Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down the health rules concerning animal by-products not intended for human consumption

(presented by the Commission)

EXPLANATORY MEMORANDUM

A. OBJECTIVES OF THE PROPOSAL

B. BACKGROUND

1. Legislative background

1.1. Community legislation

1.2. National legislation

2. The International Scientific Conference and Consultation Paper on Meat-and-Bone Meal

3. The Scientific Advice

4. Results of Community Missions to Member States

C. LEGAL BASIS AND MAIN ELEMENTS OF THE PROPOSAL

1. Legal Basis

2. Main Elements of the Proposal

(a) The exclusion of dead animals and all condemned material from the feed chain

(b) Link with Community Environmental Legislation

(c) New Legal Framework for animal by-products' sector

(d) Simplification of existing Community legislation

(e) Importation from third countries

D. POSITION OF CONCERNED PARTIES

Member States

Industry

E. THE FORM OF THE ACT

ANNEX I: Analysis of Impacts

ANNEX II: Contents of the Proposal

A. OBJECTIVES OF THE PROPOSAL

The key issue of this proposal is the prohibition of recycling certain animal by-products into the feed chain, namely dead animals and condemned animal material. The only raw material allowed to be used for the production of animal feed would then be material derived from animals declared fit for human consumption.

Furthermore, this proposal:

-introduces a number of alternative methods for the use or disposal of animal by-products;

-strengthens rules on controls and traceability of animal by-products;

-establishes a link with Environmental Community Legislation;

-creates a new legal framework for the animal by-products sector;

-simplifies existing Community legislation creating a consolidated legislative act dealing with all animal by-products not intended for human consumption.

This proposal is an Action of the White Paper for Food Safety (Action 30).

B. BACKGROUND

1. LEGISLATIVE BACKGROUND

1.1. Community Legislation

(a) Disposal and processing of animal by-products

Council Directive 90/667/EEC lays down the animal and public health requirements for

-the disposal and processing of animal waste in order to destroy pathogens which might be present in this material;

-the production of feedingstuffs of animal origin in such manner as to prevent the presence of any pathogens therein.

Animal waste is defined as carcases or parts of animals, including fish, or products of animal origin, not intended for direct human consumption. Animal waste is classified either as high-risk material, if it presents a serious risk of spreading communicable diseases to animals or humans (i.e. cadavers, animals which died with clinical signs of disease, animals killed in the framework of disease eradication plan, slaughterhouses' condemned material), or as low-risk material, if it does not present a serious risk (i.e slaughterhouses' by-products fit but not destined for human consumption, e.g. for commercial reasons).

According to the Directive, both high-risk and low-risk material must be processed in an approved plant under official veterinary surveillance in order to be incorporated into animal feed. In exceptional circumstances, it can also be disposed of by burning or burial.

From 1 April 1997, it is required that all mammalian animal waste must be processed in accordance with the following minimum parameters which are regarded as being effective for the inactivation of the agents of Scrapie and Bovine Spongiform Encephalopathy (BSE).

-maximum particle size 50 mm

-temperature > 133°C

-time 20 minutes

-pressure (absolute) 3 bar

-in a batch or continuous system.

Some products derived from mammalian animal waste are exempt from this new rendering standard, such as petfood produced with low risk material, certain rendered fats, gelatine etc., and, in general, products which can be guaranteed not to enter any food or feed chain.

Furthermore, rendered fats derived from ruminant animals destined to animal consumption must

-from 1 July 2000, be processed in accordance with the above minimum parameters, only if they are derived from high risk material,

-from 1 January 2001, be purified in such a way that the maximum levels of remaining total insoluble impurities does not exceed 0.15% in weight.

Meat-and-bone meal not produced in accordance with the above standard must be destroyed by burial, incineration, burning as fuel or a similar method which ensures safe disposal.

Ruminant rendered fats not produced in accordance with the above standards must either be destined to the oleochemical industry or be destroyed by burial, incineration, burning as fuel or a similar method which ensures safe disposal.

Meat-and-bone meal derived from non-mammalian animal by-products (for example fishmeal and poultrymeal) and rendered fats derived from non ruminant species may still be produced using alternative heat treatment systems (in the case of high risk material) laid down in Decision 92/562/EEC or other processing systems provided that the final products comply with microbiological standards.

Measures equivalent to those applied in the European Union must be required for imports of meat-and-bone meal and rendered fats from third countries.

According to Decision ../.../EC, from 1 October 2000 specified risk material, defined as the skull including brain and eyes, tonsils and spinal cord, from cattle, sheep and goats over one year of age, ileum from cattle over one year of age and spleens from sheep and goats, must be removed from all food and feed chain. Furthermore, In UK and Portugal the entire head, the thymus, the spleen, the intestine and the spinal cord of cattle above six months and the vertebral column of cattle above 30 months must be removed. In the case of fallen cattle, sheep and goats either the specified risk materials must be removed or the whole carcase must be destroyed.

According to Decision 98/272/EC animals killed or died for a TSE shall be destroyed.

(b) Feed ban

After feed containing processed ruminant waste contaminated by the infective agent was identified as the primary source of BSE, a Community wide ban on feeding protein derived from mammalian tissues to ruminants (with the exception of certain products, such as milk proteins, blood meal, gelatine, amino-acids and peptides) was established in mid-1994 by Decision 94/381/EC.

1.2. National legislation

Directive 90/667/EEC and Decision 94/381/EC have been transposed into the national legislation of all the 15 Member States of the European Union.

However, some Member States voluntary introduced rules stricter than those laid down by the above Community legislation. In particular:

-two Member States (Sweden and France) have prohibited the use of some high-risk material in animal feed:

*since 1986 Sweden has banned the use of fallen animals in the manufacture of animal feed;

*since 28 June 1996, France has banned the use of fallen animals and other high risk material in the manufacture of animal feed. Furthermore, France, from the same date, has prohibited the use of non mammalian proteins (i.e. proteins derived from poultry and fish) for the feeding ruminant animals;

*Belgium has notified the intention to ban the use of fallen animals in the manufacture of animal feed

-In United Kingdom, it has been illegal to feed any farmed livestock with mammalian proteins (excluding bloodmeal and milk proteins) since 4 April 1996.

-In Portugal, it is illegal to feed any farmed animals with mammalian proteins and fats. Furthermore, Portugal, from the same date, prohibited the use of poultry animal proteins for the feeding of ruminant animals.

2. THE INTERNATIONAL SCIENTIFIC CONFERENCE AND CONSULTATION PAPER ON MEAT-AND-BONE MEAL

The BSE crisis has led to questions being raised as to whether the EU legislation on disposal and processing of animal by-products not intended to human consumption is meeting its fundamental objectives, notably ensuring a high level of protection of public health and of consumer protection throughout the Community.

In particular, there is a general public concern on the quality of feed ingredients allowed for farm animal nutrition.

The International Scientific Conference on Meat and Bone Meal organised by the Commission and the European Parliament, held in Brussels on 1-2 July 1997, has initiated a debate concerning the production and feeding of meat-and-bone meal.

During the two days of this conference, scientific experts, Members of the European Parliament, representatives of environmental, agricultural, industrial and commercial interests and consumers groups expressed their points of view on the matter.

However, the conference called for further reflection on the future policy in this area and, in particular, on the possible exclusion of dead animals and all condemned material from the feed chain. The only raw material allowed to be used for the production of animal feed would then be material declared fit for human consumption but which, either for commercial or technological reasons, is not intended for human consumption.

In November 1997, in order to launch the widest possible public debate about the future of the Community's feed legislation on the above question, the Commission finalised a Consultation Paper on Meat-and-Bone Meal.

It aimed to provide an objective description of the present situation, and some considerations about the possible consequences of adopting different approaches.

The Commission received 75 comments on this consultation. The comments came from a wide variety of organisations, such as farmers, renderers, feed manufactures, meat producers, Member States and Third countries governments, professional organisations, consumers organisations, and individual citizens.

From the comments received, it appears that the industry, professional organisations, citizens and consumers are mainly in favour of the exclusion of dead animals and all condemned material from the feed chain, but those who would bear the cost of it, such as farmers and some governmental bodies of Member States, are opposed in the absence of sufficient scientific justification. Governmental bodies of Member States are particularly concerned by the economic, environmental and health implications of this exclusion which could result in a higher level of illegal on-farm burial.

Independent of their position regarding this exclusion, all the comments received pointed out the problems of alternative options to the rendering of animal by-products. In particular, there was a general call for more research to evaluate the health risk associated to the various means of disposal.

There was a general recognition of the need for an amendment of Directive 90/667/EEC. This Directive is considered out of date and should be revised in line with the new information on BSE.

Both third countries' governmental bodies and private sectors are against this exclusion which is considered trade restrictive and not supported by any valid scientific reason.

3. THE SCIENTIFIC ADVICE

One of the main arguments against the exclusion of certain animal material, which kept recurring in the above consultation, was that it is not scientifically justified. For this reason a number of requests for a scientific advice were submitted to the Scientific Steering Committee.

As a result, the following scientific opinions related to the animal by-products' issue, have been adopted by the Scientific Steering Committee:

*Scientific opinion on safety of meat-and-bone meal from mammalian animals, naturally or experimentally susceptible to TSEs.

Date of adoption: 26-27 March 1998 and updated on 24-25 September 1998

*Scientific opinion on the safety of tallow derived from ruminant tissues.

Date of adoption: 26-27 March 1998

*Scientific report and opinion on the safety of Gelatine.

Date of adoption: 26-27 March 1998 and updated on 20-21 January 2000

*Scientific report and opinion on the safety of dicalcium phosphate precipitated from ruminant bones and used as an animal feed additive.

