2008 round-up: European regulation
Our coverage of the first European Food Safety Authority (EFSA) health claim opinions was the most popular. EFSA kicked off the eagerly awaited health claim assessment process in late August with a slew of claim rejections that shocked some.
“This will come as a shock to industry and a blow to companies that have had their applications rejected. The potential economic damage is vast,” said regulatory expert, Patrick Coppens. “These opinions make it clear it is not going to be easy for companies to have claims approved.”
Of eight assessed claims, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected seven for failing to demonstrate causality between consumption of specific nutrients or foods and intended health benefits. EFSA has subsequently issued opinions on about 30 claims with seven drawing positive opinions.
To read the story click here.
Readers liked a story from the UK in June where the National Health Service (NHS) there published guidelines advising doctors not to recommend omega-3 food supplements and plant stanol and sterol functional foods to patients at high risk of cardiovascular disease (CVD).
Industry took the potentially damaging news well, noting the guidance related to primary prevention for those at high risk of cardiovascular disease, not the secondary role usually assigned to food supplements and functional foods.
To read the story click here.
Next up was a story about the Food Supplements Directive (FSD) where EFSA in disgust threw out 120 dossiers supposedly in support of nutrients seeking addition to the FSD’s positive list.
If EFSA was bewildered by the lack of data in the dossiers, it needn’t have been as industry freely admitted it had in many cases submitted such hollow documents to temporarily keep nutrients on-market. Sounds more complicated than it is.
To read the story click here.
Another health claims story took fourth spot. This time it was EFSA issuing a negative opinion to American DHA (docosahexaenoic acid) giant, Martek Biosciences Corporation for an infant brain and eye development claim.
This verdict demonstrated just how uncompromising EFSA was going to be in its much of the data was “not representative of the target population”.
Martek took the rejection gracefully and is in the process of resubmitting the claim.
To read the story click here.
Rounding out this top five was the hard-to-come-by Novel Foods approval granted to UK-based Croda Health Care for a vegetable oil-sourced, omega-3 ingredient.
Such approvals, which can take many years to achieve have undeniable economic benefits and Croda said “major European companies” were interested in the vegetarian potential of the ingredient to deliver heart, brain and other health benefits.
To read the full story click here.
