UK: Food Standards Agency Issues New Draft Guidance Notes On The General Food Law Regulation (EC) 178/2002

Last Updated: 19 January 2007
Article by Richard Welfare and Amy Holt

The UK Food Standards Agency ("FSA") has issued new draft Guidance Notes on Articles 14-16 and 18-20 of EC Regulation 178/2002 (the "Regulation") in response to a public consultation exercise on the EC Guidance which was held between July and October 2005.

The current FSA Guidance on the Regulation, issued on 10 March 2005, incorporates the EC Guidance issued by the European Commission on 20 January 2005.

The consultation revealed a concern in the food industry that the costs of complying with some of the recommendations of the EC Guidance were disproportionate. The FSA has requested responses by 26 January 2007 as to whether the focus in the draft FSA Guidance on requirements of the legislation rather than recommended best practice is preferable and will eliminate such costs.

The draft UK Guidance may be amended to reflect these responses once received and reviewed. Neither of the Guidance documents are legally binding and interpretation of the Regulation is ultimately a matter for the court. Due to the wide and vague manner in which the Regulation is drafted, however, in the FSA’s view it is important that guidance is in place, which will assist businesses in complying with legislation in a proportionate manner.


The Regulation lays down the general principles and requirements for food law, establishes the European Food Safety Authority and lays down procedures in matters of food safety. The overriding aim of the Regulation is to protect human health and consumers’ interests in relation to food. As feed for animals intended for human consumption can affect food safety, the Regulation also covers feed.

Articles 14 to 20 of the Regulation cover, respectively, food and feed safety requirements; presentation; general responsibilities of operators; traceability; and the need to notify, withdraw and/or recall products not conforming within the food and feed safety requirements.

The Regulation reveals that a precautionary approach has been adopted by the Community to ensure health protection. A major element of the precautionary approach is the idea of traceability. This area received the strongest response in the course of the consultation and is consequently where the major differences lie in the draft FSA Guidance compared with the EC Guidance.


As part of the precautionary approach, the Regulation provides that protection of the internal market necessitates being able to trace food and feed. The Regulation notes that a system of traceability within food and feed businesses is necessary so that "targeted and accurate withdrawals can be undertaken or information given to consumers or control officials, thereby avoiding the potential for unnecessary wider disruption in the event of food safety problems".1

Who and what does Article 18 apply to?

Article 18, which covers traceability, provides that food and feed business operators are to:

  • identify their suppliers of food, feed, food-producing animals and any substance for incorporation into food or feed
  • identify the businesses to which their products have been supplied and
  • supply this information to the competent authorities on demand.

‘Food business’ is defined widely as "any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food".

‘Food business operator’ and ‘Feed business operator’ are defined as the natural or legal persons responsible for ensuring that the requirements of food law are met within the food/feed business under their control. This covers a vast range of people/businesses including primary producers, manufacturers, wholesalers, retailers, transporters, distributors, those dealing in the purchase of sale and bulk commodities and caterers. Even if the supplier is not within the EU, businesses importing from third countries must also comply with traceability requirements, although it is not necessary for exporting third countries to comply. A food or feed business operator would also include businesses that trade in food or feed despite not physically handling or receiving the product themselves.

The definition of ‘food’ is similarly wide although the following are excluded:

  • live animals unless they are prepared for placing on the market for human consumption
  • plants prior to harvesting
  • medicinal products2
  • cosmetics3
  • tobacco and tobacco products4 and
  • narcotic or physhotropic substances5.


The EC Guidance not only contains guidance on compliance with the legislation, but also recommends systems which should be put in place for best practice. The distinction between the two is not always clear, however, and may be confusing for businesses only wishing to comply with the Regulation rather than implement recommended practices.

Types of information to be kept

In relation to types of information to be kept, Article 18 (taken at face value) requires food and feed business operators to provide the names of businesses who supply them and to whom they supply their products – a one step back, one step forward approach. Article 18 does not, however, specify what type of information should be kept by the food and feed business operators. Businesses will therefore be looking to guidance on how to comply with the Regulation and it is therefore important that guidance on this issue is consistent.

EC law should be interpreted in line with its purpose, and taking into account the notification requirements under Articles 19 and 20 (detailed below), traceability records should also include the address of the customer or supplier, the nature and quantity of the products sold/purchased and the date of the transaction and delivery. Both the EC Guidance and the draft FSA Guidance advise this information should be retained for supply to the competent authorities if requested. Practically, it is envisaged that retaining this type of information is already standard practice in businesses.

However, even though Article 18 merely requires that this information should be supplied "on demand", the EC Guidance specifies that this information should be available "immediately" to the competent authorities. In response to the consultation, the new FSA Guidance provides that this information should only be produced "within a short timescale" to allow more flexibility to businesses.

Further, the EC Guidance "highly recommends" that further information be retained, including volume or quantity, batch number, and a detailed description of the product. It advises that this information should be made available to the authorities "as soon as reasonably practicable". The new draft FSA Guidance comments that this additional information is only recommended from a best practice perspective and is not necessary for compliance. It should therefore be clearer to businesses what is required for compliance and any subsequent impact on costs.

Internal traceability?

Similarly, despite internal traceability (matching up of all inputs to outputs) not being a legal requirement of the Regulation, the EC Guidance encourages businesses to develop systems of internal traceability advising that such development would assist operators by contributing to more targeted and accurate product withdrawals. The new draft FSA Guidance stresses, however, that Article 18 does not require internal traceability and there is no obligation on businesses to develop such systems.


