What is the issue?
Veterinary medicines contain substances which may have pharmacological effects (hereafter pharmacologically active substances). The use of these medicines in food-producing animals may leave residues of the substances in foodstuffs of animal origin. These residues may pose a risk to human health. Therefore, to safeguard consumers, the safety of residues of pharmacologically active substances from veterinary medicines remaining in foodstuffs of animal origin is scientifically assessed.
What maximum residue limits are
Maximum residue limits are the highest permissible amount of a substance that can be present in a specific animal tissue or product. Through the scientific assessment mentioned above they are determined as safe for consumption and are established for various tissues and products that are typically used for food. The values may differ between different tissues and animal species.
Rules about maximum residue limits
Regulation (EC) No 470/2009 establishes the rules and procedures for setting the maximum residue limits for pharmacologically active substances from veterinary medicines in foodstuffs of animal origin.
It provides the basis for several legislative implementation measures by the Commission:
Commission Regulation (EU) No 37/2010 (as amended) classifies pharmacologically active substances regarding maximum residue limits in foodstuffs of animal origin into allowed substances and prohibited substances.
Substances allowed for use in veterinary medicines for food-producing species are listed in Table 1 of the Annex. Their maximum residue limits are specified for each target species and relevant target tissue. Some substances in Table 1 do not have numerical maximum residue limit values, particularly when all residue levels from veterinary medicine use are assessed as safe for human consumption.
Table 2 of the Annex lists substances that are considered hazardous to consumer health if present in foodstuffs obtained from treated animals. Consequently, veterinary medicines containing these substances cannot be authorised for use in food-producing animals.
The regulation is updated whenever a maximum residue limit is established or changed.
- Commission Regulation (EU) 2017/12 sets out the form and content of the applications and requests for the establishment of maximum residue limits.
- Commission Regulation (EU) 2017/880 establishes the rules and criteria for extrapolating a maximum residue limit for pharmacologically active substances used in veterinary medicines. This allows for maximum residue limits to be set for a new foodstuff, by using existing data for another foodstuff from the same animal species or even from different species, thereby avoiding the need for new studies in certain circumstances.
- Commission Implementing Regulation (EU) 2018/470 provides rules on the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated in the EU under Article 11 of Directive 2001/82/EC (so called 'cascade maximum residue limits'), now Articles 112, 113 and 114 of Regulation (EU) 2019/6.
- Commission Regulation (EU) 2018/782 (as amended) lays down the methodology to be used in the scientific risk assessment and the establishment of risk management recommendations relevant to maximum residue limit applications.
List of substances considered as not falling within the scope of Regulation (EC) No 470/2009
Certain excipients contained in veterinary medicines for use in food-producing animals fall outside the scope of the maximum residue limit regulation because they have no pharmacological effect when they are used in veterinary medicines.
Such excipients, although not included in Table 1 of the Annex to Commission Regulation (EU) No 37/2010, can still be used in veterinary medicinal products intended for administration to food-producing animals, if they are included in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 managed by the European Medicines Agency.
Related links
- Commission Delegated Regulation (EU) 2019/2090 supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances.
- Regulation (EU) 2017/625 on 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.