1. Guidance on guidance
document development
Wolfgang Reinert
European Commission
Health and Consumers Directorate General
Unit Chemicals, contaminants, pesticides
ECPA-IBMA workshop – EFSA evaluation of PPP
26 April 2012
Health and
Consumers

2. Guidance document on guidance documents
What ?
• Provide procedure for producing new and revising existing GDs
• Define
- competencies
- steps to be followed in drafting
- adoption procedure
- adoption date
• Include a (continuously updated) list of guidance documents
Health and
Consumers

3. Guidance document on guidance documents
Why ?
• Acknowledge different roles of different players
• Avoid duplication of work
• Improve quality and usefulness of the GDs
• Improve communication and create transparency (Authorities,
stakeholders, Third Countries)
Health and
Consumers

4. Stepwise approach
• Identify need
• Produce concept paper
• Evaluate and adopt concept paper
• Draft GD
• Discuss
• Adopt and set application date
• Publish
Health and
Consumers

5. History and planning
• Technical report of EFSA “Evaluation of
the European Union Pesticide Safety
review process”, from 27 August 2008
• First draft in 2009
• Drafting process interrupted…
• …and restarted in 2011
Health and
Consumers