Enhancing the efficiency of Supply Chain Communication GPS / REACH workshop 04 Oct 2011 Athens, Greece L. Heezen Manager Global Chemical Regulations

Agenda Introduction: communication up and down the Supply Chain SDS: When are they required Main challenges ES communication: REACH Libraries ESCom phrases ESCom XML Chesar

Communication down the supply chain Manufacturers and Importers of a substance/preparation shall communicate how their substances/preparations can be used in a safe way Safety Data Sheet (SDS) including Exposure Scenarios (ES): Operational Conditions (OC) and Risk Management Measures (RMM) under which the substances/preparations can be used in a safe way If a SDS is not required, the M/I shall communicate key risk information to enable appropriate risk management (article 32) Distributors to pass on information on safe use to their customers

Communication up the supply chain DU has the right to make their use known to their supplier DU has the duty to inform his supplier about: inappropriateness of the received RMM new information on the hazardous properties of the substance/preparation Distributors shall pass on the information received from DU to the next actor up in the supply chain

Agenda Chesar Introduction: communication up and down the Supply Chain SDS: When are they required Main challenges Support: REACH Libraries ESCom phrases ESCom XML Chesar

Safety Data Sheet (SDS) The purpose of the SDS is to provide the user with: necessary measures relating to protection of human health and environment information to convey down the supply chain when they are not final user (i.e. to compile the SDS for their own mixtures) Format of the SDS: The SDS follows a 16 section format which is internationally agreed. The SDS must be in the language of the country in which it is placed on the market.

Safety Data Sheet (SDS) SDS are mandatory when: Substance/mixture is classified as hazardous Substance is PBT/vPvB Substance is in candidate list (SVHC) (ECHA website) On request of recipient: SDS also for preparations not classified as dangerous but containing: Classified substance > 1% PBT/vPvB > 0.1% SVHC > 0.1% substances limited on workplace SDS not obligatory for: general public (but sufficient info on safe use) Articles (but if SVHC > 0.1 %, communication on safe use to be provided)

Safety Data Sheet (SDS) Communication down the supply chain when no SDS is required: If a SDS is not required, the M/I shall communicate key risk information to enable appropriate risk management: If Substance is subject to Authorisation/restriction: Registration number Details of granted authorisation or appropriate info if authorisation is denied Details of restriction Other available and relevant info on safe use If Substance is not subject to Authorisation/Restriction: Registration number (if risk information is provided) Available and relevant info to assure appropriate RMM

Who prepares the SDS? SDS are prepared by competent persons: Competent Persons are persons – or a coordinator of a group of people - who have, as a result of their training and continued education, sufficient knowledge for the elaboration of the respective sections of the SDS or of the entire SDS. It is not necessary that the expert knowledge is provided in full by one person. These duties can be delegated to own staff or to third parties. Competent persons should be trained regularly

How are SDS provided? SDS must be provided free of charge In an official languages of the recipient’s MS Electronically by email Posted on website + notification to downstream user to download under discussion (MS opinion is that it needs pro-active action)

Registration number in SDS Structure of registration number: <TYPE>-<BASE-NUMBER>-<CHECKSUM>-<INDEX-NUMBER> Issues: confidentiality & workability This last 4 digits may be omitted: For substances: by distributor or a downstream user For mixtures: by any supplier provided that : the supplier provides the full registration number upon request to the MS authority within 7 calendar days if the full registration number is not available to him, a copy of the request must be sent to his supplier within 7 calendar days Company specific!

Safety Data Sheet (SDS) Consistency with registration dossier Identified uses Supplier Exposure control Personal protection Phys-chem properties Etc…

SDS: transitional periods For substances 1 December 2010 – 1 June 2015: Format: Annex I of published Annex II* Classification: DSD + CLP in section 2.1 From 1 June 2015: Format: Annex II of published Annex II* Classification: CLP For Mixtures: Classification: DPD * Amendment regulation (EC) No 1907/2006 (REACH)

SDS: transitional periods-derogations Substances placed on the market before 1 December 2010: if classified, labelled and packaged according to DSD need not be re-labelled or repackaged according to CLP until 1 December 2012. If not required to be relabelled and repackaged or an update is required, need not be aligned with the new Annex until 1 December 2012. Mixtures already placed on the market before 1 June 2015: if classified, labelled and packaged according to the DPD, need not be re-labelled or repackaged according to CLP until 1 June 2017. if not required to be relabelled and repackaged or an update is required need not be aligned with the new Annex II (second version) until 1 June 2017.

