Official controls on products of animal origin intended for human consumption
In the framework of revising food hygiene law (‘hygiene package’), the European Union has established 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 dairy products.
Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption [See amending acts].
Community establishments and imports are subject to the controls laid down by this Regulation.
The competent authorities approve establishments that comply with Community regulations on hygiene of food.
Food business operators must provide the competent authority with all the assistance needed in carrying out the control, notably as regards access to premises and the presentation of documentation or records.
The official controls include audits of good hygiene practices and HACCP principles (Hazard Analysis and Critical Control Points), as well as specific controls whose requirements are determined by sector (fresh meat, bivalve molluscs, fishery products, milk and dairy products).
Appointed and authorised by the competent authority, the official veterinarian will have solid professional qualifications, recognised by having passed an aptitude test covering all the subjects for which he is competent. He will audit:
- the permanent application of good hygiene practice (maintenance of plant structure and equipment, plant hygiene, staff hygiene, training, processing of animal by-products not intended for human consumption, etc.);
- the procedures based on the HACCP (Hazard Analysis and Critical Control Point) system, notably in the following areas: compliance of products of animal origin with microbiological criteria, absence of excessive quantities of prohibited substances, contaminants or chemical residues, absence of physical hazards, such as foreign bodies, absence of patho-physiological abnormalities or changes, absence of contamination.
The inspection tasks of the official veterinarian concern the following aspects:
- food chain information giving health data concerning animals which have been sent or will be sent for slaughter.
- ante-mortem inspections (except for wild game). Within 24 hours of arrival at the slaughterhouse and less than 24 hours before slaughter, all animals must undergo ante-mortem inspections. The official veterinarian verifies the existence of any sign indicating that the welfare of the animals has been compromised or signs of any condition which might adversely affect human or animal health.
- animal welfare during transport and during slaughter.
- post-mortem inspections. Carcases and offal of slaughtered animals are subjected to visual inspection and mandatory incisions. With a view to a definitive diagnosis, or to detect the presence of an animal disease or other factors rendering the meat unfit for consumption, the official veterinarian may conduct an additional examination and take samples for scientific analysis in the laboratory. Adequate precautions must be taken to avoid contamination during examination.
- specified Risk Material. In compliance with Community legislation on transmissible spongiform encephalopathy (TSEs), specified risk material is sampled, separated and, where appropriate, marked.
- laboratory testing. The official veterinarian takes samples to detect the possible presence of zoonoses, TSE, other diseases or unauthorised substances.
- health marking for stock cattle, and large farmed and wild game. After completion of the post-mortem inspection, meat fit for consumption must be health-marked in ink or by hot branding. This mark is oval, legible, indelible, and readily visible to the controlling authorities, showing the name of the consigning country and the approval number of the establishment. The nature and content of this marking must follow specific provisions, depending on the type of meat and the type of packaging.
The results of inspections must be recorded in writing and incorporated in the relevant databases. Whenever a problem is identified, this information must be communicated to the operator of the meat establishment, the competent authority and the persons responsible for supervising the holding of provenance of the animals. The official veterinarian shall take all necessary measures and precautions to prevent the possible spread of the infectious agent.
Decisions following controls
Where controls reveal deficiencies or irregularities, appropriate measures must be taken. These include:
- decisions concerning food chain information. The animals are not accepted for slaughter intended for human consumption in the following cases: they come from a region which is subject to a movement prohibition, rules on the use of veterinary medical products have not been complied with, or there is a risk for human or animal health. When the information on the animals provided by the operator does not correspond with the true situation, the competent authority may take action against the operator such as extra controls at the operator’s expense.
- decisions concerning live animals. When the animals’ identity is not ascertainable, they must be killed separately and declared unfit for human consumption. The same applies to animals presenting a transmissible pathological risk; these must undergo detailed ante-mortem examination. In addition, the veterinary official supervises the slaughter of animals in the framework of specific disease eradication schemes (TSE, brucellosis tuberculosis, salmonella).
- decisions concerning animal welfare. The official veterinarian will make sure the rules concerning animal welfare during transport and slaughter are complied with and, if necessary, take the necessary corrective measures.
- decisions concerning meat. All meat which may constitute a danger to human health shall be declared unfit for human consumption. This includes meat from animals which have not undergone ante-mortem inspection (excluding wild game), meat from animals whose offal has not undergone post-mortem inspection, meat from animals which were dead before slaughter, stillborn, unborn or slaughtered under the age of seven days, meat from animals affected by a notifiable animal disease, meat not in conformity with the biological and radioactivity criteria, meat containing specified risk materials, chemical residues or veterinary medicinal products in excess of the permitted limits. In addition, the veterinarian may impose requirements concerning the use of meat derived from animals having undergone emergency slaughter outside the slaughterhouse.
Responsibilities and frequency of controls
The national authority shall guarantee appropriate official supervision in meat establishments. The nature and intensity of the official supervision shall be based on a regular assessment of the risks to human and animal health and the animal welfare aspects. At least one official veterinarian should be present throughout both the ante-mortem and post-mortem inspections, although some flexibility may be applied in the case of some establishments slaughtering or processing game.
In order to carry out official inspections, a certain number of professional qualifications are required. The veterinarian must also pass a test organised by the competent authority, confirming candidates’ knowledge in all the areas relating to their work (in particular national and Community legislation on health, good hygiene and farming practices, HACCP principles, and relevant aspects as regards epidemiology and TSEs). Moreover, each veterinarian must have 200 hours of practical training before being allowed to work on their own.
