Explanatory Memorandum to COM(2000)574 - Health rules concerning animal by-products not intended for human consumption - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2000)574 - Health rules concerning animal by-products not intended for human consumption. |
|---|---|
| source | COM(2000)574  |
| date | 19-10-2000 |
Contents
- 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
- 1. Legal Basis
- 2. Main Elements of the Proposal
- B. BACKGROUND
- 1. LEGISLATIVE BACKGROUND
- 1.1. Community Legislation
- -maximum particle size 50 mm
- -time 20 minutes
- Furthermore, rendered fats derived from ruminant animals destined to animal consumption must
- 1.2. National legislation
- 2. THE INTERNATIONAL SCIENTIFIC CONFERENCE AND CONSULTATION PAPER ON MEAT-AND-BONE MEAL
- 3. THE SCIENTIFIC ADVICE
- Date of adoption: 26-27 March 1998 and updated on 24-25 September 1998
- Date of adoption: 26-27 March 1998
- Date of adoption: 26-27 March 1998 and updated on 20-21 January 2000
- Date of adoption: 25-26 June 1998
- Date of adoption: 24-25 September 1998
- Date of adoption: 22-23 October 1998
- Date of adoption: 24-25 June 1999 and re-edited on 22-23 July 1999
- Date of adoption: 17 September 1999
- 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
- The alternatives
- The financing rules
- The new categorisation
- Animal Waste Directive
- Health and environmental controls
- The new proposal
- D. POSITION OF CONCERNED PARTIES
- Member States
- Industry
- E. THE FORM OF THE ACT
- ANNEX I
- 1. THE FACTS
- 1.1 The EU Rendering Industry
- 1.2 The crisis of the sector
- This concern is reflected in
- 2. ANALYSES OF ALTERNATIVES
- 2.1 Incineration
- 2.2 Co-incineration (i.e. burning of meat-and-bone meal and fats in power stations)
- 2.3 Cement kilns
- 2.4 Burning of fat as fuel
- 2.5 Disposal by burial or landfill
- 2.5.1 Burial
- 2.5.2 Landfill
- 2.6 Biogas
- Methane Biogas Heat combust. L/Kg L/Kg MJ/Kg
- 2.7 Composting
- 2.8 Use of meat-and-bone meal (MBM) as fertilisers
- 3. CONCLUSIONS
- ANNEX II
- CHAPTER III: Approval of Category 1 and 2 processing plants, biogas plants, composting plants and oleo-chemical plants
C. LEGAL BASIS AND 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).
(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).
-temperature > 133°C
-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.
-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.
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.
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.
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.
*Scientific opinion on the safety of tallow derived from ruminant tissues.
*Scientific report and opinion on the safety of Gelatine.
*Scientific report and opinion on the safety of dicalcium phosphate precipitated from ruminant bones and used as an animal feed additive.
*Scientific opinion on mammalian derived meat-and-bone meal forming a cross-contaminant of animal feedstuffs.
*Scientific report and opinion on the safety of hydrolysed proteins produced from bovine hides.
*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).
*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)
*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.
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).
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.
(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.
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.
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.
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.
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.
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.
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.
Extensive consultation has taken place with the principal parties concerned by the proposed Regulation, namely Member States and industry.
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.
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.
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.
ANALYSIS OF IMPACTS
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.
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.
-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 i
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.
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. i.
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.
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.
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.
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.
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.
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.
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:
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.
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.
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.
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.
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