Industry safety studies will be published when applications for market authorisations are submitted

In the wake of the glyphosate debacle, last week the European Parliament, Council and Commission finally reached an agreement on Commission's proposal to increase transparency and sustainability in the risk assessment model in the food chain.

New rules will oblige the European Food Safety Authority (EFSA) to publish all industry studies backing regulatory decisions on pesticides, GM foods, and feed additives.

Previously these industry studies were kept secret. Under the new rules it will still be up to industry to conduct the safety studies, but they will be published, so that independent scientists can check their contents and the conclusions that EFSA draws from them.

The proposal in detail

The Commission's proposal tables amendments in the General Food Law concerning eight pieces of EU legislation, including pesticides and GM foods.

The Commission presented the proposal last April as a response to the European Citizens' Initiative to ban glyphosate, which called on EU regulators to increase transparency in pesticide risk assessment.

Despite the attempts of the industry (and industry-friendly MEPs) to weaken the proposal, the EU regulators stood by their citizens, listened to their concerns, and finally delivered a change in regulation that truly aims to increase transparency. This would not have happened without the work of civil society organisations.  

The proposal represents a major victory for civil society organisations – particularly the following elements:

- The European Food Safety Authority, EFSA, has to publish the safety studies included in the pesticide or GMO application dossier without delay and once they are considered admissible (so immediately in the beginning of the submission before the Rapporteur starts its assessment) - Art. 39b;

- EFSA has to keep a database with all notified studies submitted by industry to support an application (if a study is not notified/registered the study will not count in the application) - Art. 32b. The notified studies will go through consultation with stakeholders.

- EFSA will carry out searches in scientific literature to consider other data than those submitted for the assessment by the applicant;

- EFSA management board "should endeavour to ensure, to the largest extent possible, that experts appointed in the Scientific Panels are scientists who are also actively conducting research, and publishing their research findings in peer-reviewed scientific journals, provided that they comply with the strict criteria of excellence and independence" to ensure that experts that have not consulted scientific progress for years - now a majority - are excluded from the panels.

No more cherry-picking of favourable data

In fact, the proposal addresses directly the following two demands of the manifesto of the coalition, Citizens for Science in Pesticide Regulation (of which GMWatch is a member), asking for a full reform of the current risk assessment and risk management system:

"6. To prevent cherry-picking of favourable data, all safety studies must be registered in advance. No safety study that is not registered shall be used in support of regulatory authorisation of a pesticide.

"14. All the results and data of all pesticide safety tests shall be published on the internet in a consistent and searchable format."

The proposal also addresses the manifesto's demand for an "independent, objective and transparent" assessment by the risk assessors (EU member states), as the law requires.

The whole text was released last Friday and can be found on the Council's website.

Reactions

From the International Union of Food, Agricultural, Hotel, Restaurant, Catering, Tobacco and Allied Workers’ Associations (IUF):
Regulating the regulators? Proposed new measures on pesticide authorization in the European Union

From Global2000 (in German):
GLOBAL 2000: Großer Erfolg für Europäische Bürgerinitiative "Stop Glyphosat"

From Euractiv:
Food safety: Midnight deal for revised General Food Law

Commission's fact sheet



With thanks to Hans Muilerman of Pesticide Action Network EU for his clear explanation of the implications of this new development