introduction to clp: classification, labelling and packaging regulation (1272/2008)

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INTRODUCTION TO CLP:CLASSIFICATION, LABELLING AND PACKAGING REGULATION (1272/2008)

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CLP Regulation 1272/2008

• Came into force in January 2009

• Will ultimately replace the current classification and labelling requirements of the Dangerous Substances Directive (67/548/EC) and Dangerous Preparations Directive (1999/45/EC)

• Progressive transition until June 2015

• Has implications for REACH and 20 pieces of downstream legislation (e.g. worker safety, consumer products, Sevesco II)


Current/old system

• The current EU system on classification, packaging and labelling of chemicals has been developed over the last 40 years and is set out in three keyinstruments

• the Dangerous Substances Directive (67/548/EEC) • the Dangerous Preparations Directive (1999/45/EC)• REACH Annex II ((EC) 1907/2006); originally the Safety Data Sheet

Directive (91/155/EEC)

• Dangerous/non-dangerous, R-phrases, S-phrases

• Well understood, effective


Why do we need CLP?

• EU together with ~ 150 other counties have agreed to implement GHS by end of 2008

• CLP is the EU implementation of GHS (global harmonised system of classification & labelling)


Why do we need GHS?

• GHS was an outcome of the 1992 Rio world summit and was developed by IOMC by 2001

• Classification of the hazards of chemicals is the cornerstone of chemical risk management

• Many different systems have been developed over time (e.g. EU, Japan, USA, Canada)

• Increased globalisation of markets made these differences increasing impractical and differences not only in systems but in actual classification undermine the integrity of all systems


Why is the GHS Important?

GHS/CLPGHS/CLP Danger (Skull & Crossbones)Danger (Skull & Crossbones)

Transport Liquid: slightly toxic; solid: not classifiedEU Harmful (St Andrew’s Cross)US ToxicCAN ToxicAustralia HarmfulIndia Non-toxicJapan ToxicMalaysia HarmfulThailand HarmfulNew Zealand HazardousChina Not DangerousKorea Toxic

Substance - oral toxicity LD50 = 257 mg/kg


Why is the GHS Important?


What is GHS?

The Globally Harmonized System of Classification and Labelling of

Chemicals

• Aims to create a common and coherent approach to:• defining and classifying chemical hazards• communicating information on labels and safety data sheets.

• Provides the underlying infrastructure for comprehensive national chemical safety programs.


GHS – STATUS WORLDWIDE EARLY 2010

ACTIVITIES

PREPARATIONIMPLEMENTATIO

N


What is CLP?

• New EU Regulation on Classification, Labelling and Packaging of substances and mixtures (CLP)

• Implements GHS in the EU

• Entry into force 20 January 2009


What is CLP?

• Scope:– substances and mixtures including C&L of Plant Protection Products and Biocide

s– certain specific articles (explosive articles)

• Although it is the EU implementation of GHS it is not exactly the same of GHS

• It scope is broader than GHS e.g.– Rules for packaging (child resistant fastenings)– Classification and labelling inventory– EU specific hazard statements (e.g ozone depletor)– Translation tables (Annex VII)– Harmonised classifications (Annex VI)– Amends REACH


What is CLP?• It takes up all GHS Hazard classes but not all GHS hazard categories (that

are not part of the current EU system) for example:

– Flammable category 4– Acute toxicity category 5– Acute aquatic toxicity categories 2 or 3– Skin corrosion/irritation category 3– Aspiration hazard category 2


Health Hazards: e.g. acute oral toxicity (mg / kg)

Example - Acute toxicityGHS

1 2

3005053 4 5

No Symbol

2.000 5.000

EU

T+ T Xn

25 200 2.000

Not contained in CLP


• CLP is similar to the current EU system:

• It provides one single system for hazard classification and labelling

• It covers approximately the same hazards• It often uses similar or equal classification

criteria• It sets up an equivalent system of hazard

communication

• CLP is different to the current EU system:

