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Germany: Proposed regulation increasing transparency at the EFSA threatens IP

On December 11 2018 the European Parliament discussed the proposal for a regulation on the transparency and sustainability of EU risk assessment in the food chain amending, inter alia, Regulation (EC) No 178/2002 [General Food Law].

Public controversy regarding the use of genetically modified organisms and herbicide glyphosate paved the way for an initiative which entailed a legislative proposal by the European Commission (COM (2018)0179). The ensuing regulation will amend the EU's General Food Law Regulation.

On February 11 2019 the European Parliament and the European Council reached a provisional agreement on the EU Commission's Proposal.

At present, the transparency rules of the European Food Safety Association (EFSA) are not as harsh as those of the other agencies – the proposed regulation makes the authorisation procedure harsher than at other agencies. Other agencies (for instance, the European Medicines Agency) publish applications and studies at the time when they publish their opinion.

It is of central interest to the food industry what this proposed regulation requires of companies in terms of when the publication of information and underlying studies in relation to applications are due and which documents must be produced. In accordance with the proposed legislative text, food companies will need to inform the EFSA immediately of the subject matter of studies commissioned.

The revised regulation will entail automatic publication of all studies and information submitted to the EFSA to support the authorisation of a proposed product or ingredient. This data will be uploaded to the EFSA website early in the approval process.

Furthermore, the regulation will establish a database of studies for the EFSA to identify whether all relevant research on a substance is considered in evaluating market applications, and stakeholders and the general public should be involved in consultations and notify the EFSA of any potentially omitted information.

The suggestions presented by the Committee on the Environment, Public Health and Food Safety, for making the proposal more workable, including the requirement that the EFSA should set up a preliminary opinion first and studies and non-confidential information should be published afterwards, were not accepted.

Under the new suggested regulation (see for updates on the status), the applicant cannot prevent its innovative idea and know-how connected to a new product being presented on the website of the EFSA at the commencement of the application procedure so that any competitor has access to such documents.

Authorisation procedures at the EFSA take up to 59 months – a time period during which competitors in third countries outside the EU will have access to sensitive data while the European application procedure is carried out.

The fact that data and studies will not be published after a consultation period but right at the commencement of the procedure imposes a serious risk of idea and know-how piracy.

EU legislation applicable to the food industry is already considered as very transparent, and the proposal which received the agreement of the council and the commission raises concerns about efficient protection of proprietary information of agri-food companies within the EU.

In this approach, the protection of intellectual property rights comes second to a transparent risk assessment process and it remains unclear how companies are supposed to comply with the requirement to provide a justification for requesting non-publication of their confidential information.

Dr Gisela Grabow

Maiwald Patentanwalts- und Rechtsanwaltsgesellschaft mbHElisenhof, Elisenstr 3D-80335, Munich, GermanyTel: +49 89 74 72 660 Fax: +49 89 77 64

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