The European Parliament's Committee on Environment, Public Health and Food Safety advocates allowing the use of NGTs in organic agriculture

Last October, the Committee on Environment, Public Health and Food Safety of the European Parliament presented a proposal for amendments to the draft of the European regulation on new genetic editing techniques by the Commission. This proposal has been well received by representatives of the biotechnology industry.

The amendments proposed refer to a clarification of what is considered an NGT product and what is defined as NGT plants. They also emphasize the need for the verification process to be supported by scientific evidence.

Additionally, these amendments provide some considerations regarding the authorization and monitoring process of NGT plants and products, primarily those falling under category 1. This includes criteria such as a maximum of 20 genetic changes proposed in the draft as one of the criteria for being considered in this category, the use of these plants and products in organic farming, as well as the labeling and traceability of these.

Below is a summary of the amendments made by the European Parliament:

Clarification and Improvement of Criteria for NGT Plants

• It is important to note that products derived from NGT plants include both food and feed. Therefore, it would be more appropriate to refer to them simply as "NGT products" without additional specifications, thus encompassing any product that originates from plants obtained through NGT. (Amendment 1, Amendment 12).
• It is suggested to revise the definition of "NGT Plant" in the proposed Regulation. Instead of considering it as a genetically modified plant obtained through directed mutagenesis, cisgenesis, or a combination of both, the proposal is to remove the term "genetically modified" to avoid connotations suggesting changes in the organism's DNA through the introduction of DNA from different organisms. (Amendment 10).
• In the definition of "directed mutagenesis," it is proposed to modify the text that mentions that mutagenesis techniques result in modifications of the DNA sequence at "precise locations" in an organism's genome, replacing it with modifications at "targeted locations" of the genome. This more accurately reflects the goal of the techniques, which is to modify a specific part of the genome but not necessarily an exact part of that specific area. (Amendment 11).
• The proposal sets forth a process to verify that an NGT plant meets the necessary equivalence criteria to be classified as Category 1. Therefore, it is argued that these plants should be subject to the same regulatory framework as conventional breeding products, without additional requirements that may be considered discriminatory. Based on this, it is more consistent to include Category 1 NGT plants in Annex IB of Directive 2001/18. (Amendment 15, Amendment 16).
• Regarding the threshold of 20 genetic changes for Category 1 NGT plants, it is suggested that this be based on the haploid genome. This is justified by the need for equivalence with conventional plants to allow crops with complex genomes to benefit from NGT in the same way as diploid crops. It is important to specify that each change in a plant and/or crop should be relative to the ploidy state of the crop in question. (Amendment 22, Amendment 23).
• It is relevant to highlight that there are multiple examples of cisgenesis applications that are used to introduce beneficial traits without creating intragenic plants or generating random insertions of endogenous genes. Excluding these applications would reduce opportunities to develop beneficial NGT applications. (Amendment 22, Amendment 23).

Authorization and Monitoring of NGT Plant Use

• The aim of this Regulation proposal is to simplify the cultivation of NGT plants in the European Union; therefore, it is suggested that Member States should not foresee measures that restrict or prohibit the cultivation of NGT plants, as this would go against this purpose. (Amendment 7).
• Regarding the authorization of a plant as an NGT, it is suggested that it should be for an unlimited period from the outset. The current proposal mentions that authorization becomes unlimited after the first renewal. (Amendment 6).
• In the Regulation proposal, there is a requirement to monitor the development and presence of NGT plants in the market and assess their impact. It is proposed, instead, that the Commission conducts an assessment of the Regulation every five years and measures progress with the aim of improvement. (Amendment 9).
• It is essential to emphasize that Member States must ensure and respect that NGT plants and their related products are part of the free movement of goods. (Amendment 8)

Ensuring a Science-Based Verification Process

• It is proposed that the criteria established in the proposal to consider an NGT plant equivalent to natural or conventionally obtained plants should be the responsibility of the competent national authority where the application is made to ensure that the declaration of NGT Category 1 is made more efficiently. (Amendment 2).
• Additionally, it is proposed that consultation of the procedure should only involve the Commission and the European Food Safety Authority if there are reasonable objections from the Member States. (Amendment 17).
• The verification process must be based on compliance with the scientific criteria that define an NGT Category 1 plant. Any intervention by the Commission must be scientifically justified and based on the proper application of the criteria proposed in Annex 1 of the proposal. (Amendment 17, Amendment 18, Amendment 19, Amendment 20)

Organic Farming

• In relation to organic farming, the use of Category 1 NGT plants should not be excluded from organic production. On the contrary, their use should be allowed, as they should be considered under similar conditions to conventional breeding products. Furthermore, it is important not to prohibit their use by farmers who follow organic farming practices. This would allow organic farmers to make independent decisions regarding the use of these products/crops. (Amendment 4)

Traceability and Labeling

• The declaration of the use of an NGT Category 1 plant should be in a publicly available database, and there is no need to create new labeling for seeds from these plants. (Amendment 3, Amendment 5).
• Additional provisions regarding labeling for seed bags of NGT Category 1 plants are discriminatory and introduce an additional intermediate category between conventional and GMOs. (Amendment 5, Amendment 21).

Access the regulation proposal here

Access the amendments here