European Union: New EU Food and Feed Hygiene Legislation Finalised

The consolidation and simplification of food and feed hygiene legislation was a key priority of the European Commission's White Paper on Food Safety published in January 2000. In July 2000 the European Commission ("the Commission") put forward a "food hygiene package" consisting of five proposals, the aim of which was to "merge, harmonise and simplify" the law on food hygiene. A parallel Regulation on feed hygiene was proposed by the Commission in April 2003. Finally, in order to facilitate the enforcement of the new hygiene rules by EU and Member State competent authorities, the Commission also proposed a Regulation on Official Food and Feed Controls in February 2003.

All these measures have now been agreed by the EU thereby paving the way for a single, transparent hygiene policy, applicable to all food and feed operators.

The new legislation will be applicable from 1 January 2006, although the application of certain provisions is in some cases delayed as specified to allow longer for compliance with the new requirements.

The aim of the food hygiene package is to streamline and consolidate the existing legislation, and create a single, transparent hygiene policy applicable to all food operators. The new food hygiene legislation will repeal and replace the existing 17 food hygiene Directives, 16 of which are commodity specific.

The package comprises the following measures:

• a general hygiene Regulation with rules applicable to all food sectors;

• a Regulation with specific rules for products of animal origin;

• a Regulation for official controls on products of animal origin intended for human consumption, which sets out rules for official controls of fresh meat, live bivalve molluscs and milk and milk products;

• a Regulation on animal health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption;

• a Directive repealing and amending existing legislation.

Responsibility - Under the new Regulations, food producers will be primarily responsible for the safety of food. Member States will be responsible for ensuring that food hygiene rules are applied and complied with.

HACCP - The use of HACCP (Hazard Analysis Critical Control Points) principles will become compulsory in all sectors of the food business except primary production on farms. HACCP involves identifying points in the production chain that are critical to food safety and putting in place, and reviewing, measures taken to minimise risks. Although the application of HACCP principles is not obligatory for primary production (as had originally been proposed), farmers are to be encouraged by Member States to use HACCP as far as is practicable.

Registration/Approval - All food businesses will have to be registered and some businesses, carrying out more hygiene-sensitive activities, such as slaughterhouses, will need to be approved (including an on-site inspection) before they can operate.

Guides to good practice - Food business operators will be encouraged to develop and use guides to good practice for hygiene and for the application of HACCP. If necessary, guides to good practice may be developed at EU level. These will be developed by, or in consultation with, representatives of European food business sectors and other interested parties (such as consumer groups) and in cooperation with the competent authorities. Draft guides will be assessed by the Standing Committee of the Food Chain and Animal Health (comprising representatives of the Member States). The development of guides on the application of HACCP are being encouraged by the EU on the grounds that they may help smaller businesses with limited resources or personnel who are obliged to introduce HACCP.

Flexibility/Exemptions - The food hygiene package allows some flexibility for small businesses, for food producers using traditional food production methods and those in remote geographical areas. The Regulations do not apply to primary production for domestic use or to the direct supply by the producer of small quantities of primary products to the consumer or local retail establishments.

Imports - In order to ensure that imported products of animal origin meet EU safety standards, imports into the Community of food products of animal origin must be from a country that is on a list of countries from which imports of that type of product are permitted. Furthermore, the product must have come from an establishment contained in a list of establishments from which imports into the community of that product are permitted. The list will be established and managed by the European Commission via the Regulatory Committee procedure1.

FEED HYGIENE REGULATION The feed hygiene Regulation covers all types of feed and all feed business operators. Feed is produced either by using soil resources (such as grass and cereals) or from by-products of the food industry (such as bakery waste). Previously food industry byproducts were not subject to specific hygiene rules. This was seen as unacceptable as contamination in the feed chain can lead to contamination in the food chain. It is because of this that the feed hygiene Regulation has been referred to as the "missing link" in the Commission's "farm to fork" approach to food safety. The Regulation introduces HACCP principles for feed production for the first time. It also requires the registration of all feed establishments, thereby extending the current requirements of Directive 95/69 on the registration and approval of certain establishments manufacturing or using sensitive substances such as certain additives.

