Date: 2018-11-20Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2018/1790 of 16 November 2018 repealing Decision 2002/623/EC establishing guidance notes on the environmental risk assessment of genetically modified organisms (notified under document C(2018) 7513) (Text with EEA relevance.)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Decision (EU) 2018/1790, issued on November 16, 2018, repeals Decision 2002/623/EC, which established guidance notes on the environmental risk assessment of genetically modified organisms (GMOs). The decision is based on the grounds that more recent and detailed guidance documents from the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA), as well as amendments to Directive 2001/18/EC, have rendered Decision 2002/623/EC obsolete. The repeal aims to simplify the regulatory landscape for environmental risk assessments of GMOs.
Key Points / Main Content:
* **Repeal of Decision 2002/623/EC:**
* Decision 2002/623/EC, which provided guidance notes on environmental risk assessment of GMOs, is repealed.
* **Reasons for Repeal:**
* More detailed guidance documents from EFSA and EMA on GMO environmental risk assessment have been adopted.
* Commission Directive (EU) 2018/350 updated Annex II to Directive 2001/18/EC, incorporating strengthened guidance on environmental risk assessment.
* Decision 2002/623/EC served as a basis for the EFSA guidance.
* Repeal simplifies the number of guidance documents for operators and authorities.
* **Addressee:**
* The decision is addressed to the Member States of the European Union.
Impact Analysis:
* **Operators Conducting Environmental Risk Assessments:**
* Impact: Operators no longer need to consider Decision 2002/623/EC when conducting environmental risk assessments under Annex II to Directive 2001/18/EC. This simplifies the process by reducing the number of guidance documents to consult.
* Action Required: Operators should rely on the updated Annex II to Directive 2001/18/EC, and more recent guidance from EFSA and EMA.
* **Competent Authorities:**
* Impact: Competent authorities no longer need to refer to Decision 2002/623/EC when evaluating environmental risk assessments of GMOs. This streamlines the review process.
* Action Required: Competent authorities should base their evaluations on the updated Annex II to Directive 2001/18/EC, and more recent guidance from EFSA and EMA.
* **Member States:**
* Impact: Member States must acknowledge and implement the repeal of Decision 2002/623/EC.
* Action Required: Ensure that national procedures and guidance are updated to reflect the repeal and the reliance on updated Annex II to Directive 2001/18/EC and more recent guidance from EFSA and EMA.
Key Entities Referenced
European Union: Political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Directive 2001/18/EC: Directive of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms.
European Parliament: The directly elected parliamentary assembly of the European Union.
Council Directive 90/220/EEC: Council Directive on the deliberate release into the environment of genetically modified organisms, which was repealed by Directive 2001/18/EC.
Commission Decision 2002/623/EC: Commission Decision establishing guidance notes supplementing Annex II to Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC.
European Food Safety Authority: The European Union agency that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
European Medicines Agency: A decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
L 293/32 EN Official Journal of the European Union 20.11.2018
COMMISSION IMPLEMENTING DECISION (EU) 2018/1790
of 16 November 2018
repealing Decision 2002/623/EC establishing guidance notes on the environmental risk assessment
of genetically modified organisms
(notified under document C(2018) 7513)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the
deliberate release into the environment of genetically modified organisms and repealing Council Directive
90/220/EEC (1), and in particular the first paragraph of Annex II thereto,
Whereas:
(1) Commission Decision 2002/623/EC (2) established guidance notes on the objectives, elements, general principles
and methodology of the environmental risk assessment referred to in Annex II to Directive 2001/18/EC.
(2) Extensive supplementary explanations regarding the implementation of Annex II to Directive 2001/18/EC have
been given in more recent and more detailed guidance documents on the environmental risk assessment of
genetically modified organisms (‘GMOs’) adopted by the European Food Safety Authority (‘the Authority’) and by
the European Medicines Agency (‘the Agency’). After the adoption of those more detailed guidance documents,
Decision 2002/623/EC has progressively lost its added value.
(3) Commission Directive (EU) 2018/350 (3), which amended Directive 2001/18/EC, updated Annex II to Directive
2001/18/EC by incorporating and building upon the strengthened guidance of the Authority on the environmen
tal risk assessment of genetically modified plants, adopted in October 2010 (4), while taking into account that
Annex II applies to all GMOs and not only to genetically modified plants. Decision 2002/623/EC itself served as
a basis for the elaboration of the guidance of the Authority. As a result, the provisions of Annex II to Directive
2001/18/EC are now more detailed and the guidance notes established by Decision 2002/623/EC are no longer
needed.
(4) Decision 2002/623/EC should therefore be repealed.
(5) Decision 2002/623/EC should also be repealed in the interest of simplification in order to reduce the number of
guidance documents that must be taken into account by operators and competent authorities when carrying out
an environmental risk assessment under Annex II to Directive 2001/18/EC.
(6) The measures provided for in this Decision are in accordance with the opinion of the Committee established
under Article 30(1) of Directive 2001/18/EC,
HAS ADOPTED THIS DECISION:
Article 1
Decision 2002/623/EC is repealed.
(1) OJ L 106, 17.4.2001, p. 1.
(2) Commission Decision 2002/623/EC of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of
the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and
repealing Council Directive 90/220/EEC (OJ L 200, 30.7.2002, p. 22).
(3) Commission Directive (EU) 2018/350 of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council
as regards the environmental risk assessment of genetically modified organisms (OJ L 67, 9.3.2018, p. 30).
(4) EFSA Panel on Genetically Modified Organisms (GMO); Guidance on the environmental risk assessment of genetically modified
plants. EFSA Journal 2010; 8(11):1879. [111 pp.]. doi:10.2903/j.efsa.2010.1879.20.11.2018 EN Official Journal of the European Union L 293/33
Article 2
This Decision is addressed to the Member States.
Done at Brussels, 16 November 2018.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission