Report on the measures taken by Member States to ensure compliance with regulation 1774/2002 of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption

TABLE OF CONTENTS

1........... EXECUTIVE SUMMARY............................................................................................ 4

2........... INTRODUCTION........................................................................................................ 5

3........... MEASURES TAKEN BY MEMBER STATES TO ENSURE COMPLIANCE WITH THE REGULATION...................................................................................................................................... 7

3.1........ Measures taken by Member States to comply with the Regulation.................................... 7

3.2........ Derogations granted by Member States under Articles 23(2) and 24................................ 8

3.3........ Overall situation on the measures taken by Member States to ensure compliance with the Regulation, as reflected in the FVO mission findings................................................................................................ 8

4........... MAIN ISSUES RAISED BY MEMBER STATES ALREADY SOLVED THROUGH COMITOLOGY PROCEDURE OR GUIDANCE................................................................................... 8

5........... ISSUES THAT CAN STILL BE SOLVED BY COMITOLOGY OR GUIDANCE OR CAN BE SOLVED ONLY BY CO-DECISION PROCEDURE.................................................................. 9

5.1........ Issues that can still be solved by Comitology or guidance................................................. 9

5.1.1..... Definitions for ABPs not yet covered............................................................................... 9

5.1.2..... Clarify EU veterinary and waste legislation applicable to ABPs........................................ 9

5.1.3..... Technical products.......................................................................................................... 9

5.1.4..... Alternatives methods for the processing, use and disposal of ABPs................................ 10

5.1.5..... Application on land of organic fertilisers and soil improvers............................................ 10

5.1.6..... Transformation standards for ABPs in composting and biogas plants and heat treatment process for manure 10

5.1.7..... Use of milk and milk-based products defined as Category 3 materials for direct feedingstuffs 11

5.1.8..... Possibility to process ABPs from other sources on same site as a slaughterhouse............ 11

5.1.9..... New import certificates for ABPs not yet covered......................................................... 11

5.1.10... Markers for ABPs intended for disposal as waste.......................................................... 11

5.1.11... Guidance to clarify issues that have arisen as a result of FVO missions........................... 11

5.1.12... Implementing rules for prohibiting intra-species recycling (cannibalism)........................... 11

5.2........ Issues that can be solved only by Co-decision procedure............................................... 12

5.2.1..... Clarification of the scope of the Regulation and amendment of Article 1.......................... 12

5.2.2..... Amendments of Articles 4, 5 and 6: clarification and need to insert new products........... 12

5.2.3..... Amendments of Articles 17 and 18: exempt certain plants from the need for further approval under ABPs Regulation.................................................................................................................... 12

6........... SIMPLIFICATION..................................................................................................... 13

7........... CONCLUSION.......................................................................................................... 13

ANNEX I
ABBREVIATIONS AND TECHNICAL TERMS USED IN THE REPORT............................. 15

ANNEX II
INFORMATION PROVIDED BY MEMBER STATES ON MEASURES TAKEN TO ENSURE COMPLIANCE WITH THE ABPs REGULATION............................................................................................ 17

ANNEX III
DEROGATION GRANTED BY MEMBER STATES UNDER ARTICLES 23(2) AND 24..... 23

ANNEX IV
MAIN ISSUES RAISED BY MEMBER STATES ALREADY SOLVED THROUGH COMITOLOGY PROCEDURE OR GUIDANCE........................................................................................................................ 24

1........... Transitional measures for Member States and Third Countries....................................... 24

1.1........ Transitional measures for Member States...................................................................... 24

1.2........ Transitional measures for third Countries....................................................................... 25

2........... Commission Regulations amending Regulation (EC) No 1774/2002............................... 26

3........... Measures taken to implement Regulation (EC) No 1774/2002....................................... 26

4........... Permanent general derogations granted.......................................................................... 27

5........... Permanent specific derogations granted on request from member States......................... 27

6........... Guidelines issued to clarify a certain number of issues..................................................... 27

ANNEX V
LIST OF THE LEGISLATION REPEALED AND REPLACED BY REGULATION (EC) NO 1774/2002 28

1. EXECUTIVE SUMMARY

Article 35 of Regulation (EC) N° 1774/2002[1] of the European Parliament and of the Council of 3 October 2001 laying down health rules concerning animal by-products (ABPs) not intended for human consumption 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 is required to submit a report to the European Parliament and the Council accompanied, if necessary, by legislative proposals.

All 25 Member States have submitted the required information.

The present report addresses the following points:

1. The measures taken by the Member States to ensure compliance with the Regulation. Overall, Member States have taken the necessary administrative and control measures to ensure compliance.

2. The main issues raised by the Member States that the Commission has already addressed through Comitology or guidelines, including implementing and amending measures to ensure the smooth application of the Regulation and derogation and transitional measures to avoid the disruption of trade.

3. The main issues raised by Member States that the Commission can still solve either through Comitology or by means of guidelines.

4. The main issues raised by Member States that can only be solved by Co-decision procedures. In particular, Member States strongly suggest redefining the scope of the Regulation.

5. Possible further simplification of certain provisions of the Regulation.

6. Finally, the report concludes that, overall Member States have taken the necessary administrative and control measures to ensure compliance. This conclusion is supported by the findings of inspections carried out by the Commission’s Food and Veterinary Office.

