1. Introduction to REACH Awareness and Compliance Assistance Workshop for the Exporters of Apparel Date: 3rd August 2011 Venue: India Habitat Centre, New Delhi Mikael Henzler, Managing Director, adelphi

2. 2 Introduction to REACH Registration How are non-EU producers affected? Evaluation Authorisation Agenda

3. 3 Introduction to REACH Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is an European Union Regulation (Regulation (EC) No 1907/2006). The REACH-Regulation entered in force in 1 June 2007. REACH addresses the production, import and use of chemical substances in Europe, and their potential impacts on both human health and the environment. Background of REACH

4. 4 Introduction to REACH “no data - no market - no production” Impact of REACH

5. 5 Introduction to REACH No differentiation: REACH creates a single system for both „existing“ and „new“ chemicals. Convergence of several chemical safety related legislation and guidance under one umbrella REACH reversed the responsibilities from the authorities to the industries. The industry now has to demonstrate the safety of chemicals on the market. =>“extended producer responsibility” Characteristics and aim of the Regulation

6. 6 Identified Use Introduction to REACH REACH in the Supply Chain Producer / Importer Downstream user End User ECHA Registration SDS Conditions of Use Chemical Safety Report (No REACH Actor) CSR SDS EU Safety Data Sheet

7. 7 Introduction to REACH All EU-manufacturers and EU-based importers producing or importing chemical substances into the EU with more than 1t/a have to register these substances. Some substances are exempted from registration. E.g. re- imports, polymers, some substances for medicinal products. Registration at European Chemicals Agency (ECHA). No data, no market! => Failure in registration means that the substance is not allowed in the EU. Registration

8. 8 Introduction to REACH Manufacturers and importers have to supply detailed data about each substance (properties, classification, uses and safe ways of handling) in the registration dossier. The larger the quantities produced, the more information regarding risk to health and the environment will be required. Registration >1t >10 t >100t >1000t Grade of information required

9. 9 Introduction to REACH How are non-EU producers affected? Non EU producer Importer Delivers substances Asks for the identity and the concentration of the imported substances and for Certification of REACH compliance ECHA Registers substance

10. 10 Introduction to REACH If non-EU producers want to avoid disclosure of sensitive information to importers, they can appoint an “only representative” within the EU. “Only representative” then fulfills the registration obligations of the importer. The only representative can represent one or several “non-Community manufacturers”. In this case importer is not obliged to register and is regarded as downstream user. „Only representative“

11. 11 Introduction to REACH „Only representative“ Gives information on the substance Non EU producer Importer Delivers substances ECHA Registers substance „Only representative“ Provides Safety Data Sheet

12. 12 Introduction to REACH The ECHA performs evaluation of registration dossier. Evaluation of dossier is to ensure that the data provided during Registration is complete and accurate. Member States will carry out substance risk checks on the chemicals used in large quantities (over 100 tones per year) and especially high-risk substances. If necessary, the authorities can ask the manufacturer for additional information or decide that a substance requires an authorization. Evaluation

13. 13 Introduction to REACH Chemicals that are known to be of very high concern require authorizations for use on an individual basis. Applicants will have to demonstrate that: o they can control the dangers, or o that no alternatives exists for the toxic chemicals and o the socio-economic arguments for authorizing such substances outweigh the risks posed by the chemical. Authorization will last only for a specified period. The European Commission can also ban substances if it finds the risks unacceptable Authorisation

14. 14 Introduction to REACH REACH also applies to articles containing chemicals, such as:  Apparel containing dyes, softners, etc  Leather containing chrome, dyes, polish, etc  Auto components containing paints, metal plating, etc.  Electrical and electronic equipments containing brominated flame retardants, lead, etc. => REACH is relevant for several exporting industries to EU-countries Substances in articles

15. 15 Introduction to REACH REACH regulates the production, import and use of chemical substances in Europe. REACH stands for Registration, Evaluation and Authorisation and Restriction of Chemicals. Industry is responsible for safety and registration. Importers in EU require detailed substances information from non-EU producers. REACH also applies for chemical substances in articles => High relevance of REACH for Indian exporting industry Key Messages

16. adelphi Caspar-Theyss-Strasse 14a 14193 Berlin T+49(0)30-89 000 68-0 F+49(0)30-89 000 68-10 www.adelphi.de office@adelphi.de Mikael Henzler Managing Director henzler@adelphi.de