Latest Updates inChemicals Managementin the EU
Seminar & Workshop on the Latest Trends in
Chemical Substances Management in the EUTokyo, Japan
14 September 2020

Jukka Malm
Deputy Executive Director
European Chemicals Agency

The European Chemicals Agency••••

EU Agency operating in Helsinki since
2007
Implementing several European
legislations related to chemicals
650 staff from 28 countries
Funding partly from fees, partly from EU
subsidy

Our competences:2Chemicals legislations managed by ECHAREACH

CLPBPR

PIC

Registration
Evaluation
Authorisation

Classification
Labelling
Packaging

BiocidesPrior InformedConsent

All chemicals≥ 1 tonne peryear

All chemicals
and mixtures

Active substancesand biocidal
products

Import/export ofcertain hazardous
chemicals

United Nations
standards

Rotterdam
Convention

Several new work areas, e.g.
• Portal for notifications of hazardous mixtures to the national poison centres• EU Nano Observatory• EU Chemicals Legislation Finder• Occupational Exposure Limits (OELs)• POPs Regulation• Database to track chemicals (Waste Framework Directive)3

Chemicals Management in the EU
Simplified version
Environmentalprotection(air, water, soil,
drinking water,industrialemissions)

Industrialchemicals(REACH)

Waste
legislation(waste,waste water,shipment,packaging)

Product
legislation(cosmetics,food contact
materials, toys,electronics)

BiocidesPesticides

General/International(Ecolabel,ecodesign,POPs, PIC)

Pharmaceuticals

Classification, labelling & packaging (CLP)
Transport,
major accidents

WorkerProtection

ConsumerProtection
4

Main actors
Providing data

Industry gathers informationand makes sure risks aremanaged

Evaluation

ECHA and Member Statesscreen and check the data
and request more if needed

Risk management

European Commission, withsupport of ECHA and MemberStates, applies EU-wide risk
management measures5Safe use under REACH

SafeuseInformation in the
supply chain
e-SDS

SafetyAssessment
Hazard & Use
InfoRegistration dossiers: Completeness check Compliance check6All substances > 1 tpa now registered• 23 000 substances - 100 000 registration dossiers• Can be searched via ECHA website

7

More data on chemicals than ever before
209

substances of very high concern

600

risk management proposals

2200

substances checked for compliance

23 000substances registered under REACH

145 000

substances classified under CLP>2 million

study summaries on chemical properties and effects
8Visit our regulatory chemicals
database – largest in theworld••

Information on hazards
and safe use of 140 000
chemicals
24 000 daily users

echa.europa.eu•9REACH registrations - Top 10 non-EUcountries
USA

27%

China

15%

Japan

14%

India

12%

Switzerland

7%

Russia6%

Taiwan4%

Republic of Korea

4%Israel

2%
0%

5%

10%

15%

20%

25%

30%

10Understanding registration
information• Registrations are prepared by companies, the data isowned by them• Data quality is not systematically reviewed by authorities• Most of the data is publically available• N.B. intellectual property rights of data owners• ECHA prepares decisions requesting further testing andinformation• Dossier and substance evaluation• Data can be consulted via ECHA website and OECD
eChemPortal

11

REACH Evaluation Action Plan
• Ambition: ECHA to check 20% of REACH
registrations by 2027 for compliance (previoustarget 5%)• 20% of registrations = around 30% of chemical
substances on EU market• Two milestones:• End 2023 for substances in tonnage bands over 100tonnes/year• End 2027 for substances in the 1-100 tonnage
bands/year• Companies can expect more compliance checks

12Updated requirements for nanomaterials• REACH information requirements for registration
have been amended to specify how to register
substances in nanoform• characterisation of nanoforms (Annex VI)• the chemical safety assessment (Annex I);• registration information requirements (Annexes III andVII-XI); and• downstream user obligations (Annex XII).

• Apply as from 1 January 2020
• IUCLID was updated to facilitate registration ofnanoforms in Autumn of 2019
• ECHA guidance on nanomaterials partly updated
13

Mapping the registered substances• ECHA’s goal is to conclude by the end of 2020
for all substances registered above 100 tonnes
per year whether they are:• of priority for regulatory risk management;• currently of low priority for further regulatory action; or• need more data for a judgement to be made.

• ECHA will draw similar conclusions for all
remaining registered substances by the end of2027.

