Content

REACHLAW’S ADVOCACY AND AUTHORISATION EXPERIENCE

LOOK BEYOND THE 2018 REGISTRATIONS

SVHC ROADMAP

WHAT SHALL A COMPANY DO?

AUTHORISATION

REACHLaw’s Advocacy Support Experience

Substance(s) Activity StatusPFOA Prepared public consultation input

for the restriction proposal for two industry sectors

Two derogations/ exemptions were granted.

DOTE Strategic planning and public consultation input

Re-classification on-going

DMTE Strategic planning for RMOA input SVHC process haltedOther organotins

Strategic planning for RMOA input No regulatory actions needed

N2H4 Exemption study & position paper & SEA analysis

EC feedback pending

REACHLaw’s Authorisation ExperiencesSubstance(s) Activity StatusAs2O3 DU authorisation application Authorisation grantedAs2O3 DU authorisation application Authorisation grantedMOCA Supplier authorisation application On-goingNa2Cr2O7 DU authorisation application Final opinionCrO3 + other chromates

Space task force use survey, scoping study and application preparation

One application submitted

CrO3 Joint DU authorisation application (CRAN)

Submitted

CrO3 DU authorisation application SubmittedNa2CrO4 DU authorisation application Final opinionCrO3 DU authorisation application/CSR

(APEAL)On-going

Na2Cr2O7 Supplier authorisation application Submitted

Content

REACHLAW’S ADVOCACY AND AUTHORISATION EXPERIENCE

LOOK BEYOND THE 2018 REGISTRATIONS

SVHC ROADMAP

WHAT SHALL A COMPANY DO?

AUTHORISATION

Page 6

REACH as commonly perceived

Registration

Courtesyof Cefic

Page 7

R 2010

R 2013

R 2018

Dossier Evaluation/ Compliance check

AuthorisationRestriction

Risk assessmentchallenged

SVHC roadmap

RMOA

Substances in Articles

Substance Evaluation

Screening

Harmonized classification

Update of dossiers

REACH for advanced

Courtesyof Cefic

How are all the other REACH processes linked?

Source: ECHA(2015)8

CoRAPlist

PACT list

ROI list

Candidatelist

AnnexXIV list

Opinionon AfA

Courtesyof ECHA

AnnexXVII list

Decisions on Annex XIV listing and Authorisation

Annex XIVRecommen-

dation

RAC&SEAC Opinions on application for authori-

sation

Draft decision

REACH Committee

OpinionFinal

decision

Right of scrutiny*

*Blocking right for Annex XIV only

Regulatory procedurewith scrutiny (Dec. 2006/512/EC)

Examinationprocedure(Reg. (EU) 182/2011)

9

REACH stands for Registration, Evaluation and Authorisation of Chemicals.

The purpose is to collect informationon substances and their uses; identifyrisks; and ultimately assure progressive replacement of substances of high concern (SVHCs) by suitable alternative substances/technologies where these are economically and technically viable.

Content

REACHLAW’S ADVOCACY AND AUTHORISATION EXPERIENCE

LOOK BEYOND THE 2018 REGISTRATIONS

SVHC ROADMAP

WHAT SHALL A COMPANY DO?

AUTHORISATION

2010 2011 2012 2013 2014 2015 2016

REACH timeline

2007 2009 2017 2020201920182008

REACH Entry into

force

1.6. 1.12.

Pre-registration

Deadline

30.11.

1000+/”SVHC” registration

Deadline

31.5.

100+ registration

Deadline

31.5.

1+registration

Deadline

Registration of Substances

Evaluation by ECHA and Member States

Candidate listing and Authorisation applications for SVHC

Restrictions for Chemical substances presenting an unacceptable risk

NOW

12

SVHC Roadmap

Substance of Very High Concern (SVHC) roadmap• Goal:

– To have all currently known SVHCs included in the candidate list by 2020 as the first step in selecting substances to be subject to authorisation.

• Which substances?– CMRs (carcinogenic, mutagenic or toxic for reproduction), – PBTs (Persistent, Bioaccumulative or Toxic for the Environment),– vPvBs (very Persistent and very Bioaccumulative), – substances of equivalent concern (such as endocrine disruptors or

sensitisers). • How to achieve this?

