Regulatory experts seek optimism in latest stage of health claims law
substantiation behind the health claims they are using to guarantee
their survival under a new European regulation, reports
Dominique Patton.
Work on new health claims and new products should also take into account the high standards of substantiation likely to be required by the new law, said Simon Pettman, executive director of the European Advisory Services at a seminar on health claims last week.
"Forget about investment if your product does not meet the highest standards of proof, including its profile and an estimation of intake data. We know how EFSA works," he told those attending the seminar on the last day of the Vitafoods exhibition.
Under the regulation, proposed by the European Commission in 2003, Europe will have a general list of health claims in addition to claims pre-authorised by the European Food Safety Authority (EFSA) including disease risk reduction claims.
However a number of articles of the proposed law have proved highly controversial with industry, which was invited to voice its concerns at the Geneva meeting last week.
Pettman pointed out some areas of progress, notably the decision by parliamentary committees drafting an opinion on the regulation to delete article four, which would require all foods carrying a claim to be subject to nutritional profiling.
They have also amended article 11, which banned slimming claims and endorsement by charities, so that these claims are allowed if they are submitted to EFSA for prior approval.
"There is confidence that most of those restrictions will disappear," Pettman told NutraIngredients.com.
"You wouldn't have expected parliament to be quite so outspoken on these issues. They seemed to understand the balance between substantiation and consumer access to information."
But while parliament's plenary vote on 25 May could well endorse some of the amendments, the council of Europe position is now so far away from the parliamentary view that compromise will have to play a major role.
"We can expect consumer groups to be actively lobbying now, they can't be happy with the committees' amendments," explained Pettman. Indeed it is thought that several MEPs from all parties are currently working on compromise amendments to article four to be submitted to the plenary vote.
"The council will not agree to completely remove nutritional profiling but there are some possible compromises, such as including reference intake values for sugars and fats on product labelling, as already done by some companies in the UK on a voluntary basis," said Pettman.
But while there appears to be progress in sight on the most controversial articles of the proposed law, industry concerns have now moved to article 12, or the issue of pre-authorisation, and the role that EFSA will play in the use of claims across Europe.
Member states are already working on lists of general health claims, which will be submitted to EFSA for an opinion before they are compiled in one EU-wide list.
However several could fail to meet the definition of general claims, as those "based on generally accepted scientific data and well understood by the average consumer".
Parliamentary committees have proposed that this clause be amended to read 'scientific knowledge' but the interpretation of this clause remains vague.
"The fear is that we will lose lots of claims with insufficient science. Anything that goes through EFSA these days is tough," Pettman warned.
He urged companies to issue compile data on the general claims they are using and then work with government and trade bodies to get these onto the lists being drawn up by member states.
Fiona Angus from Leatherhead Food noted that industry groups could work together on claims, as done by noni fruit producers for their recent novel foods application, or the omega-3 producers who have recently had approval for a claim from the UK's voluntary claims body, the JHCI.
Parliament has also proposed replacing the EFSA authorization procedure with notification when a new product reaches the market but this is unlikely to be supported by the council.
Pettman warned that although there is a degree of hope for something more reasonable, industry must be prepared for greater scrutiny of their marketing practices.
"For new health claims, when conducting research be very careful to look at all potential restrictions such as nutrient profiling," he cautioned.
The plenary vote takes place on the 25 May. After the first reading, no new amendments can be tabled although those in place can be amended prior to the second reading, expected in the latter half of this year.
