1. Introduction to Article 45 (5) of the CLP Regulation
Workshop on the Harmonisation of Information for Poison Centres
24 November 2010
Brussels
European Commission Enterprise and Industry
Karola Grodzki - Unit G2

2. Content Situation before CLP Regulation entered into force
Legal requirements under the CLP Regulation
Legal procedure
Links to other EU legislation
Issues to be discussed at the workshop
Follow-up after the workshop

3. Legal Situation before CLP
Directive 1999/45/EC (DPD) - Article 17
‘MS shall appoint body or bodies responsible for receiving information on preparations considered dangerous on the basis of their health or physical effects
Appointed bodies shall keep information confidential

4. Legal Situation before CLP (continued)
Information may be used
For medical purposes, in particular in event of emergency
Art. 17 does not define which information should be notified
Resulted in different provisions by MS, different:
Procedures
Requirements on composition/concentrations
Notification formats, tools

5. CLP Regulation - Article 45
Provisions in Art. 45 of CLP similar to Art. 17 DPD
MS shall appoint body or bodies responsible for receiving information on mixtures classified as hazardous on the basis of their health or physical effects
Appointed bodies shall keep information confidential

6. CLP Regulation - Article 45 (continued)
Information may be used
For medical purposes, in particular in event of emergency
Where requested by MS, for statistical analysis to improve risk management measures, if needed.

7. CLP Regulation - Article 45 (continued)
Article 45 (4) (introduced during co-decision procedure)
‘By January 2012, the Commission shall carry out a review to assess the possibility of harmonising the information..., including establishing a format for the submission of information by importers and downstream users to appointed bodies.

8. CLP Regulation - Article 45 (continued)
On the basis of this review, and following consultation with relevant stakeholders … the Commission may adopt a Regulation adding an Annex to this Regulation.’
Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedures with scrutiny referred to in Article 54(3).

9. CLP Regulation - Article 45 (continued)
Duties resulting from Article 45(4)
Assessment of possibility of harmonising information to PIC
Assessment of possibilities to establish a (harmonised) format for submission of information
No specific reference to a database at EU level
Consultation with stakeholders, especially EAPCCT
Legal implementation, if appropriate

10. Legal procedure If COM chooses to adopt a new Regulation
Regulatory Procedure with Scrutiny
Commission submits the draft Regulation to a Committee composed of MS representatives and chaired by the Commission
Committee responsible for matters under the CLP and REACH Regulations: REACH Committee.

11. Links to other EU legislation
Regulation on Plant Protection Products (Regulation (EC) No 1107/2009)
Biocidal Product Directive (Directive 98/8/EC)
Regulation on Cosmetic Products (Regulation (EC) No 1223/2009)

12. Links to other EU legislation (continued)
Regulation on Plant Protection Products (Regulation (EC) No 1107/2009)
Article 68
very general obligation to adopt a Regulation which amongst others "shall also contain provisions concerning the collection of information and reporting on suspected poisonings."

13. Links to other EU legislation (continued)
Biocidal Product Directive (Directive 98/8/EC)
Article 23
very similar provisions than those contained in the Dangerous Preparations Directive (Directive 1999/45/EC)

14. Links to other EU legislation (continued)
Regulation on Cosmetic Products (Regulation (EC) No 1223/2009)
Article 13
work already well advanced e.g.
Regulation contains a list of information to be submitted to the Commission
information has to be submitted electronically
responsible COM Service is developing the "Cosmetic Products Notification Portal"

15. Links to other EU legislation (continued)
Pre-condition for an amendment (if any)
Avoiding duplication of work
Ensuring that lessons are learned from discussions in other areas of EU legislation

16. Issues to be discussed today
Is it possible and appropriate to harmonise information?
if yes
Which information should be harmonised?
Should there be a common format?
Which format?

17. Follow up after the workshop
Publication of a brochure
One or two expert meetings in 2011
discuss the conclusions drawn at the workshop
discuss legal possibilities
Report on results of COM review by January 2012

18. Thank you!