Category Archives: Animal Nutrition

The agrifood sector in the European Union produces around 120 million tonnes of animal feedingstuffs annually. Good quality animal nutrition is essential, as it affects animal health and consequently food safety. Legislation on labelling and the circulation of animal feedingstuffs has been supplemented so as to shift the emphasis more towards the protection of human and animal health. In addition to the rules on hygiene and the monitoring of animal feedingstuffs, the EU thus regulates certain substances and products in order to limit or even prohibit their presence in animal feedingstuffs.

Marketing of feed

Marketing of feed

Outline of the Community (European Union) legislation about Marketing of feed

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Marketing of feed

Document or Iniciative

Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC.

Summary

This Regulation lays down rules on the placing on the market and use of feed for food-producing animals or pets. It also lays down labelling, packaging and presentation requirements.

Feed

This Regulation covers feed, i.e. any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals.

It applies without prejudice to provisions in the field of animal nutrition concerning:

  • medicated feedingstuffs;
  • undesirable substances;
  • transmissible spongiform encephalopathies;
  • animal by-products not intended for human consumption;
  • genetically modified food and feed;
  • the traceability and labelling of genetically modified organisms (GMOs);
  • additives; and
  • the production and labelling of organic products.

Marketing and use

Animal feed shall comply with safety and marketing requirements. In particular, it shall:

  • be safe;
  • not have a direct adverse effect on the environment or animal welfare;
  • be sound, genuine, unadulterated, fit for purpose and of merchantable quality;
  • be labelled, packaged and presented in accordance with the applicable legislation; and
  • comply with the technical provisions on impurities and other chemical determinants (see Annex I to the Regulation).

Feed shall not contain materials whose placing on the market or use is restricted or prohibited (see Annex III to the Regulation).

The traceability of feed shall be guaranteed at all stages of production, processing and distribution. Feed business operators must therefore be capable of identifying any person who has provided them with feed, a food-producing animal or any substance intended or likely to be incorporated into feed.

Feed which is or is likely to be placed on the market in the European Community shall be labelled or identified appropriately in order to facilitate its traceability.

If the feed business operator considers that a feed does not meet the feed safety requirements, it shall immediately initiate the procedures for withdrawing the feed in question from the market. It shall then inform the competent authorities and users without delay.

Labelling and presentation

This Regulation establishes general provisions for the labelling and presentation of all feed, such as the obligation to indicate:

  • the type of feed;
  • the name and address of the operator;
  • the batch or lot reference number;
  • the net weight;
  • the list of additives used; and
  • the moisture content.

The labelling and presentation of feed must not mislead the user concerning the intended use or characteristics of the feed. The mandatory labelling particulars shall be clearly visible on the packaging, the container, on a label attached thereto or on the document accompanying the feed. The particulars shall be clearly legible and indelible. They shall be given in at least one of the official languages of the Member State or region in which the feed is marketed.

Specific labelling requirements are laid down for feed materials, compound feed and “dietetic” feed. All claims relating to feed must be duly justified.

The labelling of pet food shall include a telephone number for customers wishing to know more about the ingredients used.

Packaging

Feed materials and compound feed shall be placed on the market in sealed packages and containers.

However, certain feed may be placed on the market in bulk or in unsealed packages or containers. This derogation concerns:

  • feed materials;
  • mixtures of grain and whole fruit;
  • deliveries between producers of compound feed;
  • compound feed delivered by the producer to the user or packaging firms;
  • quantities of compound feed not exceeding 50 kilograms in weight which are intended for the final user and are taken directly from a sealed package or container; and
  • blocks or licks.

Community Catalogue of feed materials

The Community Catalogue of feed materials is intended to improve the labelling of feed materials and compound feed. For each material listed, it includes the following particulars:

  • the name;
  • the identification number;
  • a description (including information on the manufacturing process); and
  • a glossary of definitions.

Community Codes of good labelling practice

Stakeholders are also encouraged to create Community Codes of exemplary practice in the context of optional labelling: one for pet food and one for compound feed for food-producing animals.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 767/2009

21.9.2009

OJ L 229 of 1.9.2009

Subsequent amendments and corrections to Regulation (EC) No 767/2009 have been incorporated in the basic text. This consolidated versionhas a purely documentary value”.

DEROGATION FROM THE ACT

Regulation (EU) No 454/2010 [Official Journal L 128 du 27.5.2010].
Feed intended for pet animals which is labelled in accordance with Directive 79/373/EEC and Article 16 of Directive 70/524/EEC may be placed on the market until 31 August 2011.

Related Acts

Commission Regulation (EU) No 242/2010 of 19 March 2010 creating the Catalogue of feed materials [Official Journal L 77 of 24.3.2010].

Animal by-products

Animal by-products

Outline of the Community (European Union) legislation about Animal by-products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Animal by-products

Document or Iniciative

Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002.

Summary

This Regulation facilitates the efficient management of animal by-products whilst maintaining the high level of protection that is currently in place against risks to public and animal health and to the environment.

Products concerned

This Regulation shall apply to:

  • animal by-products * and derived products * which are not intended for human consumption;
  • products intended for purposes other than human consumption:
    • products of animal origin which may be destined for human consumption;
    • raw materials for the production of products of animal origin.

End point in the manufacturing chain

This Regulation introduces the notion of an “end point” in the manufacturing of animal by-products, beyond which they are no longer subject to the rules governing this type of product, since potential risks have been eliminated. Instead, the general rules on product safety are to apply. As an example, where animal fat produced by an incinerating factory is processed and the product of that transformation is used to produce plastics, the probability that the final product might transmit a significant biological risk is very slight.

Essential guarantees for public and animal health

Products of animal origin may be used outside the food chain for various purposes: skins for leather production, powdered milk to feed animals, and blood products in diagnostic medical devices. Such by-products may be a vector of diseases affecting human beings or animals when they are used in animal feedingstuffs or to produce technical products.

This Regulation preserves the basic guarantees introduced in 2003 against such risks. In particular, it maintains:

  • a risk-based categorisation of animal by-products which determines whether they may be used as animal feedingstuffs, for the manufacture of technical products or for other purposes, or whether they must be destroyed;
  • an obligation for Member States and operators to ensure that animal by-products are collected and disposed of as soon as possible;
  • the exclusion of products that are unfit for hum an consumption from the feed chain for farmed animals; and lastly
  • a ban on feeding animals of one species with material derived from the same species (“intra-species recycling ban”).

A more coherent legal framework

Animal by-products are used to produce cosmetics, medicines and diagnostic medical devices. When they are used for the manufacture of such products, they are subject to other provisions of European law. Slaughterhouses, milk factories and other food establishments manufacturing animal by-products are already bound by European legislation on human food or animal feedingstuffs, and are the subject of inspections in this regard.

This Regulation aims at improving coherency between other provisions of European law and the health rules applying to animal by-products. The potential risks are tackled with respect to the appropriate legislation, which avoids operators being exposed to unnecessary constraints.

Being based on experience gained, this Regulation clarifies under which circumstances and in what way environmental legislation shall apply to operations involving animal by-products. This legislation applies for example where the spreading of manure as a fertiliser has effects on soil and the groundwater table.

Comitology

The current categorisation of animal by-products may now be amended by the Commission under the comitology procedure. Prior to any change, a scientific organisation such as the European Food Safety Authority (EFSA) or the Scientific Committee for Consumer Products (SCCP) must assess the possible risks of a specific animal by-product for public and animal health.

Repeal

Regulation (EC) No 1774/2002 shall be repealed with effect from 4 March 2011.

Key terms of the Act
  • Animal by-products: entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption, including oocytes, embryos and semen.
  • Derived products: products obtained from one or more treatments, transformations or steps of processing of animal by-products.
Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 41/2009

10.2.2009

OJ L 16 of 21.1.2009

Undesirable substances in animal feed

Undesirable substances in animal feed

Outline of the Community (European Union) legislation about Undesirable substances in animal feed

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Undesirable substances in animal feed

Document or Iniciative

Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed [See amending act(s)].

Summary

This Directive sets maximum levels to limit as far as possible the presence of undesirable substances and products in animal feed put into circulation within the European Union (EU).

Undesirable substances

“Undesirable substance” means any substance or product, with the exception of pathogenic agents, which is present in and/or on the product intended for animal feed and which presents a potential danger to animal or human health or to the environment or could adversely affect livestock production. The range of substances covered by the Directive comprises arsenic, lead, mercury, dioxin and certain mustards.

This Directive applies to all products intended for animal feed, including raw materials for feed, additives and complementary feedingstuffs.

List of undesirable substances

The Directive lays down a list of undesirable substances, for which it sets limit values above which their presence in animal feeds is forbidden (see Annex I to the Directive). This list is regularly updated in the light of technical progress.

