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EU Regulation on new genomic techniques won’t change the rules for GMO foods

On 8 December 2023, a member of “There is Such a People” party (ITN), Toshko Yordanov, announced from the parliamentary rostrum that the government had approved the certification of GMO products in Bulgaria. In his declaration before parliament, the minister insisted that the government’s decision:

would release new, untested GMO products into the environment;

would remove all regulations for GMOs;

would allow them to be sold without labelling or traceability;

would overturn our government’s right to ban or regulate the cultivation of GMOs within our borders.

The announcement was widely publicised by news outlets and on social media

Regardless of Yordanov’s press statement that “there was an unofficial meeting of the Council of Ministers”, the decision was in fact made during a regular government meeting on 6 December 2023. The Council of Ministers approved Bulgaria’s position before the EU Commission’s Agriculture and Fisheries Council on the 11th and 12th of December in Brussels. 

The issue concerns a proposed regulation on plants obtained through certain new genomic techniques, as well as their use in foods and animal feed. Bulgaria’s position is that the country is satisfied with the recent changes to the text and could support reaching a compromise towards the case.

Early in the morning of 8 December in a specially convened press conference, the “Bulgarian Nature” Coalition expressed disagreement with the prepared changes, arguing that the adoption of new GMO regulations would jeopardise Bulgaria’s agricultural production and make its export more difficult.

On the same day at 18:00, a joint meeting was held between the parliamentary committees on agriculture and European affairs. Early in the meeting it became clear that the Council of Ministers (CM) had changed its position. In a media statement from the government press centre, it was announced that Bulgaria would vote “abstain” in the 10–11 December meeting. The reason given for this decision was a parliamentary majority and opinions received by the CM from the non-governmental sector. 

In the discussion, most ministers admitted that they were not familiar with the proposed framework. They have decided, following the Agricultural Council meeting in Brussels, to invite representatives of the Ministry of Agriculture and experts in order to familiarise themselves with the proposed Regulation text.

Discussions on the new regulation on plants obtained through certain genomic techniques have been ongoing at the European level since 2021 with Bulgaria’s participation. The document was officially presented by the EC in July of this year, and governments had the opportunity to comment or ask questions about the proposed changes until the end of November.

What are the new genomic techniques?

New genomic techniques have grown in popularity since Jennifer Doudna and Emmanuelle Charpentier received the 2020 Nobel Prize in Chemistry for developing a technology for “high-precision genome editing”. The two researchers used a bacterial immune system to neutralise viruses by cutting out their DNA with a technique known as genetic “scissors”. It is thought that the CRISPR/Cas9 method could lead to new scientific discoveries, better agricultural crops, and new weapons in the fight against cancer and genetic diseases.

Yet agriculture has strongly relied on genetic selection for centuries, biologist Dr. Yordan Stefanov explains on his blog. “People have used archaic selection techniques, through which they have cultivated dozens of generations of the very same strain in the hope of preserving heritable change (mutation), a kind of genomic change, that will bring about the phenotype we desire — bigger fruits, sweeter taste, a more durable crop, higher yields”.

As schoolchildren we learned about more contemporary attempts by Gregor Mendel with peas and his theory of inherited traits. Bulgarians also know the name famously associated with plant cross-pollination, Ivan Michurin, in part because the modern-day town of Tsarevo bore it during socialism.

New genomic techniques (NGT) represent different biotechnological methods which change an organism on another level — through genetic modification. 

It’s how the right characteristics are determined and selected from a plant’s own DNA or that of a similar plant. Plant breeders can then use NGT to develop new traits or improve existing plants with better accuracy and speed than with conventional breeding technologies. 

Some of the NGT-derived changes could be found in nature or brought about through traditional breeding methods. 

The applied techniques for targeted mutagenesis, cisgenesis and intragenesis are believed to be the closest to natural changes in an organism. Plants are either subjected to stressful conditions, resulting in a desired mutation, or transfer their genetic material to other plants that are compatible by nature. 

With the use of other NGT products, other significant transformations can be undertaken. One such method is transgenesis, through which foreign genetic material can be introduced.

Is everything genetically modified?

A “‘genetically modified organism’ (GMO) means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating or natural recombination”, states the GMO definition laid down in the European Parliament Directive on the deliberate release into the environment of genetically modified organisms of 2001.  

Then Appendix 1 A describes the techniques that are not considered to be genetic modification and therefore do not fall under the control of this regulation. These are mutagenesis and cell fusion, in which genetic material is exchanged through traditional breeding methods. 

