The EC has confirmed it will not publish further guidance on the degree of permitted flexibility in health claim wording before enforcement of the regulations starts, probably in around eight months’ time.
This means individual European enforcement authorities – such as the UK’s Trading Standards and the Advertising Standards Authority, which regulates advertisements that are printed or broadcast – could take different approaches when it comes time to regulate the 222 claims already approved by the European Food Safety Authority (EFSA), said Owen Warnock, partner at law firm, Eversheds.
Lack of guidance
The lack of guidance means labels or advertising campaigns accepted in the UK may not meet the requirements of regulators elsewhere in Europe when firms export, said Warnock.
“The UK has the most comprehensive guidance in Europe, but that is only one country’s attempt to make sense of the regulations,” he said. “It doesn’t necessarily carry weight anywhere else.” The Irish government refers to the UK’s guidance but that is no guarantee the rest of Europe will, he added.
Further guidance would be invaluable for all European enforcement authorities and manufacturers, said a spokeswoman for the European Federation of Associations of Health Product Manufacturers (EHPM). However, a timeframe for further guidance has not been discussed by the EC Working Group on nutrition and health claims, said Warnock.
Flexibility in wording
Manufacturers were allowed a certain degree of flexibility in wording because directly translating claims could be confusing or misleading when exporting to another country, said Warnock. “If the claim is developed into one language, it may not mean the same thing when translated into another.”
Flexibility was also permitted to aid consumer understanding of health claims. For example, one potential claim says: 'Manganese contributes to the protection of cells from oxidative stress’. “Even informed consumers will not understand what is meant by that,” said Warnock. With the flexibility ruling, manufacturers could potentially amend the wording for better understanding – for example, replacing ‘oxidative stress’ with a more broadly understood term for the reduction of dangerous free radicals in cells of the body.
Firms may also be able to add a further explanation to the claim, he added. “It is essential that wordings can be adapted to consumer language,” said the EHPM spokeswoman.
However, since approving flexibility in claims late last year, the EC has left it to Member States to decide what further flexibility will be allowed. This will likely only be decided through case law, Warnock said.
Although it plans to eventually address flexibility, the EC has concentrated on producing guidance around the general use of health claims – for example, if manufacturers need to include consumption guidelines for products, said Warnock.
The final approved list of health claims will probably be published in May, after passing a European Parliament vote in March. Once published, a six-month transition period begins to allow manufacturers time to comply.