This article was originally published 5 July 2018 at www.foodnavigator.com
The new EU novel food regulation aims to make it easier to get innovative food solutions to the European Market. But this left some concerned that a lack of confidentiality could deter investment in innovation. Katia Merten-Lentz, partner at Keller and Heckman, looks at the latest protections that have been put in place.
Since 1997, every novel food must be specifically authorized before being placed on the European market. However, since January 2018 and application of the new novel foods, such authorization is not granted to the sole applicant anymore. Now, once a novel food is officially included in the Union list of authorized novel foods, any food business operator may market it within the EU.
In order not to discourage new technologies and innovations in food production, as they could reduce the environmental impact of food production, enhance food security and bring benefits to consumers, data protection and confidentiality of information provided in support of a novel food application have been introduced by Regulation 2015/2283.
Applicants may request confidential treatment of certain information where disclosure of such information may harm their competitive position. This opportunity applies not only in the context of applications and notification to support the placing on the European market of a novel food but also for the consultation process for determination of novel food status. The Commission rules on the request, and in case of disagreement, the applicant has the opportunity to withdraw its application within three weeks, during which the confidentiality is observed.
When submitting the dossier, applicants must indicate which information they wish to be treated as confidential and provide verifiable justification to substantiate this request – knowing that some basic details, such as the identity of the applicant, name, and description of the novel food, or the summary of the studies submitted, cannot be treated as confidential.
In addition, newly developed scientific evidence or scientific data supporting a novel food application may be denied to support a subsequent application, where data protection is requested and supported by appropriate and verifiable information. Notably, the applicant must justify the exclusive right of reference to the proprietary scientific data or evidence and the novel food could not be assessed – and therefore authorized, without the submission of such data.
Where the Commission concedes data protection and later approves the placing on the EU market of the novel food, it would grant, by exception, an individual and exclusive authorization to the applicant. In that case, the Union list specifies the date of inclusion, the name and address of the applicant and the end date of data protection. During the five-year period of data protection, which begins from the date of inclusion of the novel food in the Union list, only the specified applicant may place it on the market. When the period expires, protection cannot be renewed.
Concession of data protection does not prevent other food business operators to submit a dossier to seek, without reference to the proprietary scientific evidence or scientific data protected, authorization for marketing of the novel food. They may also try to obtain the agreement of the initial applicant to refer to the specific protected data or to directly market the novel food.
Importantly, the above-mentioned provisions on data protection only apply to applications for authorization. In that respect, food business operators, who wish to benefit from data protection for traditional foods from third countries, need to follow the common authorization process, which requires more numerous, specific and different information than the simplified notification and specific authorization they may, however, opt for. This specific point is likely to explain why for various insects, common authorizations were recently submitted, instead of simple notifications.
Novel food and health claims requests
Specific provision was also introduced by Regulation 2015/2283, where the applicant submits to the Commission two applications related to a novel food - one for placing it on the market and another one to use a specific health claim related to it, in accordance with Regulation (EC) 1924/2006 on nutrition and health claims made on foods. If the two applications are accompanied with a request for data protection, and in order to make it possible for the respective data protection periods to run concurrently, the applicant is now allowed to request the Commission to suspend the authorization procedure for novel food, until the Authority adopts its opinion on the health claim.
To conclude, the new Regulation on novel foods introduces interesting tools to support innovative food business operators, by giving them a competitive advantage, through the data protection of their innovative researches submitted upon novel food authorizations. However, these rules may be already challenged, by the forthcoming revision of the General Food Law Regulation, which aims to strengthen the transparency of scientific studies in the whole food safety area, including obviously novel foods.