EU Regulation of Genome Editing in Plants not yet a law
A long-awaited draft regulation from the EU Commission's DG Sante to deregulate the authorisation, risk assessment and labelling of a whole range of new genetically modified organisms (GMOs) has been published today by the College of the Commission. New Genomic Techniques (NGT) are introduced as an umbrella term for certain genetic engineering techniques that aim to modify DNA more precisely than "old" methods by targeting changes to pre-defined loci in the genome. The proposal creates two distinct pathways for NGT plants to be placed on the market. "Category 1 NGTs" are considered equivalent to conventionally bred plants and no longer require prior case-by-case risk assessment.
The EU proposal has a clear message: the requirements for simple genome-edited plants shall be significantly relaxed. There will no longer be the elaborate approval procedures that are required for genetic engineering, nor will there be a general labelling requirement. Field trials, which are so important for the first realistic tests after development in the laboratory and greenhouse, will become easier. And, unlike with conventional genetically modified plants, individual EU member states will not be able to ban the cultivation of these edited plants in their countries or prohibit field trials.
The most far-reaching relaxations apply to Category-1-NGT (New Genomic Techniques) plants, i.e. plants that have been produced using targeted mutagenesis – such as CRISPR/Cas or TALEN – and contain only genetic material that is present in the gene pool of the species used for breeding.
All NGT1 plants, regardless of the method used, could also have been bred conventionally or could have arisen by chance mutation under natural conditions. NGT1 plants defined in this way will be exempt from most of the requirements applicable to GMOs under the EU Commission’s proposal.
There is no labelling requirement for food and feed produced from NGT1 plants. However, seed or material suitable for propagation must be clearly labelled. On the basis of this information, farmers will be able to decide whether or not to grow such plants. NGT1 plants are still not allowed in organic farming, as industry associations have pushed for.
For all other plants bred using new genomic methods that do not meet the NGT1 criteria, regulations similar to those in the Genetic Engineering Act generally apply, albeit with some relief. For such plants, known as NGT2, the approval process can be simplified with a safety assessment if there is no "plausible evidence" of potential risks. However, NGT2 plants and the products made from them must be labelled. What is new is that the modified or newly added trait must be named.
But: It may be some time before the new "law on plants derived from new genomic techniques" comes into force. Once formally adopted by the EU Commission, it will have to go through the EU Parliament and the Council of Ministers. This is unlikely to happen quietly and without much debate, as many countries, such as Austria and Germany, have expressed their opposition already. Whether the Spanish Presidency of the Council of the European Union will be decisive for the votes remains to be seen. The Spanisch Biotech Organization AseBio is very much in favor of the new proposal, see comment.
Useful source: https://food.ec.europa.eu/plants/genetically-modified-organisms/new-techniques-biotechnology_en
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