Commission Implementing Regulation (EU) 2019/627Show full title

CHAPTER III U.K. LIPOPHILIC TOXIN DETECTION METHODS

A. The reference method for the detection of marine toxins as referred to in points (c), (d) and (e) in Chapter V(2) of Section VII of Annex III to Regulation (EC) No 853/2004 shall be the EU reference laboratory liquid chromatography-mass spectrometry/mass spectrometry (EURL LC-MS/MS) method. This method shall determine at least the following compounds: U.K.

(a)

okadaic acid group toxins: OA, DTX1 and DTX2, including their esters (DTX3);

(b)

pectenotoxins group toxins: PTX1 and PTX2;

(c)

yessotoxins group toxins: YTX, 45 OH YTX, homo YTX and 45 OH homo YTX;

(d)

azaspiracids group toxins: AZA 1, AZA 2 and AZA 3.

If new analogues of the above toxins appear, for which a toxicity equivalent factor (TEF) has been established, they shall be included in the analysis.

Total toxicity equivalence shall be calculated using TEFs as recommended by the European Food Safety Authority (EFSA) in Journal (2008) 589, 1-62 or any updated EFSA advice.

B. Methods other than those referred to in Part A, such as the LC-MS method, HPLC with appropriate detection, immunoassays and functional assays, such as the phosphatase inhibition assay, may be used as alternatives to, or as well as, the EURL LC-MS/MS method, provided that: U.K.

(a)

either alone or combined they can detect at least the analogues identified in Part A; more appropriate criteria shall be defined where necessary;

(b)

they meet the method performance criteria stipulated by the EURL LC-MS/MS method. Such methods must be intra-laboratory validated and successfully tested under a recognised proficiency test scheme. The European Reference Laboratory for marine biotoxins shall support activities toward inter-laboratory validation of the technique to allow for formal standardisation;

(c)

their implementation provides an equivalent level of public health protection.