BETA


2008/0110(COD) Health rules: animal by-products and derived products not intended for human consumption

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI SCHNELLHARDT Horst (icon: PPE-DE PPE-DE)
Committee Opinion AGRI SMITH Alyn (icon: Verts/ALE Verts/ALE)
Lead committee dossier:
Legal Basis:
TFEU 168-p4

Events

2009/11/14
   Final act published in Official Journal
Details

PURPOSE: to lay down health rules as regards animal by-products not intended for human consumption

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

CONTENT: the Council adopted this Regulation modernising the EU rules for animal by products, following a first reading agreement with the European Parliament. The new Regulation is aimed at introducing more risk-proportionate rules and at clarifying the rules on animal by-products, as well as their interaction with other EU legislation.

The Regulation lays down public health and animal health rules for animal by-products and derived products, in order to prevent and minimise risks to public and animal health arising from those products, and in particular to protect the safety of the food and feed chain .Animal by-products are products of animal origin which are not intended for human consumption. They arise mainly during the slaughter of animals for human consumption, during the production of products of animal origin such as dairy products, and in the course of the disposal of dead animals. Past crisis related to outbreaks of foot-and-mouth disease or the spread of bovine spongiform encephalopathy (BSE) have shown that the improper use of certain animal by-products pose a risk to public and animal health, the safety of the food and feed chain and consumer confidence. More than 15 million tonnes of animal by-products are produced in the EU every year.

The main points of the Regulation are as follows:

· the concept of an "end point" in the manufacturing of animal by-products is introduced, after which the processed products are no longer subject to the animal by-products Regulation, as some potential risks have been eliminated for example by heat or chemical substances. Instead, the general rules on product safety apply. Under the current rules, almost all material from animals which does not enter the food chain, is subject to the rules on animal by-products;

· the distinction between foodstuffs and animal by-products is clarified by confirming that operators need to make an irreversible decision, if products are destined for purposes other than human consumption. This means that once a product has become an animal by-product, it must not re-enter the food chain;

· modification of the current classification 1 of animal by-products by Comitology procedure is permitted. In addition, certain animal by-products, which so far have been classified by default as category 2 material but which have been proven to pose no major risks, are reclassified as belonging to category 3, so as to allow their use for certain feeding purposes. For any other animal by-products which are not listed under one of the three categories, the classification by default as category 2 material is maintained for precautionary reasons;

· a registration obligation is introduced for operators who transport animal by-products, in order to strengthen traceability;

· the coherence between the Regulation on animal by-products and other EU legislation (for instance the legislation on food hygiene and waste) is improved by clarifying when the appropriate legislation applies. This removes unnecessary burdens for operators (for example, approvals of slaughterhouses and dairy plants under food and feed legislation are recognised).

The current classification scheme is maintained . This means that animal by-products of category 1 (injurious to health) and category 2 (unfit for human consumption) must not be placed on the market as food, whereas material of category 3 (which comply with certain rules regarding their possible use for human consumption) may be used for certain feeding purposes.

The basic principles of Regulation (EC) No 1774/2002 on animal by-products, however, remain unchanged . These include:

the classification of animal by-products into three categories according to the degree of risk involved; the exclusion of animal by-products which are unfit for human consumption from the feed chain of farmed animals; the intra-species recycling ban (material derived from animals is not to be fed to animals of the species from which it is derived); the rule that only material from animals which have undergone veterinary inspection is to enter the feed chain for farmed animals; the ban on feeding of catering waste to farmed animals, in particular to pigs.

The technical details for the Regulation will be laid down in a separate legal act, to be adopted by comitology procedure. This implementing regulation will be prepared in the next year, so that it can enter into application simultaneously with the new basic regulation.

ENTRY INTO FORCE: 04/12/2009.

APPLICATION: from 04/03/2011.

2009/10/21
   CSL - Draft final act
Documents
2009/10/21
   CSL - Final act signed
2009/10/21
   EP - End of procedure in Parliament
2009/09/07
   EP/CSL - Act adopted by Council after Parliament's 1st reading
2009/09/07
   CSL - Council Meeting
2009/06/25
   EC - Commission response to text adopted in plenary
Documents
2009/04/24
   EP - Results of vote in Parliament
2009/04/24
   EP - Debate in Parliament
2009/04/24
   EP - Decision by Parliament, 1st reading
Details

The European Parliament adopted by 391 votes to 3, with 4 abstentions, a legislative resolution modifying, under the first reading of the codecision procedure, the proposal for a regulation of the European Parliament and of the Council laying down health rules as regards animal by-products not intended for human consumption (Animal by-products Regulation).

The amendments are the result of a compromise negotiated with the Council.

The main amendments are as follows:

Scope : the compromise clarifies that the Regulation shall apply to:

animal by-products and derived products which are excluded from human consumption under Community legislation; and the following products which pursuant to a decision by an operator are destined for purposes other than human consumption: (i) products of animal origin which may be destined for human consumption under Community legislation; (ii) raw materials for the production of products of animal origin.

Such decision shall be irreversible.

On the other hand, the Regulation shall not apply to the following animal by-products, inter alia:

entire bodies or parts of wild animals, other than wild game, which are not suspected of being infected or affected with a disease communicable to humans or animals, except for aquatic animals landed for commercial purposes; entire bodies or parts of wild game which are not collected after killing, in accordance with good hunting practice, without prejudice to Regulation (EC) No 853/2004 laying down specific hygiene rules applicable to products of animal origin; raw pet food originating from retail shops, where the cutting and storage are performed solely for the purpose of supplying the consumer directly on the spot; raw pet food derived from animals which are slaughtered on the farm of origin for private domestic consumption; excrement and urine other than manure and non-mineralised guano.

Definitions : for the purposes of this Regulation, "animal by-products" means entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption, including oocytes, embryos and semen; "derived products" means products obtained from one or more treatments, transformations or steps of processing of animal by-products; "products of animal origin" means products of animal origin as defined in Regulation (EC) No 853/2004; "carcase" means carcase as defined in point 1(9) of Annex I to Regulation (EC) No 853/2004.

Responsibilities : as soon as operators generate animal by-products or derived products falling within the scope of this Regulation, they shall identify them and ensure that they are dealt with in accordance with this Regulation (starting point).

Operators shall ensure at all stages of collection, transport, handling, treatment, transformation, processing, storage, placing on the market, distribution, use and disposal within the businesses under their control that animal by-products and derived products satisfy the requirements of this Regulation which are relevant to their activities.

Members States shall monitor and verify that the relevant requirements of this Regulation are fulfilled by operators along the entire chain of animal by-products and derived products. For that purpose, they shall maintain a system of official controls.

Member States shall also ensure that an adequate system is in place on their territory ensuring that animal by-products are: (i) collected, identified and transported without undue delay; and (ii) treated, used or disposed of in accordance with this Regulation.

Member States may fulfil their obligations in cooperation with other Member States or third countries.

Starting point : the starting point is the precise moment in the life cycle of animal by-products following which, the requirements of this Regulation should apply. Once a product has become an animal by-product, it should normally not re-enter the food chain.

