Commission Decision
of 15 March 2002
laying down detailed rules for the implementation of Council Directive 91/492/EEC as regards the maximum levels and the methods of analysis of certain marine biotoxins in bivalve molluscs, echinoderms, tunicates and marine gastropods
(notified under document number C(2002) 1001)
(Text with EEA relevance)
(2002/225/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs(1), as last amended by Directive 97/79/EC(2), and in particular Chapter V, paragraphs 3 and 5, of the Annex thereto,
Whereas:
(1) Chapter V, point 7, of the Annex to Directive 91/492/EEC provides that the customary biological testing methods must not give a positive result to the presence of diarrhetic shellfish poisoning (DSP) in the edible parts of molluscs (the whole body or any part edible separately).
(2) It has been scientifically proven that certain marine biotoxins such as those of the diarrhetic shellfish poisoning (DSP) complex (okadaic acid (OA) and dinophysistoxins (DTXs)) and also yessotoxins (YTXs), pectenotoxins (PTXs) and azaspiracids (AZAs), pose a serious hazard to human health when present above certain limits in bivalve molluscs, echinoderms, tunicates or marine gastropods.
(3) In the light of recent scientific studies it is now possible to establish maximum levels and methods of analysis for those biotoxins.
(4) Maximum levels and methods of analysis should be harmonised and be implemented by the Member States in order to protect human health.
(5) In addition to biological testing methods, alternative detection methods such as chemical methods and in vitro assays should be accepted if it is demonstrated that the performance of the chosen methods is not less effective than the performance of the biological method and that their implementation provides an equivalent level of public health protection.
(6) The proposed maximum levels are based on provisional data and should be re-evaluated when new scientific evidence becomes available.
(7) The measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,
HAS ADOPTED THIS DECISION:
Article 1
This Decision lays down the maximum levels for the marine biotoxins of the diarrhetic shellfish poisoning (DSP) complex (okadaic acid and dinophysistoxins), yessotoxins, pectenotoxins and azaspiracids and the methods of analysis to be used for their detection. It applies to bivalve molluscs, echinoderms, tunicates and marine gastropods that are intended for immediate human consumption or for further processing before consumption.
Article 2
The maximum level of okadaic acid, dinophysistoxins and pectenotoxins together in the animals referred to in Article 1 (the whole body or any part edible separately) shall be 160 μg of okadaic acid equivalents/kg. The methods of analysis are set out in the Annex.
Article 3
The maximum level of yessotoxins in the animals referred to in Article 1 (the whole body or any part edible separately) shall be 1 mg of yessotoxin equivalent/kg. The methods of analysis are set out in the Annex.
Article 4
The maximum level of Azaspiracids in the animals referred to in Article 1 (the whole body or any part edible separately) shall be 160 μg of azaspiracid equivalents/kg. The methods of analysis are set out in the Annex.
Article 5
When the results of the analyses performed demonstrate discrepancies between the different methods, the mouse bioassay should be considered as the reference method.
Article 6
This Decision is addressed to the Member States.
Done at Brussels, 15 March 2002.