GMO regulation in the EU
We believe that the relationship between biology and law is very important, although not widely discussed. Regulations help to set up a safe environment during day-to-day work in the lab, including biosecurity and biosafety measures. They determine the selection mechanism for project funding as well. When a GMO product is to be commercialised, it has to go through an approval procedure (which is in some countries very rigorous and expensive). Law therefore impacts research to a significant extent and scientists should be aware of the lawmaking process and also have their say in it.
To be able to comply with regulations or influence them, firstly we need to understand them. That is why we decided to conduct an overview of the GMO regulation in the European Union and to help others understand it.
Exclusive Interview - Michal Bobek
Michal Bobek has served as the Advocate General at the Court of Justice of the EU (CJEU) between 2015-2021. Role of the General Advocate in the court proceedings is to offer an alternative legal opinion, before the CJEU issues its final judgment. Bobek was appointed in 2016 to write his opinion on the groundbreaking case C-528/16, dealing with the question whether products obtained by new mutagenesis techniques (NMT, f.e. CRISPR) should fall under the exemption from the strict EU regulation, as is the case with X-ray mutagenesis. Despite Bobek's positive opinion, CJEU in 2018 denied this exemption for NMT and thus affected the entire European biotechnology sector. It is no surprise that this judgment has caused a big stir and is mentioned in many articles regarding the European regulation of GMO.
We invited Mr. Bobek for an interview to explain the background of the case and to share his views on the matter.
Links to the documents:
5 most important GMO legal acts
In its recent study, the EU Commision identified the 5 most important legal acts regarding GMO regulation in the EU. These are:
Directive 2001/18 on the deliberate release into the environment of genetically modified organisms
Directive 2009/41 on the contained use of genetically modified microorganisms
Regulation 1829/2003 on genetically modified food and feed
Regulation 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms
Regulation 1946/2003 on transboundary movements of genetically modified organisms
We have read these legal acts and wrote an overview article, which you can DOWNLOAD HERE. As it is good to have a basic knowledge of how the EU works, here are the brief notes:
The EU is not a federation like the USA. EU member states have transferred only part of their competencies to the EU (there is no EU army nor police for example).
Legal acts (f.e. regulations and directives) are proposed by the EU Commision and adopted by Parliament and Council. These acts can only be adopted within the scope of the competencies delegated to the EU and have a EU-wide applicability.
Decisions automatically become part of the national legal order when adopted.
Directives set out regulatory objectives to be met. The Member States are left to decide how to meet these objectives.
For more information on the EU’s structure look here.
Following the judgment C-528/16, the member states asked Commision in 2019 for a study regarding the legal status of new genomics techniques (NGT). One of their concern was, "how to ensure compliance with Directive 2001/18/EC when products obtained by means of new mutagenesis techniques cannot be distinguished, using current methods, from products resulting from natural mutation, and how to ensure, in such a situation, the equal treatment between imported products and products produced within the Union".
Commision delivered its study on April 29th 2021 (https://ec.europa.eu/food/plants/genetically-modified-organisms/new-techniques-biotechnology/ec-study-new-genomic-techniques_en), including an assessment of the views of Member States and stakeholders via questionnaire. The conclusions include these points:
NGTs raise some ethical concerns, but not to use them might be unethical as well
Particularly NGT used in plants may contribute to the goals of Green Deal and Farm to Fork strategies
Current GMO legislation lacks clear definitions of terms
Keeping legislation relevant remains an ongoing challenge
In the light of these statements, we may expect changes in recent regulation, particularly in the use of NGT in plants. However, political consensus and subsequent legislative changes may take years.