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European Commission Enterprise and Industry Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | # Introduction to Article 45 (5) of.

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Presentation on theme: "European Commission Enterprise and Industry Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | # Introduction to Article 45 (5) of."— Presentation transcript:

1 European Commission Enterprise and Industry Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | # 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 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

3 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

4 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

5 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

6 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.

7 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.

8 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 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 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

10 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.

11 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)

12 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."

13 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)

14 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"

15 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

16 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?

17 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

18 European Commission Enterprise and Industry Introduction to Article 45(4) of the CLP Regulation | 24 November 2011 | #


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