Overview of REACH andthe revision
Seminar latest trends on chemicals
management in the EU
17 March 2023 Online with Japan

Dr. Erwin Annys
Head of Unit Support and Enforcement
European Chemicals Agency©ECHAAbout us
We protect you and theenvironment by taking action on
harmful chemicals
OUR MISSION
We work for the safe use of chemicals

OUR VISION
To be the centre of knowledge on thesustainable management of chemicals
for the benefit of citizens and theenvironment©Unsplash/ Raphael Rychetsky2Topics→ EU decision making→ Chemicals legislation in the EU before REACH→ REACH→ Recent developments in REACH→ Chemicals Strategy for Sustainability3

EU decision making

EU institutions

Court ofJustice of theEuropeanUnion

5

The EU Commission• Right of initiative: proposing
new laws and policies;• Policy implementation:
managing European Union
policies and the budget;• Guardian of the Treaties:
enforcing European Union
law;• International dimension:
ensuring the Union's externalrepresentation.
6

The EU Commission’s DGs involved in chemicals
management

DG GROW: Internal Market, Industry,
Entrepreneurship and SMEs
DG ENV: Environment
DG SANTE: Health and Food Safety
DG EMPL: Worker’s health and safety

DG RTD: Research and Innovation
JRC: Joint Research Centre
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The EU Parliament

Legislative power

Budgetary power

MEPs are spread in
7 political groups

Decides on thecontent of EU
chemical legislation
with Council

26 Committees

Composed of 705
Members ofParliament (MEPs)

MEPs are elected
for 5 years

8The Council
There are two distinct institutions,which share the same building:• The European Council: sets theEU political agenda• The Council of the EU:
negotiates and votes EU laws

9

ECHA’s mandate under current chemicals legislation• REACH (Chemicalsregulation)• Classification, Labelling andPackaging(CLP)• Persistent organic
Pollutants (POPs)• Prior Informed Consent(PIC)• Biocidal product regulation(BPR)• Waste Framework Directive(WFD)• Drinking Water Directive(DWD)• Occupational Exposure
Limits (OEL)10

Chemicals legislation in
the EU before REACH

Environmental movement in Europe

1960s
Start ofenvironme
ntalmovement

1970s
Increasedattentiononenvironme
ntal impact

1980s
1990s
Expansion
Environmentalin science
globalismandknowledge

12

13

By 2007
EU wide risk assessments
141

chemicals
prioritised
at EU level

137

Agreedassessment
for human
health andenvironment

11: no concern
59: riskmanagement
2: furtherinformation14

Successes••••

Large data gathering andsummarising process for highproduction volume chemicals
Agreement on risk assessment
principles
Agreement on priority setting ofchemicals
EU harmonised risk assessments
for many controversial
substances, forming a solid basis
for EU wide risk reduction
measures15

Challenges
••
•
•
•
•

Data gaps. 86% of high production volume chemicals –less than base dataset
Risk assessment process took too much time
Burden of proof on public authorities
Generally downstream users out of the picture and actual
uses of chemicals remained unknown
Inefficient system: Industry faced with myriad of
directives and regulations
Administrative burden for new, mostly low volume,
chemicals – prevented innovation

16REACH

Principles of REACH
Adequate
information
Industryon hazards
responsible
whileNational
minimisingfor safe
enforcement
use ofmanufactur
experimentale and use
Deal with animals andTargeted‘burden ofcosts activities bypast’
ECHA,
withMember
systematicStates and EU
program forCommission
registration
for maximumof oldeffectchemicals
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REACH - Key processes
Registration
Industry gathers information on their chemicals,
ensures management of risks and documents in aregistration dossier submitted to ECHA

Member States

Evaluation
ECHA and Member States control and request further
information when needed
Member States enforce legislation

EU-wide risk management
Commission, with support of ECHA and Member States,
applies community wide risk management measures,
e.g. authorisation or restriction of certain uses
19Registration journey

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Evaluation:
overview
Dossier evaluation

Examination oftesting
proposals

Compliance
check

Substance evaluation

Examine any information
on a substance

ECHA decision requesting information

Follow-up of decisions
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Risk management: restrictions• When unacceptable risks to our health or theenvironment identified• Member State competent authorities
can submit dossiers proposing restrictions(or European Commission asks ECHA tosubmit)• European Commission Decision based on an
ECHA opinion• Annex XVII of REACH lists all restrictions

22

Risk management: authorisation• Substances of very high concern (SVHCs):
CMRs, PBT/vPvB or ‘equivalent concern’• Identification by Member States (or EuropeanCommission instructing ECHA) to ‘CandidateList’• Some transferred to ‘Authorisation List’, AnnexXIV• Once on Authorisation List, substance can only
be marketed or used after ‘sunset date’ if
authorised by European Commission who
decides based on ECHA opinion
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Transparent decision makingprocess•

Activities and regulatory processes
explained clearly•Open decision-making•

When and how stakeholders caninteract

Information available in a timelymanner• Public Activities Coordination Tool(PACT)•24

Dissemination of information

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Recent developments inREACH

Draft CoRAP (2023 – 2025)→ The draft CoRAP contains 24 substances, including 6 newsubstances compared to the current CoRAP 2022-2024; 5substances are being planned for evaluation in 2023, and 19 aredivided for evaluation in 2024 and 2025.
→ From the 27 substances included in the CoRAP update publishedon 22 March 2022, 5 are proposed to be withdrawn as substanceevaluation has been considered currently of low priority orunnecessary. For 3 out of these, the data obtained fromcompliance check or public literature are already consideredsufficient to clarify the initial concerns, while for the remaining 2,relevant information is requested under dossier evaluation
processes.
→27

Substance evaluation - CoRAP - ECHA (europa.eu)

Database• Database of information on Substancesof Concern In articles, as such or incomplex objects (Products)• Established under the Waste Framework
Directive (WFD)

echa.europa.eu/scip-database28

Database objectives
Driver for substitution ofsubstances of concern andprevention of (hazardous)
waste generation

Contribute to a morecircular economy:
improve waste
treatment operations
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Increase authorities'
information basis
on substances inarticles

Safer products& cleanermaterials cycles

Companies are delivering
Number of successful SCIP notifications received: approx. 25 million

by > 9200 companies
Number of entries/factsheets in
the SCIP database: >9 million

Time period: 28.10.2020 – 01.03.2023
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Universal PFAS restriction31Universal PFAS restriction32

Chemicals Strategy for
Sustainability

Chemicals Strategy for Sustainability main work streams→ REACH revision→ CLP revision→ One substance, one
assessment→ Data regulation→ Regulation on reattributionof scientific and technicaltasks→ ECHA basic regulation©Unsplash/Gustavo Quepón

34

More high-level/long-term topics
→→
→→→

35

Safe and Sustainable by DesignIndicators
Strategic Research and Innovation Agenda
GlobalEtc.

Main policy options REACH revision→ Polymer registration→ Extending REACH information requirements (information onvolumes, uses, exposure/emissions, taking into accountalso NAMs)→ Introduction of a Mixture Assessment Factor (MAF)→ Improve evaluation procedures→ Improve enforcement (strenghthen role Forum, newEuropean Audit Capacity?)36

Main policy options REACH revision→ A reform of restrictions and authorisations→ Develop generic approaches to risk management (GRA)→ Define criteria for essential uses
→ And until REACH is reviewed to include GRA, a restrictions
roadmap has been established37

Thank you
erwin.annys@echa.europa.eu

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