Improving the European regulatory environment for biotechnology
Major developments
Advanced Therapies - helping shape the EU regulatory system
EuropaBio is helping shape legislation on Advanced Therapies - the revolutionary area of biomedicine covering gene, tissue and cell technologies. The Advanced Therapies Medicinal Products (ATMP) regulation came into force on 30 December 2008, but the work continues - a priority is helping the EMEA in its work on guidelines, rules and scientific assessment procedures to aid correct implementation at national level. EuropaBio has been working in partnership with EBE and Eucomed on this issue.
EuropaBio brings Members' points of view to the European Food Safety Authority (EFSA)
In 2008 EuropaBio provided extensive harmonised input into several public consultations organised by the European Food Safety Authority (EFSA). In close collaboration with its members, EuropaBio coordinated industry participation and provided comments to several draft guidance documents, such as the EFSA updated guidance document for the risk assessment (RA) of GM plants and derived food and feed, and the EFSA draft guidance on the RA of GM plants for non-food and non-feed purposes.
Ag biotech receives backing by Commission College and some Member States
2008 was a year where ag biotech regulatory issues climbed the political ladder and were discussed both by the College of EU Commissioners in May and by the "Sherpas" to the 27 Member State leaders thereafter. Both Commissioners and Sherpas agreed in writing that a number of steps must be taken to ensure the approval process for ag biotech products functions correctly. Such steps included the need to ensure the approval of ag biotech products occurs without undue delays; that a technical threshold is set for the low-level presence of GM material approved outside the EU and entering the EU as traces in traded commodities as well as thresholds are set for the adventitious presence of GM seeds in conventional seeds. Cultivation of biotech crops in Europe was recognised as a reality, with ever-increasing adoption in those Member States with the necessary legislative and agricultural conditions in place.
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Get the facts about biotech |
"Can GM save the world?"
asks the BBC's Horizon programme
The BBC Horizon programme sent Jimmy Doherty - an advocate of sustainable farming - on a personal mission to get at some of the truths on GM. He concluded: "No-one is saying GM is the total solution to all these problems [food crises, drought]. But if there is a chance it can provide some of the answers, then we need to pursue it."
Read the full article here
"There will be no bio-based economy without a performance-based agriculture economy."
Nathalie Moll, Director, Green Biotechnology
Challenges and opportunities
EuropaBio continues working to:
- implement gene, cell and tissue engineering rules.
- ensure an appropriate and workable sustainability certification scheme in line with EuropaBio position.
- ensure agricultural biotech approvals; no undue delays in the setting of EU-wide thresholds for the adventitious presence of GM seeds in conventional seeds and for the low-level presence of GM material not yet approved in the EU, entering the EU in traded commodities.
- support the implementation of the Advanced Therapies regulation.
- respond to the European Commission's consultation on the Variation Regulation, ensuring that specificities of biological products are taken into account.
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