2. INTRODUCTION

Background

Regulation (EC) No 1774/2002 of the European Parliament and of the Council lays down health rules for the collection, transport, storage, handling, processing and use or disposal of all ABPs not intended for human consumption. It was adopted in response to various feed-borne crises (dioxin in 1999, classical swine fever in 2000 and foot and mouth disease in 2001, EU-wide Bovine Spongiform Encephalopathy (BSE) crisis in 2001).

The Regulation is an Action 30 of the Commission’s White Paper on Food Safety (2000). It has revamped the Community’s rules on ABPs, ensuring a high level of protection of animal and public health throughout the EU.

The overall situation surrounding the EU-wide feed-borne crises in 1999-2001 meant that the Regulation had to be applied and the Commission had to adopt by Comitology several transitional measures (including derogations and implementing measures) rapidly to avoid the disruption of trade, allowing time for operators and Member States administration systems to adapt. The Regulation entered into force on 1 November 2002 and is directly applicable in all Member States since 1 May 2003.. Some of the measures introduced have resulted in difficulties of application.

The ABPs Regulation simplified and repealed a large number of Community legislations, which were adopted in the past in reactions to crises, creating a new single legal framework for the ABPs sector. It introduced the concept of three categories of ABPs, based on risk. It requires those categories of by-products to be processed, used or disposed of without undue delay in specified approved premises. Permitted premises must operate to standards, specified where appropriate, that ensure that the end product does not pose a risk to public or animal health. Where premises do not operate in accordance with the Regulation, the competent authority must act to prevent the premises continuing to receive ABPs or processed products, or ensure that the operator takes corrective action. The Regulation introduced incineration and co-incineration as outlets for ABPs and, for certain categories of material, permitted composting and biogas production. It also provided for alternative outlets to be permitted where appropriate following a scientific opinion and enabled Member States to exercise derogations to allow national practices such as the feeding of certain types of ABPs to birds of prey, necrophagous birds, packs of hounds, zoo animals, etc. It also tightened the traceability and record keeping requirements, requiring dedicated separation, according to their risk status, of the collection, treatment and use of ABPs.

The Community’s scientific advisory body, the Scientific Steering Committee, replaced by the European Food Safety Authority (EFSA) since 2002 adopted a number of opinions in relation to the safety of ABPs, including animal feed[2]. The main conclusion of the scientific opinions was that ABPs derived from animals that are not fit for human consumption following health inspection should not enter the feed chain; they must be properly handled and disposed of following adequate pre-treatment to prevent the possible spread of pathogens. On the basis of these opinions, the Regulation restricts the type of material that may be used for feeding to livestock or pets. It prohibits the recycling of certain ABPs into the feed chain, namely fallen stock and other condemned animal material. Only raw material derived from animals declared fit for human consumption is allowed for the production of feed. Thus only Category 3 material (or material which was fit for human consumption) may be used for these purposes, after suitable processing and where permitted by the TSE Regulation No 999/2001[3]. It also prohibits intra-species recycling (cannibalism) and the feeding of catering waste to livestock. This principle was strongly upheld by the European Parliament and the Council, and is the minimum standard that Member States could support in the light of the recent EU-wide feed-borne crises.

Progress: achievements

Member States have indicated that they have made generally good progress in applying the ABPs Regulation. There is broad support for the principles of the Regulation, and the controls outlined above are proportionate in most cases. In particular, the increase in the number of outlets for ABPs and the potential for increasing the amount of material recycled is welcome. The vast majority of ABPs produced including all risk materials are now being handled in accordance with the Regulation and consigned to the permitted outlets. This is confirmed by the findings of the inspections carried out by the Commission’s Food and Veterinary Office (FVO) in Member States in 2004-2005. Although further work is still needed, the increased focus on ABPs is thought to have helped to safeguard the integrity of the food and feed chains (by reducing the risk of illegal diversion of ABPs) and to have improved the standards of handling and treatment of ABPs at all stages. As such the application of the Regulation has served to minimise the possibility of ABPs introducing or spreading pathogens to humans or animals, and has complemented other legislation, such as that applying to the environment, food hygiene, and TSE and other disease control measures. Guidance has been prepared to explain the relationship between the ABPs and environment legislation, and between the ABPs and food hygiene legislation, facilitating a harmonious application.

Issues

The Regulation is very wide-ranging. It introduced controls on some material and extended the controls on others, as well as bringing new types of outlet within its control. Thus there have been some difficulties in certain areas. Some of these have been addressed through the transitional measures, by providing time to enable the relevant industry sector to adjust. But others have arisen because, during the original negotiations, not all of the numerous uses for ABPs had been identified. For some of these uses it would be disproportionate to apply the full controls of the Regulation and Member States have indicated that a more appropriate level of control needs to be established.

Why this report?

Article 35 of the Regulation requires:

– Member States to inform the Commission of the national measures taken to ensure compliance with the Regulation within a year following its entry into force, and

– on the basis of the information received, the Commission to submit a report to the European Parliament and the Council accompanied, if appropriate, by legislative proposals.

Member States have submitted the necessary information, on which this report is based.

The report is submitted later than required under Article 35 of the Regulation. The extra time taken has enabled the Commission to take into account the situation in the new Member States and the findings of the FVO inspections in providing a full picture of the compliance situation in Member States.

