Hygiene for food of animal origin

Outline of the Community (European Union) legislation about Hygiene for food of animal origin

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Hygiene for food of animal origin

Document or Iniciative

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. [See amending act(s)].

Summary

Foodstuffs of animal origin listed in Annex I of the Treaty on the Functioning of the European Union may present microbiological and chemical hazards, necessitating the adoption of specific hygiene rules contributing to the completion of the internal market and ensuring a high level of public health protection. These rules supplement those laid down in Regulation (EC) No 852/2004 on the hygiene of foodstuffs, which primarily concerns the approval of operators.

GENERAL OBLIGATIONS

The provisions of this Regulation apply to unprocessed and processed products of animal origin, but not to foods consisting of both products of plant origin and processed products of animal origin, unless expressly indicated to the contrary. Furthermore, this Regulation does not apply to the retail trade or to primary production for private consumption, for which the provisions of the above-mentioned Regulation on the hygiene of foodstuffs are sufficient.

Registration and approval of establishments

Establishments handling products of animal origin must be registered and, where necessary, approved by the competent authority in their Member State. This does not apply to establishments engaged only in primary production, transport or storage of products not requiring temperature-controlled storage conditions, or retail operations not subject to the Regulation.

In accordance with Regulation (EC) 882/2004 on official controls performed to ensure the verification of compliance with feed and food law and with the provisions relating to animal health and animal welfare. Member States must keep up-to-date lists of approved establishments, which are given an approval number with additional codes indicating the type of products of animal origin manufactured.

Health marking and identification

Where required by the Regulation, products of animal origin must be given a health mark applied in accordance with Regulation (EC) No 854/2004 laying down specific rules on the organisation of official controls on products of animal origin intended for human consumption or, failing this, an identification mark applied to products before they leave the product establishment if their packaging and/or wrapping is removed or it is further processed in another establishment. This mark must be legible, indelible and clearly visible for the competent authorities, and must show the name of the exporting country and the establishment’s approval number where the operations took place. When applied in an establishment located within the European Union, the mark must be oval in shape and include the abbreviation CE, EC, EF, EG, EK or EY.

Imports from Non-EU Member Countries

The Commission draws up lists of Non-EU Member Countries from which imports of products of animal origin are permitted, in accordance with the Regulation (EC) 854/2004 on official controls. In principle, a third country may only be included on these lists if a European control has taken place in that country and demonstrates that the competent authority provides appropriate guarantees that their provisions comply with or are equivalent to European legislation.

Furthermore, Regulation (EC) 854/2004 provides that an establishment may only be included in these lists if the competent authority in the originating third country guarantees:

• >that the aforementioned establishment, as well as any other establishment handling raw materials of animal origin used in the production of the products of animal origin concerned, comply with the relevant European requirements, specifically with those of Regulation (EC) 853/2004 or those which have been defined as equivalent to these requirements following the decision to include this third country in the relevant list, in accordance with Article 11;
• >that an official inspection service in this country carries out monitoring of the establishments and makes available to the Commission, where necessary, all relevant information on the establishments providing raw materials;
• >that this service has the power to prevent establishments from exporting to the Union in the even that they do not comply with the requirements detailed above.

When drawing up these lists, particular account is taken of:

• the existing legislation of the third country, and the organisation and powers of the competent authority and the inspection services;
• where applicable, the situation regarding animal health, zoonoses and plant health, as well as the procedures for notifying the Commission and the competent international bodies of animal or plant diseases which occur;
• experience gained in relation to marketing vis-à-vis the third country and its collaboration in exchanging information, particularly on health risks;
• the results of EU inspections/audits carried out in the country concerned;
• the existence, in the third country concerned, of legislation on animal nutrition and programmes for monitoring zoonoses and residues.

By way of derogation, there are special provisions for imports of fishery products.

Food chain information

The Regulation also provides instructions to ensure that slaughterhouse operators receive food chain information on all animals except wild game.