• It sets criteria for both transport and supply, and use

• It defines different hazard classes and categories

• It uses partly other criteria and other cut-offs

• It uses a different approach for mixtures• It changes some labelling elements

CLP scope


Language differences between CLP and DSD/DPD

• Replaces the term “dangerous” by the term “hazardous”

• Warnings (irritant, corrosive etc) replaced by signal words (warning or danger)

• R-factors replaced by hazard codes and statements

• S-factors replaced by precautionary statements

• Symbols replaced by pictograms


New Terminology

• Classes

• Categories/Divisions/Groups

• Pictograms

• Mixtures

• Hazard statements

• Precautionary statements


Indication of danger (= Signal word)EU - IRRITANTCLP – WARNING

Risk Phrase (= Hazard statement)EU - Irritating to eyesCLP - Causes severe eye irritation

Safety phrase (= Precautionary statement)Keep out of reach of childrenDo not breath dustIn case of contact with eyes, rinse immediately with water and seek medical advice

Changes


PictogramsSymbols

DSD and DPD CLP / GHS


Source: Introductory Guidance on the CLP Regulation, ECHA, 2009

Risk Phrase Hazard statement

Safety phrase Precautionary statement


‘Old’ C&L GHS/CLP

Symbol

Indication of danger

ExplosiveExtremely/very flammableOxidisingVery toxic/toxicCorrosiveHarmful/irritatingDangerous for the environment

Risk phrase R##

Safety phrase S##

Pictogram

Signal word DangerWarning

Hazard statement

H###EUH###

Precautionary statement

P###


CLP Hazard Classes and categories• Physical hazards

– Explosives (unstable explosives, Divisions 1.1, 1.2, 1.3, 1.4, 1.5, 1.6)

– Flammable gases (Categories 1 and 2)– Flammable aerosols (Categories 1 and 2)– Oxidising gases (Category 1)– Gases under pressure – Flammable liquids (Category 1, 2, 3)– Flammable solids (Category 1, 2)– Self-reactive substances and mixtures (Type

A, B, C, D, E, F, G– Pyrophoric liquids (Category 1)– Pyrophoric solids (Category 1)– Self-heating substances and mixtures

(Category ! And 2)– Substances and mixtures which in contact

with water emit flammable gases (Category 1, 2 and 3)

– Oxidising liquids (Category 1, 2, 3)– Oxidising solids (Category 1, 2, 3)– Organic peroxides (Type A-G)– Corrosive to metal (category 1)

• Health Hazards– Acute toxicity (Category 1, 2, 3, 4)– Skin Corrosion/irritation (Category 1A, 1B,

1C, and 2)– Serious eye damage/eye irritation (Cat 1&2)– Respiratory or skin sensitisation (Category 1)– Germ cell mutagenicity (Category 1A, 1B, 2)– Carcinogenicity (Category 1A, 1B and 2)– Reproductive toxicity (Category 1A,1B&2)

plus addition category for effects by lactation– Specific target organ toxicity (STOT)-

repeated exposure (Category 1&2)– Specific target organ toxicity (STOT)- single

exposure (Cat 1&2) and Cat 3 for narcotic effects and respiratory tract irritation only

– Aspiration Hazard (Category 1)

• Environmental Hazards– Hazardous to the aquatic environment (Acute

Cat 1, Chronic Cat 1,2 3&4)– Hazardous to the ozone layer


Structure of the CLP RegulationLegal text containing principles and general rules• 79 Recitals: principles and reasoning• TITLE I - General Issues• TITLE II – Hazard Classification

– Chapter 1 Identification and Examination of Information– Chapter 2 Evaluation of Hazard Information and Decision on Classification

• TITLE III – Hazard Communication in Form of Labelling– Chapter 1 Content of the Label– Chapter 2 Application of Labels

• TITLE IV - Packaging• TITLE V – Harmonisation of C&L of Substances and the C&L Inventory

– Chapter 1 Establishing Harmonised Classification and Labelling of Substances– Chapter 2 Classification and Labelling Inventory

• TITLE VI – Competent Authorities and Enforcement• TITLE VII – Common and Final Provisions


