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Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin
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Version Superseded: 29/12/2011
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It applies to thawed unprocessed fishery products and fresh fishery products to which food additives have been added in accordance with the appropriate Union legislation.]
Textual Amendments
Textual Amendments
F2 Substituted by Commission Regulation (EC) No 1020/2008 of 17 October 2008 amending Annexes II and III to Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and Regulation (EC) No 2076/2005 as regards identification marking, raw milk and dairy products, eggs and egg products and certain fishery products (Text with EEA relevance).
In the case of establishments, including vessels, engaged in primary production and associated operations they supplement the requirements of Annex I to that Regulation.
In the case of other establishments, including vessels, they supplement the requirements of Annex II to that Regulation.
[F3In the case of water supply, they supplement the requirements of Annex II, Chapter VII to that Regulation; clean seawater may be used for the handling and washing of fishery products, the production of ice used to chill fishery products and the rapid cooling of crustaceans and molluscs after their cooking.]
Textual Amendments
F3 Inserted by Commission Regulation (EC) No 1020/2008 of 17 October 2008 amending Annexes II and III to Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and Regulation (EC) No 2076/2005 as regards identification marking, raw milk and dairy products, eggs and egg products and certain fishery products (Text with EEA relevance).
[F4By way of derogation from point (a), point 7 of Part A of Annex I to Regulation (EC) No 852/2004 may not apply to operators engaged in small-scale coastal fishing within the meaning of Article 26(1) of Council Regulation (EC) No 1198/2006 (1) , and carrying out their activities only for short periods of less than 24 hours.]
Textual Amendments
primary production covers the farming, fishing and collection of live fishery products with a view to their being placed on the market;
and
associated operations cover any of the following operations, if carried out on board fishing vessels: slaughter, bleeding, heading, gutting, removing fins, refrigeration and wrapping; they also include:
the transport and storage of fishery products the nature of which has not been substantially altered, including live fishery products, within fish farms on land;
and
the transport of fishery products the nature of which has not been substantially altered, including live fishery products, from the place of production to the first establishment of destination.
Food business operators must ensure that:
vessels used to harvest fishery products from their natural environment, or to handle or process them after harvesting, comply with the structural and equipment requirements laid down in Part I;
and
operations carried out on board vessels take place in accordance with the rules laid down in Part II.
Freezer vessels must:
have freezing equipment with sufficient capacity to lower the temperature rapidly so as to achieve a core temperature of not more than -18 °C;
have refrigeration equipment with sufficient capacity to maintain fishery products in the storage holds at not more than -18 °C. Storage holds must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;
and
meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part B, point 2.
a receiving area reserved for taking fishery products on board, designed to allow each successive catch to be separated. This area must be easy to clean and designed so as to protect the products from the sun or the elements and from any source of contamination;
a hygienic system for conveying fishery products from the receiving area to the work area;
work areas that are large enough for the hygienic preparation and processing of fishery products, easy to clean and disinfect and designed and arranged in such a way as to prevent any contamination of the products;
storage areas for the finished products that are large enough and designed so that they are easy to clean. If a waste-processing unit operates on board, a separate hold must be designated for the storage of such waste;
a place for storing packaging materials that is separate from the product preparation and processing areas;
special equipment for disposing waste or fishery products that are unfit for human consumption directly into the sea or, where circumstances so require, into a watertight tank reserved for that purpose. If waste is stored and processed on board with a view to its sanitation, separate areas must be allocated for that purpose;
a water intake situated in a position that avoids contamination of the water supply;
and
hand-washing equipment for use by the staff engaged in handling exposed fishery products with taps designed to prevent the spread of contamination.
Textual Amendments
F5 Deleted by Commission Regulation (EC) No 1020/2008 of 17 October 2008 amending Annexes II and III to Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and Regulation (EC) No 2076/2005 as regards identification marking, raw milk and dairy products, eggs and egg products and certain fishery products (Text with EEA relevance).
ensure that unloading and landing equipment that comes into contact with fishery products is constructed of material that is easy to clean and disinfect and maintained in a good state of repair and cleanliness;
and
avoid contamination of fishery products during unloading and landing, in particular by:
carrying out unloading and landing operations rapidly;
placing fishery products without delay in a protected environment at the temperature specified in Chapter VII;
and
not using equipment and practices that cause unnecessary damage to the edible parts of the fishery products.
There must be lockable facilities for the refrigerated storage of detained fishery products and separate lockable facilities for the storage of fishery products declared unfit for human consumption.
If the competent authority so requires, there must be an adequately equipped lockable facility or, where needed, room for the exclusive use of the competent authority.
At the time of display or storage of fishery products:
the premises must not be used for other purposes;
vehicles emitting exhaust fumes likely to impair the quality of fishery products must not have access to the premises;
persons having access to the premises must not introduce other animals;
and
the premises must be well lit to facilitate official controls.
Food business operators must ensure compliance with the following requirements, where relevant, in establishments handling fishery products.
Establishments on land that freeze fishery products must have equipment that satisfies the requirements laid down for freezer vessels in Section VIII, Chapter I, part I. C, points 1 and 2.