Responsibility - As with the food hygiene rules, feed business operators are responsible for ensuring feed safety. The Regulation applies to the production of feed at all levels from the primary production of feed crops all the way through to the placing of feed on the market. It applies to feed for food producing animals, including to feed imported into the EU from third countries. The wide scope of the application is intended to improve traceability which will facilitate the removal of contaminated feed, and food produced from contaminated feed, should this become necessary.

Flexibility/Exemptions - The feed hygiene Regulation does not apply to:

• the production of feed for, and the feeding of, animals for home consumption;

• the feeding of non-food producing animals;

• the retailing of pet food; and

• trade between farmers of small quantities of feed at local level.

However, provision is made for Member States to adopt their own national rules in respect of the above if they so wish.

Obligations - The Regulation restates the general obligation of EU food law2 that only safe feed may be placed on the market. It also sets specific obligations on operators dependent on the activities they undertake and the stage of production in the feed chain. The specific requirements cover areas similar to those currently applying to establishments falling within the scope of Directive 95/69, namely: facilities and equipment; personnel; production; quality control; storage and transport; and documentation and record keeping.

HACCP - One of the major changes brought about by the new Regulation is that all feed businesses (with the exception of those at primary production level) will for the first time be obliged to put in place a system based on HACCP principles. They will therefore need to identify and control those points in production critical to feed safety.

Guides to Good Practice - As in the EU food hygiene legislation, the feed hygiene Regulation makes provision and sets out procedures for the adoption of Community guides to good hygiene practice. These may be of particular importance to primary producers who are exempt from the obligation to implement systems based on HACCP principles. Member States will encourage the adoption of national guides to good practice in cases where EU-level guides are not appropriate. Provision is made for feed business operators to use guides to good practice to help them to comply with their obligations under the feed hygiene Regulation. However, the use of such guides will be voluntary.

Financial Guarantees - The original proposal envisaged an obligation on feed business operators to have financial guarantees in place to cover risks related to their business. These might include, for example, insurance to cover the cost of withdrawing unsafe products from the market. However these obligations were not imposed in the final Regulation following concerns that insurance may not always be available to cover such risks. The Commission has instead been tasked with reviewing the options in respect of potential financial guarantees within 12 months of the Regulation coming into effect (that is by 1 January 2007). Proposals for legislation in respect of financial guarantees may be put forward when the Commission's report is issued.

Approval/Registration - The feed Regulation extends the current system of registration and approval under the Certain Establishments Directive (95/69) to require the registration of all feed businesses in the EU. Some establishments (for example those manufacturing or using certain additives or other sensitive substances) will require prior approval for their activities following an on-site visit.

Imports - Feed imported into the Community from non-EU third countries must meet equivalent safety and hygiene standards to those set out in EU legislation. In order to facilitate this feed may only be imported if it originates in an establishment that is licensed to export feed to the EU by the competent authority of the exporting country. The detailed rules applying to controls on imports into the EU from third countries will be adopted by the Commission in due course via the Regulatory Committee procedure.

The Regulation on Official Food and Feed Controls ("Official Controls Regulation") defines the responsibilities of Member States who are tasked with ensuring that food and feed operators apply and comply correctly with the new legislation. It also sets out how the European Commission can evaluate the performance of Member States' controls.

Under the Official Controls Regulation the Commission's Dublin-based Food and Veterinary Office ("FVO") is responsible for auditing the Member States' performance of enforcement. The Regulation sets out a harmonised approach to the design and development of control systems throughout the EU, including setting out performance criteria to be met by the competent authorities of Member States.

The Official Controls Regulation introduces new general rules that are applicable to all food and feed production, whether produced in the EU or imported. While specific controls, such as those that deal with zoonoses, residues, pesticides and BSE (Bovine Spongiform Encephalopathy) will remain in place, the following Directives will be repealed when the Regulation comes into effect: Directive 70/373 on sampling and analysis for the official control of feedingstuffs; Directive 95/35 on official inspections in the field of animal nutrition; and Directives 89/379 and 93/99 on the official control of foodstuffs.