SECTORAL APPROACH

In Annex II to the Regulation, a sectoral approach is taken to determining the specific hygiene provisions applicable to foodstuffs of animal origin.

In order to take account of traditional production methods, the competent authority may grant special conditions for applying the appropriate hygiene rules in the sectors concerned.

Meat of domestic ungulates

This section is concerned mainly with meat from domestic animals of the bovine, porcine, ovine and caprine species.

Animals for slaughter must be collected and transported carefully so as not to cause unnecessary distress. Animals showing symptoms of disease or from contaminated herds or flocks may not be transported, except with special authorisation.

Ante-mortem and post-mortem inspections must be carried out in accordance with the Regulation on official controls on products of animal origin intended for human consumption.

With a view to minimising the possibility of any contamination of meat, specific hygiene rules cover the following aspects:

• construction and equipment of slaughterhouses;
• the slaughter process in general and emergency slaughter in particular: stunning, bleeding, skinning, dressing and evisceration;
• cutting and boning operations in cutting plants;
• control of health marking of meat by an official veterinarian;
• storage, transport and maturation of meat (temperature at which it is kept).

Meat of poultry and lagomorphs

The following provisions apply to meat of farmed birds and of rabbits, hares and rodents.

Poultry and lagomorphs must be collected and transported carefully so as not to cause unnecessary distress. Those showing symptoms of disease or from contaminated flocks may not be transported, except with special authorisation.

Ante-mortem and post-mortem inspections must be carried out in accordance with the Regulation on official controls.

Specific hygiene standards are laid down with the aim of minimising the possibility of any contamination of the meat produced, covering the following elements:

• transport of birds to the slaughterhouse;
• construction, design and equipping of slaughterhouses and cutting plants;
• the slaughter process: stunning, bleeding, skinning or plucking, dressing and evisceration;
• cutting and boning work;
• poultry reared for the purpose of producing ‘foie gras’.

Meat of farmed game

Unless the competent authority considers them inappropriate, meat of farmed game coming from even-toed mammals (Cervidae and Suidae) must be produced and marketed under the conditions laid down for meat of domestic ungulates (see above).

The provisions relating to poultry meat will apply to the production and marketing of meat from ratites (flightless birds).

In the interest of animal welfare, the competent authority may, in certain circumstances, authorise the slaughter of farmed game at the place of origin instead of at an approved establishment.

Wild game meat

Specific hygiene provisions cover the following elements:

• training of hunters in health and hygiene;
• killing, evisceration and transport of wild game to an approved establishment;
• game handling establishments.

Minced meat, meat preparations and mechanically separated/recovered meat (MSM)

This section does not apply to the production and marketing of minced meat intended for the processing industry, which is subject to the requirements for fresh meat.

Specific hygiene rules cover the following elements:

• equipping and approval of production establishments;
• raw materials used (or prohibited) in the production of minced meat;
• production, conservation and use of minced meat, meat preparations obtained from minced meat, and mechanically separated meat (MSM);
• product labelling.

Meat products

There are hygiene standards specific to meat products. Depending on the type of animal, they cover the raw materials which may not be used in the manufacture of meat products.

Live bivalve molluscs

With the exception of the provisions on purification, the following rules also apply to live echinoderms, tunicates and marine gastropods.

Live bivalve molluscs harvested from the wild and intended for human consumption must comply with high health standards applicable at all stages of the production chain:

• production of live bivalve molluscs: three types of production area (Class A, B or C);
• harvesting of molluscs and their transport to a dispatch or purification centre, relaying area or processing plant;
• relaying of molluscs in approved areas under optimal conditions of traceability and purification;
• essential equipment and hygiene conditions in dispatch and purification centres;
• health standards applicable to live bivalve molluscs: freshness and viability; microbiological criteria, evaluation of the presence of marine biotoxins and harmful substances in relation to the permissible daily intake;
• health marking, wrapping, labelling, storage and transport of live bivalve molluscs;
• the rules applicable to pectinides harvested outside classified areas.

