Independence of science in regulatory decision-making

A conference-debate was organised at the European Parliament by ALDE MEPs Corinne Lepage and Antonya Parvanova.

The Presentations were given by Dr Fiorella Belpoggi, Director at the Cesare Maltoni Cancer Research Centre in Italy; Dr John Fagan, Director, and Claire Robinson, Researcher, at Earth Open Source in the UK, and Per Bergman, Acting Director of EFSA’s Scientific Evaluation of Regulated Products Directorate.

Independent science vs. science supported by industry

Ms. Lepage opened the conference by discussing the growing concerns related to the independence of science in regulatory decision-making, giving the example of the recent decision in France to ban bisphenol A in all food contact materials [see elsewhere in this Bulletin], in the face of opposition from science supported by industry.

Ms. Parvanova stressed the importance of the role for an independent and trustworthy scientific review body to help decision makers make the correct decisions to protect the public.

Dr. Belpoggi gave a presentation on the work of the Cesare Maltoni Cancer Research Centre, a publically funded non-profit organisation. The organisation conducts long term tests which have shown negative effects from substances (aspartame and the fungicide mancozeb), in contrast to short term Good Laboratory Practices (=GLP) compliant tests conducted by industry, to highlight the dangers which arise when regulatory assessments ignore independent science.

Review of GLP standards

Dr. Fagan questioned why EFSA based its decision on bisphenol A on four studies submitted by industry and discounted 94 independent studies which concluded that the substance is harmful. Dr Fagan called for a review of GLP standards, which he claimed are used as a shield to reject independent studies which show negative results.

He also questioned the legitimacy of the EFSA Guidelines on the Plant Protection Products Regulation which he claims undermine the increased standing given to independent science in the Regulation by enabling industry to dismiss any independent study on the grounds that it is not “relevant” or “reliable”.

Central Fund

Ms. Robinson suggested that a central fund be established which industry must contribute to in order to set up independent laboratories to carry out fully independent testing of substances.

Conflicts of interest

Mr. Bergman explained the detailed procedures EFSA has put in place to avoid conflicts of interest arising with the experts involved in the decision making process, including annual declarations of interest and IT tools to screen conflicts prior to meetings.

In the debate which followed, Mr Bergman was heavily questioned on several cases of conflicts of interest arising with EFSA experts, staff and board members. He responded in part by explaining that the work of EFSA covers 34 Regulations and accordingly it is difficult to detect all possible conflicts and that EFSA is developing new guidelines focusing on the specific discussions which experts are involved in to better detect conflicts of interest.

Mr Bergman also explained that the EFSA Guidance on the Plant Protection Products Regulation, which EFSA was mandated to create by EU legislator, is not intended to reject independent science and confirmed that GLP compliant tests are not regarded as infallible.

Mr Bergman also explained the role of EFSA is to carry out risk assessments whereas it is the role of the European Commission, as the risk manager, to propose decisions.


In closing the debate Ms. Parvanova emphasised the important role industry plays in maintaining the competitiveness of the EU economy and stated that the contributions in the discussion would be included in a recommendation which the Parliament will send to EFSA.