Explanatory Memorandum to COM(2008)345 - Health rules as regards animal by-products not intended for human consumption (Animal by-products Regulation) - Main contents
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| dossier | COM(2008)345 - Health rules as regards animal by-products not intended for human consumption (Animal by-products Regulation). |
|---|---|
| source | COM(2008)345  |
| date | 10-06-2008 |
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 i (hereinafter: 'the Regulation ') was adopted. The Regulation consolidated and recast the various existing rules covering animal by-products (ABP). It also introduced stricter rules concerning the approval of premises handling ABP, the channelling and traceability of certain products and the implementation of processing standards which ensure that products produced on the basis of ABP are safe, if they are intended for feed or for technical uses. The Regulation applied as of 1 May 2003.
Article 35 of the Regulation requires Member States to inform the Commission of the measures taken to ensure compliance with the Regulation. On the basis of the information received, the Commission submitted a report to the European Parliament and the Council on 24 October 2005 reflecting the experience of all 25 Member States in applying the legislation i.
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.
On the basis of information supplied by Member States and the findings of the FVO, the Commission report concludes that it has been challenging for all Member States and economic operators to ensure compliance with the provisions of the Regulation. Nonetheless, Member States' compliance has been generally satisfactory. The official controls for most Category 1 and 2 materials are satisfactory to a large extent. However, more effort is needed to guarantee the necessary traceability of the flow of materials based on ABP throughout the various production chains. The report recommended a number of measures which could improve the uniform application of the law and the effectiveness of official controls. It also served as a basis for a wide debate with the Member States and with the wide range of stakeholders affected by the rules on ABP.
The following major issues emerged from consultations on the report as meriting reconsideration:
► The basic framework of safeguards applicable to all ABP should be maintained.
► The scope of the rules on ABP should be adjusted.
► The interaction of the rules on ABP with other Community legislation should be clarified.
► A more risk-based approach for the categorisation of ABP, as well as controls, should be introduced.
These major issues should be addressed in a way which ensures that the level ofprotection against risks to public and animal health in the Community is not compromised. Operators and competent authorities remain responsible for ensuring that ABP are only being sent to outlets authorised by the law. Adjustments to the rules may only be made insofar as progress in science and technology allows.
Upon presentation of the report to the Council at the end of 2005, Member States indicated their broad consensus with the main areas identified as requiring review. Further technical questions were brought to the Commission’s attention during discussions and are considered in the present context.
In preparing the current proposal, a number of interested parties (stakeholders, technical experts and competent authorities of the Member States, and international trading partners) have been consulted. More than 36 European associations with an interest in the food chain, animal and public health (ABP producers, processors, traders and users, and consumer organisations) have been given the opportunity to express their views on various occasions, via bilateral meetings or through an open consultation.
Owing to the interaction between the rules on ABP and other Community legislation, the Commission set up an Inter-Service Steering Group (ISSG), which met twice between February and September 2006.
Six working groups with Member States experts were held between July 2006 and December 2006, in order to discuss the major issues related to the review.
The consultations were carried out in two steps:
- As a first step, a general consultation on the issues identified and possible options to resolve them was held.
- As a second step, once the potential solutions were identified, stakeholders were asked to provide information on the likely impact of the policy options identified.
Generally, interested parties agree that the issues which have emerged from consultations reflect the major areas which merit reconsideration In particular, the majority of participants in the open consultation support the conclusion that the Regulation should be amended in order for the necessary adjustments to the rules to be made.
Since the entry into application of the Regulation, the Community's scientific advisory body (the Scientific Steering Committee, which has been replaced by the European Food Safety Authority since 2002) has adopted a number of opinions in relation to ABP. These scientific opinions advised on the capacity to contain risks via treatment standards. In general terms, the advice obtained suggests that the key principle of the Regulation, which is the exclusion of ABP derived from animals unfit for human consumption from the feed chain, should be maintained.
The conclusions also suggest that certain unsafe by-products may be recovered and used safely for the production of, for instance, technical or industrial products under certain strict health conditions.
Two main methodologies were used:
analysis of the report data submitted by the competent authorities of the 25 Member States and
analysis of data collected by the Commission's Food and Veterinary Office during 2004 to 2005.