Date of adoption: 25-26 June 1998

*Scientific opinion on mammalian derived meat-and-bone meal forming a cross-contaminant of animal feedstuffs.

Date of adoption: 24-25 September 1998

*Scientific report and opinion on the safety of hydrolysed proteins produced from bovine hides.

Date of adoption: 22-23 October 1998

*Scientific opinion of the risks of non conventional transmissible agents, conventional infectious agents or other hazards such as toxic substances entering the human food or animal feed via raw material from fallen stock and dead animals (including also: ruminants, pigs, poultry, fish, wild/exotic/zoo animals, fur animals, cats and laboratory animals) or via condemned material (Fallen stock opinion).

Date of adoption: 24-25 June 1999 and re-edited on 22-23 July 1999

*Scientific opinion on the risk born by recycling animal by-products as feed with regard to propagating TSE in non-ruminant farmed animals (Intra-species recycling opinion)

Date of adoption: 17 September 1999

*Scientific opinion on the safety of ruminant blood with respect to TSE risks

Date of adoption: 13-14 April 2000.

The main conclusion of the above scientific opinions is that the use of material derived from animals declared not fit for human consumption following health inspection, should not enter into the feed chain.

4. RESULTS OF COMMUNITY MISSIONS TO MEMBER STATES

Since October 1996, the Food and Veterinary Office of the Commission (FVO) carried out a number of rounds of inspections to Member States, to assess the presence and management of main risk factors and surveillance procedure with regard to BSE.

Part of the assessment covered the systems of commercial rendering and other methods of animal waste disposal in the Member States.

General conclusions and a number of recommendations were drawn up following these inspections and provided to the Commission and Member States.

Some of these recommendations have already been implemented into EC legislation (i.e. Decision 97/735/EC, Decision 1999/534/EC) and they are now recast in this proposed Regulation.

Other recommendations are dealt with by this Regulation, in particular in relation to:

*Traceability of products,

*Rules for intermediate storage,

*Development of guidelines for official controls of the processing industry,

*Derogations for certain local practices (i.e. Knackers' yards).

C. LEGAL BASIS AND MAIN ELEMENTS OF THE PROPOSAL

1. LEGAL BASIS

Since the proposed Regulation seeks to protect human and animal health, the legal basis for the proposal is Article 152(4)(b) of the Treaty.

2. MAIN ELEMENTS OF THE PROPOSAL

(a) The exclusion of dead animals and all condemned material from the feed chain

The prohibition

In 1998, the European rendering industry collected and transformed 16.1 million tons of animal material into 3 million tons of meat-and-bone meal and 1.5 million tons of fat suitable to enter the feed chain. 14.3 million tons of this material came from animal declared fit for human consumption following health inspection, 1.8 million tons was represented by dead animals or other condemned animal material.

This Regulation establishes the exclusion of dead animals and condemned material from the feed chain. The only raw material allowed to be used for the production of animal feed would then be material derived from animals declared fit for human consumption following health inspection.

The following benefits would arise from this prohibition:

*as recommended by the Scientific Steering Committee in its opinions, this prohibition would further reduce the risk of disease transmission and the risk of unacceptably high concentrations of chemical residues in animal feed. For example, the second wave of dioxin contamination in food of animal origin, which occurred in Belgium in 1999, was due to the fact that the animals which died because of the contaminated feed, were recycled into the feed chain after usual rendering process (i.e. 133°C 30 Min 3 bars). As this heat process (as any other commercial heat processes) was completely ineffective in inactivating chemical contaminants, the resulting meat-and-bone meal was fed back to animals with a consequent contamination of the food products derived therefrom;

*it would meet ethical objections to the feeding of animals on cadavers;

*it could improve the image of the agriculture animal products sector and restore the confidence of consumers, who perceive a risk of unfit material passing through the food chain. This would reverse the trend, which is dangerous for its environmental and economical implication, of abandoning progressively the use of valuable animal by-products in animal feedingstuffs because of their perceived negative image; in fact, an increasing number of rendering plants have stopped collecting certain animal by-products in favour of slaughterhouse's material considering that the market of meat-and-bone meal and rendered fats derived from dead animals and condemned material is collapsing;

*this exclusion would provide more clarity for the animal by-product industry, allowing it to plan for the future.

However, there are a number of potential problems as a consequence of such prohibition, and in particular:

*the economic impact and the additional cost of such an exclusion would mainly be borne by farmers; this additional cost may result in a higher level of on-farm burial with possible environmental problems;

*some of the alternative ways of disposal of this material are environmentally harmful, costly or impossible because of a current lack of capacity to process and dispose of the excluded materials;

*this additional exclusion might be considered trade restrictive by third countries which could challenge the EU in a WTO panel.

The alternatives

In order to overcome some of the above problems, in particular the environmental ones, the proposal also includes a number of alternative options to the production of feed material for the use or disposal of these animal by-products and, in particular:

*incineration,

*co-incineration (i.e. burning as fuel),

*landfill,

*composting and fish ensilage;

*biogas,

*fertilisers,

*oleo-chemical industry.

Some of these alternative methods of use or disposal allow a recovery of costs. A technical introduction to the above alternatives and an analysis of impacts of the new policy are described in Annex I.

The financing rules

A recent survey of EU Member States demonstrated a wide variety of approaches to the financial support for the processing and disposal of animal by-products. In order to avoid that this situation could affect the conditions of competition between agricultural products, the proposal establishes that a report shall be prepared by the Commission on this issue, accompanied by appropriate proposals.

The new categorisation

As the added value achieved by the re-use of animal material must be compatible with the primary need for safety, it is proposed that alternatives other than incineration or co-incineration or landfill, are restricted to certain animal by-products.

This is achieved by the following new classification of animal by-products:

*Category 1 material: this is the highest risk category, including animal by-products presenting a risk related to a transmissible spongiform encephalopathy (TSE) or an unknown risk or a risk related to the presence of residues of prohibited substances (i.e. hormones, B-agonists, etc.) or residues of environmental contaminants (i.e. dioxins, PCBs, etc.). The animal by-products belonging to this category, must be completely disposed of as waste by incineration, co-incineration or landfill;

*Category 2 material: this category includes animal by-products presenting a risk related to animal diseases other than TSEs or a risk related to the presence of residues of veterinary drugs. Manure, digestive tract contents and slaughterhouse's sludge are also included in this category. The animal by-products belonging to this category may be recycled for certain uses other than animal nutrition (i.e. biogas production, composting, fertilisers or oleochemical products, following appropriate heat treatments);

*Category 3 material: this category includes animal by-products derived from healthy animals (i.e. animals slaughtered in a slaughterhouse, which passed the health inspection in accordance with Community legislation, milk from healthy animals, fish caught in the open sea). Only animal by-products belonging to this category can be used as feed material following appropriate treatments. Therefore, this category establishes the 'positive list' of materials for the preparation of ingredients of animal origin which can be incorporated in animal feed and petfood. Furthermore, this category includes products, such as wool, hides, fur and feathers, intended for purposes other than animal or human consumption (i.e. technical products).

The Regulation contains the necessary provisions in order to guarantee:

*a clear separation during the collection and transport of the different categories of animal by- products;

*traceability of the different categories of animal by-products by means of a record-keeping system and accompanying documents or health certificates;

*a clear physical separation of establishments storing and/or processing the different categories of animal by products;

*a reliable system for the identification and registration of the final products (e.g. to dye, with an adequate marker, rendered fats and animal protein meal not destined to enter the feed chain).

(b) Link with Community Environmental Legislation

Framework Directive on Waste

The Framework Directive on Waste (i.e. Directive 75/442/EEC as amended by Directive 91/156/EEC) controls the handling, disposal and recovery of waste.

According to this Directive:

Waste is defined as "any substance or object in the categories set out in Annex I which the holder discards or intends or is required to discard".

Article 2 excludes from the scope of the Directive, where they are already covered by other legislation "animal carcases and the following agricultural waste: faecal matter and other natural, non-dangerous substances used in farming". Up to now, the Commission has officially took the view that as animal carcases are covered by Directive 90/667/EC, they are, therefore, excluded by the scope of application of Directive 75/442/EEC.

Article 4 of the Directive requires Member States to ensure that waste is recovered or disposed of without harming human health or the environment.

Whether or not a substance is waste depends on the individual circumstances of each case. For example, material produced in slaughterhouse but not intended for human consumption has a number of potential outlets. It may be sold to petfood, or rendered to produce tallow for use in soap production or animal feed. In such cases, the operator of the slaughterhouse does not discard the material as waste. The slaughterhouse operators transfers the material with the intention that it is put to beneficial use by someone who is not carrying out a waste disposal or recovery operation. In these circumstances, it remains within the normal commercial cycle/chain of utility and is not considered to be waste.

If, on the other hand, the material is transferred by the slaughterhouse operator for incineration then it is being consigned to a waste disposal operation. Rendering itself is not a waste disposal or recovery operation, but similar considerations apply when material is rendered to produce products which are themselves disposed of by incineration or landfill or consigned for waste recovery such as fuel (co-incineration). In such cases, the material is also considered to be waste.

Animal Waste Directive

Directive 90/667/EEC (i.e. the Animal Waste Directive) controls the handling, processing and disposal of animal by-products. There has been some confusion over the scope of this Directive, the borderlines between it and the Framework Directive on Waste, and whether its provisions are always sufficient to be considered to 'cover' the disposal or recovery operation. This is partly because the Directive 90/667/EEC does not always include the controls necessary to ensure that the objectives of Article 4 of the Framework Directive on Waste are achieved (i.e. that there is no harm to human health or to the environment) and also because it does not control the products of rendering. This situation has sometimes resulted in a conflict of interest as to which Government Agency is responsible for controlling any particular item and sometimes either duality or, even worse, absence of control.

