Council of Ministers close to Novel Foods agreement

Securing regulatory approval for marketing novel foods in Europe should become faster and - in many cases - cheaper and simpler next spring, following a long-awaited revision of the Novel Food Regulation.

The revised text, which proposes a new centralised authorisation procedure plus a fast-track route for foods with a safe history of use outside the EU, had its first reading in the European Parliament at the end of March.

The Council of Ministers is now pursuing a common position before the Parliamentary elections in June, which would mean a second reading in Parliament late in the autumn and adoption the following spring, barring delays.

As Parliament's composition would change post the election, however, it was “quite possible that the new set of MEPs will come up with a whole set of fresh amendments”, which could set the whole process back several months, said Dr Sandy Lawrie, head of the Food Standards Agency’s novel foods branch, which hosted a stakeholder meeting last Friday in London.
Under the proposals, applications to authorise ingredients not commonly consumed in the EU prior to 1997 would go straight to the European Food Safety Authority for assessment before going to the Commission and a final vote at the Standing Committee on the Food Chain and Animal Health.
The revision also proposes data protection for applicants for five years to stop other firms ‘piggy-backing’ on their work without spending their own time and money on research.
The new system has been broadly welcomed by industry associations, which claim the current authorisation procedure is time-consuming, costly and unfair, with approval for applications taking up to five years.
However, it is not without controversy: the Commission has already said it cannot accept 44 of the Parliament’s 80 amendments to its original proposal. Likewise, there are also disagreements over the definition of engineered nanomaterials, which are defined by law for the first time in this piece of legislation, and sharply differing views on whether they should be labelled on pack with the suffix ‘nano’
The definition of ‘traditional foods from third countries’ also needed tightening up, said stakeholders at the FSA meeting. The Parliament proposes: “natural non-engineered novel foods with a history of food use in a third country, meaning that the food has been a part of the normal diet for at least 25 years for a large part of the population of a country”
While the phrase “non-engineered” was probably included to stop some traditional herbal ingredients getting in ‘through the back door’ without rigorous assessment, it was important that the law was not worded in such a way as to imply that only whole fruits, vegetables or plants could qualify, said food law consultant Neville Craddock. “We don’t want to block the import of perfectly safe derivatives of fruits and so on. After all, to imply that the value added processing of these source materials could only be done within Europe would be unfair and a barrier to trade.”
Given that some traditional foods were only consumed in certain regions of a country, the requirement that applicants must show evidence of their consumption within a large part of the population of an entire country was also unfair, he said. “We need to nail these things down.”