PM+: GMO authorisation needs legal certainty

Ahead of the European Parliament’s vote on the use of GMOs, Nathalie Moll calls for a shift to a more coherent and science-based approach to EU policymaking.

By Nathalie Moll

Nathalie Moll is Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA)

26 Oct 2015

The European Commission has told MEPs and EU member states that there is no 'plan B' if the proposal to enable national bans on the 'use' of GMOs is rejected. Which is a good thing, given that what is actually needed to fix the problem is adhering to legal timelines and authorising safe products.

The legal timeline for the Commission to put European Food Safety Authority (EFSA) assessed products to the vote is three months. For products approved in 2015, this step alone took over 16 months. Several EU member state ministers emphasised the need to avoid undue delays at their agriculture and fisheries council meeting in July, where they urged the Commission to commit to following the timelines and processes set out in current legislation.

It is the whole EU food and feed chain's hope that this means that should the proposal be rejected, the institutions will start to abide by existing legislation and approve safe products according to legislative timelines. This would reinstate the much needed legal certainty for all operators.


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The biotech industry welcomed the authorisation of 17 GM products for imports earlier this year in April. Attention must now turn to the 40 odd additional GMO applications for import that are still pending in the system, among which five have already received a positive EFSA opinion.

We strongly believe that failing to support the EU's own best science by upholding the approval of safe products is the single most damaging element for growth, innovation and investment, as well as consumer confidence and safety.

This is why it is very concerning to see that a number of EU member states continue to regularly vote against EFSA's positive opinions on GMO approvals, leading to confusion within the general public as to the safety of products and the reliability of the European approval system in ensuring that safety.

Additionally, there appears to be no clear correlation between trade volume and voting behaviour, as member states that routinely vote against import approvals, then import and use the products once these are finally approved.

More effort should be made to disseminate information about the existence of the strict pre-market authorisation system for GMOs and what it means in terms of product safety.

Now would also be a good time for the Commission to finally put forward a proposal that has been requested by member states since 2006. This includes plans on the adventitious presence of GMOs in seeds, as well as a so-called 'technical solution' for food, which would provide the legal certainty currently lacking in these areas.

Today, numerous legal thresholds exist to cater for admixtures and impurities, including for some impurities with hazardous properties like mycotoxins known to cause cancer - but no threshold is accepted for safe GMOs approved elsewhere in the world.

I hope that the European Parliament's vote on the Commission's patchwork proposal allowing national bans on the use of GMOs will mark a shift towards coherent and science-based policymaking. It's time for sense and predictability.

Read the most recent articles written by Nathalie Moll - Rare Diseases: Why medical innovation needs to be one step ahead

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