REACH SVHC Authorisation & How to Manage Customer Deselection

REACH SVHC Authorisation

& How to Manage Customer

Deselection

Dr. Qintao Liu, FRSC

Director, Prefusion Consulting Ltd.

www.prefusion.co.ukREACHReady Regulatory Services Zone,

Chemspec, Cologne, Germany

21 June 2018

Chemical Regulation and Strategy Consulting© 2018. Prefusion. All Rights Reserved.

http://www.prefusion.co.uk/

Dr. Qintao Liu is a senior executive with 25 years’ experience with multinational companies, government committees and academia in Europe, China and North America. She has professional credibility on sustainability, advocacy strategy and risk assessment of chemicals, pharmaceuticals, personal care products, biocides and nanomaterials. Dr. Liu was lately a global director for Covestro’s polycarbonates business (2016-2018) and Dow Corning’s high-performance building business (2011-2013). She was appointed into the pool of scientific advisors for European Commission Scientific Committees on public health, consumer safety and risk assessment (SCCS, SCHER, SCENIHR) in 2009; and appointed by the UK Defra Minister as an advisory board member on hazardous chemicals (ACHS) in 2006-2012. Dr. Liu is currently a director of Prefusion Consulting Ltd. in the UK (www.prefusion.co.uk)

Dr. Qintao Liu

Director,

Prefusion

Consulting Ltd.

SPEAKER

Chemical Regulation and Strategy Consulting

Why Compliance?

Next step of challenges

Chemical regulations in EU

Business considerations

SVHCs: prioritisation of authorisation under REACH

Application for authorisation process

Business/product strategy based on chemical regulation

Regulatory scenarios

Market impact analysis

REACH in supply chain

Communicate SVHC issues to downstream users

Management of customer deselection

AGENDA


Business & Market Strategy

Product Stewardship

Government

Requirement

• License for operation / sales

• Punishment if not compliant

• Market entry route

• Competitive

advantage

• Brand effects

• Regulation for

innovation

• Product

stewardship

strategy

• Issue management

WHY COMPLIANCE?


REACH registration deadline has passed

Management of SVHCs and substance candidate lists

PBT / CMR / endocrine disrupting chemicals

Risk versus hazard, incl. exposure scenarios

REACH consortia and data sharing in SIEFs

As lead registrants or data sharing: OSOR principle

Through Only Representatives (OR)

Management of authorization / restriction

Prioritisation for authorization: what does it mean to you?

Application for authorization process

Business management of downstream issues

Advocacy strategy and value chain communication

Commertialisation and management of customer deselection

NEXT STEP OF CHALLENGES


SUBSTANCES OF VERY HIGH CONCERN

(SVHCS)

Core for REACH, referred to as

Substance of Very High Concern (SVHC)

Substance of High Concern (SHC) / potential concern

REACH Article 57, 58 and 59

CMR, PBT or vPvB chemicals (Article 57 (a)-(e))

ED properties & equivalent level of concern (Article 57 (f))

Restriction of uses on its own, in a preparation or articles

Candidate List for eventual inclusion to Annex XIV

Chemical Safety Report under Annex XV

Prioritisation of authorisation

ECHA is in the process of selecting chemicals to prioritise for

authorization

Risk Management Option Analysis is a method


PROCEDURES AND

APPROACHES FOR

IDENTIFICATION OF

SUBSTANCES OF

POTENTIAL CONCERN

Source from ECHA

SVHC 2020 Roadmap•Screening method

•RMOA method

Groups of chemicals to be covered

by the implementation plan•CMR category 1A & 1B

•Sensitisers

•PBTs and vPvBs

•Endocrine disruptors (EDs)

•Petroleum/coal stream substances

that are CMRs or PBTs

Source from ECHA

STEPS OF AUTHORISATION PROCESS

Total length of process approx. 2 years

MYTH AND TRUTH ABOUT AUTHORISATION

1. Authorisation is related to

tonnage

2. Authorisation is also applied

to the use in articles

3. Polymers are exempted

4. Authorisation is required for

substances as impurity or in

mixtures

5. Recovered substances are

exempt from authorisation

requirement

6. Only manufacturers or

importers could apply for

authorisation

1. No tonnage threshold for

authorisation requirement.

2. No, but depends.

3. Yes, but depends

4. May be, only when >

threshold.

5. No, uses of recovered

substances are not

exempted

6. No, manufacturers,

importers or downstream

users as well as duly

mandated ORs can apply.

Myth Truth


SVHC IN MIXTURES

Most chemical products are mixtures

As a result of production process

Formulated from substances or other mixtures

Safe Use of Information for Mixtures (SUMI)

Being developed by ENES, a cross stakeholder platform

Included in CSR/ES Roadmap

Cefic Lead Component Identification (LCID) Approach

Published the final version 6.1 in Feb. 2016: 120 pages!