Investigations

When these maximum levels are exceeded, Member States, in cooperation with the economic operators concerned, must carry out investigations to identify the sources of the substances concerned. They must then inform the Commission of the outcome of these investigations and the measures taken to reduce the level of the substances or eliminate them.

Mixtures

To prevent fraud, the Directive prohibits mixing a product containing undesirable substances with the same product or other products in order to dilute it.

Temporary provisions

There can be no derogations from the Directive. However, where a danger to human or animal health or to the environment becomes apparent, Member States may provisionally take more stringent measures, reducing the maximum level set in the Directive.

Context

Following the dioxin crisis in the late 1990s, the EU made many changes to European undesirable substances in order to improve food security and to better protect human and animal health and the environment.

Directive 2002/32/EC replaces Directive 1999/29/EC as from 1 August 2003.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 2002/32/EC

30.5.2002

1.5.2003

OJ L 140, 30.5.2002

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, 31.3.2009

The successive amendments and corrections to Directive 2002/32/EC have been incorporated into the original text. This consolidated versionis of documentary value only.

Related Acts

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.

In the context of the review of food hygiene legislation (“hygiene package”), this Regulation re-organises official controls of food and feed so as to integrate controls at all stages of production and in all sectors. The Regulation defines the European Union’s duties as regards the organisation of these controls, as well as the rules which must be respected by the national authorities responsible for carrying out the official controls, including coercive measures adopted in the event of failure to comply with Community law.

Animal by-products not intended for human consumption

Animal by-products not intended for human consumption

Outline of the Community (European Union) legislation about Animal by-products not intended for human consumption

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Animal by-products not intended for human consumption

The food crises of the 1990s highlighted the part played by animal by-products not intended for human consumption in the spread of certain infectious diseases. Such by-products must be kept out of the food chain. This Regulation therefore establishes strict health rules for their use, so as to ensure a high level of health and safety. In particular, it prohibits intra-species recycling.

Document or Iniciative

Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption [See amending acts].

Summary

Regulation (EC) No 178/2002 constitutes the cornerstone of the new European legislation on food safety. Adopting the “from farm to table” approach, it aims, by drawing on the latest scientific opinions, to guarantee a high standard of health and safety throughout the food chain.

Animal by-products are defined as the entire bodies or parts of bodies of animals or products of animal origin not intended for human consumption, including ova, embryos and sperm. They represent more than 15 million tonnes of meat, dairy products and other products, including manure . These materials are then disposed of or processed and re-used in many different sectors, including the cosmetics or pharmaceuticals sectors, as well as being used for other technical purposes.

Following the food crises of the 1990s, such as the bovine spongiform encephalopathy (BSE) epidemic, the role of these by-products in propagating transmissible animal diseases was brought to light. Composed of eight independent scientific experts, the Scientific Steering Committee then concluded that products derived from animals declared unfit for human consumption must not enter the food chain. Moreover, the administration to any animal of proteins obtained by processing carcasses of the same species – or cannibalism – may constitute an additional risk of disease propagation.

This Regulation sets out the measures to be implemented for the processing of animal by-products.

SCOPE

This Regulation lays down the health and surveillance rules applicable to:

  • the collection, transport, storage, handling, processing and use or disposal of animal by-products;
  • the placing on the market and, in certain specific cases, the export and transit of animal by-products and products derived therefrom.

It does not apply to:

  • raw petfood originating from retail shops;
  • liquid milk and colostrum used on the farm of origin;
  • entire bodies (or parts) of healthy wild animals, except for fish landed for commercial purposes and animals used to produce game trophies;
  • raw petfood for use on site, derived from animals slaughtered on the farm of origin for use as foodstuffs by the farmer and his family only, in accordance with national legislation;
  • catering waste, unless it is destined for animal consumption, it is destined for use in a biogas plant or for composting or it comes from means of transport operating internationally;
  • ova, embryoes and sperm intended for breeding purposes;
  • transit by sea or by air.

CLASSIFICATION OF ANIMAL BY-PRODUCTS

Category 1 material

Category 1 material comprises the following animal by-products:

  • all body parts body, including hides and skins, of animals suspected of being infected by a transmissible spongiform encephalopathy (TSE) or in which the presence of a TSE has been confirmed, animals killed in the context of TSE eradication measures, pet animals, zoo animals and circus animals, experimental animals, wild animals suspected of being infected with a communicable disease;
  • specified risk material as tissues likely to carry an infectious agent;
  • products derived from animals that have absorbed prohibited substances or substances containing products dangerous for the environment;
  • all animal material collected when treating waste water from category 1 processing plants and other premises in which specified risk material is removed;
  • catering waste from means of transport operating internationally;
  • mixtures of category 1 with category 2 and/or category 3 material.

Intermediate handling and storage of category 1 material must take place in approved intermediate establishments of the same category. Collected, transported and identified without delay, this material shall be:

  • directly disposed of as waste by incineration in an approved incineration plant;
  • processed in an approved plant by a specific method, in which case the resulting material shall be marked and finally disposed of as waste by incineration or co-incineration;
  • with the exclusion of material coming from carcasses of animals infected (or suspected of being infected) with a TSE, processed by a specific method in an approved plant, in which case the resultant material shall be marked and finally disposed of as waste by means of burial in an approved landfill;
  • in the case of catering waste, disposed of by burial in a landfill.

Category 2 material

Category 2 material comprises the following animal by-products:

  • manure and digestive tract content;
  • all animal materials other than those belonging to category 1 collected when treating waste water from slaughterhouses;
  • products of animal origin containing residues of veterinary drugs and contaminants in concentrations exceeding the Community limits;
  • products of animal origin, other than category 1 material, that are imported from third countries and fail to comply with the Community veterinary requirements;
  • animals other than category 1 that have not been slaughtered for human consumption;
  • mixtures of category 2 and category 3 material.

Except in the case of manure, the intermediate handling and storage of category 2 material must take place in approved intermediate establishments of the same category. Collected, transported and identified without delay, this material shall be:

  • directly disposed of as waste by incineration in an approved incineration plant;
  • processed in an approved plant by a specific method, in which case the resultant material shall be marked and finally disposed of as waste;
  • ensiled or composted in the case of material derived from fish;
  • in the case of manure, digestive tract content, milk and colostrum not presenting any risk of spreading a communicable disease, either a) used without processing as raw material in a biogas or composting plant or treated in a technical plant, or b) applied to land;
  • used in a technical plant to produce game trophies.

Category 3 material

Category 3 material comprises the following animal by-products:

  • parts of slaughtered animals which are fit for human consumption but are not intended for human consumption for commercial reasons;
  • parts of slaughtered animals which are rejected as unfit for human consumption but are not affected by any sign of a communicable disease;
  • hides and skins, hooves and horns, pig bristles and feathers originating from animals that are slaughtered in a slaughterhouse and were declared fit for human consumption after undergoing an ante mortem inspection;
  • blood obtained from animals declared fit for human consumption after undergoing an ante mortem inspection, other than ruminants slaughtered in a slaughterhouse;
  • animal by-products derived from the production of products intended for human consumption, including degreased bones and greaves;
  • former foodstuffs of animal origin, other than catering waste, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects;
  • raw milk originating from animals that do not show any signs of a communicable disease;
  • fish or other sea animals, except sea mammals, caught in the open sea for the purpose of fishmeal production, and fresh by-products from fish from plants manufacturing fish products for human consumption;
  • shells of eggs originating from animals that do not show any signs of a communicable disease;
  • blood, hides and skins, hooves, feathers, wool, horns, hair and fur originating from healthy animals;
  • catering waste other than category 1.

Intermediate handling and storage of category 3 material must take place in approved intermediate establishments of the same category. Collected, transported and identified without delay, this material shall be:

  • directly disposed of as waste by incineration in an approved incineration plant;
  • used as raw material in a petfood plant;
  • processed by a specific method in an approved processing, technical, biogas or composting plant;
  • composted or processed in a biogas plant in the case of category 3 catering waste;
  • in the case of raw material of fish origin, ensiled or composted.

COLLECTION, TRANSPORTATION, STORAGE, DISPATCH

With the exception of category 3 catering waste, animal by-products and processed products shall be collected, transported and identified. The regulatory procedure concerns identification and labelling of raw materials in the three categories, equipment of vehicles and containers, commercial documents, health certificates and transportation conditions. Records must be kept of all dispatches.

For the dispatch of animal by-products and processed products, the Member State of destination must have authorised the receipt of category 1 and 2 material and of processed animal proteins. Duly identified, any batch of animal by-products must be conveyed directly to the plant of destination. Information is exchanged between the Member States’ competent authorities via the TRACES system.

