The publication of the proposal for a « Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed » is scheduled for 5 July next, and the draft is circulating among the various DGs in an interservices procedure for final amendments before publication.
The text that is now circulating – unless any last-minute substantial changes – gives us an idea of the direction in which the Commission intends to go. It confirms our expectations, providing a good working basis on this file to boost innovation, and meet the health, climate and environmental challenges, ahead of the negotiations to come with the co-legislators.
First of all, a clear distinction is made between 2 groups of NGTs:
1. Plants obtained through targeted mutagenesis or cisgenesis, which could also occur naturally or be produced through conventional breeding (‘category 1 NGT plants’) would be treated similarly to conventional plants and would not require authorisation, but a simple notification. In addition, a transparency register would be established. If the notification takes place before the field trial, the verification of the criteria takes place at Member State level and the national decision has EU-wide effects and also applies to the placing on the market. For placing on the market where no field trials have been carried out in the EU, including imports, the decision is taken by the Commission, after verification of the criteria by EFSA. No specific labelling would be required.
2. All plants from NGTs that do not fall under the first case are called category 2 NGT plants’ and would fall under GMO legislation and therefore undergo an authorisation process. The risk assessment would be adapted to take into account their different risk profiles and measures would be introduced to incentivise plant products that could contribute to a sustainable agri-food system. Traceability would be maintained as well as labelling. On a voluntary basis, GMO labelling can be supplemented with information on the purpose of genetic modification, e.g. to increase the sustainability of the plant. Unlike for GMOs, for these plants it will not be possible for Member States to restrict their cultivation or circulation on the market. There will be regulatory incentives for (potential) applicants of category 2 NGT plants containing traits with the potential to contribute to a sustainable agri-food system, e.g. an accelerated procedure or where the applicant is an SME, it shall be exempted from the payment of the financial contributions to the Union Reference Laboratory and to the European Network of GMO Laboratories.
With respect to these two categories of NGTs, herbicide-tolerant NGT plants, even if they fulfil the notification criteria (category 1 NGT) will remain subject to authorisation and the related requirements, in order to be able to assess their impact on human and animal health and the environment in the medium and long term. “There is evidence to show that herbicide-resistant weeds may result from the combined use of herbicide-tolerant varieties and associated herbicide overuse, with potential health and agroecosystem impacts,” the Commission explains.
As far as organic is concerned, according to the Commission initial draft, both NGT1 and NGT2 would be banned in organic production and to enable this, it would be mandatory to indicate the use of NGT in seed labelling. Member States would have to take implementing measures for coexistence.
Once formally adopted by the college of Commissioners on the 5th July, this proposal will be discussed under co-decision by the European Parliament and Council. Both ComENVI and ComAGRI will be involved until the end of this mandate. Most probably it will be up to the next Parliament to finalise the deal and negotiate with the Council.
O artigo foi publicado originalmente em Farm Europe.
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