EU policy revisions could let allergens through

Plans to revise the EU’s Novel Food Regulation could allow products which cause unexpected allergic reactions among UK consumers onto supermarket shelves, the Food Standards Agency (FSA) has warned.

At a workshop organised by the FSA’s Advisory Committee on Novel Food and Processes (ACNFP) last week, the FSA expressed concern that revisions currently being considered by the European Council fail to take proper account of potential allergic responses to some novel foods that have a history of safe use in their countries of origin.

The FSA is about to carry out a formal consultation on the revision to the Novel Food Regulation.

In the UK, levels of allergenicity, particularly among children and young adults, are rising to alarmingly high levels. It is feared that some novel foods, including a number currently seeking approval from South American and African countries - for example, ones containing ingredients from Baobab fruit pulp and the Kiwiberry - might cause allergic reactions among European consumers.

If the revision is accepted, it would apply to food that has a history of safe use in its country of origin. To gain approval, it would be necessary to demonstrate that the food had been consumed as part of the normal diet for at least one generation by a large part of the population of that country. Member States and the European Food Safety Authority (EFSA) would then have four months to object to the food where they had concerns.

Speaking at the ACNFP workshop, Dr Sandy Lawrie, from the FSA’s Novel Food Additives and Supplements Division, expressed concerns about the lack of provision for public consultation under the new proposals. “It falls a long way short of openness on novel food approvals,” said Lawrie.

While welcoming a number of changes under the revision, the ACNFP has also raised concerns about the arbitrary nature of the ‘one generation’ rule, which Lawrie described as being “plucked out of the air”.

A main objective of the revision is to accelerate the tortuous current approvals procedure for novel foods, which takes two-and-a-half years to complete on average. “The current system is not a spur for innovation, but a barrier,” said Lawrie. The ACNFP is also worried about the proposed changes to data protection for novel food applications under the revision, said Lawrie.

Under the new proposals, authorisations will no longer be addressed to the applicant, such that anyone could market an approved novel food. An option, however, would provide data protection for proprietary scientific data for a limited five-year period. As a result, other applicants could not make use of these data without permission.

There would be a single risk assessment by the EFSA, which would have six months to provide its opinion. The European Commission would then have nine months to make a proposal for authorisation, and this would be followed by a decision, endorsed by a qualified majority voting, by Member States.

Part of the reason behind the revision to the Novel Food Regulation is to bring it up to date and take account of new regulations, such as the general food law introduced in 2002. It is also intended to clarify the scope of the regulation to include new fields of research such as non-traditional breeding of animals and plants and nanotechnology, while excluding ingredients on other positive lists, such as additives.