ARTICLE
10 December 2002

EU Move on GM Moratorium?

UK Intellectual Property
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Pressure builds as US trade war looms

The process for the approval of GM (genetically modified) crops and foods has stalled in Europe for over four years, in the face of implacable opposition from a number of Member States (and consumer/environmental lobby groups). US trade officials are reported as being poised to urge the US to bring proceedings against the EU before the World Trade Organization for blocking imports of GM food1. However, some progress was made this month as Denmark and the Commission pushed EU Ministers to reach a consensus, rather than risk a legal complaint being filed by the US and face possible trade sanctions.

EU Ministers pave the way for thresholds on labelling and adventitious GM presence

A political agreement was reached on the proposal for a regulation governing GM food and feed at the Agriculture and Fisheries Council on 27-28 November2. At that meeting, a consensus was reached upon the thresholds for products containing adventitious or technically unavoidable traces of GMOs (genetically modified organisms) intended for direct use as food or feed. In essence:

  • a product would be allowed on the market, if it contained adventitious traces of less than 0.5% of authorised3 GMOs (or GMOs which had received a favourable scientific assessment (as being risk-free), but which had not yet been authorised in the EU); and
  • a product should be labelled as containing a GMO, if it contained more than 0.9% of material of a GMO, whether destined for human consumption or animal feed. No labelling would be required for the trace presence of a GMO at below this level.

EU Agriculture Ministers endorsed this political agreement on 1 December 2002.

Traceability of GM products

However, the compromise will face a further challenge today (9 December) when EU Environment Ministers debate the same issues and, in particular, the vexed question of the import of food products (and seed) from the US which may contain unauthorised GMOs. EU Ministers are expected to endorse a system for ensuring the traceability of products containing GMOs, which includes:

  • establishing a "unique identifier" code for each GMO to allow the retrieval of information concerning its traits, characteristics and transformation processes;
  • procedures to identify the operators in the supply chain for the products;
  • transmission by operators of information concerning the identity of a specific product;
  • retention of information by operators for a period of five years; and
  • co-ordinated approaches to inspections and controls.

The proposal, if adopted, would also extend labelling provisions to pre-packaged products consisting of or containing GMOs, obliging operators to use wording such as "this product contains GMOs" on labels or in connection with the display of the product. Suppliers would be obliged to provide operators with information, so far as food and feed are to be produced or derived from such GMOs.

Further measures

Both of these political agreements will face further scrutiny by the European Parliament next year before ratification.

The question of setting the appropriate thresholds for the adventitious presence of GMOs in batches of seed remains to be agreed under a separate proposal4. However, in the light of the debate between the Commission and the EU Scientific Committee on Plants on the appropriate levels, there is a need for consistency with these measures.5

Comment

Consumer groups will welcome these political developments as promoting the freedom of choice. However, industry may be more sceptical as there is still no real insight into whether the moratorium upon approvals/commercialisation of GMOs will be lifted in the short term, despite pressure from the Commission upon Member States to do so. The US will be monitoring developments carefully as world trade talks continue on a number of trade issues with the EU. It remains to be seen whether this represents a significant step towards resolving the current deadlock.

1 The US may bring proceedings before the WTO Dispute Settlement Body claiming that the EU's position is discriminatory to the US by imposing a trade barrier, contrary to promoting free trade and competition. If the Dispute Settlement Body's panel found in favour of the US, then the US would be given the option of imposing limited trade sanctions to try to force compliance by the EU.

2 The regulation aims at establishing a framework for the traceability of products consisting of or containing GMOs, and food and feed derived from GMOs, with the objective of facilitating accurate labelling, monitoring of the effects on the environment and, where appropriate, on human health. The regulation aims also at facilitating the implementation of appropriate risk management measures including, if necessary, withdrawal of products from the market.

3 Within the EU, the regime for approval of GMOs is regulated by Directive 2001/18/EC (which came into force on 17 October 2002, replacing Directive 90/220/EEC). For a GMO to be authorised to be commercialised, it must have a full Part C marketing consent. Products including GMOs destined for food or animal feed use must also be approved the novel foods regime (Regulation (EC) 258/97).

4 In October 2000, interim measures were adopted by the EU Standing Committee for Agriculture in October 2000 (and endorsed by the UK Government) setting the permissible level of adventitious presence of GM content in conventional seed at 0.5% for any GM event authorised in compliance with Directive 2001/18/EC.

5 Following fierce lobbying by those Member States opposed to commercialisation of GM crops, the Commission proposed revised thresholds (in the absence of warning labels) of: 0.3% in seed batches of cross-pollinating crops and 0.5% in self-pollinating or vegetatively-propagated crops for authorised GM crops and 0% for non-authorised GMOs. However, the EU Scientific Committee on Plants found the Commission's proposal unworkable. The Committee recognised that a zero level of unauthorised GM seed is unobtainable in practice, since seed production is a natural process, taking place in the field, not the laboratory. Moreover, increases in GM crop production would make the proposed thresholds ever more difficult to achieve. The Committee also found it illogical to outlaw inadvertent contamination by crops awaiting approval or being field evaluated. The Committee recognised that a major constraint on defining levels of tolerance was the limit of analytical sensitivity. It found that the analytical method adopted must be capable of routine use, with appropriate sampling procedures and confidence limits. There remains no level playing field for testing or monitoring for the presence of adventitious GM material, prescribed by any form of EU-approved protocol. It is hoped that this gap will be filled to promote certainty for industry.

© Herbert Smith 2002

The content of this article does not constitute legal advice and should not be relied on as such. Specific advice should be sought about your specific circumstances.

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