ERNA welcomes EFSA dossier guidelines

The European Responsible Nutrition Alliance (ERNA) has welcomed EFSA’s recently published scientific and technical guidance for companies preparing health claims dossiers for authorisation.

The trade association applauded the European Food Safety Authority’s speedy release of the guidelines, which lay down the requirements for dossiers submitted under article 14 (reduction of disease risk claims) of the European Union’s Nutrition and Health Claims Regulation.

The document was published on Wednesday, May 16, and is currently under public consultation with stakeholders for one month. It will also be discussed at a stakeholder platform meeting on June 11 in Parma, Italy.

“We welcome this very much as it will be the guideline for companies to develop submission files for claims in future,” said Patrick Coppens, ERNA Secretary General. “It would also be appropriate for claims relating to children's health and development, but given the lack of clarity on what exactly will fall into this category of claims, no particular aspects are included yet. Although the deadline is sharp, we will study the document in detail and submit our comments. It is, however, very positive that EFSA intends this document to be a living document, so it can be adapted whenever necessary.”

ERNA highlighted however, that the document does not explain the criteria that will be used to assess the value of the scientific evidence and EFSA’s subsequent positive or negative opinion – something it says should be clarified and submitted for public consultation. The fate of claims based on newly developed scientific evidence or containing a request for the protection of proprietary data (other than reduction of disease risk claims and claims relating to children's development and health) are also still not clear.

Commenting on the protection of proprietary data Mr Coppens said: “The guidance document does not apply to such applications, indicating that EFSA and the European Commission continue to stick to their interpretation that no submissions under article 18 procedure can be made until the establishment of the article 13 list in three years time. Our experts believe this is an erroneous interpretation of the law.”

“If this interpretation continues to prevail,” he added, “Companies that had intended to use the procedure face losing return on investment because they will not be able to protect their data for the next three years.”


ERNA is made up of suppliers and manufacturers of dietary supplements and functional ingredients who work mainly on scientific grounds towards ensuring that a wide range of safe, quality products reflecting the latest in supplementation research, will be accessible in the future European market.

For more information contact Patrick Coppens, Secretary General, ERNA,
50 Rue del’Association, 1000 Brussels, tel: (+32) (0) 2 209 11 50.

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