3. MEASURES TAKEN BY MEMBER STATES TO ENSURE COMPLIANCE WITH THE REGULATION

3.1. Measures taken by Member States to comply with the Regulation

According to the areas of competence not determined by Community law or left to national rules by the Regulation, Member States have to varying degrees taken a series of measures to ensure compliance with the Regulation. The measures adopted can be broadly described as follows:

– Measures to allocate and define the competences of the relevant authorities involved in the implementation and enforcement of the Regulation;

– General implementation measures;

– Sectorial implementation measures;

– Measures laying down sanctions; and

– Guidance.

The information provided by Member States on the measures they took to ensure compliance with the ABPs Regulation is given in Annex II of the report.

3.2. Derogations granted by Member States under Articles 23(2) and 24

– Member States have provided derogation under Article 23 (2) as regards the feeding of zoo, circus and fur animals, reptiles and birds of prey other than zoo or circus animals, wild animals the meat of which is not for human consumption, dogs from kennels and maggots for fishing bait.

– Also Member States have given derogation under Article 24 of the Regulation as regards burial or burning under specific conditions and circumstances (dead pet animals, remote areas or in cases of disease outbreaks).

For a full list of the derogations and explanations see Annex III.

3.3. Overall situation on the measures taken by Member States to ensure compliance with the Regulation, as reflected in the FVO mission findings

An interim report providing an overview of the 13 missions in the old Member States has been provided, for internal purpose, by the FVO in April 2005. The scope of the missions was to evaluate the measures put in place to give effect to the ABPs Regulation.

Overall, the report concludes that in all Member States adequate arrangements and sufficient infrastructures are in place to handle most of the ABPs in accordance with the ABPs Regulation. However, more is needed to guarantee the flow of all ABPs within the allowed chains until their permitted use, separation or safe disposal in all Member States.

In particular, adequate staff resources, clear definition and distribution of responsibilities amongst the competent authorities involved, more guidance and training for and co-operation between the CA, would improve the effectiveness and/or uniformity of official control.

4. MAIN ISSUES RAISED BY MEMBER STATES ALREADY SOLVED THROUGH COMITOLOGY PROCEDURE OR GUIDANCE

The disposal infrastructure in most Member States was already suitably developed and they easily phased in the new requirements by 1 May 2003. However, some of them were not going to be able to meet that deadline. Therefore, where appropriate and justifiable, Article 32 of the Regulation allowed a possible temporary relaxation of the measures. This was used to allow less developed industry sectors or those with specific problems in adapting time to acquire the necessary facilities.

At the same time, the Commission prepared permanent implementing measures for the various Articles as well as reviewing the Annexes and general and specific derogations.

A summary of legislative acts that the Commission has adopted until 1^st September 2005 under the Comitology procedure is given in Annex IV.

5. ISSUES THAT CAN STILL BE SOLVED BY COMITOLOGY OR GUIDANCE OR CAN BE SOLVED ONLY BY CO-DECISION PROCEDURE

5.1. Issues that can still be solved by Comitology or guidance

Most issues raised by Member States can be solved by Comitology, or can be clarified by updating current guidelines already published. The main issues are listed below.

5.1.1. Definitions for ABPs not yet covered

There is a need to clarify the definition of certain ABPs in order to facilitate a harmonised application of the Regulation.

One example is the scope of the definition for “former foodstuffs” products of animal origin or containing them, which are no longer intended for human consumption for different reasons.

5.1.2. Clarify EU veterinary and waste legislation applicable to ABPs

Member States and operators consider it important to avoid duplication and any resulting unnecessary burden due to the concurrent application to ABPs of Community veterinary (under the responsibility of Health and Consumer protection Directorate General) and waste (under the responsability of the Directorate General for the Environment) legislation. Guidance has been issued which seeks to clarify the relationship between the two sets of controls. However, more legal clarity is needed. A Commission proposal, which is intended to clarify the relationship between Regulations (EC) No 1774/2002 and 259/93 in respect of waste shipments (COM(2003) 379 of 30 June 2003, as amended by COM(2004) 172) is currently subject to the Co-decision procedure, second reading.

5.1.3. Technical products

• cosmetics, medicinal products, and medical devices

The ABPs Regulation does not apply to finished products, such as cosmetic products, medicinal products, medical devices or in-vitro diagnostics.

However, the ABPs Regulation has an important regulatory impact on these sectors, some of which use processed ingredients/starting materials and substances deriving from animals and animal-by products in producing the final product. Consequently, a more complete and satisfactory solution to simplify the application of the Regulation, making it more appropriate to the risk, necessitates changes to it, through Co-decision procedure (see points 5.2.2 and 5.2.3).

Some Member States and EU operators have expressed concerns about the requirements of the ABPs Regulation being applied to the importation of certain Category 3 starting materials which require only minor further handling (e.g. mixing, packaging or labelling) to make them suitable for placing on the market or use by the end user in the EU. One example, are “intermediate products” used for the manufacture of medical devices. A draft proposal laying down specific requirements for their importation is being finalised for adoption before the end of 2005.

In addition, it has to be considered that these technical products, in many instances, use highly specialised materials and, for that purpose, it has been suggested to revise the list of third countries from which the importation of these materials is allowed.

