Classification, labelling and packaging according to CLP

Studiedag LAB 3th October 2013

Dr Saskia Walraedt

Sr Advisor

Projectleider VLARIP

sw@essenscia.be

1

Content

Introduction to CLP

General principles on classification

of mixtures

Using harmonised classification

and labelling

Action plan

2

Abbreviations

ATE : acute toxicity estimate

ATP: adaptation to technical progress

C&L: classification and labelling

CLP : classification, labelling and packaging

CMR : carcinogenic, mutagenic, reprotoxic

DPD : Dangerous product directive

DSD : dangerous substance directive

DU : downstream user

EC: European Commission

ECHA : European Chemicals Agency

GCL : generic concentration limit

GHS: Globally Harmonised System

LC: lethal concentration

MS : member states

NOEC : no observed effect concentration

OJ: official journal

RAC : Risk Assessment Committee

REACH : registration, evaluation, authorisation and restriction of chemicals

SCL : specific concentration limit

STOT SE : specific target organ toxicity single exposure

STOT RE : specific target organ toxicity repeated exposure

CLP – the basics

• European implementation of the Globally Harmonised

System (GHS), developed by UN

• But also EU specific

• List of EU harmonised classifications (annex VI)

• Notification of dangerous mixtures to national anti-poison centres

• Notification of the classification & labeling of substances to ECHA for

the C&L inventory

• Regular updates via ATP

• Extension of the Annex VI list

• Adaption to the biannual revision of GHS

GHS (VN) CLP (EU )

Binding? no yes, EU regulation

Classification yes yes GHS + EUH

Labelling yes yes

SDS yes no, REACH

Packaging no yes

Notification poison centres no yes

Notification C&L no yes

GHS vs CLP

5

CLP - a living regulation

• Extension of Annex VI list of harmonised classifications

• 1ste ATP to CLP : inclusion of 30st en31st ATP to DSD

Consolidated version: http://ecb.jrc.ec.europa.eu/classification-

labelling/clp/

• 3e ATP

• First new harmonised classifications added

• http://eur-

lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:179:

0003:0010:NL:PDF

• 5e ATP

• Notification to WTO

• expected Q2 2013

• EiF 20 d after publication in OJ

• The provisions will apply from 1st January 2015.

6

CLP- a living regulation

• Adoption to the biannual revision of GHS

• 2de ATP (regulation 286/2010)

• Adoption to 3th revision of GHS

• 4e ATP (regulation 487/2013)

• Adoption to 4th revision GHS

7

Adaptation to revisions of GHS

• New classifications

• New test methods

• Changes to H statements

• Changes to P statements

8

Impact on own classifications, labelling, SDS,

software….

* Indien al op de martkt met EU-etiket voor de deadline

ME

NG

SE

LS

ST

OF

FE

N indeling volgens

CLP optie indeling volgens EU 67/548 verplicht indeling volgens

EU 67/548 verplicht

indeling volgens CLP verplicht*

indeling volgens EU 67/548 verplicht*

indeling volgens CLP verplicht

indeling volgens EU 1999/45

verplicht

indeling volgens CLP optie

indeling volgens EU 1999/45 verplicht

indeling volgens CLP verplicht

* Zowel indeling volgens CLP als volgens EU 67/548 te vermelden in SDS

ME

NG

SE

LS

ST

OF

FE

N etikettering

volgens EU 67/548

verplicht

etikettering volgens CLP verplicht

etikettering volgens EU 67/548 optie*

etikettering volgens CLP verplicht

etikettering volgens

EU 1999/45 verplicht

etikettering volgens CLP verplicht

etikettering volgens EU67/548 of CLP

(afh. van de indeling)

1 etiket!

etikettering volgens EU67/548 of CLP (afh. van de indeling)

1 etiket! etikettering volgens EU 67/548 optie*

overgangsbepalingen

CLP mbt indeling

overgangsbepalingen

CLP mbt etikettering

CLP for mixtures – where to start

10

1/6/2015

Re-

formula-

tion and

appro-

vals

Finali-

sing

C&L,

modif.