However, special circumstances apply for the handling of certain raw materials, such as hides, handled in establishments or plants integrated at the same time into the food chain and the animal by-products manufacturing chain. In those cases, the necessary measures should be taken by means of segregation to mitigate potential risks for the food and feed chain which can arise from cross-contamination. For other establishments, risk-based conditions should be determined to prevent cross contamination in particular through separation between the two chains.

End point : for reasons of legal certainty and proper control of potential risks, an end point in the manufacturing chain should be determined for products without direct relevance for the safety of the feed chain. For certain products regulated under other Community legislation, such an end point should be determined at the stage of manufacturing. Products which have reached this end point should be exempt from controls under this Regulation. In particular, products beyond the end point should be allowed to be placed on the market without restriction under this Regulation and may be handled and transported by operators which have not been approved or registered in accordance with this Regulation.

However, it should be possible to modify such an end point, particularly in the case of new emerging risks.

Approved establishments or plants : operations with animal by-products which give rise to a considerable degree of risk to public and animal health should only be carried out in establishments or plants which have been approved in advance for such operations by the competent authority. This condition should apply in particular to processing plants and other establishments or plants which handle or store animal by-products with a direct relevance for the safety of the feed chain.

Approval : establishments or plants should be approved following the submission of information to the competent authority and following a visit carried out on site which demonstrates that the requirements of this Regulation for the infrastructure and equipment of the establishment or plant will be met, so that any risks to public and animal health arising from the process used will be adequately contained. It should be possible to grant the approvals conditionally in order to allow operators to rectify deficiencies before the establishment or plant obtains full approval.

Establishments and plants which have been approved or registered under hygiene legislation should be under the obligation to comply with the requirements of this Regulation and subject to official controls carried out for the purposes of verifying compliance with the requirements of this Regulation.

Each Member State shall draw up a list of plants, establishments and operators which have been approved or registered in accordance with this Regulation within its territory.

Animals used for experiments : animal by-products from animals used for experiments as defined in Directive 86/609/EEC should also be excluded from use in feed, due to the potential risks arising from those animal by-products. However, Member States may allow the use of animal by-products from animals which have been used for experiments to test new feed additives, in accordance with Regulation (EC) No 1831/2003 on additives for use in animal nutrition.

Traceability : the respective basic obligation of operators to ensure compliance with this Regulation should be further clarified and specified as regards the means by which traceability is ensured, such as separate collection and channelling of animal by-products. Established systems ensuring traceability for products exclusively circulating on national level by other means should continue to operate, if they provide equivalent information. Every effort should be made to promote the use of electronic and other means of documentation which do not involve paper records, as long as they ensure full traceability.

Own checks : a system of own checks is necessary to ensure that within an establishment or plant, the requirements of this Regulation are fulfilled. During official controls, the competent authorities should take into account the performance of own checks.

In certain establishments or plants own checks should be carried out through a system based on the principles of hazard analysis and critical control points (HACCP). The principles of HACCP should be based on the experience with their implementation under Community legislation on food and feed hygiene. In this respect, national guides to good practice could serve as a useful tool to facilitate the practical implementation of the HACCP principles, and of other aspects of this Regulation.

Placing on the market of animal by-products and derived products intended for feeding purposes and of organic fertilisers and soil improvers : in order to ensure the protection of the food and feed chain, the text clarifies the requirements on these points. Only Category 3 material should be used for feeding farmed animals other than fur animals.

Fertilisers produced on the basis of animal by-products may affect the safety of the feed and food chain. Where they have been manufactured from meat-and-bone meal of Category 2 or from processed animal protein, a component, such as an inorganic or an indigestible substance, should be added in order to prevent their direct use for feeding purposes. Such mixing should not be required if the composition or packaging of products, in particular of products destined for use by the final consumer, excludes the misuse of the product for feeding purposes. When determining the components, different circumstances regarding climate and soil and the objective for the use of particular fertilisers should be taken into account.

Official controls : the possible courses of action which the competent authority can take when carrying out official controls should be specified in order to ensure legal certainty, in particular regarding the suspension or permanent prohibition of operations or the imposition of conditions to ensure the proper application of this Regulation.

These official controls should be carried out in the framework of multi-annual control plans under Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.

Powers of the Commission (comitology) : the Commission shall be empowered to adopt:

· rules modifying the end point in the manufacturing chain of certain derived products and establishing such an end point for certain other derived products;

· rules in regard to serious transmissible diseases in the presence of which the dispatch of animal by-products and derived products should not be allowed and/or the conditions allowing such a dispatch;

· measures changing the categorisation of animal by-products;

· measures regarding restrictions on the use and disposal of animal by-products;

· measures laying down conditions for the application of certain derogations regarding the use, collection and disposal of animal by-products as well as measures authorising or rejecting a particular alternative method for the use and disposal of animal by-products.

The Commission shall also be empowered to adopt more specific rules concerning:

collection and transport of animal by-products; the infrastructure, equipment and hygiene requirements for plants and establishments handling animal by-products; the conditions and technical requirements for the handling of animal by-products, including the evidence to be presented for the purpose of validation of such treatment; conditions for the placing on the market of animal by-products and derived products; requirements related to safe sourcing, safe treatment and safe end uses; conditions for the import, transit and export of animal by-products and derived products; detailed arrangements for implementing official controls including rules concerning the reference methods for microbiological analyses as well as conditions for the control of the dispatch of certain animal by-products and derived products between Member States.

These measures shall be adopted in accordance with the regulatory procedure with scrutiny.

Documents
2009/03/02
   EP - Committee report tabled for plenary, 1st reading/single reading
Documents
2009/03/01
   EP - Committee report tabled for plenary, 1st reading
Documents
2009/02/17
   EP - Vote in committee, 1st reading
Details

The Committee on the Environment, Public Health and Food Safety adopted the report drawn up by Horst SCHNELLHARDT (EPP-ED, DE) amending, under the first reading of the codecision procedure, the proposal for a regulation of the European Parliament and of the Council laying down health rules as regards animal by-products not intended for human consumption (Animal by-products Regulation).

The main amendments adopted by the committee are as follows:

Definitions : MEPs note that the proposal introduces new definitions different from those which figured in previous legislation, meaning the user must be prepared for new concepts. In keeping with the principle of good, consistent lawmaking, MEPs expanded the definitions of the proposed regulation and added references to provisions in force (Regulation (EC) No 852/2004 on the hygiene of foodstuffs, for example). With a view to making clear that the regulation covers only animal by-products, the definition of 'animal by-products' should include a reference to the fact that they have been excluded from human consumption.

Scope : according to MEPs, the regulation shall not apply to :

raw pet food for use on site derived from animals slaughtered on the farm of origin for use only as foodstuffs by the farmer and his family; milk, milk-based products and colostrum which are obtained, kept, disposed of or used on the farm of origin; animal by-products for feeding to carnivorous or omnivorous animals of wild species which are being kept under human supervision and which are not intended for human consumption (provided that the animal by-products in question form part of or are based on the animals’ natural diet and are not likely to pose an increased TSE risk); pet food manufactured in registered food production establishments from material suitable for use in foodstuffs and under the same hygiene conditions as foodstuffs; pet food manufactured solely from carcases or slaughter animals suitable for human consumption originating from retail shops or premises adjacent to points of sale where the cutting, processing and storage are performed solely for the purpose of supplying the consumer directly on the spot; end products from the safe processing of biofuels derived from animal by-products.

