The new Transparency Regulation was published in the Official Journal on 6 September 2019. It entered into force 20 days after publication and became applicable as of 27 March 2021.
During the past years pressure was placed by the European Citizens’ Initiative on the European Food Safety Authority concerning the manner in which it conducted risk assessments in relation to food safety, finally leading to the introduction of Regulation (EU) No. 2019/1381 (“Regulation”).
Areas of amendment and effected substances
The Regulation mainly amends the General Food Law Regulation, targeted amendments of the General Food Law Regulation and eight other legislative acts.
The central areas are 1. Greater transparency, 2. Increased independence of scientific studies 3. Strengthened governance of EFSA and scientific cooperation 4. More comprehensive and effective risk communication. Substances particularly effected are GMOs in food and feed, food contact materials, feed additives, enzymes flavourings, smoke flavourings.
The Regulation concerns import tolerance and maximum residue level applications, as well as new approvals and renewals of active substances.
Publication of industry studies
Effectively, the Regulation seeks to impose an obligation on EFSA to publish industry studies at the beginning of the risk assessment process. However, as was addressed by an article in MIP in 2019 the obligation raises a number of concerns as to whether the increase in transparency of the work of the EU authorities is more important than keeping research confidential and IP sufficiently protected. Companies must request confidential treatment under the conditions laid down in the Regulation to ensure the protection of study data, know-how. Otherwise, the data will be published at the very early stage.
Possible impact on confidentiality
The focus on the risk assessment process and its accessibility for European citizens is a new frontier for transparency within the EU risk assessment processes, yet a challenge for innovation. This has to be seen critical, in particular in view of the strategy for innovation in life sciences is the Commission’s new action plan on intellectual property (IP). It seems that the Commission pushes forward innovation in the pharmaceuticals and life sciences sector whilst placing a strong focus on transparency in the agriculture sector. Confidential information is protected only in duly justified cases, claims for confidentiality of information are considered by EFSA. However, the basic principle is that all studies and information relating to an application must be published automatically when an application is validated or found admissible, at the very early stage of the risk assessment process.
In addition to the Regulation, the Practical Arrangements are binding means to interpret and implement the legal framework provided by the Regulation, specifying the details for the implementation of required processes, and setting forth how the Regulation will be applied by EFSA.
New regulatory changes always bring about challenges. Maiwald supports clients through the framework of European pharmaceutical and chemical regulations.