In 2018, however, following a lawsuit by French farmers, the EU Court of Justice, guided by the precautionary principle, ruled that the application of the genomic technique mutagenesis is a type of genetic modification and any organisms obtained through it should fall within the scope of GMO law.

Thus, according to current EU legislation, all plant products where new genomic techniques are used fit within the category of genetically modified organisms (GMO) and are subject to the same regulation.

What are the proposed changes to the GMO regulation?

The EU Court ruling, rapid progress in biotechnologies in recent years and a lack of understanding about their results are partly why the EU Council tasked the EC in 2019 with an in-depth study on NGT.

The Commission’s study revealed in 2021 that the existing GMO legislation does not keep pace with scientific and technological progress, nor does it sufficiently facilitate the exploitation or market release of products obtained through NGT innovations.  

The EC’s Joint Research Centre (JRC) conducts analysis on the latest scientific achievements in NGT and their development for various crop types, while the European Food Safety Authority considers scientific advice related to the safety of these products

This is the basis for the new regulatory framework. It proposes different procedures for the release of plants obtained through NGT, depending on the techniques used. It aims to distinguish those varieties “considered to be equivalent to conventional plants” from other NGT-derived plants. 

Plants modified through NGT are divided into two groups:

  • Category 1 includes plants occurring in nature or obtained through conventional breeding via mutagenesis and cisgenesis. It is mandated that they cannot differ from the mother plant by more than 20 modifications.

Before these products can be released on the market, they will be tested for their equivalence with conventional products. The verification procedure will be simplified considerably: with an application submitted to the competent authority in the respective EU country and providing information about the genetic modifications used. These plants will not necessitate a risk assessment because they are considered the same as naturally occurring products and can therefore be labelled as such.

At the consumer level, traceability will be assured through the creation of a publicly accessible register where the plants in this group will be listed.

  • Category 2 comprises all other plants obtained through NGT. The existing legislation on GMOs applies to them, as it has up to now. They can be released on the market following a risk assessment, and only after the authorisation procedure is complete. These plants are subject to special labelling and tracking.

Nowhere in the new Regulation is it indicated that the regulations for all GMO cultivation will be dropped. The new framework doesn’t affect member states’ right to ban GMO cultivation within their borders, and this option is thus not being removed.

The only GMO approved for cultivation in the EU is MON 810 corn, which is grown in Spain and Portugal, but 18 of the 27 EU states have restricted or banned its cultivation anywhere within their borders. Bulgaria is among the countries which have imposed a total ban. 

For and against the new framework

Public consultations before the document’s release demonstrate a stark divide between those in favour and those against the proposal. 

Arguments “for” include the removal of heavy regulatory and bureaucratic burdens in the use of NGT, the opportunity for innovation in crop production, product sustainability, and the fight against climate change.

Among the proposal’s proponents are the biggest agricultural lobbyists in the EU: COPA-COGECA, COCERAL (grain traders), FEDIOL (vegetable oil and protein flour producers), and others.

Opponents to the idea of categorising NGTs are largely smaller farmers’ unions and organisations involved in organic farming, ecology, and healthy eating. Their concerns are that agricultural producers’ freedom will be taken away and it will disturb the balance between nature and biodiversity. A number of organisations also envision an attempted “corporate takeover” by the bigger agrochemical companies.

Among the naysayers to these changes are IFOAM Organics Europe (organic farming movement), Friends of the Earth Europe, Slow Food, and others. At a meeting held in February of this year, they delivered a petition to the EC that had been signed by 420,000 EU citizens and in which they insisted all GMOs should be “regulated and labelled” — including those derived from so-called new genomic techniques — in accordance with the current EU directive on GMOs.

The EC Proposal has already been discussed several times in the EU Council

Member states are voicing concerns that the issue has not been researched well enough and they are worried about the testing to be carried out on category-1 products.

Bulgaria has requested additional clarification regarding the coexistence of NGT-derived products and those of conventional or organic farming and the protection of biodiversity, on equal access to the gene pool for selection activity, and about the prohibition of patent restrictions in that regard, as well as consumers’ right to make informed choices about NGT products. 

The Spanish Presidency of the EU Council (June–December 2023) suggested editing some of the texts which, as it says in the ICJ decision, have “satisfied the Bulgarian side to a large extent”. 

In the latest meeting of the Agriculture and Fisheries Council on 11 December, the ministers did not reach a compromise regarding the case in an unofficial vote, expressing concerns about safety, labelling, and social acceptance of the changes. 

Bulgaria voted “abstain”, and Minister of Agriculture Kiril Vatev explained the country’s position with “political sensitivity on the subject and public opinion regarding this issue”.