APPROVAL

Intermediate and storage establishments

Category 1, 2 and 3 intermediate and storage establishments shall be subject to approval by the competent authority. To be approved, they must meet the requirements of the Regulation aimed at preventing any risk of transmissible disease propagation.

Hygiene requirements relate to: the layout of premises, the type of facilities, staff hygiene, protection against pests (insects, rodents and birds), waste water disposal, storage temperature, cleaning and disinfection of containers and transport vehicles other than ships.

The competent authority must check these establishments regularly; in addition, intermediate establishments must apply specific own-check procedures. The competent authority shall suspend approval immediately if the conditions under which it was granted are no longer fulfilled.

Incineration and co-incineration plants

Directive 2000/76/EC defines the conditions for the incineration of waste from processed products. Where this Directive does not apply to certain animal by-products, they are disposed of in accordance with the present Regulation.

The competent authority shall approve high- and low-capacity plants. Used only for the disposal of pet animals, specified risk material and category 2 and/or category 3 material, low-capacity plants must meet strict requirements regarding the equipment and maintenance of premises, operating conditions (gaseous releases, temperature), waste water, residues (ash, slag, dust), temperature measurement and the conditions for incinerating specified risk material.

Approval shall be suspended immediately if the requirements in force are no longer met.

Category 1 and 2 processing plants

Category 1 and 2 processing plants shall be subject to approval by the competent authority, which validates and checks the manufacturing processes. To be approved, these plants must meet the requirements of the Regulation regarding: the layout of premises, the type of facilities, staff hygiene, protection against pests (insects, rodents and birds), waste water disposal, storage, cleaning and disinfection of the site and vehicles.

Depending on the category of animal by-products, seven processing methods may be used. Described in Annex V, these methods vary according to the particle size of the raw material, the temperature reached during heat treatment, the pressure applied and the duration of the process, one of them being specific to animal by-products of fish origin. Method No 1 shall be applied to:

  • category 2 material – other than manure, digestive tract content, milk and colostrum – destined for a biogas or composting plant or intended for use as organic fertilisers or soil improvers;
  • category 1 and 2 material to be disposed of in a landfill;
  • processed mammalian proteins.

The methods numbered from 1 to 5 are applied to:

  • category 2 raw material intended for incineration after processing;
  • category 1 and 2 material intended for incineration.

For each of the processing methods, identification of the critical points determining the intensity of heat treatment is essential. These critical points include: the particle size of the raw material, the temperature reached during heat treatment, the pressure applied and the duration of the process.

Approval shall be suspended immediately if the conditions under which it was granted are no longer fulfilled.

Category 3 processing plants

Category 3 processing plants shall be subject to approval by the competent authority. To be approved, these plants must meet the requirements regarding the layout of the premises, the type of facilities, hot water production capacity, heat treatment, protection against pests, waste water disposal, cleaning and disinfection of the site.

Only category 3 raw material – apart from blood, hides and skins, hooves, feathers, wool, horns, hair and fur of animals unfit for human consumption but not show any signs of a communicable disease, as well as catering waste – may be used for the production of processed animal proteins and other raw material for animal feed. Prior to any processing, the animal by-products must be subjected to a check to detect the presence of foreign bodies such as packaging material or pieces of metal.

For each of the processing methods used, the critical points determining the intensity of the heat treatment must be identified: particle size, temperature, pressure, duration of the process. Specific requirements are applicable, depending on whether the method involves processed animal proteins (e. g. method No 1 for mammalian proteins), blood products, rendered fats and fish oils, (products based on) milk and colostrum, gelatine and hydrolysed proteins, dicalcium or tricalcium phosphate.

The competent authority shall approve and inspect processing plants and shall suspend approval immediately if the requirements of the Regulation are no longer met. The plants must also introduce own-check procedures.

Category 2 and 3 oleochemical plants

Oleochemical plants shall be subject to approval by the competent authority. To be approved, these plants must process rendered fats derived from category 2 or 3 material in accordance with the standards laid down in the Regulation and establish and implement critical point monitoring and control methods. The authority shall inspect the plants and suspend approval if the conditions under which it was granted are no longer fulfilled.

Biogas and composting plants

Biogas and composting plants shall be subject to approval by the competent authority. The conditions for obtaining approval relate to the nature and equipment of the plants. In addition, these plants must implement critical point monitoring and control methods. Approval shall be suspended immediately if the conditions under which it was granted are no longer fulfilled.

Only the following animal by-products may be processed in a biogas or composting plant:

  • category 2 material subjected to processing method No 1 in a category 2 processing plant;
  • manure and digestive tract content separated from the digestive tract, milk and colostrum;
  • category 3 material.

There are specific hygiene and processing requirements for biogas and composting plants.

Petfood plants and technical plants

Plants producing petfood, articles for chewing and technical products shall be subject to control and approval by the competent authority.

The Regulation sets out the hygiene rules specific to:

  • petfood and articles for chewing;
  • manure;
  • blood and blood products;
  • serum from equidae;
  • hides and skins of ungulates;
  • game trophies;
  • wool;
  • unprocessed hair, unprocessed pig bristles, unprocessed feathers and parts of feathers;
  • apiculture products;
  • bones, horns, hooves intended for purposes other than as raw material for animal feed, organic fertilisers or soil improvers;
  • animal by-products intended for the manufacture of petfood, pharmaceuticals and other technical products;
  • rendered fats intended for an oleochemical use;
  • fat derivatives;
  • flavouring innards used in the manufacture of petfood.

The plants must establish and implement critical point monitoring and control methods on the basis of the process used. Depending on the products, they must take samples for laboratory analysis. The competent authority shall carry out checks and suspend approval if the conditions under which it was granted are no longer fulfilled.

PLACING ON THE MARKET AND USE OF PROCESSED PROTEINS

The Member States must be able to guarantee that animal by-products and processed products do not come from a geographical zone subject to health restrictions. In certain cases, animal by-products may originate from such a zone if they are neither infected nor suspected of being infected, are correctly identified and meet the hygiene requirements laid down in the Regulation.

Placing on the market and export of processed animal proteins used as feed material

Only animal proteins handled, processed, stored and transported in accordance with the provisions of the Regulation may be placed on the market. Produced in a category 3 processing plant, they must be prepared exclusively from material of the same category.

Placing on the market and export of petfood, articles for chewing and technical products

Only petfood, articles for chewing and technical products which meet the specific requirements of the Regulation and come from approved and inspected plants may be placed on the market.

Fat derivatives, placed on the market or exported, must be produced from category 2 or 3 material and prepared in an oleochemical plant; they must meet the requirements of the Regulation relating to processing and handling.

Safeguard measures

In the event of an outbreak of an epizootic disease that may constitute a risk to health, the Member State of dispatch must take – in accordance with the legislation in force – all necessary measures to eradicate the disease and, in particular, must demarcate the affected area. The Member State of destination must take the preventive measures laid down in Community legislation. These provisions apply to movements of animal by-products.

It is prohibited to:

  • feed a species with processed animal proteins derived from the bodies or parts of bodies of animals of the same species (cannibalism);
    Following a consultation of the Scientific Committee, which came out in favour, fish and fur animals are exempt from this ban.
  • feed farmed animals other than fur animals with catering waste;
  • apply organic fertilisers and soil improvers, other than manure, to pasture land.

DEROGATIONS

Derogations regarding the use of animal by-products

Under the supervision of the competent authority, the Member States may authorise the use of animal by-products for diagnostic, educational and research purposes, as well as for taxidermy purposes in approved technical plants.

Animal by-products derived from category 2 and 3 material – except for blood, hides and skins, hooves, feathers, wool, horns, hair and fur from animals unfit for human consumption but not showing any signs of a communicable disease – may be used for the feeding of the following animals:

  • zoo and circus animals;
  • reptiles and birds of prey;
  • fur animals;
  • wild animals the meat of which is not destineded for human consumption;
  • dogs from recognised kennels or packs of hounds;
  • maggots for fishing bait.

Following a consultation of the Scientific Committee, which expressed a favourable opinion, the Member States may authorise the use of entire bodies of category 1 animals containing specified risk material for the feeding of endangered or protected species of necrophagous birds (griffon vultures).

Member States must inform the Commission of the use made of the derogations and the verification arrangements introduced. They must draw up a list of authorised users and collection centres registered on their territory and assign them an official number.

Derogations regarding the disposal of animal by-products

The direct burial of dead pet animals is authorised only in limited cases.

Certain animal by-products originating in remote areas may be disposed of as waste by burning or burial on site. This concerns the bodies of pet animals and category 1 animals containing specified risk material, category 2 and 3 material originating in remote areas or animal by-products that can be burnt or buried on site in the event of an outbreak of a disease included in list A of the International Office for Epizootics (OIE).

No derogation may be granted for animals suspected of being infected with a TSE.

