Brussels, 10 June 2008
How are animal by-products currently regulated in the EU?
Currently, Regulation (EC) No 1774/2002 regulates animal by-products. It entered into application in 2003. A considerable number of additional legislative acts have been adopted on the basis of that Regulation.
The Regulation was put in place following a series of food- and feed-borne crises (related to Bovine Spongiform Encephalopathy - BSE, dioxins, foot-and-mouth disease and classical swine fever) and introduced a number of safeguards to prevent risks to public and animal health. These safeguards are
The technical standards laid down in the original Regulation have been adapted since 2003, in order to take into account scientific and technological progress. Such standards have been adopted or modified in relation to the import of pre-processed animal by-products for the manufacture of medical devices, products for in-vitro diagnosis and laboratory reagents, such as filtered blood for diagnostic purposes. Further standards concerned alternative processes for the safe treatment of animal by-products, such as a process for the production of biodiesel from animal fat. In addition, a web-based system of lists of approved plants in Member States was introduced and special conditions for the feeding of certain endangered species were laid down.
Why is the Commission proposing new legislation?
The Commission submitted a report to the European Parliament and the Council in 2005. The report evaluated the experience with the application of the Regulation and identified several key areas for which a revision of the legislation seemed necessary. The report was to be accompanied, if appropriate, by legislative proposals. It was based on information submitted by the Member States, the outcome of the continuous discussions in which the Commission is engaged with the nearly 50 European organisations of stakeholders from industry sectors, business associations and consumers with an interest in the Regulation, as well as the results of a series of inspections carried out by the Commission's veterinary inspection service in all Member States in 2004 and 2005.
What are the proposal’s key elements?
The proposal has essentially two objectives:
Regulation (EC) No 1774/2002 contains safeguards against risks for public and animal health. But operations with animal by-products can also have a potential effect on the environment. For that reason, they need to be controlled. Under the current rules, animal by-products may be transformed into biogas and into bio-fuels, in order to generate energy. Animal by-products such as manure or other organic fertilisers may be applied to land, with potential consequences for the soil and groundwater. Environmental legislation provides for the containment of such risks. However, over the years it has become clear that the way in which the two legal frameworks interact needs to be improved.
Therefore, the proposal aims for example to clarify the application of Community legislation on industrial emissions to the burning of animal as a fuel, in order to contribute to the promotion of this sustainable way of generating energy.
Food and feed hygiene legislation
Animal by-products come to a large extent from the processing of food in slaughterhouses and dairy plants and are delivered to feed producers for the production of feed for farmed animals. These establishments have to be approved and are subject to official controls by the competent authorities of Member States responsible for food and feed legislation. The proposal aims to remove double burden for operators by recognising approvals, which have been granted under food and feed legislation. At the same time, the competent authorities of Member States have to continue to carry out controls to verify that operators comply with the rules on animal by-products.
More risk-proportionate rules
“End point” in the manufacturing chain
Under the current rules, almost all material from animals, which does not enter the food chain, is subject to the rules on animal by-products. Only for very specific products, such as hides and skins, which are tanned to obtain leather, these rules specify that such material is no longer subject to any health requirement if it has been processed in a way that significantly reduces any potential risk. Through progress in science and technology, animal by-products are increasingly used for specialised applications, such as in medicine or in diagnostic tools, and they are in some cases highly refined to reduce risks.
The proposal aims to introduce the concept of an "end point" in the manufacturing chain. The basis for an end point would be that animal by-products have been treated or tested in a way which ensures that the remaining risks are minimal, for example due to the strict treatment by heat or chemical substances which has been applied to them, or when they have been tested for the absence of bacteria or viruses. If these conditions are fulfilled, the processed animal by-product would no longer be subject to any specific health rules. Instead, under product safety rules, there is an obligation of the manufacturer to place only safe products on the market.
Adaptations to the risk-based categorisation of animal by-products
The degree of risk, which an animal by-product poses to public or animal health, is the deciding factor for the product’s classification into one of three categories. Then, based on the category, a decision is made whether there is an obligation to dispose of the animal by-product in a safe way or whether it can be used, in processed or unprocessed form, for feeding or for technical purposes.
Under the current rules, the categorisation is based on the risk evaluation, which was carried out at the time of adoption in 2003. In the meantime, it has become apparent that a limited number of animal by-products can be reclassified due to the limited risk they pose. In addition, the proposal introduces a basis for re-categorising animal by-products on the basis of a risk-assessment, which has been carried out by a scientific institution such as the European Food Safety Authority (EFSA) or the Scientific Committee on Consumer Products (SCCP).
Will the proposal make it possible to use infected animal materials for the feeding of farmed animals?
No. The proposal maintains the principle that only materials from healthy animals, which have been subject to veterinary inspection before being slaughtered may be used for the production of feed for farmed animals.
Will the proposal allow feeding of catering waste to pigs?
No. The proposal will maintain the current ban on feeding of (treated or untreated) catering waste to pigs. The potential risks, especially to animal health, largely outweigh the benefits from such practice. In addition, the rules on animal by-products offer other sustainable ways of using catering waste, such as in biogas plants or for the production of bio-fuels.
Were industry sectors using animal by-products, consumers and other interested parties consulted in the drafting process?
The Commission carried out wide consultations with the nearly 50 industry associations and consumer organisations with an interest in animal by-products. In 2007, a public online consultation was carried out. The results of this consultation were used for the production of an impact assessment, which evaluated the available regulatory options. Extensive discussions were also held with experts from Member States' administrations and with third countries, which are major trading partners of the EU.
When would the proposed new Regulation enter into force?
The Commission's proposal will directly be transmitted to Council and Parliament for consideration under the co-decision procedure. Once adopted, the Regulation would enter into force 20 days after its publication in the Official Journal and then the transitional period of fifteen months for the application of the new rules would start. During this time, the implementing rules for animal by-products will be prepared, such as processing standards, traceability requirements regarding labelling and documentation and detailed provisions for the layout of establishments handling animal by-products.