ECHA’s focus on improving the information in the supply chain

1. ECHA’s focus on improving the information in the supply chain Jack de Bruijn Director Risk Management European Chemicals Agency Kemiens Dag, København 21 November 2013

2. Contents The aims of REACH State of play in 2013 How to improve quality of registration information How to improve quality of information in the supply chain Conclusions

3. Back to the basics of REACH

4. Main Problems with previouschemicals legislation Data gaps: 86% of HPVCs have less than base set data The process took (far) too much time Burden of proof was on public authorities Generally Downstream Users stayed out of the picture, actual uses of chemicals remain unknown The system was inefficient and the administrative burden for new, mostly low volume, chemicals prevented innovation

5. Protecting Human Health and the Environment

6. How in general to achieve the health and environment objective? Better knowledge on properties and uses Better safety and control measures Reducing exposures and hence negative impacts Replacing (gradually) hazardous substances with less hazardous ones Key legislative drivers: Registration, Supply chain communication, Authorisation and Restriction

7. Shifting the burden of proof REACH is based on the principle that industry should manufacture, import or use substances with such responsibility and care as may be required to ensure that, under reasonably foreseeable conditions, human health and the environment are not adversely affected Companies handling chemicals should take the necessary risk management measures in accordance with the assessment of the risks of substances and pass on relevant risk management recommendations down the supply chain for all supported uses

8. Responsibility shifted to industry Manufacturers-Importers + + Exposure Scenarios Safety Data Sheet Registration dossier C&L (GHS) Chemical Safety Report Exposure Scenarios Safety advice Information on uses Customers (Downstream Users) ECHA – EU Authorities Public echa.europa.eu

9. State-of-play

10. Progress Two registration deadlines passed – 2010 - 2013 • Substances over 100 tpa; CMRs over 1tpa • Data on > 11 000 substances from over 41 500 dossiers (> 2 million study summaries on properties and effects of chemicals) Classification and Labelling Inventory • EU harmonised classification for ~4 500 of substances and Classification for > 110 000 substances (> 6 million notifications) Information published on ECHA website Eurostat study five-year update revealed a “marked increase in quality of data & better control of risk”

11. Compliance? 1000 dossiers will have been checked by end 2013 Covering ~30% substances registered by 2010 But - many registrations found to be non-compliant Unclear substance identification in many cases Improving compliance is a key objective of ECHA

12. Quality ?

13. Quality is essential It proves that chemical companies have assumed their responsibilities as required by REACH • Reliable data are needed to make a responsible risk assessment and to recommend adequate safety measures Registration information is the basis for Authorities to judge whether risks are adequately controlled or there is a need for more regulatory actions It creates public confidence!

14. Commission REACH review on supply chain communication Increased information on substances is resulting in changes on classification (mostly more stringent) and improved risk assessments Increased info in supply chain and improved safety data sheets results in more appropriate risk management measures Nevertheless……... ECHA and Industry are encouraged to address the problems related to compilation, communication and use of extended SDSs and promote them as a central risk management tool

15. Further findings eSDS not yet widely used Confusion still exists about: • use descriptors • short titles of ESs • length and level of detail needed, info in ESs vs main body of the SDS • SDS for mixtures • Best way to communicate safety advice to ‘end-users’ • Integration of HH and ENV aspects Requirements for substances in articles not generally known in the retail sector

16. How to improve quality of registration information

17. ECHA’s strategic objective 1: Maximising high quality of information Three pillars: • Increase the compliance and quality of the information and safety assessment generated for REACH & CLP purposes • Facilitate the transfer of risk management information within the supply chain (via SDS and exposure scenarios) • Ensure that information published on the ECHA website is easily accessible and understandable by all stakeholders, incl. the public and strengthen the transparency

18. Quality: ECHA’s strategic objective Industry ECHA & MS ECHA Areas of action to affect quality Prior submission Evaluationactivities Post submission Submission time Regulatory actions Regulatory actions Supportactions Quality Control GuidanceIT toolsWebinarsFeedbackInteraction Completeness check Systematic screening Dissemination Compliance checkEnforcement

19. ECHA’s approach: Find the right action to maximise impact Development of methods and tools to systematically analyse all information received. Examples: • Targeted compliance checks: Find all dossiers with a specific issue and send a legal decision to all registrants concerned • Screenings based on automated analysis followed by a “friendly” letter, registrants are offered tailor-made advice on how to improve the dossier before ECHA starts legal actions • 2013: focus on substances registered as intermediates • 2014: focus on substance identification

