Stop-the-clock guidelines to improve efficiency and consistency of regulated product assessments

Feature story
14 April 2014

New working practices will increase the efficiency, clarity and consistency of the assessment of regulated product applications, said the European Food Safety Authority (EFSA).

During the evaluation of a regulated product application, EFSA may ask for additional information to complete its review. For the first time, the Authority has set out timelines that give applicants a clear idea of how long they have to provide this data. The requests are gathered under cross-cutting headings such as bioavailability, toxicity and exposure. Under European law when such a request is made, the clock on the regulatory timetable for risk assessment is stopped until the applicant supplies the necessary information. The new procedure comes into force on 1 May 2014.

This initiative is important because a growing part of EFSA’s work involves the evaluation of regulated products, so-called because they require scientific risk assessment by the Authority before they can be authorised by risk managers for use on the market in the European Union (EU). Every year, EFSA assesses around 400 applications for feed and food additives, food contact materials, flavourings, enzymes, genetically modified organisms, nutrition, food allergens, novel foods and pesticides. These applications currently account for about 60% of the Authority’s scientific outputs.

EFSA decided to introduce the guidelines after a review of its own working practices highlighted the need to harmonise ‘stop-the-clock’ deadlines set by the Authority’s scientific panels.

Per Bergman, who leads EFSA work in the field of regulated products, said: “We are constantly striving to strengthen our risk assessment procedures. This initiative is important because it links to three elements of this; namely making our evaluations as timely as possible, as well as ensuring equal treatment for applicants and the most efficient use of taxpayers’ money.”

EFSA considers that introducing the guidelines will strengthen the clarity and predictability of what applicants can expect from the Authority.

“This is a new approach and we recognise that the guidelines will evolve over time as we refine working practices further and consider future scientific developments,” said Dr Bergman. “While EFSA will adhere to the guidelines wherever possible, we understand that applications will need to be treated on a case-by case basis. Therefore, we will maintain a close dialogue with stakeholders as we put these new procedures into practice.”

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