REACH: registration, evaluation& risk management update
Seminar to Japanese Industry on the EU
Chemicals Legislation: REACH, CLP & BPR

3 April 2015 / Tokyo, Japan
Geert Dancet
ECHA Executive Director

Content of the update• ECHA mission and strategic objectives• REACH main processes and aims
• Registration obligation & 2018 deadline• Evaluation of registration dossiers• Communication in the supply chain• Dissemination• Authorisation and SVHC 2020 roadmap• Restrictions• Substances in articles

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ECHA eight years old• Started on 1 June 2007
• Over 500 staff from 27
countries• Originally REACH• Since 2009 Classificationand Labelling• Now also Biocides andImport & Export Regulation
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Our mission
Driving force in implementing EU’s chemicals
legislation for the benefit of human health and the environment
as well as competitiveness and innovation

Help
companies
to comply

Advance thesafe use ofchemicals

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Provideinformation on
chemicals

Address
substances ofconcern

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ECHA’s strategic objectives 2014-18
1. Maximising the availability of high quality information
to enable the safe manufacture and use of chemicals.
2. Mobilising authorities to use information intelligently toidentify and address chemicals of concern.
3. Addressing scientific challenges by serving as a hub forbuilding the scientific and regulatory capacity ofMember States, European institutions and other actors.
4. Embracing current and new legislative tasks efficiently
and effectively, while adapting to upcoming resource
constraints.

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REACH – What it’s all about• Companies to establish safe use ofchemicals by Registration• Authorities to Evaluate registrations toensure compliance• EU-wide Risk Management of• most hazardous substances through authorisationthat promotes substitution and• prohibition of unmanageable risk at EU level

through restrictions
Ø Promoting Safety, Competitiveness & Innovation
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What to register• Registration only concern Substances• … not mixtures and articles• on their own or in mixtures• as monomers in polymers• Substances over 1 ton/year• By EU manufacturers or importerso

Non-EU manufacturers can nominate an Only
Representative
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REACH Registration deadlines

Late pre-registration until 31 May 2017
New entrant registration prior manufacture or import

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What do we expect in 2018?
2010

2013

2018 ?

Substances~ 3 400~ 3 000

Up to 25 000

Dossiers~ 20 000~ 9 000

Up to 70 000• Multitude of small SIEFs• Individual registrants• Higher % of SMEs
• High % of imported substances• Less information >> need to generate new data
• Different levels of sector organisation• New economical and political contexts

à Targeted support needed
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2018 Registration Roadmap•Based on an understanding of 2018 registrants’ needs“Too much
guidance”“Complex
IT tools”“Unfair
sharing ofcosts”“More specificuser-focused
advice”……….

•The objective is adapt and streamline procedures, IT tools and support toregistrants by 2016
•Update guidance especially for avoiding certain animal tests•Guidance will not change after May 2016
•European Commission is working on mandatory SIEF rules
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Tips for 2018
• Registration is a big but manageable taskoThousands of companies have already done it• Check if your substance is already registeredoAlready registered: contact the lead registrant to verify
substance sameness, make the SIEF agreement and to obtainyour REACH-IT member tokeno

Not yet registered: contact (pre)SIEF to establish samenessand agree on a lead registrant• Substance IdentityoUnambiguous identification is a pre-requisite to most of the
REACH processes• Make use of REACH 2018 web section
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Preparing the registration dossier• Dossier in IUCLID 5 or 6 format for
substances at 1 to 100 t.p.a. standard
information linked to tonnage• Use QSAR toolbox & waiving abilities• Chemical Safety Report for substances> 10 t.p.a. (assisted by Chesar 2 or 3)• Use the support tools (IUCLID Plug-ins)
before submitting your dossiero TCC, Dossier Quality Assistant …

• Submit with REACH-IT 3 from July 2016
Chemical Safety Report

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What

does andwill do• Two versions of the application: desktop and server / Easier installation of thedesktop version; easier integration with other systems; enhanced user anddata access management; investigation of the possibility to provide IUCLID asa Service• >110 OECD Harmonised templates for reporting summaries of studies
performed according to test guidelines / All existing templates will be updated
to the latest version; new templates on Use and Exposure, Assessment Entity,
Intermediate Effects, alignment with UN GHS on physicochemical hazards• Functions available for processing IUCLID data: report generator (e.g. CSR),
filtering, fee calculation, data validation (e.g. completeness check), search /All functions updated to the IUCLID 6 format. Enhance capabilities forcustomisation of these functions (e.g. generation of other types of reports)• Organisation of the data according to legislation requirements (e.g. REACH,
OECD) / Flexible, legislation-dependent updating (legislation-specific parts of
the application have been isolated and can be developed and updated
separately)

