LISAM SYSTEMS REACH Compliant SDSs: What s Changed and What s Coming

Transcription

1 REACH Compliant SDSs: What s Changed and What s Coming Simon Bradshaw, June 2016

2 REACH Compliant SDSs: Structure, Content and Requirements Simon Bradshaw, June 2016

3 REACH... Regulation 1907/2006 Amendment 453/2010 Amendment 2015/830 Classifications GHS 12 th ATP to CLP alignment to GHS rev 6 11 th ATP translation of substance names. Vote Oct th ATP adding / amending harmonised substance classifications. Vote Sept th ATP (47 substances). Adoption 2Q th ATP aligns CLP with 5 th Ed UN GHS). Applies from 1 Jan th ATP (35 substances) Applies from 1 Jan 2017

4 COMMISSION REGULATION (EU) 2015/830 of 28 May 2015 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

5 Different EU MS require own language(s) Some EU MS often have individual specific requirements SDS continuously updated through the life cycle of the product and SDS kept 10 years after last supply Some key SDS structure changes: Emergency tel nr Section 9 incl ph and concentration (aq.) Sections 2 & 3 reversed ES for substances

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13 Requirements for the safety data sheet (SDS) are laid down in Annex II to REACH. Two conflicting amendments of Annex II were due to come into force simultaneously on 1 June 2015, one made by Article 59(5) of the CLP Regulation and the other by Commission Regulation (EU) No 453/2010. Therefore Commission Regulation (EU) 2015/830 was published to clarify these amendments. In addition, a number of small changes recently adopted into the GHS are also reflected into the new regulation. The measures took effect on 1 June 2015; however, recipients who received a SDS before 1 June may continue to use it until 31 May 2017, or until a mandated update is required. From 1 June 2017, ALL SDS must be in compliance with the Annex to Regulation (EU) 2015/830, and ALL substances and mixtures must be classified, packaged and labelled in accordance with the CLP Regulation, 1272/2008, even those already in the supply chain.

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17 Substance name in product identifier in SDS Order of precedence 1. Annex VI 2. C&L Inventory 3. IUPAC 4. Other International name 5. Other (used in REACH notification, where IUPAC >100 characters)

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19 REACH Compliant SDSs: What s Coming SUMIs, Eye Damage, Infocard, Poison Centres, Polymers, ISO Simon Bradshaw, June 2016

20 DU Sectors: Safe Use of Mixtures Information (SUMIs) End use of mixtures with clearly defined markets Sector-specific Worker Exposure Description (SWEDs) One SUMI for each SWED SUMI appended to or integrated within the SDS

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23 Timeline for SWEDs and SUMIs 1Q 2016: Sectors to publish their SWEDs and SUMIs Development of Chesar input files for SWEDs Train the trainer workshop June 2016 Publication Q4 2016

24 New Pictograms Eye Damage Pictogram Timeline?

25 Substance Infocard Timeline January 2016

26 Harmonised Classifications Assess suitability

27 CLP Article 45. Poison Centres Receive information and give advice Mixtures classified for physical and/or health hazards Mixtures classified for environment only or non-hazardous mixtures with hazardous ingredients are out of scope Medical professionals only Information received treated as confidential

28 CLP Article 45. Poison Centres Information submission Harmonised information submission to each Poison Centre Commercial mixtures, Industrial, Professional and Consumer Products (R&D samples exempt) Unique Formula Identifier (UFI) Standard electronic format for submission (XML) Group submission for similar mixtures with same hazard classification

29 CLP Article 45. Poison Centres Different Product use types Limited submission for mixtures sold to industrial users providing 24/7 ER system in place. Provide SDS Full submission for mixtures sold to Professionals and Consumers Reduced submission for mixtures used by Professionals in discussion?

30 CLP Article 45. Poison Centres Disclosure of Hazardous Ingredients May need to disclose more info about hazardous ingredients than on SDS Disclosure at <0.1 wt.% for substances of major concern for emergency health advice: Acute Toxic 1, 2, or 3 STOT-SE or STOT-RE 1 or 2 Skin Corrosion 1, 1A, 1B or 1C Serious Eye Damage 1 Exact wt.% preferred. Concentration range permitted

31 CLP Article 45. Poison Centres Disclosure of Non-Hazardous Ingredients Commission proposal for all identified non-hazardous ingredients to be disclosed down to 1 wt.% Concentration range allowed

32 CLP Article 45. Poison Centres Unique Formula Identifier (UFI) Possible solution: Unique alphanumeric code linking submitted information to a specific product UFI generated FoC by notifiers using a web tool UFI to be included on label or packaging for mixtures sold to professionals and/or consumers UFI only required on SDS for mixtures sold for industrial use

33 UFI format could be similar to batch number seen on mixtures LISAM SYSTEMS 2016

34 CLP Article 45. Poison Centres Timeline REACH Committee vote 2016 Transitional period 3 years 2016 regulation in force (3Q?) 2019 Consumer and Professional use 2020 Professional use 2021 Industrial use

35 CLP Article 45. Poison Centres Updates to a notification Change to mixture name Change to mixture classification Composition change Submission without undue delay

36 Chemical Agents Directive 98/24/EC entry into force 1998 Amendment 2007/30/EC entry into force 2007 Amendment 2014/27/EU 2014 Assessing and Preventing Risk Employers must take measures to eliminate or reduce risks to a minimum Where possible chemicals or processes must be replaced with less dangerous ones

37 A legal SDS? A real world SDS? Beware of jurisdiction obligations and culture

38 Non-Mandated SDS Recommend 16 section REACH format for familiarity Safety Information Sheet

39 Established: 1999 local, global, presence Acquisitions: ESI Protheus, Telegis, etc 110+ professionals 850+ clients worldwide Industry Solutions : incl. Cosmetics/ Detergents/ Fragrances/ Petrochem Active in Chemical Federations C# / MS.NET4 with Microsoft SQL Server Easily integrates with printing and ERP systems REACHReady, EIGA, Microsoft Gold Increased compliance efficiency Auto language/jurisdiction generation Auto SDS creation and management Simplified data management Easily integrates new regulatory lists Standardising safety data and work processes All jurisdictions, GHS and non-ghs 50+ languages Easy to generate compliance reports

40 Thank you. Questions? LISAM SYSTEMS 2016 REACH Compliant SDSs: What s Changed and What s Coming Simon Bradshaw, June 2016 simon.bradshaw@lisam.com