Sources

Решение на МС, с което България подкрепя предложението за регламент относно растенията, получени чрез някои нови геномни техники, и храните и фуражите от тях: https://www.bta.bg/bg/news/bulgaria/oficial-messages/582315-ministerski-savet-resheniya

Съвместно заседание на Комисията по земеделие и Комисията по европейски въпроси, с което се променя позицията на България на “въздържал се”: https://www.parliament.bg/bg/parliamentarycommittees/3211

Нобелова награда за химия 2020: https://www.nobelprize.org/prizes/chemistry/2020/summary/

Какво представлява геномната ножица: https://www.nature.com/articles/nature09886

Д-р Йордан Стефанов блог: https://6nine.net/2023/12/10/8-laji-na-toshko-yordanov/

Кой е Грегор Мендел: https://www.nature.com/scitable/topicpage/gregor-mendel-and-the-principles-of-inheritance-593/

Кой е Иван Мичурин: https://megabook.ru/article/%D0%9C%D0%B8%D1%87%D1%83%D1%80%D0%B8%D0%BD%20%D0%98%D0%B2%D0%B0%D0%BD%20%D0%92%D0%BB%D0%B0%D0%B4%D0%B8%D0%BC%D0%B8%D1%80%D0%BE%D0%B2%D0%B8%D1%87

Директива на ЕП относно съзнателното освобождаване на генетично модифицирани организми в околната среда от 2001 г.: https://eur-lex.europa.eu/legal-content/BG/TXT/PDF/?uri=CELEX:32001L0018

Принцип на предпазливостта: https://www.era-comm.eu/Introduction_EU_Environmental_Law/EN/module_2/module_2_10.html#:~:text=Where%20there%20is%20uncertainty%20about,wait%20until%20the%20harm%20materialises.

Решение на Съда на ЕС от 2018 г.: https://curia.europa.eu/juris/document/document.jsf?text=&docid=204387&pageIndex=0&doclang=bg&mode=lst&dir=&occ=first&part=1&cid=1991979

Проучване на ЕК относно НГТ: https://food.ec.europa.eu/plants/genetically-modified-organisms/new-techniques-biotechnology/ec-study-new-genomic-techniques_en

Анализ на Съвместния изследователски център на ЕК (JRC): https://publications.jrc.ec.europa.eu/repository/handle/JRC121847

Европейски орган за безопасност на храните – научни становища, свързани с НГТ и безопасността на продуктите: https://www.efsa.europa.eu/en/efsajournal/pub/6314

„Регламент относно растенията, получени чрез някои нови геномни техники, храните и фуражите от тях“: https://eur-lex.europa.eu/legal-content/BG/TXT/?uri=CELEX:52023PC0411

ГМО, разрешени за използване в ЕС: https://www.europarl.europa.eu/EPRS/EP-answers-New-GMO-legislation-EN.pdf

НГТ въпроси и отговори: https://ec.europa.eu/commission/presscorner/detail/bg/qanda_23_3568

Обществено обсъждане преди представянето на Регламента: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13119-Legislation-for-plants-produced-by-certain-new-genomic-techniques_en

Предложение на Испанското председателство на Съвета на ЕС: https://data.consilium.europa.eu/doc/document/ST-16443-2023-INIT/bg/pdf

Резултати от неофициалното гласуване на Съвета на на 11 декември: https://www.euronews.com/green/2023/12/11/agriculture-ministers-reject-compromise-over-gm-crop-regulation-reform

Кирил Вътев за решението на България: https://www.mzh.government.bg/bg/press-center/novini/ministr-vtev-blgariya-glasuva-vzdrzhal-se-po-predl/

Публикацията е създадена с подкрепата на Европейския съюз. Отговорността за съдържанието е изцяло на Factcheck.bg.

Elena Furnadzhieva
Elena Furnadzhieva
Elena Furnadzhieva is a journalist with over 25 years of professional experience. She graduated in Slavic Philology, majoring in Czech Philology at Sofia University "St. Kliment Ohridski ”. Her professional career began at Darik Radio when the radio was found. She was working as a judicial and political reporter and was among the journalists covering the protests against Videnov's cabinet in the winter of 1996-1997. In 2001 she joined the BTV team as a producer, and was the Editor-in-Chief of the News and Current Affairs Department. Elena became one of the founders of BiT's Bulgarian office in 2015, where she worked as Chief Executive Producer. She currently lives with her family in Florence, Italy. She speaks English, Italian, Czech, Slovak and Russian.

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