Hygiene : the general hygiene requirements should not be dealt with in the implementing provisions, which are covered by the comitology procedure. Instead their importance is such that they should be set out in the body of the regulation. A new ‘Annex I’ therefore deals with general hygiene requirements for the handling and processing of animal by-products.

Pets : MEPs call for the ban on the use of raw materials in Categories 1 and 2 to manufacture pet food to be maintained.

General animal health restrictions : MEPs deleted Article 5 of the proposal because the provisions on combating animal diseases, which are essentially based on EU law, already lay down in detail which products can be removed from restricted areas.

Placing on the market of other derived products outside the feed chain : MEPs believe that animal by-products can be processed to such an extent that they pose no risk to human or animal health. The end point in the life cycle of an ABP is a concept central to the new, revised regulation and limits its scope as defined in Section 1 of Chapter 1. They therefore propose that the end point should already be described in Section I.

Plants and establishments requiring approval : MEPs consider that the text does not make it clear whether pet food factories must be registered or approved. They believe that across-the-board approval for all pet food manufacturing establishments is essential for uniformity in the sector, in order to forestall problems in connection with trade. Within the EU, for the purposes of issuing health certificates an establishment must be approved in the country in question, so that imports into the EU can be approved. MEPs also call for the compulsory registration of operators who transport animal by-products.

Exemptions from the requirement for approval : MEPs reject the exemption from the requirement for approval in respect of the processing, storage and handling of animal by-products in establishments registered pursuant to Regulations (EC) No 853/2004 and No 183/2005 or approved pursuant to Regulation (EC) No 183/2005 laying down requirements for feed hygiene. Moreover, they consider that a blanket exemption from the requirement for approval for biogas and composting plants in which animal by-products or derived products are transformed in accordance with the standard parameters laid down in the regulation is unacceptable. Operators whose plants or establishments are exempt from approval shall, before commencing operations, notify the relevant competent authority of the existence of the plants or establishments.

Approval of establishments and plants : according to MEPs, this provision (approval of plants following an on-site visit, conditional approval) should also apply to establishments. The wording should be brought into line with the parallel provision in Regulation (EC) No 882/2004. In addition, it should then be made clear that the granting of both conditional and final approval can be made subject to compliance with specific requirements.

In this context, the competent authority shall initiate procedures to withdraw the establishment's or plant's approval if, when carrying out official controls. it identifies serious deficiencies or has to stop production at an establishment or plant repeatedly and the operator is not able to provide adequate guarantees regarding future production. However, the competent authority may suspend an establishment's or plant's approval if the operator can guarantee that it will resolve deficiencies within a reasonable time.

Operators’ obligations and responsibility : MEPs specify that the responsibility for ensuring that animal by-products and derived products are accompanied by a commercial document - so that this provision can be enforced and breaches of it punished - should lie with the transporter . With a view to facilitating trade, the commercial document may also be drawn up electronically. Any operator consigning, transporting or receiving animal by-products or derived products shall keep a record of consignments.

In line with previous legislation on food production, operators should continue to be held responsible . In particular, operators of such plants shall take the following measures: (i) identify any hazards that must be prevented, eliminated or reduced to acceptable levels; (ii) identify the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels; (iii) establish critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards; (iv) establish and implement effective monitoring procedures at critical control points; (v) establish corrective actions and procedures, which shall be carried out regularly, to verify that the measures are working effectively; (vi) establish a system ensuring the traceability of each batch dispatched.

Restrictions concerning the use of animal by-products : MEPs consider that the feeding of fur animals with processed animal protein and grazing on organically fertilised land are fundamental issues dealt with by the regulation. They should not be regulated in the implementing rules. However, technical details concerning compliance with prohibitions and thresholds in connection with the contamination of feed with animal protein should be regulated in such a way.

Disposal of by-products : a new article has been added covering all the possibilities for disposal for all categories of by-products in order to avoid repetition of their final uses.

Disposal and use of catering waste : MEPs recall that the Directive currently in force permits national regulation of the use of catering waste in biogas and composting plants. Until efficient Community provisions are adopted, the law currently in force should continue to apply. MEPs believe that, with regard to storage, collection and transport of catering waste, uniform provisions should also apply, in the interests of uniform economic conditions in the EU.

Derogations regarding the collection and use of animal by-products for the specific purpose of animal feed : a new article provides that implementing measures may be adopted by the Member States, with notification to the European Commission, in order to exclude the collection of material from Categories 1, 2 and 3 in certain areas of the Natura 2000 network or other areas in which, for reasons of conservation of endangered and protected species, or protected necrophagous birds, such measures are needed.

Official controls : the entire chain of animal by-products, from the place where the by-product arises to processing, use or disposal, shall be subject to official controls.

Traceability : the report stresses that cooperation between the competent authorities of Member States controlling the flow of material should be enhanced so as to ensure traceability and to avoid illegal relabeling of meat and meat products, which has led to rotten meat scandals in the past. Lastly, MEPs consider that every effort should be made to promote the use of animal by-products as sources of bioenergy.

2009/01/30
   EP - Amendments tabled in committee
Documents
2009/01/22
   EP - Committee opinion
Documents
2009/01/09
   EP - Committee draft report
Documents
2008/10/22
   ESC - Economic and Social Committee: opinion, report
Documents
2008/07/14
   EP - SCHNELLHARDT Horst (PPE-DE) appointed as rapporteur in ENVI
2008/06/24
   EP - SMITH Alyn (Verts/ALE) appointed as rapporteur in AGRI
2008/06/19
   EP - Committee referral announced in Parliament, 1st reading
2008/06/10
   EC - Legislative proposal
Details

PURPOSE: to lay down health rules as regards animal by-products not intended for human consumption.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

BACKGROUND: in response to several crises linked to products of animal origin which threatened the

safety of public and animal health (TSE, dioxin, FMD), the Community introduced a comprehensive legislative framework to maintain a high level of safety along the whole production and distribution chain, from "farm to fork". In this context, Regulation (EC) No 1774/2002 laying down health rules concerning animal by-products not intended for human consumption was adopted. The Regulation, which has been applicable since 1 May 2003, consolidated and recast the various existing rules covering animal by-products (ABP).

The Commission presented a report in October 2005 reflecting the experience of all 25 Member States in applying the legislation. In addition, the Commission's Food and Veterinary Office (FVO) carried out a round of inspections in all 25 Member States throughout 2004 and 2005 to assess the level of compliance of the Member States.

The following major issues emerged from consultations on the report as meriting reconsideration:

a) the basic framework of safeguards applicable to all ABP should be maintained;

b) the scope of the rules on ABP should be adjusted;

c) the interaction of the rules on ABP with other Community legislation should be clarified;

d) a more risk-based approach for the categorisation of ABP, as well as controls, should be introduced.

