EC moves to block health claim withdrawals

By Shane Starling

- Last updated on GMT

Related tags Health claim European union

EC moves to block health claim withdrawals
The European Commission and European Union member states are moving to halt the flood of nutrition and health claim withdrawals in a bid to preserve what it is calling “transparency in the regulation”.

With the likes of Nestle, Unilever and Valio and most recently, Danone, pulling claims from the process as it became apparent only the strongest of dossiers would meet the European Food Safety Authority’s scientific criteria, the Commission is moving to stop the exodus.

“We are looking to restrict possibilities for companies to withdraw claims from the process,”​ EC administrator, Lars Korsholm, told this morning.

It is believed some high profile claims have been withdrawn from the process after draft negative opinions were issued by EFSA. Some of these claims are being modified by companies so that claim wording better reflects the available science or by gathering additional data, but others are unlikely to re-enter the process.


But Korsholm said the 2006 nutrition and health claim regulation stipulated in article 20 that rejected claims along with the reason for their rejection should appear in the Community Register of health claims as well as those that are authorised.

To this end, the EC and member states will suggest at a June 22 meeting that the regulation be amended to ensure claims remain in the system post-submission. Such an amendment can be performed in article 15.4 of the regulation, Korsholm said.

“It is all about transparency in the regulation and proper use of public resources,”​ Korsholm said. “We want to avoid a situation where claims are being withdrawn after EFSA delivers opinions. This procedure needs to be subject to public scrutiny.”

He said any amendment would not be applied retrospectively, so those claims that had been withdrawn from the process would not be forced to resubmit.

The process so far

Since publishing its first opinions in August, 2008, EFSA has adjudicated on about 60 health claim dossiers, with about 80 per cent of them drawing negative verdicts.

All of the assessed dossiers so far have related to emerging or proprietary science claims (article 13.5) or children’s and disease reduction claims (article 14).

A batch of 1024 generic article 13.1 claims is due for publication by the end of July but the EC’s head of Food Law, Nutrition and Labelling, Basil Mathioudakis, has admitted the January, 2010 deadline to complete the assessment of all 4000+ claims is not going to met.

EFSA June 15 stakeholder’s meeting

In response to increased industry nervousness and uncertainty about the process, EFSA has invited about 120 select members of industry to Brussels on June 15 for a meeting on various aspects of the process and to assist industry understand what the scientific assessor expects in health claim verification.

It issued a Q&A on the matter last month which can be found here.

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