EU Nutrition, Health Claim Reg Would Establish Approved-Claims Registry

Health claims referring to "children's development and health" will undergo a more stringent authorization process in the EU than other non-disease-risk-reduction claims, according to regulatory language adopted by the European Parliament May 16.

The Nutrition & Health Claims Regulation aims to harmonize the governance of health-related claims language across the European Union. The establishment of a positive list of approved health claims within three years of the reg's publication in the Official Journal of the European Communities is the directive's main provision for health claims.

An initial list of "well-established 'function' health claims (such as 'calcium may be good for your bones')" will be drawn up by the European Commission "on the basis of claims submitted by Member States," a same-day release from the EC explains. The Member States' submissions will include claims already approved at a national level.

Once that list is complete, health claims based on new scientific data will need to be submitted to the European Food Safety Authority (EFSA) for inclusion in the registry.

However, the EP and the Council reached a compromise during the May 15-18 plenary sitting of the European Parliament in Strasbourg, France that establishes "an accelerated type authorization" for all new health claims, except those referring to the reduction of disease risk and the development and health of children.

The "simplified process" was added to the reg "in order to encourage innovation in the food industry."

Under the accelerated procedure, if EFSA's opinion on a submitted claim is positive, then the EC will decide whether or not to authorize it after "simple consultation of Member States," the Commission states. If EFSA's opinion is negative, then the EC will make its decision following a vote by Member State experts in the Standing Committee on the Food Chain & Animal Health.

The EFSA must give its opinion no later than five months from the receipt of the claim application. If EFSA requests additional information from the applicant, the time limit will be extended by two months.

Risk reduction and children's health claims will not be able to be authorized by "simple consultation." These claims will require submission of a scientific dossier to EFSA, and they will be authorized on a case-by-case basis following standard Comitology procedure.

"A claim should be scientifically substantiated by taking into account the totality of the available scientific data, and by weighing the evidence," the legislation states.

The regulation will also apply to "any trademark that can be construed as a health or nutrition claim," the EC notes. However, "products bearing trademarks or brand names existing before 1 January 2006" will have 15 years from the reg's official publication to be phased out of the market.

The Commission's "Questions & Answers on Health & Nutrition Claims" release cites "existing brand names suggesting health benefits (such as promises of weight loss)" as those effected by the reg. "However, certain generic descriptors (e.g. digestives, aperitifs) may apply for derogation from this rule."

The reg covers all claims, including, for example, those made in leaflets and websites. It completely bans "information in labeling, marketing or advertising about the nutritional or health benefits of foods which is not clear, accurate or substantiated."

Additionally, the rule bans "claims referring to rates or amounts of weight loss" and "claims referring to recommendations of individual doctors," the release notes. However, recommendations or endorsements by "national associations of medical, nutrition or dietetic professionals and health-related charities" may be allowed if explicitly permitted under national law.

The legislation's primary provision for nutrition claims is the establishment of "clear definitions of claims such as 'low [calorie],' 'low fat,' 'high fiber' or even 'reduces cholesterol,'" a press release from the Commission explains.

Other claims for which a "nutrient profile" will be established include, "increased [name of the nutrient]," "high [name of vitamin/s] and/or [name of mineral/s]" and "low sugar." A nutrient profile will establish the nutritional "threshold" a product will have to meet before it can make a certain claim.

For example, "a claim that a food is high in fiber, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 6 g of fiber per 100 g or at least 1.5 g of fiber per 100 calories," the EC memo "Nutrition Claims & Conditions Applying To Them" states.

The nutrient profiles will be established under standard Comitology procedure, and the EC will present the profiles to the Committee within 2 years of the reg's official publication. Following a favorable Committee vote, the profiles will be published in the Official Journal.

The EP and the Council agreed to allow a nutrition claim on a product if "only one nutrient (e.g. salt, sugar or fat) exceeds the limit of the nutritional profile," the Commission's release notes.

However, "a statement about the specific nutrient" must appear "in close proximity to, on the same side and with the same prominence as the claim," the legislation states. "This statement shall read as follows: 'High content of [x].'"

A press release from the EP notes that one of the "gains" made by the European Parliament during the negotiations with the Council was "support" for small to medium sized enterprises/companies [SMEs] "to help comply with this regulation." The effect the health claims reg could have on SMEs is an industry concern.

The European Association of Craft Small & Medium-sized Enterprises (UEAPME) "mildly welcomed" the reg, noting that "SME producers might relinquish the idea of adding health claims to their products, if the required procedure is exceedingly complicated for their limited capacities," in a May 17 release.

During negotiations, the following language was added to the reg: "In order to facilitate the implementation of this Regulation, the Agency should make available appropriate technical guidance and tools, in due time, especially for SMEs."

The directive also notes that exclusive rights to research should be limited in duration to allow SMEs to have access to claims since they "rarely have the financial capacity to carry out research activities."

Companies submitting "data designated as proprietary" in support of a proposed health claim would be granted proprietary license over the data for five years. The Council had previously suggested a seven-year period (¹ (Also see "EU Policy Would Harmonize Health Claims, Grant Proprietary Rights – Lawyer" - Pink Sheet, 10 Apr, 2006.), p. 9).

According to the EC, "the formal adoption" of the reg by the Council is "expected by this autumn." The Council should present their political agreement to Parliament's amendments "in the coming weeks."

"The regulation will enter into force within 20 days of its publication in the Official Journal," and it will be effective six months thereafter. However, "as a transitional measure, existing nutrition claims will be able to remain on the market for two years, and existing health claims for three years."

The EP also voted in favor of the Fortified Foods Regulation May 16, which aims to harmonize rules for adding vitamins and minerals to food across the EU.

The legislation creates a positive list of vitamins and minerals approved for addition to foods. The EP amended the Council's common position to include language making only vitamins and minerals "in a form that is bio-available to the human body" acceptable for food fortification.

Additionally, the reg "establishes the criteria for setting the minimum and maximum levels for such nutrients added to food, on the basis of scientific advice," an EC document says. "All foods which contain nutrients would have to be labeled to inform consumers about their nutritional value," the Commission adds.

The legislation also "would establish a procedure involving [EFSA] which, for the first time, would allow the examination" of novel additives such as herbal extracts, amino acids and proteins "to assess any possible risk to human health."

"On the basis of the EFSA opinion, a decision on possible restrictions on these substances will be taken by the Commission and Member States through Comitology procedure."

The Council should formally adopt the regulation "in the coming weeks," according to the EC. Twenty days after its official publication, the reg will enter into force. "The new rules on fortification will start to apply six months from this date."

Products not in compliance with the food fortification legislation will have a three-year grace period, "provided they were labeled or placed in the market prior to [the reg's] entry into force," the EC adds.

- Katia Fowler