Health and environmental controls

Although the Directive 90/667/EEC permits burning in certain circumstances, it does not contain any provisions specifying how human health or the environment shall be protected when burning is carried out. Thus burning cannot be said to be covered by this Directive and, therefore, the provisions in the Framework Directive on Waste apply.

On the other hand, burial is also a permitted disposal option in certain circumstances. In this case, the Directive 90/667/EEC specifies that burial shall be carried out in such a way that it prevents contamination of water tables or any environmental nuisance. In this case this Directive contains the necessary provisions to protect human health and the environment, and is considered to cover burial. As a result, burial in these circumstances is not subject to control under the Framework Directive on Waste.

The products of rendering (meat-and-bone meal and rendered fats) are not controlled by Directive 90/667/EEC. Thus if they are to be subject to a waste disposal or recovery operation, they are controlled by the Framework Directive on Waste.

The new proposal

This proposal presents an opportunity to clarify the relationship between the Animal Waste Directive and the Framework Directive on Waste and to create a link between the two. It is suggested that, for both unprocessed and processed animal by-products, there are three potential outlets:

*A waste disposal operation (eg landfill, burial, incineration);

*A waste recovery operation (eg co-incineration); or

*'placing on the market' (eg rendering with production of processed animal protein and rendered fats to be used in animal feed or fertilisers or in cosmetic or pharmaceutical products, the production of petfood, the manufacture of leather goods, etc.)

In the light of the above, the proposal establishes that if an animal by-products is consigned to a disposal or recovery operation listed above, it shall be treated as waste. Therefore, the controls on these disposal and recovery operations must be intended to ensure that the waste is disposed of or recovered in such a way that the objectives of Article 4 of the Framework Directive on Waste are achieved and that human health and environment are protected.

(c) New legal framework for animal by-products' sector

Directive 90/667/EEC is mainly drawn up to cover the industry known as "rendering" (i.e. animal protein and fats producers). Only passing reference is made to other sectors and the emphasis on one method of processing in particular brings about confusion. Complete reference is made to some processes, while other uses of those part of animal not required for human consumption are completely ignored. In cattle this can mean up to 60% of the live animal weight.

The uses are many and varied and the methods used for handling the materials are equally diverse.

Because of its emphasis on the one sector, which generally involves just a single transfer from slaughterhouse to rendering plant, the more complex form of trading in other sector is not adequately dealt with. This in turn results in inadequate provisions being made to control all the different facets of some operations.

Furthermore, certain processes such as those involving animals that have not passed through a slaughterhouse need to have very high standards of processing and parameters laid down for the finished products. This is to ensure any notifiable pathogens are destroyed and the products are safe to use.

Others, such as the use of feathers for bedding, are more simply a case of correct handling to ensure that these materials are clean and suitable for their intended use.

This proposal takes these differences more fully into account and provide a framework for the many varied uses animal by-products are utilised by society with the sole aim being to protect human and animal health. Where products are more likely to be trade on the broad EC market and where the risks to human and animal health are high if they are not dealt with properly, standards are laid down in the Regulation.

In particular, this proposal establishes rules to tighten up the controls so that animal by-products in any sector can be traced by the competent authority until it is satisfied that they do not create a danger to human or animal health, and particularly does not get back into the animal feed chain, in the case of certain animal by-products, or in the human food chain.

(d) Simplification of existing community legislation

Another important element of the present proposal is the simplification of Community legislation relating to:

*processing and disposal of animal waste (i.e. Council Directive 90/667/EEC, Commission Decision 92/562/EEC, Council Decision 95/348/EC, Commission Decision 97/735/EC, Council Decision 1999/534/EC);

*trade and import conditions of products of animal origin destined to animal consumption or other technical use (i.e. Council Directive 92/118/EC as amended by the Act of Accession, by Council Directives 96/90/EC and 97/79/EC and by Commission Decisions 95/339/EC, 94/723/EC, 96/405/EC, 94/466/EC and 96/103/EC; several Commission Decisions implementing Directive 92/118/EC).

These Directives and Decisions have been gradually developed since 1990 in response to the needs of the internal market. The multiplicity of these legislative acts has led to a complex situation. This situation can be improved by placing the legal requirements in a single Regulation.

(e) Importation from third countries

The proposal establishes conditions for the importation from third countries of animal by-products and derived products. In particular, in order to ensure that the products imported from a third country are of a hygiene standard which is at least equal or equivalent to the standards applied by the Community, a system of approval is introduced for the third countries and their establishments, together with a Community inspections procedure to ensure that the conditions of such approval are observed.

Furthermore, this proposal establishes model health certificates, which must accompany the imported products, to satisfy the competent authority of the place of destination that the consignment complies with the Community provisions.

The European petfood industry relies on third countries sources for the supply of raw material for petfood production. In order to allow this trade to continue, the proposal establishes that the import of petfood and raw material for petfood production, derived from animals which have been treated with certain substances prohibited in accordance with Directive 96/22/EC, shall be permitted under specific conditions to be laid down by the Commission.

D. POSITION OF CONCERNED PARTIES

Extensive consultation has taken place with the principal parties concerned by the proposed Regulation, namely Member States and industry.

Member States

Several meetings were convened by the Commission and attended by national experts from the Member States.

The preliminary position of the Member States may be summarised as follows:

-Belgium, Denmark, Finland, France, Ireland, Italy, The Netherlands, Sweden and United Kingdom have indicate a favourable position on the proposal;

-Austria and Germany have indicate reservation about the proposal for the following main reasons:

*They dispute the scientific justification for aspects of the proposal;

*They claim that the process standards laid down by current Community legislation guarantee that any animal by-products is safely treated and therefore should not be amended;

*They claim that the economical impact and the additional cost of the new policy would be substantial. Furthermore, in imposing additional costs on the industry, the exclusion of fallen stock may result in a higher level of on-farm burial;

-Spain, Greece and Luxembourg have an uncertain and/or unclear position.

Industry

Industrial interests are represented by

EURA (European Renderers Association)

UNEGA (Union Europeenne des Fondeurs et Fabricants de Corps Gras Animaux)

FEDIAF (European Petfood Industry Federation)

EAPA (European Animal protein organisation)

The above organisations have expressed their general support for the proposed new policy.

E. THE FORM OF THE ACT

The Commission believes that Community law in the form of a Regulation presents a number of advantages, such as the guarantee of a uniform application throughout the single market, a better transparency of Community law and the possibility for rapid updating of Community legislation to take account of technical and scientific developments. It is for these reasons that the present proposal is submitted in the form of regulation.

ANNEX I

ANALYSIS OF IMPACTS

1. THE FACTS

1.1 The EU Rendering Industry

More than 400 rendering plants are approved in the EU. These plants, which employs 17.000 workers, collect and transform approximately 50.000 tons of raw animal material per day.

In 1998, the European rendering industry collected and transformed 16.1 million tons of animal by-products into 3 million tons of animal meal and 1.5 million tons of fat suitable to enter the feed chain (feed for farm animals, petfood, feed for fur animals) and for use in various technical products (cosmetics, pharmaceutical products). It represented an annual revenue for European agriculture of more than 2.2 billion Euro.

In particular, 14.3 million tons of the above animal by-products came from slaughterhouses and 1.8 millions tons (i.e. approximately 15% of the total amount of animal by-products) was represented by animals which died or other condemned material.

1.2 The crisis of the sector

As mentioned before, the BSE and, more recently, the dioxin crisis has created a general public concern on the quality of feed ingredients of animal origin allowed for farm animal nutrition.

This concern is reflected in

-the current price of meat-and-bone meal (MBM) (50%) is 130 Euro/ton against the price of 250 Euro/ton reached before the BSE crises;

-Most of the EU MBM derived from dead animals or other condemned material is sold to third countries (i.e. Asia and Eastern European countries).;

-An increasing number of rendering plants have stopped collecting dead animals or other condemned material in favour of slaughterhouse's by-products considering that the market of MBM and rendered fats derived from condemned material is collapsing;

-Community legislative proposals, such as the proposal of Organic Farming Directive and the Quality beef Regulation, already prohibit the use of animal by-products (i.e. meat-and-bone meal and rendered fats) for the feeding of farm animals covered by these regulations.

-Many European supermarket chains already qualify their own-labelled food of animal origin (i.e. poultry meat, eggs, etc.) as derived from animals which have never been fed with animal proteins or fats.

The exclusion of the dead animals or other condemned material from the feed chain would meet this public concern. Furthermore, this exclusion would reverse the trend, which is dangerous for its environmental and economical implication, of abandoning progressively the use of valuable animal by-products in animal feedingstuffs because of their negative image.

1.3 Government or local authority support to the rendering industry in certain EU Member States [1]

[1] Source: Meat and Livestock Commission, 1998.

A recent survey of certain EU Member States demonstrated a wide variety of approaches to the financial support for the processing and disposal of animal by-products.

Since 29 March 1996, in the UK all mammalian meat-and-bone meal was prohibited from any use in livestock rations. The UK Government agreed to support the rendering sector. This support was removed completely at the end of February 1998. From then on, the cost of collection and disposal of animal waste is met by farmers and by the meat industry.

In DENMARK the question of support does not arise, because they have a co-operative system; the farmers own the abattoirs and the abattoirs own the rendering plants. Changes in markets and the cost of the services provided are reflected in the price levels.

In ITALY, IRELAND and the NETHERLANDS, it is the market price of meat-and-bone meal and fats which largely determine the cost of the collection and processing.