Structure of CLP -Annexes

• Annex I: Classification and labelling for substances and mixtures• Annex II: Special labelling rules (EU phrases)• Annex III: Hazard (H) statements (23 languages)• Annex IV: Precautionary (P) statements

– general; prevention; response; storage; disposal• Annex V: Hazard pictograms• Annex VI: Harmonised classifications

– 3.1 CLP; 3.2 ‘old’ Annex I of 67/548/EEC• Annex VII: Translation table (DSD/DPD => CLP)


Roles and obligations• Manufacturers and importers:

– Classify, label and package substances and mixtures according to CLP before placing on the market

– Classify substances not placed on market but which are subject to registration or notification under REACH

– Notify the classification and labelling elements to the classification and labelling inventory established by ECHA

– Take all reasonable steps to make yourself aware of new technical/scientific information that may effect the classification of substances and mixtures you place on the market and in the event that such information becomes available review your classification

– Update the label following any change to the classification and labelling– If you have information that may effect the harmonised classification you should

submit proposal to the MS where the substance is placed on the market– Retain information relative to the classification and labelling under CLP for a

period of 10 years after ceasing supply


Roles and obligations• Downstream users:

– Classify, label and package substances and mixtures placed on the market according to CLP – however you may adopt the classification for a mixture derived in accordance with CLP by an actor up the supply chain provided you do not change the composition of the substance or mixture

– Take all reasonable steps to make yourself aware of new technical/scientific information that may effect the classification of substances and mixtures you place on the market and in the event that such information becomes available review your classification

– Update the label following any change to the classification and labelling– If you have information that may effect the harmonised classification you should submit

proposal to the MS where the substance is placed on the market– Retain information relative to the classification and labelling under CLP for a period of 10

years after ceasing supply


Roles and obligations• Distributors (including retailers)

– Label and package substances you place on the market– May adopt the classification of a substance or mixture carried out in accordance with CLP

by an actor up the supply chain– Retain information relative to the classification and labelling under CLP for a period of 10

years after ceasing supply

• Producers of certain specific articles:– If you produce/import and place on the market an explosive article (sec 2.1 of annex1) you

must classify, label and package according to CLP

– Producers/importers of articles not placed on the market but which require registration or notification under REACH should classify in accordance with CLP


Key deadlines

• 1 December 2010 - deadline for the (re)classification of substances to CLP

• 3 January 2011 (in practice 24 December 2010?) first deadline for the notification to the classification and labelling inventory of substances placed on the market on 1 December 2010 (notifications are due 30 days after placing on the market starting from 1 December 2010)

• 1 June 2015 for the (re)classification of mixtures to CLP


Transitional arrangements

• Transitional arrangements:– CLP classifications will have to be applied to all classification of substances

from 1st December 2010

– Prior to 1st December 2010 existing DSD classification applies but new CLP classification is optional (where CLP is used then labelling and packaging must follow CLP rules not DSD and it must be included on safety data sheet)

– Upto 1st June 2015 DSD classification must be included on safety data sheets

– For preparations (mixtures) classification using DPD must be applied until 1st June 2015 but classification under CLP is optional (where CLP is used it must be included in any safety data sheet and CLP labelling and packaging will apply)


Timelines for CLP and REACH

20 Jan 2009CLP entry into force; repeal of Annex I to DSD

1 Dec 2010*Obligation to apply CLP to substances

1 June 2015*Obligation to apply CLP to

mixtures

*derogation for already placed on the market:- substances until 1.12.2012- mixtures until 1.6.2017

1 Jun 2007REACH entry

into force

1 Jun – 1 Dec 2008Pre-registration

period

1 Dec 20101st Phase

registration deadline

1 Jun 20132nd Phase


1 Jun 20183rd Phase



C&L notification

The following substances will have to be notified to the C&L Inventory:

•Substances subject to REACH registration (≥ 1 t/y) and placed on the market. Notification is not necessary where a manufacturer, importer or OR has already registered the substance;

•Substances classified as hazardous under CLP and placed on the market irrespective of the tonnage. This includes substances which are classified as hazardous under CLP, but which are exempted from registration, e.g. polymers referred to in REACH Article 6(3);

•Substances classified as hazardous under CLP and present in a mixture above the concentration limits specified in Annex I of CLP or as specified in Directive 1999/45/EC, which results in the classification of the mixture as hazardous, and where the mixture is placed on the market irrespective of the tonnage.


