Exposure Scenarios and mixtures: What are the obligations?

Brenntag Cleaning Seminar30 March 2017

Dr. Hans Razenberg

NVZ

• Founded in 1948.

• Represents ±60 companies and 80-85 % of the market value

• Located in Zeist.

• Portfolio: detergents, maintenance products, disinfectants for both consumer and professional market and also…..

• Professional cleaning equipment

• 3 under I roof: NVZ, NCV and NAV.• International associations: A.I.S.E. and

Eunited Cleaning

Keys to NVZ

RebrandingFrom product driven…

3

To value driven

4

NVZ and her membership, in collaboration with stakeholders, want to create clean, hygienic and sustainable environments for all Dutch residents.

VISION

The NVZ Team

European Detergent Industry

Content

• Introduction REACH

• REACH Supply Chain Communication

• Obligations for downstream users

• REACH in practice: Detergents Sector

Introduction REACH

Main goal

• Ensuring a high level of protection of human health & the environment

Method

• Manufacturers and importers of raw materialsresponsible: no safe use, no market!– Collecting and generating data on substances

– Undertake Chemical Safety Assessment (CSA) forall identified uses in the supply chain• Also for use in mixtures

• Communication of CSA results via Exposure Scenarios(ES)

REACH Supply Chain Communication

Manufacturer

Formulator

End-user

SDS

ESSDS

Use infor-

mation

Use infor-

mation

Safe Use Info

Chemical Safety

Assessment

SDSSDSSDSIdenti-fiedUses

Supply Chain Communication: Pre-REACH vsREACH

Upstream communication

Downstream users have the right to make their use of a substance an identified use

• Informing supplier of substance uses‒ Use Descriptor System (PROCs, SU, LCS etc.)

‒ Distributors have obligation to pass this on to next actor

• Deadline: May 31st 2017 for 2018 registration deadline, or within one monthof first supply of substance (new customer)

• Registrant has obligation to address allidentified uses

Downstream user obligations

Three main obligations after receivingSDS with Exposure Scenarios:

1. Use Check

2. Identify and apply appropriate risk control measures

3. Recommend risk control measuresfor mixture uses (formulators)

Downstream user obligations

1. Use Check

• Are all my uses of the substancecovered in one or more ESs?

• Formulators: Are the foreseen uses of my mixtures covered?‒ When the substance contributes to CLP

classification of mixture

• If not: action required‒ Inform supplier; or

‒ Change supplier/substance; or

‒ Perform own DU CSA (if required)– Notify ECHA within 6 months of receiving SDS with ESs

Downstream user obligations

2. Identify and apply appropriate risk control measures

• Follow the conditions and risk management measures from…‒ The relevant exposure scenario(s); or

‒ The results from my own DU CSA.

• Within 12 months of receiving anSDS with ESs!

Downstream user obligations

3. Recommend risk control measures for mixture uses (formulators)

• Options for communicating ES-information for mixtures

1. Integrate information in main body SDS

2. Append safe use of mixture information

3. Attach relevant substance ESs as annex

ECHA DU Guidance: “The process should be efficient, risk-proportionate, and relevant and understandable to recipients.”

The Detergents sector

Professional Cleaning & Hygiene

• Broad range of products

• Many different product uses

• Many SME end-user customers– NL: >10.000 SME cleaning

companies

Common issues

Formulator

• Several (end)uses not covered in Exposure Scenario’s

• Unrealistic safe use conditionsdescribed

Mixture SDSs often do not yetcontain ES-related safe useinformation

Common issues

End-user

• Limited resources‒ Many SME companies

• Often lack of sufficiently educated personnel

• Determining safe use conditions difficult

‒ Own safety assessment needed

‒ Chemical/toxicological knowledge needed

Sector use maps

Manufacturer

Formulator

End-user

SDS

ESSDS

Use infor-

mation

Use infor-

mation

Safe Use Info

Chemical Safety

Assessment

SDSSDSSDSIdenti-fiedUses

Sector use map

Sector association

Analysis of typical end-uses

20

Sector use maps

• Overview of typical uses within sector

• Describes actual use situation

– Duration? Ventilation? Protective equipment?

• Standardized format used by all sector associations

Example uses

Example uses from detergentssector use maps: professional cleaning

• Diluting a product in a spray flask

‒ Max. 1 hour per day, no LEV possible, …

• Spraying a product on a surface‒ Max. 1 hour per day, no LEV possible, …

• Brushing a product on a surfaceby hand

Safe use of mixtures

Communication to end-users: Safe Useof Mixtures Information (SUMI)

• Simplified, tailored communication on safe use of mixtures

• Based on analysis of typical end-uses: Sector use maps

Safe use of mixtures

Communication to end-users: Safe Use of Mixtures Information (SUMI)

• Simplified, tailored communication on safe use of mixtures

• Industry-wide harmonised format

• Based on uses specified in sector use maps

• Use-specific document– One SUMI may be applicable for multiple

mixtures

• Does not replace SDS– SDS includes product-specific information

SUMI: Safe Use of Mixtures

Information for end-users

Sector logo

Sector_SUMI_code: Title of SUMI

General description of process covered

May include use descriptor codes or reference to

SWEDOperational Conditions

Maximum duration: xx min.

Other: xxx

Risk Management Measures

Required RMMs, use of pictograms

Reference to Section 8 of SDS for RMM specifications

Disclaimer

Disclaimer on boundaries of SUMI use

Sector_SUMI_code / version number

Mandatory SUMI content

If applicable: any environmental measures

SUMI Format

Optional SUMI content

Additional information on product composition

Good practice advice

If relevant, applicable (sector-specific) good practice

advice

Use of pictograms

when available

To include references to other relevant sections of SDS

or product label

Sector_SUMI_code / version number

SUMI Format

A.I.S.E. SUMI example

DRAFT

A.I.S.E. SUMIs

How to use A.I.S.E. SUMI as formulator?• Define relevant uses of mixture

– Not classified? SUMI not needed.

• Check ESs of substances– Substances contributing to classification– Uses from sector use map covered?

• Select and send output– A.I.S.E. SUMI-code in Section 1.2 of SDS– Append applicable SUMIs

Use maps benefits

Formulator

• Reliable, high-quality exposure scenarios

• Realistic use conditions described

• Standardized communication to end-users possible

– Safe Use of Mixtures Information (SUMI)

Use maps benefits

End-user

• Reliable, realistic conditions of safe use

• Standardized, harmonized communication between suppliers

– SUMIs, tailored information for end-users

• Using the results of a chemical safety assessment done at manufacturer level

Summary

• Use maps improve upstream communication…‒ More detailed information on actual uses

• …and therefore also downstream communication…‒ High quality, reliable exposure scenarios

• …which enables safer workplaces, especially at end-user level.‒ Using the assessment results from a more

knowledgeable player in supply chain• Acceptance from OHS authorities required

Thank you!

Thank you for your attentionUseful links:

• www.nvz.nl

• www.aise.eu (A.I.S.E. Sector Use Maps)