EFSA to publish remaining article 13.1 opinions in three 2011 batches

An EFSA spokesperson confirmed that the April batch would be followed by another at the beginning of June, with the job completed in a third batch to be published at some point after a plenary meeting of its Panel on Dietetic Products, Nutrition and Allergies (NDA) also set for early June.

The publication of each batch will follow these plenary meetings, the first of which occurred on January 26-28. The second is scheduled for March 23-25 and the third June 8-10.

The Federation of Associations of Health Product Manufacturers (EHPM) said a meeting with the NDA revealed only in “exceptional circumstances” ​would any opinions be held over for the scheduled September plenary NDA meeting.

Botanicals​

The NDA said it was awaiting further guidance on how to treat botanical submissions, after the European Commission last year removed them from the process for reconsideration at an as yet unconfirmed future date.

When the announcement was made in September last year to remove botanicals, Basil Mathioudakis, the EC’s Unit Head of Food Law, Nutrition and Labelling said no decision had been taken about how they would end up being treated.

But he said guidance found in other regulations such as the Food Supplements Directive and the Traditional Herbal Medicinal Products Directive would play a part, and that history of use data may gain greater prominence than it has in the botanical opinions the NDA had issued so far.

“There is much that needs to be considered in this area,” ​Mathioudakis said.

At the same time the EC announced that it intended to simultaneously write all article 13.1 opinions into EU law books, and that it hoped to do this by the beginning of 2012.