REACH: registration, evaluation& risk management update
Ｔhe Latest Trends in the EU

Chemicals Management: REACH, CLP & BPR
Petteri Mäkelä

Outline• European Chemicals Agency• Registration• Supply chain communication• Risk Management• Authorisation• Restrictions• Substances in articles

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ECHA – six years old and growing• 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 international activities• Collaboration on harmonising chemical management
tools and approaches beneficial for authorities andindustry• OECD-related work: e.g. IUCLID, QSAR toolbox, eChemPortal• Cooperation with peer regulatory authorities: Australia,
Canada, Japan & the USA• Support to European Commission multilateral work e.g. UN
Conventions• Awareness raising on requirements and how tocomply in 3rd countries• Support to EU candidate countries• Presentations to authorities & industry in third countries
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REACH – What it’s all about• Companies to prove safe use of chemicals
by Registration• Authorities to Evaluate registrations toensure compliance• Risk Management of most hazardous
substances through Authorisation that
promotes substitution and prohibition ofrisky uses through Restrictions

 Safety, Competitiveness & Innovation
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What to register• Registration only concern Substances• … not preparations and articles• 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 prepre-registration until 31 May 2017
New entrant registration prior manufacture or import

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Substance Identity• Unambiguous identification is a prerequisite to most of the REACH processes• Companies must have sufficient
information on the identity of theirsubstance• Correct identification enables:o Sharing of informationo Assessment of the applicability of test data, read-acrossproposals
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SIEF agreement (1/2)• REACH legal requirementso Cooperation & communication in the SIEF
o Data sharing (Ownership of data)o Cost compensation (Agreement on cost sharing)o Joint submission (except opt-out claim) (Liability)• Varying number of SIEF participants• All SIEF participants not familiar with
REACH requirements > uncertainty• SIEF Operating rules are strongly
recommended
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Data sharing• ECHA has a limited remit regarding data
sharingo Assists registrants involved in “disputes”
o Promotes best practice2010/13 findings

Data sharing provisions presented some challengeso Around 80% of the registrations submitted jointly
o The complexity of substance identificationo

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Registration milestones
2010~ 20 000 Dossiers~ 3 500 Substances

7/09

1/10

Deadline2010

Deadline
2013

2013
9 300 Dossiers
2 998 Substances

8/10
2/11
11/2010

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9/11

4/12

10/12

5/13
5/2013

11/13

6/14

12/14

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Registration dossiers – overview
Received
9 084

Grand total
Registration type

Standard registrations (all uses)
Registrations for intermediate uses only

Forecast~9 3007 232
1 798• Intermediate use: limited data requirements––

Specific conditions
Critical to ensure safe use• Verification by ECHAPUBLIC

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Company Size

Company size

Registered by a large company
Registered by an SME
Medium company
Small company
Micro company

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%

80%
19%
11%
5.5%
2.5%

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Company Type

Role in the supply chain

Manufacturer
Manufacturer and importer
Importer
Only Representative of a non-EU
manufacturer

%

40%
12%
25%
23%

Non-EU companies can export to the European Union through two
different routes under REACH: either via an importer who hasregistered the substance, or by appointing an Only Representative.
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Registration Status• Two registration deadlines passed – 2010 - 2013oo

~7,400 substances registered; ~40,000 dossiers
Substances over 100 tpa; most hazardous over 1 tpa• More than 100,000 substances in the C&L inventory• Information published on ECHA website• Eurostat study 5-year update revealed a “marked
increase in quality of data & better control of risk”• From that perspective REACH is delivering
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Registration findings• Timelines very challenging but achievable• Collaboration of authorities and industry
before the deadline important in achieving a
successful result• The one substance one registration
concept generally worked well
• IT systems critical for functioning of thesystemPUBLIC17

Dissemination• Information• owned by theregistrants• identical as inregistration dossiers• Confidential BusinessInformation removed• Information now
available online• Over 8,000 substances
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Always published(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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Search substances on ECHA home page

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Dissemination of information

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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 registeredooAlready registered: contact the lead registrant to verify

substance sameness, make the SIEF agreement and to obtainyour REACH-IT member token
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

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Preparing the registration dossier• Dossier in IUCLID 5 format for
substances at 1 t.p.a. submitted using

