Cristina de Avila
DG Environment, Safe and Sustainable
Chemicals Unit
Ministry for the Environment
Government of Japan
17 March 2022
Revision of EU chemicals regulations- Classification, Labelling and Packaging (CLP)- REACH

2030 vision – towards a toxic-freeenvironment• Chemicals are produced/used in a way thatmaximises their benefits to society while
avoiding harm to planet & people• Production and use of safe and sustainablechemicals becomes the EU market norm and a
global standardTOXIC-FREE ENVIRONMENT: 5 building
blocksInnovation,competitiveness,recoverySimplification &coherence

Strengthen
legislation for
better protection

Knowledge andscience

Global2. Strengthening legislation•••

Endocrine
disruptors

All chemicals on the market to be used safely andsustainably.
Substitute and minimise as far as possible substancesof concern
Avoid the most harmful chemicals in consumer
products esp. for vulnerable groups
PFAS

New hazard classes

Mixtures

Environmental
impactConcept of ‘essential uses’Classification Labelling and Packaging
Regulation (CLP)

CLP: “cornerstone” of chemicals safety (based on UN Globally Harmonised system):•identifies hazards in chemicals (e.g. to classify as flammable, carcinogen)•communicates hazards and safety precautions on the label (e.g. 'wear gloves')•set out packaging rules of hazardous chemicals (e.g. tactile warnings, child resistant fastenings)•

requests information being sent to EU Poison centres (chemicals information in case of intoxication)

CLP users: consumers, workers, companies and authorities
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CLP Revision – New Hazard classes• Introduce new hazard classes for➢Endocrine disruptors➢Persistent Bio-accumulative and Toxic / very Persistent andvery Bio-accumulative (PBTs/vPvBs)➢Persistent Mobile and Toxic / very Persistent and very Mobile(PMTs/vPvMs)
to apply across all legislation (chemicals, specific products)
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CLP Revision – Endocrine Disruptors (1)• Discussions with Member States ongoing• Based on the definition of the WHO.

• Building on criteria already developed for pesticides and biocides.
• To be applied across all legislation.

CLP Revision - Endocrine Disruptors (2)• Separation of classes: human health and the environment.
• Introduction of categories➢ Category 1: Known or presumed endocrine disruptors (ED HH 1and ED ENV 1)➢ Category 2: Suspected endocrine disruptors (ED HH 2 and EDENV 2)• Development of new labels elements (H- and P-statements)
potentially combined with existing ones.

CLP Revision – Harmonised Classification• A mandate for European Commission to request European

Chemicals Agency (ECHA) to initiate, develop and submit a
proposal for harmonised classification• Harmonisation of human health and environment-based safetyvalues• (for example: predicted no-effect concentration (PNEC), derived no-effect level (DNEL)

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CLP Revision – Next steps• Impact assessment• Proposal by the Commission in 2022.
• After adoption, ED criteria to be proposed under UN GloballyHarmonised System• Each downstream legislation will need to be modified to take into

account the new criteria when establishing risk management
measures (implementation of the Chemicals Strategy).

REACH – the instruments➢ Registration of substances produced or imported≥ 1 tonne/year => manufacturer or importer submit dossierwith hazard and uses/exposure info to European Chemicals
Agency (ECHA)➢ Over 26,000 substances in database➢ Evaluation of dossiers (ECHA) and of substances (MemberStates)➢ Restrictions of substances of very high concern when theypose unacceptable risk to health and/or the environment➢ Authorisation for substances of very high concern with theaim of substituting by chemicals of lower concern or nonchemical methods

REACH Revision – Registration• More information on critical hazard properties(carcinogenicity, endocrine disruption etc.) to ensurehazard identification and risk assessment• Registration of certain polymers of concern• Request information on environmental footprint• More information on use and exposure.

REACH Revision – Registration andcommunication• Request Chemical Safety Assessment for 1-10 tonnes/year

substances• Introduce a Mixtures Assessment Factor• Introduce a Derived Minimal Effect Level for non-threshold

substances with a dose-response relationship• Revise requirements for supply chain communication and e-safety data sheets (e-SDS)REACH Revision – Evaluation• All registrations must comply with the legal requirements• Allow revocation of registration numbers• Improve procedures for filling of data gaps, incl. by group assessmentand mandating testing• Streamline substance evaluation procedures

REACH Revision – Authorisation• Extend definition of Substances of Very High Concern (Article57)➢Endocrine disruptors (without Equivalent Level of Concern)➢Persistent, mobile & toxic (PMT)➢Very persistent, very mobile (vPvM)➢ General reference to CLP classifications• Reform of authorisation & restriction processes

REACH Revision – Restrictions• Extend the use of the Generic Approach for Risk Management(Article 68(2) on consumer products)➢First: Endocrine disruptors, PBT/vPvBs➢Later: Immunotoxicants, neurotoxicants, respiratory sensitisers,
specific target organ toxicity (STOTs)• Extend to products for professional use• Exempt essential uses (to be defined)

REACH Revision – Indicative timing ofactions• Inception Impact Assessment (roadmap) for 4 weeks stakeholder

consultation – May 2021
• Supporting actions and studies – Q1 2021 to Q1 2022
• Public consultation – open until 15 April 2022
• Impact Assessment – Autumn 2021 to Autumn 2022
• Drafting proposal for revision of REACH – 2022

• Commission adoption of proposal – end 2022

Thankyou
Thank you© European Union 2020
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