1. Development and implementation of Guidance Documents – the role of the European Commission
Karin Nienstedt - DG SANTE / E3
ECCA-ECPA Conference, March 2015, Brussels

2. Outline - why guidance documents (GDs)?
- what kinds of guidance documents
- process (how?)
- update on on-going work (COM-GDs)

3. Why guidance documents?
- GDs are not legally binding, but…
- GDs are important because they …
organise our work and…
harmonise our approaches, therefore …
…avoid discussions on particular issues coming up again and again (efficiency!)
…give clarity and predictability to all involved parties (risk assessors, risk managers, notifiers, stakeholders, …)

4. How to draft and agree a GD?
Complex situations
Ressources needed (e.g. time)
Many players: MS + EFSA + stakeholders

5. GDs are published / referred to in…
- Commission Communications 2013/C 95/01 and 2013/C 95/02 - (linked to Regulations (EU) No 283/2013 and 284/2013 on data requirements for AS and PPPs)
- Commission GDs on SANTE's website:

6. Different kinds of GD procedural guidance
technical guidance (… on risk assessment)
… on interpretation of legislation (decision making at risk manager level) or requested by legislation
 … but also some "mixed" GD…

7. 1 - Procedural GDs - aim to agree on a way of working (process)
- examples:
GDs on confirmatory information,
… on comparative assessment,
… on draft registration report (mutual recognition / Zonal authorisation)
… on parallel trade …
(meanwhile more than 25 GDs)

8. 1 - Procedural GDs Proposal COM or MS Consultation of stakeholders
Discussion at PAFF (MS, EFSA)
Taking note at PAFF
revision

9. 2 - Technical guidance documents
- mainly on risk assessment or related technical issues
- aim to give clarity on how to do RA in a given regulatory context
- different pre / post 2002 process (creation of EFSA)
- recent examples:
Bee GD
Aquatic GD
Exposure GD …

10. 2 - Technical GDs (EFSA involvement)
Mandate to EFSA
(selftask or COM)
Endorsement by PSN
EFSA Scientific Opinion (PPR / SC)
RM consultation (e.g. prot. goals)
EFSA Guidance document
PAFF discussion
PAFF taking note
revision

11. 2 - Technical GDs (EFSA involvement)
Mandate to EFSA
(selftask or COM)
Endorsement by PSN
EFSA Scientific Opinion (PPR / SC)
RM consultation (e.g. prot. goals)
EFSA Guidance document
PAFF discussion
PAFF taking note
revision
Impact?
stakeholders
Implementation date?
Impact?
stakeholders
… still finding the optimal way…

12. 3 - GD on interpretation of / requested by Legislation
- process chaired by COM
- recent examples:
strategic GD on monitoring (Art. 7.3 Directive 2009/128/EC)
Interpretation of "negligible exposure" (Annex II Regulation 1107/2009)
Seed Treatments

13. 3 - GD on interpretation of / requested by Legislation (new procedures (!))
MS experts (WG + PAFF)
Stakeholder consultation
Inter Service Consultation (COM)
GD adopted by COM (College)
Draft Guidance Document ?

14. Interpretation of / requested by Legislation – on-going work
strategic GD on monitoring (Art. 7.3 Directive 2009/128/EC)
Draft GD discussed with MS and within COM
Stakeholder consultation soon
Interpretation of "negligible exposure" (Annex II Regulation 1107/2009)
Advanced draft developed at MS WG – difficult discussions because of different MS-positions
Next steps: Stakeholder consultation + ISC

15. Conclusions
- Guidance documents are efficient non-legislative tools which increase harmonisation.
- Discussions are sometime not easy – but just the fact of having a discussion is helping to agree on a GD between the parties
- drafting / agreeing on GD need resources from all parties

16. Thanks to all parties for
the useful discussions so far and the commitment shown to agree on Guidance Documents!