In GERMANY the primary aim of the rendering industry under German law, is to protect public health. The secondary aim is to produce valuable by-products. Since 1939 (i.e. first major and comprehensive rendering law, which was updated in 1975) the rendering plants are secure in the knowledge that public funds would be used to ensure that public health responsibilities could be met. The principle of providing a public health safeguard lies behind the fact that support is only applicable to material which has the potential to cause a health risk (i.e. fallen stock and rejected material). The collection and treatment of this material is, by State law, the responsibility of Local Authorities (communes). Rendering plants have taken over the job so they provide services on behalf of the communities. Communities have to pay for these services where costs are not counterbalanced by revenues from sales of meat-and-bone meal and fats. The rendering plant calculates annually the cost of collection and treatment. This is considered against the revenue received for the by-products. If there is a negative value the rendering seeks the balance from the community. If it is a positive value, the rendering plant pays the surplus to the community.

The financial arrangements for the collection and treatment differ in each Lander. However, there is an overriding principle that the farmer does not pay directly for the provision of this service. Each Lander operates an 'animal insurance fund'. This fund covers all measures relating to animal safety, including the provision of veterinary services. In some Lander it is only the farmer who pays through the animal insurance fund. Elsewhere it is the local community (Landkreis) which pays. More common is a system where the support is met from 3 sources : the Landkreis, the animal insurance fund and the Lander.

In FRANCE, the Government, with the imposition of a tax on the price of meat, meat products and feed paid by the wholesale traders, is funding the collection, transport and processing of Specified Risk Material (SRM), cadavers and slaughterhouse condemned material. This support amounts to about 600 Mio FF.

In SPAIN, in some autonomous regions, the collection, transport and disposal of fallen stock is met from taxation. However, farmers are required to take cadavers to designated collection points. In other regions, the cost of disposal of cadavers is met by farmers.

In the light of the above, in order to avoid that this situation could affect the conditions of competition between agricultural products, this Regulation establishes that harmonised rules on this issue may be laid down at Community level.

2. ANALYSES OF ALTERNATIVES

At present, the vast majority of animal by-products is processed by the rendering industry and therefore recycled into the feed production chain with minor dispersion into the environment.

There are a number of potential problems arising from the prohibition of recycling dead animals and condemned material from the feed chain. The most obvious problems are related to the environmental and economic repercussion of this new policy.

In order to overcome some of the above problems, in particular the environmental ones, the proposed Regulation includes a number of alternative options to the production of feed material, for the use or disposal of these animal by-products.

In making the analysis of the different alternative uses, it must be noted that different conditions in the EU Member States give different solutions to the alternative use of animal by-products:

*The needs for alternative use or disposal are different in the different Member States depending on BSE status. This means that the capacity of the systems for alternative treatment will vary considerably;

*Tax laws are different. Sale of energy, disposal of waste and outlet of polluting flue gases are normally connected with taxes. Several disposal methods for animal by-products generate values as heat or electric power and lead to outlet of polluting gases. Energy and pollution taxes are obviously essential for the economy of such solutions;

*In several Member States, waste-handling policies will encourage systems recovering energy, recycling waste and minimising pollution, and systems having a neutral global warming impact. For such systems considerable grants are given, and this is essential for the economy of the systems. Often 'bio energy' can be sold for market process taking advantage of a high energy tax;

*Public resistance against the erection of plants for combustion of meat-and-bone meal can make it almost impossible to get a permission to erect a combustion plant. Similar fear of the public opinion might prevent burning meat-and-bone meal in power stations and in cement kilns.

The following is an overview of the alternative ways of disposals to rendering proposed by the new regulation and a preliminary analyses of the involved costs. [2].

[2] Source: Summary of Comments on Consultation Paper on Meat-and-Bone Meal, 1997; EURA, 1999.

2.1 Incineration

Since untreated animal by-products can only be stored for a short time, it is often appropriate to pre-treat the material by removing the water and fats in order to obtain a products which can be stored until it can be further incinerated or burned; the cost of collection and pre-treatment of animal by-products is estimated in EUR 150/ton.

The cost of incinerating animal by-products is estimated in EUR 225/ton.

2.2 Co-incineration (i.e. burning of meat-and-bone meal and fats in power stations)

Animal by-products contain fat and meat-and-bone meal, both having a considerable heat of combustion (lower value). In particular:

*Animal by-products 9 MJ/Kg (water 60%, MBM 25%, fat 15%)

*MBM 17-20 MJ/Kg (depending on fat content)

*Fat 39 MJ/Kg

*Fuel oil 40 MJ/Kg

It must be noted that animal by-products contain water, which must be removed either before or during combustion. This can be done in a traditional rendering process during drying or during the combustion process.

Theoretically the wet animal by-products can be combusted directly, but the water will disturb the combustion process, and it is necessary first to heat up the water to the boiling point, then the water must be evaporated and finally the steam must be heated to the combustion temperature. In practice this is difficult and at present the only industrial size combustion technology able to handle this is the fluidised bed combustor. Other combustors need de-watered animal by-products or dried MBM.

The combustion process will as result give flue gases and ash.

The use of meat-and-bone meal in power stations is recognised as one of the most energetically effective solutions, but should, ideally, result in some economic return to the livestock producer; in reality, it was pointed out that this option would in general provide some economic compensation compared with incineration without recovery of generated heat/energy, but the margins would be small;

In power station meat-and-bone meal can be mixed with coal and used as fuel. This solution has the advantage that the capacity is high and the facilities for cleaning the flue gases are available. The ash will be mixed with ash from other fuels;

It appears that the limitation of using this method is connected with political consideration and public resistance more that with technical difficulties;

In the Netherlands it is planned to burn meat-and-bone meal from Specified Risk Material in a power station. The power station will burn the meat-and-bone meal free of charge; the value of the energy will meet the costs.

2.3 Cement kilns

During cement production meat-and-bone meal can be mixed with raw material for cement production and heated together in a rotary oven. This method has the advantage of high capacity and the ash will be part of the cement production.

In France the maximum amount of meat-and-bone meal which can be used in a cement kiln can be estimated to approximately 10% of the cement production. The cement production in France is approximately 20 Mio. tons per year and meat-and-bone meal production is 0.425 Mio tons per year.

The maximum amount of meat-and-bone meal which can be used for cement production is limited by the phosphorus and chloride content of the meat-and-bone meal. The limitations will vary according to the cement production system and other raw materials used during cement production. The high nitrogen content in meat-and-bone meal will require measures to reduce NOx during cement production.

Meat-and-bone meal combustion in cement kilns is used in France and in Switzerland.

2.4 Burning of fat as fuel

Animal fat can be burned in most normal boilers and the caloric value is approximately 90% of the caloric value of fuel oil. The sulphur content of animal fat is low and this makes animal fat attractive as fuel.

In some cases animal fat is considered as a 'bio fuel' which means that the fuel tax is added to the price of the fat. In such cases the value of the fat might be higher than for feed purposes.

2.5 Disposal by burial or landfill

2.5.1 Burial

Most of the comments received during the public consultation on meat-and-bone meal stressed that burial on the farm should be prohibited on health and environmental grounds. This practice is blamed for breaking the chain of traceability and introduces possible uncontrolled release routes for carcases of dead animals into unlawful trade areas.

In particular one comment indicated that in certain countries, as a consequence of the measures on BSE, the quantity of fallen stock presented to the processing chain has fallen in recent years and is declining very quickly; therefore there must be an equivalent increase in on-farm burials. The risks to the environment, human health, animal health, trade and commerce from uncontrolled disposal routes for fallen stock are exceptionally high.

2.5.2 Landfill

In general, most of the comments addressing this kind of disposal suggested that the use of landfill should be discontinued; seepage could be a serious problem leading to possible water pollution.

However, if landfill is accepted as an option, it was stressed that landfill of rendered material is environmentally preferable to landfill of unprocessed material, although the overall costs of disposal are considerably increased;

Landfill of meat-and-bone meal is used in the UK where at present 3000-5000 tons meat-and-bone meal per week is landfilled. The landfill sites are selected in order not to pollute the ground water and membranes are used as additional safety for the ground water. In the UK 37 Euro per t meat-and-bone meal is charged for lanfilling.

It must be noted that landfill is expected to be replaced by other, more environmentally friendly, methods in the future.

2.6 Biogas

Biogas can be produced form organic materials such as carbohydrates, fats and proteins. The biogas consists mainly of methane and carbon dioxide. Theoretically the amounts of gas produced (30°C) are:

Methane Biogas Heat combust. L/Kg L/Kg MJ/Kg

Carbohydrate 415 830 14.7

Protein 504 793 17.9

Fat 1014 1444 37.3

Normally only approximately 90% of the theoretical values are obtained. The energy required to run the biogas plant is approximately 10-20% of the biogas produced.

Biogas can not be produced from pure animal material as the nitrogen content is too high for proper methane production. The nitrogen content must be below 5.5 g N/L. Therefore animal waste must be mixed with other organic matter in order to reduce the nitrogen content.

In Sweden biogas plants are operated on sterilised (133°C, 20 min, 3 bars, 50mm) animal by-products mixed with digestive tract content, manure and sewage sludge. The sterilised animal by-products is delivered free of charges to the biogas plant. The biogas consists mainly of methane and the energy content of the biogas is very similar to the energy obtained by combustion of the same amount of dry matter from fat and MBM. The biogas is then cleaned, compressed and it is mainly used as fuel for vehicles (i.e. busses for public transportation). In particular, it is the only vehicle fuel approved for Environment Class A according to the Alternative Fuel Study and offers environmental benefits in the form of lower noise, no net contribution to the greenhouse effect, no emissions of particles or dust and low emissions of nitrogen oxides.

