Protection of Scientific Dossiers Under Discussion: Proposal for EU Regulation on Transparency and Sustainability in the Food Chain

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On April 11, 2018, the European Commission presented its Proposal for a Regulation of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain (COM(2018) 179, the “Proposal”). The Proposal would amend Regulation (EC) No 178/2002, which lays down the general principles and requirements of food law, and would introduce new regulations on the disclosure of scientific or study data. Specifically, the European Commission proposes that risk assessment-related studies and documents that are submitted to the European Food Safety Authority (EFSA) be made publicly available in the Union Register of Studies.

 Disclosure of scientific data

Under the Proposal, scientific data, studies and other information supporting applications for authorization under European Union food law, including supplementary information supplied by applicants, would be made public by competent authorities.

Applicants would have the option to apply for confidential treatment of the supporting scientific data and other supplementary information, but confidentiality would be granted only where the disclosure of study information is deemed to significantly harm the interests concerned. Specifically, under the Proposal, applicants may request confidential treatment only for (i) the method and other technical and industrial specifications used to manufacture or produce the subject matter of the request for a scientific output, including a scientific opinion; (ii) commercial links with a producer or importer; (iii) commercial information revealing sourcing, market shares, or business strategy; and (iv) quantitative composition of the subject matter. Also, applicants would be obliged to file both a confidential version and a nonconfidential version of the study data, which the competent authority would share with the European Commission and the other EU Member States. Although the European Commission and the EU Member States are obliged to take necessary precautions to prevent public disclosure of information for which confidential treatment has been granted, citizens’ claims for information against competent authorities may undermine this protection of confidentiality.

 What are the next steps?

The Proposal was open for feedback until June 25, 2018, and numerous stakeholders commented on the proposed disclosure of study data and the associated risks from a business perspective. The Proposal is currently being debated in the European Parliament, where the stakeholders’ feedback will be considered and factored into the discussion. It remains to be seen whether the European Parliament and/or the Council of the EU will propose amendments introducing a stronger protection of confidential business information, or whether the Regulation will be adopted as proposed by the European Commission.

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