Fishery products

Fishery products caught in their natural environment may have to be handled for bleeding, heading, gutting and the removal of fins. They are then chilled, frozen or processed and/or wrapped/packaged on board vessels in accordance with the rules laid down in this section.

Specific hygiene requirements cover the following elements:

• equipment and facilities on fishing vessels, factory vessels and freezer vessels: areas for receiving products taken on board, work and storage areas, refrigeration and freezing installations, pumping of waste and disinfection;
• hygiene on board fishing vessels, factory vessels and freezer vessels: cleanliness, protection from any form of contamination, washing with water and cold treatment;
• conditions of hygiene during and after the landing of fishery products: protection against any form of contamination, equipment used, auction and wholesale markets;
• fresh and frozen products, mechanically separated fish flesh, endo-parasites harmful to human health (visual examination), and cooked crustaceans and molluscs;
• processed fishery products;
• health standards applicable to fishery products: evaluation of the presence of substances and toxins harmful to human health;
• wrapping, packaging, storage and transport of fishery products.

Raw milk and milk products

As regards primary production of raw milk, the specific health requirements are as follows:

• raw milk and colostrum must come from females of the species (cows, buffaloes, ewes, goats, other) which are in a good general state of health that do not show any symptoms of infectious diseases communicable to humans through the milk or colostrum and which are not suffering from any infection of the genital tract with discharge, enteritis with diarrhoea and fever, or a recognisable inflammation of the udder. The animals must not have any udder wound likely to affect the milk or the colostrum;
• subject to further, more specific provisions, raw milk must comply with microbiological criteria and standards for plate count and somatic cell count.
• milking, collection and transport of raw milk and colostrum must comply with clearly-defined hygiene rules in order to avoid any contamination. The same applies to persons involved, premises, equipment and utensils used in production.

The Regulation sets out the general hygiene requirements for heat-treated drinking milk and other milk products, dealing mainly with the preparation of pasteurised milk and Ultra High Temperature (UHT) milk.

Wrapping and packaging must be designed to protect milk and/or milk products from harmful effects of external origin. For control purposes, the labelling must clearly show the characteristics of the product, including where applicable the terms ‘raw milk’, ‘made with raw milk’, ‘colostrum’ or ‘colostrum-based’.

Eggs and egg products

At the producer’s premises and until sale to the consumer, eggs must be kept clean, dry, free of extraneous odour, protected from shocks and direct sunlight, stored and transported at an optimal temperature for conservation. They must be delivered to consumers within 21 days of laying.

The hygiene rules governing egg products (e.g. albumin) cover:

• the availability of suitable rooms within approved production establishments in order to separate egg product manufacturing operations;
• the raw materials used in egg products: conditions for using eggshells and liquid egg;
• the manufacture of egg products in such a way as to avoid any contamination during production, handling and storage;
• analytical specifications for various residues and for butyric and lactic acids;
• labelling and identification marking.

Frogs’ legs and snails

Only approved establishments with the required facilities, having due regard to handling and preparation, may prepare and kill frogs and snails.

Frogs and snails which are found dead are not fit for consumption. The same applies to those considered to present a hazard on the basis of an organoleptic examination carried out by sampling.

Rendered animal fats and greaves

Hygiene standards for storage, preparation and preservation apply to establishments collecting or processing raw materials.

The hygiene rules in respect of rendered animal fats, greaves and by-products cover:

• raw materials: these must come from animals deemed fit for consumption after inspection, consisting of adipose tissues or bones which are reasonably free from blood and impurities;
• the originating establishment which must be registered or approved pursuant to Regulation 852/2004 and pursuant to this Regulation;
• preservation during the collection, transport and storage of these raw materials;
• the rendering methods: heat, pressure, decantation, prohibition of solvents;
• the composition of animal fats;
• the storage of finished products intended for human consumption.

