European Food and Feed Safety Regulations.



This section looks at two important new pieces of EU regulation;

  • Regulation (EC) No.1829/2003 on genetically modified food and feed.
  • Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.

Since 1998 there has been a de-facto moratorium on the commercialisation of GM crops in the EU. Initially, this moratorium was to last until the revised Deliberate Release Directive (now 2001/18/EC, previously 90/220/EEC) had come into force on 17th October 2002. However, the revised Directive failed to deal fully with the issue of labelling and traceability and several Member States insisted that this be addressed prior to any commercialisation.

In addition, the European Food Safety Authority (EFSA) was set up in 2002 and it was agreed that a more transparent procedure for the authorisation GM food and feed was required. This gave rise to the development of the what have become known as the 'food and feed' and the 'traceability and labelling' regulations.

How the regulations work

GM Food and Feed

EU regulations and decision making processes can be long and complicated, especially if there is not agreement amongst all parties. The following is, therefore, a simplified overview of how these regulations work.

Applications to commercialise GMOs, and GMO derived products that are to be used as either human food or animal feed in the European Union, must apply for an authorisation via the GM food and feed regulation (EC No. 1829/2003).

This new regulation provides a procedure whereby, if a GMO is to be used for food and/or feed use, the applicant can submit one application under the regulation that will cover both the environmental requirements of the Deliberate Release Directive (2001/18/EC) and the food safety regulations.

The application must contain information about the safety of the GMO and/or its derived products from an environmental, human and animal health perspective. The applicant (e.g. the biotechnology company) must submit the application to one of the 15 EU Member States, who then pass it on to the EFSA. At that stage the EFSA must make a summary of the application available to the public.

Within 6 months the EFSA must produce an opinion on the application. This will be arrived at by consulting with its own committees and with all the EU Member States. They may also ask the applicant for further information. Once the EFSA has determined its opinion it must pass it to the EU Commission and make it available to the public. At this point the public will have 30 days to make comments on the application to the EU Commission.

Within 3 months of receiving the EFSA's opinion, the Commission must make its decision. The application is then either officially accepted or rejected. If accepted it will be placed on to a public register. As well as considering the EFSA's view the Commission can consider any relevant provisions of EU Law and "other legitimate factors" - Article 7 regulation (EC) 1829/2003.

Traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.

The rational for the traceability and labelling regulation

  • to facilitate the removal GM line from the supply chain should new evidence of harm come to light.
  • and to provide consumer choice

The traceability and labelling provisions of these regulations cover, all whole, live genetically modified organisms, such as plants (including viable seeds), animals, fish and micro-organisms. The traceability system will work by using unique identifiers.

'Unique identifiers' are a series of letters and numbers that are unique to each GM line. The system was developed by the OECD (Organisation for Economic Development and Co-operation), but is being adopted by the Biosafety Protocol (see section 5). These unique identifiers will give each GM line an internationally recognised code that will help prevent confusion.

As each line of a GMO is bought and sold it will be accompanied by paper work explaining exactly what it is. If, at any point, there is a mixing of two or more GM lines, the paper work will need to contain information on all the GM lines the mixture contains.

Once a GMO has been processed and become a 'product derived from a GMO' it will require a paper based audit chain stating that it is from a GM source.

This industry wide process will make identification, segregation and labelling of GMOs and GM derived products much simpler. This will result in a more transparent regime and allow clearer information to be passed on to the consumer. The regulations should also enable any GMO to be removed from the food chain quickly should new evidence of harm come to light.

Key features.

  • A major improvement in these regulations is the extension of labelling. Previously only products which contained genetically modified DNA or protein that could be tested and which were over the level of 1% had to be labelled. This meant that products such as vegetable oil - which may contain GM soya, maize or oilseed rape oil - did not have to be labelled.
  • Under the new rules, products which contain testable DNA or protein, and all products that have been derived from a GMO at a level above 0.9% (unavoidable contamination - see below) will have to labelled. This extension will allow people to make real choices about eating GM food and allow those choices to be based on health, environmental, ethical or social grounds.
  • The extension of labelling also now covers animal feed, however it does not cover products from animals fed a GM diet (see below).
  • As described above, GM labelling will be necessary for those ingredients containing above 0.9% contamination with a GMO or GMO derived product. However, this 0.9% level will only be allowed for 'adventitious and technical unavoidable' contamination. Companies will be require to show appropriate steps were taken to avoid the contamination.
  • The new rules mean that GM products will now be tracked throughout the food chain. This will make it easier for the public to choose or avoid them and, if there are problems, make it easier for the authorities to remove specific products.
  • Another major change is around food safety assessments. In the past companies have been able to argue that a product is substantially equivalent to its conventional counter part and that the product does not need to go through a full safety assessment process. This argument has often been used, for example, when companies have wanted to import products which contain oils from maize or soya from the USA. Because of the lack of segregation, the maize or soya is likely to have been genetically modified. Companies have used the idea of substantial equivalence to argue that the oil from the GM crops is exactly the same as from non-GM crops.

The new regulations, whilst still allowing the concept of substantial equivalence, will not allow this to be a reason to by-pass a full safety assessment.

  • The new regulations will give the pubic opportunity to assess the applications and to make comments on them. In the past this was not possible for food safety assessments.
  • Under current regulations, there is no specific requirement to assess animal feed safety. The new rules change this. In the USA products licensed for animal feed only, have found their way into the human food chain. Due to these cases the new EU laws will only give authorisation for joint human food and animal feed use.

Areas where improvements could still be made:

Whilst GM food labelling has been extended to cover animal feed it will not cover the products produced from animals fed a GM diet (e.g. meat, milk, eggs). Currently the majority of the GM crops being imported into the EU are being used for animal feed only (due to consumer rejection of GM products on supermarket shelves). In addition, the crop nearest commercialisation in the UK is a forage maize that will most likely be grown by farmers and fed to their own dairy cattle. The lack of labelling of will mean consumers cannot avoid those animal products produced from animals fed a GM diet.

The new regulations stipulate that products only have to be labelled as GM once the level reaches 0.9%. This is a small improvement on the old level of 1% however it does not go far enough. These levels have led to discussions about how much contamination will be allowed in seeds sold to farmers, with levels ranging from 0.3%-0.7 % being discussed, depending on the species. There is however much concern that these levels will be too difficult to measure accurately and to control and therefore environmental and consumer groups have argued for the level to be set at the limit of detection; currently about 0.1%. This is the level at which supermarket have been working to ensure they remain within the legal limit of 1%.

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