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, and amending Regulation (EU) 2017/625

Annexes to the Proposal

Update

The EU has set out how it will regulate the marketing of crops produced using certain new techniques that change genetic material in plants (new genomic techniques, NGTs). NGT plants that could occur naturally or by conventional breeding will not be considered to be genetically modified organisms (GMOs), so will not need to be risk-assessed and authorised. Other NGT plants, where changes to the plant could not occur naturally or through conventional breeding, will require risk assessment and authorisation under GMO legislation.

Given differing views on GMOs, reaching agreement on this proposal among EU institutions is expected to be difficult. Exporting countries have an opportunity to provide initial feedback on the proposal to the Commission until 2 November 2023.

What is changing?

Scope

The proposed Regulation applies to plants produced using certain NGTs that do not insert genes from other plants (these are known as “NGT plants”). The relevant techniques are targeted mutagenesis and cisgenesis (see Background section for more detail). The rules apply to food, feed and products containing NGT plants, but not to microorganisms, fungi or animals.

Two categories of NGT plants

The proposal creates two categories of plants and related products from NGTs.

Category 1 NGT plants/products

These are considered equivalent to plants produced by conventional breeding. They are not considered to be GMOs and therefore do not have to comply with the general GMO rules (Directive 2001/18/EC and Regulation 1830/2003). For non-EU suppliers, commodities that are category 1 NGT plants may be placed on the EU market in the same way as conventional commodities. They do not require specific labelling or traceability.

Products of category 1 NGT plants can only be placed for the first time on the EU market following a verification procedure that checks the status of the plant/product, including its equivalence to conventionally bred plants, and does not involve risk assessment and risk management. Annex I of the proposed Regulation sets out a list of criteria that determine whether NGT plants can be considered equivalent. The Commission will establish a public database listing decisions on the status of category 1 NGT plants.

Category 2 NGT plants/products

NGT plants that are not equivalent to those produced by conventional breeding must be risk-assessed and authorised under GMO legislation. The proposal provides some flexibility around risk assessment requirements to take into account the wide variety of NGT plants.

Organic production

GMO crops or products may not be produced in organic production. The Commission proposes that category 1 NGT plants should also be prohibited in organic production, although they do not fall under GMO legislation.

Why?

The EU's rules on GMOs were adopted in 2001 (Directive 2001/18/EC). Since then, a variety of NGTs have been developed. A 2021 review of GMO legislation concluded that the current rules did not reflect scientific and technological progress, and prevented the development and marketing of NGT products that could be beneficial to farmers, consumers and the environment (European Commission 2021).

Timeline

Feedback on the proposal can be submitted via the Commission’s website, Legislation for plants produced by certain new genomic techniques, until 2 November 2023.

The proposal will be discussed and amended by the European Parliament and the European Council. Discussions will start in autumn 2023.

What are the major implications for exporting countries?

If adopted, this Regulation will allow non-EU suppliers of products from NGT category 1 plants to place products on the EU market without specific traceability or labelling requirements.

It will provide legal certainty and confidence to suppliers of all commodities/products that NGT category 1 plants can be grown in the exporting country without risk of damaging exports to the EU.

Recommended Actions

Feedback on the proposal can be submitted to Commission’s website, Legislation for plants produced by certain new genomic techniques, until 2 November 2023. This feedback will feed into the legislative debate.

Background

Discussions centre on the distinction between “conventional” genetic engineering and “new” genomic techniques. In conventional genetic engineering, certain traits related to one organism can be transferred into a second organism by inserting entire genes into the genome of another (third) organism. These genes are not targeted, but inserted randomly into the genome.

By contrast, certain NGTs involve targeting individual parts of the DNA (nucleotides) to obtain certain effects, similarly to natural mutations that occur in living cells. NGTs include:

• mutagenesis: modification of the DNA sequence at precise locations in the genome of an organism
• cisgenesis: insertion in the genome of genetic material already present in the breeder’s gene pool.

EFSA (2021) concluded that the mutations induced by NGTs can sometimes be comparable to those that occur in conventional plant breeding. This allows the proposal to distinguish two categories of plants: those where the effects of NGTs could occur in conventional breeding, and those where they could not.

There is considerable debate within Europe about whether all NGTs should be subject to the same legislation as conventional GMO techniques. The Commission’s proposal has been welcomed by some farm and food industry groups that see NGTs as offering innovative solutions to current farming challenges (CEJA 2023, Copa-Cogeca 2023 [direct download], FoodDrinkEurope 2023). Organic producers are concerned that without stricter traceability and labelling it may not be possible to segregate NGT and organic plants, and that consumers will not know whether they are eating GMOs (IFOAM 2023). Environmental groups have expressed concerns that not assessing some NGT plants could compromise consumer safety, and they challenge claims that NGT plants could contribute to sustainable agriculture (Greenpeace 2023, PAN Europe 2023).

Resources

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