REACH-IT• Standard information linked totonnage• Chemical Safety Report for substances> 10 t.p.a.
• Use the support tools (Plug-ins) before
submitting your dossiero TCC, Dossier Quality Assistant …
Chemical Safety Report

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Only Representatives – Concept• A non-EU manufacturer can appoint an Only
Representative to carry out the registration
obligations of the importers• Non-EU manufacturer then needs to inform allimporters about the Only Representative• Only Representative can be any legal entity
established in the EU with sufficient skills &knowledge• A non-EU manufacturer can only appoint one
Only Representative per substance

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Only Representatives – Responsibilities
Need to:•comply with all obligations of importers under
REACH (pre-registration, data-sharing,…)•keep up-to-date information on EU importers andthe quantities imported which are covered by theregistration•cover in the dossier all uses of the substance by theimporters included in the registration•If an OR represents different non-EU
manufacturers, separate registrations are needed(trough separate accounts in REACH-IT)
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What happens after registration?
• ECHAo

Verify confidentiality claims
examine proposals for new tests on the 2013 substancesocheck compliance of at least 5% of dossiers per tonnageoby 1 June 2016

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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Requirement to spontaneously updates•

Change in substance status•

New identified uses/uses advised against•

New knowledge on risks•

Change in classification and labelling•

CSR/Safe Use amendments•

Testing proposal needed•••

Changes in tonnage band
Change from intermediate to “normal” registration
Change in composition

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Evaluation

1.Provide confidence that industry is
meeting obligations
2. Prevent unnecessary animal testing
3.Build up information basis for eventual
risk management measures at EU level

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REACH - Evaluation

Member States

Dossier evaluation

Substance evaluation

Testing proposal
examination

Compliancecheck

Examine any information
on a substance

Output• accept/reject a testing proposal• request of information, because the dossier is not compliant(CC) or the potential risk needs clarification (SEV)28

Evaluation – the mechanics

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Dossier Evaluation: compliance check

ECHA questions ECHA examination
conclusions
Info requirements

adequately fulfilled? Decision:
Adaptations

adequately
justified?

CSA & CSR comply

1. Request further information
2. No further action

with Annex I?

Risk Management

Numbers andtimelines
Select at least 5% of total
received for each tonnage
band

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Draft decision withinfrom starting theevaluation

monthsMeasures areadequate?

Explanations forseparate submission

1,200 registration dossiers from 2010 deadline will be checked
for compliance by end of 2013
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Compliance Check• The Agency may perform on any registration
dossier• Some priority setting is suggested in thelegislation:oooDossiers submitted separately (opting-out of joint submission)
Dossiers [1, 10t], not fully falling under Annex VII
Substance is on Community Rolling Action Plan

• Random selection• Concern-driven selection
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Compliance Check Findings
Common shortcomings in dossiers•Substance identity (66 %)•Exposure assessment & risk characterisation(23 %)•Prenatal developmental toxicity study (26 %)•Sub-chronic toxicity study (18 %)PUBLIC32

2013 Dossier Information Quality• Detailed information not yet available• ECHA’s actions to improve quality:oooo

New IT tools e.g. Dossier Quality Assistant
IT screening: personalised advice for registrants
More experience
More support available• Screening will be done on key issuesooSubstance identification
Use as intermediate

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Dossier Evaluation: testing proposals

ECHA questions

ECHA examination
conclusions

Numbers andtimelines

Proposed test
adequate andjustified?

Decision:

All testing
proposals

Unnecessary animal

testing avoided?
3rd party info valid?

1. Accept testing
2. Reject testing
3. Change test conditions
4. Request additional testingNon phase-in
Phase-in•: draftdecision in 6 months•
submitted
according to schedule

Over 1,100 testing proposals from 2010 have beenprocessed
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Testing Proposal Assessment• Stimulates and supports
industry towards efficienttesting• Ensures that testing
conducted only if needed,in particular on vertebrate
animal testing

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Testing Proposal Assessment• Required by REACH Annexes IX & X:ooRegistrants identify a data gap and cannot otherwise fulfil the
REACH information requirements;
Additional testing is triggered by risk:• available information of the substance is inconclusive;• further investigation is needed• Deadlines:oofor non phase-in substances: 180 days after receipt
for phase-in substances:• by 1 Dec 2012 (if received by 1 Dec 2010)• by 1 Jun 2016 (if received by 1 Jun 2013)• by 1 Jun 2022 (if received by 1 Jun 2018)
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Substance Evaluation

MSCA
questions

MSCA examination
conclusions

Numbers andtimelines

Is there a

Decision:

Would further
data clarify theconcern related
to thesubstance?