Lead Component Identification

Substance concentration

Priority substance = SHC or SVHC

Detailed illustration on roles and responsibilities of

different players in supply chain

Scaling tools are recommended: quantitative assessment


SVHC IN OTHER PRODUCTS

Plant Protection and Biocidal Products

Active Substances approval under PPP & BPR

Treated articles included into the BPR

Chemicals with endocrine disrupting properties

Cosmetic Products (CPR)

Industrial chemicals, e.g. siloxanes D4 and D5

Chemicals with endocrine disrupting properties

Consumer Products

PFOA and its salts used in textiles and cookware

DecaBDE used in textiles, furniture and electronics

(RoHS)


Requirements for Safety Data Sheets The supplier of a substance or a preparation shall provide the

recipient of the substance or preparation with a safety data sheet

compiled in accordance with Annex II – Article 31 (1)

Communicate information down the supply chain

Communicate information on substances in articles

within 45 days

Communicate information up the supply chain Distributors shall pass on that information to the next actor or

distributor up the supply chain - Article 34

Access to information by workers

INFORMATION REQUIREMENTS IN THE

SUPPLY CHAIN


ROLES & RESPONSIBILITIES IN THE SUPPLY CHAIN

Manufacturers / Importers

Register substance manufactured/imported >1 t per year.

CSR for substances >10 t per year, incl. exposure scenarios (ESs) for all

identified uses in case substances meet the criteria of Art. 14 of REACH;

eSDS with one or more ESs as Annexes to the eSDS.

Formulators

•Produce products/mixtures by formulating substances or other mixtures;

•Check hazard identification & ESs* in SDS/eSDS received from suppliers;

•Classification & labelling, incl. assess. hazardous potential of mixtures;

•Describe OCs and RMMs to handle mixtures in a safe way;

•Prepare SDS of mixtures to be sent to customers **.

Downstream Users (DUs)

•Apply substances/mixtures in industrial or professional applications;

•If classified as hazardous, then SDS of substances/mixtures (incl. SUMI);

•Notification to ECHA of uses not covered by ESs received from suppliers;

•DU CSR may be applied for new ESs, if not exempted;

•CSR for mixtures identified as hazardous (optional).

Distributors involve several times in the supply chain; they are not

considered as Downstream Users.


Downstream Users•Formulators

•End users

Information on uses

to registrants

Registrants

Use mapsESCom

SCEDs

SpERCs

Roadmap activity 2

Roadmap activity 3

Short titles

Extended SDS

to downstream users

eGuide

ES for communication

Roadmap activity 4

Supply chain

CommunicationSWED

ECETOC TRA

Adapted from ECHA ENES

SUPPLY CHAIN COMMUNICATION: ESDS,

EXPOSURE SCENARIOS AND E-TOOLS


KEY QUESTIONS ON BUSINESS / PRODUCT

STRATEGY FOR SVHCS

Are my products listed as SVHCs under REACH

Up to date, there are 181 substances identified as SVHCs

43 substances are included in the authorisation list

If yes, what is the evidence for SVHC?

PBT, CMR or equivalent concern, e.g. EDCs

Will it be prioritised for authorisation?

Is my product used as a monomer only to produce polymers? What

are related uses?

Are there any alternatives?

If not, will it likely to be a Substance of potential Concern?

What is the business / market impact if my product is authorised

in the next 1 year, 3 years or 5 years?

What is my responsibility? What is business decision?

Communication to the value chain / customers?

Authorisation application?


BUSINESS/PRODUCT STRATEGY

Beyond regulatory science

Understand your product profile

Short, medium and long-term regulatory impact

Need to consider multi-dimensional issues

Science and regulation: false positive

Politicalisation of the issue

Customer and value chain deselection

Communication to the public, e.g. chemophobic

Should be in the top agenda of the highest level

If your company’s business is relying on the chemical,

which is or will be a SVHC under REACH


MANAGEMENT OF SVHCS AND BUSINESS

STRATEGY

Aware, advocate and decide Health and environmental hazards: CMR, PBT, vPvB

Endocrine disrupting properties

Compliance strategy, customer demands and business decisions

REACH authorization and advocacy CSR of the substances and/or mixtures, incl. ESs

Develop SDS and eSDS, incl. using e-tools

SIEF or REACH consortia participation / representation

Engage with expert groups and commitees, e.g. PBT, ED, RAC/SEAC

Participate into public consultations

Business or product strategy Product profile and compliance check

Business / market impact based on regulatory scenarios

Management of customer deselection

Value chain communication

THANK YOU AND QUESTIONS

www.prefusion.co.uk

[email protected]

+44 (0)7900 197300

+86 13810169243


PREFUSION - CHEMICAL REGULATION AND

STRATEGY CONSULTING

March 2010: Established in the UK

Corporate/product strategy, REACH, CLP/GHS, EMEA, PPP, BPR, CPR

2006-2012: Dr. Liu appointed as an UK ACHS member by Defra Minister

2007: Dr. Stanley appointed as an UK ACHS member by Defra Minister

2009: Dr. Liu appointed as an expert advisor in the pool for DG SANCO

committees (SCCS, SCHER & SCENIHR)

2010: Prof. Le Grys served as 3rd party auditor for BRC Global Food Stds.

Sept. 2014: Collaboration with China partner on REACH

2015-2018: Chemical Watch Global Service Provider

May 2015: Beijing office established

July 2015-: CIA REACHReady Approved Service Provider

2016-: Significant projects on SVHC and value chain advocacy

www.prefusion.co.uk

Documents

REACH SVHC Authorisation & How to Manage Customer Deselection