European Union: Commission Issues Guidance on the Implementation of Regulation 178/2002 on General Food Law - Including Guidance on Traceability

On the 20 January 2005 guidelines were issued to facilitate the implementation of some of the major requirements set out in Regulation 178/2002 laying down general principles and requirements of food law and establishing the European Food Safety Authority ("Regulation 178/2002"). The guidelines were agreed by the Standing Committee on the Food Chain and Animal Health, which is made up of representatives from Member States. The guidance is an attempt to encourage harmonised implementation across Member States of Regulation 178/2002, which entered into force on 1 January 2005. In particular the guidance document deals with the following aspects of Regulation 178/2002:

• traceability of food and feed products
• withdrawal of dangerous food and feed products from the market
• operators' responsibilities, and
• operators' responsibilities, and
• requirements applicable to imports and exports.

Strictly, the guidance has no formal legal status. It is the responsibility of the Court of Justice to interpret EU legislation. However, the Commission hopes the guidelines address some of the practical issues that have been raised by food and feed business operators relating to the new obligations set down by Regulation 178/2002, and will help both business and national authorities in understanding the new requirements.

The guidance follows on from the conclusions of the EU level working group that consisted of experts from the Member States.

Article 18 of Regulation 178/2002 lays down a general requirement of traceability that came into force throughout the EU in respect of food (including drink) and feeding stuffs on 1 January 2005. In particular, Article 18 requires:

• food and feed businesses must be able to identify any person from whom they have been supplied with a food/feed and/or food producing animals (or any other substances)
• food and feed businesses must be able to identify to whom their products have been supplied
• food and feed businesses are required to have systems in place to make this information available to the authorities on demand.

In other words, food and feed businesses must know where they have obtained their ingredients from and where they supplied their food products to. The guidance states that this "one step back" and "one step forward" approach implies for food business operators that:

The guidance clarifies that Article 18 of Regulation 178/2002 applies to food business operators at all stages of the food chain from primary production (food producing animals, harvest), food/feed processing to distribution.

Despite internal traceability not being a legal requirement, the guidance states that Article 18 has the underlying logic that a certain level of internal traceability will be put in place by food business operators. This is because Article 18 has to be read in conjunction with recital 28 which refers to "comprehensive system of traceability within food and feed businesses so that targeted and accurate withdrawals can be undertaken …, thereby avoiding the potential for unnecessary disruption in the event of food safety problems". An internal traceability system will benefit the operator by contributing to more targeted and accurate withdrawals. Therefore the guidance suggests that food business operators should be encouraged to develop systems of internal traceability. The decision on the level of detail of an internal traceability system should be left to the business operator and should be commensurate with the nature and size of the food or feed business.

Article 18 does not specify what type of traceability information should be kept by the food and feed business operators. However, the guidance defines two categories of information according to the level of priorities. The first category of information includes any information which must be made available to competent authorities in all cases:

• name, address of supplier, nature of products which were supplied from him
• name, address of customer, nature of products which were delivered to that customer
• date of transaction/delivery.

The second category of information includes additional information which is highly recommended to be kept:

• volume or quantity
• batch number, if any
• more detailed description of the product (prepacked or bulk product variety of fruit or vegetable, raw or processed product).

In respect of the time of reaction for traceability data to be made available to the authorities, the guidance notes that Article 18 requires food and feed operators to have in place systems and procedures to ensure traceability of their products. The guidance states that the minimal information, which belongs to the first category defined above, shall be immediately available to competent authorities and information belonging to the second category shall be available as soon as reasonably practicable, within deadlines appropriate to circumstances.

Article 18 does not foresee any minimum period of time for record keeping. However, the guidance suggests that commercial documents are usually registered for a period of five years for taxation controls and therefore this five year period if applied to data of manufacturing or delivery would be likely to meet the objective of Article 18. However, this common rule would need to be adapted in some cases:

• for products without a specified shelf life, the general rule of five years applies
• for products with a shelf life above five years, records should be kept for the period of shelf life plus six months
• for highly perishable products, which have a use-by date of less than three months or without a specified date (such as fruit and vegetables) destined directly to the final consumer, records should be kept for the period of six months after the date of manufacturing or delivery.

