EFSA GM guidance may require more data from biotech firms
EFSA's GMO unit proposed the changes in its draft guidance document for the risk assessment of the renewal of authorisation of GM plant products as required by regulation EC no 1829/2003.
This update of the 2006 guidance was self-tasked by EFSA in an effort to provide clarity and reflect the now greater availability of plant data.
The draft released for stakeholder feedback last year read: "This Guidance document describes the mandatory requirements for renewal applications, which should contain the identification of the transformation event(s), a copy of the authorisation, post-market monitoring and post-market environmental monitoring reports, systematic search and evaluation of literature, updated bioinformatics and any additional documents or studies on the GM food and feed."
At its plenary yesterday in Brussels - the first open meeting to be held away from the organisation's base in Parma - some panel members expressed concern over whether this additional data, like updated bioinformatics, would be mandatory and if so whether this went beyond legal requirements.
Asking or telling?
One panel member said: "I'm not a lawyer, but I have my doubts."
The panel discussed removing the word 'mandatory' in the final version.
Another asked: "What will the consequence be for authorisation? That is not clear for me. If I'm asking for more information, I want to know what I'm going to do with this information."
Speaking after the event, one observer told FoodNavigator this question of voluntary vs mandatory meant the issue was currently "blurred" for industry.
The consultant, who preferred not to be named, added that biotech firms were likely to adhere to the guidance regardless of whether it was mandatory since to ignore EFSA's clear preference would risk delays if the application was sent back with a request for more data.
How much do you want to know?
Some of the panel members said the exercise was necessary to establish whether the plant had changed since the original authorisation ten years previously and stood by the request for bioinformatics as a new method for establishing this.
Companies are already required to submit annual monitoring documents to the Commission, but the panel's chair Professor Joe Perry said he doubted whether this alone meant all data was up to date. Some observers told us these monitoring documents were also set to come under EFSA's remit.
Sceptics on the panel asked whether this 10-year exercise was about "ticking a legal box" in which less information was needed or "carrying out a new risk assessment" in which case more was needed, meaning neither was fulfilled under the current draft document.
According to one member of the working group, the comments received in the consultation period split down to around 60% saying EFSA had asked for too much data and 40% saying EFSA hadn't asked for enough.
EFSA has processed 25 renewal applications under the 2006 guidance.