In its draft Guidance, the FSA has interpreted the legislation to afford a greater discretion to businesses in the information to be retained for traceability purposes. The FSA Guidance indicates that it is the information itself which is important, not the format in which it is kept. However, if the competent authority demands this information, from a practical point of view the information can only be dispatched quickly if there is some form of system in place and some sort of order to the records. Businesses should be prepared to supply such information in the event that it is requested from the competent authority quickly and should not take undue comfort from the discretion highlighted in the new FSA Guidance.

A similar point can be illustrated by how long traceability records should be kept. While the Regulation does not provide any guidance on this, the EC Guidance recommends records are kept for a five year period. The new draft FSA Guidance advises that it is for businesses to decide how long they should keep their records (bearing in mind the nature of the food or feed, its product life and the circumstances under which such records might be required). The draft FSA Guidance, however, advises that failure to produce such documentation constitutes an offence. Again, although businesses have more discretion under the draft FSA Guidance, businesses should be aware of the requirement to provide information and therefore a need to retain such records.


Although there are no material differences between the draft FSA Guidelines and the EC Guidelines, a summary of the notification requirements for food and feed and the differences between them follows. Articles 19 and 20 impose an obligation on food and feed businesses to recall and/or withdraw food and feed if they do not comply with the safety requirements of Articles 14 and 15 respectively.


Article 14 provides that food shall not be placed on the market if it is "unsafe" which it defines as being either injurious to health6 or unfit for human consumption7.

Article 19 paragraph 1 provides that where a food business operator considers or has reason to believe (the applicable test to be an objective one) that a food which it has imported, produced, processed, manufactured or distributed:

  • is not in compliance with the food safety requirements; and
  • has left the immediate control of the initial business food operator,

the competent authorities should be notified and immediate procedures should be initiated to withdraw84 the food from the market. Even if there is some uncertainty as to whether or not the food is in breach of the food safety requirements, the obligation under Article 19 still operates.

Where products have reached the consumer, there is an obligation on food businesses to inform consumers effectively and accurately of the reason for the withdrawal of the product (detailing why the product is unsafe) and to initiate a recall9 of products already supplied. This obligation also applies to food business operators responsible only for retail or distribution activities10.

If food which does not meet the food safety requirements has not left the immediate control of the food business operator, removal of the food from the food chain does not constitute a withdrawal meaning that there is no obligation to notify the competent authority. However, obligations may still arise under Article 19(3).

Under Article 19(3), if a food placed on the market is potentially injurious to human health, the competent authorities should be notified immediately11 advising them of action taken to minimise the risk to the final consumer. Note that this obligation only applies to food which is potentially injurious to health, not food which, although unfit for human consumption, is not potentially injurious to health.


Article 15 imposes a prohibition on feed being placed on the market if it is considered to be ‘unsafe’ which the Article defines as feed which is considered to:

  • have an adverse effect on human or animal health; or
  • make the food derived from food-producing animals unsafe for human consumption.

If a feed business operator considers or has reason to believe that a feed which it has imported, produced, processed, manufactured or distributed does not comply with feed safety requirements, it should immediately initiate proceedings to withdraw the feed in question12 and immediately inform the competent authorities13.

There is no requirement, as Article 19 provides in relation to food, that the feed must have left the immediate control of the initial feed business in order for the obligation to withdraw the feed from the market and notify the competent authorities to apply. The other major difference between obligations on food business operators and feed business operators is that the feed shall be destroyed if it does not satisfy the feed safety requirement (in Article 15) unless the competent authority advises otherwise. The feed business operator must also inform the competent authorities of the action to be taken to prevent the risk arising from use of the feed. This obligation extends to food business operators responsible only for retail or distribution activities.14

The operator is obliged to inform users of the feed for the reason for its withdrawal and, if necessary, recall from them products already supplied in the absence of other measures which would achieve a high level of health protection.


The new FSA Guidance seeks to make the distinction between what is best practice and what is legally required clearer so that businesses are able to ensure they are complying with the legislation whilst having more discretion to implement best practice systems. However both the FSA and the EC Guidance stress that they are not legally binding and that the interpretation of the Regulation is ultimately for the courts. Currently, because more proportionate guidance is being proposed, what is required for compliance is uncertain. In view of the serious sanctions in the UK (fines and imprisonment for both the company in breach and responsible officers/ directors of the company) for non-compliance under the General Food Regulations 2004, together with the precautionary approach adopted by the Community, business operators in the UK would be wise to err on the side of caution and follow the EC Guidance until the draft proposed FSA guidance has been accepted and formally approved.


1 Recital 28.

2 Within the meaning of Council Directives 65/65/EEC and 92/73/EEC.

3 Within the meaning of Council Directive 76/768/EEC.

4 Within the meaning of Council Directive 89/622/EEC.

5 Within the meaning of United Nations Single Convention on Narcotic rugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971.

6 Article 14(4) sets out criteria to be considered when determining if food is "injurious to health":

  • the effects on health are to be viewed long term, specifically the effect on subsequent generations
  • probable cumulative toxic effect and
  • the particular sensitivities of a specific category of consumers where food is intended for that category of consumers.

7 Article 14(5) provides that in deciding whether a food is "unfit for human consumption" regard will be had as to whether the food is unacceptable for human consumption according to its intended use for reasons of contamination, by extraneous matter or otherwise, or through putrefaction, deterioration or decay.

8 The Guidance defines ‘withdrawal’ as "the process by which a food is removed from the market up to and including the retail stage which includes action by food producers, packers distributors, wholesalers and retailers, as appropriate".

9 The Guidance defines ‘recall’ as "the process by which consumers are advised, for example, by means of public notices and other publicity, to return food supplied to them".

10 Paragraph 2 of Article 19.

11 Paragraph 3 of Article 19.

12 Paragraph 1 of Article 20.

13 Paragraph 3 of Article 20.

14 Paragraph 2 of Article 20.

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.

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