Explanatory Memorandum to COM(2002)377 - Specific rules for the organisation of official controls on products of animal origin intended for human consumption

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1. Introduction

1. On 14 July 2000 the Commission adopted a package of 5 proposals that constitute a recast of existing Community legislation on food hygiene and veterinary legislation that is currently contained in 17 Directives [document COM (2000) 438]. These proposals are:

- A proposal for a Regulation of the European Parliament and of the Council on the hygiene of foodstuffs [2000/0178 (COD)].

- A proposal for a Regulation of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin [2000/179 (COD)].

- A proposal for a Regulation of the European Parliament and of the Council laying down detailed rules for the organisation of official controls on products of animal origin intended for human consumption [2000/180 (COD)].

- A proposal for a Council Regulation laying down the animal health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption [2000/181 (CNS)].

- A proposal for a Directive of the European Parliament and of the Council repealing certain Directives on the hygiene of foodstuffs and the health conditions for the production and placing on the market of certain products of animal origin intended for human consumption, and amending Directives 89/662/EEC and 91/67/EEC [2000/182 (COD)].

These proposals are at present under discussion in the European Parliament and in the Council in accordance with the procedures laid down for that purpose.

2. Since the time these proposals were made new developments have taken place and notably:

- New scientific advice has become available, in particular on issues that relate to meat safety. This information allows for meat inspection to be organised on a basis that takes account of hazards that threaten human health today, thus making it more science-based and risk-based. It also allows the full integration of the stable-to-table approach, an element that is believed to be of great importance with regard to meat safety.

- The Commission is preparing, as announced in the White Paper on Food Safety [document COM (1999) 719], a proposal for a Regulation laying down in a horizontal way the principles that are the basis for official feed and food controls. These principles will also be applicable to the organisation of meat inspection.

These developments require that the Commission's proposal for a Regulation of the European Parliament and of the Council laying down detailed rules for the organisation of official controls on products of animal origin intended for human consumption [2000/180 (COD)] be revised in a fundamental way.

3. The Commission therefore decided, on 11 December 2001, to withdraw the proposal contained in Document 2000/180 (COD), and to submit a revised proposal.

4. This proposal contains a revised version of document 2000/180 (COD) and replaces completely this document. The revision concerns mainly official controls of fresh meat. At the same time, the risk management measures for live bivalve molluscs as well as for milk and milk products, have been strengthened. This proposal is fully consistent with the proposal for a Directive of the European Parliament and of the Council repealing certain Directives on the hygiene of foodstuffs and the health conditions for the production and placing on the market of certain products of animal origin intended for human consumption, and amending Directives 89/662/EEC and 91/67/EEC [2000/182 (COD)].

1.

II. Official controls on meat


5. The proposed system for official controls on fresh meat production is characterised by the following:

- it is science-based;

- it addresses all known hazards that are relevant for the safety of the meat;

- the official veterinarian plays a central role in the system;

- it consists of official audits of the systems put in place by the operator, and also of official inspection activities;

- it clearly integrates the stable-to-table approach;

- it deals with the relevant animal health and animal welfare issues;

- the frequency and intensity of official controls is risk-based;

- it contains, for certain sectors and on certain conditions, the possibility of involvement of staff of the establishment;

- it contains training requirements for all staff carrying out official controls.

These characteristics are further elaborated below.

2.

6. Science-based


The proposal has been developed on the basis of the latest opinions of the Scientific Committee on Veterinary Measures relating to Public Health (europa.eu.int/comm/food/fs/sc/scv/index_en). The requirements concerning inspection procedures can be adapted in a flexible way in order to take into account scientific opinions as soon as they are released. This may concern, among other things, new scientific data on emerging hazards, the use of technology and specific inspection procedures.

3.

7. Relevant hazards


The proposed system contains procedures for controls on all relevant microbiological, chemical and physical food safety hazards. The proposal contains standards for a number of these hazards, and makes reference to standards stated in other Community legislation, especially concerning microbiological and chemical hazards. Only healthy meat, that is in line with the standards in Community legislation, can be declared fit for human consumption.

4.

8. The official veterinarian


The official veterinarian plays a central role in the system. He/she carries out audits and inspection activities and takes all relevant decisions. To function optimally in the proposed, risk-based meat inspection system, the official veterinarian needs specific training. The proposal contains clear requirements in this respect. The proposal also specifies the training requirements for the official auxiliaries, that can assist the official veterinarian.

5.

9. Audits of the systems put in place by the operator


On the basis of the new European legislation in the field of hygiene, the operator has to ensure, through the application of good hygienic practices (GHP) and procedures based on the principles of Hazard Analysis and Critical Control Points (HACCP), that the meat produced is in line with the standards mentioned in Community legislation. The official veterinarian carries out audits to check whether the GHP and the HACCP-based procedures of the operator achieve the required standards. These audits are carried out on an on-going basis.

6.

10. Inspection activities


Besides carrying out audits of the systems put in place by the operator, the official veterinarian carries out inspection activities. These inspection activities cover the following issues:

- the relevant records from the holding of provenance of the animals;

- ante-mortem inspection;

- animal welfare;

- post-mortem inspection;

- specified risk materials;

- laboratory testing;

- health marking.

In carrying out his inspection activities, the official veterinarian takes into account the results of the audits mentioned above.

7.

11. Stable-to-table approach


Animals are not accepted for slaughter if they are not accompanied by relevant food safety information from the farm. The official veterinarian carries out his inspection activities taking into account this information. The results of these inspections are communicated to the person responsible for raising the animals on the farm. Where appropriate, part of the ante-mortem inspection can take place on the farm.

8.