SDS

Notifica-

tion

poison

centres

Label-

ling and

packa-

ging

knowled

-ge

CLP?

CLP

C&L

ingre-

dients

Estima-

ting

C&L

own

mixture

Collecting data

Verification against criteria

classification Labelling

Packaging

Notification

poison centre

Notification

C&L

CLP – how it works

Collecting data for own mixtures

• Fysical properties : classification on mixtures

• Human tox : no animal testing for C&L!

• aquatoxicity : based on aquatox data of ingredients

12

Original concentration of a substance Max deviation

< of = 2,5% ca 30%

2,5 < C < of = 10% ca 20%

10 < C < of = 25% ca 10%

25 < C < of = 100% ca 5%

DATA

• Use available data

ANNEX VI

• Check Annex VI tabel 3.1 for harmonised C&L

Conversion table

• Use the conversion table (annex VII) for each substance not on annex VI and for which no data are available

DATA

• Use available information on the mixture

• Use data of comparable mixtures

Componenten

• Use information on C&L of substances to classify the mixture

Conversie-tabel

• Use conversion table (annex VII) on DPD classification of the mixture till 1/6/2015

13

For substances For mixtures

Fysische gevaren

DPD

Explosive

Oxidising

Flammable, highly flammable,

extremely flammable

CLP

Explosive

Flammable gas

Chem unstable gases

Aerosols

Oxidising gas

Pressurised gas

Flammable liquid

Flammable solid

Self react

Pyroforic liq

Pyroforic solid

Self heating

Water reacting

Oxidising liquid

Oxidising solid

Organic peroxides

Metal corrosives

14

CLP :

No 1-to-1 conversion possible

Physical state important

Many new classes

Flammable Liquids

15

°C flashpoint

CLP

DSD/DPD

21 23 55 60

Cat. 2 Vp < 23 °C & Tk > 35°C

Cat. 1 Vp < 23 °C & Tk < 35°C

Cat. 3 23 °C < Vp < 60°C

Cat. 4 60 °C < Vp < 93°C

93

GHS

danger warning warning

F+, ,R12

Vp <0 & Tk < 35°C R10

F, ,R11

Humane tox

DPD

Harmful, toxic, very toxic

Corrosive

Irritant

Sensitizer

CMR

CLP

Acute tox oral

Acute tox dermal

Acute tox inhalation

Skin corr or irr

Eye damage or irr

Resp sensitiser

Skin sensitiser

CMR

STOT SE

STOT RE

Asp tox

16

CLP

New classes

New concept for calcution acute

tox of mixtures based on ATE

More stringent

Acute toxicity estimate : ATE

• ATE = acute toxicity estimate

• To calculate acute tox of mixtures

• If available ATE = LC50

• If LC50 not available and only category known, use ATE of

table 3,1,2

17

New!

18

ATE

• When data available on all substances

ATE mix = 100 / (∑ Ci / ATEi)

met Ci = concentration of substance i (% w/w of % v/v)

i = the individual substances 1 to n

n = number of substances

ATEi = acute toxicity estimate for substancei

19

n ATEi

Ci

ATEmix

100(Formule 3.1.3.6.1.)

n

Acute toxicity for mixtures

New!

Tabel 3.1.1 : determining acute tox category

20

Blootstellings-route

Categorie 1 Categorie 2 Categorie 3 Categorie 4

Oraal (mg/kg lichaamsgewicht)

ATE ≤ 5 5 < ATE ≤ 50

50 < ATE ≤ 300 300 < ATE ≤ 2000

Dermaal (mg/kg lichaamsgewicht)

ATE ≤ 50

50 < ATE ≤ 200 200 < ATE ≤ 1000

1000 < ATE ≤ 2000

Gases (ppmV 1 ) ATE ≤ 100

100 < ATE ≤ 500

500 < ATE ≤ 2500

2500 < ATE ≤ 20 000

Dampen (mg/l) ATE ≤ 0.5

0.5 < ATE ≤ 2.0 2.0 < ATE ≤ 10.0

10.0< ATE ≤ 20.0

Stofdeeltjes en nevels (mg/l)

ATE ≤ 0.05

0.05 < ATE ≤ 0.5

0.5 < ATE ≤ 1.0 1.0 < ATE ≤ 5.0

• If acute tox is not known for all substances

Substance with unknown acute tox ≤ 10 %

Formule 3.1.3.6.1.