The resulting sludge from the biogas plants will contain 3-4% dry matter and the nitrogen is present as ammonia. The sludge is spread over farmland except grass field. Biofertilisers have all the benefits of organic fertilisers, are odourless, and use farmers' own waste as a new resource.

The economy of the biogas is improved as the gas used as fuel is sold including the high fuel tax. The gas is sold at a price corresponding to diesel fuel. Biogas plants already exist in several Member States, mainly in Northern Europe.

2.7 Composting

Composting is an aerobic-thermophilic biotechnical process in which organic material is metabolised. The compost produced is normally used as fertiliser.

Open composting is a relatively slow process requiring large areas and extensive management and is not always suitable from an environmental perspective (leachate problems, uncontrolled release of gases, smell and pests problems). Consequently, the so-called reactor-based techniques (i.e. closed processes) are preferred, as they can be checked and controlled. In fact, with these techniques, the degradation takes place more rapidly and is more complete and the emissions can be measured and cleansed.

The method is mainly used in rural areas for treatment of small quantities of organic waste.

2.8 Use of meat-and-bone meal (MBM) as fertilisers

The use MBM as fertiliser would partially recover costs.

To be used as fertiliser, MBM must be properly defatted and milled. Distribution on land is facilitated by pelletising the MBM.

The opinion of the SSC on safety of fertilisers states that only material from animals suspected or confirmed to carry the TSE agent is unsuitable for the production of fertiliser. This means that category 2 material can be used as fertiliser. The SSC also states that ingestion by man or ruminants must be prevented. This last remark means that the use as fertiliser on grass fields must be avoided.

The recovery costs of using MBM as fertiliser is not known. For many years MBM has been used in gardens for fertiliser. For this purpose prices as high as for feed or better can be obtained, but the market for such products is of a limited size. Very little information on the use of MBM as fertiliser for grains is available. In Denmark some testing of MBM as fertiliser for grains is on-going.

From a commercial point of view, it was underlined that MBM constitutes as excellent organic matrix for the production of organic and organic-mineral fertilisers. From the point of view of actual possibility of use, there are no problems when considering that the processing of category 2 material in all EU countries could produce about 350 000 tonnes of animal protein meal. Considering that typically 150 Kg nitrogen per ha is used, corresponding to approximately 2000 kg MBM per ha, all EU MBM derived from category 2 material could be used at low dosages to fertilise an area of 3 500 km . From the point of view of added value, the use as fertiliser definitely represents the highest value if compared to the alternative uses to animal feeding. From a health risk point of view, a total absence of risk could be achieved, if this protein meal is not derived from animals suspected of TSEs and it is submitted to the new rendering standards.

3. CONCLUSIONS

In conclusion:

-Besides the ecological disbenefits and the local lack of availability of capacities, the disposal of MBM by means of incineration, co-incineration or landfill does not allow any recovery of costs.

In particular, the estimated costs of disposal of 450 000 tons of MBM derived from the collection and pre-treatment of 1.8 millions tons of fallen stock and condemned material produced each year in the EU by the above ways are as follows:

*Incineration: 1.8 billion Euro

*Cement kilns: 87.7 million Euro

*Landfill: 84.1 million Euro

-In contrast, the co-incineration of fats provides an interesting economical return;

-The composting and the use MBM as fertiliser could provide certain ecological benefits and would guarantee a partial recovery of costs;

-The biogas production, an evolving technology, besides the many beneficial effects for the environment, offer the prospect of a net recovery of the costs with the production of 'green' energy.

Given the above, certain options, namely biogas, composting or fertilisers, are obviously to be encouraged whenever is possible, rather than the alternative of disposing of the animal by-products in incinerators or landfill.

ANNEX II

CONTENTS OF THE PROPOSAL

CHAPTER I: General provisions

Article 1: Scope

Article 2: Definitions

Article 3: General obligations

CHAPTER II: Categorisation, collection, transportation and intermediate storage of animal by-products

Article 4: Category 1 material

Article 5: Category 2 material

Article 6: Category 3 material

Article 7: Collection and transportation

Article 8: Records

Article 9: Intermediate plants and storage plants.

CHAPTER III: Approval of Category 1 and 2 processing plants, biogas plants, composting plants and oleo-chemical plants

Article 10: Approval of Category 1 and Category 2 processing plants

Article 11: Approval of oleo-chemical plants

Article 12: Approval of biogas plants and composting plants

Article 13: Dispatch of processed animal by-products to incineration or co-incineration plants or to landfill

CHAPTER IV: Placing on the market of processed animal proteins and other feed material, petfood, dogchew and technical products

Article 14: General animal health provisions

Article 15: Approval of Category 3 processing plants

Article 16: Approval of petfood plants and technical plants

Article 17: Placing on the market of processed animal proteins and other feed material

Article 18: Placing on the market of petfood, dogchew and technical products

Article 19: Safeguard measures

Article 20: Organic fertilisers and soil improvers

CHAPTER V: Derogations

Article 21: Derogations

CHAPTER VI: Controls and inspections to be carried out on intermediate and processing plants

Article 22: Plants' own-checks

Article 23: Official controls

Article 24: Frequency of checks and microbiological analyses

Article 25: List of approved plants

CHAPTER VII: Community controls

Article 26: Community controls

CHAPTER VIII: Provisions applicable to the importation of certain animal by-products and products derived therefrom into the Community

Article 27: General provisions

Article 28: Prohibitions

Article 29: Compliance with Community rules

Article 30: Equivalence

Article 31: Community inspections and audits

CHAPTER IX: Final provisions

Article 32: Amendments to Annexes and transitional measures

Article 33: Regulatory procedure

Article 34: Consultation of scientific committees

Article 35: Communication of national provisions

Article 36: Financing rules

Article 37: Repeal

Article 38: Entry into force

ANNEX I: Definitions

ANNEX II: Hygiene requirements for the collection and transport of animal by-products

ANNEX III: General hygiene requirements for animal by-products processing plants

Chapter I: General conditions for the approval of animal by-products processing plants

Chapter II: General conditions of hygiene

Chapter III: Processing methods

Chapter IV: Supervision of production

Chapter V: Validation procedures

ANNEX IV: Hygiene requirements for processing and disposal of animal by-products destined to biogas or composting plant or to an oleo-chemical plant

Chapter I: Special conditions for the processing of Category 1 or Category 2 material

Chapter II: Special requirements for biogas and composting plants

Chapter III: Treatment standards for further process of ruminant rendered fats

ANNEX V: Specific conditions for placing on the market and importation of processed animal protein and other feed material

Chapter I: General requirements

Chapter II: Special conditions for processed animal protein

Chapter III: Special conditions for blood products

Chapter IV: Special conditions for rendered fats and fish oil

Chapter V: Special conditions for milk, milk-based products and colostrum

Chapter VI: Special conditions for gelatine and hydrolysed protein

Chapter VII: Special conditions for dicalcium phosphate

ANNEX VI: Specific conditions for placing on the market, trade and importation of petfood, dogchew and technical products

Chapter I: General conditions for approval of petfood and technical plants

Chapter II: Petfood and dogchews

Chapter III: Manure, processed manure and processed manure products

Chapter IV: Blood and blood products used for technical or pharmaceutical purpose, in vitro diagnosis or laboratory agents, excluding serum of equidae

Chapter V: Serum of equidae

Chapter VI: Hides and skins of ungulates

Chapter VII: Game trophies

Chapter VIII: Unprocessed wool, hair, pig bristles, feathers and parts of feathers

Chapter IX: Apiculture products

Chapter X: Bones and bone products (excluding bone meal), horns and horn products (excluding horn meal) and hooves and hoof products (excluding hoof meal) intended for use different from animal consumption or fertilisers

Chapter XI: Unprocessed animal by-products for the manufacture of petfood and pharmaceutical or technical products

Chapter XII: Rendered fats for oleo-chemical purpose

ANNEX VII: Health certificate for processed animal by-products intended to be incinerated or co-incinerated in another Member State

ANNEX VIII: Hygiene requirements for intermediate and storage plants

Chapter I: Requirements for the approval of intermediate plants

Chapter II: General conditions of hygiene

Chapter III: Requirements for the approval of storage plants

ANNEX IX: Rules applicable to the treatment of certain Category 2 and Category 3 materials intended to be used as feedstuffs for categories of animals listed in Article 21

ANNEX X: Models of health certificates for the importation from third countries of certain animal by-products, and products derived therefrom

ANNEX XI: Lists of third countries from which Member States authorise imports of animal by-products not intended for human consumption

2000/0259(COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying down the health rules concerning animal by-products not intended for human consumption

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission [3],

[3] OJ C

Having regard to the opinion of the Economic and Social Committee [4],

[4] OJ C

Having regard to the opinion of the Committee of the Regions [5],

[5] OJ C

Acting in accordance with the procedure laid down in Article 251 of the Treaty [6],

[6] OJ C

Whereas:

(1) Council Directive 90/667/EC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedstuffs of animal or fish origin and amending Directive 90/425/EEC [7] established the principle that all animal waste, regardless of its source, may be used for the production of feed material following appropriate treatment.

[7] OJ L 363, 27.12.1990, p. 51. Directive as last amended by the Act of Accession of Austria, Finland and Sweden.

(2) The Scientific Steering Committee has adopted a number of opinions. The main conclusion of those scientific opinions is that animal by-products derived from animals not fit for human consumption following health inspection should not enter the feed chain.

(3) In the light of those scientific opinions, a distinction should be drawn between the measures to be implemented on the basis of the nature of animal by-products used. The possibility of using certain animal materials should be limited. Alternative methods to the production of feed material should be laid down for the use or disposal of animal by-products.