Treated stomachs, bladders and intestines

In addition to the storage requirements for these products, specific hygiene rules govern the production and placing on the market of treated stomachs, bladders and intestines, as regards the animals they come from and the establishments where they are treated.

Only products which have been cleaned and scraped, then salted, heated or dried, and treated to avoid any new contamination, are suitable for human consumption. There are also rules on conservation, in particular the temperature of products that are not salted or dried.

Gelatine

The following raw materials, derived from animals declared fit for consumption after inspection and slaughtered according to the existing hygiene rules, may be used in the manufacture of gelatine which is to be used in foodstuffs:

• bones, tendons and sinews;
• hides and skins of farmed ruminant animals, pigs, poultry and wild game;
• fish skin and bones.

Specific provisions apply to:

• collection centres and tanneries authorised to supply raw materials;
• the transport and storage of raw materials;
• the gelatine manufacturing process;
• the maximum limits for residues in finished products;
• labelling.

Collagen

Collagen may be manufactured from the same raw materials as gelatine, with the exception of hides and skins that have undergone a tanning process.

Specific provisions also apply to:

• collection centres and tanneries authorised to supply raw materials;
• the transport and storage of raw materials;
• the collagen manufacturing process;
• the maximum limits for residues in finished products;
• labelling.

BACKGROUND

This Regulation forms part of the ‘hygiene package’, a body of law laying down hygiene rules for foodstuffs, which, in addition to this Regulation, includes the following acts:

• Regulation (EC) No 852/2004 defining the food safety objectives to be achieved, leaving food operators responsible for adopting the safety measures to be implemented in order to guarantee food safety;
• Regulation (EC) No 854/2004 putting in place a Community framework for official controls on products of animal origin intended for human consumption and laying down specific rules for fresh meat, bivalve molluscs, milk and milk products.

The following acts supplement the Community legislation on food hygiene:

• Regulation (EC) No 178/2002 laying down the general principles of food law. This Regulation explains the food safety procedures and establishes the European Food Safety Authority (EFSA);
• Regulation (EC) No 882/2004 reorganising official controls on foodstuffs and feedingstuffs so as to integrate controls at all stages of production and in all sectors;
• Directive 2002/99/EC laying down the conditions for placing products of animal origin on the market and the restrictions applicable to products from non-EU countries or regions of non-EU countries subject to animal health restrictions.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 853/2004	20.5.2004	–	OJ L 139 of 30.4.2004

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 219/2009	20.4.2009	–	OJ L 87 of 31.3.2009

Successive amendments and corrections to Regulation (EC) No 853/2004 have been incorporated into the basic text. This consolidated versionis for reference purposes only.

Related Acts

Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) 854/2004 [Official Journal L 338, 22.12.2005].
See consolidated version

Report from the Commission to the Council and the European Parliament on the experience gained from the application of the hygiene Regulations (EC) No 852/2004, (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 on they hygiene of foodstuffs [COM(2009) 403 final – Not published in the Official Journal].
The Commission reviews the experience gained from the application of the aforementioned regulations. It presents the progress achieved and the difficulties encountered by all the interested actors in the implementation of the 2006 – 2008 hygiene package. It concludes that overall Member States have taken the necessary administrative and control steps to ensure compliance, but that there is still room for improvement in relation to implementation. The main difficulties identified are in relation to:

• certain exemptions from the scope of the hygiene Regulations;
• certain definitions laid down in these Regulations;
• certain practical aspects concerning the approval of establishments handling foods of animal origin and the marking of such foods;
• the import regime for certain foods;
• the implementation of HACCP-based procedures in certain food businesses; and
• the implementation of official controls in certain sectors.

This report does not suggest any detailed solutions. However, on the basis of the difficulties identified, the Commission will consider the need for any proposals to improve the food hygiene package.