CONTROLS AND INSPECTIONS

Plants’ own checks

Operators and owners of intermediate establishments and processing plants must put in place a permanent procedure developed in accordance with the principles of the system of hazard analysis and critical control points (HACCP). They must:

  • identify the critical points in order to establish a monitoring and control method;
  • in the case of a processing plant, take samples for analysis;
  • record the results of checks and tests and keep them for a period of at least two years;
  • introduce a system ensuring the traceability of each batch dispatched.

Where the results of a test on samples do not comply with the provisions of the Regulation, the operator of the plant must notify the competent authority immediately, establish the causes of failures of compliance, stop the dispatch of contaminated material, increase the frequency of testing of production and take appropriate steps to decontaminate the plant.

Official controls and lists of approved establishments and plants

The competent authority shall inspect approved establishments and plants at regular intervals. In the case of processing plants, the supervision of production covers the following:

  • general conditions of hygiene of the premises;
  • equipment and staff;
  • the efficacy of the own checks carried out by the plant;
  • the standards of the products after processing;
  • storage conditions;
  • description of the process;
  • identification of critical control points (CCP).

The frequency of inspections and supervision shall depend on the size of the establishments and plants, the type of products manufactured and the risk assessment in accordance with the principles of the HACCP system.

Each Member State shall draw up a list of the approved establishments and plants within its territory and assign them an official identification number. It shall sends copies of the list and updated versions to the Commission and the other Member States.

Community controls in the Member States

Experts from the Commission experts may make on-the-spot checks in cooperation with the competent authorities of the Member States. The Commission shall inform the Member State’s competent authority of the results of the checks made.

IMPORTATION AND TRANSIT OF CERTAIN ANIMAL BY-PRODUCTS

The provisions applicable to the importation of animal by-products from third countries shall provide equivalent guarantees to those applicable to the production and marketing of these products in the Community.

Imported products must come from a third country on an updated list which takes account of criteria relating to that country’s legislation and health situation. Similarly, establishments and plants producing for export to the European Union shall be approved by the competent authority in the third country and entered on a Community list. Pending the compilation of such lists, the Member States may maintain the controls provided for in Directive 97/78/EC.

A health certificate, which may be drawn up according to various models shown in the Regulation, shall identify the product and certify that it is safe.

Experts from the Commission may make on-the-spot checks with a view to drawing up the list of third countries and verifying compliance with import and/or transit conditions. The Commission shall meet the costs incurred for these checks. If a check reveals a serious infringement of the health rules, the Commission shall immediately ask the third country to take appropriate measures or shall suspend consignments to the Union and immediately inform the Member States.

According to the product concerned, the lists of third countries from which the Member States may authorise imports of animal by-products are given in Annex XI of the Regulation.

FINAL PROVISIONS

After consultation of the appropriate scientific committee on any question that could have an impact on animal health or public health, the Annexes may be amended or supplemented and any appropriate transitional measures may be adopted by a decision of the Commission.

The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health and by the appropriate scientific committees.

National provisions

Within one year of the entry into force of the Regulation, the Member States shall communicate to the Commission the text of the provisions of any national law that they adopt in order to comply with the new Community provisions.

On the basis of the information received, the Commission shall submit to the European Parliament and the Council a detailed report accompanied, if appropriate, by legislative proposals. It shall also prepare a report on the financial arrangements in by the Member States for the processing, collection, storage and disposal of animal by-products.

The Member States may adopt or maintain more restrictive national rules concerning the use of organic fertilisers and soil improvers and of fat derivatives produced from category 2 raw material.

Repeal

Directive 90/667/EEC and Decisions 95/348/EC and 1999/534/EC shall be repealed with effect from six months after the entry into force of the Regulation.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1774/2002 30.10.2002 OJ L 273 of 10.10.2002

DEROGATION

Decision 2003/324/EC [Official Journal L117 of 13.05.2003]

This derogation is granted to Finland and Estonia with regard to the intra-species recycling of fur animals (fox and raccoon dog) with processed animal protein derived from the bodies or parts of bodies of animals of the same species.

See consolidated version (pdf)

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 808/2003 13.05.2003 OJ L 117 of 13.05.2003

Successive amendments and corrections to Regulation (EC) No 1774/2002 have been incorporated into the original text. The consolidated version (pdf ) is intended purely as a documentation tool.

CHANGES TO THE ANNEXES

Annexe I – Specific definitions:
Regulation (EC) No 808/2003 [Official Journal L 117 of 13.05.2003];
Regulation (EC) No 668/2004 [Official Journal L 112 of 19.04.2004];
Regulation (EC) No 181/2006 [Official Journal L 29 of 2.2.2006];
Regulation (EC) No 829/2007 [Official Journal L 191 of 21.7.2007];
Regulation (EC) No 1432/2007 [Official Journal L 320 of 6.12.2007].

Regulation (EC) No 777/2008 [Official Journal L 207 of 5.8.2008].

Annexe II – Hygiene requirements for collection and transport:
Regulation (EC) No 808/2003 [Official Journal L 117 du 13.05.2003];
Regulation (EC) No 93/2005 [Official Journal L 19 du 21.01.2005].
Regulation (EC) No 829/2007 [Official Journal L 191 of 21.7.2007];
Regulation (EC) No 1432/2007 [Official Journal L 320 of 6.12.2007].

Annexe III – Hygiene requirements for intermediate and storage plants:
Regulation (EC) No 808/2003 [Official Journal L 117 of 13.05.2003].

Annexe IV – Requirements for incineration and co-incineration plants to which Directive 2000/76/EC does not apply:
Regulation (EC) No 808/2003 [Official Journal L 117 of 13.05.2003];

Annexe V – General hygiene requirements for the processing of category 1, 2 and 3 material:
Regulation (EC) No 808/2003 [Official Journal L 117 of 13.05.2003];
Regulation (EC) No 93/2005 [Official Journal L 19 of 21.01.2005].
Regulation (EC) No 777/2008 [Official Journal L 207 of 5.8.2008]

Annexe VI – Specific requirements for the processing of category 1 and 2 material and for the production of biogas, for composting as well as for the marking of certain processed products:
Regulation (EC) No 808/2003 [Official Journal L 117 of 13.05.2003];
Regulation (EC) No 208/2006 [Official Journal L 36 of 08.02.2006];
Regulation (EC) No 1432/2007 [Official Journal L 320 of 6.12.2007].

Annexe VII – Specific hygiene requirements for the processing and placing on the market of processed animal protein and other processed products that could be used as feed material:
Regulation (EC) No 808/2003 [Official Journal L 117 of 13.05.2003] ;
Regulation (EC) No 668/2004 [Official Journal L 112 of 19.04.2004].
Regulation (EC) No 829/2007 [Official Journal L 191 of 21.7.2007].
Regulation (EC) No 437/2008 [Official Journal L 132 of 22.5.2008].

Regulation (EC) No 777/2008 [Official Journal L 207 of 5.8.2008].

Annexe VIII – Requirements for the placing on the market of petfood, dogchews and technical products:
Regulation (EC) No 808/2003 [Official Journal L 117 of 13.05.2003] ;
Regulation (EC) No 668/2004 [Official Journal L 112 of 19.04.2004];
Regulation (EC) No 208/2006 [Official Journal L 36 of 08.02.2006].
Regulation (EC) No 2007/2006 [Official Journal L 379 of 28.12.2006];
Regulation (EC) No 829/2007 [Official Journal L 191 of 21.7.2007].

Regulation (EC) No 399/2008 [Official Journal L 118 of 6.5.2008].

Regulation (EC) No 523/2008 [Official Journal L 153 of 12.6.2008].

Annexe IX – Rules applicable to the use of certain category 2 and category 3 material for the feeding of certain animals in accordance with Article 23(2):
Regulation (EC) No 808/2003 [Official Journal L 117 of 13.05.2003].

Annexe X – Model health certificates for the importation from third countries of certain animal by-products and products derived therefrom:
Regulation (EC) No 668/2004 [Official Journal L 112 of 19.04.2004].
Regulation (EC) No 2007/2006 [Official Journal L 379 of 28.12.2006];
Regulation (EC) No 829/2007 [Official Journal L 191 of 21.7.2007].

Regulation (EC) No 437/2008 [Official Journal L 132 of 22.5.2008].

Regulation (EC) No 523/2008 [Official Journal L 153 of 12.6.2008].

Annexe XI – List of third countries from which member states may authorise imports of animal by-products not intended for human consumption:
Regulation (EC) No 668/2004 [Official Journal L 112 of 19.04.2004];
Regulation (EC) No 416/2005 [Official Journal L 66 of 12.03.2005].
Regulation (EC) No 829/2007 [Official Journal L 191 of 21.7.2007].

