Protection of proprietary data. Why published data should not be excluded from protection under Article 21 of Regulation 1924/2006

The nutrition and health claims regulation applies a system of generic approvals with the exception of claims that are approved on the basis of proprietary data. Such data enjoy a five years term of protection. In a recent decision the European Commission proposes as sole criterion for recognising the ‘proprietary’ status of data the fact that they have not been published previous to the submission of the claims application. The article argues that this interpretation is insufficiently supported by the text of the Regulation. Furthermore it is likely to have a negative impact on the scientific level of substantiation of health claims and on the cooperation between science and the business sector. For these reasons and on the basis of the Regulation’s recitals, the article argues that as decisive criterion should be recognised whether investment has been made in bringing forth the data