This article, written by Reed Smith attorneys Paule Drouault-Gardrat and Juliette Peterka, was first published in Insights, the conference bleue newsletter.  Reprinted with permission.

Article 21 of the Regulation No. 1924/2006 on nutrition and health claims made on foods of 20 December 2006 provides data protection for applicants who wish to register a nutritional or health claim not included in the Community list. The Community list of authorized health or nutrition claims will be established on the basis of proposals made by Member States with the assent of the Commission before 31 January 2010.

The difficulty is that if a manufacturer wants to use a claim which is not listed, it will have to proceed to a scientific evaluation of the claim. This raises two types of issues. Firstly, this is quite expensive. Consequently, this will cause small and middle sized companies to increase their costs every time they consider using a new claim. The second issue relates to the protection of the company’s private data. The Commission thus decides to provide data protection to new applicants, under Article 21 of the Regulation No. 1924/2006.

Article 21 provides that “the scientific data and other information in the application required under Article 15(3) may not be used for the benefit of a subsequent applicant for a period of five years from the date of authorization, unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, where:

(a) the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and

(b) the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and

(c) the health claim could not have been authorized without the submission of the proprietary data by the prior applicant.

In other words, the applicant becomes the exclusive user of the claim and of the data submitted to the Commission. The protection is quite broad since “the scientific data and other information […] may not be used for the benefit of a subsequent applicant.” The Regulation does not specify which data ought to be protected. But the scope of Article 21 probably encompasses the results of research funded by the applicant.

Similarly to data exclusivity of the data of Marketing Authorization files for medicinal products, the aim of such provision is to protect the applicant which has taken the initiative to launch and finance research in order to obtain results significant enough to justify the use of a health or nutritional claim on a specific food product.

The protection is meant to last for a five-year period, starting from the date of the individual Community authorization. Unless the applicant has specifically given its authorization, it is strictly forbidden for the Commission to refer to data and information contained in its application, to authorize a subsequent applicant to use the same health or nutritional claim.

Thus, once a new nutritional and health claim is registered in the Community list, and if the claim could not have been authorized without submission of such data, the applicant is then the sole holder of the right to use the data and the health or nutritional claim for a period of five years.

However, a subsequent applicant may be authorized by the prior applicant to use the health or nutritional claim. Moreover, if another company asks for the authorization to use the same claim but on different scientific data, then it will be able to use the said health or nutritional claim.

Still, the claim will not be usable by other manufacturers which are not able to establish the same justifications. The latter will have to await the end of the time period to be authorized to use the data legitimately, unless the Commission decides that the registration on the Community list could have been done without submission of these data:

“unless and until the Commission takes as decision on whether a claim could be or could have been included in the list provided for in Article 14 or, where appropriate, Article 13 without the submission of data designated as proprietary by the prior applicant.”

In addition, if a competitor eventually establishes that the data was not essential to justify the claim or if the exclusive property of the applicant is questioned, the Commission will have to decide whether or not the conditions of use of the claim have to be modified.

In view of the above, it seems that the data protection granted by Article 21 is a step forward for the applicant of a new nutritional or health claim. Nevertheless, as for medicinal products, its implementation may give raise in the future to interpretation issues and consequently litigations.