SDS: main challenges New structure of headings and sub-headings: IT softwares to adapt! Complexity of transitional periods for voluntary/mandatory provisions: several formats & contents co-existing! Consistency SDS main body with Exposure Scenario Annexes and registration dossier Different national provisions Role of formulators: SDS for mixtures

Modifications after substance registration: identified uses and exposure scenarios Where a Chemical Safety Report is required, the Safety Data Sheet shall contain information on all the identified uses relevant to the recipient of the Safety Data Sheet. This information shall be consistent with the identified uses and exposure scenarios set out in the annex to the Safety Data Sheet: Extended Safety DataSheet (eSDS)

Extended Safety Datasheet (eSDS) Modifications after substance registration: identified uses and exposure scenarios Extended Safety Datasheet (eSDS) Exposure Scenario: describes safe use of a substance on its own or in a mixture during its life cycle Process condistions Operational conditions Risk Management Measures and waste treatment measures Exposure estimation and model used Information for DU to find out if his use is in range of described ES

Agenda Chesar Introduction: communication up and down the Supply Chain SDS: When are they required Main challenges Support: REACH Libraries ESCom Phrases ESCom XML Chesar

REACH Libraries – Objectives To facilitate availability of information to support the development of Exposure Scenarios across industry To support consistency and efficiency of Exposure Scenario development The Libraries are available via the Cefic website

Cefic libraries TF: overview 28 sectors included including solvents, coatings, plastics, silicons, catalysts, metals, etc. Available information: uses, OC’s, RMM’s, GES, templates, etc. Links to available information Updated monthly with new information, sectors, etc… http://cefic.be/en/reach-for-industries-libraries.html

The ESCom Package Exposure Scenario Communication = ESCom Standard for the electronic exchange of ES information in the supply chain. Developed in two projects: ESCom Phrases – Standard phrases for Exposure Scenarios – Developed in CEFIC led project ESCom XML – Electronic exchange standard for Exposure Scenarios – Developed in DUCC led project, Participants: CEFIC, VCI, BDI, IT-Companies (SAP/Technidata, IHS/Atrion, The Wercs, Ariel/3E, Lisam, Kisters, CGI, Safeware, Qualisys, Selerant, UMCO, ESKA …) Involvement of ECHA to facilitate alignment with CHESAR development.

ESCom Package - Products ESCom XML Rel. 1.1 – The Container for ES Info XML Schema-definition ESCom XML guidance document Technical documentation Example of an XML-File ESCom Standard-Phrases - The Content for ES Info Master-File with standard-phrases (incl. phrase-codes) Template for phrase proposal submission Guidance document for phrase development Chesar XML for ESCom import All products are freely accessible at http://www.cefic.org/Industry-support/Implementing-reach/IT-Tools/

ESCom Products Phrase catalog contains some 1800 phrases. Phrases are consensus phrases. Phrase codes are aligned with EUPhraC Phrases are available with phrase codes and metadata (partly). Continuous process is installed to adopt additional phrases ESCom XML offers more than 160 data fields. No possibility to transport free text.

What are the benefits? Automated exchange of Exposure Scenario information replaces manual data entries – avoids retyping. Standard Phrase codes facilitate transformation of ES into other languages. Standardized exchange of Exposure Scenario information avoids interpretation errors. Standardized exchange of Exposure Scenario information leads to steeper learning curve among DUs and enforcement bodies. Standardised exchange of ES info allows company IT systems to translate the information into company specific lay out without interpretation problems.

Agenda Chesar Introduction: communication up and down the Supply Chain SDS: When are they required Main challenges Support: REACH Libraries ESCom phrases ESCom XML Chesar

Chesar Chemical Safety Assessment and Reporting Tool (Chesar) Under development by EU Chemicals Agency Release 1.2 available Uses Ecetoc TRA for workers/consumers and EUSES for environment as default Results of other estimating tools can be processed Helps in the assessment process Generates some reporting, like CSR chapters Generates ES for communication

Organisation of Chesar Manage substances Reporting of uses Manage assessment ES building and CSR generation Generation of ES for eSDS Administration tools

SDS management system by formulators Chesar and SDS systems Substance properties info Use info Use conditions/exposure info IUCLID PBT assessment Chesar Maps of Uses External ES libraries External Exposure Estimation Tools CSR ES for eSDS SDS management system by formulators SDS generation system

Chesar is supporting … PBT assessment description of identified uses with a view to exposure assessment exposure assessment description of conditions of use exposure data from built-in exposure estimation tools from external exposure estimation tools and from sets measured data characterising certain conditions of use risk characterization generation of CSR generation of exposure scenarios for communication

Useful links http://www.cefic.org/Industry-support/Implementing-reach/ Cefic website: guidance’s and tools http://www.cefic.org/Industry-support/Implementing-reach/ Cefic library overview Http://www.cefic.org/Industry-support/Implementing-reach/Libraries/ Chesar http://echa.europa.eu/reachit_en.asp Thank you LHE@cefic.be