• Other technical products

Other products having been processed in a way that they no longer pose a risk , such as fat derivatives for the production of fertilisers, could be excluded from the scope of the Regulation (see point 5.2 1) or subjected to limited control requirements as above.

5.1.4. Alternatives methods for the processing, use and disposal of ABPs

Technical amendments to a new Regulation allowing 5 new alternative methods for the use/disposal of ABPs (see Annex IV) are expected to accommodate the recent EFSA opinions (see also point 6).

5.1.5. Application on land of organic fertilisers and soil improvers

Article 22(1)(c) of Regulation (EC) No 1774/2002 restricts the application to pastureland of organic fertiliser or soil improvers, other than manure. A scientific opinion has been issued by EFSA concerning the conditions under which Category 2 and 3 materials can be applied to land, on the basis of which a draft proposal is being prepared.

5.1.6. Transformation standards for ABPs in composting and biogas plants and heat treatment process for manure

Member States and operators have raised concerns at the strictness of the transformation standards for composting and biogas plants and heat treatment for manure, and have asked the Commission to allow for alternative transformation parameters (time, temperature, and microbiological validation agents).

Following EFSA opinions on the issues, the Commission will lay down such alternative standards.

5.1.7. Use of milk and milk-based products defined as Category 3 materials for direct feedingstuffs

A new Regulation (EC) No 79/2005 has been adopted allowing the direct feeding to farmed animals of dairy products produced to food standards (under Council Directive 92/46/EEC[4]), subject to animal health conditions in line with current scientific opinions. This Regulation could be amended further in the light of the EFSA opinion that is expected before end 2005.

5.1.8. Possibility to process ABPs from other sources on same site as a slaughterhouse

Commission Regulation EC 808/2003 amending, Regulation No 1774/2002 permits the operation of rendering plants adjacent to slaughterhouses, subject to certain conditions. One of the conditions is that the ABPs to be processed in the rendering plant must originate only in the adjacent slaughterhouse. The Commission is considering introducing risk-based provisions to avoid the difficulties resulting from this condition.

5.1.9. New import certificates for ABPs not yet covered

New certificates are being laid down in order to harmonise the import requirements for certain products wool, feathers, manure, composite products, etc) not yet covered by the Regulation..

5.1.10. Markers for ABPs intended for disposal as waste

The Regulation requires the marking of ABPs intended for disposal. The Commission is still investigating the appropriate markers. A trial for this purpose is under way. Once identified and validated, the markers will then be approved by means of a Commission decision.

5.1.11. Guidance to clarify issues that have arisen as a result of FVO missions

More questions have arisen as a result of the FVO missions in all Member States in 2004-2005. An additional Commission guidance is being prepared with the view to facilitating further harmonious application of the Regulation.

5.1.12. Implementing rules for prohibiting intra-species recycling (cannibalism)

Implementing rules for the prohibition of intra-species recycling (cannibalism) have only been laid down with regard to fish, because the use of processed animal protein other than fishmeal in the feeding of farmed animals has been prohibited by the BSE feed ban (Article 7 of Regulation (EC) No 999/2001 as amended). Progress has been made in the development of methods specifically detecting ruminant proteins in feedingstuffs, being one of the main conditions to review the BSE feed ban

5.2. Issues that can be solved only by Co-decision procedure

5.2.1. Clarification of the scope of the Regulation and amendment of Article 1

The Regulation is wide ranging. The provisions applicable to processed or finished products are not always clear. Thus a clarification in this respect is needed.

Certain processed products, having been processed in a way that they no longer pose a risk, could be excluded from the scope of the Regulation or subject to a low level of control. For example, processed ingredients for the production of cosmetics, medical devices or medicinal products are not to be considered as “animal by-products”. Moreover, the ABPs Regulation clearly does not apply to finished products, such as cosmetic products, medicinal products, medical devices or in-vitro diagnostics. (see point 5.1.3)

For ABPs from wild animals not suspected of being diseased, it should be further clarified that, in accordance with the objectives of the Regulation, the ABPs produced in any premises used for processing mammals or birds for human consumption, are covered by the Regulation. The inclusion in the scope of the Regulation of shellfish and other sea animals should also be better expressed.

5.2.2. Amendments of Articles 4, 5 and 6: clarification and need to insert new products

As regards the categorisation of materials, a review exercise could be carried out to clarify the applicability of the provisions in case new material may be categorised under different entries.

In addition, it is necessary to consider the possibility of including in the different categories other products that, for the time being, cannot be classified properly.

In this context the classification of ABPs that pose a very low risk as Category 2 (e.g. worms, insects, insect larvae, invertebrates intended for feeding to wild birds, use in pet-food or starting material used for cosmetic, medical devices and medicinal products like dead bees etc) should be re-visited. Such material may be classified as Category 3.

5.2.3. Amendments of Articles 17 and 18: exempt certain plants from the need for further approval under ABPs Regulation

Certain premises already approved under food or other Community legislation must fulfil also the requirements set out in the ABPs Regulation. For those premises (e.g. producing tallow, eggs, gelatine etc.) for which Article 17 of the Regulation currently requires an approval, there should be no need to be re-approved by the competent authority under the ABPs Regulation.