Other outcomes:

Substances in the CoRAP;
about 50 per year
Draft decision within 12

suspected risk? • Request additional testing• Substance evaluation report• Conclusions for further actions(risk management)

months from the publication of
the CoRAP

CoRAP = Community Rolling Action Plan
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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:ooohazard information
exposure information
tonnage (incl. aggregated tonnage)• Ways to find substances:oooIT-based screening
Member States make notifications
Via dossier evaluation
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Community Rolling Action Plan
• Duration 3 years• CoRAP lists of substances & evaluating
Member States and initial concerns• Substance specific justification documents
published (from 2013)• Consequences of inclusion into CoRAPooo

No legal impact on the substance/registrant
Substances need to be evaluated within 12 months from thepublication of the CoRAP
Evaluation of substances listed for the 2nd and the 3rd year
only starts from the publication of CoRAP updates in thoseyears
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Substances in the CoRAP

CoRAP 2012-14

CoRAP 2013-15

Published 29 Feb
2012

Published 20 March2013

Contains 90
substances:

Contains 115
substances:

Contains 125
substances:•36 for 2012;•46 for 2013;•56 for 2014;•23 for 2013;•46 for 2014;•49 for 2015;•31 for 2014•23 for 2015

•20 for 2016

Draft decisions for 32 substances

21 Member States

20 Member States

17 Member States

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Draft CoRAP
2014-16

To be published in
March 201440

Interaction with Registrants
Formally – opportunity to comment on a draft decision

Value of a co-ordinated response from registrants
Informally – Registrants can contact the Member States(details on the CoRAP)– Member States can contact registrant(s) (issues withsubmission of updates/pending studies)

Communication to the registrants and Downstream
Users on how to act during Substance
Evaluation
A leaflet Substance Evaluation:

Tips for Registrants and Downstream UsersWork on-going on a harmonised policy across Member
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Follow up to Substance evaluation
New information
submitted within
deadline given(dossier update)Member Stateevaluates
new data provided(12 months)
No further
actionNo

Concern(s)?

PotentiallyNeeds
further informationnd
2 draft decision

Finalise the evaluation report.

YES

C&L
Harmonisation?
Restriction?

Authorisation?

Voluntary action
by registrant?
Other legislation?

The MSCA informs ECHA of its conclusions as to whether or how to use the information
obtained (Art. 48 – Follow-up). ECHA informs the Commission, the Rregistrant and theother MSCAs.
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New factsheet on Dossier Evaluation
Decisions• Published on 15 October• Describes the process
steps and the possible
outcome documents• Addresses communication
issues after the decision
has been received• Provides useful reminders
for registrants
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Reporting• Annual Evaluation reports
since 2008
• Reports available on ECHA
website• Informs registrants onoocommon pitfalls
ECHA recommendations• All registrants should read
• 2011 Report on animal testingo

Use of alternative methods
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Elements of supply chain communication

Safety data
sheet

Chemicalsafety report
includingexposure
scenarios

Exposure
scenarios

Appropriate and relevant
information to protect humanhealth and the environment
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Improving quality CSR & ES quality

ENES: Exchange Network for Exposure Scenarios
ENES-5 - 21-22 November 2013
http://echa.europa.eu/enes

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Improving quality of chemical safety
report - Illustrative example CSR• Part 1: General advice (8 pages)• Part 2: Worked example ofchemical safety report• Part 3: IUCLID dataset forchemical safety report• Part 4: Chesar dataset for
generating CSR
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Difference between Restrictions & Authorisation
Restrictions

Authorisation

Restricteduses

Authorised
uses

General exemptions= not restricted/authorised= forbidden/restricted
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PUBLICREACH does not stand on its own• Other sectoral chemicals legislation exists:ooPlant Protection Products - pesticides
Biocidal Products - biocides• Other important policy areas with links tochemicals management:

