EU health claims legislation could see health claims drop by around 80%

EU health claims legislation could see health claims drop by around 80%

A great majority of health claims have - to date - failed to make the grade under EU regulations governing the communication of the various health benefits offered by foods. This has prompted many in the industry to suggest that the new requirements are too stringent, while others have raised concerns that the inability to market products that have health benefits will deter manufacturers from investing in health and wellness NPD. Katy Humphries reports.

Under European legislation first introduced in 2006, in the next year or so, food manufacturers will be required to have obtained approval from European regulators before linking consumption of their products to the betterment of health within the EU.

To this end, the European Food Safety Authority has been examining the scientific basis of existing health claims made by food manufacturers in communications to consumers. This lengthy process began in earnest at the beginning of 2008 and EFSA said earlier this month that it has now completed its detailed assessment of 80% of all claims submitted to it for consideration.

The food watchdog was upbeat on the progress it has made in examining the "huge body" of evidence brought before it - some 44,000 claims in total - and its ability to complete its assessment of the remaining claims by the extended deadline of this June (two years on from when it was originally scheduled to have completed the assessments).

However, it also emerged that the vast majority - 80% - of claims considered by the agency failed to meet EFSA's requirements and were subsequently rejected. Additionally, positive opinions were mainly assigned to health claims relating to vitamins and minerals. With these claims stripped out, the failure rate rises to a startling 95%.

A spokesperson for EFSA tells just-food that the primary reasons for the high failure rate were a "lack of evidence" in support of claims, that the claims themselves were "too general - lacking in precision" and that "information gaps" in the documentation supplied made it "impossible" for the agency to reach a favourable decision.

"Many of the claims submitted were not backed up with a sufficient body of supporting evidence," the spokesperson says.

However, the high rejection levels have prompted many in the industry to suggest that it is EFSA's assessment criteria and process that has been found wanting rather than the health claims themselves.

A spokesperson for the European Federation of Associations of Health Product Manufacturers (EHPM), insists that the claims assessment process should be revisited.

"The whole assessment process needs a total rethink," the spokesperson suggests. "This fourth batch of opinions saw the high failure rate continuing not because 80% of claims currently made are false, but because 80% of claims made have failed to meet the criteria defined by the EFSA."

According to EHPM, a significant proportion of claims failed due to "discrepancies in the way information was compiled" and the way the EFSA is carrying out its assessment, meaning that they were rejected without proper consideration of the evidence. Claims were also rejected due to the agency's reliance on randomised control tests that "look at an isolated food component rather than the whole food", EHPM claims. The trade body also suggests that EFSA's interpretation of nutrition and health claims regulations are "unduly restrictive" - making it impossible to assess a number of health effects.

In the wake of the latest batch of health claim decisions, EHPM, along with European Botanical Forum (EBF) and the European Responsible Nutrition Alliance (ERNA), issued an open letter calling for wholesale changes to the way that health claims are assessed.

In the letter, the industry representatives said the European Commission should not block claims already rejected by EFSA until they could be resubmitted under different criteria.

EFSA, they said, should consider the "totality" of the evidence and base judgements on scientific consensus instead of the current requirement for "significant scientific agreement". They suggested that the agency should reconsider claims rejected due to the characterisation of a substance or because the claim was not specific enough, as well as reconsidering the treatment of claims "contains antioxidants" or "contains probiotics".

Under the current regime, if a health claim is rejected, food makers will have six months to phase out its in commercial communications, such as advertising or labelling.

However, if the claim was rejected on the basis of insufficient evidence it would qualify for follow-up reassessment. Food makers have three months to submit so-called "clarification claims" to member states, who screen them during a two-month period. Member states then refer such claims back to the Commission, who in turn refers the claim back to the EFSA for reassessment. Food makers can continue to legally market the claim during the lengthy reassessment process.

If a health claim is rejected it is also possible for food makers to apply to use it under the criteria for nutrition claims, which do not make the final "benefits" link, says Owen Warnock, a partner at law firm Eversheds.

While it will control any unethical use of health claims, Warnock says that the regulations will undoubtedly result in a reduction in health and nutrition claims made by the food industry. And cutting the number of health claims permissible in Europe by around 80% will clearly have a significant impact on the health and wellness sector.

According to Warnock, this means that the focus of NPD and innovation will probably shift away from areas where health claims have already been rejected, while consumer demand may "drop-off because health benefits can no longer be communicated".

However, he adds, the sector is likely to see an increase in reformulation to meet the EU's health claims criteria while future new product development will likely revolve around disease reduction claims that have been legalised.

The resilient nature of the food industry means that manufacturers will continue to invest in innovation. What remains to be seen is whether the increasing difficulty of making health claims in Europe will deter investment in health and wellness products.

While savvy food companies will likely seek alternative means of communicating the health benefits of various ingredients to consumers, it is also possible that a reduction in marketing will result in a reduction in demand for healthy products in the EU. An unintentional - but certainly possible - side effect of Brussels' move to tighten the regulations governing the health and wellness sector.