Overview of CLP and therevision
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→ What & Why classification & labelling?

→ Harmonised vs self-classification→ Harmonised classification: key steps and interlinks withother processes→ The CLP revision3

What & why classification& labelling

What is classification and labelling?
→ A way to determine if a substance (or mixture) is“hazardous” to health and/or environment→ Based on hazard, not risk
• Do not consider exposure
or socio-economic consequences→ How to achieve it ?
• By comparing hazard information on
the substance(s) (e.g. study results) withclassification criteria (Annex I, CLP)
• By deciding on the most appropriate
hazard class and category5

Why classify and label?
→→→→→→

6

Worker and consumer health and safety
Environmental protection
Ensure correct storage/handling/ transport
Prevent consumer access to most dangerous substancesand mixtures
Prevent accidents and response
Instructions for handling and discarding waste

7Consequences of classification

Pesticides &biocides

Labelling&SDS

Classification
REACH

Hazardous
waste

Storageandtransport

SVHC

Restrictions
Cosmetics

Workingenvironment

Why classify and label?

→ Effective communication of identified hazards
in safety data sheets (SDS) and on labels• Hazard pictograms• Signal word• Warning (Wng), Danger (Dgr)• Hazard statement, e.g.
• H200 – Unstable explosives• H301 – Toxic if swallowed

8• Precautionary statements, e.g.
• P201 – Keep out of reach of children• P372 – Explosion risk in case of fire

ECHA’s main tasks under CLP•

Processing proposals for Harmonised Classification andLabelling (CLH)•

Adopted via the Risk Assessment Committee•

Maintaining/developing the C&L Inventory•

Handling applications for Alternative chemical names for
substances in mixtures••9Notifications on self-classifications of hazardous
substances on the EU market

Formulators of mixtures apply for use ofalternative names for hazardous substances onlabels and safety data sheets

Packaging→ Material must not be susceptible to be damaged by its
content→ Packaging and fastenings shall be strong and solid→ Repeated refastening of replaceable
fastening must be possible without thecontents escaping→
Package containing a hazardous
substance / mixture supplied to thegeneral public shall not mislead consumers.
10Special rules on packaging→ Child-resistant fastenings• Example: mixture contains methanol ≥ 3 % or dichloromethane≥ 1%→ Tactile warnings

Hazard Criteria
fastenings
Acute toxicity (category 1 to 3)
Acute toxicity (category 4)
Flammable gases (category 1, 2)
11Child-resistant
Yes-Tactile warnings
Yes
Yes
Yes

Harmonised versus
self classification

Harmonised classification and labelling
EU harmonised classification
versus“self-classification”

13Harmonised classification and labelling•

Agreement of classification and labellingof a substance at EU-level•

Legally binding: obligatory to use forevery manufacture, importer or downstream user of thesubstance within EU• List of harmonised classifications Annex VI to CLP• Over 4500 entries (including many group entries)
14

Harmonised classification and labelling
Which substances should be harmonised?
→ CLP Regulation focuses on substances which are of mostconcern to human health, i.e.:• Carcinogenic (C)• Mutagenic (M)• Reproductive toxicants (R)• Respiratory sensitisers (RS)→ Other hazard classes can be harmonised on a case-by-casebasis – justification needed, but…
→ Active substances in plant protection products (PPPs) andbiocidal products (BPs) are harmonised15Harmonised classification and labelling→

Who can submit a CLH proposal to ECHA?
• Member State Competent Authorities (MSCAs)• M/I/DUs can submit• Exception: PPP, BP, removal or revision of an existing classification / differentiationin an Annex VI entry• Pesticidal and biocidal active substances – only MSCAs→

Adopted via the Risk Assessment Committee (RAC)• Scientific committee (MSCA representatives)• Discusses and gives an opinion on the classification proposal→Commission takes final decisionInclusion in Annex VI of CLP – list of harmonisedclassifications

