Document 01
Ref. Ares(2020)124228 - 09/01/2020
Annex
Request for a scientific opinion on genetically modified plants developed through new
genomic techniques
Background
On 8 November 2019, the Council of the EU has approved Council Decision (EU) 2019/1904
requesting the European
judgment in Case C-528/16 regarding the status of new genomic techniques (NGTs) under
Union law, and a proposal, if appropriate in view of the outcomes of the study.
of the Treaty on the Functioning of the
European Union, requests the Commission to submit:
a study, by 30 April 2021, regarding the status of new genomic techniques under Union
if appropriate, in view of the outcomes of the study, a proposal (accompanied by an
impact assessment) or otherwise to inform the Council on other measures required as a
follow-up to the study.
As regards the requested study, the Commission needs an analysis of the status of new
genomic techniques that includes safety considerations. In this respect, the Commission
intends to include in the study relevant existing scientific opinions addressing the safety
assessment of plants developed through NGTs.
EFSA published in 2012 a scientific opinion addressing the safety assessment of plants
developed using Zinc Finger Nuclease 3 and other Site-Directed Nucleases with similar
function (SDN 3)1. In 2012 EFSA also published a scientific opinion addressing the safety
assessment of plants developed through cisgenesis and intragenesis2. Work by EFSA is
currently ongoing on a scientific opinion on plants developed using type 1 and type 2 Site-
Directed Nucleases and oligonucleotide directed mutagenesis.
Terms of reference
Considering the relevant expertise in EFSA and the above-mentioned work of EFSA on
NGTs, the European Commission asks EFSA, in accordance with Article 29 of Regulation
(EC) No 178/2002, to provide an overview on the risk assessment of plants developed through
NGTs, based on its own previous and current work and on work carried out at national level.
For the purpose of the overview, the following definition for new genomic techniques applies:
techniques that are capable to alter the genetic material of an organism and that have emerged
or have been developed since 2001.
1 EFSA Scientific opinion addressing the safety assessment of plants developed using Zinc Finger Nuclease 3 and
other Site-Directed Nucleases with similar function. EFSA Journal 2012;10(10):2943.
2 EFSA Scientific opinion addressing the safety assessment of plants developed through cisgenesis and
intragenesis. EFSA Journal 2012;10(2):2561.
For this overview, EFSA is not requested to develop new opinions on plants developed
through specific NGTs. Rather, EFSA is asked to take into account its previous scientific
opinions, its ongoing work on the topic as well as opinions published by competent
authorities and national institutions since 20123, where available.
3 This timeline is proposed to align with the first EFSA scientific opinions on NGTs dating from 2012.