Regulation (EC) No 437/2008 [Official Journal L 132 of 22.5.2008].

Regulation (EC) No 523/2008 [Official Journal L 153 of 12.6.2008].

Related Acts

PROPOSALS

Proposal for a Regulation of the European Parliament and of the Council laying down health rules as regards animal by-products not intended for human consumption (“Animal by-products Regulation”) [COM (2008) 345 final – Not published in the Official Journal].

In this proposal the basic framework of safeguards applicable to animal by-products (ABP) is maintained. Nevertheless, the regulations will be clarified and a more risk-based approach will be introduced. The proposal also aims to ensure that the health rules on ABP are consistent with other Community legislation. Finally this proposal specifies the circumstances and methods related to the implementation of environmental legislation and facilitates the use of materials of animal origin for technical uses.

Codecision Procedure (COD/2008/0110).

Commission Regulation (EC) No 1192/2006 of 4 August 2006 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards lists of approved plants in Member States [Official Journal L 215 of 5.8.2006].

Category 1 material

Commission Regulation (EC) No 92/2005 of 19 January 2005 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards means of disposal or uses of animal by-products and amending its Annex VI as regards biogas transformation and processing of rendered fats [Official Journal L 19 of 21.1.2005].

Commission Regulation (EC) No 811/2003 of 12 May 2003 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the intra-species recycling ban for fish, the burial and burning of animal by-products and certain transitional measures [Official Journal L 117 of 13.5.2003].

Commission Decision 2003/322/EC [Official Journal L 117 of 13.5.2003]

(Use of category 1 materials for the feeding of certain necrophagous birds)

See consolidated text (pdf ).

Category 3 material

Commission Regulation (EC) No 79/2005 [Official Journal L 16 of 20.1.2005]

(the use of milk, milk-based products and milk-derived products, defined as Category 3 material).

See consolidated version (pdf ).

TRANSITIONAL MEASURES

Commission Regulation (EC) No 197/2006 of 3 February 2006 on transitional measures under Regulation (EC) No 1774/2002 as regards the collection, transport, treatment, use and disposal of former foodstuffs [Official Journal L 32 of 4.2.2006].
Member States can authorise the collection, transport, treatment and use and disposal of former foodstuffs of animal origin or containing products of animal origin not intended for human consumption, which carry no risk for human or animal health. This transitional measure is valid until 31 July 2009.

Regulation (EC) No 878/2004 [Official Journal L 162 of 30.4.2004]

(importation and placing on the market of certain by-products from categories 1 and 2.

REPORTS

Report from the Commission to the Council and the European Parliament of 21 October 2005 on the measures taken by Member States to ensure compliance with regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption [COM(2005) 521 – Official Journal C 49 of 28.02.2006].

 

Feed hygiene

Feed hygiene

Outline of the Community (European Union) legislation about Feed hygiene

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Feed hygiene

Document or Iniciative

Regulation 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene [See amending act(s)].

Summary

This Regulation requires feed business operators to comply with obligations relating to hygiene and traceability and the registration and approval of their establishments. The objective is to achieve a high level of protection of human and animal health, notably by ensuring that feed is safe and of good quality.

Scope

The Regulation applies to the activities of feed business operators, starting with primary production of feed * up to and including its placing on the market and imports of products intended for animal nutrition from third countries. This also includes the feeding of food-producing animals.

The following are excluded from the scope of this Regulation:

  • the private domestic production of feed for food-producing animals intended for private domestic consumption and for animals not intended for food production, and the feeding of these animals;
  • the direct supply of small quantities of primary products at local level by the producer to local farms;
  • the retailing of pet food.

Obligations incumbent on operators

Feed business operators responsible for the primary production of feed must take the measures necessary to prevent, eliminate or reduce feed safety hazards during the production, preparation, cleaning, packaging, storing and transport of these products (Annex I). These operators must keep records relating to measures put in place to control contamination hazards.

Feed business operators other than at the level of primary production of feed must adopt appropriate measures to guarantee the safety of the products that they manufacture, transport or use. These measures are detailed more precisely than those concerning the primary production of feed (Annex II) and chiefly concern facilities and equipment used by the operators, staff training, the organisation and monitoring of different stages of production, and the documents which the operators must keep.

Feed business operators other than at the level of primary production of feed must apply HACCP principles (hazard analysis and critical control points) and must keep documents demonstrating that they respect these principles.

These principles prescribe a certain number of requirements to be met throughout the cycle of production, processing and distribution in order to permit, via hazard analysis, identification of the critical points which need to be kept under control in order to guarantee food safety:

  • identify any hazards that must be prevented, eliminated or reduced to acceptable levels;
  • identify the critical control points at the step or steps at which control is essential;
  • establish critical limits beyond which intervention is necessary;
  • establish and implement effective monitoring procedures at critical control points;
  • establish corrective actions when monitoring indicates that a critical control point is not under control;
  • implement own-check procedures to verify whether the measures adopted are working effectively;
  • keep records to demonstrate the effective application of these measures and to facilitate official controls by the competent authority.

Feed business operators are responsible for any infringement of the law governing feed safety. In order to prepare an effective system of financial guarantees for operators in this sector, the Commission presents a report on financial guarantees in the feed sector to the European Parliament and the Council (see “Related Acts”).

Feed business operators (including those responsible for the primary production of feed) must register their establishments with the competent authority of their Member State. They must provide the authority with up to date information and cooperate with it in the event of controls.

Where required by national or Community legislation, businesses in the food sector must be approved by the competent authority and may not operate without such approval. The competent authority of each Member State must keep a list of approved establishments. When an approved establishment no longer complies with the requirements governing its activities, the approval may be temporarily suspended or revoked.

Operators who import products from third countries must ensure that:

  • the country concerned is included in a list drawn up pursuant to Regulation (EC) No 882/2004 on official controls of food and feed;
  • the supplier is entered in a list kept by the third country testifying to the firm’s conformity with Community hygiene standards or equivalent standards.

Guides to good practice

The Member States encourage the preparation of national guides to good practice in the feed sector and national guides on the application of HACCP principles. Member States must assess such national guides to ensure that their contents are practicable, that they have been developed taking into account the appropriate principles of the Codex Alimentarius and that all interested parties have been consulted. National guides deemed to be in conformity are forwarded to the Commission, which enters them in a register.

Standardised Community guides may be prepared if the Commission considers this advisable. The Standing Committee on the Food Chain ensures that the content of such guides is practicable, that they have been prepared taking into account the appropriate principles of the Codex Alimentarius, and that the national guides and all the interested parties have been consulted.

BACKGROUND

Regulation (EC) No 178/2002 constitutes the cornerstone of the new European legislation on food safety. Adopting the “from farm to table” approach, it aims, by drawing on the latest scientific opinions, to guarantee a high standard of health and safety throughout the food chain. This approach also covers the entire animal feed chain, including the primary production of feed (which is not covered by the old legislation), animal nutrition and the production of feed.

Following the recent health crises and the occurrences of contamination of animal feed and feed materials (bovine spongiform encephalopathy, dioxin, hormones, etc.), the European Union is equipped with an appropriate legal instrument to ensure safety of all kinds of feed, to ensure that all feed businesses operate in accordance with harmonised hygiene requirements, and to improve traceability.

The Regulation replaces Directive 95/69/EC.

Key terms used in the act

Primary production of feed: production of agricultural products, notably including cultivation, harvesting, milking, breeding (before slaughter) or fishing, terminating exclusively in products which have not been subjected to any other processing after harvesting, gathering or capture, with the exception of simple physical processing.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 183/2005

8.02.2005

OJ L 35 of 8.02.2005

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

Related Acts

Report from the Commission to the European Parliament and the Council on existing legal provisions, systems and practices in the Member States and at Community level relating to liability in the food and feed sectors and on feasible systems for financial guarantees in the feed sector at Community level in accordance with Article 8 of Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene [COM(2007) 469 – Not published in the Official Journal].

This report consitutes the basis for a system of financial guarantees for feed business operators. On the basis of Regulation (EC) No 183/2005, which assigns to operators financial liability for infringements of Community legislation on the safety of animal feed, this report analyses the different guarantee options which could ensure enforcement of this liability in the framework of an efficient system. With this aim, the report takes account of the role of compulsory and optional insurance, bank guarantees and sectoral pooling systems. The report underlines the complexity of the problem and proposes launching a wide-ranging public debate on the various options. This debate is to take place over the two years following publication of the report and will take the opinions of all stakeholders into consideration.

