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Residues of veterinary medicinal products in foodstuffs of animal origin

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Residues of veterinary medicinal products in foodstuffs of animal origin

SUMMARY OF:

Regulation (EC) No 470/2009 — EU procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin

SUMMARY

WHAT DOES THE REGULATION DO?

The regulation lays down rules on maximum residue limits for pharmacologically active substances, such as antibiotics, used in veterinary medicine in respect of food of animal origin, including meat, fish, milk, eggs and honey — in order to ensure food safety.

In this regard, it establishes

the maximum residue limit*

the reference point for action* regarding cases where a maximum residue limit has not been calculated.

KEY POINTS

The applicant for a marketing authorisation for a veterinary medicinal product — in which any pharmacologically active substance is used — must submit an application to the European Medicines Agency. The Agency must give an opinion consisting of a scientific risk assessment and risk management recommendations.

The Agency will decide whether to apply established maximum residue limits for a particular food or species. The European Commission fixes rules on the conditions regarding this calculation of residue limits.

The risk assessment must weigh up whether the type and amount of residue considered presents a safety concern for human health.

Risk management recommendations must assess a variety of factors, including the availability of alternative substances for the treatment of the relevant species.

The Commission classifies the pharmacologically active substances that have already been subject to an opinion from the Agency. It can establish reference points for action for residues of pharmacologically active substances that are not classified.

In certain cases, the Commission or an EU country may submit a request for an opinion on maximum residue limits to the Agency. Such cases include circumstances where the substance in question is authorised for use in a non-EU country.

A number of substances are excluded from the scope of this Regulation, including substances covered by the EU’s Regulation on contaminants in food.

FROM WHEN DOES THIS REGULATION APPLY?

It entered into force on 6 July 2009.

BACKGROUND

Previous EU rules on this issue were too complex and led to a decrease in the availability of medicines for food-producing animals in the EU. This regulation was introduced to ensure both consumer safety and the availability of veterinary medicines to treat specific diseases.

KEY TERMS

* Maximum residue limit: the maximum concentration of a residue of a pharmacologically active substance which may be permitted in food of animal origin.

* Reference point for action: the level of a residue of a pharmacologically active substance established for control reasons in the case of certain substances for which a maximum residue limit has not been laid down. The reference points for action are established in consultation with official control laboratories.

ACT

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 (OJ L 152, 16.6.2009, pp. 11-22)

RELATED ACTS

Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, pp. 1-72)

Successive amendments and corrections to Regulation (EU) No 37/2010 have been incorporated into the original text. This consolidated version is for reference only.

last update 02.12.2015

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