Data exclusivity and food claims in Europe

The IPKat's attention was attracted this morning to the Commission Decision of 17 December 2009 authorising a health claim on the effect of water-soluble tomato concentrate on platelet aggregation and granting the protection of proprietary data under Regulation (EC) No 1924/2006 of the European Parliament and of the Council, which was published this morning on the Official Journal's website. By Article 2 of this Decision,
"The scientific data and other information included in the studies identified in the Annex to this Decision shall be restricted for use for the benefit of the applicant for a period of 5 years from the date of authorisation under the conditions laid down in Article 21(1) of Regulation (EC) No 1924/2006.".
This Decision follows an application by Provexis Natural Products Ltd, submitted nearly a year ago in relation to a health claim relating to the effects of water-soluble tomato concentrate (WSTC) I and II on the blood platelet activity in healthy people. The claim consisted of the immediately forgettable phrase ‘Helps to maintain a healthy blood flow and benefits circulation’.

Regulation 1924/2006 of 20 December 2006 on nutrition and health claims made on foods, in effectively conferring protection on data relating to health claims, is part of the vast and growing body of European intellectual property law and, a little embarrassed, the Kat must confess that he missed it at the time of its passage. He wonders whether his readers, through their commercial activities or academic pursuits, have any experiences or insights as to the working of this Regulation and as to how it compares with the provisions relating to data exclusivity in the pharmaceutical sector.

European Food Safety Authority report on the product claim here
Patent for a means of prolonging feline life here
Data exclusivity and food claims in Europe Data exclusivity and food claims in Europe Reviewed by Jeremy on Friday, December 18, 2009 Rating: 5


  1. Chapter 19 of my Pharmaceuticals Biotechnology and the Law book (Butterworths 2009) discusses this (para 19.26) and other EU non-pharma RDP regimes (Chapter 18 deals with the pharma one, and Chapter 17 the RDP provisions in TRIPs).

    Unfortunately there was no experience of the operation of this particular regulation in practice when it was written, last year.

  2. I monitor EFSA as part of my professional duties (I am an information officer with a specialism in IP rather than a patent attorney/agent).

    I confess that I had not seen this as an aspect of IP.

    Anyway, the reports below were recently published.

    Community Register of nutrition and health claims made on food - Rejected health claims Article 14(1)(a) health claims referring to reduction of disease risk

    Community Register of nutrition and health claims made on food -
    Rejected health claims
    Article 14(1)(b) health claims referring to children's development and health

    Community Register of nutrition and health claims made on food -
    Rejected health claims
    Article 13(5) health claims based on newly developed scientific
    evidence and/or including a request for the protection of proprietary


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