Interactions between IED and REACH Exploring the opportunities for cooperation Valletta, Malta October 2013 Geert Dancet Executive Director Conference on Implementation and Enforcement of Environmental legislation

ECHA Driving legislations Roles of ECHA

3 Driving legislations for ECHA REACH entry into force June 2007 CLP entry into force Jan 2009 Classification, Labelling and Packaging of substances and mixtures Biocides entry into force 17 July 2012 entry into operation on 1 September 2013 PIC entry into force 16 Aug 2012 entry into operation on 1 March 2014

4 Main roles of ECHA Manage REACH, CLP, Biocides and PIC Disseminate information on substances Develop scientific IT tools Provide regulatory assistance to industry, i.e. ECHA Helpdesk and guidance Support the REACH Committees and the Forum (enforcement) Advise on chemical safety to EU institutions and Member States Assist EU’s international activities (UNEP and OECD; accession countries)

REACH and IED Aims Key aspects Processes and actors

6 Aims REACH Ensure a high level of protection of human health and the environment Ensure the free circulation of substances on the internal market Enhance competitiveness and innovation IED Prevent pollution or If prevention not practicable reduce emissions from installations and industrial activities

7 Key aspects REACH 1.EU level (regulation) 2.Substance by substance approach 3.All chemical substances and mixtures (apart from exemptions addressed in other legal acts) 4.Registration and evaluation, regulatory risk management processes, data sharing and supply chain communication IED 1.National level (directive) 2.Integrated approach 3.Emission of polluting substances 4.Environmental permit, BREFs and BAT conclusions

8 REACH and CLP – main processes and actors Pre-registration Data sharing Registration Self-classification Facilitated by ECHA Industry gathers information and ensures management of risks Authorisation Restriction Harmonised C&L Commission, with support of ECHA and MSCAs, applies community wide risk management measures ECHA and MSCAs control and request for further info Evaluation  Dossier evaluation  Substance evaluation Member States Enforcement National enforcement authorities (NEAs), support from Forum Member States

Manufacturer, Importer (place substances on the market) 1.Information collection for registration purposes 2.Hazard/exposure assessment of substance 3.Identification and communication of risk management measures (RMM) Manufacturers and importers (unless OR) are registrants. Downstream user (use substances in an industrial or professional activity) 1.Communication upstream to suppliers (uses, hazard information, conditions of use, RMM) 2.Implementation of risk management measures to ensure safe use 3.Communication to customers downstream 9 Actors of REACH and their obligations

REACH information on substances Provided by and available to industry Available to all Available to REACH enforcement authorities Available to REACH competent authorities

11 Information provided by registrants Registration dossier 1.Technical dossier (IUCLID file) for all registrations 2.Chemical Safety Report when registration tonnage is above 10 t/a Data requirement is dependant on tonnage band of registration but to summarise, registration dossier contains: Information on the registrant Information allowing identification of the substance, its properties and its hazards Information on the manufacture and use(s) of the substance covered by the dossier Hazard assessments (human health, environment, incl. PBT, vPvB) and risk characterisation Exposure information/assessment, guidance on risk management measures and safe use

12 Information communication to downstream users (DU) CSR SDS ES Technical dossier with Chemical Safety Report (if tonnage above 10 t/a) Safety Data Sheet with Exposure Scenarios (extended SDS) Registrants DU (if subject to IED)

13 Information available to DU Main body Classification and labelling information Registered Uses Threshold values for exposure (DNELs and PNEC) Physicochemical data Toxicological and eco- toxicological data Exposure scenarios Use-specific operational conditions Use-specific risk management measures How to control exposure of humans and the releases to environment Safety Data Sheet Safety Data Sheet + Exposure Scenario Provided in the supply chain of the substance

14 Information available to all Dissemination activity of ECHA REACH regulatory status of chemical substances registration, authorisation, restriction, C&L etc. Information from registration dossiers such as C&L, uses and exposure, toxicological and eco- toxicological information, guidance on safe use etc. (filtered and aggregated before publication) Classification and Labelling Inventory Free access to information from the ECHA website

15 Information available to REACH enforcement authorities REACH Information Portal for Enforcement, RIPE What is it: RIPE is a web-based application What does it do: RIPE enables access to information submitted to ECHA by REACH national enforcement authorities (NEAs) Includes information from registrations and notifications Purpose: Inspectors must have access to this data to verify compliance of industry and thus effectively enforce REACH

16 Information extracted from registration dossiers General information on submission Information on updates to the dossier Company Information Substance identification information Life cycle information: uses & uses advised against Classification & labeling information (CLP & DPD) Guidance on safe use Summary information on substance properties (Physico- chemical, Toxicological and Ecotoxicological) Generic exposure potential (possible routes of exposure) Information available to REACH enforcement authorities

17 Access to the full REACH database for evaluation and regulatory risk management activities Information available to REACH competent authorities

Cross legislative use of information A few examples from an environmental perspective

19 Information use by industry Duty under IEDInformation source in REACH Description of substances SDS: classification and hazard information on substances, threshold values for exposure ECHA dissemination: search for extra/missing information Preventive measures against pollution CSR or Exposure Scenario (ES) to help/support: Identification of possible release route Quantification of potential release (emission) Identification of risk management measures (RMM) required to achieve adequate control of risks Reducing waste and waste impact Safety Data Sheet (SDS): section on disposal considerations ES: waste stage of the substance

20 Information use by industry REACH obligationInformation source in IED Substances subject to authorisation (substitution when feasible alternatives are available) BREF document: Emerging techniques described in the document can provide information on potential alternatives in terms of techniques and/or substances to be used

Conclusions

22 Conclusions 1.Identifying the interactions/synergies is the first step 2.Cross-legislative use of information increases efficiency and should be encouraged 3.For industry this could be seen as a “return on investment” 4.REACH can also benefit from IED but more elaboration is needed (e.g., BREF-development) 5.Collaboration is needed to develop tools and guidance needed by national authorities and industry to get the full value from the information available Note: In addition to REACH – IED interactions and synergies also other cross-legislation interactions exist

23 Thank you for your attention!

24 Questions to prepare What REACH info will IED authorities have access to (in addition to public info)?