Regulation (EC) No. 470/2009 on maximum residue levels of pharmacologically active substances in food of animal origin

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Regulation (EC) No. 470/2009

Title: Regulation (EC) No. 470/2009 of the European Parliament and of the Council of 6 May 2009 on the creation of a Community procedure for the establishment of maximum levels for residues of pharmacologically active substances in food of animal origin, repealing Regulation (EEC) No. 2377 / 90 of the Council 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
Scope: EEA
Basis: EC Treaty , in particular Article 37 and Article 152 paragraph 4 letter b
Procedure overview: European Commission
European Parliament
IPEX Wiki
Date of issue: May 6, 2009
Release date: 16 June 2009
Come into effect: July 6, 2009
To be used from: July 6, 2009
Reference: OJ L 152 of 16.6.2009, pp. 11-22
Full text Consolidated version (not official)
basic version
Regulation has entered into force and is applicable.
Please note the information on the current version of legal acts of the European Union !

The Regulation 470/2009 (EC) regulates the limits of pharmacologically active substances in foodstuffs of animal origin , and is used for consumer protection . The regulation is of fundamental importance for the use of veterinary medicinal products in food production . It does not apply to vaccines .

history

The regulation on the creation of a Community procedure for the establishment of maximum levels for residues of pharmacologically active substances in food of animal origin, repealing Regulation (EEC) No. 2377/90 and amending Directive 2001/82 / EC and Regulation (EC) No. 726/2004 was decided by the Council of the European Union on May 6, 2009. It came into force on July 6, 2009 and replaces Regulation 2377/90 (EEC) on maximum levels for veterinary drug residues in food of June 26, 1990.

content

The core contents of regulation 470/2009 (EG) are:

  • Procedure regulation for the establishment of maximum quantities for pharmacologically active substances in food of animal origin
  • Prohibition of use for substances not classified or classified as prohibited according to the regulation with reference to animals that are used for food production
  • Food control based on maximum residue levels and reference values
  • Marketing ban of contaminated food of animal origin

The following pharmacologically active substances are relevant for setting maximum residue limits (Articles 3, 9 and 19):

  • Substances used in EU veterinary medicinal products
  • Substances that are contained in drugs used in the so-called “ therapeutic emergency ” and in veterinary drugs from third countries
  • Substances present in a substance used in animal husbandry biocide contained

No veterinary medicinal product may be approved for livestock without a specified maximum residue limit. The use of prohibited or untested substances in food-producing animals is not permitted (Article 16). Food monitoring has to assess prohibited or untested substances using reference values, the ordinance also regulates the procedures for setting such reference values ​​(Articles 18, 19). It lays down measures on how to proceed in the event of evidence of pharmacologically active substances in foods of animal origin (Article 24). The regulation prohibits the EU-wide marketing of food of animal origin for which maximum residue levels or reference values ​​are exceeded (Article 23).

The classification of pharmacologically active substances is carried out by the European Commission based on the recommendations drawn up by the Committee for Veterinary Medicinal Products ; they are listed in a separate regulation ( Regulation (EU) No. 37/2010 on pharmacologically active substances and their classification with regard to the maximum residue levels in food of animal origin ). The regulation does not apply to pharmacologically active substances such as auxiliary substances and certain substances of natural origin.

Regulated active ingredients

Regulation (EU) No. 37/2010 on pharmacologically active substances and their classification with regard to the maximum residue levels in food of animal origin , which came into force on January 20, 2010, contains four different from the old system of Regulation (EEC) No. 2377/90 Attachment a simplified list: There is now only one attachment, which is divided into two separate tables.

The first table includes the permitted substances (formerly Appendices I, II and III of the now obsolete Regulation (EEC) No. 2377/90), either with information on the maximum permitted amounts for residues of veterinary medicinal products in various edible tissues ( meat , offal , fat ) and products such as milk , honey and eggs , or without setting a residue limit if the substances in question do not pose a health risk based on current knowledge.

The second table contains all prohibited substances (formerly Annex IV of the now obsolete Regulation (EEC) No. 2377/90). Substances which are assumed to be harmful to human health, even in the smallest concentration, are prohibited. The use of these medicinal substances is therefore generally prohibited in food-producing animals in the European Union. These active ingredients include preparations made from pipe flowers , chloramphenicol , chloroform , chlorpromazine , colchicine , dapsone , dimetridazole , metronidazole , nitrofurans and ronidazole .

Individual evidence

  1. ↑ Maximum residue limit check
  2. ↑ Substances considered as not falling within the scope of Regulation (EC) No 470/20091, with regard to residues of veterinary medicinal products in foodstuffs of animal origin (PDF; 100 kB), document EMA / CVMP / 519714/2009 – Rev. 7 of the European Medicines Agency of October 14, 2011.

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