Presentation on theme: "Introduction to Article 45 (5) of the CLP Regulation"— Presentation transcript:
1Introduction to Article 45 (5) of the CLP Regulation Workshop on the Harmonisation of Information for Poison Centres24 November 2010BrusselsEuropean Commission Enterprise and IndustryKarola Grodzki - Unit G2
2Content Situation before CLP Regulation entered into force Legal requirements under the CLP RegulationLegal procedureLinks to other EU legislationIssues to be discussed at the workshopFollow-up after the workshop
3Legal 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 effectsAppointed bodies shall keep information confidential
4Legal Situation before CLP (continued) Information may be usedFor medical purposes, in particular in event of emergencyArt. 17 does not define which information should be notifiedResulted in different provisions by MS, different:ProceduresRequirements on composition/concentrationsNotification formats, tools
5CLP Regulation - Article 45 Provisions in Art. 45 of CLP similar to Art. 17 DPDMS shall appoint body or bodies responsible for receiving information on mixtures classified as hazardous on the basis of their health or physical effectsAppointed bodies shall keep information confidential
6CLP Regulation - Article 45 (continued) Information may be usedFor medical purposes, in particular in event of emergencyWhere requested by MS, for statistical analysis to improve risk management measures, if needed.
7CLP 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.
8CLP 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).
9CLP Regulation - Article 45 (continued) Duties resulting from Article 45(4)Assessment of possibility of harmonising information to PICAssessment of possibilities to establish a (harmonised) format for submission of informationNo specific reference to a database at EU levelConsultation with stakeholders, especially EAPCCTLegal implementation, if appropriate
10Legal procedure If COM chooses to adopt a new Regulation Regulatory Procedure with ScrutinyCommission submits the draft Regulation to a Committee composed of MS representatives and chaired by the CommissionCommittee responsible for matters under the CLP and REACH Regulations: REACH Committee.
11Links 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)
12Links to other EU legislation (continued) Regulation on Plant Protection Products (Regulation (EC) No 1107/2009)Article 68very general obligation to adopt a Regulation which amongst others "shall also contain provisions concerning the collection of information and reporting on suspected poisonings."
13Links to other EU legislation (continued) Biocidal Product Directive (Directive 98/8/EC)Article 23very similar provisions than those contained in the Dangerous Preparations Directive (Directive 1999/45/EC)
14Links to other EU legislation (continued) Regulation on Cosmetic Products (Regulation (EC) No 1223/2009)Article 13work already well advanced e.g.Regulation contains a list of information to be submitted to the Commissioninformation has to be submitted electronicallyresponsible COM Service is developing the "Cosmetic Products Notification Portal"
15Links to other EU legislation (continued) Pre-condition for an amendment (if any)Avoiding duplication of workEnsuring that lessons are learned from discussions in other areas of EU legislation
16Issues to be discussed today Is it possible and appropriate to harmonise information?if yesWhich information should be harmonised?Should there be a common format?Which format?
17Follow up after the workshop Publication of a brochureOne or two expert meetings in 2011discuss the conclusions drawn at the workshopdiscuss legal possibilitiesReport on results of COM review by January 2012