(4) In the light of the experience gained in recent years, it is appropriate to clarify the relationship between Directive 90/667/EEC and Council Directive 75/442/EEC of 15 July 1975 on waste [8], in order to avoid confusion and conflict of interest among the competent authorities of the Member States. In particular, when an animal by-product is consigned to a disposal or recovery operation, it should be treated as waste in order to ensure that it is disposed of or recovered in such a way that the objectives of Article 4 of Directive 75/442/EEC are achieved and the human health and environment are protected.

[8] OJ L 194, 25.7.1975, p. 39. Directive as last amended by Commission Decision 96/350/EC (OJ L 135, 6.6.1996, p. 32).

(5) The International Scientific Conference on Meat-and-Bone Meal organised by the Commission and the European Parliament, held in Brussels on 1-2 July 1997, has initiated a debate concerning the production and feeding of meat-and-bone meal. The conference called for further reflection on the future policy in this area. In November 1997, in order to launch the widest possible public debate about the future of the Community's feed legislation, the Commission finalised a Consultation Paper on Meat-and-Bone Meal. Following that consultation, it appears that there is a general recognition of the need to amend Directive 90/667/EEC in order to bring it in line with the new scientific information.

(6) From October 1996, the Food and Veterinary Office of the Commission (FVO) carried out a number of rounds of inspections to Member States, to assess the presence and management of main risk factors and surveillance procedures with regard to BSE. Part of the assessment covered the systems of commercial rendering and other methods of animal waste disposal. General conclusions and a number of recommendations were drawn up following those inspections, with particular reference to the traceability of animal by-products.

(7) In order to avoid any risk of dispersal of pathogens and/or residues, animal by-products should be processed and stored in an approved and supervised plant designated by the Member State concerned or else be disposed of in another suitable manner. In certain circumstances, especially when it is justified by distance, time of transport, or capacity problems, the designated processing, incineration or co-incineration plant could be located in another Member State.

(8) Specific rules should be laid down on controls for processing plants, with particular reference to detailed procedures for the validation of processing methods and self-supervision of production.

(9) In order to take into account certain practices, it should be possible to derogate from the processing laid down for controlled uses.

(10) Community inspections should be carried out in the Member States in order to ensure uniform implementation of the health requirements. Such inspections should also include audit procedures.

(11) The basis for Community legislation on health issues is sound science. To this end, the relevant scientific committees set up by Commission Decisions 97/404/EC [9] and 97/579/EC [10] should be consulted wherever necessary.

[9] OJ L 169, 27.6.1997, p. 85. Decision as amended by Decision 2000/443/EC (OJ L 179, 18.7.2000, p. 13).

[10] OJ L 237, 28.8.1997, p. 18. Decision as amended by Decision 2000/443/EC.

(12) A wide variety of approaches exist in Member States as regards the financial support for processing and disposal of animal by-products. In order to ensure that the conditions of competition between agricultural products are not affected, it is necessary to carry out an analysis and, if necessary, to take appropriate measures at Community level.

(13) In the light of the above, a fundamental revision of the Community rules applicable to animal by-products appears to be necessary.

(14) Animal by-products not destined to human consumption (in particular processed animal protein, rendered fats, petfood, hides and skins andwool) are included in the list of products in Annex I to the Treaty. The placing on the market of such products constitutes an important source of income for part of the farming population. In order to ensure rational development in this sector and increase productivity, animal health and public health rules for the products in question should be laid down at Community level. Given the significant risks of the spread of diseases to which animals are exposed, particular requirements should apply to the placing on the market of certain animal by-products, particularly in regions with a high health status.

(15) In order to ensure that products imported from third countries are of a hygiene standard which is at least equal or equivalent to the hygiene standard applied by the Community, a system of approval should be introduced for third countries and their establishments, together with a Community inspection procedure to ensure that the conditions for such approval are observed. The importation from third countries of petfood and raw material for petfood can take place subject to conditions different from those applicable to such material produced in the Community, in particular as regards the guarantees required concerning the residues of substances prohibited in accordance with Council Directive 96/22/EEC [11]. In order to ensure that such petfood and raw material are only used for their intended purpose, it is necessary to lay down appropriate control measures on importation of material covered by such derogations.

[11] OJ L 125, 23.5.1996, p. 3 [amendment proposed by COM(2000) 320].

(16) The accompanying document for products of animal origin is the best way of satisfying the competent authority of the place of destination that a consignment complies with the provisions of this Regulation. The health certificate should be maintained for the purposes of verifying the destination of certain imported products.

(17) The abovementioned objectives are pursued by Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC [12].

[12] OJ L 62, 15.3.1993, p. 49. Directive as last amended by Commission Decision 1999/724/EC (OJ L 290, 12.11.1999, p. 32).

(18) Several Decisions implementing Directives 90/667/EEC and 92/118/EEC have been adopted by the Council and by the Commission. Furthermore, Directive 92/118/EEC has been substantially amended and further amendments are to be made. Consequently, at present the sector of products of animal origin not destined to human consumption is regulated by a great number of different Community legislative acts. Therefore, there is a need for a simplification of the Community legislation dealing with these products.

(19) Such a simplification will also lead to more transparency with regard to specific health rules for products of animal origin not destined to human consumption. Simplification of the specific health legislation must not lead to deregulation. It is therefore necessary to maintain and, where required to ensure public and animal health protection, tighten the detailed health rules for products of animal origin not destined to human consumption.

(20) The products concerned should be subject to the rules for veterinary checks and any protective measures laid down by Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market [13].

[13] OJ L 224, 18.8.1990, p. 29. Directive as last amended by Directive 92/118/EEC.

(21) Effective checks should be carried out on products imported into the Community. This can be achieved by implementing the controls laid down in Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries [14].

[14] OJ L 24, 30.1.1998, p. 9.

(22) Directive 90/667/EEC, Council Decision 95/348/EC of 22 June 1995 laying down the veterinary and animal health rules applicable in the United Kingdom and Ireland to the treatment of certain types of waste intended to be marketed locally as feedstuffs for certain animal categories [15] and Council Decision 1999/534/EC of 19 July 1999 on measures applying to the processing of certain animal waste to protect against transmissible spongiform encephalopathies and amending Commission Decision 97/735/EC [16] should therefore be repealed.

[15] OJ L 202, 26.8.1995, p. 8.

[16] OJ L 204, 4.8.1999, p. 37.

(23) In order to take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Veterinary Committee set up by Council Decision 68/361/EEC [17].

[17] OJ L 255, 18.10.1968, p. 23.

(24) Since the measures necessary for the implementation of this Regulation are measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [18], they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision,

[18] OJ L 184, 17.7.1999, p. 23.

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1 Scope

1. This Regulation lays down:

(a) the animal health and public health rules for the collection, transport, storing, handling, processing and use or disposal of animal by-products in order to prevent these products from presenting a risk to animal or public health;

(b) the animal and public health rules for the placing on the market, trade and importation of animal by-products and products derived therefrom, intended for purposes other than human consumption.

2. Without prejudice to the relevant animal and public health rules, this Regulation shall not apply to:

(a) raw petfood originating from retail shops or in premises adjacent to sale points, where the cutting and storage are performed solely for the purpose of supplying the consumer directly on the spot;

(b) liquid milk and colostrum disposed of or used on the farm of origin;

(c) carcases or parts of wild animals not suspected of being infected with diseases communicable to man or animals;

(d) 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.

3. This Regulation shall not affect national veterinary legislation applicable to the eradication and control of certain diseases and to the use of catering waste.

Article 2 Definitions

For the purpose of this Regulation, the following definitions and the definitions laid down in Annex I shall apply:

(1) Animal by-products: carcases or parts of animal or products of animal origin referred to in Articles 4, 5 and 6 not intended for human consumption, with the exception of ova, embryos, semen and catering waste;

(2) Category 1 material: animal by-products referred to in Article 4;

(3) Category 2 material: animal by-products referred to in Article 5;

(4) Category 3 material: animal by-products referred to in Article 6;

(5) Animals: any vertebrate or invertebrate animal (including fish, reptiles or amphibians);

(6) Farmed animals: any animal which is kept, fattened or bred for the production of food (meat, milk, eggs,) wool, fur, feathers, skins, or any other product of animal origin;

(7) Wild animals: animals not kept by man, excluding fish;

(8) Pet animals: animals belonging to species normally nourished and kept, but not consumed, by man for purposes other than farming;

(9) Competent authority: the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any authority to which it has delegated that competence;

(10) Placing on the market: any operation the purpose of which is to supply animal by-products, or products derived therefrom covered by this Regulation, to a third party for sale, or any other form of transfer against payment or free of charge to a third party and storage with a view to supply to a third party, regardless of whether the operation takes place within a Member State, between Member States or between a Member State and a third country or vice versa;

(11) Trade: trade between Member States in goods within the meaning of Article 23(2) of the Treaty;

(12) Producer: any person whose activity produces animal by-products;

(13) Processing plant: an animal by-products processing plant;

(14) Category 1 processing plant: a plant in which Category 1 material is processed before its final disposal or further transformation;

(15) Category 2 processing plant: a plant in which Category 2 material is processed before its final disposal or further transformation;

(16) Category 3 processing plant: a plant in which Category 3 materials are processed into feed material;

(17) Processing methods: methods listed in Annex III, Chapter III;

(18) Oleochemical plant: a plant processing rendered fats derived from Category 2 material or Category 3 material under conditions set out in Annex IV, Chapter III;

(19) Incineration: the disposal of animal by-products or products derived therefrom in an incineration plant;

(20) Co-incineration: the disposal of animal by-products or products derived therefrom in a co-incineration plant;

(21) Incineration plant: disposal site as defined in Article 3(4) of Directive 2000/.../EC of the European Parliament and of the Council [on the incineration of waste] [19];

[19] [COM(1998) 558 final].

