Hello, my name is Karine
I am a scientist – biochemist –working at EFSA, the European
Food Safety Authority. Today I am here to talk about food and
feed-related regulated products, and the role played by EFSA in their
authorisation for the EU market. First of all I would like
to explain what we mean by regulated products and
market authorisation. In the European Union, products
related to the food chain must be authorised before
they can go on the market. Examples include
food and feed additives, food packaging, GM plants, pesticides and health claims
made about food products. The requirements for authorisation vary depending on the applicable
legislation for each type of products. To be precise, for regulated products evaluated
by EFSA, there are 34 European regulatory
frameworks for these approvals. But who authorises regulated products? Is it EFSA?
No. EFSA never authorises nor bans
regulated products. In the European food safety system there is a clear distinction between, on the one hand the risk
assessors – like EFSA – who provide independent
scientific advice, and on the other hand
the risk managers – like the European
Commission and the Member States – who make
the decisions. Both work together, but
independently to ensure that the safety of European consumers
remains a high priority. So what exactly is EFSA’s
role in this process? Well only products that are shown to be
safe can be placed on the market. EFSA is required to give
independent scientific advice about their safety. EFSA’s experts
evaluate the safety taking into consideration
the risk assessment performed by applicants
as well as any other available scientific studies
in line with the EU legislation and EFSA
guidance documents. Until recently, each regulated
product application was received, registered,
processed according to their respective scientific areas. However in 2011, EFSA created a
dedicated Application Helpdesk. The main functions of the
new Application Helpdesk are first, to support
the applicants and in particular small and
medium-sized enterprises, as well as stakeholders such
as Member States and national authorities
when they submit their application or required information on
the processing of an application. Second, to centralise,
streamline the administrative tasks so that the scientific staff can focus
on their scientific work. This is improving efficiency at EFSA. Third, to promote transparency
and openness by cooperating with stakeholders and creating more understanding
about EFSA’s work. Importantly the Application
Helpdesk is also available to answer any questions from applicants,
stakeholders and other interested parties about EFSA’s work in the area
of regulated products. You can submit questions on-line, for example
about the status of an application or about the process under specific
legislation in a given area. Thank you very much, and if you have a question
about regulated products, send your question to
Application Helpdesk.

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