Moreover plants producing final products such as medical devices, cosmetic and medicinal product shall be clearly excluded from the approval obligation under the ABP regulation

As well, for pet-food and technical establishments receiving processed animal proteins(PAPs), for which Article 18 of the Regulation currently requires an approval, there should be no need for re-approval by the competent authority under the ABPs Regulation considering that PAPs no longer pose a risk to animal and public health and are already approved under other Community legislation meeting the objectives of the ABPs legislation.

Also, many products destined for technical products are produced in controlled laboratories, university, research and hospital laboratories or in the medical device, cosmetic or pharmaceutical plants themselves. For these premises approval as described in the current regulation may not be necessary or appropriate.

6. SIMPLIFICATION

The Regulation, a new legal framework covering the whole sector, from “farm-to-table” under the Commission White Paper on Food Safety, has simplified and repealed the previous 19 legislative acts (see list in Annex V).

It has replaced the rules in various Commission Decisions, which lay down rules on animal and public health for the processing, disposal, placing on the market and use of products of animal origin not intended for human consumption.

The actions highlighted in paragraphs 5.1 and 5.2 will be guided by the same simplification principle. In addition, particular attention will be given to the following two areas:

– clarification of the scope of the Regulation

– approval procedure for alternative methods for the processing, uses and disposal of ABPs

7. CONCLUSION

Member States and operators have indicated that they have made generally good progress in applying the ABPs Regulation. There is broad support for the principles of the Regulation, and the controls are proportionate in most cases. In particular, the increase in the number of outlets for ABPs and the potential for increasing the amount of material recycled is welcome. The vast majority of ABPs produced including all risk materials are now being handled in accordance with the Regulation and consigned to the permitted outlets.

According to the Food and Veterinary Office inspections, the official controls of most Category 1 and 2 materials are satisfactory to a large extent. In all Member States adequate measures (arrangements and infrastructures) are in place to ensure the proper handling of most of the ABPs in accordance with the ABPs Regulation. In particular, there are adequate systems in place to ensure the proper disposal of the risk materials (Category 1 and 2 materials).

However, more work is needed to guarantee the flow of all ABPs within the allowed chains until their permitted use, separation or safe disposal in all Member States. In particular, adequate staff resources, a clear definition and distribution of responsibilities amongst the competent authorities involved, more guidance and training for and co-operation between the competent authorities, would improve the effectiveness and/or harmonisation of official controls.

The ABPs Regulation covers a wide range of fields and, in particular, further clarification of the scope of the Regulation would help to achieve full compliance, enhancing common understanding by all operators involved and help to address the real risks that derive from animal by-products. This harmonisation of the rules will increase the competitiveness of operators in the light of the Lisbon strategy.

While the changes proposed under points 5.1 and 5.2 reflect the main issues raised by Member States and stakeholders until now, it can be expected that on the basis of more experience gained over the next few years, it might be necessary to accommodate unforeseen issues and/ or emerging policy.

The Commission is considering the necessary legislative proposals to address the issues referred to under point 5.2 via the co-decision procedure involving the Council and the European Parliament. The Commission continues to address the issues referred to under point 5.1 by Comitology.

