Article 13.5 fast track decision will nourish competitive market

The European Commission’s decision to fast track claims based on newly developed science and those requesting proprietary data protection will help companies keep ahead of the competition, an industry consultant has said.

Patrick Coppens, Food Law Manager at Brussels consultancy EAS, said that the decision to allow these claims to be submitted in February 2008 instead of having to wait until 2010 will boost industry competitiveness on the European Union food market.

The procedure, which falls under Article 13.5 of the Nutrition and Health Claims Regulation, enables companies to have their file approved through an accelerated procedure, and allows exclusive use of their proprietary data for five years.

“Such submissions are vital for companies that invest in scientific research for new claims,” Mr Coppens said in a podcast interview. “When a company has invested in research it doesn't necessarily want to be put on a list that can be used by all of the competition. Article 13.5 allows data protection, which means that competitors must have similar data of their own to submit in order to make the same claim. It is at least some return on investment.”

The authorisation procedure is expected to take a maximum of eight months, and while in the interim claims that fall under Article 13.5 can continue to be used, Mr Coppens stressed that companies should have a thorough understanding of the procedure.

“Those claims currently in use that are not based on proprietary data should already be scientifically justified, which makes it difficult to say then that the claim is based on newly developed scientific evidence,” he said. “Such claims should be introduced into the Article 13 list before the deadline of 31 January. If they are not, then the companies would either have to withdraw their claim when the claims list is established in 2010, or in the intervening time submit a file to have it approved under the Article 13.5 procedure.”

To listen to the full podcast interview with Mr Coppens visit


EAS provides strategic consulting advice on European, Asian and international regulation on food and nutritional products. It provides companies with regulatory and strategic advice for the marketing and approval of their products in Europe and Asia. EAS also advises governments, trade associations and companies on the impact of European, Asian and global policy.

EAS has offices in Brussels, Italy and Singapore. EAS-Italy is a branch of EAS located in northern Italy to follow EFSA developments in Parma closely.

For more information on EAS-Europe contact EAS, 50 Rue de l’Association, 1000 Brussels, tel: (+32) (0) 2 218 14 70, email [email protected] or visit

For information on EAS-Asia contact EAS Strategic Advice Pte Ltd, 3 Killiney Road, 07-04 Winsland House I, Singapore 239519, tel: (+65) 68 38 12 70, email: [email protected] or visit

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