1. REACH and CLP What formulators need to know

2. Purpose of this presentation This presentation, with notes, was prepared by ECHA, the European Chemicals Agency, to assist you in preparing a presentation about REACH and CLP relating to downstream users. The intention is that you can select relevant slides and modify them as necessary to suit your audience, whether it is management, workers, environmental health and safety professionals, authorities etc. You may use it without additional permission. This presentation aims to provide relevant and useful information to help formulators to fulfil their obligations under REACH and CLP. It forms part of a series of presentations relating to downstream users and REACH/CLP, which are on the ECHA website. We welcome your comments and suggestions at downstream_users@echa.europa.eu. Legal notice: The information contained in this presentation does not constitute legal advice and does not necessarily represent in legal terms the official position of the European Chemicals Agency. The European Chemicals Agency does not accept any liability with regard to the contents of this document. Release: September 2015 2

3. Contents 1.Background 2.Formulators’ role in REACH and CLP Communicating information on uses upstream Communicating information on safe use downstream Classification, labelling and packaging of mixtures Managing substances of concern in your mixtures 3.Conclusions 3

4. 1. Background 4

5. Formulators Formulators produce mixtures, which are usually supplied further downstream Examples of mixtures: paints, lubricants, cleaning agents and adhesives 5 …are downstream users under REACH and CLP

6. Other suppliers of mixtures Importer any natural or legal person established within the Community who is responsible for import. 6 Re-filler transfer substances or mixtures from one container to another, generally in the course of repackaging or rebranding. Distributor 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 preparation, for third parties.

7. The supply chain 7 INFORMATION FOR REGISTRANTS

8. 2. Formulators have a central role 8 Classification, labelling and packaging of mixtures Communicating information on uses upstream Communicating information on safe use downstream Managing substances of concern in your mixtures

9. 9 Classification, labelling and packaging of mixtures Communicating information on uses upstream Communicating information on safe use downstream Managing substances of concern in your mixtures Formulators role in communicating upstream

10. Communicating information upstream Formulators are a critical link in the information chain as they are likely to know also the uses and conditions of uses of their customers Formulators may provide information regarding their uses and customer uses to their suppliers This is voluntary, but beneficial, as the information received includes the relevant uses Sector organisations have developed harmonised way of communicating uses, called use maps It helps formulators when their uses are included in use maps for their sector 10

11. Upstream communication Several industry organisations have developed Sector Use Maps for registrants to use Act now to include uses for substances that are to be registered in 2018 11 Sector use maps INFORMATION FOR REGISTRANTS

12. 12 Classification, labelling and packaging of mixtures Communicating information on uses upstream Communicating information on safe use downstream Managing substances of concern in your mixtures Formulators role in communicating downstream

13. The safety data sheet (SDS) SDS are the main communication tool between suppliers and users of substances and mixtures REACH defines When an SDS must be provided What to do when you receive an SDS What an SDS should contain What is the format of an SDS When exposure scenarios should be annexed 13

14. Format and content of the SDS and ES Main body according to REACH Annex II, including: Classification and labelling information Registered uses Threshold values for exposure (OELV, DNEL, PNEC) Physicochemical data Toxicological and eco- toxicological data Exposure scenarios include: Use-specific operational conditions Use-specific risk management measures Exposure estimates Additional advice Format not legally prescribed, but work is ongoing to harmonise 14

15. When a safety data sheet (SDS) should be provided 15 When substance or mixture is hazardous Substance or mixture is classified as hazardous Substance is PBT/vPvB Substance is on the Candidate List Non-classified mixture contains certain hazardous substances above specified limits (on request) It is sold to downstream user(s) SDS are not required for the general public but sufficient information for safe use must be provided Or an SDS has been requested If a substance or mixture is sold to both downstream users and general public, SDS need not be supplied, unless requested by downstream user or distributor

16. When exposure scenarios should be provided 16 When it is a substance For mixtures, the supplier may communicate the information from exposure scenarios for ingredient substances in other ways …and registered > 10 tonnes/year A chemical safety assessment is not required for quantities <10 tonnes / year …and it is hazardous Exposure scenarios are generated only for hazardous substances

17. Formulating mixtures for end users 17 Supplier 2 Substance A Supplier 3 Substance B Mixture C Supplier 1 Substance A Mixture D (=A+B+C) What to communicate and how?

18. Generating safe use information for mixtures Formulators need to identify the appropriate information from exposure scenarios to communicate downstream. Industry and authorities are developing and testing approaches to generate aligned safe use information for mixtures. Two general approaches: 1.Exposure scenario approach, ‘top-down’ 2.Existing controls approach, ‘bottom-up’ 18

19. What to communicate Top down approach 1.Lead component for various routes of exposure is identified (methodology under development by industry sectors) 2.This identifies which OC/RMMs to communicate 3.This is communicated as safe use information on mixture 19 1 2 3

20. What to communicate Bottom up approach 1.Existing conditions of safe use are identified within sectors 2.Provided as Safe Use of Mixtures Information (SUMI) 1.Harmonised template 2.Uses clear language, pictograms, in sector terminology 3.Formulator cross checks that use is covered by supplier ES 20 1 2 3

