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

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

Introduction to Article 45 (5) of the CLP Regulation

Workshop on the Harmonisation of Information for Poison Centres

24 November 2010Brussels

European CommissionEnterprise and Industry

Karola Grodzki - Unit G2


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


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


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


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


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.



• 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.



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).



• 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


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.


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)


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."



• Biocidal Product Directive (Directive 98/8/EC) Article 23

• very similar provisions than those contained in the Dangerous Preparations Directive (Directive 1999/45/EC)



• 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"



• Pre-condition for an amendment (if any) Avoiding duplication of work Ensuring that lessons are learned from

discussions in other areas of EU legislation


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?


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


Documents

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