CONTENT: the proposal takes into account the results of the review carried out on Regulation and re-enacts the reviewed provisions, as well as the remaining part of the enacting provisions, in a single text. In the light of the practical and scientific experience gained and the outcome of the consultation, the main elements of the proposal are to maintain a high level of food and feed safety and consumer protection, and at the same time to provide:

1) Clarification

an end point in the life-cycle of ABP is being introduced so as to clarify the point from which ABP cease to be covered by the requirements of the Regulation along the manufacturing chain. This point can be fixed at various stages, depending on the nature of ABP used, the characteristics of a treatment process or the intended end use of the product manufactured on ABP basis; with respect to legal uncertainties regarding the scope of the rules on ABP from wild game, potential sanitary gaps are being closed by introducing parallel provisions to the legislation on food hygiene; with regard to the interaction with other Community legislation , the approval of establishments and the performance of official controls, duplication between requirements is being avoided insofar as the objectives protected by one legislative framework can be considered to be covered sufficiently by another legislative framework.

2) A more risk-based approach

the primary responsibility of operators to ensure that the requirements of the Regulation are met, in line with the approach adopted in Community legislation on food and feed hygiene, is being reinforced. This should allow the competent authorities to focus resources on verifying compliance of operators with this obligation; in particular regarding the manufacture of products based on ABP without direct relevance to the safety of the (food and) feed chain (other than those produced as feed to farmed animals or as organic fertilisers), operators are entrusted with increased responsibility for the placing on the market of safe products. Provided they use safe raw materials for the production, develop safe manufacturing processes or use ABP for end purposes which are on balance safe, ABP of all categories may be used. Further details regarding this option may be laid down by way of implementing rules; new products, which have been proven to pose only limited risks, should be introduced into the classification of ABP . At the same time, the precautionary provision, whereby any ABP which are not expressly classified fall under Category 2 and may not be used in feed to farmed animals, should be maintained. current derogations regarding the exceptional burial and burning on site in cases of disease outbreaks should be clarified and extended to situations in which recovery operations in accordance with the general rules of the Regulation become practically very difficult, such as during natural disasters.

The provisions laid down in the Annexes to the Regulation, as well as provisions laid down in separate Community acts implementing or derogating from that Regulation, such as Regulations (EC) No 811/2003, 79/2005, 92/2005 or 181/2006, will be re-enacted in an implementing Regulation, under the comitology procedure. This will be prepared in parallel, so as to enter into application simultaneously with the current proposal.

2008/06/10
   EC - Document attached to the procedure
2008/06/10
   EC - Document attached to the procedure
2008/06/09
   EC - Legislative proposal published
Details

PURPOSE: to lay down health rules as regards animal by-products not intended for human consumption.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

BACKGROUND: in response to several crises linked to products of animal origin which threatened the

safety of public and animal health (TSE, dioxin, FMD), the Community introduced a comprehensive legislative framework to maintain a high level of safety along the whole production and distribution chain, from "farm to fork". In this context, Regulation (EC) No 1774/2002 laying down health rules concerning animal by-products not intended for human consumption was adopted. The Regulation, which has been applicable since 1 May 2003, consolidated and recast the various existing rules covering animal by-products (ABP).

The Commission presented a report in October 2005 reflecting the experience of all 25 Member States in applying the legislation. In addition, the Commission's Food and Veterinary Office (FVO) carried out a round of inspections in all 25 Member States throughout 2004 and 2005 to assess the level of compliance of the Member States.

The following major issues emerged from consultations on the report as meriting reconsideration:

a) the basic framework of safeguards applicable to all ABP should be maintained;

b) the scope of the rules on ABP should be adjusted;

c) the interaction of the rules on ABP with other Community legislation should be clarified;

d) a more risk-based approach for the categorisation of ABP, as well as controls, should be introduced.

CONTENT: the proposal takes into account the results of the review carried out on Regulation and re-enacts the reviewed provisions, as well as the remaining part of the enacting provisions, in a single text. In the light of the practical and scientific experience gained and the outcome of the consultation, the main elements of the proposal are to maintain a high level of food and feed safety and consumer protection, and at the same time to provide:

1) Clarification

an end point in the life-cycle of ABP is being introduced so as to clarify the point from which ABP cease to be covered by the requirements of the Regulation along the manufacturing chain. This point can be fixed at various stages, depending on the nature of ABP used, the characteristics of a treatment process or the intended end use of the product manufactured on ABP basis; with respect to legal uncertainties regarding the scope of the rules on ABP from wild game, potential sanitary gaps are being closed by introducing parallel provisions to the legislation on food hygiene; with regard to the interaction with other Community legislation , the approval of establishments and the performance of official controls, duplication between requirements is being avoided insofar as the objectives protected by one legislative framework can be considered to be covered sufficiently by another legislative framework.

2) A more risk-based approach

the primary responsibility of operators to ensure that the requirements of the Regulation are met, in line with the approach adopted in Community legislation on food and feed hygiene, is being reinforced. This should allow the competent authorities to focus resources on verifying compliance of operators with this obligation; in particular regarding the manufacture of products based on ABP without direct relevance to the safety of the (food and) feed chain (other than those produced as feed to farmed animals or as organic fertilisers), operators are entrusted with increased responsibility for the placing on the market of safe products. Provided they use safe raw materials for the production, develop safe manufacturing processes or use ABP for end purposes which are on balance safe, ABP of all categories may be used. Further details regarding this option may be laid down by way of implementing rules; new products, which have been proven to pose only limited risks, should be introduced into the classification of ABP . At the same time, the precautionary provision, whereby any ABP which are not expressly classified fall under Category 2 and may not be used in feed to farmed animals, should be maintained. current derogations regarding the exceptional burial and burning on site in cases of disease outbreaks should be clarified and extended to situations in which recovery operations in accordance with the general rules of the Regulation become practically very difficult, such as during natural disasters.

The provisions laid down in the Annexes to the Regulation, as well as provisions laid down in separate Community acts implementing or derogating from that Regulation, such as Regulations (EC) No 811/2003, 79/2005, 92/2005 or 181/2006, will be re-enacted in an implementing Regulation, under the comitology procedure. This will be prepared in parallel, so as to enter into application simultaneously with the current proposal.