When carrying out inspections, the official veterinarian may be assisted by official auxiliaries placed under his authority. Auxiliaries, whose tasks are clearly defined, must first have received training (at least 500 hours of theoretical training and 400 hours of practical training) which must be approved by an aptitude test covering all the subjects for which they are competent.
Moreover, Member States may authorise staff of poultry and rabbit slaughterhouses to carry out certain inspection activities normally carried out by official auxiliaries. The staff in question must have received specific prior training.
LIVE BIVALVE MOLLUSCS
The competent authority must fix the location and the boundaries of production areas for bivalve molluscs. The production areas from which harvesting of bivalve molluscs is authorised are divided into three classes:
- Class A areas: areas from which molluscs may be collected for direct human consumption;
- Class B areas: areas from which molluscs may be collected but may be placed on the market for human consumption only after treatment in a purification centre or after relaying;
- Class C areas: areas from which molluscs may be collected but may be placed on the market only after relaying over a long period (at least two months), whether or not combined with purification.
In order to enable production areas to be classified the competent authority must make an inventory of the sources of pollution from human or animal origin and examine the quantities of organic pollutants released during the different periods of the year and their circulation characteristics. It must establish a sampling programme to verify the microbiological quality of the bivalve molluscs and check for the presence of toxin-producing plankton and chemical contaminants. This programme is based on sampling plans that determine the frequency of these controls.
Where the results of sampling reveal non-compliance with the essential health standards, the harvesting of molluscs shall be prohibited within the production area concerned. The production area may not be re-opened until two consecutive analyses separated by at least 48 hours produce satisfactory results.
In addition to the monitoring of relaying and production zones, a control system including laboratory tests must be set up in order to verify compliance with the requirements applicable to the end products.
In addition to the common control requirements, specific official controls on fishery products shall be carried out at the time of landing or before first sale at an auction or wholesale market. The official controls shall include:
- organoleptic surveillance testing;
- total volatile basic nitrogen tests;
- histamine testing;
- surveillance testing for contaminants;
- microbiological checks;
- parasite screening tests;
- checks for the possible presence of poisonous fish species or fish containing biotoxins.
Fishery products shall be declared unfit for human consumption if organoleptic, chemical or microbiological checks on such products reveal the presence in excessive quantities of substances dangerous to human health.
MILK AND DAIRY PRODUCTS
In addition to the common control requirements, specific official controls shall include:
- Inspection of holdings. Animals must undergo regular veterinary inspections to ensure compliance with the health requirements for raw milk production (health status of the animals, use of veterinary medicinal products).
- Control of raw milk upon collection. The competent authority shall organise control schemes in order to ensure compliance with the standards that apply to raw milk. When the raw milk fails to meet mandatory food safety criteria the competent authority may suspend the delivering of the milk in question and ask the farmer to take the necessary measures.
IMPORTATION OF PRODUCTS OF ANIMAL ORIGIN FROM NON-EU MEMBER COUNTRIES
List of Non-EU Member Countries
The Commission, assisted by the Standing Committee on the Food Chain, draws up lists of third countries or parts of third countries from which the importation of products of animal origin is authorised. A third country may only be listed if the country in question provides the appropriate guarantees and after a Community inspection has been carried out in the country.
Furthermore, the Commission draws up a list of establishments from which products of animal origin may be imported or dispatched. An establishment may only be listed if the competent authority in the third country of origin guarantees that the said establishment complies with the relevant Community requirements. Regular Community inspections are carried out in order to check these guarantees.
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 the food operators responsible for adopting the safety measures to be implemented in order to guarantee food safety;
- Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin in order to guarantee a high level of food safety and public health.
The following acts supplement Community legislation on the hygiene of foodstuffs:
- Regulation (EC) No 178/2002 containing general principles of food law, which explains food safety procedures and establishes the European Food Safety Authority;
- 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.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
Regulation (EC) No 854/2004
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 882/2004
OJ L 165 of 30.4.2004
Regulation (EC) No 219/2009
OJ L 87 of 31.3.2009
Successive amendments and corrections to Regulation (EC) No 854/2004 have been incorporated in the basic text. This consolidated version has a purely documentary value.
AMENDMENT OF ANNEXES
Annexe I – Fresh meat:
Regulation (EC) No 2074/2005 [Official Journal L 338 of 22.12.2005];
Regulation (EC) No 2076/2005 [Official Journal L 338 of 22.12.2005];
Regulation (EC) No 1663/2006 [Official Journal L 320 of 18.11.2006];
Regulation (EC) No 1791/2006 [Official Journal L 636 of 20.12.2006];
Regulation (EC) No 1021/2008 [Official Journal L 277 of 18.10.2008].
Annexe II – Live bivalve molluscs:
Regulation (EC) No 2074/2005 [Official Journal L 338 of 22.12.2005];
Regulation (EC) No 1021/2008 [Official Journal L 277 of 18.10.2008];
Regulation (EU) No 505/2010 [Official Journal L 149 of 15.6.2010].
Annexe IV – Raw milk, colustrum, dairy products and colostrum based products
Regulation (EC) No 1663/2006 [Official Journal L 320 of 18.11.2006].
Annexe VI – Requirements regarding certificates accompanying imports
Regulation (EC) No 1663/2006 [Official Journal L 320 of 18.11.2006].