ANNEX II

INFORMATION PROVIDED BY MEMBER STATES ON MEASURES TAKEN TO ENSURE COMPLIANCE WITH THE ABPs REGULATION

Member State	Measures taken to ensure compliance with the ABPs Regulation
1. Belgium	Belgium has drawn up a convention to define the competence of each authority involved in the enforcement and implementation of the Regulation. In Belgium 6 different authorities are responsible for cover the scope of the Regulation.
2. Czech Republic	From 1 May 2004, after the EC accession, the Regulation is in force in the Czech Republic. The reference to this Regulation was mentioned in Decree N° 295/2003; An amendment to Act on veterinary care is being prepared currently and a reference to the enforcement of Regulation (EC) No 1774/2002 shall be included in this amendment
3. Denmark	Since 2003, a number of Orders, circulars and guidance notes have been issued to give effect to the ABPs Regulation. Violation of the ABPs rules has been made punishable by Order no. 355 of 19. May 2003, which also identifies the competent authority for ABPs
4. Germany	An Act implementing Community provisions on the processing and disposal of ABPs not intended for human consumption has been adopted (Gesetz zur Durchführung gemeinschaftlicher Vorschriften über die Verarbeitung und Beseitigung von nicht für den menschlichen Verzehr bestimmten tierischen Nebenprodukten vom 25 Januar 2004)
5. Estonia	The Infectious Animal Disease Control Act lays down the general rules for processing ABPs. The Regulation of the Minister of Agriculture N0 52/2004 “approving procedure for ABPs plants” lays down the procedure for handling the approval documentation. Estonia (and Cyprus) was granted under Commission Decision 2004/467/EC, from 1.5.2004 to 31.12.2004 the derogation to allow burial of ABPs
6. Greece	“Pending the promulgation of the Presidential Decree, which had already taken its final form since 2003, at the Official Journal of the Government, we use the competent authorities for the approval, supervision and posing sanctions from the Presidential Decree 243 of 1993 with the demand from the producers, enterprises and activities involved with ABPs to fulfill all the requirements of the ABPs Regulation.”
7. Spain	The Royal Decree 1429/2003 of 21 November 2003 lays down the arrangements for implementing the Regulation. The Decree refers in particular to the allocation of responsibilities among the various government bodies specific to the Spanish legal order (the General State Administration, the Autonomous Regions, the local authorities).
8. France	The measures adopted by France can be grouped into four categories: implementation measures at national level of broad character; specific implementation measures for some sectors; measures adopted in accordance with Article 23(2), providing derogations; administrative or penal sanctions, as set in the different national texts.
9. Ireland	The national implementing rules giving effect to the Regulation in Ireland are set down in the European Communities (ABPs) Regulations – Statutory Instrument 248 of 2003.
10. Italy	The Ministry of Health has issued implementation guidelines of the Regulation to ensure a uniform and correct implementation throughout the national territory. This has been made in co-operation with the Regions and Autonomous Provinces, with the Ministry of Environment and with the Ministry of Agricultural and Forest Policies. In addition, the legislative Decree N. 63 of 17 March 2005 has been published concerning sanctions/measures to be applied in relation to the sanitary rules on ABPs.
11. Cyprus	The Regulation has been introduced into the national legislation under the implementation of EC Legislation in the Veterinary Sector Law of 2004 N° 149(1). Cyprus (and Estonia) was granted under Commission Decision 2004/467/EC, from 1.5.2004 to 31.12.2004 the derogation to allow burial of ABPs. Cyprus has obtained an extension of this derogation until 31 October 2005.
12. Latvia	The Regulation is directly applicable since the date of accession. General requirements have been laid down in the Law on Veterinary Medicine (1 July, 2001). Responsibility in case of failure to meet these requirements is laid down in the Penal Law and in the Code of Administrative Misdemeanor. Requirements laid down in regulations, which are not directly applicable have been transposed into Regulations of the Cabinet of Ministers No 606 of 20 July, 2004 on veterinary and hygiene requirements to the chain of ABPs not fit for human consumption (27 July, 2004).
13. Lithuania	The Regulation has been introduced into Lithuanian legislation by Order N° B1-996 of the Director of the State Food and Veterinary Service of 23 December 2003. From 1 May 2004, all EC Regulations are directly incorporated into the national legislation in accordance with the relevant national provisions (Resolution N° 1180 of 18 September 2003).
14. Luxembourg	The implementation provisions have concerned mainly the repartition of competence. A number of national rules are in place regarding the categories of material that could be disposed of by incineration or landfill. Several circulars and other instructions have been issued regarding removal, identification and disposal.
15. Hungary	The Regulation is directly applicable since the date of accession. However, a new national legislation to enforce it is being drafted and will be in place at the end of 2005 and the existing Ministerial decree will be repealed.
16. Malta	Malta has published in the national official “gazette” on 18 January 2005 a draft regulation applying the ABPs Regulation opened for 4 weeks’ comment period. Draft national legislation on waste has been issued in November 2004 for consultation and will enter into force shortly (FVO mission). This sets out a system of registration for hauliers of ABPs, among others, and the requirements they must fulfill.
17. The Netherlands	National provisions have been made in a specific national implementing Regulation: “implementation of EU Regulation on ABPs not intended for human consumption” and the “Regulation on inspection and trade of ABPs” applicable since 9 September 2003.
18. Austria	After its publication in the European Official Journal, the Regulation and the associated transitional measures and implementing provisions were made known to the relevant authorities and the industry in Austria by means of Erlässe (official circulars) and by announcements in the official veterinary bulletin (AVN), pointing out that the provisions in question are directly applicable. The Animal Materials Act (Tiermaterialiengesetz) that came into force 1 January 2004 deals with the procedures for approval, the responsibility of competent authorities for control, an obligation for owners/producers of ABP/fallen stock to hand over ABP to approved plants and repeals previous national legislation in this field. In addition, complementary legislation provides for the obligation for the food establishments for proper collection, storage and hand over of ABP.
19. Poland	The ABPs regulation and related transitional measures are legally binding and directly applicable in Poland by the date of accession. The act of protection of animal health and control of infectious diseases of animals of 11 March 2004 provides for official supervision and approval of plants dealing with ABPs. Moreover, the Act provides for penal sanctions for business operators failing to meet veterinary requirements.
20. Portugal	Portugal has published the following legal texts: Dispatch n° 8137/2003 of 9 May, which defines a system for the collection of fallen stock. Decree-law N° 244/2003 of 7 October 2003, which requires all operators of slaughterhouses, cutting plants, incubation centres and egg product industries to present a plan for the disposal of Category 2 and 3 of ABPs. Dispatch n° 9134/2005 of 26 April 2005, which defines competence of the various competent authorities with regard to the classification, separation marking, weighing, sealing and expedition, where appropriate, of Category 1, 2 and 3 ABPs, at slaughterhouses and cutting plants.
21. Slovenia	The Regulation entered into force in accordance with the Slovenian legal order, on the day of accession. Imposing of sanctions and the competence of services are governed by sectoral acts such as Veterinary Practice Act, Environmental Protection Act, etc. Several implementation rules have been adopted in 2004 concerning in particular repartition of competences and the concept and conditions of public utility service.
22. Slovak Republic	The Regulation has been implemented as it is.
23. Finland	Finland has undertaken a series of measures to implement the Regulation: National Statutes have been established to give effect to Regulation (EC) No 1774/2002, application guides have been published to clarify the legislation and lectures have been given in different part of Finland to authorities, operators and people working in the agriculture sector.
24. Sweden	An adjustment of the Swedish Regulation to rules in the ABPs Regulation was made at the 1^st of October 2003. The necessary national implementing rules to ensure i.e. sanction possibilities are set down in the Swedish Act (1992:1683) and the appointment of competent authority of ABPs in the Swedish Ordinance (1998:134). Both entered into force at the 1^st of January 2004.
25. United Kingdom	Four Regulations have been issued in England, Scotland, Wales and Northern Ireland. These Regulations provide for the administration and Enforcement of the Regulation in the different parts of the United Kingdom.