Documents

Activities

AmendmentsDossier
130 2008/0110(COD)
2008/12/12 AGRI 31 amendments...
source: PE-416.581
2009/01/30 ENVI 99 amendments...
source: PE-419.854

History

(these mark the time of scraping, not the official date of the change)

docs/0/docs/0/url
Old
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2008/0345/COM_COM(2008)0345_EN.pdf
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https://www.europarl.europa.eu/doceo/document/AGRI-AD-414308_EN.html
events/0
date
2008-06-09T00:00:00
type
Legislative proposal published
body
EC
docs
summary
events/2
date
2009-03-02T00:00:00
type
Committee report tabled for plenary, 1st reading
body
EP
docs
url: https://www.europarl.europa.eu/doceo/document/A-6-2009-0087_EN.html title: A6-0087/2009
events/3
date
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  • date: 2009-01-09T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE418.148 title: PE418.148 type: Committee draft report body: EP
  • date: 2009-01-22T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE414.308&secondRef=02 title: PE414.308 committee: AGRI type: Committee opinion body: EP
  • date: 2009-01-30T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE419.854 title: PE419.854 type: Amendments tabled in committee body: EP
  • date: 2009-03-02T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2009-87&language=EN title: A6-0087/2009 type: Committee report tabled for plenary, 1st reading/single reading body: EP
  • date: 2009-06-25T00:00:00 docs: url: /oeil/spdoc.do?i=16797&j=0&l=en title: SP(2009)3507 type: Commission response to text adopted in plenary
  • date: 2009-10-21T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=[%n4]%2F09&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 03639/2009/LEX type: Draft final act body: CSL
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  • date: 2008-06-10T00:00:00 type: Legislative proposal published body: EC docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2008/0345/COM_COM(2008)0345_EN.pdf title: COM(2008)0345 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2008&nu_doc=345 title: EUR-Lex summary: PURPOSE: to lay down health rules as regards animal by-products not intended for human consumption. PROPOSED ACT: Regulation of the European Parliament and of the Council. BACKGROUND: in response to several crises linked to products of animal origin which threatened the safety of public and animal health (TSE, dioxin, FMD), the Community introduced a comprehensive legislative framework to maintain a high level of safety along the whole production and distribution chain, from "farm to fork". In this context, Regulation (EC) No 1774/2002 laying down health rules concerning animal by-products not intended for human consumption was adopted. The Regulation, which has been applicable since 1 May 2003, consolidated and recast the various existing rules covering animal by-products (ABP). The Commission presented a report in October 2005 reflecting the experience of all 25 Member States in applying the legislation. In addition, the Commission's Food and Veterinary Office (FVO) carried out a round of inspections in all 25 Member States throughout 2004 and 2005 to assess the level of compliance of the Member States. The following major issues emerged from consultations on the report as meriting reconsideration: a) the basic framework of safeguards applicable to all ABP should be maintained; b) the scope of the rules on ABP should be adjusted; c) the interaction of the rules on ABP with other Community legislation should be clarified; d) a more risk-based approach for the categorisation of ABP, as well as controls, should be introduced. CONTENT: the proposal takes into account the results of the review carried out on Regulation and re-enacts the reviewed provisions, as well as the remaining part of the enacting provisions, in a single text. In the light of the practical and scientific experience gained and the outcome of the consultation, the main elements of the proposal are to maintain a high level of food and feed safety and consumer protection, and at the same time to provide: 1) Clarification an end point in the life-cycle of ABP is being introduced so as to clarify the point from which ABP cease to be covered by the requirements of the Regulation along the manufacturing chain. This point can be fixed at various stages, depending on the nature of ABP used, the characteristics of a treatment process or the intended end use of the product manufactured on ABP basis; with respect to legal uncertainties regarding the scope of the rules on ABP from wild game, potential sanitary gaps are being closed by introducing parallel provisions to the legislation on food hygiene; with regard to the interaction with other Community legislation , the approval of establishments and the performance of official controls, duplication between requirements is being avoided insofar as the objectives protected by one legislative framework can be considered to be covered sufficiently by another legislative framework. 2) A more risk-based approach the primary responsibility of operators to ensure that the requirements of the Regulation are met, in line with the approach adopted in Community legislation on food and feed hygiene, is being reinforced. This should allow the competent authorities to focus resources on verifying compliance of operators with this obligation; in particular regarding the manufacture of products based on ABP without direct relevance to the safety of the (food and) feed chain (other than those produced as feed to farmed animals or as organic fertilisers), operators are entrusted with increased responsibility for the placing on the market of safe products. Provided they use safe raw materials for the production, develop safe manufacturing processes or use ABP for end purposes which are on balance safe, ABP of all categories may be used. Further details regarding this option may be laid down by way of implementing rules; new products, which have been proven to pose only limited risks, should be introduced into the classification of ABP . At the same time, the precautionary provision, whereby any ABP which are not expressly classified fall under Category 2 and may not be used in feed to farmed animals, should be maintained. current derogations regarding the exceptional burial and burning on site in cases of disease outbreaks should be clarified and extended to situations in which recovery operations in accordance with the general rules of the Regulation become practically very difficult, such as during natural disasters. The provisions laid down in the Annexes to the Regulation, as well as provisions laid down in separate Community acts implementing or derogating from that Regulation, such as Regulations (EC) No 811/2003, 79/2005, 92/2005 or 181/2006, will be re-enacted in an implementing Regulation, under the comitology procedure. This will be prepared in parallel, so as to enter into application simultaneously with the current proposal.
  • date: 2008-06-19T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
  • date: 2009-02-17T00:00:00 type: Vote in committee, 1st reading/single reading body: EP summary: The Committee on the Environment, Public Health and Food Safety adopted the report drawn up by Horst SCHNELLHARDT (EPP-ED, DE) amending, under the first reading of the codecision procedure, the proposal for a regulation of the European Parliament and of the Council laying down health rules as regards animal by-products not intended for human consumption (Animal by-products Regulation). The main amendments adopted by the committee are as follows: Definitions : MEPs note that the proposal introduces new definitions different from those which figured in previous legislation, meaning the user must be prepared for new concepts. In keeping with the principle of good, consistent lawmaking, MEPs expanded the definitions of the proposed regulation and added references to provisions in force (Regulation (EC) No 852/2004 on the hygiene of foodstuffs, for example). With a view to making clear that the regulation covers only animal by-products, the definition of 'animal by-products' should include a reference to the fact that they have been excluded from human consumption. Scope : according to MEPs, the regulation shall not apply to : raw pet food for use on site derived from animals slaughtered on the farm of origin for use only as foodstuffs by the farmer and his family; milk, milk-based products and colostrum which are obtained, kept, disposed of or used on the farm of origin; animal by-products for feeding to carnivorous or omnivorous animals of wild species which are being kept under human supervision and which are not intended for human consumption (provided that the animal by-products in question form part of or are based on the animals’ natural diet and are not likely to pose an increased TSE risk); pet food manufactured in registered food production establishments from material suitable for use in foodstuffs and under the same hygiene conditions as foodstuffs; pet food manufactured solely from carcases or slaughter animals suitable for human consumption originating from retail shops or premises adjacent to points of sale where the cutting, processing and storage are performed solely for the purpose of supplying the consumer directly on the spot; end products from the safe processing of biofuels derived from animal by-products. Hygiene : the general hygiene requirements should not be dealt with in the implementing provisions, which are covered by the comitology procedure. Instead their importance is such that they should be set out in the body of the regulation. A new ‘Annex I’ therefore deals with general hygiene requirements for the handling and processing of animal by-products. Pets : MEPs call for