Substance with unknown acute tox > 10 %

ATE mix = (100 – (∑Cunknown if > 10 %) ) / (∑ Ci / ATEi)

21

n

Acute toxicity

New!

Generic concentration limits (GCL)

22

DPD DPD Conc

limit

CLP CLP conc. limit

Corr C, R34 10% Skin corr 1B en 1C 5%

Corr C, R35 5% Skin corr 1A 3%

Irr Xi, R38 20% Skin irr cat. 2 10%

Irr XI, R36 20% Eye irr 2A 10%

Irr Xi, R 41 10% Eye dam 1 3%

Repr R60 of R61 0,5% Repr 1 0,3%

Repr R62 of R63 5% Repr 2 3%

environment

DPD

Aq tox acute

Aq tox chronic

Ozone depletion

CLP

Aq Tox Acute

Aq tox Chronic

Ozone depletion

23

New calculation rules

New concept of M-factor for class 1

substances

Use of EC50 and NOEC values

Biodegradability taken into account

Annex VI : for which substances?

• Only for substances or groups of substances

• Group 1 :

• CMR cat 1A,1B or 2

• respiratory sensitisers cat 1

• When EU considers that harmonisation is required

• To be submitted by the MS (or industry)

• Attention :for all other hazards : self –classification required!

Annex VI : for which substances?

• Group 2:

• Voor plant protection products and biocides

• Only to be submitted by MS

• For all end points

Specific concentration limits (SCL)

• In annex VI or

• Determined by registrant, importer or DU based on data

• To be indicated in section 3 of SDS

• Always check first if SCL available

• Priority : SCL > GCL, indepent of SCL value higher or lower

than GCL value

27

opleiding REACH en CLP

ATP’s adapting Annex VI

28

Registry of

Intentions

Public consultati

on

RAC

advise

EC decision

ATP in OJ

Follow up as soon as

substance on RoI

Impact own business?

Reformulation required?

To be adopted even if still on

DPD ! (before 6/2015)

CLP for mixtures – where to start

29

1/6/2015

Re-

formula-

tion and

appro-

vals

Finali-

sing

C&L,

modif.

SDS

Notifica-

tion

poison

centres

Label-

ling and

packa-

ging

knowled

-ge

CLP?

CLP

C&L

ingre-

dients

Estima-

ting

C&L

own

mixture

GEVAARLIJK VOOR HET

AQUATISCH MILIEU

GHS09

CLP pictograms

30h

EXPLOSIEF

GHS01

ONTVLAMBAAR

GHS02

OXIDEREND

GHS03

CORROSIEF

GHS05

GIFTIG

GHS06

! IRRITEREND,

SENSIBILISEREND,

SCHADELIJK

GHS07

LANGE TERMIJN

GEZONDHEIDSGEVAARLIJK

GHS08

GASSEN ONDER DRUK

GHS04

http://www.unece.org/trans/danger/publi/

ghs/pictograms.html

Labelling

31

Hazard statements

Precautionary statements

Max 6 statements

How to select?

• Use priority guidelines ECHA

guidance

• Avoid duplicates

• Consider at least 1 P statement

per hazard

• Selling to industrial users/

professional/consumers?

Multiple languages OK but keep it readable!

32

CLP for mixtures – where to start

33

1/6/2015

Re-

formula-

tion and

appro-

vals

Finali-

sing

C&L,

modif.

SDS

Notifica-

tion

poison

centres

Label-

ling and

packa-

ging

knowled

-ge

CLP?

