The European Commission has proposed changing EU rules for authorisation of food-related products – including, in principle, food contact materials (FCMs). The aim is to increase trust in risk assessment.
Under the revised rules, companies would have to notify regulatory authorities of all safety studies initiated for the purposes of future applications for authorisation.
The proposal covers all studies, plus supporting information, submitted to the European Food Safety Authority (Efsa) for risk assessments. It deals with changes to the General Food Law Regulation, plus eight related sectorial legislative acts, including the FCMs Regulation.
Under the current rules, companies seeking authorisation for FCMs conduct whatever studies are necessary, according to Efsa guidance, and then compile the data in a dossier for submission to the authorities.
The Commission says that the changes will guarantee that companies submit all relevant information and do not withhold "unfavourable" studies.
The Commission also says they will give citizens automatic and immediate access to all safety-related information submitted by industry in the risk assessment process.
Currently, dossiers are evaluated by Efsa's scientific panels. These provide Opinions on the risks associated with the substances involved and the conditions under which they might be used safely. The final decision about authorisation is made by the Commission, based on the scientific factors outlined in the Opinion, plus others factors that might be, for example, socio-economic.
Efsa routinely publishes the Opinions of its scientific panels, but it provides the dossiers – with redactions to account for confidential business information (CBI) – only on request.
Under the revised rules, a company claiming CBI would submit two versions of the dossier, a public one and a confidential one. Efsa would make the public version available, "proactively and automatically, at the very early stage of the process". It would then evaluate the CBI claims and subsequently make more information available as appropriate.
The proposal also includes measures to:
- establish an EU register of industry studies, which would be managed by Efsa;
- require consultation of stakeholders and the public on studies submitted by industry to support product authorisation requests; and
- give Efsa the power to – with a mandate from the Commission – request additional studies, financed by the EU budget.
"We fully support the proposal’s objective to improve citizens’ trust in Efsa," European Chemical Industry Council (Cefic) told Chemical Watch. "In this regard, we are also in favour of strengthening the transparency of the risk assessment process and citizen access to information submitted by the industry or other stakeholders. This should be done with respect to confidential business information (CBI) in order to safeguard the industry’s innovation potential."
The Commission will submit the proposal to the European Parliament and the member states, with an aim of adoption by mid-2019.