the ban on the use of raw materials in Categories 1 and 2 to manufacture pet food to be maintained. General animal health restrictions : MEPs deleted Article 5 of the proposal because the provisions on combating animal diseases, which are essentially based on EU law, already lay down in detail which products can be removed from restricted areas. Placing on the market of other derived products outside the feed chain : MEPs believe that animal by-products can be processed to such an extent that they pose no risk to human or animal health. The end point in the life cycle of an ABP is a concept central to the new, revised regulation and limits its scope as defined in Section 1 of Chapter 1. They therefore propose that the end point should already be described in Section I. Plants and establishments requiring approval : MEPs consider that the text does not make it clear whether pet food factories must be registered or approved. They believe that across-the-board approval for all pet food manufacturing establishments is essential for uniformity in the sector, in order to forestall problems in connection with trade. Within the EU, for the purposes of issuing health certificates an establishment must be approved in the country in question, so that imports into the EU can be approved. MEPs also call for the compulsory registration of operators who transport animal by-products. Exemptions from the requirement for approval : MEPs reject the exemption from the requirement for approval in respect of the processing, storage and handling of animal by-products in establishments registered pursuant to Regulations (EC) No 853/2004 and No 183/2005 or approved pursuant to Regulation (EC) No 183/2005 laying down requirements for feed hygiene. Moreover, they consider that a blanket exemption from the requirement for approval for biogas and composting plants in which animal by-products or derived products are transformed in accordance with the standard parameters laid down in the regulation is unacceptable. Operators whose plants or establishments are exempt from approval shall, before commencing operations, notify the relevant competent authority of the existence of the plants or establishments. Approval of establishments and plants : according to MEPs, this provision (approval of plants following an on-site visit, conditional approval) should also apply to establishments. The wording should be brought into line with the parallel provision in Regulation (EC) No 882/2004. In addition, it should then be made clear that the granting of both conditional and final approval can be made subject to compliance with specific requirements. In this context, the competent authority shall initiate procedures to withdraw the establishment's or plant's approval if, when carrying out official controls. it identifies serious deficiencies or has to stop production at an establishment or plant repeatedly and the operator is not able to provide adequate guarantees regarding future production. However, the competent authority may suspend an establishment's or plant's approval if the operator can guarantee that it will resolve deficiencies within a reasonable time. Operators’ obligations and responsibility : MEPs specify that the responsibility for ensuring that animal by-products and derived products are accompanied by a commercial document - so that this provision can be enforced and breaches of it punished - should lie with the transporter . With a view to facilitating trade, the commercial document may also be drawn up electronically. Any operator consigning, transporting or receiving animal by-products or derived products shall keep a record of consignments. In line with previous legislation on food production, operators should continue to be held responsible . In particular, operators of such plants shall take the following measures: (i) identify any hazards that must be prevented, eliminated or reduced to acceptable levels; (ii) identify the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels; (iii) establish critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards; (iv) establish and implement effective monitoring procedures at critical control points; (v) establish corrective actions and procedures, which shall be carried out regularly, to verify that the measures are working effectively; (vi) establish a system ensuring the traceability of each batch dispatched. Restrictions concerning the use of animal by-products : MEPs consider that the feeding of fur animals with processed animal protein and grazing on organically fertilised land are fundamental issues dealt with by the regulation. They should not be regulated in the implementing rules. However, technical details concerning compliance with prohibitions and thresholds in connection with the contamination of feed with animal protein should be regulated in such a way. Disposal of by-products : a new article has been added covering all the possibilities for disposal for all categories of by-products in order to avoid repetition of their final uses. Disposal and use of catering waste : MEPs recall that the Directive currently in force permits national regulation of the use of catering waste in biogas and composting plants. Until efficient Community provisions are adopted, the law currently in force should continue to apply. MEPs believe that, with regard to storage, collection and transport of catering waste, uniform provisions should also apply, in the interests of uniform economic conditions in the EU. Derogations regarding the collection and use of animal by-products for the specific purpose of animal feed : a new article provides that implementing measures may be adopted by the Member States, with notification to the European Commission, in order to exclude the collection of material from Categories 1, 2 and 3 in certain areas of the Natura 2000 network or other areas in which, for reasons of conservation of endangered and protected species, or protected necrophagous birds, such measures are needed. Official controls : the entire chain of animal by-products, from the place where the by-product arises to processing, use or disposal, shall be subject to official controls. Traceability : the report stresses that cooperation between the competent authorities of Member States controlling the flow of material should be enhanced so as to ensure traceability and to avoid illegal relabeling of meat and meat products, which has led to rotten meat scandals in the past. Lastly, MEPs consider that every effort should be made to promote the use of animal by-products as sources of bioenergy.
  • date: 2009-03-02T00:00:00 type: Committee report tabled for plenary, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2009-87&language=EN title: A6-0087/2009
  • date: 2009-04-24T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=16797&l=en title: Results of vote in Parliament
  • date: 2009-04-24T00:00:00 type: Debate in Parliament body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20090424&type=CRE title: Debate in Parliament
  • date: 2009-04-24T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2009-323 title: T6-0323/2009 summary: The European Parliament adopted by 391 votes to 3, with 4 abstentions, a legislative resolution modifying, under the first reading of the codecision procedure, the proposal for a regulation of the European Parliament and of the Council laying down health rules as regards animal by-products not intended for human consumption (Animal by-products Regulation). The amendments are the result of a compromise negotiated with the Council. The main amendments are as follows: Scope : the compromise clarifies that the Regulation shall apply to: animal by-products and derived products which are excluded from human consumption under Community legislation; and the following products which pursuant to a decision by an operator are destined for purposes other than human consumption: (i) products of animal origin which may be destined for human consumption under Community legislation; (ii) raw materials for the production of products of animal origin. Such decision shall be irreversible. On the other hand, the Regulation shall not apply to the following animal by-products, inter alia: entire bodies or parts of wild animals, other than wild game, which are not suspected of being infected or affected with a disease communicable to humans or animals, except for aquatic animals landed for commercial purposes; entire bodies or parts of wild game which are not collected after killing, in accordance with good hunting practice, without prejudice to Regulation (EC) No 853/2004 laying down specific hygiene rules applicable to products of animal origin; raw pet food originating from retail shops, where the cutting and storage are performed solely for the purpose of supplying the consumer directly on the spot; raw pet food derived from animals which are slaughtered on the farm of origin for private domestic consumption; excrement and urine other than manure and non-mineralised guano. Definitions : for the purposes of this Regulation, "animal by-products" means entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption, including oocytes, embryos and semen; "derived products" means products obtained from one or more treatments, transformations or steps of processing of animal by-products; "products of animal origin" means products of animal origin as defined in Regulation (EC) No 853/2004; "carcase" means carcase as defined in point 1(9) of Annex I to Regulation (EC) No 853/2004. Responsibilities : as soon as operators generate animal by-products or derived products falling within the scope of this Regulation, they shall identify them and ensure that they are dealt with in accordance with this Regulation (starting point). Operators shall ensure at all stages