(22) Co-incineration plant: disposal site as defined in Article 3(5) of Directive 2000/.../EC;

(23) Landfill: disposal site as defined by Council Directive 1999/31/EC [20];

[20] OJ L 182, 16.7.1999, p. 1.

(24) Biogas plant: a plant in which biological degradation of organic material is undertaken under anaerobic conditions for the production and collections of biogas;

(25) Composting plant: a plant in which biological degradation of organic material is undertaken under aerobic conditions;

(26) Technical products: products derived from certain animal by-products, intended for purposes other than human or animal consumption, including tanned and treated hides and skins, game trophies, processed wool, hair, bristles, feathers and part of feathers, apiculture products, serum of equidae, blood products, pharmaceutical, bone products for china, gelatine and glue, processed manure;

(27) Technical plant: a plant producing technical products;

(28) Category 1 or Category 2 intermediate plant: a plant in which unprocessed Category 1 or Category 2 material is handled and/or temporarily stored for the purpose of further transportation to its final destination; it may be used for certain preliminary processing activities, such as removal of ruminant hides and skins, performing of post-mortem examination;

(29) Category 3 intermediate plant: a plant in which unprocessed Category 3 material is sorted and/or cut and/or chilled or deep frozen into blocks and/or temporarily stored for the purpose of further transporting to its final destination;

(30) Collection centres: premises collecting and treating certain animal by-products intended to be used as feed for categories of animals referred to in Article 21(1)(c);

(31) Storage plant: a plant, other than establishments and intermediaries covered by Council Directive 95/69/EC [21], in which processed animal by-products are temporarily stored before their final use or disposal;

[21] OJ L 332, 30.12.1995, p. 15.

(32) Unprocessed animal by-products: animal by-products which have only undergone refrigeration or other treatment not resulting in sufficiently safe destruction of pathogenic agents;

(33) Processed animal protein: animal proteins derived entirely from Category 3 material, which have been treated so as to render them suitable for direct use as feed material or organic fertilisers or soil improvers or in a feedingstuff for animals or in petfood ; it includes fishmeal, meatmeal, bonemeal, meat-and-bone meal, bloodmeal, dry greaves, feathermeal, hoofmeal, hornmeal and other similar products, including mixture or products containing these products;

(34) Feed material: feed of animal origin for farmed animals, including processed animal proteins, rendered fats, fish oil, gelatine and hydrolysed proteins, dicalcium phosphate, milk and milk products;

(35) Organic fertilisers and soil improvers: materials of animal origin that are used to maintain or improve plant nutrition and the physical and chemical properties and biological activity of soils, either separately or together; they may include compost or digestion residues from biogas production;

(36) Batch: a quantity of a product produced, manufactured or packaged under practically the same conditions;

(37) Rendered fats: fats derived from processing of Category 2 material or Category 3 material;

(38) Greaves: the protein-containing residue of rendering, after partial separation of fat and water;

(39) Petfood: food for pet animals containing Category 3 material;

(40) Dogchews: untanned edible products for pet animals produced from hides and skins of ungulates or other animal material;

(41) Petfood plant: a plant producing petfood or petfood ingredients or dogchews and in which certain animal by-products are used in the preparation of such petfood or petfood ingredients or dogchews;

(42) Manure: any excrement and/or urine of cloven-hoofed animals, equidae and/or poultry, with or without litter, and guano;

(43) TSEs: all transmissible spongiform encephalopathies with the exception of those occurring in humans;

(44) Specified Risk material: Material referred to in Annex II, Chapter B, to Regulation (EC) No .../... of the European Parliament and of the Council [laying down rules for the prevention and control of certain transmissible spongiform encephalopathies] [22].

[22] OJ L

Article 3 General obligations

Animal by-products, and products derived therefrom, shall be collected, transported, stored, handled, processed, disposed of, placed on the market, imported from third countries and used in accordance with this Regulation.

CHAPTER II

CATEGORISATION, COLLECTION, TRANSPORTATION AND INTERMEDIATE STORAGE OF ANIMAL BY-PRODUCTS

Article 4 Category 1 material

1. Category 1 material shall comprise animal by-products of the following description, or any material containing such by-products:

(a) all parts of the body, including hides and skins, of the following animals:

(i) animals suspected of being infected by a TSE or in which the presence of a TSE has been officially confirmed, including animals which were killed in the context of TSE eradication measures,

(ii) animals other than farmed animals and wild animals, including in particular pet animals, zoo animals and circus animals,

(iii) experimental animals as defined by Article 2 of Council Directive 86/609/EEC [23],

[23] OJ L 358, 18.12.1986, p. 1.

(iv) wild animals not kept by man when suspected of being infected with diseases communicable to man or animals;

(b) specified risk material, including dead ruminant animals containing such material;

(c) products derived from animals to which have been administereted substances prohibited under Directive 96/22/EC and products of animal origin containing residues of environmental contaminants and other substances listed in Group B (3) of Annex I to Council Directive 96/23/EC [24], if such residues exceed the permitted level laid down by Community legislation or, in the absence thereof, by national legislation;

[24] OJ L 125, 23.5.1996, p. 10.

(d) all animal material collected when treating waste water from Category 1 processing plants and slaughterhouses in which specified risk material is removed, including screenings, materials from desanding, grease and oil mixture, and sludge, and materials removed from drains from those premises;

(e) mixtures of Category 1 material with either Category 2 material or Category 3 material or both.

2. Category 1 material shall be collected and transported without undue delay in accordance with Article 7, and shall be:

(a) directly disposed of as waste by incineration in an incineration plant approved under Directive .../... /EC [on the incineration of waste];

(b) processed in a processing plant approved under Article 10 and the resulting material shall be finally disposed of as waste by incineration or by co-incineration in an incineration or co-incineration plant approved under Directive .../... /EC [on the incineration of waste];

(c) with the exclusion of material listed in paragraph 1(a)(i), processed in a processing plant approved in accordance with Article 10 following processing method 1, and the resulting material shall be finally disposed of as waste in a landfill approved under Directive 1999/31/EC;

(d) disposed of by other means that are approved in accordance with the procedure referred to in Article 33(2), after consultation of the appropriate Scientific Committee.

3. Intermediate handling or storage of Category 1 material shall take place only in intermediate plants approved in accordance with Article 9.

4. By way of derogation from paragraph 2, dead pet animals may be directly disposed of as waste by burial in accordance with Article 4 of Directive 75/442/EEC.

Article 5 Category 2 material

1. Category 2 material shall comprise animal by-products of the following description, or any material containing such by-products:

(a) manure from all animal species and the digestive tract content from mammalian species;

(b) all animal materials collected when treating waste water from slaughterhouses other than slaughterhouses referred to in Article 4(1)(d) or from Category 2 processing plants, including screenings, materials from desanding, grease and oil mixture, and sludge, and materials removed from drains from these premises;

(c) products of animal origin containing residues of veterinary drugs and contaminants listed in Group B (1) and (2) of Annex I to Directive 96/23/EC, if such residues exceed the permitted level laid down by Community legislation;

(d) mixtures of Category 2 material with Category 3 material;

(e) animal by-products other than Category 1 material or Category 3 material.

2. Category 2 material shall be collected and transported without undue delay in accordance with Article 7, and shall be:

(a) disposed of as waste by incineration or by co-incineration in an incineration or co-incineration plant approved under Directive .../... /EC [on the incineration of waste];

(b) processed in a processing plant approved in accordance with Article 10 and:

(i) the resulting material shall be disposed of as waste either by incineration or by co-incineration in an incineration or co-incineration plant approved under Directive .../... /EC [on the incineration of waste] or in a landfill approved under Directive 1999/31/EC, or

(ii) the rendered fats shall be further processed into fat derivatives for use in organic fertilisers or soil improvers or other technical use in an oleo-chemical plant approved in accordance with Article 11,

(c) processed in a processing plant approved in accordance with Article 10 following processing method 1 and:

(i) the resulting proteinaceous material shall be used as organic fertiliser or soil improver, or

(ii) the resulting material shall be treated in a biogas plant or in a composting plant approved by the Member State in accordance with Article 12;

(d) in case of material of fish origin, ensiled in compliance with rules to be adopted in accordance with the procedure referred to in Article 33(2);

(e) in the case of manure and digestive tract content and material collected from slaughterhouses referred to in paragraph 1(b):

(i) used without processing as raw material in a biogas plant or in a composting plant or treated in a technical plant approved for this purpose,

(ii) if not suspected of being capable of spreading a serious transmissible diseases, spread on land in accordance with this Regulation;

(f) disposed of by other means that are approved in accordance with the procedure referred to in Article 33(2), after consultation of the appropriate Scientific Committee.

3. Intermediate handling or storage of Category 2 material shall take place only in intermediate plants approved in accordance with Article 9.

4. By way of derogation from paragraph 2, the competent authority may, where necessary, decide that Category 2 material may be disposed of as waste by burial on site where:

(i) a widespread epizootic disease leads to a lack of capacity at the processing plant or incineration plant, or

(ii) the animal by-products concerned originate from a place with difficult access and, therefore, the quantity and the distance to be covered does not justify collecting the animal by-products.

Burial shall be carried out in accordance with Article 4 of Directive 75/442/EEC.

