Residues of veterinary medicinal products in foodstuffs of animal origin
This Regulation classifies pharmacologically active substances used in veterinary medicinal products with a view to ensuring food safety. It determines permissible content in foodstuffs of animal origin and lays down maximum limits for residues of veterinary medicinal products in these foodstuffs.
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (Text with EEA relevance).
This Regulation aims at defining the rules and procedures to be applied when setting maximum residue limits for medicinal products in foodstuffs of animal origin in order to guarantee food safety.
This Regulation establishes on the one hand the maximum concentration of a residue of a pharmacologically active substance which may be permitted in foodstuffs of animal origin and on the other defines the level of residues of medicinal products for which a maximum limit has not yet been set.
Active principles of biological origin used in immunological veterinary medicinal products and substances covered by the Regulation on contaminants in foodstuffs for human consumption are excluded from its scope.
Maximum residue limits
Substances intended for use in veterinary medicinal products
The European Medicines Agency issues an opinion on any application relating to a pharmacologically active substance intended for use in veterinary medicinal products. This opinion consists of a scientific risk assessment and risk management recommendations. The Agency ensures that the final opinion of the Committee is given within 210 days.
Other substances requiring an opinion from the Agency
The European Commission or Member States may submit to the Agency a request for an opinion on maximum residue limits in the following cases:
- the use of the substance in question is authorised in a third country but has not been subject to an application for the establishment of a maximum residue limit by the Agency;
- the substance in question is contained in a medicinal product but has not been subject to an application for the establishment of a maximum residue limit by the Agency.
The Agency shall ensure that the opinion of the Committee concerning a relevant request from the European Commission or Member States is given within 210 days.
Once the opinions have been published, the Commission, in consultation with the Agency, Member States and interested parties, shall adopt the following measures:
- methodological principles to be applied following the risk assessment and recommendations described above;
- rules concerning the use of a maximum residue limit for medicinal products.
The Commission classifies the pharmacologically active substances which have already been subject to an opinion from the Agency. This classification includes a list of pharmacologically active substances and the therapeutic classes to which they belong, as well as the following:
- a maximum residue limit;
- a provisional maximum residue limit (for a period not exceeding five years);
- the absence of the need to establish a maximum residue limit;
- a prohibition on the administration of a substance.
A maximum residue limit may be provided if scientific data is incomplete, as long as the substance does not constitute a hazard to human health. It is presupposed that the residues do not constitute a hazard to the health of individuals.
It is possible to obtain an emergency authorisation for a veterinary medicinal product or biocide product by making an application to the Agency to carry out an accelerated procedure for the assessment of the maximum residue limit. The Agency shall ensure that the final opinion of the Committee is given within 120 days.
Reference points for action
The Commission can establish reference points for action for residues of pharmacologically active substances which are not classified.
Reference points for action are established in consultation with official control laboratories in accordance with a method corresponding to Community requirements.
A request for a risk assessment may be sent to the European Food Safety Authority (EFSA) in order to determine whether the reference points for action are adequate.
The Agency consults Community reference laboratories using analytical methods which are appropriate for analysing residues. The aim of this consultation is also to achieve harmonised controls in order to provide information on the methods used during the authorisation procedure for official control laboratories.
When placed on the market, foodstuffs of animal origin which contain residues of medicinal products at a level exceeding the limit established by this Regulation or containing an unclassified substance are not considered as complying with the legislation.
This Regulation repeals Regulation (EC) No 2377/90. The Commission includes pharmacologically active substances and their classification from Regulation (EC) No 2377/90 in Annexes I to IV.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Regulation (EC) No 470/2009||
OJ L 152 of 16.6.2009