Supply chain communication- What are the options to communicate criticial information not in the SDS? Randi Hanstveit, REACH Specialist, Sealed Air
. Markets we serve Health Care Hospitality INFECTION PREVENTION SUSTAINABILITY Retail Food Service OPERATIONAL EFFICIENCY FOOD SAFETY Building Service Contractors Distribution LABOR PRODUCTIVITY INNOVATION
Key Categories of Cleaning products Building Infection Fabric Consumer Food Care Control Care Brands Safety
The problem to be solved The Supply Chain requirement of REACH: [31.7] […] Any downstream user [= formulator] shall include relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses. ECHA DU Guidance: The objective is to convey information that helps to protect human health and the environment in a way the recipient can easily understand .
What is relevant critical REACH information? • Required exposure controls • PPE, ventilation, organisational control, containment etc • Assumed conditions of use or ‘ operational conditions’ (OC) Normally not in • Duration, frequency, max concentrations etc SDS • Substance data: • Phys/chem characteristics that may be relevant for risk assessment • DNELs, PNECs • (Eco)toxicity data where available and relevant for safety NOT 1 – to-1 copy from substance to mixture!!! • Reactions • Change of physical state (dilution) • >1 supplier per substance, AND: Different requirements for concentrated product/use solution
REACH Supply chain Communication [ECHA DU guidance] Ideal situation….
REACH Supply chain Communication [ECHA DU guidance] With new tools SWED SPERC SCED that are (being) developed at EU LCID level to AISE: Use Map Improve communication in SUMI supply chain
REACH communication in supply chain (Actual) Synthesis Manufacturer Raw Material Downstream user Use communication Trader Distributor With ECHA’s Formulator- Diversey Descriptor Downstream user system! (SU, Sales Co Distributor PROC, PC, ERC) Distributor Distributor Customer End - User Send Safety Data Waste Sheet Identify Use
End-user REACH obligations [Art 37] • End users shall identify, apply and recommend appropriate measures to adequately control the risk of the use of a product as given in SDS. • Shall check in SDS if their use AND conditions of use are covered in SDS. • If so=> OK. • If not, the downstream user has to take action! not compliant [Art 35] Workers shall have access to information (for example via worker instruction card) • BUT: Occupational Health and Safety (OHS) legislation also applies! • => Workplace risk assessment (RI&E in the Netherlands) 9
Supply chain communication & formulator options in REACH: • Formulators pass relevant information in substance extended SDS (esds) along the supply chain to their customers . • (REACH) Options for mixtures: 1. Integrate the information into the main body of the SDS (= current SealedAir method) 2. Append safe use information for the mixture 3. Attach relevant exposure scenarios for the substances in the mixture in an annex Not possible 4. NEW INDUSTRY DEVELOPMENT: combination 1,2 : GEIS (NL) now ‘ SUMI’ (EU) 10
Why was SUMI (fka GEIS) developed in the Netherlands ? • Conflict between REACH requirements and existing practice for complying to occupational law and the ‘ Risk Inventory & Evaluation’ (RI&E) • ‘Stoffenmanager*’ required by authorities/ advised by cleaning companies trade organisation for Risk Inventory • In the past only available option • Not aligned with REACH • Not appropriate for mixtures • Too specific knowledge required for most small companies (SME)s • Formulators could not deliver required information • Enforecement organization in NL agreed that Stoffenmanager could be replaced with REACH data GEIS =Generic Exposure Information Sheet 11 *Stoffenmanager= Dutch risk/exposure assessment tool
GEIS- project (NVZ) • Goal: standardize and simplify the way of communicating safe use information to end users in our industry sector. • ‘ Appendix ‘ to the SDS of professional cleaning products (optional) • Using standardized use processes: EU trade organisation (AISE) contributing scenarios • Easy to understand and use by cleaning companies (also small companies) • Easy to implement for formulators Source: Dutch industry trade body NVZ, the Netherlands, www.NVZ.nl