Article 6 Category 3 material

1. Category 3 material shall comprise animal by-products of the following description, or any material containing such by-products:

(a) all parts of slaughtered animals which are declared fit for human consumption in accordance with Community legislation, but are not intended for human consumption for commercial reason;

(b) all slaughtered animal parts which have been rejected as unfit for human consumption but are not affected by any signs of diseases communicable to man or animals and have been derived from carcases passed fit for human consumption in accordance with Community legislation;

(c) hides and skins, hooves and horns, pig bristles and feathers originating from animals which have been slaughtered in a slaughterhouse, have undergone an ante-mortem inspection and been passed fit, as a result of such inspection, for slaughter in accordance with Community legislation;

(d) blood obtained from animals which have been slaughtered in a slaughterhouse, have undergone an ante-mortem inspection and been passed fit, as a result of that inspection, for slaughter in accordance with Community legislation;

(e) animal by-products derived from the production of products intended for human consumption, including degreased bones and greaves;

(f) foodstuffs of animal origin, or foodstuffs containing products of animal origin, which were originally intended for human consumption but are destined for animal consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects which do not present any risk to humans or animals, which are destined for farmed animals and have not been processed in accordance with animal health legislation for the production of swill;

(g) raw milk originating from animals which do not show clinical signs of any disease communicable through that product to man or animals;

(h) fish or other sea animals, except sea mammals, caught in the open sea for the purposes of fishmeal production;

(i) fresh fish offal from plants manufacturing fish products for human consumption;

(j) shells, hatchery by-products and cracked egg by-products originating from animals which did not show clinical signs of any disease communicable through that product to man or animals;

(k) blood, hides and skins, hooves, feathers, wool, horns, hair and fur originating from animals which did not show clinical signs of any disease communicable through that product to man or animals.

2. Animal by-products shall be collected and transported without undue delay in accordance with Article 7, and shall be:

(a) disposed of as waste by incineration or by co-incineration in an incineration or co-incineration plant approved under Directive .../... /EC [on the incineration of waste];

(b) processed in a processing plant approved in accordance with Article 15;

(c) transformed in a technical plant approved in accordance with Article 16;

(d) used as raw material in a petfood plant approved in accordance with Article 16;

(e) processed in a processing plant approved in accordance with Article 10 or in a processing plant approved in accordance with Article 15 and the resulting material is finally disposed of as waste either by incineration or by co-incineration in an incineration or co-incineration plant approved under Directive .../... /EC [on the incineration of waste] or in landfill approved under Directive 1999/31/EC; or

(f) transformed in a biogas plant or in a composting plant approved in accordance with Article 12.

3. Intermediate handling and/or storage of Category 3 material shall take place only in intermediate plants approved in accordance with Article 9.

Article 7 Collection and transportation

Unprocessed and processed animal by-products shall be collected, transported and identified in accordance with Annex II.

Article 8 Records

1. Producers consigning animal by-products from any premises shall keep a record of each consignment showing:

(a) the date on which the material was taken from the premises;

(b) the quantity and description of the material;

(c) the destination to which it was consigned; and

(d) the name of the haulier transporting it.

2. Any person transporting animal by-products shall, at the time of collection, record:

(a) the address of the premises from which the material was collected;

(b) the date on which the material was collected;

(c) the quantity and description of the material;

(d) the destination to which it is to be taken.

3. Any person receiving animal by-products shall keep a record of incoming consignments showing:

(a) the date on which the material arrived;

(b) the address of the premises from which the material was consigned;

(c) the quantity and description of the material;

(d) the name and address of the haulier who transported it.

4. The records referred to in paragraphs 1, 2 and 3 shall be kept for a period of at least two years for presentation to the competent authorities.

Article 9 Intermediate plants and storage plants

1. Animal by-products intermediate plants and storage plants shall be subject to approval by the competent authority.

2. In order to be approved , the Category 1 or Category 2 intermediate plant must:

(a) meet the requirements of Annex VIII, Chapter I;

(b) handle and store Category 1 or Category 2 material in accordance with Annex VIII, Chapter II, Part B;

(c) have undergone the establishment's own checks provided for in Article 22;

(d) be checked by the competent authority in accordance with Article 23.

3. In order to be approved , the Category 3 intermediate plant must:

(a) meet the requirements of Annex VIII, Chapter I;

(b) handle and store Category 3 material in accordance with Annex VIII, Chapter II, Part A;

(c) have undergone the establishment's own checks provided for in Article 22;

(d) be checked by the competent authority in accordance with Article 23.

4. In order to be approved, storage plants must:

(a) meet the requirements of Annex VIII, Chapter III;

(b) store processed animal by-products in accordance with Annex VIII, Chapter III, point 3;

(c) be supervised by the competent authority.

CHAPTER III

APPROVAL OF CATEGORY 1 AND 2 PROCESSING PLANTS, BIOGAS PLANTS, COMPOSTING PLANTS AND OLEO-CHEMICAL PLANTS

Article 10 Approval of Category 1 and Category 2 processing plants

1. Member States shall approve for all or part of their territory one or more Category 1 and Category 2 processing plants for the collection and processing of Category 1 or Category 2 material. A Member State may decide to designate a Category 1 or Category 2 processing plant in another Member State after agreement with that State.

2. In order to be approved by the competent authority, Category 1 and Category 2 processing plants must:

(a) meet the requirements of Annex III, Chapter I;

(b) handle, process and store the Category 1 or Category 2 material in accordance with Annex III, Chapter II and Annex IV, Chapter I;

(c) be validated by the competent authority in accordance with Annex III, Chapter V;

(d) have undergone the establishment's own checks provided for in Article 22;

(e) be checked by the competent authority in accordance with Article 23;

(f) establish and implement methods of monitoring and checking the critical control points on the basis of the process used;

(g) ensure that the products after processing satisfy the requirements of Annex IV, Chapter I.

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

Article 11 Approval of oleo-chemical plants

1. Oleo-chemical plants shall be subject to approval by the competent authority.

2. In order to be approved, an oleo-chemical plant must:

(a) process the rendered fats in accordance with the standards laid down in Annex IV, Chapter III;

(b) establish and implement methods of monitoring and checking the critical control points on the basis of the process used;

(c) keep a record of the information obtained pursuant to point (b) for presentation to the competent authority;

(d) be under the supervision of the competent authority to ensure that the operator or manager of the establishment complies with the requirements of this Regulation.

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

Article 12 Approval of biogas plants and composting plants

1. Biogas plants and composting plants which transform animal by-products shall be subject to approval by the competent authority.

2. In order to be approved, a biogas plant and composting plant must:

(a) meet the requirements of Annex IV, Chapter II, section A;

(b) handle and transform the animal by-products in accordance with Annex IV, Chapter II, sections B and C;

(c) be checked by the competent authority;

(d) establish and implement methods of monitoring and checking the critical control points;

(e) ensure that digestion residues comply with the microbiological standards laid down in Annex IV, Chapter II, section D.

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

Article 13 Dispatch of processed animal by-products to incineration or co-incineration plants or to landfill

1. Processed animal by-products may be sent for disposal by incineration or co-incineration or landfill only subject to the following conditions:

(a) processed animal by-products must be:

(i) transported in sealed covered containers or vehicles which bear the clear indication 'not for animal consumption - for incineration/co-incineration/landfill only', as appropriate,

(ii) consigned only to incineration or co-incineration plants approved under Directive .../... /EC [on the incineration of waste] or to landfill approved under Directive 1999/31/EC;

(b) the competent authority of the place of origin must inform the competent authority of the place of destination of the dispatch of each consignment;

(c) the competent authority of the place of destination must inform the competent authority of the place of origin of the arrival of each consignment;

(d) the competent authority of the place of destination must ensure that the designated plant or landfill uses the consignment only for the authorised purposes and keeps full records demonstrating compliance with this Regulation.

2. Processed animal by-products may be sent for disposal by incineration or co-incineration to other Member States only subject to the following conditions:

(a) the Member State of destination must have authorised the receipt of the material;

(b) the processed animal by-products must:

(i) be accompanied by an official certificate as laid down in Annex VII,

(ii) be transported in sealed covered containers or vehicles which bear the clear indication 'not for animal consumption - for incineration or co-incineration only,' if appropriate in the language of the Member States of origin, destination and transit,

(iii) be conveyed directly to the incineration or co-incineration plant;

(c) Member States which send processed animal by-products to other Member States must inform the competent authority of the place of destination of each consignment by means of the ANIMO system and the words 'Not for animal consumption - For incineration or co-incineration only' must be contained in the ANIMO message;

(d) Member States of destination must inform the competent authority of the place of origin of the arrival of each consignment by means of the ANIMO system;

(e) Member States of destination must ensure that the designated plants on their territory use the consignment only for the authorised purposes and keep full records demonstrating compliance with this Regulation.

CHAPTER IV

PLACING ON THE MARKET OF PROCESSED ANIMAL PROTEINS AND OTHER FEED MATERIAL, PETFOOD, DOGCHEW AND TECHNICAL PRODUCTS

Article 14 General animal health provisions

1. Member States shall take all necessary measures to guarantee that animal by-products and products derived therefrom, referred to in Annex V and Annex VI, are not dispatched from any holding, situated in zone subject to restrictions because of the occurrence of a disease to which the species from which the product is derived is susceptible or from any plants or zone from which movements or trade would constitute a risk to the animal health status of the Member States or areas of Member States except where products are treated in accordance with this Regulation.

2. The measures referred to in paragraph 1 shall guarantee that the products are obtained from animals which:

(a) come from a holding, territory or part of a territory or, in the case of aquaculture products, from a farm, zone or part of a zone, not subject to animal health restrictions applicable to the animals and products concerned, and in particular restrictions under disease control measures imposed by Community legislation or by virtue of a serious transmissible disease listed in Council Directive 92/119/EC [25];

[25] OJ L 62, 15.3.1993, p. 69.

(b)