Many health claims concerning foods (including dietary supplements) currently used in the European Union are set to become illegal later this year.

This is the result of the adoption in May 2012 of a limited list of authorized "generally accepted" health claims relating to functions of the body, following scientific evaluation by the European Food Safety Authority and European Commission approval.  This list includes claims such as:

  • "Protein contributes to growth in muscle mass"
  • "Reducing consumption of saturated fat contributes to the maintenance of normal blood cholesterol levels"

The relevant legislation (Regulation 432/2012), which has significant implications for food companies' product positioning strategies, prohibits approximately 1,600 existing claims that were not approved for inclusion on the Regulation's permitted list from being used following a transitional period set to end on December 14, 2012.

Many claims will not be permitted, even if scientifically valid, because they do not refer to a specific nutrient, substance, food or food category (but only to the product itself) or explain how the stated beneficial effect is obtained.

Some specific categories of health claims, including certain plant or herbal substances (botanicals), are still awaiting completion of the review process.  These may continue to be used, subject to satisfying the general claims criteria, pending an authorization or non-authorization decision.

Preparing for Approaching Restrictions

In order to avoid non-compliant claims and potential enforcement action, food companies should be actively reviewing health claims concerning their products made in any commercial media (labeling, websites, or advertising) in order to ensure their compliance or removal prior to the December 14 deadline.

This should include verifying compliance with any specified conditions for use of permitted claims, including:

  • Minimum daily intake of substance required to obtain beneficial effect claimed
  • Maximum permitted levels of substance allowed
  • Specific labeling requirements

Companies may still choose to seek individual authorization of claims not on the permitted list through submission of a scientific dossier to substantiate the claim.  However, this is a long and resource-heavy process that may not result in any authorization or non-authorization decision prior to the December deadline.

How Steptoe Can Help

Health claims are already a focus of enforcement attention in a number of EU Member States and enforcement is expected to increase following the December deadline.

Steptoe has experience advising food and dietary supplements manufacturers on compliance with a wide-range of regulatory requirements concerning their products marketed in key sales jurisdictions.  This includes working with former officials who were responsible for approval of health claims as well as scientific experts previously involved in their review.  We can assist in reviewing the regulatory status of claims and advise on regulatory strategies, including authorization, for maintaining product positioning in the case of non-compliant claims.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.