Information provided

• Identity of notifier• Other M/I covered by the notification• Substance identity (as in REACH) e.g.

– Identifier codes– Structure– Composition– Purity– Impurities

• Classification (CLP), positive or negative; and whether based on data or absence of data

• Specific concentration limits + M-factors• Label elements• Volume information is voluntary and not for publication


Methods to notify

1. Using IUCLID5

2. On-line submission tool• Reduced number of fields• Use of defaults• Link to the C&L Inventory

3. Bulk submission using XML files. Some limitations:• Must have a CAS or EC #• Single composition• No ‘M’ factors or specific concentration limits possible


C&L Inventory

• All C&L notifiers would receive a submission report which can be copied to group members to show compliance

• C&L Inventory to be publicly available on ECHA website

• Each notification will require up to 200 data fields to be completed so cooperation (group submissions) highly recommended

• Nothing in CLP asks for mixture information

• What was not dangerous before REACH and CLP may be hazardous now


Process of classification for substances• Options

– Harmonised classification– Self classification

• Start form scratch• Use translation tables


Harmonised classification• Substances with a harmonised classification under DSD Annex 1 have been

transferred to Annex VI of CLP

• Annex VI includes both DSD classification (table 3.2) and translated CLP classification (table 3.1)

• CLP allows the Commission, member States and Manufacturers/importers to propose new entries to the Annex VI

• Where a substance has a harmonised classification this must be used for classification purposes

• Under certain circumstances M/I may apply a more severe category than this minimum classification . These circumstances are set out in section 1.2.1 of Annex VI


Harmonised classification Annex VIIndex No International

Chemical Identification

EC No CAS No Classification Suppl.hazard inform. Code(s)

Labelling Codes

Specific Conc. Limits,M-factors

Classification Annex I Dir 67/548/EEC

Hazard ClassCode(s)

Hazard statement Code(s)

001-001-00-9

hydrogen 215-605-7

1333-74-0

Flam. Gas 1 H220

F+; R12

003-001-00-4

lithium 231-102-5

7439-93-2

Water-react. 1Skin Corr. 1B

H260H314

EUH014

F; R14/15C; R34

003-002-00-X

n-hexyllithium 404-950-0

21369-64-2

Water-react. 1Pyr. Sol. 1Skin Corr. 1A

H260H250H314

EUH014

F; R14/15-17C; R35

004-002-00-2

beryllium compounds with the exception of aluminium beryllium silicates, and with those specified elsewhere in this Annex

- - Carc. 1BAcute Tox. 2 *Acute Tox. 3 *STOT Rep. 1Eye Irrit. 2STOT Single 3Skin Irrit. 2Skin Sens. 1Aquatic. Chronic 2

H350iH330H301H372 **H319H335H315H317H411

A Carc. Cat. 2; R49T+; R26T; R25-48/23Xi; R36/37/38R43N; R51-53

006-003-00-3

carbon disulphide

200-843-6

75-15-0 Flam. Liq. 2Repr. 2STOT Rep. 1Eye Irrit. 2Skin Irrit. 2

H225H361fdH372 **H319H315

F; R11Repr. Cat. 3; R62-63T; R48/23Xi; R36/38


Self classification – Translation tables• The translation tables are given in Annex VII

• M/I/DU may use the translation tables where the substance mixture has been classified in accordance with DSD and no other information relative to classification is available to you

• The translation tables covers only these hazards where there is a reasonable correlation between the two systems. Where no translation is available it will be necessary to self classify as per Annex 1

– E.g. flammable solids – Acute toxicity the classification bands overlap


Annex VII – transitional tablesClassification under Directive 67/548/EEC Physical state of the

substance when relevantClassification and hazard statements assigned under this Regulation

Classification Hazard statement

E; R2 No translation possible.

