(Utkast) Delegert kommisjonsforodning (EU) .../... av 24. juli 2026 om endring av vedlegg II og III til europaparlaments- og rådsforordning (EU) nr. 853/2004, med hensyn til særlige hygieneregler for levende muslinger
Hygieneregler for næringsmidler av animalsk opprinnelse: endringsbestemmelser om levende muslinger
Utkast til delegert kommisjonsforordning sendt til Europaparlamentet og Rådet for klarering 24.7.2026
Bakgrunn
(fra kommisjonsforordningen)
(1) Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. In particular, Article 5(1), point (b), of that Regulation requires food business operators not to place on the market a product of animal origin, including live bivalve molluscs, unless it has an identification mark, to be applied in accordance with Section I of Annex II to that Regulation.
(2) In addition, according to Section VII, Chapter I, points 9(b) and (c), of Annex III to that Regulation (EC) No 853/2004, intermediary operators can send live bivalve molluscs from class B or C production areas to purification centers or to processing establishments respectively. Since these molluscs are not fit for direct human consumption but are nevertheless to bear an identification mark as they are placed on the market, it is appropriate to clarify that they should not bear an identification mark. Section I, Part A, point 3, of Annex II to Regulation (EC) No 853/2004 should be amended accordingly.
(3) Section VII of Annex III to Regulation (EC) 853/2004 refers to re-immersion of live bivalve molluscs either in a natural site or in an establishment. However, Regulation (EC) No 853/2004 does not define the activity of re-immersion, and this can create ambiguity. That activity should therefore be defined. Section VII of Annex III to that regulation should be amended accordingly.
(4) Section VII, Chapter I of Annex III to Regulation (EC) No 853/2004 lays down the general requirements for the placing on the market of live bivalve molluscs, including, in point 4, the information that the registration document which accompanies a batch of live bivalve molluscs is to contain. In order to reduce administrative burden for operators and competent authorities performing official controls, food business operators should be required to provide the registration document in accordance with a model available in the Trade Control and Expert System (TRACES). To comply with the standardised model available in TRACES, Section VII, Chapter I, of Annex III to Regulation (EC) No 853/2004 should therefore be amended accordingly. To reflect the amendment of the information to be included in the registration document, Section VII, Chapter X, of Annex III to Regulation (EC) No 853/2004, which lays down the model registration document accompanying a batch of live bivalve molluscs, should also be amended.
(5) In order to reduce administrative burden for operators and competent authorities performing official controls, food business operators should also be required to issue in TRACES the registration document that is to accompany a consignment of live bivalve molluscs. Considering the complexity of the practical arrangements for food business operators to issue the registration document in TRACES, it is appropriate to provide for sufficient time to allow competent authorities and operators to comply with the obligation to use TRACES.