The risk assessment approach compares GM animals and derived food and feed with their respective conventional counterparts, integrating food and feed safety, and animal health aspects.
All stakeholders and interested parties are invited to provide their comments through an online public consultation that runs until 30 September.
The draft guidance outlines the methodology required for the comparative assessment of health and welfare aspects of GM animals. This assessment is applied in relation to the GM animal itself, where the assessment should focus on the effective functioning of the animal’s body system, and in relation to the food and feed risk assessment.
The draft guidance highlights the need for extensive comparative analysis of the characteristics and traits of GM animals, including physiological parameters, with those of their conventional counterparts. It also proposes that health and welfare should be assessed at all stages of development of the GM animal, up to the point at which it would receive authorisation (should this be granted).
In the final chapter of the draft guidance document, recommendations are made for the post-market monitoring and surveillance of GM animals and derived food and feed, which seeks to identify any potential unintended effects related to the genetic modification which might arise after the product has been authorised for placement on the market.
Following the public consultation, EFSA will assess all comments made and, where relevant, these will be incorporated in a revised guidance document to be adopted by EFSA’s GMO and AHAW Panels at the end of 2011.
Source: EFSA
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