July 2010: When EU health claim compliance reaches store shelves

By Shane Starling

- Last updated on GMT

Related tags: European union

The European Commission has set itself the goal of processing the 94 generic article 13.1 health claim opinions issued by EFSA recently by the end of January, meaning claim rulings could be enforceable at retail level by July, 2010.

A European Union official told NutraIngredients.com the member states have six months to apply EC-ratified health claim opinions. Under such timings products bearing claims that appear on the new European Union negative list would have to alter their marketing or be pulled from shelves.

The 94 opinions issued by the European Food Safety Authority relate to 523 dossiers. About 70 per cent of those dossiers were deemed not to have demonstrated a positive link between consumption of a nutrient and proposed health benefits. Weight management, probiotic and botanical claims did particularly poorly.

Food and supplements companies trading in high profile ingredients handed partial negative opinions such as folate (foetal and infant development), omega-3 (some aspects of heart health) and glucosamine and chondroitin (joint health), are in line for formulation and marketing changes if EFSA’s opinions pass through the EC committee level largely intact.

The EC official said it is likely most of the opinions will pass through the process and onto either the negative or positive list with little amendment.

“It is clear from assessing the opinions that have come through from EFSA that there are a handful that will require more negotiation and discussion than others,”​ she said.

“But we envision that most of them will pass through with little change. Most of the evaluations were straightforward.”


The fact EFSA has issued so many negative opinions across the board of generic (article 13.1), proprietary and emerging science (article 13.5) and children’s health and disease reduction claims (article 14) is understandably concerning industry.

It is becoming increasingly apparent that the 2006 nutrition and health claims regulation is going to deliver a highly restrictive health claims regime – perhaps the most restrictive in the world.

Several major companies spoken to by this publication said they were putting worst-case scenario contingency plans into place that could see major rebranding, marketing and formulation initiatives enacted before next year’s July deadline.

Others are taking a more combative approach and consulting legal teams to test how water tight the regulation is and whether there is scope for it to be challenged in a court such as the European Court of Justice (ECJ).

But with the next batch of about 700 article 13.1 claims not due for publication until February, 2010, industry eyes now turn to the EC committees to see how EFSA’s opinions are interpreted for ultimate ratification and application on product shelves.

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