New Genomic Techniques: regulatory implications of the last Commission’s report

May 27th, 2021

Press Release by Farm Europe

Farm Europe discussed, today, the regulatory implications of the last report (1) presented by the European Commission on the status of new genomic techniques (NGT), during a digital event that gathered representatives from EU institutions and scientists.

The opinion that the current regulatory framework needs to be reviewed is widely shared. NGTs are a breakthrough innovation that represents a game-changer: they have the potential to decisively impact the transition toward resilient food systems, contributing to lower their environmental footprint, improve their capacity to adapt to climate change, and protect biodiversity while at the same time achieving our food security goals.

A revision of the European Genetic Modified Organism (GMO) legislative block, following a science and data-based impact assessment, is a topical issue that the Commission should address taking into account the latest scientific developments and breeding methods. The key amendments (see the annex for details) that Farm Europe proposes aim at excluding from the scope of the GMO legislative block the outcomes of the following processes:

  • A plant in which a native trait has been edited to reproduce the functionality associated with a known trait present in the genetic heritage of the species.
  • A plant in which a native trait has been edited to reproduce the functionality associated with a known trait present in the genetic heritage of a plant outside the species.
  • A plant with a native edited trait with novel functionality, whose sequence changes obtained by genome editing are of the same type as those that can be obtained by spontaneous or induced mutagenesis.
  • A plant in which a known gene present in the genetic make-up of the species has been inserted into a selected site in its genome.

Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16” published on April 29th, 2021.

END

Annex – Revision of the regulations on edited plants

Genetic techniques are constantly evolving. Among them, gene editing makes it possible to add, delete or replace nucleotides precisely at a specific site in the genome of a receiving organism, thereby modifying its genetic information. Plants derived from these editing techniques are currently subject to Directive 2001/18/EC, which blocks their commercial use.

When these techniques only modify, activate, or inhibit the characteristics of genes present within the genome of the receiving plants, they make changes identical to those obtained by traditional breeding methods. Such techniques, limited to this framework, accelerate the process of varietal selection and act with more precision than traditional methods.

The time saved in creating a new variety provides farmers with better adaptation and resilience to climate change. These techniques are essential to achieve the Green Deal objectives and to meet citizens’ expectations. For farmers, they represent a useful tool for achieving both economic and environmental performances.

 Thus, an adaptation of the regulatory framework seems necessary so to exclude from the scope of Directive 2001/18/EC the following categories of edited plants:

  • A plant in which a native trait has been edited[1] to reproduce the functionality associated with a known trait present in the genetic heritage of the species[2]. This method is equivalent to crossing a wild plant with a sexually compatible cultivated variety. High oleic soybeans have been obtained in this way.
  • A plant in which a native trait has been edited to reproduce the functionality associated with a known trait present in the genetic heritage of a plant outside the species. This is an extension of the previous category to genes shared by a donor and recipient plant that are sexually incompatible but have a common ancestor between two traits of the same gene. Blight resistant wheat is an example of a plant obtained by this method.
  • A plant with a native edited trait with novel functionality, whose sequence changes obtained by genome editing are of the same type as those that can be obtained by spontaneous or induced mutagenesis. Using traditional breeding methods, this change would be equivalent to that achieved by selecting a plant carrying a modified trait as a result of a spontaneous or induced mutation, which plant is then crossed with a crop plant to select for the mutation of interest. Tomatoes with a high GABA content were obtained in this way.
  • A plant in which a known gene present in the genetic make-up of the species has been inserted into a selected site in its genome. This is equivalent to the natural duplication of a gene, inserted in another part of the genome, away from its usual site of origin. Late blight resistant potato plants have been obtained in this way.

The above-mentioned categories are distinguished from plants produced by transgenesis because no genes from other living beings (plants of a species other than the edited plant, animals or bacteria) have been introduced into their genome by means of a bacterium.

An edited plant will be eligible for exclusion after validation by a competent authority that it belongs to one of these categories, justifying the technique used and the modifications made.


[1] The terms “editing” or “edited” refer to the use of genomic editing technologies.

[2] The term “genetic heritage of the species” is defined as including all the genes and their characteristics (alleles, which correspond to different versions of the same gene) from plants that can exchange genes sexually and those from distantly related species with which genes can be exchanged sexually using traditional breeding methods.

THE UK-AUSTRALIA FTA WILL HURT THE EU BEEF SECTOR

News have circulated that the UK-Australia Free Trade Agreement (FTA) is reaching the final legs of negotiation.

The UK would have offered full free access to its market, including in beef and sheep, with a phasing-out of quotas and tariffs for these two sectors in 15 years. It is also rumoured that the UK would accept to reduce the phasing-out to only 10 years.

Our British friends will excuse us, but this note will focus on the knock-on effects into the EU agriculture, and in particular the beef sector.

A 10 years phasing-out on all import restrictions will likely consist of initial quotas being gradually increased, till full liberalization. The impact will depend on the size of the quotas (and less significantly on the in-quota tariff rates); and on whether or not the out-of-quota tariffs will also be gradually reduced.

