Food Law News - EU - 2005

EFSA Press Release, 18 July 2005

GMOs - EFSA consults widely on risk assessment of GM Microorganisms

The European Food Safety Authority (EFSA) has today launched an open consultation on its guidance document for the risk assessment of Genetically Modified Microorganisms (GMMs)

EFSA’s guidance document is intended as an aid to applicants requesting authorizations for GMMs and their derived products intended for food and feed use, and notably with respect to the information required for their risk assessment. The document provides guidance for the risk assessment of a broad spectrum of GMMs and derived products ranging from pure compounds used in food and feed (e.g. additives and flavourings) to viable GMMs (e.g. probiotics and starter cultures for dairy products or beverages). Typical GMMs covered by the guidance document are various forms of non-harmful bacteria, yeasts, fungi and microalgae used in food or feed. The guidance document identifies 3 groups of GMMs, with the highest level of scrutiny reserved for products containing viable GMMs.

EFSA is interested in receiving input and comments on the guidance document from potential applicants, national food safety authorities and other regulatory bodies, key stakeholders and other interested parties. Through this consultation EFSA hopes to be able to take into account the views of all those concerned by GMM risk assessment and to cater for the needs of end-users.

Dr. Harry Kuiper, Chair of EFSA’s Panel on Genetically Modified Organisms (GMO) which drafted the guidance document said:

“This is the second consultation which EFSA has undertaken on GMO risk assessment and attests to EFSA’s commitment to openness and transparency. Through this process, we intend to involve all those interested in the risk assessment of GMOs. Genetically Modified Microorganisms can be very important to food and feed production. We hope that this document will provide industry with clear guidance and facilitate both applications and the risk assessment of GMMs by our Panel.”

EFSA welcomes input from stakeholders and interested parties before 15th September 2005. The consultation document and instructions on how to provide input are available on EFSA’s website at

The consultation document is also available on this site: Draft Guidance Document for the Risk Assessment of GMMs and their Derived Products Intended for Food and Feed Use

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