of collection, transport, handling, treatment, transformation, processing, storage, placing on the market, distribution, use and disposal within the businesses under their control that animal by-products and derived products satisfy the requirements of this Regulation which are relevant to their activities. Members States shall monitor and verify that the relevant requirements of this Regulation are fulfilled by operators along the entire chain of animal by-products and derived products. For that purpose, they shall maintain a system of official controls. Member States shall also ensure that an adequate system is in place on their territory ensuring that animal by-products are: (i) collected, identified and transported without undue delay; and (ii) treated, used or disposed of in accordance with this Regulation. Member States may fulfil their obligations in cooperation with other Member States or third countries. Starting point : the starting point is the precise moment in the life cycle of animal by-products following which, the requirements of this Regulation should apply. Once a product has become an animal by-product, it should normally not re-enter the food chain. However, special circumstances apply for the handling of certain raw materials, such as hides, handled in establishments or plants integrated at the same time into the food chain and the animal by-products manufacturing chain. In those cases, the necessary measures should be taken by means of segregation to mitigate potential risks for the food and feed chain which can arise from cross-contamination. For other establishments, risk-based conditions should be determined to prevent cross contamination in particular through separation between the two chains. End point : for reasons of legal certainty and proper control of potential risks, an end point in the manufacturing chain should be determined for products without direct relevance for the safety of the feed chain. For certain products regulated under other Community legislation, such an end point should be determined at the stage of manufacturing. Products which have reached this end point should be exempt from controls under this Regulation. In particular, products beyond the end point should be allowed to be placed on the market without restriction under this Regulation and may be handled and transported by operators which have not been approved or registered in accordance with this Regulation. However, it should be possible to modify such an end point, particularly in the case of new emerging risks. Approved establishments or plants : operations with animal by-products which give rise to a considerable degree of risk to public and animal health should only be carried out in establishments or plants which have been approved in advance for such operations by the competent authority. This condition should apply in particular to processing plants and other establishments or plants which handle or store animal by-products with a direct relevance for the safety of the feed chain. Approval : establishments or plants should be approved following the submission of information to the competent authority and following a visit carried out on site which demonstrates that the requirements of this Regulation for the infrastructure and equipment of the establishment or plant will be met, so that any risks to public and animal health arising from the process used will be adequately contained. It should be possible to grant the approvals conditionally in order to allow operators to rectify deficiencies before the establishment or plant obtains full approval. Establishments and plants which have been approved or registered under hygiene legislation should be under the obligation to comply with the requirements of this Regulation and subject to official controls carried out for the purposes of verifying compliance with the requirements of this Regulation. Each Member State shall draw up a list of plants, establishments and operators which have been approved or registered in accordance with this Regulation within its territory. Animals used for experiments : animal by-products from animals used for experiments as defined in Directive 86/609/EEC should also be excluded from use in feed, due to the potential risks arising from those animal by-products. However, Member States may allow the use of animal by-products from animals which have been used for experiments to test new feed additives, in accordance with Regulation (EC) No 1831/2003 on additives for use in animal nutrition. Traceability : the respective basic obligation of operators to ensure compliance with this Regulation should be further clarified and specified as regards the means by which traceability is ensured, such as separate collection and channelling of animal by-products. Established systems ensuring traceability for products exclusively circulating on national level by other means should continue to operate, if they provide equivalent information. Every effort should be made to promote the use of electronic and other means of documentation which do not involve paper records, as long as they ensure full traceability. Own checks : a system of own checks is necessary to ensure that within an establishment or plant, the requirements of this Regulation are fulfilled. During official controls, the competent authorities should take into account the performance of own checks. In certain establishments or plants own checks should be carried out through a system based on the principles of hazard analysis and critical control points (HACCP). The principles of HACCP should be based on the experience with their implementation under Community legislation on food and feed hygiene. In this respect, national guides to good practice could serve as a useful tool to facilitate the practical implementation of the HACCP principles, and of other aspects of this Regulation. Placing on the market of animal by-products and derived products intended for feeding purposes and of organic fertilisers and soil improvers : in order to ensure the protection of the food and feed chain, the text clarifies the requirements on these points. Only Category 3 material should be used for feeding farmed animals other than fur animals. Fertilisers produced on the basis of animal by-products may affect the safety of the feed and food chain. Where they have been manufactured from meat-and-bone meal of Category 2 or from processed animal protein, a component, such as an inorganic or an indigestible substance, should be added in order to prevent their direct use for feeding purposes. Such mixing should not be required if the composition or packaging of products, in particular of products destined for use by the final consumer, excludes the misuse of the product for feeding purposes. When determining the components, different circumstances regarding climate and soil and the objective for the use of particular fertilisers should be taken into account. Official controls : the possible courses of action which the competent authority can take when carrying out official controls should be specified in order to ensure legal certainty, in particular regarding the suspension or permanent prohibition of operations or the imposition of conditions to ensure the proper application of this Regulation. These official controls should be carried out in the framework of multi-annual control plans under Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Powers of the Commission (comitology) : the Commission shall be empowered to adopt: · rules modifying the end point in the manufacturing chain of certain derived products and establishing such an end point for certain other derived products; · rules in regard to serious transmissible diseases in the presence of which the dispatch of animal by-products and derived products should not be allowed and/or the conditions allowing such a dispatch; · measures changing the categorisation of animal by-products; · measures regarding restrictions on the use and disposal of animal by-products; · measures laying down conditions for the application of certain derogations regarding the use, collection and disposal of animal by-products as well as measures authorising or rejecting a particular alternative method for the use and disposal of animal by-products. The Commission shall also be empowered to adopt more specific rules concerning: collection and transport of animal by-products; the infrastructure, equipment and hygiene requirements for plants and establishments handling animal by-products; the conditions and technical requirements for the handling of animal by-products, including the evidence to be presented for the purpose of validation of such treatment; conditions for the placing on the market of animal by-products and derived products; requirements related to safe sourcing, safe treatment and safe end uses; conditions for the import, transit and export of animal by-products and derived products; detailed arrangements for implementing official controls including rules concerning the reference methods for microbiological analyses as well as conditions for the control of the dispatch of certain animal by-products and derived products between Member States. These measures shall be adopted in accordance with the regulatory procedure with scrutiny.
  • date: 2009-09-07T00:00:00 type: Act adopted by Council after Parliament's 1st reading body: EP/CSL
  • date: 2009-10-21T00:00:00 type: Final act signed body: CSL
  • date: 2009-10-21T00:00:00 type: End of procedure in Parliament body: EP