CLP

C&L

ingre-

dients

Estima-

ting

C&L

own

mixture

Notification to Be poison centre

1. According EU directives and regulations • Gevaarlijke preparaten (KB 11/01/1993 - vervangen door KB van

17/07/2002) art. 17 DPD

• CLP (art 45)

• Pesticides (KB 28/02/1994)

• Biocides (KB 5/09/2001)

2. Additional nationale regulations • Cosmetics (KB 15/10/1997)

34

Melding anti-gifcentrum :

http://www.poisoncentre.be/rubrique.php?id_rubrique=9

0&lang=nl

Opleidingscyclus CLP

voor experten 2013 pag. 35

CLP for mixtures – where to start

36

1/6/2015

Re-

formula-

tion and

appro-

vals

Finali-

sing

C&L,

modif.

SDS

Notifica-

tion

poison

centres

Label-

ling and

packa-

ging

knowled

-ge

CLP?

CLP

C&L

ingre-

dients

Estima-

ting

C&L

own

mixture

Logistics

• Consumer market ? Other packaging may be required!

• New software labelling?

• New color printer or preprinted label?

• Warehouse organisation :

• Mixtures which were previously not classified may become CLP classified!

• E.g. flammables, irritating…

• Packaging requirements

• For consumer products : tactile warnings and child proof caps?

• If ADR labelling required :

• Inner label : CLP, outer label : ADR and CLP optionally

• Single packaging : CLP picto may be omitted if = ADR labels

37

CLP for mixtures – a team effort

38

EHS – classification impact?

IT dept – software impact?

Logistics dpt – labelling and packaging

impact?

R&D dpt – reformulation required?

Marketing/sales dpt – commercial

impact?

Conversion to CLP

• CLP training, build a CLP team

• Allow time

• Plan budget

• Discuss with suppliers (of mixtures)

• Inform internally (sales, purchasing, production,

warehouse…) and externally (customers and

suppliers)

More info on ECHA website

40

Opleidingscyclus CLP voor experten 2013

ECHA guidance

• http://echa.europa.eu/web/guest/guidance-documents/guidance-on-clp

41

Opleidingscyclus CLP voor experten 2013

Usefull links

• http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html

• http://ec.europa.eu/enterprise/reach/ghs/index_en.htm

• http://ecb.jrc.ec.europa.eu/classification-labelling/

• http://www.ghs-helpdesk.nl/

• http://ec.europa.eu/enterprise/sectors/chemicals/documents/classific

ation/index_en.htm

• http://www.napofilm.net/en/napos-films

• http://www.youtube.com/watch?v=PjJiLPeeFsE

• http://www.youtube.com/watch?v=BrcrICA5XIs&feature=related

42

Belgian helpdesk CLP

• Federale overheidsdienst (FOD) Volksgezondheid,

Veiligheid van de Voedselketen en Leefmilieu

Eurostation II

Victor Hortaplein, 40 bus 10

1060 Brussel

Contact Center : +32 (0)2 524.97.97

E-mail : info@health.fgov.be

• http://www.health.belgium.be/eportal/Environment/Chemi

calsubstances/index.htm

43

Conclusions

Follow up on the adaptation of other legislations,

i.e. SEVESO, VLAREM…

Make an action plan for the conversion of own

production to CLP

Regular changes to the classification of mixtures

possible, even before switching to CLP new data from the REACH registrations of the substances

new harmonised classifications

Disclaimer

Alle gegevens op dit document worden door essenscia vzw/essenscia vlaanderen met de grootste zorgvuldigheid

samengesteld. Voor deze informatie worden enkel betrouwbare bronnen aangewend. Ondermeer door de snelle

evolutie van de behandelde materie blijft de mogelijkheid bestaan dat de gegevens toch niet volledig accuraat zijn,

daarom wijst essenscia vzw/essenscia vlaanderen elke aansprakelijkheid voor fouten of onvolkomenheden af.