ANNEX II
Criteria for the selection of specific combination of substance groups and commodity groups for national risk-based control plan for production in the Member States (as referred to in Article 2(2))
A. Group A substances
1.
Combinations of substance groups and commodity groups:
Commodity group
Substance group by reference to Annex I
Bovine, ovine and caprine
Porcine
Equine
Poultry
Aquaculture (finfish, crustaceans and other aquaculture products)
Raw bovine, ovine and caprine milk
Hen eggs and other eggs
Rabbits, farmed game and, reptiles and insects
Honey
Casings ( *1 )
A(1), point (a)
X
X
X ( *2 )
A(1), point (b)
X
X
X
X ( *3 )
A(1), point (c)
X
X
X
X ( *4 )
X ( *3 )
A(1), point (d)
X
X
X ( *3 )
A(1), point (e)
X
X
X
X
X ( *3 )
A(2)
X
X
X
X
X
X
X
X
X
X
A(3), point (a)
X
A(3), point (b)
X
X
X
X
X
X
X
X
X
A(3), point (c)
X
X
X
X
X
X
X
X ( *2 )
X
A(3), point (d)
X
X
X
X
X ( *2 )
A(3), point (e)
A(3), point (f)
X
X
X
X
X
X
X
X
X
A(3), point (g)
—
The residue or substance groups shall be analysed in samples drawn from food-producing animals including, where appropriate, their excrements, body fluids and unprocessed animal products, feed, water and animal by-products.
—
When there are indications or suspicions that illegal treatments may take place for residue or substance groups in species or products not covered by the table of this Annex, these controls shall be also included in the risk-based control plan for production in the Member States.
2.
Criteria for selecting specific substances for testing within each substance group:
—
frequency of the detection of non-compliance in the Member State or reported in the results from other Member States, or in third countries’ samples, especially when reported under the Rapid Alert System for Food and Feed (‘RASFF’) or the Administrative Assistance and Cooperation System (‘AAC’) or where there is evidence that substances not authorised for use in food-producing animals in the Union are used in third countries;
—
availability of suitable laboratory methods and analytical standards;
—
pharmacologically active substances likely to be misused in order to increase production or increase feed conversion efficiency;
—
prohibited or unauthorised substances for which there are indications of misuse;
—
possible risk for consumers or certain population groups arising from consumption of residues present in food, taking into account the relevant information available from, inter alia, the European Medicines Agency, European Food Safety Authority and the Codex Alimentarius Joint Expert Committee on Food Additives or in absence of such information, other sources of information such as scientific publications or national risk assessment.
3.
Criteria for the selection of animals and products of animal origin:
—
indication of the use of specific pharmacologically active substances, including mutilations at the ears or the tail or the presence of injection sites;
—
secondary sexual characteristics, behavioural changes, signs of disease or chronic disorders, different health status of specific animals within a group;
—
sex, age and pregnancy status of the animals;
—
veterinary history of the animal and health certificate;
—
animals showing a good physical conformation and well-developed muscles with little fat.
B. Group B substances
1.
Criteria for selecting specific substances for testing within each substance group:
—
frequency of the detection of non-compliance in the Member State’s samples, in other Member States’ samples or in third countries’ samples, especially when reported under the RASFF or AAC;
—
availability of suitable laboratory methods and analytical standard;
—
information on the quantities of veterinary medicinal products produced, imported, exported, marketed and sold for a specific food-producing animal species;
—
information on the veterinary medicinal product distribution chain, the national register of pharmacologically active substances authorised as veterinary medicinal products or feed additives, information on the most popular prescribing patterns;
—
the likelihood of misuse of the pharmacologically active substances;
—
maximum residue limits and maximum levels for pharmacologically active substances and feed additives including restrictions (e.g. not for use in lactating animals);
—
formulations of veterinary medicinal products for which long withdrawal periods, post-animal treatment, have been established to ensure that edible unprocessed animal products comply with EU MRLs;
—
possible treatment of food-producing animals under Articles 113 and 114 of Regulation (EU) 2019/6 of the European Parliament and of the Council ( 1 ) .
2.
Criteria for the selection of substance groups and animals and products of animal origin:
—
information on the marketing authorisations for veterinary medicinal products containing pharmacologically active substances for specific animal species and production classes;
—
information on the marketing authorisations for feed additives for specific animal species and production classes;
—
information on the frequency of the use of substances from specific substance categories in specific animal species;
—
frequency of the detection of non-compliance for residues of pharmacologically active substances and feed additives per production category;
—
information on the rates of antimicrobial resistance in certain animal production sectors.
( *1 ) As defined in Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin ( OJ L 174, 3.6.2020, p. 379 ).
( *2 ) Not relevant for insects
( *3 ) Relevant only for reptiles
( *4 ) Relevant only for finfish
( 1 ) Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC ( OJ L 4, 7.1.2019, p. 43 ).
