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) Targeted (a) insertion of a contiguous DNA sequence or (b) substitution of an endogenous DNA sequence with a contiguous DNA sequence, where the contiguous sequence is in the breeders' gene pool and the modification does not result in an intragenic plant (though the definition of NGT does not include temporary insertion of genetic material from outside the breeders' gene pool during development of the new plant);
(4) Targeted inversion of a sequence of any number of nucleotides; or
(5) Any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (possibly with modifications as accepted under points 1 and/or 2) in a species from the breeders' gene pool.
Further, these 20 or fewer modifications must be in "predictable" DNA sequences that share "sequence similarity" with the targeted site, though the degree of required similarity is not clear.
Thus, the technical scope of "equivalence" is theoretically quite broad, though one will still be required to show that the modified sequence is "predictable" and shares some (presumably relatively high) sequence identity. Overall, these acceptable modifications seem largely designed to include methods that have a long history of safe use (such as random mutagenesis and subsequent selection, which often result in, for instance, the first and second types of modifications listed above), and modern targeted editing, such as CRISPR, can be used to make any of the above modifications.
1. No authorization or labeling duties for category 1 NGT plants
For NGT plants that could also occur naturally or be produced by conventional breeding and not harbor traits that can have a negative impact on sustainability, this regulation would provide a procedure to determine that the genetic modifications made and traits achieved are indeed of such a nature (a "notification procedure"), thereby classifying them as category 1 NGT plants. Category 1 NGT plants need to fulfill the criteria of equivalence to conventional plants set out in Article 5 and Annex I of the Proposal, i.e., when it differs from the recipient/parental plant by no more than 20 genetic modifications.
Category 1 NGT plants defined in this way will not be subject to the rules and requirements of the EU GMO legislation, unless the new legislation doesn't introduce new rules (Recital 11). Category 1 NGT plants will also be subject to any regulatory oversight that applies to conventionally bred plants (Recital 23). Despite the fact that category 1 NGT plants will not be subject to the rules and requirements of the EU GMO legislation, they would remain subject to the prohibition of use of GMOs in organic production to meet the demands of the sector (Recital 17).
The most striking change in the legal situation is that category 1 NGT plants in the future will no longer have to be authorized before they are placed on the market or used for any other purpose. Articles 6 and 7 of the Proposal provide for a notification procedure to a national authority to prove that the respective NGT plant, or food or feed produced from such plants, meets the requirements for classification as category 1.
According to Art. 7(2) of the Proposal, for example, to place a NGT plant on the market, the notification must include:
(a) The name and the address of the notifier;
(b) The designation of the NGT plant;
(c) A description of the trait(s) and characteristics which have been introduced or modified;
(d) The information necessary to demonstrate that the plant is a NGT plant; and
(e) An identification of the parts of the notification that the applicant requests to be treated as confidential.
In addition, it should be noted that there will be no labeling requirement for category 1 plants. The EU Commission explicitly states that labeling can be done "on a voluntary basis" (Recital 29).
All recognized – and thus approved – category 1 NGT plants must be entered in a publicly accessible database (Art. 10). Individual Member States may not restrict or even prohibit the deliberate release or placing on the market of category 1 NGT plants and the respective free movement of goods (Art. 9).
2. Authorization requirements for category 2 plants are less strict
For all other NGT plants (category 2 NGT plants), the Proposal provides for a simplification of the authorization procedures of the current GMO legislation, in particular, a risk assessment adapted to the risk profile of the plant (Articles 15 and 22). Given the wide variety of NGT plants, food, and feed, the type and amount of information necessary for the risk assessment will vary on a case-by-case basis (Annex II). Factors to be considered are, inter alia:
(a) The trait(s) introduced;
(b) The function of the modified or inserted genome sequence(s);
(c) The function of any gene disrupted by the insertion of a cisgene/intragene or parts thereof:
(d) Prior experience with the consumption of similar plants or their products; and
(e) Prior experience with the cultivation of the same plant species or plant species exhibiting similar traits or in which similar genome sequences have been modified, inserted, or disrupted.
This, however, only applies to NGT plants for food and feed. Category 2 NGT plants created for uses other than food or feed will only need a notification sent to the national authority (Article 16). However, it is mandatory to label category NGT2 plants and any products obtained from them (Article 26).
B. The EU Commission's reasoning
The Proposal is part of the European Green Deal, a set of proposals to make the EU's climate, energy, transport, and taxation policies fit for reducing net greenhouse gas emissions by at least 55% by 2030. With a liberalization of the legal situation for NGTs, the Commission hopes that the agricultural sector can also contribute to the targeted greenhouse gas reduction and the EU's Farm to Fork Strategy, aiming to reduce the environmental and climate impact of food production and consumption in the EU.
The EU Commission considers the existing GMO legislation not fit for the purpose of certain plant applications of new genomic techniques and too strict for NGT organisms. The existing authorization procedures and risk assessment requirements can therefore be disproportionate or inadequate (Recital 7).
C. Outlook
The Proposal is to be presented by the EU Commission on July 5, 2023. It will then have to go through the regular EU legislative process. The timetable for EU lawmakers is currently tight and quite challenging. After all, new elections to the EU Parliament are due in June 2024. In order not to interrupt the implementation of the project and unnecessarily postpone it, it is hoped there will be a speedy implementation within the next year.
The ambitious goals of the Commission are an important sign that could lead to Europe becoming a location for innovation. An overhaul of the outdated strict legal NGT framework will lead to increasing research into future technologies and enhance the competitiveness of the EU agri-food sector, while maintaining a high level of protection of human and animal health and the environment.
Research assistant Tim Stripling substantially contributed to this article.
For more information, read our previous client alerts:
CJEU Raises Bar for Use of CRISPR in Europe's Agribusiness: What You Need to Know
Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
© Morrison & Foerster LLP. All rights reserved
