The health and nutrition claims regulation entered into force in January. Although much of the detail still needs to be hammered out, some claims, such as those relating to children, will not be permitted as of July 1 pending approval at EU level.
Owen Warnock, partner and food law expert at Eversheds, says that the new legislation will have a significant effect on food manufacturers across the board, particularly since health and wellness is strong current running through the industry. Since the time frame for compliance is tight and some aspects of the law lack clarity, there is no time for companies to waste in getting their house in order.
In particular, Warnock says it could be a dangerous strategy for businesses to rely on submissions made by others if claims are already approved. The danger is that such claims could inapplicable across a broader category. Rather, Eversheds advises firms to compile their own detailed scientific evidence and submit their own claims for approval.
"Compiling the evidence to support specific health and nutrition claims may take some time and therefore food businesses need to act early. For categories of claim where there are no transitional arrangements, for example relating to children's health or for claims about preventing disease, this issue is particularly important," he said.
At the beginning of March the UK's Food Standards Agency issued a consultation paper on implementation of the regulation, which underscores the possible serious implications of non-compliance. It proposes that making false or unsubstantiated claims be a criminal offence.
Stakeholders have until May 24 to submit comments on the FSA's consultation paper.
Also up for comment is the draft guidance published by the European Food Standards Authority (EFSA) on how to make submissions.
Although this draft guidance is incomplete and EFSA advises companies not to make submissions until complete guidance is available in the summer.
However the initial document will be instrumental for companies wanting to take an early initiative towards having their claims approved. It covers a series of questions that companies may have, including eligibility of health claims for evaluation, organisation and format of submissions, making multiple submissions, timings and timescales, and how to communication with EFSA (the European Food Standards Agency) or its scientific panel on dietetic products, nutrition and allergies.
Warnock said that the draft guidance is revealing as it gives in insight into health claims the authority expects to cause the most disruption and uncertainty - and outlines areas where there is hope that further information on the practicalities of approvals will be forthcoming.
"Any manufacturer considering submitting a health claim for approval should read the draft guidance since it contains some useful suggestions about what kind of scientific evidence EFSA is likely to demand."
The new legislation is intended to create a level playing field for claims made on foods throughout the EU, while at the same time ensuring that consumers are not mislead.
Since science is increasingly recognised as a foundation for health and functional foods, a number of companies have express their approval that the legislation is to take effect. One outcome is that it will separate those companies with strong evidence to support their products from those making nebulous or unsubstantiated claims.
However some industry groups fear that it could be detrimental to the interests of small and medium enterprises, many of which are at the driving edge of innovation, since they do not have the resources to compile expensive dossiers.
Moreover, EFSA is currently considering whether it will charge fees to companies for the review of dossiers required under several pieces of EU legislation in order bridge the gap that has occurs as its growing responsibilities have outpace budget.