Food business operators manufacturing mechanically separated fishery products must ensure compliance with the following requirements.
The raw materials used must satisfy the following requirements.
Only whole fish and bones after filleting may be used to produce mechanically separated fishery products;
All raw materials must be free from guts.
The manufacturing process must satisfy the following requirements:
Mechanical separation must take place without undue delay after filleting.
If whole fish are used, they must be gutted and washed beforehand.
After production, mechanically separated fishery products must be frozen as quickly as possible or incorporated in a product intended for freezing or a stabilising treatment.
fishery products to be consumed raw or almost raw;
fishery products from the following species, if they are to undergo a cold smoking process in which the internal temperature of the fishery product is not more than 60 °C:
herring;
mackerel;
sprat;
(wild) Atlantic and Pacific salmon;
and
marinated and/or salted fishery products, if the processing is insufficient to destroy nematode larvae.
epidemiological data are available indicating that the fishing grounds of origin do not present a health hazard with regard to the presence of parasites;
and
the competent authority so authorises.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Food business operators must ensure compliance with the following requirements in establishments handling certain processed fishery products.
come from establishments, including vessels, registered or approved pursuant to Regulation (EC) No 852/2004 or in accordance with this Regulation;
derive from fishery products which are fit for human consumption and which comply with the provisions set out in this Section;
be transported and stored in hygienic conditions;
be chilled as soon as possible and remain at the temperatures set out in Chapter VII.
By way of derogation from point 1(d), the food business operator may refrain from chilling the fishery products when whole fishery products are used directly in the preparation of fish oil for human consumption, and the raw material is processed within 36 hours after loading, provided that the freshness criteria are met and the total volatile basic nitrogen (TVB-N) value of the unprocessed fishery products do not exceed the limits set out in point 1 of Chapter I of Section II of Annex II to Commission Regulation (EC) No 2074/2005 (2) .
In addition to ensuring compliance with microbiological criteria adopted in accordance with Regulation (EC) No 852/2004, food business operators must ensure, depending on the nature of the product or the species, that fishery products placed on the market for human consumption meet the standards laid down in this Chapter. [F3 The requirements of Parts B and D shall not apply to whole fishery products that are used directly for the preparation of fish oil intended for human consumption.]
Food business operators must carry out an organoleptic examination of fishery products. In particular, this examination must ensure that fishery products comply with any freshness criteria.
Food business operators must ensure that the limits with regard to histamine are not exceeded.
Unprocessed fishery products must not be placed on the market if chemical tests reveal that the limits with regard to TVB-N or TMA-N have been exceeded.
Food business operators must ensure that fishery products have been subjected to a visual examination for the purpose of detecting visible parasites before being placed on the market. They must not place fishery products that are obviously contaminated with parasites on the market for human consumption.
Fresh, prepared, frozen and processed fishery products belonging to the family Gempylidae , in particular Ruvettus pretiosus and Lepidocybium flavobrunneum , may only be placed on the market in wrapped/packaged form and must be appropriately labelled to provide information to the consumer on preparation/cooking methods and on the risk related to the presence of substances with adverse gastrointestinal effects.
The scientific name of the fishery products must accompany the common name on the label.]
is not a source of contamination;
is stored in such a manner that it is not exposed to a risk of contamination;
intended for re-use is easy to clean and, where necessary, to disinfect.
Food business operators storing fishery products must ensure compliance with the following requirements.
Fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice.
[F1Frozen fishery products must be kept at a temperature of not more than – 18 °C in all parts of the product; however, whole fish initially frozen in brine intended for the manufacture of canned food may be kept at a temperature of not more than – 9 °C.]
Fishery products kept alive must be kept at a temperature and in a manner that does not adversely affect food safety or their viability.
Food business operators transporting fishery products must ensure compliance with the following requirements.
During transport, fishery products must be maintained at the required temperature. In particular:
fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice;
[F1frozen fishery products, with the exception of whole fish initially frozen in brine intended for the manufacture of canned food, must be maintained during transport at an even temperature of not more than – 18 °C in all parts of the product, possibly with short upward fluctuations of not more than 3 °C.]
Food business operators need not comply with point 1(b) when frozen fishery products are transported from a cold store to an approved establishment to be thawed on arrival for the purposes of preparation and/or processing, if the journey is short and the competent authority so permits.
If fishery products are kept under ice, melt water must not remain in contact with the products.
Fishery products to be placed on the market live must be transported in such a way as not adversely to affect food safety or their viability.]
Editorial Information
[X1 [F4 OJ L 223, 15.8.2006, p. 1 .] ]
[X1 [F2 OJ L 338, 22.12.2005, p. 27 .] ]
Editorial Information
X1Substituted by Corrigendum to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (Official Journal of the European Union L 139 of 30 April 2004).
Textual Amendments
F2 Substituted by Commission Regulation (EC) No 1020/2008 of 17 October 2008 amending Annexes II and III to Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and Regulation (EC) No 2076/2005 as regards identification marking, raw milk and dairy products, eggs and egg products and certain fishery products (Text with EEA relevance).
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