The European Commission announced Monday that it has revised the way it will adopt rulings on Article 13 health claims into law. Under the new approach, the adoption of accepted health claims will come in two steps, rather than in a series as was the case previously. Claims for substances other than botanicals will be finalized and adopted by June 2011, with botanicals claims to follow sometime thereafter.
According to both the Commission and the International Alliance of Dietary/Food Supplements Associations (IADSA), this change was because of the many concerns raised by stakeholders in the process. Many in the industry complained long and hard about the potential market distortions to which the previous process could have given rise between companies whose claims have been rejected and companies marketing products using claims for which assessment is still pending.
"This new approach announced today by the Commission is an excellent result for the food supplement sector that has been achieved due to the huge amount of work that is being carried out by the European associations," IADSA said in a press release today.
Among the industry-friendly features of the new ruling, the group singled out:
- The adoption of all claims (except for botanicals) will now avoid the distortion of the market that would have followed a batch-wise approach.
- The singling out of botanicals is legitimate because of the unequal treatment as compared to medicinal products.
- This new approach is pragmatic, it will increase legal certainty and will ultimately benefit the consumer.
- The new timeline resulting from this new approach provides a significant amount of time to the industry to continue the discussions with the European Commission and the Member States.
The European Food and Safety Authority will continue to issue its advisory rulings Article 13 health claims in a batch format, with the next set due out in October. The previous sets of rulings have featured mostly negative opinions, with health claims for probiotics and antioxidants hit particularly hard. Monday's action by the Commission affects how those rulings will ultimately become law, but doesn't necessarily alter the way in which EFSA comes to advisory opinions on whether scientific evidence adequately supports the health claims associated with ingredients in dietary supplements and functional foods.