20. Be proactive ! Registration is not the end of the process Keep information up-to-date • Read the Evaluation reports reflecting dossier quality findings • Update the dossiers before receiving formal feedback from ECHA Be prepared (within the joint submission) for requests for updates from ECHA, e.g. screening letters, Evaluation decisions 09 October 2013

21. How to improve quality of information in the supply chain

22. ECHA’s strategic objective 1: Maximising high quality of information Three pillars: • Increase the compliance and quality of the information and safety assessment generated for REACH & CLP purposes • Facilitate the transfer of risk management information within the supply chain (via SDS and exposure scenarios) • Ensure that information published on the ECHA website is easily accessible and understandable by all stakeholders, incl. the public and strengthen the transparency

23. Extended safety data sheet – tool for communication Main body Exposure scenarios • Use-specific operational conditions • Use-specific risk management measures • Registered Uses • Include DNEL’s and PNECs if available • Summary of Risk Management Measures from Exposure Scenarios

24. Life cycle approach – number of ESs attached The entire life cycle of a substance is covered by ESs – from manufacturing, through formulation to end use and waste • End-uses - substance • Use by workers at industrial sites • Use by professional workers • Consumer use • Service life - article • by workers at industrial sites • by professional workers • by consumer Manufacturing Formulation Formulation Enduse Waste

25. Our response – I: Exchange Network on Exposure Scenarios (ENES) Joint initiative with Cefic, Eurométaux, CONCAWE, Fecc and A.I.S.E. Participants: manufacturers, downstream users, industry associations, Member State competent & enforcement authorities and European Commission Aims to identify good practices on preparing and implementing exposure scenarios, and to develop an effective communication exchange between supply chain actors http://echa.europa.eu/web/guest/about-us/exchange-network-on-exposure-scenarios

26. Our response – II: The CSR/ES roadmap Roadmap towards good quality information on the safe use of chemicals in the REACH chemical safety report and the extended safety data sheet. Action plan towards 2018 with medium- and long-term orientation Two main elements: • Exposure scenarios in the Chemical safety report • Exposure scenarios annexed to the (extended) safety data sheet http://echa.europa.eu/csr-es-roadmap

27. Summary of key actions Short term (practical/methodological) issues to solve; • Short titles of ESs • Effective link between CSA and ESs (eg. through Chesar) • Guidance and exemplifying safe use information for mixtures Medium-term; • Harmonisation/standardisation of safety phrases • Improve communication to end-users Long-term perspective; • Facilitate the effective use of REACH information by DUs to comply with their obligations under other legislation

28. Roles in the chemicals supply chain Demonstrates control of risk for all uses in the CSR submitted to authorities ECHA Manufacturer of substances Carries out the Chemicals safety assessment Communicates substance characteristics and conditions of safe use Trade & Sector associations Collect and consolidate information on current conditions of use; inform suppliers. Producer of mixtures Integrates safe use measures into the product design Communicates mixture characteristics and conditions of safe use Industrial and professional user of chemicals Implements conditions of safe use

29. Need for cooperation! ECHA is determined to support DUs with development of necessary methods, tool and formats but……… Optimal supply-chain communication is really a matter for industry sectors • Knowledge on uses • Knowledge on risk management • Knowledge on how best to communicate Crucial that sector organisations at national level become involved and take actions to ensure that the results at European level are percolated to the right companies DU should accept their responsibility in terms of requesting good quality information from their suppliers, and hence protect their business and long term interests

30. Vision for REACH 2020 in practice • Increased information down the entire supply chain • Methodologies regarding mixtures are developed • Formulators use effective systems for handling information • Good communication between suppliers, formulators and users results in improved business environment .. Helps to protect human health and the environment echa.europa.eu

31. Conclusions REACH registration is living up to expectations, but quality of information needs improvement Companies need to keep their dossiers up-to-date and are advised to proactively improve the information Supply-chain communication and DU obligations are key to the success of REACH Problems have been recognised, an action plan has been set up and first actions have been taken Need for cooperation on implementation methods and tools at EU and national sector level

32. Tak! jack.de-bruijn@echa.europa.eu

33. Use chemicals? Use them safely! http://echa.europa.eu/downstream