REACH, 12 Nov Supply chain communication Tatjana Humar –Jurič, M.Sc. Semira Hajrlahović Mehić, LL.M.

REACH, 12 Nov CONTENT Overview of information Communication DOWN the supply chain Communication UP the supply chain Importers and Non - Community companies Guidance, FAQ

REACH, 12 Nov Basic framework under REACH

REACH, 12 Nov OVERVIEW REACH TITLE IV : Information in the supply chain; Articles Actors: suppliers Communication Instruments:  SDS  CSR/Exposure scenario

REACH, 12 Nov Actors Supplier of S/P(mix.) means any:  Manufacturer M  Importer I  downstream user DU or  distributor D placing on the market a substance, on its own or in a preparation, or a preparation Producer P of articles Consumer C

REACH, 12 Nov Actor's roles Different roles in supply chain REACH: majority of obligations apply to M/I Non-EU manufacturers do not have direct obligations under REACH Importer established within the Community, needs to comply with REACH

REACH, 12 Nov GOALS of Supply Chain Communication Safety use of substance/preparation/article Risk managment (to lower the risk) To pass on information received from supplier to customers M/I of substances should supply the information on risk managment to other professionals such as DS or D P/I of articles should supply information on the safe use of articles to industrial and professional users, and consumers on request.

REACH, 12 Nov Risk manegment Risk characterisation under REACH: Estimation of incidence and severity of adverse effects likely to occur in a population/ecosystem due to exposure to a substance Addressing several potential toxic effects and human (sub)populations, and considering each (sub)population’s exposure by relevant exposure routes Focus on most critical effect (with consideration of time scale) Quantitative or qualitative provisons

REACH, 12 Nov Risk manegment: main goal Environmental risk characterisation Human risk characterisation RCR = intake or concentration/DNEL or DMEL Risk controlled if <1

REACH, 12 Nov Informing of users CHEMICAL SAFETY REPORT (prof. users) SAFETY DATA SHEET (prof. users, DU, distrib.) LABELL (all users) extent of information, tonage….

REACH, 12 Nov Chemical Safety Report (CSR) and Safety Data Sheet (SDS) = informing of users = risk manegment

REACH, 12 Nov Communication DOWN the supply chain (1) SDS OBLIGATORY for transmitting safety info on S/P DOWN the supply chain:  S/P meets the criteria for classification as dangerous- hazardous  Substance is PBT or vPvB  Substances to be included in Annex XIV (substances subject to authorisation)

REACH, 12 Nov Safety Data Sheet-SDS (1) REACH Regulation (Art.31, Annex II) Provides safety information on all classified chemicals and information from the relevant Chemical Safety Report (CSR) down the supply chain Exceptions:  not hazardous preparations (mixtures)  chemicals e.g.: metals in massive form, alloys, compressed gases … (Annex VI, 67/548/EEC) Enable users to take the necessary measures relating to protection of human health and safety at the workplace, and protection of the environment.

REACH, 12 Nov SDS (2) Information provided by SDS shall: Meet the requirements set out in Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work Enable the employer to determine whether any hazardous chemical agents are present in the workplace, and to assess any risk to the health and safety of workers arising from their use

REACH, 12 Nov SDS (3) Format is given in Annex II of REACH Official language of MS where S/P is placed on the market Free of charge in paper or electronically Enforcement: MS Competent Authorities

REACH, 12 Nov SDS (4) On request also for preparation not classified as dangerous but containing certain dangerous or very high concern substances (authorisation candidates, PBT, vPvB) No SDS obligations for:  S/P for general public (as well as a sufficient info is provided )  Articles

REACH, 12 Nov SDS (5) – the content 1. IDENTIFICATION OF THE S/P AND OF THE COMPANY/UNDERTAKING 2. HAZARDS IDENTIFICATION 3. COMPOSITION/INFORMATION ON INGREDIENTS 4. FIRST AID MEASURES 5. FIRE-FIGHTING MEASURES 6. ACCIDENTAL RELEASE MEASURES 7. HANDLING AND STORAGE 8. EXPOSURE CONTROLS/PERSONAL PROTECTION 9. PHYSICAL AND CHEMICAL PROPERTIES 10. STABILITY AND REACTIVITY 11. TOXICOLOGICAL INFORMATION 12. ECOLOGICAL INFORMATION 13. DISPOSAL CONSIDERATIONS 14. TRANSPORT INFORMATION 15. REGULATORY INFORMATION 16. OTHER INFORMATION ANNEX (information from CSR!)

REACH, 12 Nov SDS (6)- new under REACH  Exposure Scenarios (including use and exposure) in an annex to the SDS  The information on uses of S in SDS must be consistent with the ES in the annex, indicating which uses are covered by the single ES  Results from hazard assessments the should be incorporated into the SDS.  SDS for Substances of Very High Concern subject to Authorisatin (SVHC Candidate list )  Structure changes (sections 2 and 3)  Additional info (registration No., address..)

REACH, 12 Nov What is a Chemical Safety Report (CSR)? - Document, which details the process and the results of Chemical Safety Assesment (CSA) - CSR shall be : completed for all substances subject to registration in accordance with in quantities of 10 tonnes or more per year per registrant conducted in accordance with paragraphs 2 to 7 of Art.14 and with Annex I of REACH for: - either each substance on its own or - in a preparation or - in an article or a group of substances.