Environment(Water - priority hazardous substances, Waste -use of hazardous
substances in electronic equipment, Air - quality objectives)o Worker protection legislation (Framework Directive on Health and
Safety at Work, Occupational exposure limits, Carcinogens and Mutagens Directive)o Consumer Protection (General Product Safety Directive, Toys, Cosmetics)o Health (Medicinal products and medical devices)o Food (Food contact materials)o49
PUBLICAuthorisation (1/2)• Focus on:omost hazardous substances = Substances of Very High
Concern (SVHC)• Carcinogens, Mutagens and toxic for Reproduction: CMRs  Human Health• Persistent, Bioaccumulative and Toxic for the environment: PBTs  Environment• very Persistent and very Bioaccumulative: vPvBs  Environment• Substances of “equivalent level of concern” (e.g. endocrine disruptors, potent respiratory sensitisers)ofor which uses may lead to significant exposure• Principle: after a certain date “sunset date”

the use of an Annex XIV substance is forbidden
unless specifically authorised (or exempted)• Ultimate goal: substitution by safer alternatives
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PUBLICAuthorisation (2/2)• Some general exemptions:oooscientific Research & Development
all intermediates
substances for which management of risks for humanhealth and/or environment are already covered by otherrelevant Community legislation (medicinal products,
cosmetic products, food and feed, food contact material,
biocides and pesticides, fuels)• NOT covered by the authorisation requirement:oomanufacturing processes
imported articles containing the substance51
PUBLICSubstances of Very High
Concern (SVHC)

Step 1: Identification of SVHC
MS

Preparation ofAnnex XVSVHC dossier

Publicconsultation[Art.59(2),(3)]Identification of
SVHC & Candidate
list inclusion[Art.59(1)]‘Candidate list’of SVHC for Annex
XIV inclusion

Step 2: Inclusion of SVHC in Annex XIVMS

Prioritisation of
Candidate list
substances

Publicconsultation[Art.58(3)]Inclusion of
Candidate list
SVHC in Annex
XIV [Art.58(1)]Step 3: Application for Authorisation
MS

Application for
Authorisation to
use Annex XIV
SVHC [Art.62]

Publicconsultation

RAC & SEAC
Committees
draft opinions
COM decision‘Authorisation
list’ of SVHC
(Annex XIV)
Authorisation

granted (or not) fora use of an SVHC
[Art.60]
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Step 1a: Candidate List - Implications• Directly after inclusion in the Candidate ListoSuppliers of the substance:oSuppliers of articles containing the substance:

 provide their customers with a safety data sheet provide information to allow safe use of the article tocustomers or to consumers, upon request (45 days!)• Six months after the inclusion:oProducers/importers of articles have to notify ECHA if
their article contains a substance on the Candidate List

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PUBLICStep 1b: Annex XIV listing - implications• After the « sunset date », industry is notallowed to place an Authorisation Annex (XIV)
substance on the market or use it unlesscompanies have an authorisation granted by
the Commission

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PUBLICStep 1a: Candidate List & 1b: Authorisation List
138
Substances

14 Substances

ECHA website

Official Journal(ECHA website)

Examples:Examples:• Phthalates• Arsenates• Cobalt compounds• Lead compounds• (Di)chromates
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PUBLIC• Musk Xylene• MDA• HBCDD• Phthalates (DEHP, BBP, DBP)

Step 2: Applications for authorisation• An applicant can be:oooomanufacturer
importerdownstream user
any combination of these• An application can besubmitted:oofor one or several uses
for one or a «group of»
substance(s)Fee » Fee Regulation
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PUBLICFactsheet published in late 2013

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When will an authorisation be granted?

The Commission shall grant an authorisation if:•risks are adequately controlled adequate control route!NB:

not applicable for substances with PBT, vPvB
properties and non-threshold CMRs

The Commission may grant an authorisation if:•socio-economic benefits outweigh the risks
and•there are no alternatives available that (1) reduce theoverall risk and (2) are technically and economicallyfeasible for the applicants socio-economic route
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Authorisation decisions• An authorisation is substance, use and supply-chain
specific• Commission decisions will specify:• the identity of the substance(s)• the persons to whom the authorisation is granted• the uses for which it is granted• any conditions under which it is granted, incl. any monitoringarrangement• a time-limited review period (case-by-case approach)
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PUBLICAuthorisation
Procedure includes public consultations
Step 1a

Step 1b

Step 2

Identification of
Substances ofVery High
Concern

Subjecting priority
substances toauthorisation

Granting
authorisation

Candidate
List

REACH
Annex
XIV

Authorisation
decision

5 months

6 + 12 months
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up to 2 years
1/29/201460