The data received and used is too extensive and varied to be summarised here.
A copy of the Commission reports can be found at:
ec.europa.eu/food/food/biosafety/animalbyproducts
ec.europa.eu/food/fvo/index_en
The Commission carried out an in-house Impact Assessment (IA) as referred to in its work programme 2006. An assessment report is accessible on:
ec.europa.eu/food/food/biosafety/animalbyproducts
The IA considered three main options:
(a) No action
(b) Self-regulation, guidance or co-regulation
(c) Review of the legislation.
The IA concludes that to “no action” is likely to lead to trade disruption and severe negative socio-economic costs for operators. Self-regulation, guidance or co-regulation will not alleviate the burden resulting from disproportionate provisions in the legally binding text.
In line with the findings of the IA, option (c) a review of the legislation, is the solution which is most suitable to the existing problems.
Contents
- LEGAL ELEMENTS OF THE PROPOSAL
- 2. THE COMMISSION REPORT
- 3. THE ISSUE
- 4. CONSULTATION AND IMPACT ASSESSMENT
- 4.1. Consultation of interested parties
- 4.1.1. Consultation method, sectors targeted
- 4.1.2. Responses and follow-up
- 4.2. Collection and use of expertise
- 4.2.1. Scientific opinions
- 4.2.2. Methodology used
- 4.3. Impact Assessment
- 5.1. Summary of the proposed action(s)
- 5.2. Legal basis
- 5.3. Subsidiarity principle
- 5.4. Proportionality and simplification
- 6. SCOPE OF THE PROPOSAL
- i. Clarification
- ii. A more risk-based approach
- 7. OTHER INFORMATION
- 7.1. Consistency with other policies and objectives of the Union
- 7.3. Other
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. 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.
The primary objective of the Regulation is the protection of animal and public health. Therefore, as the current Regulation, the proposal is based on Article 152(4)(b) of the Treaty.
The subsidiarity principle applies insofar as the proposal does not fall under the exclusive competence of the Community.
The objectives of the proposal cannot be sufficiently achieved by Member States’ actions.
Risks from animal by-products may seriously endanger the safety of the food and feed chain, as well as the health status of livestock throughout the Community. Experience in recent years with bovine spongiforme encephalopathy (BSE), foot-and-mouth disease (FMD), classical swine fever (CSF) and dioxin has shown that a response at Member State level alone does not sufficiently contain major health threats, not least because of the close interconnection of the economic sectors throughout the Common Market.
In addition, ABP and products manufactured on the basis of ABP are being imported from third countries into the Community. It should be ensured that imported consignments meet sanitary standards which are at least equivalent to those applicable within the Community.
The objectives of the proposal can be better achieved by the Community.
ABP are included in the list of products in Annex I to the Treaty. Their placing on the market constitutes an important source of income for parts of the farming population, as well as for industries which process certain ABP. To ensure the rational development in this sector, increase productivity and stimulate competitiveness, animal health and public health rules for the products in question are needed at Community level.
The proposal further simplifies the legislation, reducing the administrative burden for the competent authorities (EU, national and third countries) and for economic operators while preserving a high level of protection of the public and animal health.
It aims to allow for the consolidation of all the implementing measures and derogations (to date 14 acts in total) adopted since the application of the Regulation on the basis of a single text.
The interaction between the rules on animal by-products and other Community sector legislation (food, feed, waste, cosmetic products, pharmaceutical and medical devices) will be clarified. Wherever the necessary level of protection allows such a solution, duplication of approval and channelling requirements should be avoided.
The adoption of the proposal will lead to the repeal of the current Regulation.
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:
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.
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 proposal is consistent with other Community policies, in particular the policy on the protection of the environment and of public health in relation to the use of animal by-products in feed, cosmetics, medicinal products and, medical devices.
Budgetary implication
The proposal has no financial implications for the budget of the European Community.
The proposal is in line with the Commission's Lisbon Strategy commitment to improve the acquis communautaire, addressing possible health risks by adequate measures, while enhancing competitiveness. It is also in line with the 'Better Regulation' Programme of the Commission i.