Strategic advice on nutritional products

The novel food debacle: good intentions turned sour

16 March 2011

** EAS comment piece by Xavier Lavigne, EAS Food Law Manager

The European Parliament and the Council of the European Union (Council) are at loggerheads over the revision of the EU’s novel food regulation. With two failed consensus meetings this year and a "last-chance" conciliation meeting scheduled for 28 March, hopes of approval are rapidly fading.

Should the two institutions fail to agree the revision next week, the draft, which has been worked on for more than two years, will go back to the European Commission’s drawing board. It may decide to draft a new proposal, or defer discussions and develop specific frameworks on the issues of contest in order to ease future discussions by deleting problematic issues.

Quite an unexpected failure considering that the regulation is not new, but a revision of an existing one, and something originally considered by the Commission to be a routine exercise.

So what has caused this impasse? The main point of disagreement between the European Parliament and the Council is the issue of cloning: the European Parliament would like a total ban on foods from clones and their offspring/descendants from the EU market.

The European Commission and some members of the Council however, do not accept this as they consider offspring to be bred using normal (or traditional) methods, therefore not falling under the definition of novel food. The European Commission has tried to be conciliatory by suggesting having a specific report on cloning and promising a specific legislation on the topic, but with the European Parliament pushing for a ban this solution has been turned down.

If the final conciliation meeting next week ends in no agreement, chances are that the European Commission will defer discussions on novel food on the basis that the dossier is not ready for approval, and develop cloning and nanotechnologies frameworks for future discussions on the regulation’s revision. In that case, those discussions would potentially be delayed for a few years.

This result would be a disappointment for regulators and industry alike: revision of the regulation was put on the table in 2008 because many essential elements and issues needed to be discussed and resolved, such as the definition of a “significant degree” of consumption and all the legal borderline issues that exist for certain products, such as extracts or concentrates.

Certainly, the industry had hoped that the revision would accelerate the authorisation procedure, thereby providing a good incentive for research and innovation.  Approval can currently take up to three years, hardly an acceptable figure for a region struggling to demonstrate its innovative potential.

If the conciliation attempt does finally fail, the impact on the sector will be significant since many issues will remain unclear for the foreseeable future, not to mention the general impact a non-agreement will have on the European Commission's credibility and within world trade.

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