FSA issues health claims guidance

The UK Food Standards Agency (FSA) has issued a detailed 81-page document advising companies on how to negotiate the various European Commission processes involved in health claims submission, approval and application.

The document explains all aspects of the regulation, defines the various claim options and details what is expected in scientific dossiers and how to go about submitting them to the relevant authority.

It also details how the regulation will be policed and advises staying in close communication with local authorities in the development of claims submissions.

"If you make, or plan to make, a nutrition or health claim, as well as using the rest of these guidance notes, you are advised to consult your Home Authority to ensure you meet with the requirements of the Regulation," FSA writes.

The guidance contains a comprehensive Q&A section that discusses every aspect of the regulation as well as a glossary of relevant terminology.

Timings FSA notes that although the regulation came into effect on July 1, 2007, various transition periods of up to 15 years are written into it.

In the case of nutrient profiles, which have to be adopted by January 19, 2009, a two-year transition period exists for product claims affected by the yet-to-be-finalised rules.

The document contains a table outlining all significant dates going forward as January 19, 2022, when trade marks and brand names that can be construed as health or nutrition claims must comply with the regulation.

Further guidance The guidance discusses the difference between commercial and non-commercial communications and notes that the regulation only applies to claims made in the commercial context.

Product specific advertising in any form, including in print, broadcast, internet or direct mail, promotional features in print media, in store promotion and catalogues or product directories, whether printed or on line (this is not an exhaustive list) all qualified as commercial communications.

Feature articles and missives issued by health professionals did not.

Detailed guidance is also given on how to apply for nutrition claims and health claims and how to employ them if they are approved.

For instance in regard to disease reduction claims, article 14 states claims must be accompanied by a statement that the disease has multiple risk factors and altering one of these factors may or may not have a beneficial effect.

Food agencies, trade associations and individual companies from the European Union's 27-member states and internationally, submitted thousands of health and nutrition claim dossiers to the European Commission (EC) before the January 30, 2008 deadline, but further claim submissions in areas of new or emerging science can still be made.

These claims (article 18), along with disease reduction claims or those related to children's development and health (article 14) will be passed to the European Food Safety Authority (EFSA) by the EC for assessment with an eight-month guaranteed turnaround period (which does not apply to the bulk of article 13 claims).

Under the tenets of the health and nutrition claims regulation, all claims must be adjudicated on by January 30, 2010.