Animal nutrition

Animal nutrition

Outline of the Community (European Union) legislation about Animal nutrition

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Animal nutrition

The agrifood sector in the European Union produces around 120 million tonnes of animal feedingstuffs annually. Good quality animal nutrition is essential, as it affects animal health and consequently food safety. Legislation on labelling and the circulation of animal feedingstuffs has been supplemented so as to shift the emphasis more towards the protection of human and animal health. In addition to the rules on hygiene and the monitoring of animal feedingstuffs, the EU thus regulates certain substances and products in order to limit or even prohibit their presence in animal feedingstuffs.

MISCELLANEOUS PROVISIONS

  • Feed hygiene
  • Undesirable substances in animal feed
  • Marketing of feed

OFFICIAL CONTROL OF ANIMAL FEEDINGSTUFFS

  • Official feed and food controls

ADDITIVES IN ANIMAL NUTRITION

  • Use of additives in feedingstuffs
  • Community strategy against antimicrobial resistance

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

  • Transmissible Spongiform Encephalopathies (TSEs)

GENETICALLY MODIFIED FEEDINGSTUFFS

  • Traceability and labelling of GMOs
  • Food and Feed (GMO)

ANIMAL WASTE AND PATHOGENIC AGENTS

  • Animal by-products
  • Animal by-products not intended for human consumption

OTHER FEEDINGSTUFFS

  • Preparation and marketing of medicated foodstuffs for animals
  • Animal nutrition: specifications on certain proteins

Animal nutrition: specifications on certain proteins

Animal nutrition: specifications on certain proteins

Outline of the Community (European Union) legislation about Animal nutrition: specifications on certain proteins

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Animal nutrition: specifications on certain proteins

The European Union regulates the use of products manufactured by certain technical processes which act as direct or indirect protein sources and are put into circulation within the Community as feedingstuffs or in feedingstuffs.

Document or Iniciative

Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition [See amending acts].

Summary

The basic Directive concerns products manufactured by certain technical processes which act as direct or indirect protein sources and are put into circulation within the European Union (EU) as feedingstuffs or in feedingstuffs. Specifically, these are substitution products developed by the feedingstuffs industry.

Since these products are obtained using new manufacturing techniques, it is necessary to regulate their marketing in the EU as feedingstuffs or constituents of feedingstuffs by prescribing, for each group concerned, which individual products are authorised and under what conditions of use.

Before including a new product in one of the groups concerned, it must be ascertained that it has the required nutritional value. It must also be established that these products, when used sensibly, have no detrimental effect on human or animal health or on the environment and do not harm the consumer by impairing the distinctive features of animal products.

In certain cases it is essential to provide for labelling to protect the user against fraud and to facilitate the optimal use of the products available to him.

The products in question are listed in the annex. Provision has been made for a Community procedure to adapt the provisions of the annex and the guidelines laid down for the submission of dossiers relating to certain products and, where necessary, to fix criteria of composition and purity as well as the physico-chemical and biological properties of these products in the light of the development of scientific and technical knowledge. In the event of amendment of the annex, the European Food Safety Authority must be consulted.

Member States must prescribe that the products listed in the annex may not be marketed as feedingstuffs or incorporated in feedingstuffs unless any particulars laid down in the annex appear on the package or container or on a label attached thereto.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 82/471/EEC 15.07.1982 15.07.1984 OJ L 213 of 21.07.1982
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Directive 84/443/EEC 27.07.1984 30.06.1985 OJ L 245 of 14.09.1984
Directive 85/509/EEC 13.11.1985 30.06.1986 OJ L 314 of 07.11.1985
Directive 86/530/EEC 29.10.1986 30.06.1988 OJ L 312 of 07.11.1986
Directive 88/485/EEC 29.07.1988 30.06.1989 OJ L 239 of 30.08.1988
Directive 89/520/EEC 14.09.1989 31.12.1990 OJ L 270 of 19.09.1989
Directive 90/439/EEC 25.07.1990 30.06.1991 OJ L 227 of 21.08.1990
Directive 93/26/EEC 22.07.1993 31.03.1994 OJ L 179 of 22.07.1993
Directive 93/56/EEC 07.07.1993 30.06.1994 OJ L 206 of 18.08.1993
Directive 93/74/EEC 23.09.1993 30.06.1995 OJ L 237 of 22.09.1993
Directive 95/33/EC 07.08.1995 30.06.1996 OJ L 167 of 18.07.1995
Directive 96/25/EC 12.06.1996 30.06.1998 OJ L 125 of 23.05.1996
Directive 1999/20/EC 25.03.1999 30.09.1999 OJ L 80 of 25.03.1999
Directive 2003/104/EC 20.11.2003 20.05.2004 OJ L 295 of 13.11.2003
Regulation (EC) No 1829/2003 11.07.2003 OJ L 268 of 18.10.2003
Regulation (EC) No 1882/2003 20.11.2003 OJ L 284 of 31.10.2003
Directive 2004/116/EC 31.12.2004 30.06.2005 OJ L 379 of 24.12.2004

Related Acts

Directive 83/228/EEC [Official Journal L 126 of 13.05.1983]
Council Directive of 18 April 1983 on the fixing of guidelines for the assessment of certain products used in animal nutrition.

Decision 85/382/EEC [Official Journal L 217 of 14.08.1985]

Commission Decision of 10 July 1985 prohibiting the use in feedingstuffs of protein products obtained from Candida yeasts cultivated on n-alkanes.

 

Use of additives in feedingstuffs

Use of additives in feedingstuffs

Outline of the Community (European Union) legislation about Use of additives in feedingstuffs

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Use of additives in feedingstuffs

Document or Iniciative

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [See amending act(s)].

Summary

The aim of this Regulation is to establish a standardised procedure for the authorisation and use of feed additives and to lay down rules for the labelling and supervision of these substances.

Scope

This Regulation applies to all feed additives * except:

  • processing aids *; and
  • veterinary medicinal products as defined by Directive 2001/82/EC.

Conditions for authorization

The applicant must prove that the additive for which it has submitted an application for authorisation for placing on the market complies with certain conditions, i.e.:

  • the additive must have a favourable influence on the characteristics of the feed into which it is incorporated or on animal production;
  • the additive must not have an adverse effect on animal health, human health or the environment;
  • the additive must not harm the consumer by impairing the distinctive features of animal products;
  • the presentation of the additive must not mislead the user.

Antibiotics, other than coccidiostats or histomonostats, may not be used as feed additives.

Authorisation procedure

Additives intended for use in animal feeds must receive a favourable opinion from the (EFSA) before obtaining an authorisation for their use and placing on the market.

Applications for authorisation are submitted to the Commission. The latter then ensures that the applications are notified to Member States before forwarding the applications to the EFSA. The applicant himself must send the EFSA the copy of the application and certain information (the name and address of the applicant, a description of the method of production, manufacturing and intended uses of the additive, proposed conditions for placing the additive on the market, the safety and efficacy studies, etc.). In addition, he must send samples to the Community Reference Laboratory for analysis. The EFSA may, if necessary, ask for further information.

Within six months of receipt of an application the EFSA gives an opinion based on the information provided by the applicant and on the evaluation report forwarded by the Community Reference Laboratory. If this opinion is favourable, it must include information on the specific conditions or restrictions relating to handling, monitoring requirements following placing on the market and use of the additive, including the animal species and categories of animals for which the additive is to be used, information on specific additional requirements for labelling of the additive, and, where appropriate, a proposal for the establishment of Maximum Residues Limits (MRLs) in the relevant foodstuffs of animal origin.

Based on the EFSA opinion, the Commission decides whether or not to authorise the additive. An authorisation is valid for ten years and may be renewed. An authorisation may be renewed by means of simplified provisions.

This Regulation contains provisions concerning the use of non-authorised additives for research purposes and provisions concerning the use of certain additives (in particular those produced from genetically modified organisms).

Persons using an authorised additive or placing it on the market are responsible for ensuring compliance with any conditions or restrictions imposed by the Commission.

Based on the opinion given by the EFSA, the Commission may decide to amend, suspend or revoke an authorisation.

Information on additives

The additives are entered in a register made available to the public. They are allocated to one or more of the following categories: technological additives; sensory additives; nutritional additives; zootechnical additives; coccidiostats and histomonostats. These categories are themselves divided into functional groups according to the additives’ principal functions.

Additives must be labelled clearly and indelibly and include certain information, including the specific name given to the additives upon authorisation and their identification number, the name and address of the person responsible for these particulars, the net weight or net volume of the additives, directions for use and any safety recommendations regarding use and, where applicable, the specific requirements mentioned in the authorisation.

Following the applicant’s request, certain information provided by the latter may remain confidential if the Commission considers that its disclosure is likely to compromise the rules on competition.

Background

Directives 70/524/EEC and 87/153/EEC are repealed but some of their provisions remain temporarily in force.

