Regulation (EC) No 1924/2006(1) stipulates that health claims must be submitted to the European Food Safety Authority (EFSA) for assessment.
The health claims under Article 13 of that regulation were submitted to the Commission in January 2008. The first series of health claims under Article 13 that were assessed by the EFSA were published on 1 October 2009. Approximately one-third of the assessments were positive. For the remaining two-thirds the result was negative, often because the information to support the claim was insufficient (considering the EFSA's current requirements), unknown or unclear at the time of submission. As a result, operators will no longer be able to use health claims which have long been accepted in various Member States on the basis of generally accepted scientific evidence.
The impact will be particularly negative in the case of food supplements, since the lack of health claims could potentially make many products disappear from the market and could harm consumers, who will no longer be able to receive information to help them to choose the right product for their requirements. They are therefore then likely to consider products from uncontrolled trade channels.
A further consequence will be a reduction in investment in research and innovation in Europe.
Has the Commission carried out an assessment of the impact on the market of the assessment criteria used in the process set out in Regulation 1924/2006?
Does the Commission consider that companies have had access from the start to all the information that is necessary to back up in a sufficient and exhaustive manner the health claims submitted?
Has the Commission considered the possibility of providing for a review of the applications that are incomplete due to insufficient or unclear guidelines and/or guidelines that have been updated since December 2008?
Has the Commission considered a transition period to allow for adjustment on the basis of well defined assessment criteria?
Has the Commission considered that the publication of EFSA opinions in different periods and protracted over time (from October 2009 up to 2011) will create considerable market distortions, encouraging unfair competition?