ANNEX IV

MAIN ISSUES RAISED BY MEMBER STATES ALREADY SOLVED THROUGH COMITOLOGY PROCEDURE OR GUIDANCE

1. Transitional measures for Member States and Third Countries

Member States are acquainted with the local conditions of the industry and were asked to assess the likely effects of the Regulation on the industry and to submit appropriate requests for transitional measures. Interested Member States submitted requests, and the following transitional measures have been granted.

1.1. Transitional measures for Member States

· Feeding catering waste (swill feeding) to animals (Austria and Germany). Commission Decision 2003/328/EC (Expiry date: 31/10/2006).

· Feeding used cooking oil to animals (Ireland and United Kingdom). Commission Decision 2003/320/EC (Expired on 31/10/2004).

· Total separation between plants handling Category 1, 2 and 3 materials (Finland and France). Commission Decision 2003/325/EC (Expired for France on 30/04/2004 and expiry date for Finland: 31/10/2005).

· Separation of oleo-chemical plants (Belgium, Germany, Italy, Netherlands, Spain, Sweden and United Kingdom). Commission Decision 2003/326/EC. (Expiry date: 31/10/2005).

· Separation of intermediate plants (France and Italy). Commission Decision 2003/323/EC. (Expired on 30/04/2004).

· Low-capacity incinerators/co-incinerators (Finland and United Kingdom). Commission Decision 2003/327/EC. (Expired on 31/12/2004).

· Manure processing standards (Belgium, France, Finland and Netherlands). Commission Decision 2003/329/EC as amended by Commission Decision 2005/14/EC (Expiry date: 31/12/2005 pending a scientific opinion by the EFSA adopted on 07/09/2005)

· Composting standards (all Member States). Commission Regulation (EC) No 809/2003 as amended by Commission Regulation (EC) No 12/2005 (Expiry date: 31/12/2005 pending a scientific opinion by the EFSA adopted on 07/09/2005)

· Biogas standards (all Member States) Commission Regulation (EC) No 810/2003 as amended by Commission Regulation (EC) No 12/2005 (Expiry date: 31/12/2005 pending a scientific opinion by the EFSA adopted on 07/09/2005)

· Processing standards for mammalian blood (Germany, Italy, Spain and United Kingdom). Commission Decision 2003/321/EC (Expired on 31/12/2004).

· Collection of wastewater (Austria, Denmark, France, Finland, Italy, Ireland, Portugal, Spain, Sweden, Estonia and Hungary). Commission Decision 2003/334/EC and Commission Decision 2004/468/EC (Expired on 30/04/2005).

· The possibility of on-site burning or burial of ABPs (Estonia and Cyprus: for the latter an extension of the transitional measures has been granted until 1.11.2005 in order to allow extra time to the industry to comply with the requirements of the Regulation). Commission Decision 2004/467/EC (Expired on 01/01/2005) and Commission Decision 2005/62/EC (Cyprus).

· Separation of Category 1 and 2 processing plants and the inclusion of ABPs establishments in the list of establishments in transition in Latvia. Commission Decision 2004/464/EC and Commission Decision 2004/476/EC. (Expired on 31/12/2004).

· Collection, transport and disposal of former foodstuffs. Commission Regulation 813/2003/EC (Expiry date: 31/12/2005).

1.2. Transitional measures for third Countries

General transitional arrangements were granted to third countries postponing the application of the import provisions of the Regulation allowing adequate time for them to adjust to the new requirements and to allow the Commission time to update the rules on importation in Annexes VII and VIII and the model of health certificates in Annex X.

In addition, the following specific transitional measures were granted:

· Import of gelatine produced from vertebrae bones from Japan and United States to Netherlands, France and United Kingdom intended for making photo films in the EU (Commission Decision 407/2004: to be reviewed as appropriate in the light of new scientific advice).

· Import and placing on the market of certain materials of animal origin classified as Categories 1 and 2 intended for technical purposes (all third countries) (Commission Regulation 878/2004/EC: to be reviewed as appropriate in the light of new scientific advice).

· Separation of Category 1, 2 and 3 intermediate plants and the separation of Category 1, 2 and 3 processing plants (Australia, Canada, China and USA) (Commission Regulation 780/2004/EC – expiry date: 31/10/2005).

2. Commission Regulations amending Regulation (EC) No 1774/2002

Five Commission Regulations have been introduced amending the Annexes to the Regulation:

· Regulation (EC) No 808/2003 has amended Article 12(3) to allow the incineration of specified risk material and bodies of animals in low-capacity incinerators in line with the SSC opinion and has introduced some other technical amendments to the Annexes, in line with the wording of the Articles.