12. Animal health and welfare


Ante-mortem inspection is carried out by the official veterinarian. He checks among other things whether any animal disease is present and whether the relevant animal welfare rules are being respected. Animals showing clinical signs of systemic disease or emaciation, shall not be slaughtered for human consumption. Only healthy animals, that are clean, identified in accordance with Community rules and accompanied by the relevant information from the farm shall be accepted for slaughter.

9.

13. Frequency and intensity of official controls is risk-based


The frequency and intensity of official controls is based on an assessment of the health risks, represented by the type of animals and the type of process. At least one official veterinarian shall be present throughout ante- and post-mortem inspection. However, some flexibility exists for small enterprises and for the poultry sector.

10.

14. Involvement of staff of the establishment


Member States may, under specific conditions, allow staff of the establishment to carry out certain inspection activities (normally carried out by official auxiliaries) in the control of poultry, rabbits, fattening pigs and fattening veal; the staff of the establishment must have received prior training equivalent to the training of official auxiliaries.

Only operators that have a good record in meeting the legal requirement, and are motivated to do so, can be allowed, under strict conditions, to have their staff carrying out activities of auxiliaries. By doing so, responsibilities are more clearly divided between operator and competent authority: the operator can better fill in the primary responsibility that he has for the safety of the meat and the official veterinarian can carry out his control activities in a more independent way.

11.

III. Live bivalve molluscs


15. Live bivalve molluscs may present, as a consequence of their special physiological characteristics, certain risks for human health. As filter-feeders, they have the capacity to concentrate in their tissues micro-organisms (bacteria and viruses), toxins from algae that are present in the aquatic environment, and other contaminants. Special risk management measures including close monitoring of the environment are therefore required so as to ensure that live bivalve molluscs do not present a hazard to human health.

16. The present proposal aims to identify better the actions that must be undertaken by the competent authority in order to ensure the safety of the products. These actions include the establishment of a monitoring programme of harvesting areas in order to check:

- the microbiological quality of live bivalve molluscs,

- the presence of toxin-producing plankton,

- the presence of chemical contamination.

If these monitoring programmes show that Community levels have been exceeded, prompt action must be taken in order to prevent molluscs from reaching the consumer.

The proposal also imposes upon Member States the establishment of control systems for Pectinidae harvested outside classified production areas.

12.

IV. Milk and milk products


17. It was felt that there was a need to specify more precisely the responsibilities of the competent authorities with regard to official controls for milk and dairy products. In the milk sector, there is in several Member States a close co-operation between the sector itself and the competent authority, especially with regard to checking health and quality criteria of raw milk upon collection.

Within that context, the present proposal aims at enshuring that where raw milk fails to meet the health standards, corrective action is taken at farm level, and that milk that might constitute a hazard to human health is not delivered for human consumption.

13.

V. Feed and food controls: the coherence of Community legislation


18. The controls in the present proposal must be seen in the wider context of the Community legislation that is being developed as a consequence of the adoption of the White Paper on Food Safety and in particular:

- the recently adopted Regulation laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, and

- the establishment of a proposal for a Regulation of the European Parliament and of the Council on official feed and food controls (Action 4 of the Annex to the White Paper on Food Safety).

19. The basic principles related to responsibilities of the Member States authorities are already laid down in the Regulation laying down the general principles of food law, establishing the European Food Authority and laying down procedures in matters of food safety. This Regulation stipulates in particular that 'Member States shall enforce food law and monitor and verify that the relevant requirements of food law are fulfilled by food and feed business operators at all stages of production, processing and distribution. For that purpose they shall maintain a system of official controls and other activities as appropriate to the circumstances, including public communication on food and feed safety and risk, food and feed safety surveillance and other monitoring activities covering all stages of production, processing and distribution. Member States shall also lay down the rules on measures and penalties applicable to infringements of food and feed law. The measures and penalties provided for shall be effective, proportionate and dissuasive'.

20. In the White Paper on Food Safety it is stated that:

"There is a clear need for a Community framework of national control systems, which will improve the quality of controls at Community level, and consequently raise food safety standards across the European Union. The operation of such control systems would remain a national responsibility. This Community framework would have three core elements.

- The first element would be operational criteria set up at Community level, which national authorities would be expected to meet. These criteria would form the key reference points against which the competent authorities would be audited by the FVO, thereby allowing it to develop a consistent, complete approach to the audit of national systems.

- The second element would be the development of Community control guidelines. These would promote coherent strategies, and identify risk-based priorities and the most effective control procedures. A Community strategy would take a comprehensive, integrated approach to the operation of controls. These guidelines would also provide advice on the development of systems to record the performance and results of control actions, as well as setting Community indicators of performance.

- The third element of the framework would be enhanced administrative co-operation in the development and operation of control systems. There would be a reinforced Community dimension to the exchange of best practice between national authorities. This would also include promoting mutual assistance between the Member States by integrating and completing the existing legal framework."

The preparation of a Commission proposal on such a Community framework of national control systems is well advanced and this proposal will formally be submitted by the Commission in 2002. It covers in a horizontal way for all feed and food those issues that are important for the organisation of official controls at a national and at Community level.

21. In addition to the principles and rules referred to in paragraphs 19 and 20 it must be considered that for a number of issues more specific rules must be laid down, so as to describe in a more precise manner what the duties of the competent authorities are with regard to these issues. Examples of specific control requirements already exist in Community legislation: residue controls, controls of zoonotic diseases, controls of certain transmissible spongiform encephalopathies etc. Likewise, it must be envisaged that for products of animal origin such as meat, milk, fishery products and live bivalve molluscs more specific controls are necessary. These products present a number of hazards that fully justify the definition of such specific controls. These specific controls must be seen in the more general context described above.