Animal By-Products [EU]

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.

ACT

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].

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

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.

Movement

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.

Marketing of Processed Proteins

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.

Misc

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.