Data: 21/10/2021

Feedback of the Italian Society of Agricultural Genetics, regarding the EU Commission Initiative "Legislation for plants produced by certain new genomic techniques"

Submitted online on Oct. 20, 2021

The Italian Society of Agricultural Genetics (SIGA), welcomes the initiative to propose a legal framework for plants obtained by targeted mutagenesis and cisgenesis (new genomic techniques, NGTs) and for their food and feed products. SIGA believes it is time to revise the EU regulatory framework of plants produced using recombinant DNA technology, mainly established by Directive 2001/18/CE. The aim of such revision is to exempt most NGTs products from the Directive, as rapidly as possible.

It is important to underline that, as mentioned in the Inception Impact Assessment, the EU Commission study published in April 2021 concluded that plants obtained from NGTs have the potential to contribute to the objectives of the European Green Deal and in particular to the Farm to Fork and Biodiversity Strategies and the United Nations’ Sustainable Development Goals (SDGs) for a more resilient and sustainable agri-food system, and that, on the other hand, the current legislative framework does not take into account whether products have the potential to contribute to societal challenges, notably sustainability. It therefore lacks mechanisms to incentivize the development and placing on the market of products that contribute to the sustainability objectives of the European Green Deal and Farm to Fork and Biodiversity strategies, provided they are safe.

Indeed, Directive 2001/18/CE is unsuited to take into consideration the progress that has been made in the last two decades, and which is obviously still ongoing, regarding our knowledge of the structure and evolution of plant genomes, plant domestication, and new molecular genetics technologies. Currently, the best example of such discrepancy is the fact that, at the moment, genome editing falls within the extremely strict and discriminatory rules of Directive 2001/18/EC but has received the 2020 Chemistry Nobel Prize award with the motivation that it has not only revolutionised basic science, but also resulted in innovative crops and will lead to ground-breaking new medical treatments.

In the last century, genetic improvement of agricultural plants has been the main drive for increased productivity and quality. The natural development of such progress, NGTs, have enormous potential for sustainable, organic and zero-residue farming, in addition to yield, nutraceutical value and sensorial quality. This has been recognized by all major Nations outside the EU by updating their legislation for plants produced by recombinant DNA techniques, in ways that lift scientifically unreasonable obstacles for the registration and cultivation of plants produced by NGTs. The last example has been Japan: despite a very traditional agricultural setting, in September 2021, it was the first country to commercialize an edited tomato variety with increased health-promoting properties. Given this international scenario, also underlined in the Commission Impact Assessment, any reluctance to revise the EU legal framework will negatively affect our scientific innovation and our global competitiveness in the agricultural sector.
Our view follows the strategy illustrated during recent years by many EU scientific societies and organizations, including ourselves. This strategy has been, for example, summarized in a joint statement by the German National Academy of Sciences Leopoldina, German Research Foundation and Union of the German Academies of Sciences and Humanities (2019), as well as in a statement by the European Academies’Science Advisory Council (2020), and can be briefly explained as follows:

1. Given the urgency to exempt from the GMO regulations a number of genome editing products, a first, short term action should amend ANNEX I B of Directive 2001/18/CE

2. A probably long term action should develop a completely new legal framework, based on the traits of the new variety instead of the technology used to introduce that trait. This will imply abolishing any legal use of the term Genetically Modified Organism, which has no scientific or merely rational meaning.

Our proposal regards step 1, and it is conceived to be as simple and clear as possible, to avoid entering into unfruitful, and probably not very scientific, discussions about details of the length and composition of the introduced mutations. It is instead based on the simple principle that gene inactivation and the introduction of natural gene variants from the same species or a species that can be interbred have been, serendipitously or based on rational knowledge, the aim of any plant selection or breeding programme, since the origin of agriculture. It thus links the new techniques to the historical tradition of exploiting natural biodiversity, in this case with unprecedented precision and safety.

We propose the following modification of ANNEX I B.

PROPOSAL OF MODIFICATION OF ANNEX I B OF DIRECTIVE 2002/18
TECHNIQUES REFERRED TO IN ARTICLE 3

Techniques/methods of genetic modification to be excluded from the Directive, on the condition that they do not involve the use of organisms other than those produced by one or more of the techniques/methods listed below, and that the recombinant DNA molecules possibly used to introduce the modification have been completely eliminated, are:

(1) mutagenesis,
(2) cell fusion (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods,
(3) the induction of targeted DNA breaks in selected sites, without the use of nucleic acid molecules as template for DNA repair,
(4) the induction of targeted DNA breaks in selected sites, with the use of a nucleic acid molecule as template for DNA repair that introduces a targeted single base substitution,
(5) the induction of targeted DNA breaks in selected sites, with the use of a nucleic acid molecule as template for DNA repair that introduces a sequence already present in the species’ gene pool, or a modification identical to a known allele of the same gene or to a known structural variant present in the gene pool of the species, or of a species with which it can be interbred.

At this stage our proposal is obviously open to improvements, but we think it is really time to finalize all the general suggestions made by the EU scientific community in the last years.

We are aware that, as underlined in the Impact Assessment, the major opposition to an update of the Directive that takes into account the progress of science comes from the organic agriculture sector and the associations that support it as the only form of sustainable agriculture, against any scientific evidence. We wish to be very clear on this. The concerns raised by organic agriculture regarding NGTs have nothing to do with their freedom to operate, food safety and risks for biodiversity. Organic farmers are free to follow their own regulations, which, without any scientific justification, prohibit the use of any plant produced using recombinant DNA technology. What organic farming cannot do is to limit the freedom to operate of the rest of the agriculture sector. Once a plant is considered safe for health and the environment, independently on the technique used to develop it, there should be no question about making it available to whoever wishes to cultivate it and making its products available on the market.


Edgardo Filippone, President