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 CareINFECTION PREVENTION

RetailOPERATIONAL EFFICIENCY

DistributionINNOVATION

Food ServiceFOOD SAFETY

HospitalitySUSTAINABILITY

Building Service ContractorsLABOR PRODUCTIVITY

Building Care

Infection Control

Consumer Brands

Food Safety

Fabric Care

Key Categories of Cleaning products

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)

• Duration, frequency, max concentrations etc

• 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

Normally not in SDS

REACHSupply chain Communication[ECHA DU guidance]

Ideal situation….

REACHSupply chain Communication[ECHA DU guidance]

With new tools that are (being) developed at EU level toImprove communication in supply chain

SWED

AISE: Use Map

SUMI

LCID

SPERC SCED

REACH communication in supply chain (Actual)

Manufacturer

Distributor

Downstream user

Downstream user

Distributor

End - User

Waste

Distributor

Customer

Distributor

Formulator- Diversey

Synthesis

Sales Co

Raw Material

Trader

Identify UseSend Safety Data Sheet

Use communicationWith ECHA’sDescriptor system! (SU, PROC, PC, ERC)

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 dataGEIS =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

Specific for cleaning sector (highly diluted use solutions)See: http://www.ducc.eu/Publications.aspx For SUMI format and guidance

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 compliance check for end user

Complete Risk Assessment (including wet work, vulnerable worker, slip danger etc)

Combination of all AISE_SUMI AISE

SUMI.[PW/IS].[PROC#].[A(noPP

E)/B(goggles)/C(gloves+goggl

es)/D(LEV+gloves+goggles)][1

(480min)/2(240min)/3(60min)/4

(15min)].version#

AISE SUMI.PW.8a.C3.v1Transfer of product to a container

(bottle/bucket/machine)PW PROC8a 60 No No Yes Yes

AISE SUMI.PW.8a.B3.v1Transfer of product to a container

(bottle/bucket/machine)PW PROC8a 60 No No Yes No

AISE SUMI.PW.8a.A3.v1Transfer of product to a container

(bottle/bucket/machine)PW PROC8a 60 No No No No

AISE SUMI.PW.1.A1.v1Using a product in fully closed

equipmentPW PROC1 480 No No No No

AISE SUMI.PW.4.A1.v1Using a product in semi-closed

equipmentPW PROC4 480 No No No No

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

Eye

protecti

protecti

on of

RMM

Respira

tory

use descriptorsExposure

Modifier

Duration

per dayLEV?SUMI-Code

Short description of

process or activity

Life

Cycle

Process

Category

13published ‘ GEIS’ NEW:18 SUMIs for professional use21 SUMIs for industrial use

‘ Core data’ for SUMIs: Overview SUMI with OC/RMM

How to use SUMI as formulator

Define relevant uses of mixture

Check ESs of substances

• Only for substances contributing to classification

• Required activities and use conditions covered by

substance suppliers?*

Select relevant SUMI per product and send output

• SUMI-code in Section 1.2 of SDS

• Optional: Append applicable SUMIs

Principle of SUMI continued

Bigeffort

for formulator!

Source: NVZ*Base check on Use maps and ‘ SWEDs’ as published by EU trade organisation AISE

Note: Not classified? SUMI not needed.

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Example kitchen surface cleaner

formulator’s task

16

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 bottle (transfer)

PW PROC 8a AISE SUMI.PW.8a.C3.v1

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

AISESUMI

example

DRAFT

AISESUMI

example

DRAFT

DRAFT

AISESUMI

example

Principle of SUMI for end userHow 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/

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

SUMI acceptance in the Netherlands

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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 Stoffenmanager

Use check / check safety advice in SDS and SUMI

Use check / check safety advice in SDS*

Collect substance/productdata from formulator for risk assessment (not possible)

End user will get appropriate information from formulator

Checks other safety aspects than chemistry (wet work, vulnerable workers etc)

No change No change

End user creates WIC End user creates WIC, but can use WIK-maker

No change

*Check how supplier communicates operational conditions and use descriptors

Transition to SUMIValidation project ongoing -European Trade Organisation (AISE)

• Create sector use maps:

− reworking list of SUMIs/contributing scenarios into new format of ECHA.

• Create SWEDS, SPERCS, SCEDS (for communication with registrants)

• Validate SUMIs , professional (NVZ) and Industrial (IHO)

Timing:

use maps: expected Q3 2016

SUMI publication: end 2016

Implementation by companies >2016!

NOTE: Companies are not obliged to provide SUMIs!

http://www.ducc.eu/Publications.aspx