It should be noted that at a certain point in time it will become profitable for the Australians to export their beef out-of-the –quota to the UK, paying whatever will be the full tariff, as the volumes exported under the quota make the overall exports economically viable.

Thus, in a shorter period of time than the 10 years foreseen, the quantities of Australian beef sold in the UK market will be similar to those under full free trade.

What happens to our exports of beef to the UK? They will face dramatic competition from cheaper Australian cuts, and their UK market will shrink accordingly.

This is no minor effect, as the UK is the top destination for Irish beef exports, over 1 billion euros annually. Ireland will be faced with the losses in the UK market and the difficulties in finding other export markets outside the EU that could compensate for those losses.

Inevitably a good part of prior UK exports will land in continental Europe, competing with other EU producers in a stagnant market, under pressure from all sides ( F2F, methane emissions, recommended diets).

Farm Europe has warned since Brexit was voted by the UK that, even with a fully-fledged EU-UK FTA, the EU agri-food sector would lose market share in the UK as a result of the UK opening up its market to other countries. So this does not come as a surprise, but the negative impact is coming closer with a CAP reform process coming to an end without fully integrating this new major challenge for the years ahead.

As bad news rarely fly alone, the fact that the UK is willing to phase-out all import restrictions on beef to Australia will set the tone for the remaining UK FTAs under negotiation. Specifically, it will flow logically that the US will accept no less. Therefore what we are saying about the impact of Australian imports will be compounded by US exports in the future.

This note focus on the beef sector. But we also know that the UK is willing to enter the Trans-Pacific Partnership Free Trade Agreement (TPP). Other sectors, like dairy, poultry and sugar, would benefit from preferential access conditions to the UK market. Top world exporters are part of the TPP – New Zealand for dairy, just to give an example. And again, this would have a negative knock-on effect on our exports to the UK.

There is very little we in the EU can do about decisions that are made in the UK. The best way to absorb the shock is to become more competitive, to conquer more export markets, in other words to be very strong and resilient economically. However, what we are witnessing as proposals coming out of the European Commission has the opposite effect, piling up further restrictions and increasing producing costs. It is urgent to change course, and address environmental and other issues using science, and mobilizing technologies and resources to achieve our objectives without making us all poorer and ultimately more dependant on imports.`

Impact on the EU agricultural sectors of the reformed CAP and the Farm to Fork and Biodiversity strategies proposals

As part of the Green Deal guidelines for the European agricultural sectors, the Commission has presented its proposals for a Farm to Fork and a Biodiversity strategies which are intended to add to the decisions which will be taken (this week) in the framework of the CAP reform.

Thus, from 2023 onwards, when the reformed CAP will be implemented, the European regulatory environment for the agricultural and food sectors will be in constant evolution, with 48 new initiatives planned by the Commission to be put in place between 2023 and 2026 (and negotiated between 2021 and 2024).

Notwithstanding the profound changes that these proposals are intended to bring about, the Commission has refused to release any assessment of their cumulative impacts.

full note available on FE Members’ area

NEW BREEDING TECHNIQUES: Commission publishes its study

On April 29th the Commission published its study on the “Status of new genomic techniques under EU law and in light of the Court of Justice Ruling in case C/528-16” where it analyses the state of play of the debate on NBTs by interviewing Member States and stakeholders and concluding that the EU legislation on GMOs should undergone a revision process. In France, Agriculture minister reiterated once again his position on the need for a change in the EU legislation. At the same time, Austrian researchers have warned about the risks of simplification of the EU legal framework given the many unknown. A survey commissioned by Greens political group says that 86% of EU citizens want food containing GMOs to be labelled accordingly. 

full note available on FE Members’ area

Measures and impacts related to the COVID-19 crisis: Support for several EU countries and for mink farmers in Denmark

In the month of April 2021, Belgium, Spain, Italy, Romania, and France approved schemes to support the agri-food sector in coping with COVID-19 impacts.
In Denmark, a scheme for mink farmers was approved to support mink farmers and related businesses in the context of the coronavirus outbreak, which led to the culling of millions of minks last November. full note available on FE members’ area

Livestock in the EU: New Animal Health Law, ANIT Meeting and “End of Cage” ECI Hearing


In April 2021, issues of animal transport were discussed in meetings of the Committee of Inquiry on the Protection of Animals during Transport (ANIT). On April 15th, the AGRI and PETI Committee met for a Hearing on the “End the Cage Age” ECI, which sparked debates across Europe. On April 21st, Regulation 2016/429, the new Animal Health Law, covering transmissible animal disease came into force.
full note available on FE members’ area

CAP REFORM NEGOTIATIONS: closer to deal on eco-schemes

April marked the turning point for the negotiations on some matters in the Strategic Plan regulation, notably on the eco-schemes. In fact, the Portuguese presidency proposed a compromise on the ring-fencing of funds under the first pillar that would include 22% during the learning period (2023-24) to be raised at 25% in 2025. During their meeting, Ministers seemed to generally support this idea (even if some delegations would stick to the initial Council position of 20%). Also, institutions might be closer to a definition of active farmer, given the Commissioner’s advancement of some indicators. However, Parliaments’ negotiators do not share this optimism.

