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EU: New Rules on Coccidiostat Carry-over Residue Levels in Food Effective Today.

1 July 2009 - Newly-established maximum residual levels for coccidiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feed are effective in the European Union as of today 1 July 2009.

Commission Regulation (EC) No. 124/2009, which was published in the Official Journal of the European Communities on 11 February 2009 and came into force on 2 March 2009, set maximum levels for coccidiostats or histomonostats carry-over residues in food products with a view to ensure a proper functioning of the internal market and to protect public health.

Coccidiostats are substances intended to help prevent coccidiosis -- i.e., infestations of the gastro-intestinal tract by certain single-celled micro-organisms (protozoa), mainly in poultry -- which are authorised under EC Regulation 1831/2003 on feed additives.

The absence of tolerances for the potential carry-over of residues of coccidiostats is viewed as a problem for feed manufacturers who may produce a range of feeds within one establishment, where a number of different feed products may be manufactured on the same production line.

The establishment of maximum permitted levels for these residues are therefore expected to provide harmonised rules without posing increased risks to animal and human health. At the same time, the new rules will help avoid Member States setting their own, different, national limits, which would vary depending on their differing analytical capabilities and rates of detection.

"Due to the fact that the unavoidable carry-over of coccidiostats or histomonostats into non-target feed may result in the presence of these substances as contaminants in derived food, it is appropriate to take a comprehensive and integrated approach to address the issue through the simultaneous adoption and application of this Regulation and the Directive 2009/8/EC setting maximum levels for the unavoidable carry-over of coccidiostats or histomonostats into non-target feed", stated the European Commission in the February regulation.

The new maximum levels were proposed further to a European Food Safety Authority (EFSA) assessment, which looked at the risks involved for animal health and public health as a result of this unavoidable residue carryover. For each coccidiostat or histomonostat authorised as feed additive, EFSA took into account hypothetical carry-over rates of 2%, 5% and 10% from feed produced with the highest authorised dose of the coccidiostats or histomonostats into the afterwards produced non-target feed.

Taking into account all prevention measures, EFSA concluded that their presence was unlikely to result in adverse animal health effects and that the risk to consumers' health from the ingestion of residues in products from animals exposed to cross-contaminated feed was negligible. However, due to the different approaches applied in the Member States to address the unavoidable cross-contamination, EFSA and the European Commission saw a need to set harmonised maximum levels.

11 substances are concerned: Lasalocid sodium, Narasin, Salinomycin sodium, Monensin sodium, Semduramicin, Maduramicin, Robenidine, Decoquinate, Halofuginone, Nicarbazin, and Diclazuril.

The main changes introduced are:

- Article 1(1) provides that the foodstuffs listed in Annexe to the new Regulation shall not be placed on the market where they contain a contaminant listed in this Annexe at a level exceeding the maximum levels set in the Annexe.

- In case of a finding of a significant residue below the maximum level set out in the Annexe, it is appropriate for the competent authority to carry out investigations to confirm that the residue is present as a consequence of unavoidable carry over in the feed and not as the consequence of illegal administration of the coccidiostat or histomonostat.

- Foodstuffs complying with the maximum levels set out in the Annexe shall not be mixed with foodstuffs which exceed these maximum levels.

- Article 1(2) -- when applying the maximum levels set out in the Annexe to this Regulation to foodstuffs which are dried, by diluted, processed or composed of more than one ingredient, changes of the concentration of the contaminant caused by drying, diluting or processing, as well as the relative proportion of the ingredients in the product shall be taken into account.

- Article 1(3) -- the maximum levels established in Annexe to the new Regulation are without prejudice to the provisions and the MRLs (maximum residual levels) established by Council Regulation (EEC) No. 2377/90 and the MRLS established by Regulation (EC) No. 1831/2003.

The European Commission also stated that the provisions provided in Annex should be reviewed by 1 July 2011 at the latest to take account of developments in scientific and technical knowledge.
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Publication:Feedinfo News Service
Date:Jul 1, 2009
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