Health food chiefs query EFSA's claims assessment process

Industry leaders raised concerns over the final Article 13 health claims list published by the European Food Safety Authority in January.

The list consists of more than 4,000 health claims submitted to EFSA by European Union member states for assessment under the European Nutrition & Health Claims Regulation.

But trade bodies question EFSA's handling of a list of claims compiled jointly by four trade bodies — the European Federation of Associations of Health Product Manufacturers; The European Responsible Nutrition Alliance; the Confederation of the Food and Drink Industries in the EU and the European Botanical Forum.

EHPM and ERNA said aspects of the joint industry list compiled by the four trade bodies were modified on the final list "without clear explanation" or had been omitted altogether.

"We are pleased that the list has finally been published so that everybody at last can have a clear view on what EFSA will assess, after almost one year of guessing," said Gert Krabichler, chairman of ERNA. "However, our assessment shows that many entries from our industry list have been modified, some are missing and EFSA comments are included quite inconsistently.

"In a way it is inevitable that given the number of claims in the list, inconsistencies and errors creep in, but we hope there will be an opportunity to clarify and rectify."

Fears were also raised by EHPM and ERNA about EFSA's methods for assessing claims on the Article 13 list.

They expressed concern that EFSA intended to follow an identical process of assessment for article 13 claims, which are based on generally accepted scientific evidence, as for assessing individual dossiers submitted under article 14 claims, which are disease risk reduction and children's claims. This, they insist, was not the original intention of the law.

EHPM said the intention of regulation when it had been initially been discussed and adopted was for claims that had been accepted on national level based on generally accepted scientific evidence — Article 13.1 claims — to undergo a quicker assessment process than the full authorisation procedure for Article 14 claims, and be allowed to continue to be used.

"We believe that the task of EFSA as originally intended by the regulation should be to check and confirm that the evidence supporting Article 13.1 claims is considered as generally accepted, by taking into account and weighing all of the existing evidence," said Lorene Courrege, EHPM's director of regulatory affairs.

"However, EFSA would have great difficulties in applying the same assessment process as that used for Article 14 claims, as the regulation has not requested member states to provide the same detailed information, since the claims were deemed to be supported by long established and non-controversial science. We believe the insistence of EFSA to apply the same process of assessment simply does not make sense and could potentially decimate the final article 13.1 list. We hope to clarify this in further talks with EFSA."

Patrick Coppens, secretary-general of ERNA, said: "This may result in many claims being rejected, not because they are not true but because they will not meet criteria that EFSA has defined. The EFSA scientists are looking for proof from intervention trials to show cause-effect relationship with measurable effects. This is, and should be, possible for submissions under the authorisation procedure, but is not necessarily appropriate for many claims submitted in the Article 13 list."

Article 13 covered health claims that described or referred to the role of a nutrient or other substance in growth, development and the functions of the body, Coppens said.

He added: "Many of the nutrients and substances that we eat have a certain function, and their intake is intended to contribute to the maintenance of that function, not necessarily to a measurable improvement of it. If EFSA does not appreciate this in its opinions, the list will be decimated."

EFSA will now begin its assessment of the list, after which the European Commission and EU member states will make the final decision on the article 13.1 claims that will be allowed for use in the final Community List.

* Cantox Health Sciences International is staging a seminar to explore the health claims process. European Health Claim Submissions: Mistakes Made and Lessons Learned takes place on 24 March in Geneva, Switzerland. Visit for more information.

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