REACH, 12 Nov Format of CSR PART A 1. Summary of risk management measures 2. Declaration that risk management measures are implemented 3. Declaration that risk management measures are communicated PART B 1. Identification of the substance, its physical and chemical properties 2. Manufacture and uses 3. Classification and labelling 4. Environmental fate properties 5. Human health hazard assessment 6. Human health hazard assessment of physicochemical properties 7. Environmental hazard assessment 8. PBT and vPvB assessment 9. Exposure assessment 10. Risk characterisation

REACH, 12 Nov Goals of Chemical Safety Assessment (CSA) To ensure that risks (to workers, consumers and the environment) are controlled - identify and apply the appropriate measures accordingly Shall address all identified uses of the M/I or DU Develop exposure scenarios if substances are classified as dangerous or considered to be a PBT/vPvB Document the assessment in the chemical safety report (CSR), including listing of the exposure scenarios, covering Risk Management Measures (including C&L and down stream consequences) To communicate information using the SDS

REACH, 12 Nov What is an exposure scenario (ES)? describes the conditions under which a substance (as such, in a preparation or in an article) or a group of substances can be ‘safely’ used. is a major element in the CSA on which the exposure assessment and the risk characterisation is based is an instrument for communicating operational conditions of use and risk management measures that are suitable to ensure adequate control of risk in the supply chain (the ES is integrated into the Safety Data Sheet (SDS) system in Annex !!). shall be developed for both the manufacturer’s own manufacturing process and for identified uses; including both uses by the manufacturer or importer and uses further down the chemical supply chain

REACH, 12 Nov New under REACH: Any actor in the supply chain who is required to prepare a CRS shall place the relevant : Exposure scenario (ES) in an annex to the SDS covering identified uses and including specific conditions resulting from the application!!

REACH, 12 Nov SDS (8)- update New information on hazards becomes available Info which may affect the risk management measures Authorisation has been granted or refused Restriction has been imposed Access to SDS and other info is given to workers

REACH, 12 Nov Communication DOWN the supply chain (3) Supplier of ARTICLES: shall inform consumers about substances of very high concern contained in conc. >0,1% ; Also consumer can request such information Distributor: shall pass on info received from supplier to costumer to ensure safety use of S/P

REACH, 12 Nov Communication DOWN the supply chain (4) If SDS is not required supplier has to communicate:  key risk info about S, in particular if the S is subject to authorisation or restriction  Other relevant/available info to enable appropriate risk management

REACH, 12 Nov Communication UP the supply chain (1) Applies if you are using S/P in the context of industrial or professional activities and you do not supply further down the chain Communicate to your supplier next up the chain

REACH, 12 Nov Communication UP the supply chain (2) Communication of :  NEW INFO on hazardous properties that become available, regardless of the uses concerned  Any other information that might call into question the appropriateness of the risk management measures identified in SDS

REACH, 12 Nov Communication UP the supply chain (3) Distributors: obligation to pass on info received to the next actor in the supply chain Downstream users:  Have right to make their use known to the supplier  Provide sufficient info to prepare an exposure scenario (important for registrants preparing CSR including ES)

REACH, 12 Nov DU Follow the RM advice and the operational conditions of use described SDS received from the supplier, including the exposure scenarios If relevant, forward the advice to actors further down the supply chain Obligation to use S according to the conditions laid down in the authorisation granted Notify to ECHA the use of S subject to authorisation

REACH, 12 Nov DU should inform (in writing) suppliers about use of a substance → supplier considers use in relation to his registration. use be an identified use and have an ES your conditions of use, unless the registrant cannot support the use. Before informing supplier: check the use mappings prepared by industry association, and/or any communication from supplier about the uses he intends to cover. ECHA has published a Fact Sheet that provides background information and further details about the DS’ right to inform their suppliers of the use they make of thesubstance (see gudiance!). If the substance needs to be registered before 1 December 2010: DU must inform the supplier till 30 Nov. 2009!!

REACH, 12 Nov DU DU obligations when his use is not covered by the SDS-options:  Adapt the conditions of use to those described in the SDS  Implement or recommend ES which includes as a minimum the conditions described in the ES communicated to him  Make the use known to the supplier with the aim of making it an identified use based on the manufacturer’s CSA  Perform your own CSA for that particular use and record it in a Chemical Safety Report - CSR (if the total amount used is 10 t/year or more). Notify your use to ECHA  Switch to another supplier of the substance if that supplier covers your specific use in his SDS

REACH, 12 Nov Importers and Non - Community companies Non Community manufacturers do not have direct obligations under REACH Non Community manufacturers:  Work with EU importer  Established or use EU-legal entity  Use Only representative

REACH, 12 Nov Importers Identify which S/P require SDS:  new format, include ES  submit to costumer Identify S subject to restriction/authorisation and pass info down the chain For articles:  Check if article contains SVHC  Provide info on safe use (min. name of S)

REACH, 12 Nov : Preparing the registration dossier 3.1: Preparing the registration dossier 3.3: Information requirements 3.3: Information requirements 3.2: Preparing the CSR 3.2: Preparing the CSR 3.10: Guidance on substance ID 3.10: Guidance on substance ID 3.5: Guidance for downstream users 3.5: Guidance for downstream users 3.8: Requirements for articles 3.8: Requirements for articles 3.6: Guidance on C&L under GHS 3.6: Guidance on C&L under GHS 3.7: Guidance on applications for authorisation 3.7: Guidance on applications for authorisation 3.9: Guidance on SEA 3.9: Guidance on SEA 3.4: Guidance on data-sharing 3.4: Guidance on data-sharing RIP-3 REACH Guidance for Industry

REACH, 12 Nov Thank you!