Article 19 imposes obligations from 1 January 2005 on food business operators to withdraw from the market food that does not meet the food safety requirements and to notify this to competent authorities. Where the product may have reached the consumer the operator shall inform the consumer and, if necessary, recall from consumers products already supplied to them. The guidance sets common criteria triggering the withdrawal or recall of dangerous food from the market. Situations where operators are required to inform competent authorities of this withdrawal are specified. There are two separate obligations under Article 19(1) and 19(3).

Obligation to withdraw from the market under Article 19(1) applies when two cumulative criteria are met:

• the food in question is considered by the operator as not being in compliance with the food safety requirements, and
• a food is on the market and has left the immediate control of the food business.

Some practical guidance is given on what is considered to be safe and unsafe food as described in Article 14.

When a food business operator withdraws a food in accordance with Article 19(1), it has to notify this withdrawal to the competent authority which supervises the establishment. It is then up to the national authority to trigger the Rapid Alert System for Food and Feed (RASFF).

When a food business operator takes out of the food chain a food that does not meet the food safety requirements but that is in its immediate control, there is no obligation to notify a competent authority under Article 19(1).

Where a food may have reached the consumer, food business operators must:

• inform the consumer of the reason for withdrawal, and inform the consumer of the reason for withdrawal, and
• if necessary, recall from consumers products already supplied to them.

Article 19(3) is triggered if:

• the food in question is placed on the market, and
• the food may be injurious to health.

In this case food operators must immediately inform the competent authorities and detail the action to prevent the risk. Withdrawal is not automatic.

The objectives of this Article are the same as those of Article 19. However, some of the wording used in Article 20 are specific to the feed sector and therefore some guidance has been given on their meaning. In particular in the context of feed, it is important to take into account some type of feed in its raw state, prior to processing, that is not fit for animal consumption.

According to the guidance, there are two cumulative criteria for Article 20(1) to require withdrawal similar to those in Article 19(1). The withdrawal of a feed from the market implies that the feed is on the market. However, the further condition "which has left the immediate control" is not included in Article 20(1). This will mean that feed operators will have to withdraw and notify unsafe feed that is placed on the market but might be still in their immediate control. In practice this will concern the holding of feed for the purpose of sale. The holding for sale takes place once all internal processes making a product ready for sale are applied and therefore, according to the guidance, actions including taking a product out of the food chain undertaken before the product is ready for sale are not meant to be withdrawals within the meaning of Article 20.

The second cumulative criteria is that the feed is considered by the operator as not meeting the feed safety requirements. This is similar to the criteria used under Article 19(1). In particular, the feed safety requirements will have to be taken into consideration. Since Article 15 on feed safety provides that feed shall be deemed to be unsafe for its intended use if it either has adverse effect on human or animal health or can make the food derived from the food producing animals unsafe for human consumption, the requirements of Article 14 in relation to the determination of an unsafe food also have to be taken into account to implement Article 15.

The requirements under Article 20(3) are similar to those in Article 19(3).

Article 17 imposes on food business operators an obligation according to which they must actively participate in implementing food law requirements. Though Article 17 is directly applicable from 1 January 2005, the determination of liability of food businesses will remain for national legislation.

The guidance notes that the traceability provisions of the Regulation do not have extra-territorial effect outside the EU. Therefore, the requirements cover all stages of production, processing and distribution in the EU, namely from the importer up to the retail level. In other words, exporters in trading partner countries are not generally required to fulfil the traceability requirement imposed within the EU, except in certain circumstances (for example, in the veterinary sector).

Under Article 12 food or feed intended for export or re export, should comply with the relevant EU requirements, unless otherwise required by the authorities, legislation or administrative procedures of the importing countries. In other words, when no requirements are set by the authorities of the importing countries, the food and feed intended for export or re export must comply with relevant requirements of EU food and feed law.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.