EU policy and best practices on access to information on GMOs

Aude L'hirondel, Directorate General Health and Consumer

The EU strongly committed

• Party to the Aarhus Convention since 2005

• Ratified the Almaty amendment in 2008

• Party to the Cartagena Protocol since 2003

• Commitment towards access to information fully reflected in EU legal framework on GMOs

Setting the scene: some data

• 2 GMOs authorised in the EU for cultivation

• 7 cultivation files with favourable scientific opinions

• 52 GMOs authorised for food/feed use

• 14 GM food/feed pending files with favourable scientific opinions

Outline of the presentation

• Information provided all along the process of authorisation of GMO applications

• Access to documents and confidentiality

Fundamental principles

• Principle of transparencyPublic consultation (Art. 9 of General Food Law)Public information (Art. 10 of General Food Law)

• Consumer informed choiceArt. 8 of the General Food Law

• Public access, consultation & information of the publicEU legislation on GMOs and Regulation on access to documents

Other relevant legal acts

• Public access to documents held by EU institutions (Regulation 1049/2001/EC)

• Public access to environmental information (Directive 2003/4/EC) and public participation (Directive 2003/35/EC)

• Application of the Aarhus Convention to EU institutions and bodies (Regulation (EC) 1367/2006)

• Transboundary movement of GMOs (Regulation (EC) 1946/2003)

Information and consultation all along the process

•GMO applications and risk assessment

Summary of the applications for authorisation of GMOs published on EFSA and JRC web-sites

EFSA scientific opinions and Member States Assessment Reports published on internet

o 30 days : possible comments from the public to the Commission – sent to EFSA for assessment

Information and consultation all along the process of authorisation

•Draft agendas and minutes of MS Committees on SANCO website

•Information of the press when GMOs authorised

•Comitology Register: decisions of authorisations public after vote of Member States

Information and consultation all along the process of authorisation

•Register of authorised GMOs under on GM food and feed Regulation on DG SANCO website and Register of GMOs authorised under Directive 2001/18/EEC on JRC web-site

•Regularly updated

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Information and consultation all along the process of authorisation

•Post-Market Environmental Monitoring reports on SANCO website

Information on monitoring

Information on other Commission's initiatives

• Plenary and technical meetings of the Advisory Group of the Food Chain, Animal and Plant Health (e.g. on GM-free labelling, co-existence, socio-economic impacts)

• Conferences (e.g. in 2012 on post-market environmental monitoring, in 2011 on socio-economic aspects and on risk assessment)

Access to documents

• Transparency is the rule

• To be balanced with confidential information

Transparency is the rule

• Regulation 1049/2001 on public access to document, and the EU legislation on GMOs aim to ensure a high level of transparency and provide wide access to documents and information to all citizens.

• GMO applications are not "secret" or confidential. All scientific data, including raw data, of a GMO application are disclosed by the Commission and EFSA upon request.

To be balanced with confidential information

• Legal requirements concerning the information that cannot be treated as confidential by Commission or Member States

• Only limited information can be claimed as confidential: If shared data would harm the competitive position/commercial

interests of the company; DNA sequences; Personal data.

THANK YOU