Key terms used in the act
  • Additives for animal feed: substances: micro-organisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more of the following functions: satisfy the nutritional needs of animals, favourably affect the characteristics of feed or animal products, the colour of ornamental fish and birds, the environmental consequences of animal production, animal production, performance or welfare, or have a coccidiostatic or histomonostatic effect.
  • Processing aid: a substance which is not consumed as a feedingstuff by itself, intentionally used in the processing of feedingstuffs or feed materials to fulfil a technological purpose during treatment or processing which may result in the unintentional but technologically unavoidable presence of residues of the substance or its derivatives in the final product.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) 1831/2003

7.11.2003

OJ L 268 of 18.10.2003

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 378/2005

25.3.2005

OJ L 59 of 5.3.2005

Regulation (EC) No 596/2009

7.8.2009

OJ L 188 of 18.7.2009

Regulation (EC) No 767/2009

21.9.2009

OJ L 229 of 1.9.2009

Successive amendments and corrections to Regulation (EC) No 1831/2003 have been incorporated into the basic text. This consolidated versionis for reference only.

Related Acts

Commission Regulation (EU) No 516/2010 of 15 June 2010 concerning the permanent authorisation of an additive in feedingstuffs [Official Journal L 150 of 16.6.2010].

Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives [Official Journal L 133 of 22.5.2008].
Applications for authorisation of a feed additive are presented using the form in Appendix I of the Regulation. They are accompanied by a dossier which should enable the efficacy and safety of the feed additive for humans, animals and the environment to be evaluated. For applications submitted before 21June 2008, the Appendix to Directive 87/153/EEC is still valid.

Official feed and food controls

Official feed and food controls

Outline of the Community (European Union) legislation about Official feed and food controls

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Official feed and food controls

Document or Iniciative

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. [See Amending Acts].

Summary

This Regulation is designed to fill in the loopholes in the existing legislation concerning the official control of food and feed thanks to a harmonised Community approach to the design and implementation of national control systems.

The purpose of this Regulation is:

  • to prevent or eliminate risks which may arise, either directly or via the environment, for human beings and animals, or reduce these risks to an acceptable level;
  • to guarantee fair practices as regards trade in food and feed and the protection of consumers’ interests, including labelling of food and feed and any other form of information intended for consumers.

Official controls are defined as “any form of control performed by the competent authority or by the Community for the verification of compliance with feed and food law, as well as animal health and animal welfare rules”.

This Regulation does not apply to official controls for the verification of compliance with the rules on common market organisations agricultural products.

OBLIGATIONS RELATING TO OFFICIAL CONTROLS

The basic principles related to responsibilities of the Member States’ authorities are already laid down in the Regulation (EC) No 178/2002, which lays down the general principles of food law. The present regulation describes in more detail how these principles must be interpreted and implemented.

The official controls carried out by the Member States must enable them to verify and ensure compliance with national and Community rules on feed and food. To this end, official controls must in principle be carried out at any stage of production, processing and distribution of feed and food. These controls are defined as a function of the identified risks, the experience and knowledge gained from previous controls, the reliability of the controls already carried out by the business operators concerned, and a suspicion of possible non-compliance.

Competent authorities

The Member States designate the competent authorities responsible for performing the official controls. These authorities must satisfy the operational criteria ensuring their effectiveness and their impartiality. They must also have the necessary equipment and suitably qualified staff (areas specified in Annex II) and have contingency pans. Internal or external audits may be carried out to ensure that the competent authorities are achieving the objectives of the Regulation.

When some of the controls are delegated to regional or local authorities, it is necessary to ensure effective cooperation between the central authority and these authorities.

The competent authority may delegate certain control tasks to non-governmental bodies provided these bodies meet the strictly defined conditions set out in this Regulation. Hence a procedure is therefore provided to define the tasks that can (or cannot) be delegated to such bodies. The adoption of coercive measures may not be delegated. The competent authority may proceed to audit or inspect the bodies to which the tasks have been delegated.

Transparency and confidentiality

The competent authorities must ensure that relevant information they hold is made available to the public, notably when there are reasonable grounds to suspect that food or feed may present a risk for human or animal health.

The staff of the competent authorities are required not to disclose information acquired when carrying out their control duties which by its nature is covered by professional secrecy.

Sampling and analysis

The methods of sampling and analysis used within the context of official controls must be fully validated in accordance with Community legislation or with internationally accepted protocols. These analysis methods must take into account the criteria set out in Annex III and must be implemented by laboratories approved to this end in compliance with the standards laid down by the European Committee for Standardisation (CEN).

Intervention plans

Contingency plans must be prepared which set out the measures to be implemented in the event of an emergency where feed or food have been found to pose a serious risk to humans or animals either directly or through the environment. These contingency plans specify the administrative authorities to be engaged together with their powers and responsibilities.

Controls on products from Non-EU Member Countries

This regulation supplements the provisions set out in Directive 97/78/EC concerning controls applicable to feed and food of animal origin. For example, it introduces the following principles for feed and food of non-animal origin:

  • regular official controls by the Member States of feed and food of non-animal origin imported into the European Union (EU). These controls can take place at any point of the distribution of the goods: before release for free circulation or afterwards, e.g. at the importer’s premises, during processing or at the point of retail sale. There shall in any way be a close co-operation between the customs services and the competent authority;
  • at Community level, a list of at-risk feed and food must be established and updated. Such feed and food must be presented at specially designated and equipped inspection posts for the carrying out of the necessary checks. These controls must be carried out at the point of entry in the EU before the goods are released for free circulation.
  • the possibility of carrying out official controls on feed and food originating in Non-EU Member Countries which enter into free zones and free warehouses or is placed in transit, customs warehousing, inward processing, processing under customs control or temporary admission.

The abovementioned controls include at least a documentary control, an identity control and, where relevant, a physical control.

In the case that non-compliance with the legislation is ascertained, the products may be seized or confiscated, and shall be destroyed, submitted to a special treatment, or re-dispatched outside the Community; the operator responsible for the consignment in question shall be liable for the costs incurred.

Specific pre-export checks performed by a Non-EU Member Country may be approved provided they satisfy the requirements of the Community or requirements which are at least equivalent. If such an approval is granted, the frequency of the controls carried out by the Member States may be adapted.

Financing of official controls

Member States must ensure that adequate financial resources are made available for official controls.

Inspection fees are imposed on feed and food business operators, common principles must be observed for setting the level of such fees and the methods and data used for the calculation of the fees must be published or otherwise made available to the public.

When official controls reveal non-compliance with feed and food law, the extra costs that result from more intensive controls must be borne by the feed and food business operator concerned.

Certification

This proposal provides for a procedure making it possible to specify the cases and conditions in which official certification must be granted.

Reference laboratories

A number of Community Reference Laboratories (CRLs) have been established (Annex VII) under Community legislation in force. They may be entitled to EU financial support and are responsible for:

  • providing national reference laboratories with details of analytical methods;
  • organising comparative testing, coordinating within their area of competence the practical and scientific activities necessary for developing new analytical methods;
  • conducting training courses;
  • providing scientific and technical assistance to the Commission.

For each CRL, Member States must ensure that one or more national reference laboratories are designated. These function as the point of communication between the CRL and all the official laboratories in the Member States.

ADMINISTRATIVE MEASURES

Assistance and cooperation

When the official controls require action by more than one Member State, the competent authorities must afford each other administrative assistance. This assistance may involve active cooperation, including participation in on-the-spot controls carried out by experts from one Member State in another Member State.

Each Member State must designate a single liaison body whose role is to assist and coordinate the communication, transmission and reception of requests for assistance. Where it receives a reasoned request (existence of a serious risk), the liaison body contacts the authorities concerned and ensures that the requesting authority is provided with all necessary information and documents enabling the latter to verify compliance with the law.

When the competent authority of a Member State receives information from a Non-EU Member Country, that authority must pass that information on to the competent authorities of the Member State which might be interested in it.

Administrative assistance applies to the exchange of all information, except that which cannot be released because of it being the subject of legal proceedings or because it may adversely affect the commercial interests of natural or legal persons.

National Control Plans

The Member States must prepare an integrated multi-annual national control plan. This plan, whose implementation must begin by 1 January 2007 at the latest, sets out the national control system and activities in a global and comprehensive way. The plan will have to be developed along the lines that are contained in guidelines to be established by the Commission in consultation with the Member States.

One year after starting the implementation of the national control plans, and subsequently every year, the Member States must submit to the Commission a report indicating an update of their initial control plan. The Commission must establish a general report on the overall operation of the official control systems on the basis of the national reports and the results of the audits which it has carried out. It passes this report on to the European Parliament and the Council and publishes it.