O; R8 gas Oxid. Gas 1 H270

O; R8 Liquid, solid No translation possible.

Xn; R20 Vapours Acute Tox. 4 H332

T+; R27 Acute Tox. 1 H310

C; R34 Skin Corr. 1B H314

C; R35 Skin Corr. 1A H314

T+; R39/27 STOT Single 1 H370

R43 Skin Sens. 1 H317

Xn; R48/20 STOT Rep. 2 H373

Xn; R65 Asp. Tox. 1 H304

R67 STOT Single 3 H336

Xn; R68/20 STOT Single 2 H371

Carc. Cat. 1; R45 Carc. 1A H350

Repr. Cat. 2; R61 Repr. Cat. 3; R62 Repr. 1B H360Df

N; R50 Aquatic. Acute H400

N; R50-53 Aquatic. Acute Aquatic. Chronic

H400H410

N; R51-53 Aquatic Chronic H411

N; R59 Additional EU classification EUH059


Self classification using Annex 1• Four basic steps:

– Gather available information• In house information from DSD classification• Information does not have to be purchased• Information potentially available from SIEFs• Information from ECHA website• Published data can be used regardless of ownership• Carry out new tests

– Examine information and ensure it is adequate and reliable• May require expert judgement

– Evaluate available information against classification criteria specified in Annex 1• May require expert judgement• Weight of evidence may be used • New test may need to be commissioned

– Decide on appropriate classification• Special concentration limits (SCL) and M-factors may need to beset


Classification of MIXTURES: Tiered approach to classification

Generally use test data for the mixture, when available

Use bridging principles, if applicable

For health and environmental hazards, estimate hazards based on the known ingredient information

Sometimes an additivity approach will apply in others not (sometimes even a variation within the same end-point)


Classification of mixtures

Bridging Principles • If test data are not available for a mixture but there are available test data

for a similar mixture, it is possible to classify the untested mixture using bridging principles. There are different types of bridging principles:

1. Dilution2. Batching3. Concentration of highly toxic mixtures4. Interpolation within one toxicity category5. Substantially similar mixtures


Hazard Communication

• Labels CLP

• Safety Data Sheets REACH(SDS/ MSDS)


Labelling• A substance or mixture contained in a package should be labelled in accordance with

CLP rules if:•

– The substance or mixture is classified as hazardous– If in the case of a mixture it contains one or more substances classified as hazardous above

concentrations referred to in part 2 of Annex II – It is an explosive article as specified in part2 of Annex 1

• The size of the label is specified (Sec 1.2.1 of Annex 1)

• Label should be in the language of the of the member state where the substance or mixture is placed on the market (unless MS provides otherwise)


Hazard pictograms

Signal wordName, address and telephone

number of the supplier

Supplemental information Precautionary statements

Hazard statements

Product identifiers

Instructions for use

CLP Label


Main role for ECHA

• Provide industry with technical and scientific guidance and tools on how to comply with the obligations of CLP (Article 50);

• Provide Member State CAs with technical and scientific guidance on the operation of CLP (Article 50);

• Provide support to the national CLP helpdesks (Article 44);

• Establish and maintain the classification and labelling inventory (database) and to receive notifications to the inventory (Article 42);

• Receive proposals for harmonised classification of a substance from Member State CA and suppliers, and to submit an opinion on such proposals to the Commission (Article 37);


Guidance documents for CLP

• Guidance on application of CLP developed under RIP 3.6– Module 1 General guidance (for managers)

• Basics of C&L under CLP• Basics of hazard assessment• Links with REACH and other legislation• Consequences on downstream legislation• Differences between current and CLP classification systems• General explanation of new items such as ATE value, bridging principles etc.• The C&L inventory

– Module 2 – detailed, technical guidance (for experts)

Guidance published on ECHA homepagehttp://guidance.echa.europa.eu/docs/guidance_document/clp_en.htm

http://guidance.echa.europa.eu/docs/guidance_document/clp_en.htm

introduction to clp: classification, labelling and packaging regulation (1272/2008)

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