In Germany, Länders have reached their common position for the future CAP.

The Commission published a study on the “Evaluation of the impact of the CAP on generational renewal, local development and jobs in rural areas” concluding that the CAP tools at disposals are unsuited for the purpose.

full note available on the Members area

THE EUROPEAN UNION NEEDS A DATABASE TO ENSURE TRANSPARENCY AND TRACEABILITY OF RENEWABLE FUELS

The potential for large scale fraud in Europe’s renewable fuels sector arises from the Renewable Energy Directive being designed in such a way as to give a market value to certain waste-based biofuels feedstocks – such as used cooking oil – of up to double the value of the least cost virgin vegetable oil alternatives – such as palm oil. This creates profit opportunity for unscrupulous operators. At the same time the Directive does not impose requirements to physically check or inspect supply chains for authenticity and traceability. Thirdly, there is no EU body charged with detecting or investigating irregular trends or practices. Fraud is, literally, unchecked.

With demand for used cooking oil (UCO) rising 45% annually in the EU, its consumption in the biofuels sector has grown 1000% in the six years to 2020, to reach over 4 million tonnes. World UCO capacity is limited and requires significant investment in collection infrastructure to increase supply, whereas palm oil is cheap, abundant and can be readily procured in ever larger quantities. Palm oil imports disguised as UCO are not checked whilst the fraud is highly profitable.

The problem is well known, and it’s getting worse. Palm oil disguised as UCO can easily originate in recently deforested areas, causing a negative environmental and climatic impact. Imported deforestation is a hot political issue in the EU, and the European Parliament has taken the European Commission to act to tackle the problem. No loopholes should be left open, such as the current unchecked UCO imports.

In 2018 the EU Renewable Energy Directive RED2 was signed into law and it mandated that a “Union database be put in place to ensure transparency and traceability of renewable fuels”.

This measure was included in order to address the large scale fraud risk that exists under the Directive, as described by the European Court of Auditors in its 2016 Special Report on the matter.

The objective of the Union database is to improve transparency over the supply chains, which involve 27 member states, 14 certification schemes and several thousand collectors, traders, processors and buyers across 170 countries. The database should allow stakeholders detect suspicious trends and imbalances. For instance it would allow stakeholders check for coherence between the amounts of UCO biodiesel placed on the EU market and the amounts of UCO feedstock collected at source. Any suspicious swelling of volumes along the supply chain could be detected and investigated. Similarly, it would allow regulators examine whether the amounts declared as originating from a given country were plausible, in relation to that country’s ability to generate, certify and export such volumes. This is especially important, for instance, in cases where a country has limited UCO collection capacity, easy access to palm oil and no national regulation preventing the substitution of UCO with palm oil.

However the database has not been implemented as of April 2021, and there are few indications of real progress being made. In fact, over two years since the legislation was passed, it has not yet been designed and there are no visible indications of material progress being made.

The current work at the European Commission to build the database does not impress by the amount and expertise of the resources engaged in the project. There is no evidence of a governance structure being in place for the project, to oversee progress, manage risk and report on it to the legislators and stakeholders who mandated it, and who depend on it for the correct functioning of the legislation.

Farm Europe calls on the European Commission, in particular on DG ENER, to give this project a higher commitment and priority. Fraud should never be allowed to go unchecked, and the reputation of the Commission is at stake.

CAP REFORM NEGOTIATIONS: super-trilogue saves the “C” of the CAP

March has seen many institutional meetings concerning the CAP negotiations that led, eventually, closer to a general agreement between Council and Parliament. In fact, EP Agricultural Commission discussed the advancement in trilogues, as did the Minsters, before the end-of-the-month “Super-trilogue” which resembled the negotiating teams of all three legislative files at once. The outcomes resulted in agreements on control system & indicators, deviation rate on convergence, sanctions on cross-compliance, performance assessment, and on the wine sector. Nevertheless, percentages of distribution of funds between pillars, capping, degressivity, the definition of eco-schemes, active, young, new, and small farmers, green architecture & social conditionality are some of the topics that co-legislators still have to agree upon.

In the meantime, the Commission published its guidelines on the support of the Organic farming sector: a roadmap that lays out the action the EU executive intends to implement in order to reach the Farm To Fork target of 25% of organic farming land in the Eu by 2030. Commissioner Wojciechowski, answering to a Council’s demand, assured that DG AGRI services are working on an Impact Assessment of the Green Deal’s impacts on the agri-food.

full note available on the Members area

NEW BREEDING TECHNIQUES: GROUP ON ETHICS publishes its opinion

While in the U.K (England) the debate on changing the legislation on gene editing has started, the U.S Department for Agriculture took some step further to loosen rules on genetically engineered animals. In the EU, the independent group on Ethics that advises the Commission’s executive, published its opinion on gene-editing, according to which an inclusive societal debate and international engagement towards global governance are needed; moreover, this technology could help attain the Farm to Fork targets.

full note available on FE Members’ area