21. How to communicate the information from the ES 21

22. 22 Classification, labelling and packaging of mixtures Communicating information on uses upstream Communicating information on safe use downstream Managing substances of concern in your mixtures Formulators role in CLP

23. Formulators’ obligations under CLP You must classify, label and package mixtures in accordance with CLP before placing them on the market If you are formulating or changing the composition of a mixture, you must derive the classification of the mixture If you do NOT change the composition of a mixture, you may take over the classification for the mixture already derived by another actor in the supply chain If you import a hazardous mixture, you must also classify the ingredient substances according to CLP and notify the C&L Inventory (if the substances lead to or contribute to the classification of the mixture). You must keep up-to-date with new scientific or technical information that may affect the classification of the mixtures you place on the market (Article 15(1) CLP). 23

24. Change from DSD/DPD to CLP From 1 June 2015 the Dangerous Substances and the Dangerous Preparations Directives (DSD and DPD) have been fully replaced by the CLP Regulation For mixtures, a transition period to CLP for mixtures already placed on the market before June 2015 applies until June 2017 24 1 June 2015 CLP in force 1 June 2017 Transition period for mixtures ends CLP (EC 1272/2008) implements the Globally Harmonised System of classification and labelling of chemicals (GHS, UN 2007) in the EU

25. Example of a difference between old legislation and CLP 25 DSD CLP Acute toxicity: changed limit values

26. Types of classification 26 Classification is agreed at EU level Mandatory, you must use it May apply only to certain hazard classes*, so don’t forget to take into account the other hazard classes which need to be self- classified. Applies only to substances Harmonised Substances and mixtures are self-classified by manufacturer/importer/downstream user Substances are self-classified as appropriate when classification is not harmonised for the substance or particular hazard All mixtures are self-classified Self-classified

27. Information on how to classify a mixture 27 echa.europa.eu/support/mixture- classification

28. Important points when you classify your mixture 1.If an ingredient substance has a harmonised classification and labelling (Part 3 of Annex VI to CLP), that classification must be taken into account in classifying the mixture. 2.The supplier is responsible for evaluating all the relevant hazard classes and, where necessary, for adding the self-classification for any additional relevant hazard classes and differentiations not covered by the harmonised classification and labelling. Thus, the full classification received from the substance supplier, including both the harmonised classification and the possible self-classification, must be applied when deriving the classification of a mixture. 28

29. Label your mixture 1.If the mixture is classified as hazardous, you must ensure that it is labelled and packaged in accordance with CLP before placing it on the market. 2.You, as supplier, are responsible for the information on the label. 3.The information on the label must be consistent with the information on the SDS. 29 +

30. Classification & labelling inventory The C&L Inventory is a point of reference on how manufacturers and importers have classified their substances. Where there are differing entries in the Inventory for the same substance, the notifiers and registrants must make every effort to come to an agreed entry to be included in the inventory. A formulator using a substance can facilitate this agreement by contacting their suppliers and alerting them about the differing classifications. Ask your suppliers to make use of the Inventory Discussion Platform 30

31. C&L Inventory 31 Harmonised classification in the blue fields, notified entries in orange.

32. In addition: DU report on classification differences You may decide to classify an ingredient substance differently to that of your suppliers If your classification is different to that of all of your suppliers, the REACH Regulation requires you to report this to ECHA 32 Note: Reporting classification differences is not required for a substance used in quantities less than 1 tonne per year http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach- it/submitting-a-downstream-user-report-classification-differences

33. 33 Classification, labelling and packaging of mixtures Communicating information on uses upstream Communicating information on safe use downstream Managing substances of concern in your mixtures Formulators role in managing substances of concern

34. Substances of Concern Authorities identify substances of concern under REACH and CLP and regulate as appropriate Formulators can play an important role in finding safer alternatives to substances of concern in their products. They can also help to ensure that the information available for decision-making on regulatory risk management options is reliable and realistic If a substance is restricted or on the authorisation list, the supplier must include specific information to their customers (Article 32 of REACH). If a substance is on the authorisation list, the formulator needs to substitute it or be authorised for that use 34

35. Regulatory control of substances of concern 35 Authorities control risks at a regulatory level by identifying and regulating substances of concern under REACH and CLP. The typical approach is: Identify substance of concern Analyse the risk management options No action Harmonised classification and labelling Authorisation List Restriction Other legislation Candidate List

36. Formulators role in controlling substances of concern Investigate substituting substances of concern with a safer alternative substance or process Provide your supplier with accurate information on your use and use conditions via use maps, either directly or through your supplier organisation. This ensures that registration dossiers are based on realistic information Participate in public consultation, to make sure decisions are made on the best available information 36 Harmonised classification and labelling Candidate List Authorisation List Restriction

37. 3. Conclusions Benefits of managing substances of concern harmful substances are eliminated from mixtures supplied downstream by switching to safer formulations you may have wider impact than other downstream users if you decide not to re-formulate, you are in position to apply for authorisation also for your customers Benefits of communicating safe use information improved business environment improved general confidence in chemical safety improved basis for decision making by regulators worker safety and health appropriate safe use information and efficient communication give added value to your products 37

38. Information for formulators on the ECHA website 38 http://echa.europa.eu/regulations/reach/downstream-users/who-is-a-downstream- user/formulators