Transcript 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.

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
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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.
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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.
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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 nonessential elements of this Regulation, by
supplementing it, shall be adopted in
accordance with the regulatory procedures
with scrutiny referred to in Article 54(3).
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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.
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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)
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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."
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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)
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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"
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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?
if yes
• Which format?
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
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
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›
European Commission
Enterprise and Industry
Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | ‹#›