– Screening– Risk Management Option Analysis (ROMA)– The rest is defined by the legal text: Annex XV dossier, Candidate

listing, Prioritisation and Annex XIV listing

Screening:Select potential SVHCs of highest priority

• Performed annually• Short list of potential SVHCs based on hazard and non-hazard

properties (ECHA IT Screening) ~ 1500 substances• Manual screening potential SVHCs by Member States• Estimate ~400 RMOAs of potential SVHCs to be conducted by

Member States in the period 2014 – 2020

RMOA• Key questions:

– the available information does not demonstrate that there is a risk that is not adequately controlled and needs to be addressed at EU level, otherwise a restriction process should be started;

– the known uses of the substance are not exempted from the authorisation requirement and are not already regulated by specific EU legislation that provides a pressure for substitution

– Exception: PBT, vPvB, and endocrine (ED) substances• Main conclusion

– Identification as SVHC (entering the Candidate List before prioritised for REACH authorisation)

– REACH restriction – REACH substance evaluation – CLP harmonized classification and labelling – Other EU-wide measures– No need for follow up regulatory action at EU level

From potential SVHC to SVHC

IT screening Manualscreening RMOA

Annex XV dossierSVHC

Candidatelisting SVHC

PrioritisingSVHC

Comitologydecision

PublicationAnnex XIV

Authorisationrequest by

industry

~5 yearsto Annex

XIV

PACT Publication

InformationexchangeMemberState and Stakeholders

Public consultation for CL SVHC Public consultation for Annex XIV

InformationexchangeMemberState and StakeholdersYearly 1 M 1-6 M

6 M - 1 year1 year1 year

4 M

Content

REACHLAW’S ADVOCACY AND AUTHORISATION EXPERIENCE

LOOK BEYOND THE 2018 REGISTRATIONS

SVHC ROADMAP

WHAT SHALL A COMPANY DO?

AUTHORISATION

What can I do?Pre-emptive RMOA approach

Analysing

Monitoring

Strategic planningIntervening

PACT list

ECHA’s disseminationtool

Registrationdossier up-to-

date

PC: rightinformation at

the right time to the right party

• Information collection• Mitigation of risks in

supply chain• Timely obsolescence

management• Cost-effectivereplacement plan

• Portfolio optimation• Effective public

communication

CoRAPlist

Content

REACHLAW’S ADVOCACY AND AUTHORISATION EXPERIENCE

LOOK BEYOND THE 2018 REGISTRATIONS

SVHC ROADMAP

WHAT SHALL A COMPANY DO?

AUTHORISATION

Different ways to get organized

Stand-alone DU application

• Pros– Easy to get data on exposure,

economic impacts, etc.

– Clear understanding of the alternative situation

– Simple in scope

– No demanding communication along the supply chain

– Generally good feedback from authorities

• Cons– Rather costly

• Example– As2O3 application for zinc refinery

Upstream application

• Pros– Supply is guaranteed

– Whole supply chain covered

– Cost efficient

• Cons– Demanding supply chain

communication

– Different players may have different interests

– Difficult to make a representative application for a group of company with monitoring data as well as consistent arguments for AoA and SEA

• Example– MOCA

End-user sector specific application

• Pros– In some cases, similarity in process,

alternative suitability, non-use scenario and socio-economic impacts.

– Possible to make a representative application for all companies in the sector with arguments for AoA and SEA

– Cost efficiency improved

• Cons– Supply is not guaranteed

– Subcontractors needed to be covered

– May not be an optimal solution for sectors with complex supply chains

• Example– Space task force for CrVI

Joint DU application by a homogeneous group

• Pros– Similarity in process, alternative

suitability, non-use scenario and socio-economic impacts.

– Possible to make a representative application for a group of company with monitoring data as well as arguments for AoA and SEA

– Cost efficiency improved

• Cons– Supply is not guaranteed

– Multiple ECHA fee

• Example– Nordic hard chrome plating companies

Cost implications

• Publicly available information

• Rolls-Roys– One substance, one use, one applicant

– Total cost 250 000€

• HBCDD consortium– One substance, 2 uses, 13 application

– Dossier preparation costs: around 300k€

– Joint applicaiton ECHA fee: 550k€

• According to ECHA: – In average 200 000€/applicant/use,

down from 230 000€/applicant/use

• REACHLaw’s rough cost estimation

We need to make joint application work.

Lessons learned

• A good AfA needs:– Sufficient evidences on the control of risks;– Robust analysis on alternatives and socio-economic impacts

• A good and cost efficient AfA needs in addition:– Joint effort with homogeneity at some level

• How to do it?– Make an effort at the scoping phase– Balance between broad and narrow use definitions – Prepare the dossier at the DU level

REACHLaw’s 5-stepped approach for the use definition in complex supply chains

Initial infomaion collection

Initial use definition and project scoping

Detailed information collection

Analysis of the data

Final use definition, application strategy and filing

Defining the use applied for

Dossier preparation

” REACHLaw, the best partner in Global Compliance”

REACHLawVänrikinkuja 3FI-02600 EspooFinland

www.reachlaw.fi

Ying Zhu, Ph.D, M.Sc (Econ.)COO, Partner

ying.zhu@reachlaw.fi

Contact details

David Chatfield, VP EHS&S, Dorf Ketal