Bayer (one of DiversityInc’s Noteworthy Companies) supports the principles established by the European Court of Justice (ECJ) concerning the extent to which authorities must ensure public access to crop protection product studies under the provision that confidential data is protected.
The ECJ has set rules throughout Europe for authorities, the industry and the public which will promote greater transparency and public involvement. Bayer supports this development but emphasizes that the protection of confidential data such as product composition and manufacturing processes needs to be safeguarded in any public access request.
Bayer intends to offer support to the authorities in dealing with requests for access to safety-relevant crop protection data as needed. The company is also working on a solution to enable public access to the safety-relevant study reports while safeguarding the company’s confidential product composition and manufacturing processes. In this way, Bayer wants to foster an open and transparent dialog with interested parties.
Crop protection products are today among the most thoroughly investigated and most strictly regulated chemicals in the EU. They are an important tool for farmers all over the world and enable the production of safe, healthy and affordable food. On average, approximately 1,200 studies are required for the marketing authorization of an active ingredient, and the average research and development investment for a new active substance amounts to approximately EUR 250 million.
In two separate cases, the ECJ was called upon to decide the extent to which the European Commission and the Dutch regulatory authorities (Ctgb – College voor de toelating van gewasbeschermingsmiddelen en biociden) have to grant third parties access to studies submitted by the industry. The applicants invoked the Aarhus Convention, an international agreement which, among other aspects, regulates access to official, environmentally relevant information.