April 30, 2010
In the conclusion of our report on the European health-claims process, we present what companies need to know about the developing European health-claims situation. We dig into the most recent developments and examine issues surrounding resubmission of failed claims. Mark J. Tallon, PhD
On February 25, the European Food Safety Authority (EFSA) published an additional 416 health-claim opinions that were submitted under Article 13.1 (claims based on 'generally accepted science'). This makes a total of 939 assessed claims of which about 80 per cent have been rejected. The rationale for most of the rejections rests on three criteria: poor characterisation of the active ingredient, a lack of scientific evidence for the claimed health relationship and a submission that does not match the scope of this route of assessment.
The biggest shock to the industry was the rejection of all 170 antioxidant claims and 65 rejections on claims related to the health benefits of probiotics and yeast. Imagine every fruit-based food or beverage you know on the wellness market having now to remove its use of the term 'antioxidant'. This is the likely fallout if EFSA continues with the same hard line it has shown in the first two batches of health claim analysis.
Possible enforcement actions
The EFSA opinions are merely scientific evaluations for the commission to adopt or reject, and until and unless they are adopted into law, they are not legally binding. But EFSA's rejection of health claims is already showing effects in the marketplace. In February, the UK's Advertising Standards Authority (ASA), which implements a self-regulatory code, sent a warning letter to Healthspan, a Guernsey-based company, concerning claims made by the manufacturer connecting St John's wort to an effect on 'mood.' ASA ruled that such claims should not appear in their current form because 'the claims had not been authorised by the European Commission.'
Extension of transition periods?
EFSA has missed the January 31 deadline for the adoption of the more than 4,000 health claims that made up the community list. In addition, EFSA has also failed to specify a nutrient profiling system used to determine those foods that are healthy enough to bear an approved health claim. These delays mean it may be some time before we see significant EU-wide enforcement of all conditions described within the Nutritonal and Health Claims Regulation (NHCR). Even those products that have been rejected have a six-month grace period after the EFSA opinions become law. Taken together, these procedural delays mean February 2011 is the earliest date enforcement could legally take place on 13.1 claims.
However, one component of the regulation that could already be enforceable are nutrition claims, which include terms such as low fat, low sugar, isotonic, hypertonic, superfruit, and source-type claims (for example, 'excellent source of DHA'). These types of claims are covered in the annex of the regulation and are included after a member state submits them to EFSA's review panel. In the case of the UK, those nutrition claims previously covered under national provisions were passed onto EFSA. Many of these are now part of the annex and so could carry the force of law.
According to the UK-based advisory agency LACORS (the local government central body responsible for overseeing regional regulation), any nutrition claim that was not in the annex by January 19 is technically no longer permitted for use in the food and beverage market. But some claims that are pending most likely will be included when the annex is updated. Therefore, LACORS is asking UK enforcement agencies to adopt a flexible and pragmatic approach to assessment, meaning enforcement actions concerning nutrition claims are unlikely in the UK in the short term.
Similarly, in the case of 13.1 claims, EFSA's practice of releasing opinions in batches could inconvenience companies that market formulations with multiple ingredients. Consider, for example, the hypothetical case of a formulation including 12 ingredients. If EFSA gave a positive opinion on one ingredient in the first batch of opinions while the others are pending, when this is adopted into law the claims for the remaining 11 ingredients may have to be removed from the label and only added back in as each associated claim becomes law. This creates significant logistical and practical difficulties for the industry.
Based on such problems, LACORS advocates that products bearing any rejected health claim should be allowed to continue to be sold during the product's shelf life. But should a large majority of product/ingredient claims ultimately be rejected, companies carrying such claims would need to discontinue their use and come to phasing-out agreements with regional enforcement agencies. The take home from these messages, at least from a UK viewpoint, suggests non-compliant products will be legally in breach sometime starting after August 2011.
The NCHR can be enforced through food labelling and advertising laws. But the most likely enforcement route will be via statutory instruments (SI) specific to each member state. In the UK the NHCR is enforced via SI 2007 No 2080 (Nutrition & Health Claims for England), which lays out the following penalties:
A prison term not exceeding two years or a fine or both;
On summary conviction, a term of imprisonment not exceeding three months or a fine not exceeding the statutory maximum (£20,000) or both.
Other enforcement action for non-compliant claims would include the forced removal of all products carrying rejected claims and strictures against the ability to operate a business and/or marketing food products. Making sure products are in compliance well in advance of enforcement is key to a legal market presence.
Which route: article 13.4 or 13.5?
One major problem with the process of health claims assessed under the term generally accepted science (13.1 claims) is that little guidance was provided by EFSA at the time of submission resulting in flawed dossiers and an 80 per cent failure rate. So where does industry go?
At present there seem to be only two options for altering the significant number of health-claim rejections/failures, with both options offering the ability to set out a more robust dossier to support each health-claim submission. Article 13.4 of the NHCR allows 'changes' to the community list while article 13.5 governs 'additions' to the list. The 13.5 route is already well known and in use, and offers a well-defined application process to support any claim. However, unlike article 13.5, no detailed implementation procedures are currently available for an article 13.4 submission, although there is reason to believe it will be similar to the application process under 13.5 (described in Article 18).
It's likely that using the Article 13.5 submission route could provide a significant time savings. Any 'addition' as set out in 13.5 could presumably be set in motion as soon as the list is completed. On the other hand, 'changes' as set out in Article 13.4 could well have to wait until all current 13.1 opinions are ratified, a process that could tack on an additional six-to-10 months for companies that use the 13.4 route.
Because of the ambiguity surrounding the use of the 13.4 route to resubmit failed 13.1 health claims, I suspect most companies will simply add additional data to those failed applications and resubmit them based on 'new science' using the 13.5 route.
Editor's note: This article neither represents nor implies legal advice in any form.
Mark J Tallon, PhD, is founder of NutriSciences Ltd, a consultancy firm specialising in health-claim substantiation, product development and technical writing. www.NutriSciences.com
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