29. 10. 97 Official Journal of the European Communities L 295/35 COUNCIL DIRECTIVE 97/61/EC of 20 October 1997 amending the Annex to Directive 91/492/EEC laying down the health conditions for the production and placing on the market of live bivalve molluscs THE COUNCIL OF THE EUROPEAN UNION, 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 placing on the market of live bivalve molluscs ('), and in particular Article 11 thereof, Having regard to the proposal from the Commission, Whereas Chapter V of the Annex to Directive 91/492/EEC sets the acceptable limit values for two types of marine toxin that constitute a danger to public health; Whereas there is scientific evidence that a new marine toxin ‘Amnesic Shellfish Poisoning’ (ASP) that could endanger consumer health has appeared in the areas where bivalve molluscs are produced; Whereas the public health requirements concerning live bivalve molluscs in Chapter V of the Annex to Directive 91/492/EEC must be adjusted to take account of this new marine toxin; Whereas an acceptable limit value must be set for this new marine toxin, in order to protect public health; Whereas experience has shown that the registration docu- ment for the identification of the batches of molluscs provided for in point 6 of Chapter II of the Annex to Directive 91/492/EEC  should contain information concerning the health status of the area of origin and any purification or relaying operations that have been carried out on the molluscs; Whereas it must be possible to trace the origin of bivalve molluscs placed on the market; whereas to do this it should be possible to link the information shown on the registration document with each batch placed on the market in a register kept by the dispatch centre; Whereas a standard registration document would be more easily understood by operators and inspection services regardless of the language in which it is drawn up; whereas such standard document should be introduced by the Commission, (') OJ L 268, 24.9. 1991, p. 1. Directive as amended by the 1994 Act of Accession. HAS ADOPTED THIS DIRECTIVE: Article 1 The Annex to Directive 91/492/EEC is hereby amended as follows: 1. point 6 of Chapter II shall be replaced by the fol- lowing: ‘6. A registration document for the identification of batches of live bivalve molluscs during transport from the production area to a dispatch centre, puri- fication centre, relaying area or processing plant must be issued by the competent authority upon request by the gatherer. For each batch, the gatherer must complete legibly and indelibly the relevant sections of the registration document which must contain the following information: — the gatherer’s identity and address, — the date of harvesting, — the location of the production area described in as precise detail as is practicable or by a code number, — the health status of the production area as referred to in Chapter I, — the shellfish species and quantity indicated in as precise detail as is practicable, — the approval number and place of destination for wrapping, relaying, purification or proces- sing. The registration document must be dated and signed by the gatherer. The registration documents must be numbered regularly and in sequence. The competent authority must keep a register indicating numbers of registra- tion documents together with the names of the persons collecting live bivalve molluscs to whom the documents were issued. The registration docu- ment for each batch of live bivalve molluscs must be date-stamped upon delivery of a batch to a dispatch centre, purification centre, relaying area or processing plant and must be kept by operators of such centres, areas or plants for at least twelve months. In addition, the gatherer is also obliged to keep it for the same period.