  • date: 2009-11-14T00:00:00 type: Final act published in Official Journal summary: PURPOSE: to lay down health rules as regards animal by-products not intended for human consumption LEGISLATIVE ACT: Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) CONTENT: the Council adopted this Regulation modernising the EU rules for animal by products, following a first reading agreement with the European Parliament. The new Regulation is aimed at introducing more risk-proportionate rules and at clarifying the rules on animal by-products, as well as their interaction with other EU legislation. The Regulation lays down public health and animal health rules for animal by-products and derived products, in order to prevent and minimise risks to public and animal health arising from those products, and in particular to protect the safety of the food and feed chain .Animal by-products are products of animal origin which are not intended for human consumption. They arise mainly during the slaughter of animals for human consumption, during the production of products of animal origin such as dairy products, and in the course of the disposal of dead animals. Past crisis related to outbreaks of foot-and-mouth disease or the spread of bovine spongiform encephalopathy (BSE) have shown that the improper use of certain animal by-products pose a risk to public and animal health, the safety of the food and feed chain and consumer confidence. More than 15 million tonnes of animal by-products are produced in the EU every year. The main points of the Regulation are as follows: · the concept of an "end point" in the manufacturing of animal by-products is introduced, after which the processed products are no longer subject to the animal by-products Regulation, as some potential risks have been eliminated for example by heat or chemical substances. Instead, the general rules on product safety apply. Under the current rules, almost all material from animals which does not enter the food chain, is subject to the rules on animal by-products; · the distinction between foodstuffs and animal by-products is clarified by confirming that operators need to make an irreversible decision, if products are destined for purposes other than human consumption. This means that once a product has become an animal by-product, it must not re-enter the food chain; · modification of the current classification 1 of animal by-products by Comitology procedure is permitted. In addition, certain animal by-products, which so far have been classified by default as category 2 material but which have been proven to pose no major risks, are reclassified as belonging to category 3, so as to allow their use for certain feeding purposes. For any other animal by-products which are not listed under one of the three categories, the classification by default as category 2 material is maintained for precautionary reasons; · a registration obligation is introduced for operators who transport animal by-products, in order to strengthen traceability; · the coherence between the Regulation on animal by-products and other EU legislation (for instance the legislation on food hygiene and waste) is improved by clarifying when the appropriate legislation applies. This removes unnecessary burdens for operators (for example, approvals of slaughterhouses and dairy plants under food and feed legislation are recognised). The current classification scheme is maintained . This means that animal by-products of category 1 (injurious to health) and category 2 (unfit for human consumption) must not be placed on the market as food, whereas material of category 3 (which comply with certain rules regarding their possible use for human consumption) may be used for certain feeding purposes. The basic principles of Regulation (EC) No 1774/2002 on animal by-products, however, remain unchanged . These include: the classification of animal by-products into three categories according to the degree of risk involved; the exclusion of animal by-products which are unfit for human consumption from the feed chain of farmed animals; the intra-species recycling ban (material derived from animals is not to be fed to animals of the species from which it is derived); the rule that only material from animals which have undergone veterinary inspection is to enter the feed chain for farmed animals; the ban on feeding of catering waste to farmed animals, in particular to pigs. The technical details for the Regulation will be laid down in a separate legal act, to be adopted by comitology procedure. This implementing regulation will be prepared in the next year, so that it can enter into application simultaneously with the new basic regulation. ENTRY INTO FORCE: 04/12/2009. APPLICATION: from 04/03/2011. docs: title: Regulation 2009/1069 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32009R1069 title: OJ L 300 14.11.2009, p. 0001 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2009:300:TOC
other
  • body: EC dg: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers commissioner: VASSILIOU Androulla
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ENVI/6/64097
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  • ENVI/6/64097
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http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32009R1069
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https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32009R1069
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  • Regulation
  • Repealing Regulation (EC) No 1774/2002 2000/0259(COD) Amended by 2013/0140(COD) Amended by 2013/0191(COD) Amended by 2016/0084(COD)
procedure/subject
Old
  • 3.10.08 Animal health requirements, veterinary legislation and pharmacy
  • 3.10.08.01 Feedingstuffs, animal nutrition
  • 3.10.08.05 Animal diseases
  • 4.20 Public health
  • 4.20.05 Health legislation and policy
  • 4.60.04.04 Food safety
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3.10.08
Animal health requirements, veterinary legislation and pharmacy
3.10.08.01
Feedingstuffs, animal nutrition
3.10.08.05
Animal diseases
4.20
Public health
4.20.05
Health legislation and policy
4.60.04.04
Food safety
procedure/summary
  • Amended by
  • Amended by
  • Repealing Regulation (EC) No 1774/2002
links/European Commission/title
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PreLex
New
EUR-Lex
activities
  • date: 2008-06-10T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2008/0345/COM_COM(2008)0345_EN.pdf celexid: CELEX:52008PC0345:EN type: Legislative proposal published title: COM(2008)0345 type: Legislative proposal published body: EC commission: DG: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers Commissioner: VASSILIOU Androulla
  • date: 2008-06-19T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP responsible: False committee: AGRI date: 2008-06-24T00:00:00 committee_full: Agriculture and Rural Development rapporteur: group: Verts/ALE name: SMITH Alyn body: EP responsible: True committee: ENVI date: 2008-07-14T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: SCHNELLHARDT Horst
  • date: 2009-02-17T00:00:00 body: EP committees: body: EP responsible: False committee: AGRI date: 2008-06-24T00:00:00 committee_full: Agriculture and Rural Development rapporteur: group: Verts/ALE name: SMITH Alyn body: EP responsible: True committee: ENVI date: 2008-07-14T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: SCHNELLHARDT Horst type: Vote in committee, 1st reading/single reading
  • date: 2009-03-02T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2009-87&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A6-0087/2009 body: EP committees: body: EP responsible: False committee: AGRI date: 2008-06-24T00:00:00 committee_full: Agriculture and Rural Development rapporteur: group: Verts/ALE name: SMITH Alyn body: EP responsible: True committee: ENVI date: 2008-07-14T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: SCHNELLHARDT Horst type: Committee report tabled for plenary, 1st reading/single reading
  • date: 2009-04-24T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=16797&l=en type: Results of vote in Parliament title: Results of vote in Parliament url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20090424&type=CRE type: Debate in Parliament title: Debate in Parliament url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2009-323 type: Decision by Parliament, 1st reading/single reading title: T6-0323/2009 body: EP type: Results of vote in Parliament
  • date: 2009-09-07T00:00:00 body: CSL type: Council Meeting council: Agriculture and Fisheries meeting_id: 2959
  • date: 2009-09-07T00:00:00 body: EP/CSL type: Act adopted by Council after Parliament's 1st reading
  • date: 2009-10-21T00:00:00 body: CSL type: Final act signed
  • date: 2009-10-21T00:00:00 body: EP type: End of procedure in Parliament
  • date: 2009-11-14T00:00:00 type: Final act published in Official Journal docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32009R1069 title: Regulation 2009/1069 url: http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2009:300:SOM:EN:HTML title: OJ L 300 14.11.2009, p. 0001
committees
  • body: EP responsible: False committee: AGRI date: 2008-06-24T00:00:00 committee_full: Agriculture and Rural Development rapporteur: group: Verts/ALE name: SMITH Alyn
  • body: EP responsible: True committee: ENVI date: 2008-07-14T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE-DE name: SCHNELLHARDT Horst
links
National parliaments
European Commission
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  • body: EC dg: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers commissioner: VASSILIOU Androulla
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2008/0110(COD)
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Legislation
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Health rules: animal by-products and derived products not intended for human consumption
type
COD - Ordinary legislative procedure (ex-codecision procedure)
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