EU health claims loophole can benefit the rejected

By Shane Starling

- Last updated on GMT

EU health claims loophole can benefit the rejected

Related tags European union European food safety authority

Rejected health claims may remain usable for extended periods after confirmation from the European Commission that rejected article 13.5 claims can gain an extended life if there exists a duplicate article 13.1 general function claim.

The European Food Safety Authority (EFSA) has two batches of article 13.1 opinions left to publish this year, at which point the 3000 or so opinions from the full six batches will be processed by the European Commission and member states before entering the official European Union register at some point in 2012.

Unless there is a highly unlikely wholesale revision of EFSA’s opinions by the EC and member states, six months after the register is updated about 80% of those claims will be banned across the European Union.

But that timeframe is offering an extension of life for some article 13.5 claims already condemned to the rejected section of the register.

One such company is Hong Kong-based Gencor Pacific which saw five article 13.5 weight management rejections enter EU law books at the start of this month for its Slimaluma product whose ingredients are sourced from ethanol-water extract of the aerial parts of Caralluma fimbriata.

Because three similar article 13.1 claims are awaiting adjudication, products containing the ingredient can continue with their claim-making until the article 13.1 list is finalised and writ into law (and as long as they have approval in the relevant markets).

“[This procedure] could take months,”​ Gencor managing director RV Venkatesh. And once it undergoes that process, there is still a six months time period during which claims can still be made. So we believe that till then claims can be made legally on Slimaluma.”

Isn’t it a botanical anyway?

Timeframes aside, Venkatesh questioned the validity of the rejection given the substance is a botanical and the European Commission had in September 2010 decided to remove botanicals from the EU nutrition and health claims regulation (NHCR) process – long before its own rejection was formalised.

“So at the time the EC announced that botanicals would be temporarily kept outside the purview of the claims legislation, both our 13.1 and 13.5 claims were not yet acted or decided upon,”​Venkatesh said.

“So, as on that date Slimaluma's legal claims position was undecided and should have also been kept under abeyance until the EC decides how to handle botanicals as a whole.”

But EFSA spokesperson Lucia DeLuca said the EC decision to “put botanicals on ice”​ botanicals related only to the article 13.1 list, not article 13.5, and that the remaining two batches would contain no botanicals.

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