Principle of SUMI THIS IS SUMI THIS IS NOT SUMI Industry-wide harmonised format. Does NOT replace worker instruction card Flexible: combination of activities possible Use-specific document (not product specific) Does NOT replace Safety Data Sheet • SDS includes product-specific information Formulator is doing the substance use Complete Risk Assessment (including compliance check for end user wet work, vulnerable worker, slip danger etc) Specific for cleaning sector (highly diluted use solutions) See: http://www.ducc.eu/Publications.aspx For SUMI format and guidance
‘ Core data’ for SUMIs: Overview SUMI with OC/RMM Combination of all AISE_SUMI AISE SUMI.[PW/IS].[PROC#].[A(noPP Exposure E)/B(goggles)/C(gloves+goggl use descriptors RMM es)/D(LEV+gloves+goggles)][1 Modifier (480min)/2(240min)/3(60min)/4 (15min)].version# Short description of Life Process Respira Eye protecti Duration SUMI-Code LEV? per day process or activity Cycle Category tory protecti on of Transfer of product to a container AISE SUMI.PW.8a.C3.v1 PW PROC8a 60 No No Yes Yes 13published ‘ (bottle/bucket/machine) GEIS’ Transfer of product to a container AISE SUMI.PW.8a.B3.v1 PW PROC8a 60 No No Yes No (bottle/bucket/machine) NEW: Transfer of product to a container AISE SUMI.PW.8a.A3.v1 PW PROC8a 60 No No No No 18 SUMIs for (bottle/bucket/machine) professional Using a product in fully closed AISE SUMI.PW.1.A1.v1 PW PROC1 480 No No No No equipment use Using a product in semi-closed AISE SUMI.PW.4.A1.v1 PW PROC4 480 No No No No 21 SUMIs for equipment industrial use AISE SUMI.PW.11.A3.v1 (Trigger) spraying of a product PW PROC11 60 No No No No AISE SUMI.PW.11.B3.v1 (Trigger) spraying of a product PW PROC11 60 No No Yes No
Principle of SUMI continued How to use SUMI as formulator Note: Not classified? Define relevant uses of mixture SUMI not needed. Check ESs of substances Big • Only for substances contributing to classification effort • Required activities and use conditions covered by for substance suppliers?* formulator! Select relevant SUMI per product and send output • SUMI-code in Section 1.2 of SDS • Optional: Append applicable SUMIs Source: NVZ *Base check on Use maps and ‘ SWEDs’ as published by EU trade organisation AISE
Example kitchen surface cleaner formulator’s task Recommended Activity: Cleaning in kitchen, trigger spray application 1) Select required Life cycle stage & PROC LCS & PROC SUMI in section 1.2 Dilution of product in PW PROC 8a AISE SUMI.PW.8a.C3.v1 bottle (transfer) trigger spraying PW PROC 11 AISE SUMI.PW.11.A3.v1 wipe PW PROC 10 AISE SUMI.PW.10.A1.v1 2) Ensure that these uses/conditions are covered by the raw material suppliers/registrants for all substances in product 3) Include SUMI codes in SDS (section 1.2). 4) Customer can find relevant SUMIs on AISE/NVZ website, or get the relevant copies 16 16
AISE SUMI example DRAFT
AISE SUMI example DRAFT
AISE SUMI example DRAFT
Principle of SUMI for end user How to use SUMI as end – user? SUMI intended for employer, not directly for worker Check section 1.2 of SDS for SUMI codes and relevant SUMIs • Are your uses covered in SDS? • Collect the relevant SUMIs • Check SUMI and SDS. Do you have the correct safety controls in place? • Prepare worker instruction Use SUMI to prepare Worker Instruction Cards (or similar documents) • Cleaning company association (OSB/RAS) developed tool with TNO • Tool aligned with SUMIs • See https://www.arboschoonmaak.nl/wik-maker/
SUMI acceptance in the Netherlands Dutch Cleaning company association working on tool to get from SUMI to ‘Workplace Instruction Card’ (WIK in Dutch) See WIK maker (https://www.arboschoonmaak.nl/wik-maker/) Trade association members (Formulators) enthusiastic about simple approach to comply with REACH Authorities openly supportive Dutch enforcement body: if compliant with SUMI conditions, no own (chemical) risk assessment needed for mixture KEEP IN MIND: OTHER OPTIONS ARE ALLOWED AS WELL 21
Task end user- What is changed due to SUMI in the Netherlands Old situation New Situation SUMI REACH data incorporated in SDS Risk assessment with Use check / check safety Use check / check safety Stoffenmanager advice in SDS and SUMI advice in SDS* Collect substance/product End user will get appropriate information from formulator data from formulator for risk assessment (not possible) Checks other safety aspects No change No change than chemistry (wet work, vulnerable workers etc) End user creates WIC End user creates WIC, but No change can use WIK-maker *Check how supplier communicates operational conditions and use descriptors
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