Antonia Reihlen, Ökopol GmbH

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1 Roles and obligations Antonia Reihlen Ökopol GmbH

2 Introduction The role of roles under REACH Types of roles and related obligations How to identify roles of the company

3 The role of roles REACH aims to ensure protection of humans and the environment from chemical risks and to enhance competitiveness and innovation in Europe Both goals require a common approach to identify, communicate and control risks from chemicals All actors in the supply chain and the authorities have their role to play

goals require a common approach to identify, communicate and control risks from

4 The role of roles - 2 Roles are defined in relation to substances as such, contained in preparations or contained in articles Each actor can have several roles, depending on the type of substance and where it is sourced from Obligations are defined depending on the role and the specific substance, respectively

several roles, depending on the type of substance and where it is sourced

5 Types of roles Manufacturer + = Manufacturer Manufacturer

6 1. REGISTRATION > 1 ton/year Agency M > 10 ton/year CSR > 10 ton/year Substance Producer 2. COMMUNICATION SDS Supply chain > 10 ton/year SDS Painter

7 Types of roles Importer EU I Substance Preparations Article

8 Importers have the same obligations as manufacturers however, there are practical differences: Chemical safety report misses manufacturing and Imported substances (in preparations) need to be identified and quantified to determine if tonnage threshold is exceeded.

manufacturing and Imported substances (in preparations) need to

9 Types of roles Downstream user DU Professional I M DU DU Formulator Article Producer

10 SDS SDS EXPOSURE SCENARIO Information DU CSR Conditions of?! use = RMM Formulator Implementation

11 SDS DU New hazard information Risk Management Measures DU Formulator SDS SDS

12 Types of roles Article producers Article producers may (!) have to Register substances intended to be released or Notify the content of specific substances Communicate the content of specific substances in DU the supply chain Article Producer

13 Types of roles Distributor DEFINITION A distributor is any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties. Distributors have to forward any information they receive from up or down the supply chain

within the Community, including a retailer, who only stores and places on the market

14 Role identification Roles depend on the specific substances Structured approach = chemicals inventory Input = purchased substances, preparations, (articles) Name, type, identification (substance or preparation?) Source (own manufacture/import/eu, distributor/manufacturer) Output = manufactured products = substance or preparation or article Identification of M/I/DU/D and obligations

15 Tools for role identification ECHA has produced a Navigator tool Interactive dialogue leading to identification of obligations linked to respective guidance (where available) Furthermore, flowtext on REACH REACH implementation project on developing guidance for downstream users (RIP 3.5) Separate document on roles of downstream users to be published soon (more detailed)

it/ Furthermore, flowtext on REACH REACH implementation project on developing guidance for downstream users

16 HSE has web-pages on REACH Tools for role identification Flow text on roles and obligations with links to further information Official helpdesk Questions can be asked E-learning tool on REACH

links to further information http://www.hse.gov.uk/reach/role.

GE Healthcare Approach to REACH

2008/SOM1/SCSC/TFTF/005 Agenda Item: 5 GE Healthcare Approach to REACH Purpose: Information Submitted by: GE Healthcare Sub-Committee on Standards and Conformance Trade Facilitation Task Force Meeting