Time running out to prevent EU health-claim bans

Many health claims could be banned if companies don't act swiftly to meet tight deadlines established in the European Union health and nutrition regulation due to be enacted this month. European and international companies will have only a year to make health-claims submissions under the regulation. After this one-year window, the European Food Safety Authority (EFSA) is commissioned to assess dossiers and publish a central registry of permitted health claims within the EU's 27 member states by January 1, 2010.

Those that don't make the central list cut-off date will have to go through a separate authorisation process that has been criticised for not being transparent enough. Many believe it will be both time-consuming and costly.

UK Health Food Manufacturers Association director, David Adams, said many UK businesses were largely ignorant of the regulation's implications, including the fact all foods and supplements manufacturers making claims for their products — be they labels or advertising (including websites) — "should know that the claims will have to obtain prior approval or be banned."

Adams said: "The most straightforward and least costly way of obtaining approval for health claims is via inclusion on a generic, or community, list, and this requires the national authority to compile and submit a national list for EU evaluation and decision."

In regard to the central registry, in some jurisdictions such as the UK, the submission timeframe is even tighter.

The UK Food Standards Agency, which receives the dossiers before forwarding them to the EFSA, has said it aims to have all submissions shipped to the EFSA by the end of September this year — a mere nine months away.

The EFSA said: "To be eligible for consideration, claims must be based on generally accepted science and relate to the role of a nutrient or other substance in growth, development and functions of the body, psychological and behavioural functions, or slimming and weight control."

Widespread concern
More than 200 European companies and associations expressed their concerns at an EFSA conference on the regulation at its Bologna headquarters in late November.

The European food and drink industry confederation, the CIAA, noted widely held concerns about the implications of nutrient-profiling guidelines that will restrict what can be said about foods that might broach thresholds in certain ingredients such as fat, sugar and salt.

"The problem with profiling is that it looks at foods in isolation," said Andreas Kadi, EU scientific and regulatory affairs director at Coca-Cola and chairman of the taskforce for new claims regulations, CIAA.

"You might have a problem with olive oil because it is 100 per cent fat but there are positive health elements of using olive oil. You have to see the whole picture. People don't drink olive oil by the glass. It has to be seen in context."

Kadi questioned how nutrition claims (ie, low in fat) would work in conjunction with health claims (ie, calcium helps build strong bones).

"A product could say it contains vitamins but at the same time it has a high fat content. What we are very concerned about is that such a nutrient profile really has a scientific basis because a lot of the discussion around profiling as the legislation was being proposed was highly political."

A flood of submissions?
How the EFSA will deal with the submissions from 27 member states when they come flooding in later this year has not been clarified.

How EFSA will deal with submissions from 27 member states when they come flooding in later this year isn't clear
But with a member state such as Finland revealing it has already received more than 600 product submissions, it is clearly going to be a busy time for the EFSA.

Liberals have been heartened by statements about the criteria the EFSA is likely to follow in assessing dossiers made in Bologna by a European Commission spokesperson.

Robert Vanhoorde, the head of the EC's science and stakeholder relations unit, said too-strict policing of scientific evidence could be detrimental to research and development efforts.

"If we only allowed claims that are based on strict evidence, we would not have allowed claims for the benefits of folate products in protecting the neural tubes of unborn babies 10 years ago," he told the conference. "It was not so proven then."

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