· Regulations (EC) No 668/2004 and No 416/2005 have introduced some technical amendments to bring the Annexes in line with the text of the Articles and have updated the model of health certificates and introduced new models for the import of certain products that may be used as feed material, pet-food, dogchew and technical products. The list of third countries has been updated in accordance.

· Regulation (EC) No 92/2005 has amended the Regulation as regards biogas transformation and processing of rendered fats.

· Regulation (EC) No 93/2005 has amended Annexes II and V of the Regulation (see point 3).

3. Measures taken to implement Regulation (EC) No 1774/2002

Measures have been introduced implementing the various Articles. The following implementing Regulations have been introduced:

· Use of milk, milk-based products and milk-derived products (Regulation (EC) No 79/2005). The Regulation allows the direct feeding to farmed animals of dairy products produced to food standards subject to animal health conditions in line with current scientific opinions, waiting for the opinion of EFSA

· Means of use or disposal of ABPs (Regulation (EC) No 92/2005). The Regulation provides for the possibility to dispose of ABPs by five other alternative methods.

· Processing of ABPs of fish origin and a commercial document for the transport of ABP (Regulation (EC) No 93/2005). The Regulation establishes a specific method for the processing of ABPs of fish origin and lays down a harmonised model of commercial document for the transport of ABPs.

4. Permanent general derogations granted.

The following derogations have been granted:

· Derogation from the intra-species recycling ban for fish with regard to the feeding of fish with processed animal protein derived from the bodies or parts of bodies of animals of the same species (Article 22(2) of the basic regulation). In addition it was necessary to provide transitional arrangements to allow adequate time so that the industry can adjust to the new requirements as regards the feeding of fish with processed animal protein derived from the bodies or parts of bodies of animals of the same species. (Regulation (EC) No 811/2003).

· Detailed requirements of how burial and burning should be carried out in accordance with Article 24(1) of the basic regulation. (Regulation (EC) No 811/2003).

5. Permanent specific derogations granted on request from member States

Implementing measures have been introduced to allow the continual feeding of:

· Fur animals with processed animal protein derived from the bodies or part of bodies of animal of the same species (Finland, Estonia). Commission Decision 2003/324/EC.

· Endangered or protected species of necrophagous birds with dead ruminants containing specified risk material (Article 23(2) (Italy, France, Spain, Portugal, Greece and Cyprus). Commission Decision 2003/322/EC, as amended by Commission Decision 2004/455/EC.

6. Guidelines issued to clarify a certain number of issues.

Two guideline documents have been issued (see Annex II):

· “Guidance on applying the new ABPs Regulation (EC) No 1774/2002” in the form of questions and answers clarifying the main concerns raised by Member States and stakeholders.

· “Guidance note on the application to ABPs of community legislation regarding animal and public health and waste”.

A full list of legislation, plus guidance notes and other information relating to animal by-products, are available on the ABP web site of the Directorate General for Health and Consumer Protection, and may be accessed via:

http://europa.eu.int/comm/food/food/biosafety/animalbyproducts/index_en.htm

[1] OJ L 273 of 10.10.2002, p. 1.

[3] OJ L 147, 31.5.2001, p. 1.

[4] OJ L 268, 14.9.1992, p. 1.

[5] OJ L 200, 24.8.1995, p. 42.

ABPs	Animal By-Products (part of animal that is not intended for human consumption)
ABP Regulation	Regulation No 1774/2002 of the European Parliament and the Council laying down health rules concerning animal by-products not intended for human consumption
BSE	Bovine Spongiform Encephalopathy is one of a group of diseases known as transmissible spongiform encephalopathies, or TSEs, which are caused by the build-up of abnormal prion proteins in the brain and central nervous system
Category 1	High-risk animal by-products referred to in Article 4 of the ABP Regulation (e.g. animals infected with TSE)
Category 2	Medium risk animal by-products referred to in Article 5 of the ABP Regulation (e.g. dead on-farm poultry and other ABPs that are neither Category 1 nor Category 3)
Category 3	Low or non-risk animal by-products referred to in Article 6 of the ABP Regulation (safe ABPs from animals "fit for human consumption")
Comitology	Legislative procedure requiring approval of measures to be taken by the Commission by a regulatory committee composed of the representatives of the Member States and chaired by the representative of the Commission
Competent authority (CA)	The authority of a Member State responsible for the implementation and enforcement of the ABPs Regulation
EFSA	European Food Safety Authority: Independent European body that provides assistance and scientific advice concerning risk assessment and risk analysis to the Commission, European Parliament and the Member States
FVO	Food and Veterinary Office – Directorate F of DG Health and Cosumer Protection (SANCO) located in Grange (Ireland) responsible for verification of the implementation of Community food safety legislation in the Member States and in third countries
Intra-species recycling (cannibalism)	Feeding of a species with processed animal protein derived from the bodies or parts of bodies of animals of the same species (e.g. pig protein given to pig)
Processed animal protein	Parts of animals that are processed e.g. fish meal, meat and bone meal, bloodmeal
TSE	Transmissible Spongiform Encephalopathies: family of diseases including BSE, Chronic Wasting Disease, Scrapie and Creutzfeldt-Jakob Disease
White paper on Food Safety	Policy paper developed by DG SANCO in 1999, following a number of food crises, to develop a new food safety strategy