Dear President,

I have received a complaint against the European Commission from two environmental non-governmental organisations.

The complainants are concerned about how the Commission is carrying out the impact assessment concerning ‘new genomic techniques’ (NGTs) in response to a request by the Council of the EU[1]. As you are aware, that request came in response to the ruling by the Court of Justice of the EU[2] that organisms obtained through new targeted mutagenesis are subject to the requirements of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs)[3].

Following targeted stakeholder consultations, on 29 April 2021, the Commission published the study requested by the Council, regarding the status of NGTs under EU law. Based on the conclusions of the study, the Commission announced that it would follow up by initiating measures on plants produced by targeted mutagenesis and cisgenesis, involving an impact assessment and a public consultation. Subsequently, on 24 September 2021, the Commission published an inception impact assessment and organised a public consultation between 29 April 2022 and 22 July 2022.

The complainants have raised concerns about how the Commission organised the targeted stakeholder consultations and how it prepared the study as part of the ongoing impact assessment.

The complainants consider that the impact assessment process is not in line with the Better Regulation Guidelines and Toolbox. They also raised concerns about the representativeness of the stakeholder consultations, the transparency of the impact assessment process and whether it took into account the risks to the natural environment.

After careful consideration of the complaint, I have decided to open an inquiry to secure a written reply from the Commission to the concerns raised by the complainants, notably to those concerns that the Commission has not yet (fully) addressed in its correspondence with the complainants. In particular, I would be grateful if the Commission could reply to the following questions:

1) How did the Commission ensure that the study and the ongoing impact assessment process included a comprehensive analysis of existing research on NGTs, distinguishing stakeholder opinions from empirical scientific research?

2) How did the Commission ensure that the study and the ongoing impact assessment take into account all relevant factors, including those raised in the expert opinion from the German Federal Agency for Nature Conservation (BfN) to which the complainant refers?

3) How did the Commission ensure that the impact assessment also includes an assessment of the risks to the natural environment of products obtained through NGTs?

4) Did the Commission assess the reliability of declarations, especially those coming from the private sector, regarding products in development that rely on NGTs? If so, how?

5) The inception impact assessment lists, in its section B ‘Objectives and Policy options’, objectives of the initiative and “[d]ifferent policy elements” that “will be considered in the subsequent development of the policy options”. Could the Commission please clarify whether it was required, under the Better Regulation Guidelines, to publish the envisaged policy options prior to the public consultations?

6) Does the dedicated Commission website[4] contain complete and up-to-date information about all the meetings and exchanges between the Commission, the Member States and the stakeholders?

7) How has the Commission ensured the transparency of consultation activities carried out by the contractor mentioned by the complainant?

I would kindly request the Commission to send its reply to the complainant by 24 July 2023 and to forward my Office a copy of its response. Based on the Commission’s reply, and the complainants’ comments on that reply, I will then decide whether there are grounds to inquire further into the complaint.

If, in the course of this inquiry, the Commission becomes involved in court proceedings concerning the same subject matter as this complaint, I would ask you to let us know.

Yours sincerely,

Emily O'Reilly

European Ombudsman

Strasbourg, 25/04/2023

 

[1] Council Decision 2019/1904 requesting the Commission to submit a study in light of the Court of Justice’s judgment in Case C-528/16 regarding the status of novel genomic techniques under Union law, and a proposal, if appropriate in view of the outcomes of the study https://eur-lex.europa.eu/eli/dec/2019/1904/oj

[2] Case C 528/16 Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt https://curia.europa.eu/juris/liste.jsf?language=en&num=C-528/16

[3] https://eur-lex.europa.eu/eli/dir/2001/18/2021-03-27

[4] https://food.ec.europa.eu/plants/genetically-modified-organisms/new-techniques-biotechnology_en