REACH, SDS and CLP EU REGULATIONS ON CHEMICALS Everything you need to know! SCC Ontario March 25 th, 2014 Marie Roussel & Ariane Divetain

Transcription

1 REACH, SDS and CLP EU REGULATIONS ON CHEMICALS Everything you need to know! SCC Ontario March 25 th, 2014 Marie Roussel & Ariane Divetain

2 Introduction to EcoMundo European Research Projects EcoMundo is launched Regulatory expertise Toxicology & Ecotoxicology Specialist of EU Chemical Regulations Software & Database Multidisciplinary team 30 engineers of which 5 PhDs for expert services Recognition US & Ca nadian Governments Export.gov + Canadainternational.gc.ca

3 International presence 2009 Brussels office European Commission contact Vancouver office Contact with North American clients Paris office Headquarters

4 Overview of the presentation Substance Mixture Article Raw material Finished formula REACH Registration 2 SVHC SDS CLP Regulation New Cosmetic Regulation 1223/2009

5 European Economic Area + European Union (28 countries) Norway + Iceland + Liechtenstein = 31 countries concerned with the REACH Regulation

6 List of concerned countries In alphabetical order: 1. Austria 11.Germany 2. Belgium 12.Greece 3. Bulgaria 13.Hungary 4. Croatia 14.Iceland 5. Cyprus 15.Ireland 6. Czech Republic 16.Italy 7. Denmark 17.Latvia 8. Estonia 18.Liechtenstein 9. Finland 19.Lithuania 10.France 20.Luxembourg 21.Malta 22.Netherlands 23.Norway 24.Poland 25.Portugal 26.Romania 27.Slovakia 28.Slovenia 29.Spain 30.Sweden 31.United Kingdom

7 THE REACH REGULATION REACH 1 REACH Registration 2 SVHC

8 Before REACH: the chaos! FOURTY DIRECTIVES 2007 ONE SINGLE REGULATION COMPLEXITY A different interpretation for each country HARMONIZATION Common obligations to all 31 countries

9 REACH stands for R egistration Of chemicals substances > 1 MT per year to gather data E valuation Dossier verification by ECHA Risk assessment for each substance A uthorization SVHC listed in Annex XIV. Ban except if special permission is given. Ch and Restriction of emicals Complete ban on uses that pose unacceptable risks

10 Key principles of REACH 1 2 No data, No market No business without key data registration: impacts, safe use, risk assessment, etc. Precautionary Principle Chemical products are considered as suspect until the industry proves otherwise 3 Communication in the supply chain Data sharing is essential between companies

11 What must be registered? 1 REACH Chemical substances placed on the EU market > 1 MT per year The chemical to be registered can be found: As a substance on its own In a raw Material In a finished formula

12 Above 1 metric tonne p/y 1 REACH How to calculate the tonnage? > 1 MT p/y Three-year rolling average of the annual tonnage > 1 MT p/y Per legal entity in Europe

13 The three tonnage bands 1 REACH Registration deadlines based on tonnages and dangers: 2010 > 1,000 tonnes CMR > 1 t and R50/53 > 100 t to 1,000 tonnes 2018 From 1 to 100 tonnes

14 Who must register? 1 REACH The EU importer faces the obligation However, for BUSINESS reasons, non-eu companies can register too! ONLY REPRESENTATIVE (OR)

15 Case scenario #1 1 REACH You export 1.5 MT overall, but 500 Kg to each EU client A 500 Kg 500 Kg B C All is good! 500 Kg D

16 Case scenario #2 1 REACH You export 10 MT of a chemical to one EU client A 10 MT B > 100 MT MT A Change A is designates covered of tonnage by OR B for band now secure for EU B business

17 OR = more EU clients 1 REACH Without OR, you can only export to compliant clients A Having an OR = competitive advantage

18 OR = strategy & safety 1 REACH I export to a single distributor in Europe A With OR = more control on your supply chain

19 OR = total freedom 1 REACH I appoint an Only Representative (OR) based in Europe A I can sell to anyone in Europe

20 I don t sell to Europe! 1 REACH My clients are Canadian and US companies only B A Your Unless client B is B a appoints Distributor an OR

21 Who is the OR? 1 REACH Canadian manufacturer Who can be OR? 1. EU subsidiary 2. Distributor / Importer 3. Regulatory Expert Only Representative Must be based in Europe Legal or natural person

22 1 chemical = 1 dossier 1 REACH Lead Registrant Other manufacturers + Your company Your own data JOINT DOSSIER MEMBER DOSSIER All registrants of one chemical = a SIEF group

23 Content of the dossiers Annexe VII 1 REACH Technical dossier > 1 tpy + Chemical Safety Report > 10 tpy 1.Hazards Assessment 2.Exposure Assessment 3.Risk characterisation

24 Required data 1 REACH The manufacturer must provide to the OR Name and address of EU clients Identity and uses of the substances to be registered Exact tonnages of past 3 years exported to Europe Analytical studies required: For organic substances IR = Infra-red UV = Ultra-Violet NMR = Nuclear Magnetic Resonance Chromatography For inorganic substances X-Ray Diffraction (XRD) X-Ray Fluorescence (XRF) Atomic Absorption Spectroscopy (AAS) And description of methods used

25 Data requirements 1 REACH Depend on the tonnage band Physico-chemical Toxicological Ecotoxicological Tox and Ecotox Specific rules Waiving strategy Annex IX, X : testing proposals Annex X Annex IX Annex VIII Annex VII 1-10 T

26 What are the costs? 1 REACH Letter of Access Lead Registrant or Consortia Member dossier Regulatory Expert Submission fees Full envelop between $10,000 to $50,000 on average