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What Chesar2 does and Chesar3 will do• Putting together elements relevant for CSA:
• Substance properties from IUCLID• Use description from use maps developed by sector organisations• Exposure assessment based on exposure assessment inputs (SpERCs,
SCEDs, SWEDs) using imports of extended use maps by use sectors• Consistent outputs:• CSR for monoconstituents and more complex cases (‘assessment entities’)• CSR extract from IUCLID• ES for communication in eSDS and exporting to EscomXML format• Exposure estimation• Via the built in exposure tool: ECETOC TRA for consumers and workers;
EUSES for environment• Possibility to• plug in more tools• Import output files from tools• Manually input output of external tools

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QSAR toolbox (OECD tool)
Main features of the QSAR Toolbox:
ü Toolbox contains ~1milion data points for over 80 000 substancesü Data covers: Phys-Chem., Environmental Fate and (eco)Toxicologicalproperties required by REACH

ü Provides over 100 profiling methods and QSARs combined with 13
metabolism and transformation predictors
Main reasons for using QSAR Toolbox:ü Allow to fill data gaps by read-across, trend analysis and (Q)SARs forassessing (eco)toxicity hazards of chemicals under REACH
ü Help in reducing the cost and the need for testing on animals;ü Allows direct data exchange with IUCLID;
ü Is one of the most popular tools used by REACH registrants*;
ü Is free of charge, for more information and download please visit:www.qsartoolbox.org
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• What2 does and3 will do• Data submission by industry, Representatives and Member states / (1) Help
small companies to fulfil their 2018 registration duties by making theapplication more intuitive and user friendly; (2) Easy online dossier creation
for Member of Joint Submission; (3) More intuitive online dossier creation
for C&L (GHS)• Technical processing of the submitted data / Full automation of thetechnical verification of the data submitted and associated payment to gain
efficiency• Communication and information hub for Industry in relation to submitted
data / (1) Easier to retrieve key information (e.g. decisions); (2)Assignment of tasks with deadline; (3) Clear and easy way for Industry to
manage its contacts• Data sharing / Improve the tools to allow industry to easier contact eachother and work better together
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• ECHAoDisseminates public data of each dossier and registeredsubstanceoVerifies confidentiality claims which may complete theinformation disseminatedochecks compliance of at least 5% of the submitted
dossiers per tonnage band (target end 2016)• Member States: substance evaluation• Screening for authorisation/restriction aspart of 2020 Roadmap• Enforcement: no registration, no market
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Evaluation
1. Provide confidence that
registrants are meeting
REACH information
requirements
2. Prevent unnecessary
animal testing

3. Build up database for
eventual EU-wide risk
management measures

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Compliance Check Strategy 2015 onwards• high-tonnage registrations with data gaps in human healthor environment endpoints• high potential for exposure: workers, general public or
environment• ‘external’ information and IT screening used for prioritisationand selection of substances• some dossiers will still be picked up randomly• No updating of dossiers allowed after draft decision but
companies are encouraged to update dossiers for candidate
substances after their have been published- other measures to improve the information on chemicals:dissemination, guidance, IT-tools, webinars, website anddirectly contacting registrants (e.g. screening letters) toincite dossier updates.
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Substance Evaluation• Selected in collaboration with the Member
States• Based on the agreed risk-based criteria orother risk-based national priorities• Criteria cover - hazard information,
exposure information & tonnage• Community Rolling Action Plan lists ofsubstances & evaluating Member States andinitial concerns• Duration 3 years, renewed each year
• Substance evaluation performed by Member
States within 12 months

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Substance Evaluation substances• 201 substances listed on CoRAP• 13 concluded without decision• 26 Decisions taken (waiting on information from IND)
• 94 Ongoing• 68 Not started• In tabular form on ECHA website:• SID – Initial grounds for concern – status• Available reports:• Justification document (why substance was placed on
CoRAP)• Decision on required information• Final conclusion when information is received
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Reporting• Annual Evaluation reports
since 2008•

Information on:ocommon pitfallso

ECHA recommendations• All registrants should read
• 2011 & 2013 Reports on
animal testingo

Use of alternative methods

http://echa.europa.eu/web/guest/about-us/the-way-we-work/plans-and-reports

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REACH and CLP –benefits for downstream users• Registration process generates more and better
information on chemical hazards and uses
• Regulatory Process leads to substitution of substances ofconcern and Safer Products• Chemical safety assessment leads to improved
information in the supply chain regarding safe use

