‘Argue for your deviation!’ EFSA tells industry

“If you deviate from the defined approach, just argue,”​ urged Dr Josef Schlatter, a member of EFSA’s novel food working group, while discussing data requirements on absorption, distribution, metabolism and excretion.

This was a sentiment repeated several times by EFSA at its stakeholder meeting on its draft guidance for applications under the updated regulation.

One attendee of the meeting, Dr Luca Bucchini, managing director of Rome-based Hylobates Consulting, called this advice a “​double-edged sword”.​

“We'd like the process to be predictable, and reasonable. Dossiers should be complete, so there's little discretion for EFSA either way. When you have deviations, you put yourself in the hands of the working group,” ​he told us after the event.

“However, I realise that without some flexibility few applications would ever be approved, because the requirements are so demanding. So on balance I think it should be welcomed.”​

Regulatory pathways

Meanwhile another attendee, ​Intertek scientific and regulatory consultant Nigel Baldwin, told us issues may arise now the applications must filter first through EFSA’s Applications HelpDesk.

“They are not the scientific secretariat, they work with checklists so wherever there is deviation from the guidance they will pick it up first and it may cause administrative delays if you are inexperienced in arguing your case.”​

For traditional foods, EFSA’s guidance says qualitative and quantitative compositional testing should be provided on at least five representative batches of the product that have been independently produced. 

This should include the main constituents, characterising components, anti-nutritional factors, toxic, addictive, psychotropic or other substances, impurities or by-products, residues and contaminants, as well as stability testing. ​

One member of the audience asked why the guidance did not focus more on portion sizes that would actually be consumed as opposed to batches, citing the example of infant formula which would be watered down.

Schlatter said given the huge range of foods and ingredients the regulation could apply to, flexibility was needed. 

“It depends on the food. The problem we had was to make this fit all foods and supplements.”​

Henk van Loveren, and chair of EFSA’s novel foods working group and panel on Dietetic Products, Nutrition and Allergies (NDA) vice-chair, added: “This is not set in stone – if there is a concern, we do need to talk about it.” ​

The draft guidance is now open to public feedback, with final publication set for June or September depending on the number of comments received. 

Deadline 21 April! #EFSA seeks your input on draft guidance docs for #NovelFood and traditional food!  https://t.co/mkVf5tEK6t

— EFSA (@EFSA_EU) April 12, 2016

'we are here to listen to you'​

van Loveren said the panel was open to amendments to the draft.

“You may be here to listen to us but we are here to listen to you,”​ said van Loveren, who is also professor of immunotoxicology at Maastricht University in the Netherlands.

“We did our best but the panel members are people too and there may have been some oversights. We are discussing what is a draft.”​

EFSA will also be holding a webinar on novel foods at the end of the year. 

One member of the audience suggested the European Commission should hold similar stakeholder meetings when setting regulation.

Indeed van Loveren said about 75% of the questions asked at the meeting on Monday (11 April) concerned the regulation itself, not EFSA’s guidance.