Commission Plans Liberalization Of New Genomic Techniques (NGTs) In The EU

• Published date: 05 July 2023
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Food and Drugs Law, Biotechnology & Nanotechnology
• Law Firm: Morrison & Foerster LLP
• Author: Mr Wolfgang Sch'nig

After undergoing an extensive three-year consultation process, the EU Commission's proposal for a regulation on plants obtained by certain new genomic techniques like CRISPR-Cas (the "Proposal") is finally available for consideration (see Proposal). Although the official presentation is scheduled for July 5, 2023, the document was leaked and reveals a significant reversal away from the existing legislation on genetically modified organisms (GMOs), especially in the 2001 GMO Directive (see Directive 2011/18/EC) and the 2003 Regulation on genetically modified food and feed (see Regulation 1829/2003/EC). A new risk-based approach leads away from strict authorization procedures and labeling requirements.

A. Overview of the planned framework: Introduction of two categories of NGT plants

The new regulation is applicable to NGT plants and their food and feed. According to Article 3(2) of the Proposal, "'NGT plant' means a genetically modified plant obtained by targeted mutagenesis, cisgenesis, intragenesis, or a combination thereof, on the condition that the NGT plant does not contain any genetic material originating from outside the breeders' gene pool that temporarily may have been inserted during the development of the NGT plant."

"Breeders' gene pool" has been defined to mean "the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses."

The regulation follows a risk-based approach. Risk profiles associated with NGT plants are very diverse, from plants with risk profiles similar to conventionally bred plants to plants with various types and degrees of hazards and risks that might be similar to those of plants obtained by established techniques of genetic modification. The Proposal therefore adjusts the level of regulatory oversight according to this variety of potential risks posed by NGT plants and products (Recital 12). The Commission plans to introduce two categories of NGT plants (category 1 and category 2 NGT plants), in which category 1 plants are subject to less stringent requirements than category 2 plants.

Category 1 plants are considered "equivalent" to conventional plants, and must differ from the recipient or parent plant by no more than 20 genetic modifications of the following types:

(1) Substitution or insertion of no more than 20 nucleotides;

(2) Deletion of any number of nucleotides;

(3)...