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Using REACH and CLP data to prioritise substances
EFSA FCM Network
Henna Piha
Scientific officer, PhD
Classification and prioritisation
European Chemicals Agency
10-11 July 2017
3
REACH & CLP: main processes & actors
Registration
Regulatory risk management
• Authorisation
• Restriction
• Harmonised classification and labelling
Evaluation Member States
• Substances manufactured and imported into EEA are registered with ECHA
• Information for safe use is communicated in the supply chain
• Testing proposal examinations
• Compliance checks of registration dossiers
• Substance evaluations
4
Towards minimising adverse effects of chemicals
•Chemicals produced & used minimizing significant adverse impacts on human health & environment by 2020
WSSD 2020 goal
•All relevant currently known SVHCs (substances of very high concern) included in Candidate List by 2020
SVHC Roadmap 2020
•Tackling all phases in the lifecycle of products
•Ensuring safe use of recycled materials
Circular economy
• REACH and CLP key regulatory tools helping to achieve these goals
5
Regulatory strategy for “substances that matter most”
Substances that matter
the most
Focus on substances with biggest impact on protection of
people & environment
through regulatory
action
Integrated selection and priority setting
Effective use of the evaluation process
Predictable follow-up with regulatory action where needed
6
Using REACH and CLP data to prioritise substances
Available data Prioritising substances
Dialogues with sectors
Substances of Very High Concern 173
460 Risk management proposals
1 500 Dossiers for high prod. vol. chemicals checked for compliance
120 000 Substances classified by industry
2 million Study summaries on properties and effects of chemicals
14 000 Substances registered under REACH
7
Available data
8
Available data
9
• Requirements depend on tonnage
• Chemical safety assessment covers a substance’s whole life cycle
• CSA aims to demonstrate how substance can be used safely
Substance properties
Phys.chem.
Tox.
Ecotox.
Chemical safety
assessment
Hazard assessment
Exposure assessment
Supply chain communic.
Available data: information requirements
10
• Chemical safety assessment needs information on substance properties and conditions of use
Manufacturer Knows the properties
of a substance
Downstream user Knows how the
substance is used
• Types of activities
• Foreseen products
• Concentrations and amounts
• Operational conditions
• Risk management measures
Communication in the supply chain is key Allocation of assessment responsibility
Available data: supply chain communication
Downstream users
End users
Downstream users
Formulators
Registrants
Uses Existing conditions
Exposure Scenarios
= Safe conditions of use
• What are the existing uses (customer groups)?
• Under which conditions do they take place?
Available data: supply chain communication
12
Prioritising substances
13
Prioritising substances
14
• The objective is to identify among the (potentially) hazardous substances those which have:
A high tonnage for wide dispersive uses within the scope of substance evaluation, CLH, authorisation, restriction
• Combination of information
• P, B and T properties, carcinogenicity, mutagenicity, reprotoxicity, endocrine disruption, sensitisation &
• Use and exposure information
Prioritising substances: screening
15
• Priority is given to substances which have
At least one suspected data gap in the higher tier human health/env. endpoints and/or
Indication of hazard in the endpoints of concern
AND
High potential for exposure of humans or environment and hence relevance for safe use
• Maximises the impact on the safe use of chemicals
Prioritising substances: screening
16
Prioritising substances: current directions
• Need to find effective ways to improve quality of registration data
• Sufficient data needed to prioritise and deprioritise substances
• More information needed especially on use and exposure
Shifting focus from working with single substances to groups of substances
Dialogues with sectors
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Dialogues with sectors
18
Dialogues with
sectors
Petrolium & coal subst.
UV filters
Plastic additives
Organotin comp.
Essential oils
Concrete form
release agents
19
Dialogues with sectors: plastic additives
Objectives
• Ensuring sufficient data
• Common priorities for updating registration dossiers
• Avoiding overlapping activities
• Supporting sustainable substitution
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Inventory of plastic
additives
Use maps for plastic
additives (incl. service
life)
Method development for ranking based on release
potential
Way forward to dealing
with substance data gaps
Dialogues with sectors: plastic additives
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0 200 400 600 800 1000
Total no subst
UV stabilisers
Plasticisers
Pigments
Other stabilisers
Nucleating agents
Flame retardants
Antistatics
Antioxidants
Substances included in the initial inventory
Dialogues with sectors: plastic additives
22
• Approaches and criteria to determine release potential from plastic articles • Harvest knowledge from industry and other stakeholders
• Rank substances for regulatory work
Dialogues with sectors: plastic additives
23
ECHA has REACH and CLP data on over 120 000 chemicals.
Goal to focus regulatory measures on substances that matter most.
Sector activities support to improve data quality and reach the goals efficiently!
Addressing substances of concern is our common goal!
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