27 Summary 1 REACH 1. Tonnage of export? Key registration date? Under one tonne per year, you are not concerned 2. Supply chain situation? Compliance of your clients 3. What are the costs? Dossier, letter of access, submission fee to ECHA 4. Designate an Only Representative (OR) He fulfils all your legal responsibilities

28 What is an SVHC substance? 2 SVHC At least one of the following criteria: CMR = Carcinogenic, Mutagenic or toxic to Reproduction PBT = Persistent, Bioaccumulative and Toxic vpvb = very Persistent and very Bioaccumulative Equivalent danger = endocrine disruptors (example) DOUBLE OBJECTIVE better communication on SVHC gradually ban them from the EU market

29 Lists of substances 2 SVHC About 140,000 chemicals Registration Candidate list: 151 substances Annex XIV 22 substances Traceability Communication Notification Authorization Watch: these lists are updated twice a year on average

30 Obligations for articles 2 SVHC REGISTRATION Substances released > 1 T ARTICLE SVHC SUBSTANCES NOTIFICATION to ECHA > 1 T AUTHORIZATION Substances in Annex XIV COMMUNICATION to Downstream users > 0,1 % w/w

31 Communication >0,1% w/w 2 SVHC 1 Collect SVHC data from your suppliers 2 Calculate the % (w/w) of SVHC in each article Information to communicate: Name of SVHC Rules to ensure safe use 3 Communicate terms and conditions of use to clients 4 Following consumer request, you have 45 days to answer

32 The 0.1 % w/w calculation 2 SVHC Official rule: 0.1% applies to the entire article. Buckle + leather = 2 articles But some countries consider each component as an article. The calculation can vary from country to country!

33 Summary 2 SVHC 1. Determine the presence of SVHC Data collection from your suppliers 2. Assess the SVHC concentration Calculation according to the countries 3. Above 0.1 % (w/w), check your obligations Registration, Communication, Notification 4. Pay attention to updates of the Candidate list Anticipate and subscribe to alerts

34 SAFETY DATA SHEETS REACH 13 SDS

35 1 The sections to follow closely 3 SDS The SDS is a passport For industrial hazardous chemicals SDS = main target in custom controls Sanctions = fines, confiscations, ban to export / manufacture

36 1 The sections to follow closely 3 SDS Specific SDS obligations SDS = mandatory if the substance or mixture is: classified as hazardous (according to CLP, DSD, DPD) classified as PBT or vpvb listed as an SVHC SDS = must be translated in the language of the export country When the substance is REACH registered, the SDS lists the registration number and covered uses

37 1 The sections to follow closely 3 SDS 5.5 SDS in the supply chain 1. Collect SDS from your suppliers 3. Send compliant SDS to your clients in their language for free Supplier A Supplier B YOUR COMPANY 2. Keep SDS of substances and mixtures used on-site Client X Client Y

38 1 The sections to follow closely 3 SDS 16 mandatory sections 1. Identification of the substance/mixture and of the company/undertaking 2. Hazard 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 17. ANNEXES extended SDS when REACH registration

39 1 The sections to follow closely 3 SDS Is your SDS compliant? Quick check-list before sending your SDS to Europe: Order of the 16 sections must be respected Date and version Section 1: check the uses of your DU are covered Section 2: classification according to CLP and DSD Translation is the right language Emergency call number (different for each EU country)

40 Summary 3 SDS 1. List hazardous substances + mixtures Pay attention to updates of the SVHC list 2. Define their classification According to CLP, DSD and DPD criteria 3. Update the format of your SDS + translate According to REACH and CLP Regulations 4. Send your compliant SDS to clients Only for your industrial clients

41 THE CLP REGULATION REACH 14 CLP

42 Harmonization through CLP 4 CLP Globally Harmonized System (GHS) drafted by the United Nations Previous directives DSD = Substances DPD = Mixtures CLP Regulation In force since 2009 Classification Labelling Packaging

43 Deadlines 4 CLP Classification DSD and CLP June 2015 CLP DPD or, DPD and CLP June 2015 CLP Notification to ECHA for substances > 1 MT and those classified Packaging Labelling CLP only DPD or CLP June 2015 CLP

44 The 9 pictograms 4 CLP

45 Substance classification rules 4 CLP Reversible skin irritants effects at 5.0% erythema/eschar, oedema, persisted inflammation Effects on cornea, conjunctivae (redness, oedema) but fully reverse within 21 days at 5.0% Evidence in humans of skin sensitization Positive responses from in vivo tests Skin Irrit.2 : H315 Eye Irrit.2 : H319 Skin Sens.1: H317

46 Mixture classification rules 4 CLP 2% Skin Irrit.2 : H315 C 5.0 % Eye Irrit.2 : H319 C 5.0 % Skin Sens.1: H317 Skin Sens.1 H317

47 Labelling changes! 4 CLP To comply, a label must include: name, address, phone number of the supplier nominal quantity of the substance or mixture (general public) hazard pictograms, signal words, hazard statements and precautionary statements

48 Canada & USA 4 CLP GHS has been adopted since 2012, known as HAZCOM It will be fully implemented in US companies can thus anticipate. Canada is preparing the amendment of its Hazardous Products Act (HPA) to be ready for Until then, Canadian companies must comply with the WHMIS standards.

49 Summary 4 CLP 1. List hazardous substances + mixtures Caution : dates differ for substances and mixtures 2. Check the DSD / DPD / CLP classification Pay attention to the date 3. Notify to ECHA, to the C&L inventory Any substance above 1 MT (via your OR) 4. Change your labels and packaging accordingly Use the new CLP pictograms

50 Thank you for your attention!