The Official Controls Regulation provides that official controls should be carried out using appropriate techniques including routine surveillance checks and more intensive controls such as inspections, verifications, audits, sampling and the testing of samples. Premises, facilities, equipment, machinery, installations and materials may all be inspected. Staff carrying out the controls should receive training, especially with regard to the implementation of HACCP principles so that competent authorities act in a consistent way throughout the Community.

The frequency of official controls should be regular and proportionate to the risk, taking into account the results of own-checks carried out by the business operator and experience from previous inspections. Ad-hoc controls should be carried out if noncompliance is suspected and may be carried out at any time, even if there is no suspicion of noncompliance.

The Official Controls Regulation does not affect the requirements for veterinary checks on feed and food of animal origin set out in Directive 97/78. However imports of feed and food of non-animal origin will be subject to controls based on a multiannual national control plan drawn up in light of potential risks. This means that if a particular product is known to present a particular risk, then the sampling frequency may be more stringent than for products that are viewed as lower risk.

The Regulation provides that appropriate and dissuasive sanctions should be imposed as breaches of the feed and food law or the animal health and welfare rules may constitute a threat to the health and welfare of humans, animals and/or the environment. Member States can impose administrative or criminal sanctions under their own national laws. Administrative sanctions include the withdrawal or suspension of an approval, withdrawal from the market or destruction of a product, and restrictions on the scope or scale of the operator's activities.

The Commission, together with the Member States within the Standing Committee or on its own initiative, may take special measures if there has been a serious failure in a Member State's control system which may constitute a possible and widespread risk for human health, animal health or animal welfare. Measures may include suspending the placing of certain feed or food on the market and laying down special conditions or measures necessary to protect human, animal or plant health, animal welfare or the environment. These powers may only be invoked after Community controls have revealed non-compliance with EC legislation and the Member State has failed to correct the situation upon request and within the time limit set by the Commission.

Member States are responsible for ensuring that they have the financial resources available for carrying out official controls. The Regulation gives them the power to raise these funds by whatever means considered appropriate, including through the use of general taxation and the establishment of fees or charges.

The Regulation requires Member States to charge fees:

• where they are currently collecting fees under Directive 85/73 for veterinary checks on products of animal origin from Community establishments;

• where they are currently collecting fees under Directive 85/75 in relation to veterinary checks on products entering the Community from third countries;

• for the approval of feed establishments; and

• where "excess" controls are required following the detection of non-compliance.

When fees are charged by Member States, whether they are compulsory or optional, the level of the fees may be fixed at a flat rate on the basis of the costs borne by the competent authorities over a given period of time, or, where applicable, at the amounts set out in the Annexes which prescribe minimum rates for different types of controls (for example fees applicable to slaughter inspection, fees applicable to cutting plants, fees applicable to game processing houses, fees applicable to milk production). The minimum rates set out in the Annexes will be updated at least every two years through the Regulatory Procedure. Until 1 January 2008 Member States will be able to continue to use the rates currently applied under Directive 85/73 for veterinary checks on products of animal origin from Community establishments.

For a transitional period until 1 January 2008, Member States will be able to continue to use the current rates under Directive 85/73 for veterinary checks on products of animal origin from Community establishments. In setting fees Member States are to take into consideration:

• the type of business concerned and relevant risk factors;

• the interest of businesses with a low throughput;

• traditional methods used for production, processing and distribution;

• the needs of businesses located in regions subject to particular geographical constraints.

The Regulation also allows Member States to set the fees for specific official controls at a level below the minimum rates specified in the Annexes to take into account the above four factors or when official controls are carried out with a reduced frequency in view of the own-check and tracing systems implements by the feed or food business and the level of compliance found during official controls. Before setting fees at a lower rate Member States must provide the Commission with a report specifying the type of feed or food or activity concerned, the controls performed by the feed and food business concerned and the method for calculating the reduced fee.

The Commission will review the charging arrangements within three years of the Regulation coming into force with a view to extending mandatory fees into other controls.

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