14

Find out what is on our radar• Substances of potential concern• Screening of substances is an ongoing process• We focus on substances that may need regulatory
action -> risk management option analysis (RMOA)•••

Substances of very high concern (SVHC)
Persistent, bioaccumulative, toxic (PBT, vPvB)Endocrine disruptors• Increased focus on grouping of substances• See on ECHA website, e.g:
• PACT – public activities coordination tool
• Section ’addressing substances of concern’
15

Risk management: restrictions• When unacceptable risks to humans or theenvironment have been identified• Member State competent authorities
can submit dossiers proposing restrictions(or European Commission asks ECHA to submit)• ECHA prepares a scientific opinion, always
preceded by a consultation on the proposal• European Commission makes a decision• Annex XVII of REACH lists all restrictions
27 ECHA opinions – 71 entries in
REACH Annex XVII
16

Restriction proposals currently
under consideration• Calcium cyanamide• 5 cobalt compounds• Formaldehyde and formaldehyde releasers• Microplastics• D4, D5, D6 (siloxanes)• Perfluorohexane sulfonic acid (PFHxS), its salts
and related substances• Skin sensitizing substances in textile, leather,hide and fur articles
17

Risk management: authorisation• Substances of very high concern (SVHCs): CMRs,
PBT/vPvB or ‘equivalent concern’• Identification by Member States (or European
Commission instructing ECHA) onto the ‘Candidate
List’• Some transferred onto the ‘Authorisation List’,Annex XIV
• Once on the Authorisation List, the substance canonly be marketed or used after ‘sunset date’ if
authorised by the European Commission who decides
based on ECHA opinion
209 substances on Candidate List – 54 on Authorisation List–>300 ECHA opinions ->150 Authorisation Decisions

18Classification and labelling– ECHA’s role
• Establish and maintain C&L inventory• Self classification by industry• Over 6 million notifications covering morethan 140 000 substances• Harmonised C&L• Proposals by Member States or industry• Opinion by ECHA Risk Assessment Committee• Commission decision (Annex VI of CLP)
Ca. 400 ECHA opinions
19

SCIP database in a nutshell
SCIP = Database of
Substances of (very high) Concern In articles and Products

SCIP database context
EU action plan for
the CircularEconomy
Legal basis:
Waste Framework Directive(WFD)
Establish and maintain adatabasefor info communicated down inthe supply chain on substancesin articles
21

SCIP database - Objectives
Reduce the content of hazardous substances in materials
and products, including recycled materials
Push for substitution ofsubstances of concern andprevention of (hazardous)
waste generation

Contributing to amore circular
economy: improve
waste treatment
operations

Increase authorities'
information basis on
substances inarticles
22Target audiences

Waste operators

Authorities

Available info to drive waste stream
decisions
 support compliant
re-use increase recycledmaterials

 SVHC monitoring toaddress regulatory
actions Available info tosupport (waste)
policy decisions
 Support
enforcement

Consumers and otherinterested parties
 Empower informed choices
 Improve targeted disposal

23

When does the SCIP
notification duty apply?
Substance ofconcern (SVHC)

Article0,1% w/w

 Duty to supply sufficient information to allow safeuse of the article (Art. 33(1) REACH)

24

What is an Article in SCIP?
ArticleComplex object
Articles remain articles whenincorporated in “complexobjects” (“O5A principle”)

25Who needs to submit a
SCIP notification?
Any supplier of articles containing above 0.1% w/w of a
substance of very high concern on the Candidate List

EU producers & Importers

Assemblers

Distributors** Except retailers that supply directly and exclusively to consumers
26

Non-EU suppliers• Not allowed to submit
SCIP notifications.

• Should support importersof their articles in the EU tofulfil their regulatory
obligations, namely to submit
SCIP notifications to ECHA.

27

What information isrequired?

Substance ofconcern (SVHC) inthe article(Concern element)

ArticleIdentification

Safe use
information- Identifiers- Name- Article category(TARIC/CN code)- SVHC identifiers- Concentration range- Material category

Detailed information requirements published on ECHA website
28

How to submit?
There are three ways to prepare the SCIP notifications

2. Offline in thecompany’s own
IT system

DesktopServerCloud

1. Online

3. System-to-System Service29

Roles and milestones

4 July 2018
Entry into
force ofDirective (EU)2018/851

Q1 2020
ECHAdatabaseestablished

5 July 2020
Member Statetransposition

5 January
2021Suppliers ofarticles submit
info to ECHA

• Establish a database + Enable submission of info by EU
suppliers of articles• Provide access to the database to “waste treatmentoperators”, and to consumers (upon request)

MSs• Transpose into national law• Enforce30

Where are we now?
SCIP prototype released on 17 February 2020:• Allows companies to get familiar with the tools toprepare and submit a SCIP notification.
• Allows users to provide feedback to further
improve the tool31

Release of SCIP v1(planned for end of October 2020)
Open to received data to fulfil legal obligation

17Feb2020

SCIP
prototypereleased

Oct2020SCIP v1
release(open toreceivedata)

5 Jan
2021

Obligation
to notify
kicks in32

Thank you!
jukka.malm@echa.europa.eu

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