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Companies need a workable time frame in which to comply with the European Commission's Article 13.1 health claims regulation.
The European Union’s Nutrition and Health Claims Regulation has been intensely scrutinized, and nearly every step of the implementation process has faced controversy. Much of the focus has centered on disagreements between industry members and regulators over Article 13.1 health claims (claims based on generally accepted scientific evidence). EU member states have ranged in opinion on whether the scientific methodology used to assess submitted claims has been appropriate-and if not appropriate, whether a number of rejected health claims should in fact merit inclusion in the final Union Register of approved claims.
Now, all eyes are on the EU as the European Commission (EC) moves forward with a draft list of permitted Article 13.1 health claims. The EC submitted this draft list on January 27, 2012. Already, members of the European Parliament have begun objecting to the proposal.
If the European Parliament does not exercise its right to block the draft list of approved claims by April 27, 2012, the list will be deemed approved and will be published in the Official Journal of the European Union in May 2012. Should this happen, EU law will enforce the approved list within six months-thereby giving the food and nutritional sector until only November of this year to make the required changes to their products to ensure that none of their products carry health claims that are not on the approved list.
It should be noted that the health claims that the draft list does recognize as approved do not appear to be in dispute. Some members of the European Parliament have said that they do not question that those health claims in the permitted list are scientifically substantiated.
But controversy still surrounds the health claims that have been omitted from the approved list; namely, the high number of Article 13.1 health claims that have been rejected-many say, because of an inappropriate and disproportionate evaluation procedure. Some of the arguments include that in evaluating many now-rejected claims, EFSA did not consider the totality of evidence, or that it required pharmaceutical-standard substantiation and did not take into account the fact that nutrients are foods rather than drugs. For example, the health claim for dietary fiber received a negative opinion, despite the health benefits for fiber that are widely accepted and part of dietary guidelines in numerous Member States.
In addition to the rejected claims themselves, so many other details are still in flux-for instance, how flexible the regulation should be regarding claims wording, the definition of children’s claims, and what conditions apply to nutrition content claims. In fact, the latest European Commission Working Group meeting served to highlight the many interpretation issues that are still under discussion and without agreement.
With all this uncertainty, the short transition period to phase out claims is one bone of contention between industry and regulators related to the implementation of the regulation.
For one thing, while so much legal uncertainty and need for clarity still surrounds the issue of rejected claims, is now the right time to ask companies to invest in the permanent and significant costs required to carry out label changes and product reformulations within six months?
The costs for companies to make changes would be significant. Given the high number of claims (95%) that have been given a negative opinion and are due to be rejected, a high number of claims would need to be removed. Also, given the long shelf life of food supplements (often up to three years), the short length of time for transition would result in significant costs for small and medium-sized businesses. Companies still have a lot of good products on the shelf that they would have to now disregard if those products don’t meet the regulation. Companies would have to change those labels, produce new packaging on short notice, and find a way to sell through their existing stock.
The message from industry is that a proportionate and workable transition period is needed-of around 24 months rather than the mere six months allocated for transition in the regulation.
Article 28.1 of the original Nutrition and Health Claims Regulation foresaw a 24-month transition period for companies to comply with other aspects of the regulation. A transition period of 24 months was also judged acceptable for the application of a yet-to-be-developed and still-on-hold nutrient profiles system intended to determine whether foods are eligible or not to bear claims on the basis of their nutrient content.
It is on this basis that industry has argued that a similar transition period of 24 months should be acceptable for Article 13.1 health claims. Certainly, a 24-month timeframe is more workable for the sector than a six-month timeframe.
By Jennifer Grebow, Editor-in-Chief
Nutritional Outlook spoke to Cédric Bourges, CEO of scientific and regulatory consultancy Nutraveris (Ploufragan, France; and Morristown, NJ), about how companies can proceed as the EU moves forward on a permitted list of health claims. Most importantly, how can companies now market their products without health claims that can no longer be used?
What should companies do if they can no longer use a health claim because it is not on the approved list?
First, they should keep in mind that the definition of a health claim is “any message or representation…, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that…a relationship exists between a food category, a food or one of its constituents and health.”
This means that it is not sufficient if you only remove the claims wording, such as “This product has been shown to reduce body weight,” from your marketing-while still keeping a brand name or a logo that suggests the product is a slimming product. Rather, any reference to the claim must be removed from all forms of marketing communication.
Going forward, what health-claims options do companies have for marketing their products in the EU?
Several solutions can be considered by companies who want to convey the health benefits of their ingredient. Also, keep in mind that this community list of approved claims is not intended to be set in stone. Rather, it will evolve with the market and the science, and new claims for new ingredients will, of course, be included in the future.
The first option is to submit new health claims applications by putting together strong science, carrying out new studies if necessary, and building top-notch dossiers to have them approved. This is the only route for companies who are only willing to use high-value Article 13.5 claims to differentiate their product from competitors’.
The second option is that companies can communicate marketing through already-approved generic health claims. We call them “generic” because anyone can use them, as long as they follow the conditions stated in the EFSA opinions. For vitamins and minerals, which represent most of the positive opinions, this usually means ensuring that a product is at least a source of the concerned vitamin/mineral (i.e., 100 g, or 100 ml, of the finished product provides an amount of the vitamin/mineral that represents at least 15% of Recommended Daily Allowance).
For other nutrients, more-specific conditions may be outlined, but those conditions are always clearly described by EFSA in opinions. For instance, the requirement for claiming that glucomannan contributes to weight loss is that “In order to obtain the claimed effect, at least 3 g of glucomannan should be consumed daily in three doses of at least 1 g each, together with 1 to 2 glasses of water before meals, in the context of an energy-restricted diet.”
About 200 of these generic health claims are expected to be included in the Community List, all based on generally accepted science and related to non-specific foodstuffs or ingredients (mostly vitamins, minerals, and fibers). Approved claims cover a wide range of health benefits, such as contribution to normal cognitive function (attributed to iodine, iron, zinc, and water); contribution to normal function of the immune system (vitamins A, B6, B9, B12, C, D, zinc, copper, iron, and selenium); or improvement of intestinal transit/bowel function (fibers from various origins). Claims about weight loss, or maintenance of weight after weight loss, will be a “privilege” exclusively limited for now to konjac mannan and meal replacements.
To summarize, companies will have to choose from a very small range of ingredient health claims, and respect very precise wording. For example, in the huge market of weight-loss supplements (which does not include meal replacements), everyone will have to use konjac mannan as the only active ingredient, and stick to the following wording: “Glucomannan contributes to weight loss in the context of an energy-restricted diet.” As a result of such strict wording limitations, we predict that generic health claims will no longer serve as key elements of marketing strategies.
The third option is…Well, there is no third option. The only ways for companies to communicate legally, clearly, and directly, and let consumers know about their ingredients’ health benefits, are listed above. All other ways to communicate could be illegal, and therefore potentially highly detrimental to business.