16Harmonised classification and labelling→ As for substances, mixtures shall be classified for physical,
human health and environmental hazards

17•

Based on test data for the mixture as a whole (also forphysical properties)•

Based on the use of ”bridging principles” (someprinciples under discussion with MSs and Commission)•

Based on the hazardous properties of the individual
constituents of the mixture (concentration limits and cut
offs - calculations)Harmonisedclassification: key
steps and interlinks
with other processesCLH process(Webpage)19

Harmonised classification and labelling - process

Max 18 months to adopt a CLH
opinion (Art. 37(4) of CLP)
Main actors:
Dossier submitter (DS)

ECHA/RAC
20

Parties concerned

RAC plenary /written procedure

2nd draft

RAC consultation

1st draft

DS RCOM

Public consultation

Accordance check

Dossier submission

SID-check

CLH intention

RAC opinion development

CLP and REACH Regulations needed to be integrated/synchronised being central
elements in the EU chemical policy⚫

Many provisions in REACH are based on classification (What is REACH without CLP and⚫

what is CLP without REACH?)
21

ECHA’s network on CLP
CARACAL*

C&LCriteriaAdviceUN GHS

Member state CAs

RACCOM
DG
GROW
DG ENV

CLH
Art. 24

ECHA

C&L notifications

Manufacturers Importers
orDownstream
users

InformAdvice& Agreeon C&L

EFSA

Stakeholders,parties concerned etc.

* Competent Authorities
for REACH and CLP

DG SANTE
22

The CLP revision

CLP Revision in 2 parts

New
hazardclassesDone!

OLP
Ordinary Legislative
Procedure(change of CLP”body” text)

Co-decision via
Parliament andCouncil

DA
Delegated Act

EU notwaitingfor UN
GHS(changing Annex I)

COM decision via
CARACAL
consultations
24

COM proposals for legal revisions of CLPa) The adopted Delegated Act (new hazards
classes, C(2022)9383 final)→ CLP Delegated Act (europa.eu),b) The proposal to change CLP regulation(COM(2022)748 final)→ Proposal for CLP revision (europa.eu)
https://ec.europa.eu/commission/presscorner/deta
il/en/IP_22_7775
25

ECHA’s task to prepare update of the Guidance on the Application of theCLP Criteria to include the new hazard classes

Timing?
OLPDA

Consolidated draft
published 19.12.2022

Published 19.12.2022

Only 1 reading inEP/Council?

2-m scrutiny period byEP/Council

Entry into force – earliest
June 2024

Transitional period –18…42 months? → Jan
2026 ?

Entry into force
Q2 2023

Transitional period
Substances 24 months (2y) → Q2 2025
Mixtures 36 months (3 y)→ Q2 2026

Reclassification
Transitional period
Substances 42 months(3,5 y) → Q4 2026
Mixtures 60 months (5 y)→ Q2 2028
26

DA (Annex I)– What’s in→

27

Setting the new criteria for ED (HH), ED(ENV) PBT,vPvB, PMT, vPvM
• Definitions• EDs Cat 1 (known/presumed) and Cat 2 (suspected)• PBT/vPvB – no subcategories• PMT/vPvM - no subcategories• New hazard statements (EUH)• Generic concentration limits/mixture classification• No symbol/pictogram for the new hazard classes• Symbol to be discussed at UN-GHS

New hazard classes
Hazardclass andcategory
code

Hazardstatement
code

Hazard statement

ED HH 1

EUH380

May cause endocrine disruption in humans

ED HH 2

EUH381

Suspected of causing endocrine disruption in humans

ED ENV 1

EUH430

May cause endocrine disruption in the environment

ED ENV 2

EUH431Suspected of causing endocrine disruption in the environment

PBT

EUH440

Accumulates in living organisms including in humansvPvB

EUH441

Strongly accumulates in living organisms including in humans

PMT

EUH450Can cause long-lasting and diffuse contamination of water resources

vPvM

EUH451

Can cause very long-lasting and diffuse contamination of waterresources

28

OLP – What’s in CLP (1/7)• COM right of initiative• ECHA & EFSA to prepare CLH-proposals• Obligatory Registry of Intentions (RoI)• MSs and IND to notify intentions• ECHA to publish intentions (within 1 week)• What normally prioritised for CLH (Art 36.1)• Now: C, M, R, resp sens
• Add: EDs, PBT, vPvB, PMT, vPvM

