new rules, effective Dec. 15, 2022, define the criteria to be followed in multi-year national control and surveillance plans. Ending the ‘transitional’ measures introduced a quarter century ago (Directive 96/23/EC).
1) Official controls on veterinary drugs, reg. EU 2022/1644
Regulation (EU) 2022/1644 establishes the criteria for:
- Sampling and analysis on pharmacologically active substances (banned, unlicensed and licensed) 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 (All. II),
- sampling strategy for the purpose of national risk-based production control plans in member states (All. III),
- randomized national production surveillance plans, selection of specific combinations of product substance groups (All. IV),
- sampling, strategy to be followed in the of national randomized production surveillance plans in member states (All. V),
- Risk-based imports from third countries. Criteria for selecting specific combinations of substance groups and product groups for the purpose of national control plans (All. VI),
- risk analysis on imports from third countries and related sampling strategy to be followed in national control plans (All. VII).
2) Multi-annual national control plan (MANCP) and risk analysis.
Reg. EU 2017/625 (Official Controls Regulation, OCR), as did the former reg. EC 882/04, requires member states to carry out official controls based on themulti-annual national control plan (MANCP) as well as risk analysis and its evaluation (3,4).
EU Regulations 2022/1644 and 2022/1646 (5) define the criteria to be followed in the development of risk-based national plans and randomized national surveillance plans related to official controls on the use of pharmacologically active substances (veterinary drugs, feed additives) and their residues.
3) Groups of active substances
National surveillance plans for the detection of residues or pharmacologically active substances should 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; nonsteroidal anti-inflammatory drugs, corticosteroids and glucocorticoids; other pharmacologically active substances, coccidiostats and histomonostats).
3.1) Combination criteria of specific substance groups. Group A
The identification of criteria for combining substances and species, products and matrices included in control plans is a key element of risk assessment for the purpose of the control nation plan.
The criteria identified for Group A substances include:
(a) the combination of substances in animal food products,
(b) the selection of specific substances for control (frequency of detection of non-compliance, availability of appropriate laboratory methods and analytical standards),
(c) the selection of animals and animal products (taking into account the results of controls on the use of specific pharmacologically active substances, the presence of injection sites, the veterinary history of animals and health certificates.
3.2) Group B
Group B substances, on the other hand, must come under control based on combination criteria that consider:
(a) selection of specific substances for the purpose of control. Also having regard to information on the distribution of the drug, the national register of authorized active substances, maximum residue limits of active substances and feed additives,
(b) selection of substance groups and animals and animal products. Also having regard to:
– Marketing authorizations for veterinary drugs and additives containing active substances for specific animal species,
– Information on the frequency of use of substances belonging to specific substance categories and antimicrobial resistance rates, viz.
– The frequency of detection of noncompliance cases.
4) Sampling strategy
The sampling strategy for the control of combinations of substances and products, according to reg. EU 2022/1646, must be included in the MANCP(multi-annual national control plan) on production, again based on risk analysis. Reg. EU 2022/1644 establishes the sampling criteria, which must be performed:
- at varying intervals, equally distributed throughout the year or production period under consideration,
- at or near the time of slaughter, capture or collection, as well as at all stages of the animals’ life cycle.
If specified in the analytical results, samples taken from injection sites may be useful for monitoring illegal substance use. Outside these assumptions, multiple sampling must be avoided by complying with the criteria for selection and frequency of sampling.
4.1) Selection criteria and sampling frequency.
The authorities of veterinary services must comply with the selection criteria and frequency of sampling on animals and products established for each food business operator, slaughterhouses and cutting plants, milk production establishments, establishments producing and placing on the market of aquaculture products, honey and egg production establishments, and egg packing centers.
4.2) Specificity of sampling for substance group controls.
Samplingfollows some specifics, related to the groups of substances covered by official controls:
- For Group A, sampling should detect illicit treatments with banned or unauthorized substances. With attention to animals where there is greater likelihood of illicit treatment. On-farm sampling should consider drinking water and feed, as well as inedible materials,
- for Group B, only edible textiles and/or products can be considered for compliance with maximum residue limits. Again, having regard to the tissues and/or products of animal origin that (based on the risk analysis) are most likely to be noncompliant.
5) National randomized surveillance plans.
National randomized surveillance plans in turn must follow differentiated criteria in relation to the two groups of substances:
- Group A. The samples to be taken should consist of a combination of substance groups and product groups, in addition to what is provided in national risk-based production control plans,
- Group B. Controls of combinations of groups of substances and groups of products should be carried out on as many pharmacologically active substances as possible.
Maximum residue limits of pharmacologically active substances in food of animal origin are given in reg. EU 37/2010. (6) Feed additives are themselves regulated by reg. EC 1831/2003. (7)
5.1) Randomized surveillance plans, sampling strategy.
Surveillance is also subject to a rendomized sampling strategy, to be included in national plans. Sampling, in this case random (random), should be done at or near slaughter (or harvest) and be representative of production/consumption. With the specifics pertaining to the two groups of substances:
A) sampling must be carried out during the production process of food-producing animals and unprocessed animal products. On live animals and the most appropriate matrices,
(B) sampling should 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 sample size adequacy.
7) Notification of national plans to Brussels.
National risk-based and randomized surveillance plans must be submitted by March 31 each year to the European Commission, which evaluates and comments on them within the following four months.
Member states may in any case maintain the control plans already prepared without the need to update them. provided it gives reasons for its decisions with regard to the reservations expressed by Brussels.
Dario Dongo and Giulia Pietrollini
Notes
(1) Reg. EU 2022/1644 Supplementing reg. EU 2017/625 with specific requirements for performing 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 ABCs of the new rules. GIFT (Great Italian Food Trade). 22.1.20
(3) Dario Dongo, Giulia Torre. Official public controls, EU Regulation 2017/625 kicks off. 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) Reg. EU 2022/1646, on uniform practical arrangements for carrying out official controls on the use of pharmacologically active substances authorized as veterinary drugs or as feed additives, and their residues, and on the use of banned or unauthorized pharmacologically active substances and their residues, on the specific content of multi-year national control plans and on specific arrangements for their preparation https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=CELEX%3A32022R1646&qid=1673006114153
(6) Reg. EU 37/2010, concerning pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin. Consolidated text as of 9.5.22 on Eur-Lex https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=CELEX%3A32010R0037&qid=1673009397365
(7) Reg. EC 1831/2003, on additives for use in animal nutrition. Consolidated text as of 3/27/21 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.
