Commercial Information Circulars

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Ref : EIC 230/2/12

15 July 2009

Dear Sirs,

Commercial Information Circular No. 361/2009

European Union (EU)* : Maximum Residue Limits of Pharmacologically Active Substances in Foodstuffs of Animal Origin

The European Parliament and the Council of the EU has adopted a Regulation laying down the procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin. Details are set out in Regulation (EC) No. 470/2009 of the European Parliament and of the Council (the Regulation). The Regulation can be accessed through the following link:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:152:0011:0022:EN:PDF.

DETAILS

2. In order to ensure food safety, the Regulation lays down the rules and procedures to establish:
   • -the maximum concentration of a residue of a pharmacologically active substances (expressed in mg/kg or μ g/kg on a fresh weight basis) permitted in food of animal origin (Maximum Residue Limit, MRL);
   • -the level of a residue of a pharmacologically active substance established for control reasons in the case of certain substances for which a MRL has not been laid down in the Regulation.
3. Under the Regulation, the European Commission (the Commission) shall classify the pharmacologically active substances, and include a list of the substances and the therapeutic classes to which they belong. This classification shall also establish, for each of the substance and specific foodstuffs or species, one of the followings:
   • -a MRL;
   • -a provisional MRL;
   • -the absence of the need to establish a MRL; or
   • -a prohibition on the administration of a substance.
4. The Commission may also establish reference points for action for residues from pharmacologically active substances not subject to a classification mentioned above.
5. Only pharmacologically active substances which are classified in accordance with para. 2 above may be administrated to food producing animals. Besides, food of animal origin which contains residues of pharmacologically active substances exceeding the MRLs established, or exceeding the reference points set for the unclassified substances shall not be imported or placed on the market of the EU.

ENQUIRIES

6. For enquiries concerning the content of this circular, please contact the undersigned at telephone number 2398 5556.

Yours faithfully,

(Miss Peggy LEUNG)

for Director-General of Trade and Industry

* The EU includes Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.