Explanatory Memorandum to COM(2003)180 - Requirements for feed hygiene - Main contents
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| dossier | COM(2003)180 - Requirements for feed hygiene. |
|---|---|
| source | COM(2003)180  |
| date | 15-04-2003 |
The main purpose of the current Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector (as last amended by Council Directive 1999/29/EC of 22 April 1999) is to ensure that certain establishments and intermediaries that manufacture, produce or put into circulation certain additives, premixtures, compound feedingstuffs and products covered by Directive 82/471/EEC are approved or registered by competent authorities verifying compliance with the technical specifications detailed in the annexes.
Commission Directive 98/51/EC of 9 July 1998 lays down certain measures for implementing Council Directive 95/69/EC.
The production or use of some of the products requires only registration, based on an undertaking by the establishment to comply with a number of conditions.
The production or use of some other products requires approval of the plant on the basis of very strict conditions designed to safeguard animals, humans and the environment. Such approval is subject to a mandatory on-the-spot verification by the competent authority that the conditions laid down in the Directive have been complied with.
According to the current legislation, the different level of risk to human health, animal health and the environment justifies this dual regime for the production and use of the different substances. Approval applies to establishments which intend to manufacture or use products deemed sensitive, whilst mere registration applies to establishments using less sensitive products.
Upon completion of the procedure, applicants are issued with an approval number or a registration number, as the case may be, and the firms concerned are entered in lists drawn up by the competent authority.
Feed businesses operating in the feed chain and carrying out activities other than those described in Directive 95/69/EC are exempt from the registration or approval requirement.
The Directive has been in force since 8 February 1996, and Member States should have adopted, not later than 1 April 1998 the laws, regulations and administrative provisions necessary to comply with it.
Contents
- II. The need for changes
- a) The HACCP system
- b) Traceability
- c) Responsibilities and hygiene
- d) Imports of feed from non-member countries
- e) The farm to table approach and primary production
- f) Flexibility
- IV. Feed hygiene and the Commission's White Paper on food safety
- V. Summary
- VI. The Form of the Acts
Following the BSE crisis, the two occurrences of serious dioxin contamination and other concerns such as the contamination of feed materials and feedingstuffs with nitrofen or hormones, a need has been identified for an appropriate legal instrument to:
- ensure safety of all kinds of feed;
- ensure that all feed businesses operate in accordance with harmonised hygiene requirements; and
- improve traceability
III. Feed Hygiene
The implementation of Directive 95/69/EC has shown that some of the conditions remain valid and that their application could be extended to the production of all kinds of feed.
It therefore makes sense at the present time to lay down requirements for feed businesses which at present fall outside of the scope of Directive 95/69/EC and, at the same time, to revise the minimum conditions in order to make general and clearer rules applicable to all feed businesses, provide greater transparency and take into account recent developments in feed hygiene:
In order to bring animal nutrition legislation into line with the principles of food hygiene laid down by the Codex Alimentarius, it is proposed that the Hazard Analysis and Critical Control Points (HACCP) principles prescribed by that organization be introduced. The implementation of these principles will be mandatory for all feed business operators other than at the level of primary production. It prescribes a number of steps to be followed by operators throughout the production cycle in order to facilitate - through hazard analysis - the identification of points where control is critical with regard to feed safety.
In implementing HACCP, operators will have to live up to their responsibilities. They will need to design a specific monitoring programme. All potential hazards must be identified and proper control procedures for each feed business individually established. Corrective action must be taken when controls show that problems may occur. Regular updates of the system must be made.
The principles contain the obligation to keep documents and records of whatever checks are carried out. This allows for more efficient and effective control by the competent authorities.
Traceability is already a general requirement laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 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.
Experience has clearly shown animal feed to be the cause of some incidents that could pose a risk to human and animal health.
Successive feed crises have demonstrated that identifying the origin of feed is of prime importance in terms of health protection. In particular, traceability facilitates the withdrawal of feed and food and enables the competent authorities to be provided with targeted and accurate information on whatever products are involved.
The new proposal introduces the compulsory registration of all feed businesses by the competent authority. In certain cases, where it is necessary to have certainty about whether feed businesses are complying with the hygiene rules, approval will be required. In such cases the competent authority will give official approval following an on-the-spot visit to check on compliance.
Under European food law, and more especially in hygiene legislation, the primary responsibility for ensuring compliance with food law, and in particular the safety of food, rests with food businesses. This proposal will extend the principle to the entire feed chain.
This proposal seeks to ensure that feed safety is considered at all stages that may have an impact on feed and food safety. A feed business must therefore ensure that feed for which it is responsible does not have the potential to cause a feed or food safety problem, and should ensure that working practices are such that feed and food safety is not compromised. The proposal establishes a requirement that only safe feed be placed on the market and establishes a link with the need to ensure that food from animals fed on such feed is safe.