• MSCA to inform ECHA
• Acceptance or refusion of a classification revision proposal by M,I or DU• ATE• Add definition for acute toxicity estimates

29

OLP – What’s in CLP (2/7)
Role of SVHC and PPP/BP ED, PBT
assessments?

SVHCCLH• COM delegated act to add existing candidate list(SVHC) substances and PPP and BP active substances
identified into Annex VI of CLP• In the future CLP route to be used: 1S1A hazard
identification
30

OLP – What’s in CLP (3/7)• Changes to C&L Inventory• Publication of notifier names• Reasons for divergence in self-classification• Update of notifications within 6 m after a decision tochange a classification is madeSME
benefit31

OLP – What’s in CLP (4/7)• Clarification of mixture rules on MOCS

MOCS
More than one
constituent
substance• Definition Multi-constituent substance =“a substance that contains more than one constituent”• Information on the constituents to be used for identification andexamination of available information••Disclaimer
Essential oils
exemption?

Muta, carc, repro, ED HH, ED ENV
Biodegradation, persistence, mobility and bioaccumulation properties within Aquatic
Acute/Chronic, PBT, vPvB, PMT and vPvM

• Data on the multi-constituent substance itself shall be taken into account:••

If data demonstrates Muta, carc, repro, ED HH, ED ENV, biodegaradation, persistence,
mobility and bioaccumulation properties
Data supports the conclusions based on the relevant available info on the constituents• Data on the multi-constituent substance itself showing absence of certain
properties or less severe properties shall not override the info on theconstituents.
32

OLP – What’s in CLP (5/7)• Online sales (distance sales)• Improve hazard communication and enforcement••

Advertisement of substance/mixtures must contain:• hazard pictogram,• signal word,• hazard class and• hazard statements
A supplier in EU to ensure the requirements by CLP are met
i.e. consumer not becoming the importer

33

OLP – What’s in CLP (6/7)• Changes to labelling, on-pack label vs digital label•••••

Minimum dimension of label, pictograms and font size
Label updates within 6 or 18 months after new evaluation
Broader use of fold out labels
Exemptions on very small packaging (< 10 ml)
Voluntary digital label••

To contain info instrumental to the protection of health and environment
Researchable, available in less than 2 clicks• Sales in refillable containers•

Chemicals with less severe hazards• Derogations: ammunition, ready mixed cement, fuel34

OLP – What’s in CLP (7/7)• Poison centres (PC)• More robust legal basis for ECHA’s role•

ECHA to be Appointed Body•
•Confirms ECHA’s role in processing and dispatching notifications (emergencyhealth information)

ECHA (and COM) may ask appointed bodies to analyse and share their
PCN data for RRM purposes• Duty holder definition: Also distributors must notify to PCN
emergency health information•

Distributor rebranding/relabelling & supplying to another MS than the one
in which the mixture was notified35

Impact→ 1st route: Harmonised classification is the firststep and corner stone for many risk management
actions•••••

Biocides a.s.(re)assessment and authorisation
PPP a.s.(re)assessment and authorisation
Authorisations and Restrictions under REACH
Generic restrictions (GRA)
A variety of other pieces of downstream legislation→ 1S1A: Even more central with the classification
criteria for the new hazard classes•

36

But EU needs to convince the rest of the world…GHS

Thank you
erwin.annys@echa.europa.eu

echa.europa.eu/subscribe
Connect with usecha.europa.eu/podcasts

European Chemicals Agency@one_healthenv_eu@EU_ECHA@EUECHA

EUchemicals