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EU Traceability Regulations Overview

FDA Traceability Regulations Overview

FDA Traceability Regulations Overview


EU traceability regulations overview

The new EU Food Law – Regulation (EC) No. 178/2002

A regulation which lays down the general principles and requirements of food law, establishes the European Food Safety Authority and lays down procedures in matters of food safety.

The background reasons for this legislation are the recent food scares where products were found to be unsafe and which involved not only the withdrawal of product from the supply chain including the retail point but also the communication of accurate information to consumers in a timely manner.

This new Food Law which takes effect from 1st January 2005, just over 18 months from now places considerable responsibilities on Food and Feed Business Operators (the natural or legal persons responsible for ensuring that the requirements of food law are met within the food/feed business under their control). Food business means 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. The Regulation states that Food Law shall aim at the protection of the interests of consumers and shall provide a basis for consumers to make informed choices in relation to the foods they consume. It shall aim at the prevention of:

  • fraudulent or deceptive practices;
  • the adulteration of food; and
  • any other practices which may mislead the consumer

It applies both to food/feed imported into the Community as well as exported from the Community. Article 14 covering Food safety requirements states that:

  • Food shall not be placed on the market if it is unsafe.
  • Food shall be deemed to be unsafe if it is considered to be:

          a) injurious to health;
          b) unfit for human consumption.
In the case of feed, it shall be deemed to be unsafe for its intended use if is considered to:

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

Where any food/feed which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe.

Article 17 on responsibilities, states that food and feed business operators at all stages of production, processing and distribution within the businesses under their control, shall ensure that food or feeds satisfy the requirements of food law, which are relevant to their activities and shall verify that such requirements are met.

Article 18 states that:

  • The traceability of food, feed, food-producing animals and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution.
  • Food and feed business operators shall be able to identify any person from whom they have been supplied with a food or feed, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a food or feed.

To this end, such operators shall have in place systems and procedures which allow for this information to be made to the competent authorities on demand.

  • Food and feed shall have in place systems and procedures to identify the other businesses to which they their products have been supplied. This information to be made to the competent authorities on demand.
  • Food or feed which is placed on the market or is likely to be placed on the market in the Community shall be adequately labelled or identified to facilitate its traceability, through relevant documentation or information in accordance with the relevant requirements of more specific provisions.

Articles 19 and 20 deal with the responsibilities of food and feed business operators respectively and state that, if an operator considers, or has reason to believe, that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market. Where it has left their immediate control they must inform the competent authority. Where it may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal and if necessary recall products already supplied to them.

Other definitions of note are:

Feed (or feed stuffs) means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals.

Feed business means any undertaking whether for profit or not and whether public or private, carrying out any operation of production, manufacture, processing, storage, transport or distribution of feed including any producer producing, processing or storing feed for feeding to animals on his own holding.

Retail means the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer and includes distribution terminals, catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets.

Placing on the market means the holding of food or feed for the purpose of sake, including offering for sale or any other form of transfer, whether free of charge or not and the sale, distribution and other forms of transfer themselves.

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