This document summarizes a presentation by Jukka Malm from the European Chemicals Agency on the European regulatory framework for chemicals. The framework aims to protect human health and the environment from harmful chemicals while supporting the chemicals industry. The European Chemicals Agency implements several EU laws regarding chemicals classification, biocides, REACH registration, and others. Under these laws, industry provides data on chemicals while the Agency evaluates the data, identifies substances of concern, and supports risk management by the EU. The system has improved availability of chemical data but continued efforts are needed for full compliance and safe chemical usage in support of EU priorities like the zero pollution ambition.

1. European Regulatory
Framework for chemicals –
protecting citizens and the
environment
Jukka Malm
Deputy Executive Director
European Chemicals Agency
3 December 2019

2. 2
Aims of the framework
• Protection of human health and the
environment from the harmful effects of
chemicals
• Support to the efficient functioning of the
single market of chemicals
• Support the global competitiveness of the
European chemicals industry

3. The European Chemicals Agency
• EU Agency operating in Helsinki since
2007
• Implementing several European
legislations related to chemicals
• 600 staff from 28 countries
• Funding partly from fees, partly from EU
subsidy
Our competences:
3

4. Working for the safe use of chemicals
Classification, labelling, packaging
substances and mixtures
Biocides
active substances in biocidal products
REACH
substances as such, in mixtures and articles
Waste
database of products
with substances of
concern
PIC
import and export
of hazardous
substances
POPs
persistent organic
pollutants
Workers
occupational
exposure limits
4

5. 5
Main actors – REACH and CLP Regulations
Providing data Industry gathers information
and makes sure risks are
managed
Risk management European Commission, with
support of ECHA and Member
States, applies EU-wide risk
management measures
ECHA and Member States
screen and check the data
and request more if needed
Evaluation

6. More data on chemicals than ever before
201
substances of very high concern
600
risk management proposals
2200
substances checked for compliance
23 000
substances registered under REACH
145 000
substances classified under CLP
>2 million
study summaries on chemical properties and effects
6

7. • Information on hazards
and safe use of 140 000
chemicals
• 24 000 daily users
echa.europa.eu
Visit our regulatory chemicals
database – largest in the
world

8. 8
Proposed restriction on microplastics
Prohibition on ‘placing on the market’
Uses where microplastic releases to the
environment are inevitable
Derogated uses
Natural/biodegradable polymers; uses with no
microplastic release; already regulated
Mandatory ‘safe use information’
Uses where microplastic release can be
minimised with instructions for use
Mandatory ‘reporting’
Identity, description of use (function), tonnage,
releases
Microplasticdefinition

9. System is working but
improvements are necessary

10. Reinforce the foundation
• Our goal: Robust data is available on all
chemicals in Europe
• We keep on working on compliance of industry dossiers
 Compliant data allows the substances to be adequately
classified, labelled and used safely
 We can conclude which substances
• are of concern;
• are currently not of concern; or
• need more data for a judgement to be made.
 Substances of concern are addressed via regulatory
risk management
10

11. REACH Evaluation Action Plan
• Ambition: ECHA to check 20% of
REACH registrations by 2027 for
compliance (current target 5%)
• 20% of registrations = around 30%
of chemical substances on EU market
• Two milestones:
• End 2023 for substances in
tonnage bands over 100
tonnes/year
• End 2027 for substances in the
1-100 tonnage bands/year
11

12. Building on the right foundation
• Safe and sustainable use of chemicals by
industry
• Ensure better compliance of supply chain
communication, but also go beyond
• Companies should move from reactive to proactive
• Encourage companies to integrate chemicals
management within corporate sustainability strategies
• Promote substitution – data, tools, best practice,
capacity building – avoid regrettable substitution
• Increasing demands from consumers, retailers &
investors
12

13. How investing in chemicals legislation
can benefit other legislation areas
REACH
CLP
Biocides
Occupational
health and
safety
Waste
framework
directive
Restriction of
Hazardous
Substances
directive
(RoHS)
End of life
vehicles
directive
Water
framework
directive
Drinking
water
directive
Improved consistency of
legislative framework
Stronger protection of
environment and human health
Boosting innovation and promoting
safe substitution
Knowledge and science for non-
toxic material cycles
Global standards
13

14. EU priorities

15. 15

16. The zero pollution ambition is
dependent on the sustainable
production and use of chemicals
“For the health of our citizens, our
children and grandchildren, Europe
needs to move towards a zero-
pollution ambition. I will put forward
a cross-cutting strategy to protect
citizens’ health from environmental
degradation and pollution, addressing
air and water quality, hazardous
chemicals, industrial emissions,
pesticides and endocrine disrupters.”
Ursula von der Leyen

17. Chemicals in circular economy
• Material =
mixture of
chemicals
• Chemicals, waste, products interface
• Continue
generating hazard
data for substances
• Develop tracking and
tracing of substances in
material cycles
• Non-toxic material cycles
17

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