Community controls in the Member States

Until now, Community controls in the Member States were organised in function of the mandates the Commission has in the different sectoral Directives.. The creation of a single legal basis with this Regulation and the establishment of control plans will allow the EU control services to perform a general audit of the Member States’ control systems globally. If needed, these inspections and national audits performed by the Commission’s Food and Veterinary Office (FVO) can be supplemented by more specific audits and inspections for a particular sector or problem. For each control carried out, the Commission establishes a report on its findings and, where appropriate, this report contains recommendations which must be followed up by the Member States.

This Regulation also provides that Commission experts may carry out controls in Non-EU Member Countries and require that these countries have control plans comparable with those of the Member States in respect of the products they export to the European Union. These plans must be technically and economically feasible taking account of specific situation of the Non-EU Member Country as well as the nature of the products exported to the Community.

Non-EU Member Country controls in Member States

Non-EU Member Countries which wish to export goods to the EU must provide the Commission with information on the organisation and general management of their health surveillance systems. If this information is not satisfactory, provisional measures may be taken by the Commission after consulting the country concerned.

The Commission must take account of the lists drawn up pursuant to Regulation (EC) No 854/2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption. For other types of products the Commission may eventually draw up comparable lists or adopt other measures (certificates, special import conditions, etc.).

Training of control officials

There must be a Community framework for training control staff in the Member States in order to ensure a uniform level of the decisions taken by such staff Hence the Commission may organise training courses relating to legislation, control measures and techniques, the manufacture, processing and marketing of food and feed.

Non-EU Member Country controls in the Member States

The authorities of Non-EU Member Countries may organise controls in the Member States, accompanied where appropriate by representatives of the FVO, who can assist Member States by providing information and data that are available at Community level and that may be useful in the context of the Non-EU Member Country control carried out.

National enforcement measures

Where non-compliance is ascertained during official controls, the competent authority concerned must take appropriate measures taking into account the nature of the non-compliance and that operator’s past record with regard to non-compliance. This may involve administrative measures (withdrawal from the market or destruction of a product, closure of a business or suspension of an establishment’s approved status, etc.) or penalties. These penalties must be effective, proportionate and dissuasive.

Community enforcement measures

This regulation adds a new dimension to the safeguard measures provided for in Regulation (EC) No 178/2002, hence allowing the Commission to take measures when there is proof that a Member State’s control system is inadequate. These may include the suspension of the placing on the market of certain feed or foodstuffs or the laying down of special conditions for certain feed or foodstuffs. These measures are taken if Community controls have shown non-compliance with Community legislation and the Member State concerned has failed to correct the situation upon request and within the time limit set by the Commission.

BACKGROUND

In January 2000 the Commission presented a complete overhaul of the legislation concerning food hygiene and veterinary issues. The overhaul contained four proposals, on the following subjects:

  • food hygiene;
  • the rules related to hygiene for food of animal origin;
  • official controls on products of animal origin intended for human consumption;
  • animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption ;
  • official controls of food and feed, which are the subject of this information sheet.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 882/2004

20.05.2004

OJ L 165 of 30.04.2004

Regulation (EC) No 1162/2009 [Official Journal L 314 of 1.12.2009].
Regulation (EC) No 1162/2009 grants additional time to laboratories located in slaughterhouses carrying out official testing for Trichinella to obtain full accreditation. The granting of the exception is subject to compliance with certain conditions. In particular, the laboratories in question must demonstrate that they have taken steps in view of their accreditation and offer satisfactory guarantees regarding the quality of the analyses they carry out.

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1029/2008

10.11.2008

OJ L 278 of 21.10.2008

Regulation (EC) No

596/2009

7.8.2009

OJ L 188 of 18.7.2009

The successive amendments and corrections to Regulation (EC) No 882/2004 have been incorporated into the original text. This consolidated versionis of documentary value only.

Related Acts

Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border inspection posts, laying down certain rules on the inspections carried out by Commission veterinary experts and laying down the veterinary units in Traces [Official Journal L 296 of 12.11.2009].
See consolidated version

Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC [Official Journal L 194 of 25.7.2009].
See consolidated version

Community strategy against antimicrobial resistance

Community strategy against antimicrobial resistance

Outline of the Community (European Union) legislation about Community strategy against antimicrobial resistance

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Community strategy against antimicrobial resistance

Document or Iniciative

Communication from the Commission of 20 June 2001 on a Community strategy against antimicrobial resistance [COM(2001) 333 final, Volume I – not published in the Official Journal].

Summary

Background
Antimicrobial substances are synthetic or natural substances used to destroy or inhibit the growth of viruses, bacteria, etc. (antibiotics are a form of microbial agent which react exclusively against bacteria). There is no doubt that these substances have contributed to improvements in the health of the population. However, certain micro-organisms have developed a resistance to them as a result of their excessive and uncontrolled use, thus jeopardising the medical conquests achieved.

This is a worrying global phenomenon. The Commission has therefore decided to formulate an overall approach in order to augment and reinforce the existing legislation. The Communication is accompanied by a proposal for a Recommendation on the prudent use of antimicrobial agents in human medicine.

Specific objectives


It should be noted that humans are exposed to antimicrobial agents not only through medicinal products but also through food. The same goes for animals. The strategy therefore embraces both human and veterinary medicine. It comprises action priorities in four key areas, namely:

  • surveillance: monitoring the evolution and the effects of interventions;
  • prevention of communicable diseases, and infection control to reduce the need for antimicrobial agents, partly through the prudent use of such agents;
  • research and development of alternative products;
  • international cooperation.

Key area 1: surveillance
This is based on two priorities:

  • Develop surveillance networks at European level and encourage the participation of non-EU countries;
  • Put in place and improve the collection of data on consumption of antimicrobial agents in all sectors.

As regards the surveillance networks, these need to keep track not only of resistance to antimicrobial agents but also of trends in communicable diseases, infections such as salmonella and infections contracted during hospitalisation (nosocomial infections) etc. Disease outbreaks can be a sign of resistance to antimicrobial agents. A network for the epidemiological surveillance and control of communicable diseases at Community level was set up in 1999. The specific networks set up within this framework are numerous and include the EARSS – the European Antimicrobial Resistance Surveillance System. These networks need to be improved to make them more cohesive and more coordinated. Similar networks exist in the field of veterinary medicine.

Key area 2: prevention
Several key activities have been proposed in this area, including the following:

  • Increase the importance of antimicrobial resistance information for the market authorisation process in all fields.
  • Support, at Community level, educational campaigns directed at professionals and the general public to avoid overuse and misuse of antimicrobial agents.
  • Make sure that antibacterial substances are available in human and veterinary medicine by prescription only and distributed in a controlled way in agriculture, and assess whether the prescription-only rule should be applied to all antimicrobial agents.
  • Reinforce and promote infection prevention programmes, in particular immunisation programmes.
  • Reinforce the food monitoring system as regards methods of analysis, sanctions and reporting systems.
  • Phase out and replace antimicrobial agents used as growth promoters in feed (this action has already been undertaken, in part, under existing or proposed legislation).
  • Review the use of the two authorised antimicrobial agents in food (Nisin (E 234) and Natamycin (E 235)) – food preservation agents).
  • Give particular attention to GMOs which contain genes expressing resistance to antibiotics used for medical or veterinary treatment, with a view to identifying and eliminating those GMO genes which may have adverse effects on human health and the environment.

Key area 3: Research and product development
There are three key actions in this area:

  • Encourage the development of new antimicrobial agents.
  • Encourage the development of alternative treatments and vaccines.
  • Support the development of rapid and reliable diagnostic and susceptibility tests.

Research targeted at antimicrobial resistance has already been going on at Community level for a number of years, chiefly within the Framework Programme for Research and Technological Development (the Fifth Framework Programme (1998-2002) is currently in progress).

Key area 4: International cooperation
Antimicrobial resistance is no respecter of frontiers and the expansion in global trade and travel has increased the speed of its spread. The Community has therefore established links with numerous international organisations, including the WHO. It has also put the problem on the agenda in its external cooperation forums such as Euro-Med and the Northern Dimension Action Plan and in the EU enlargement process.

The two priority actions in this area are as follows:

  • Encourage strongly the development of co-operation, co-ordination and partnership at international level.
  • Pay special attention to candidate and developing countries by helping them put in place the appropriate structures.

Related Acts

Council Recommendation of 15 November 2001 on the prudent use of antimicrobial agents in human medicine [COM(2001) 333 final, Volume II – not published in the Official Journal]

This recommendation is a follow-up to the Communication from the Commission of 2001 on a Community strategy against antimicrobial resistance. Its aim is to limit the spread of antimicrobial resistance and to thus maintain the effectiveness of these agents.

Council Resolution of 8 June 1999 on antibiotic resistance ‘A strategy against the microbial threat’ [Official Journal C 195, 13.07.1999]

The aim of this resolution was to establish a common strategy and coordinated action to combat antibiotic resistance.