Food Law News - EU - 2010

FSA Enforcement Letter (ENF/E/10/027), 23 July 2010

HYGIENE - Regulation (EU) No. 558/2010 amending Annex III to Regulation (EC) No 853/2004

You will wish to be aware of a recent amendment to EC regulation 853/2004 [see Commission Regulation (EU) No 558/2010 of 24 June 2010]. Detailed below are some of the main changes, and I should be grateful if you would bring this letter to the attention of all relevant authorised officers and support staff.


Non Filter Feeding Gastropods and Bi-valve Molluscs

(Chapter II of Section VII of Annex III)

Under current EC hygiene regulations the Food Standards Agency is responsible for classifying production and relaying areas for live bi-valve molluscs, live echinoderms, live tunicates and live marine gastropods. The amendment means that non-filter feeding gastropods such as periwinkles and whelks will no longer require to be harvested from classified areas.

In accordance with the amended provisions [Chapter IX of Section VII of Annex III to Regulation (EC) No 853/2004] of 853/2004 (establishing specific requirements for pectinidae and live marine gastropods which are not filter feeders harvested outside classified production areas), checks for such species will now move on-shore.


Marine gastropods are generally not filter feeder animals. Consequently, the risk of accumulation of micro-organisms related to faecal contamination is considered to be remote. In addition, no epidemiological information has been reported to link the provisions for classification of production areas with risks for public health associated with marine gastropods which are not filter feeders. For this reason, such marine gastropods, are now excluded from provisions on the classification of production areas as laid down in Chapter II, of Section VII of Annex III to Regulation (EC) No 853/2004.

However marine gastropods, which are not filter feeders, may not be placed on the market unless they are harvested and handled in accordance with Chapter II, Part B, and meet the standards laid down in Chapter V, as proved by a system of own-checks. This now mirrors the on-shore provisions already applicable to pectinidae such as wild king scallops.

The changes require that marine gastropods, which are not filter feeders, may not be placed on the market for human consumption otherwise than via a fish auction, a dispatch centre or a processing establishment.

Authorised officers should ensure that food business operators handling such species must comply:

(a) with the documentary requirements of Chapter I, points 3 to 7, where applicable. In this case, the registration document must clearly indicate the location of the area where the live marine gastropods were harvested; or

(b) with the requirements of Chapter VI, point 2 concerning the closing of all packages of live marine gastropods dispatched for retail sale and Chapter VII concerning identification marking and labelling.

Wrapping and packaging of LBMs

(Chapter VI of Section VII of Annex III)

The requirement that individual consumer-size packages of LBM must be closed and remain closed when transported after leaving the dispatch centre until they are presented for sale to the final consumer remains unchanged. However, in order to protect public health, the requirement to close packages has been extended to all packages leaving a dispatch centre, including if packages are destined for another dispatch centre.


(Point A of Chapter III of Section VIII of Annex III)

The amendment to point 1 of the introductory part of this section has the effect of extending the scope of the requirements for fishery products to include thawed unprocessed fishery products and fresh fishery products to which food additives (for example: sodium metabisulphite is used to prevent black spots in prawns) have been added to ensure preservation.

Storage and transport of fishery products

(Point 2 of Chapter VII and Point 1b of Section VIII of Annex III

The Regulations require frozen fishery products to be stored and transported at a temperature of not more than -180C. However, the amendment permits derogation from these requirements for whole frozen fish initially frozen in brine intended for the manufacture of canned food. Such products may be stored or transported at a temperature of not more than -90C.


Transport of meat

(Chapter VII of Section 1 of Annex III)

(Chapter V of Section II of Annex III)

As soon as meat from poultry and farmed lagomorphs (rabbit and hares) is cut and, where appropriate, packaged, it must be chilled to a temperature of not more than 40C. It must attain this temperature before transport and be maintained at that temperature during transport. However, there is provision, if authorised by the competent authority, for the transportation of livers for the production of foie gras to be carried out at a temperature above 40C provided that transport from one establishment to another takes no more than 2 hours and is in accordance with any other requirements specified by the competent authority.


(Point 1(a), Chapter I, Section XIV of Annex III)

The list of raw materials for the production of gelatine has been amended and now clarifies that any bones used should not include specified risk material as defined in the TSE legislation.


(Points 1(a) and (e), Chapter I, Section XV of Annex III)

The list of raw materials for the production of collagen has also been amended and now allows the use of bones, other than specified risk material (as defined in the TSE legislation) and sinews.

(Point 1, Chapter III, Section XV of Annex III)

The production process has been amended and now gives different criteria depending on whether bones used are ruminant bone material (derived from animals born, reared or slaughtered in countries or regions with a controlled or undetermined BSE risk as determined in accordance with Article 5 of Regulation (EC) No 999/2001) or other raw material.

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