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Process overview

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Chemical Safety Report Roadmap
FOCUS AREAS
Main driver: Increase efficiency and effectiveness of communication byharmonising and standardising• Information up – use maps: developing template and content on how thesubstances are used in practice• Information down - exposure scenarios: templates and examples. ESCom
catalogue of standard phrases and XML for electronic communication of ES.
Methodologies to consolidate ES information for safe use of mixtures.
Main driver: Raise awareness and knowledge of downstream users• Range of supports: Webpages, webinars, standard presentations, articles,
conferences, guidance, practical guides, eGuides
ECHA, industry and member states working together:• CSR/ES Roadmap defines common priorities and areas of work
• ENES is a network of several hundred who meet biannually to identify andpromote good practices
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Dissemination of information on chemicals• Information$OZD\VSXEOLVKHG

• owned by the registrants• identical as in submitted
dossiers• Confidential BusinessInformation removed(a) name in the IUPAC nomenclature(b) name as given in EINECS(c) classification and labelling(d) physicochemical data(e) toxicological and ecotoxicological data(f) derived no-effect level (DNEL) or predictedno-effect concentration (PNEC)(g) guidance on safe use(h) analytical methods

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ECHA information on chemicals• Registered substances information (13 000 substances; > 2 million
study summaries on properties and effects of chemicals)• Public C&L inventory (120 500 substances; > 6 million notifications)• EC Inventory (106 213 substances)• Candidate list of Substances of Very High Concern (SVHC) (161
substances) and Substances in Articles (SiA) notifications• Registry of intentions for risk management proposals (Restriction, SVHCand Harmonised C&L)

• Information on active substances (113 substances) and biocidal products• Notifications and explicit consent under Rotterdam Convention (PIC)(e.g. 71 explicit consents and waivers from Japan)

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What to expect in 2015
• Enhanced advance search capabilities on substance uses
and hazards• Integration of multiple regulatory activities in one single
integrated search – facilitate substance regulatory activities
follow-up• Graphic design of Registered substances pages (including
study records) improved with enhanced navigation
capabilities• Tiered approach to information– Infocards– Brief Profiles

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Tiered Approach to Information
Infocard (1st tier)
Allow users to further identify thesubstance
Provide high-level information toconcerned citizens on:
substance’s critical properties
classification and hazards
uses and exposures

Provide an overview of main
regulatory processes on-going forthe substance

Substance Brief Profile (2nd tier)Extend Infocard information

Provide information on scientificproperties:
Physical chemical properties,
Environmental fate and pathways
Ecotoxicological Information(including PNEC)
Toxicological Information (including
DNEL)
Study records type overview

Provide links to the source data

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Substances of VeryHigh Concern• EU policy commitment• To have all relevant currently known SVHCs includedin the Candidate List by 2020Ø The Commission finalised the SVHC Roadmap in March 2013
Ø Actions needed to achieve this policy goal
http://register.consilium.europa.eu/doc/srv?l=EN&f=ST%205867%202013%20INIT

Ø ECHA draw up the Roadmap Implementation Plan inNovember 2013
Ø How to carry out the required actions
http://www.echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/svhc-roadmap-implementation-plan• ECHA published its first report in March 2015
• Results covering activities of 2013 and 2014
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2020 SVHC Roadmap - Objectives• Build a common understanding between EU Commission,
Member States and ECHA of the main principles• Share responsibilities for an effective management of
resources• Set priorities: in which order should we process relevant
substances?
• Ensure transparency for stakeholders by communicating
authorities intentions• Increase predictability for Industry for planning andresources management E.g. “Substitution or application forauthorisation?”
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Substances addressed
Substances of very high concern (SVHC)• CMR: carcinogenic, mutagenic or toxic for
reproduction– Category 1A or 1B in accordance with the CLP Regulation(EC) 1272/2008• PBT, vPvB: (very) persistent, (very)
bioaccumulative and toxic for the environment (PBTor vPvB)– According to REACH (Annex XIII)• Equivalent level of concern: identified on a caseby-case basis, cause an equivalent level of concern
as with CMR or PBT/vPvB substances– e.g. endocrine disruptors, sensitisers[Article 57 REACH]
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Public Activities Coordination Tool (PACT)• Informs on authorities selection of substances for:o assessment of the hazard properties (to be included in
PACT next year) oro analysis of the Risk Management Options• Inclusion in the PACT does not mean confirmed concern
or firm regulatory action• In March 2015 116 substances with RMOA intentions in
PACT• In SVHC Roadmap preliminary worst case assumption of
maximum 440 known SVHCs to be RMO assessed
between 2013-2020 but new SVHCs may be identified
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Authorisation• Focus on:omost hazardous substances = Substances of Very High
Concern (SVHC)o