Restrictions• Ensure protection of human health and or
the environment, whereooManufacturing, placing on the market or use causes
unacceptable risk
These risks need to be addressed on Community-widebasis• Ensure functioning of the internal market
Can cover• any substance on its own, in mixtures and/or in articles• manufacturing of substances• Import of articles containing substance61
PUBLICRestrictions• Some general exemptionsoooScientific research and development
Risks to human health due to use in cosmetic products
On site isolated intermediates• Restriction entries (Annex XVII)ooInherited from previous legislation (Dir 76/769/EEC)
New restrictions (amendments of existing restrictions
and new entries)

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PUBLICRestriction procedure (1/2)• Registry of Intentions (RoI)ooMember States have to notify their intentions to preparea restriction dossier
ECHA from the request of the Commission• Annex XV dossier (technical dossier andAnnex XV report) submission to ECHAoo

MSs within 12 months from the notification
ECHA within 12 months from the request• Conformity checkoLegal requirement for Committee for Risk Assessment
RAC and Committee for Socio-economic Analysis SEAC
to check if the dossier conforms with the requirements
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PUBLICRestriction procedure (2/2)• Consultation of interested parties
Conforming Annex XV reports on ECHA’s website
Interested parties have 6 months to provide commentsoo• Developing the opinions

RAC has to give its opinion in 9 months from publicationoooIs the suggested restriction appropriate in reducing the risk?

SEAC gives first draft opinion, interested parties have 2

months time to comment on the draft opinion, final opinion
within 12 monthsoAre the costs as a result of a restrictions proportionate to the reduced risk?

• Commission decision
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PUBLICSpecific restrictions• CMR substances category 1A and 1B usedby consumers (substance as such, in mixture
or in articles)oCommission proposes the restriction without ECHA
involvement• Authorisation list substances (Annex XIV )oAfter sunset date ECHA considers if the use of thesubstance in articles causes risk that is not adequately
controlled and prepares an Annex XV proposal

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Restrictions• All restrictions listed in Annex XVII
o
o
o
o
o

Full ban or ban on certain uses
Certain derogated uses
Specific conditions of use
Currently 63 entries in Annex XVIINew/revised entries under scrutiny and underconsideration• Obligation to:ooComply with any conditions set out in Annex XVII
Update Safety Data Sheet
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PUBLICRecently adopted restrictions• Lead and its compounds in jewellery
articles• Dimethylfumarate in articles• Mercury in measuring devices• 4 Phenylmercury compounds• Cadmium and its compounds

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Restrictions under consideration• Opinions submitted to the Commissionoo

4 classified phthalates in certain articles (opinions: nobasis for restriction)
Chromium VI in leather articles• Under consideration in ECHA/Committeesoo1,4 -dichlorobenzene in toilet blocks
Lead and its compounds in consumer articles• Notified intentions to submit a restriction
dossiero1-methyl-2-pyrrolidone (NMP) (April 2013)
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PUBLICRestrictions
Procedure includes public consultations
Step 1

Step 2

Step 3

Substance
Identification assessmentof interest

ECHA
reviewCommission
decision

Registryof intent

Opinion

REACH Annex
XVII update

12 months

3 months

Dossier

12 months
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Substances of Very High Concern in Articles‘Article’ Definition - REACH“an object which during production
is given a special shape, surface ordesign which determines its
function to a greater degree thanits chemical composition”

Producers, importers or
suppliers of articles may havelegal obligations under REACH if
a Candidate List substance(SVHC) is contained in theirarticles
http://echa.europa.eu/web/guest/candidate-listobligations

Decision-making scheme
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Notification of substances in articles
Purpose of notification:-Ensure that sufficient information is available on use of
substances of very high concern (SVHCs) in articles notcovered by registrations-To support the identification of cases which may require
regulatory risk management
ECHA must consider restriction of Annex XIV substances inarticles after the sunset date Information on SVHCs in imported articles important toallow ECHA to understand possible needs for derogations
from such restrictions
Only a few notifications received (xxx by December 2013)
Need for improvement
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Online notification webform

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Worth to Remember• Registration is a way to ensure
safe use of chemicals• 1-substance-1-registration applies• A wealth of registration
information is available online• Authorisation & Restriction are
regulatory instruments for risk
management at EU level• Candidate Listing of a substancecreates compliance requirements
petteri.makela@echa.europa.eu

Thank you !