Conditions for feed business operators may differ according to whether they are or are not operating at the level of primary production.
For instance, the duration of the production cycle at primary level can predispose to unavoidable events that may occur, such as weather-related or environmental factors. It is difficult then to develop the awareness needed to identify all possible risks and to establish an appropriate control programme to deal with them.
Then again, unacceptable risks may occur on manufacturing premises, for example, as a result of wrong practices at any stage of the preparation, processing, manufacturing, packaging, storing, transportation, distribution and handling of feed. The idea is to improve preventive measures by establishing appropriate control systems, with the various processing stages being analysed to establish the relevant risk. The feed chain is very complex, and the multi-ingredient composition of feed is often also complicated, so failures at any stage in the chain can have huge consequences. Feed business operators must ensure then, by providing a financial guarantee, that they are covered for risks related to their business, more especially, costs arising from the withdrawal from the market, treatment and/or destruction of feed, and food produced therefrom, that can present a serious risk to human or animal health and/or the environment.
Provisions are made for feed imported into the Community to comply with the Community hygiene standards or with equivalent standards in Commission's proposal for a Regulation (EC) .../... on official feed and food controls.
More particularly:
- the third country of dispatch must appear on a list of third countries from which imports of feed are permitted;
- the establishment of dispatch must appear on a list of establishments from which imports of feed are permitted;
It is essential to be consistent with the cornerstone of the food and feed safety policy, i.e. the 'farm to table' approach, and to include the primary production stage under conditions of registration and feed hygiene. Hazards in feed may originate at the farm, which is why it is proposed that the hygiene rules be extended to cover hygiene at farm level. This will provide Community legislation with an instrument that covers the entire feed chain and the food chain, from farm to table. To achieve the required level of hygiene at farm level, it is suggested that possible hazards occurring in primary production and methods to control such hazards be addressed in guides to good practice.
To exempt farms producing feed, and to exclude animal feeding, would give rise to a divergence in the approach to food legislation, a degree of inconsistency and some lacunae, which would be difficult to justify.
Experience in the Community has shown that a certain flexibility is needed, in particular for small businesses, especially those situated in regions suffering from special geographical constraints.
The proposal aims to provide for such flexibility by requiring Member States, as a matter of subsidiarity, to ensure the appropriate level of hygiene in these businesses, without compromising the objectives of feed safety. The competent authorities in the Member States are the most appropriate bodies to judge about the needs at that level, and they must take their responsibility in this issue.
The own-checking system has to be made sufficiently flexible to take account of the different circumstances which may be present in practice, in particular with regard to small businesses. For that purpose, guides of practices can be developed to help implement the HACCP system.
The proposal takes into account the principles of food safety that are spelt out in the Commission's White Paper on food safety i, in particular that:
- The farm to table policy, covering all sectors of the feed chain (including primary production, animal feeding and feed production), needs to be systematically implemented.
- Feed safety policy must be based on a comprehensive and integrated approach.
- Feed businesses, manufacturers and farmers have the primary responsibility for feed and food safety, with the competent authorities taking on a monitoring and enforcement role.
- A successful food policy depends on the traceability of feed and food and their ingredients.
- Feed safety policy must be risk-based.
This proposal also takes into account some of the provisions laid down in Regulation (EC) No 178/2002, such as:
- To provide a high level of animal and human health and also for the environment;
- To ensure effective functioning of the internal market in safe feed;
- To ensure feed traceability;
- To make feed business operators primarily responsible for safe feed;
- To make Member States responsible for the enforcement of food law;
- To ensure that only safe feed is placed on the market;
- To make feed business operators responsible where their products or activities may have an adverse impact on feed safety.
In conclusion, it is proposed in this Regulation that some general feed safety conditions be extended so as to cover hygiene at all levels in the feed chain.
This proposal for a European Regulation responds to all these commitments by laying down requirements for a comprehensive system of registration of all feed business operators and requirements for feed production.
This Regulation will also lay down responsibilities and obligations for feed businesses which will address the causes of feed safety problems in a broad manner and will include requirements for feed businesses at the level of primary production.
General principles and definitions relating to feed production, including the responsibilities of feed business operators on the one hand and of the Member States' authorities on the other hand, are already laid down in Regulation (EC) 178/2002 and in the Commission's proposal for a Regulation (EC) .../...on feed and food controls.
As explained in the Commission's Green Paper on the general principles of food law in the European Union, the Commission believes that enacting Community law in the form of regulations presents a number of advantages, such as guaranteeing uniform application throughout the single market, making Community law more transparent and enabling it to be updated quickly to take account of technical and scientific developments. It is for these reasons that the present proposal is submitted in the form of a Regulation.