For which uses may lead to exposure• Principle: after a certain date “sunset date”
the use of an Annex XIV substance is forbidden
unless specifically authorised• Ultimate goal: substitution by safer alternatives

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The authorisation procedure:a two-step approach• Step 1: subjecting substances to theauthorisation
requirement
Step 1.1: Identification of SVHCs à “candidate list”

Step 1.2: Prioritisation of substance(“recommendation”) and Inclusion in
Annex XIVà “authorisation list”• Step 2: authorisation applications and decisions
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Lessons learnt on
Applications for Authorisation• Application system works!
oIncentive to industry to substitute towards safer
substancesoLeads to further improvement of risk management
measuresoTransparent and predictable• Room for further improvement existo

Costs have reduced (by over 30%) but for certain cases
the process is too burdensomeoFinding balance in “upstream” broad applications• Work ongoing/planned to further simplify/streamline process

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Restrictions• Ensure protection of human health and or
the environment, whereoManufacturing, placing on the market or specific use
cause unacceptable riskoThese risks need to be addressed on Community-widebasis• Ensure functioning of the internal market• Can covero

any substance on its own, in mixtures and/or in articlesomanufacturing of substancesoImport of articles containing substance•Member States have the initiative
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Substances in Articles• A key objective of REACH: to ensure the safe use ofchemicals (workers, consumers, environment)• Articles can contain a broad range of chemicalsosome of them being hazardousoexposure may occur during the service-life or wastephase• A substantial share of articles on the EU market areimported from outside EU• REACH obligations on the EU importers have an impact on
non-EU article producers
http://echa.europa.eu/web/guest/regulations/reach/candidate-list-substances-in-articles

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Legal obligations for EU importers ofarticles (1/2)• When articles contain substances which are on the REACH
Candidate List:oNotify substances in articlesoCommunicate in the supply chain sufficient information
to allow safe use of the article

Ø EU importer needs to know how to comply with his
obligationowhether the article includes Candidate List substancesandobrief description of use of the substance in the article(technical function) and, the uses of the article andhow to use them safely

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Legal obligations for EU importers ofarticles (2/2)• To comply with existing restrictions (Annex XVII)Examples:• Nickel in articles intended to come into direct and prolonged
contact with the skin / Lead and its compounds in jewellery• Azocolourants in textile and leather articles• 6 phthalates in toys and childcare articles• Dimethylfumarate (DMFu) in articles• PAHs in consumer products
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How to prepare for customer requirements• Actively communicate with your EU clients toensure that they can comply with their legal
obligations• Actively communicate with your own suppliers:
they (or their suppliers) have the relevant
information on the substances contained in yourfinal articles• Plan for the future:oFollow PACT and the Candidate ListoConsider substitution of (potential future) Candidate List
substances
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Nanomaterials• Covered by the EU legislation but scientific and policy
challenges remain• ECHA addresses nanomaterials through REACH andBiocides regulation and is an active dialogue partner in
discussions on risk assessment of nanomaterials also atinternational level•

No explicit reference in REACH but need to demonstrate the safe use of
substance including nano form•

Biocides regulation has specific references• Compliance check•

Insufficient information on nanomaterials > data requested mainly on
granulometry• Substance evaluation•

Selected: Silicon dioxide (2012 by The Netherlands), Silver (2015 by The
Netherlands) & Titanium dioxide (2015 by France)• ECHA support to industry•

Webinar, workshops , info sessions and contacts with individual registrants
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Endocrine disruptors• REACH, Biocides and Plant Protection Products address Endocrine
Disruptors and under CLP endocrine disruption is a mode of actionthat may lead to CMR classification•••

REACH: authorisation, Safety Data Sheet & Safety Report – PBT assessment
Biocides: exclusion criteria for approval of active substances and Authorisationof biocidal products (some exceptions apply)
Plant Protection Products EDs authorised only exceptionally• Once the criteria for Endocrine Disruptor identification has been
established on the Community level, ECHA will apply the criteria
for the REACH and the Biocide Regulations• Substance evaluation under REACH is best suited to investigate ED
properties• ECHA ED Expert Group supports selection of substances for
Substance evaluation and Authorisation• Currently:••

Substance evaluation: 47 substances with suspected ED properties in CoRAP
Authorisation: 4 substances on the Candidate List of SVHC due to ED
properties
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Worth to Remember• Preparations for 2018 deadline
ongoing & submit from mid-2016• Supply chain communication isessential• Learn from evaluation & update
dossiers proactively• Dissemination more transparent &informative from Dec 2015
• Authorisation applications work
• Follow Candidate List & PACT for
substances of (potential)concern inarticles•geert.dancet@echa.europa.eu

Thank you !