Transcript Was macht das Umweltbundesamt?

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)
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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 key
instruments
•
•
•
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
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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)
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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
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Why is the GHS Important?
Substance - oral toxicity LD50 = 257 mg/kg
GHS/CLP
Danger (Skull & Crossbones)
Transport
EU
US
CAN
Australia
India
Japan
Malaysia
Thailand
New Zealand
China
Korea
Liquid: slightly toxic; solid: not classified
Harmful (St Andrew’s Cross)
Toxic
Toxic
Harmful
Non-toxic
Toxic
Harmful
Harmful
Hazardous
Not Dangerous
Toxic
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Why is the GHS Important?
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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.
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GHS – STATUS WORLDWIDE
EARLY 2010
ACTIVITIES
PREPARATION
IMPLEMENTATION
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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
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What is CLP?
• Scope:
– substances and mixtures including C&L of Plant Protection Products and
Biocides
– 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
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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:
–
–
–
–
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Flammable category 4
Acute toxicity category 5
Acute aquatic toxicity categories 2 or 3
Skin corrosion/irritation category 3
Aspiration hazard category 2
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Example - Acute toxicity
GHS
No Symbol
1
2
3
5
4
50
300
25
200
T+
T
Not contained
5
5.000
2.000in CLP
2.000
Xn
EU
Health Hazards: e.g. acute oral toxicity (mg / kg)
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CLP scope
•
CLP is similar to the current EU system:
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CLP is different to the current EU system:
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It provides one single system for hazard
classification and labelling
•
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It covers approximately the same hazards
•
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It often uses similar or equal classification
criteria
•
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It sets up an equivalent system of hazard
communication
It sets criteria for both transport and
supply, and use
It defines different hazard classes and
categories
It uses partly other criteria and other cutoffs
•
It uses a different approach for mixtures
•
It changes some labelling elements
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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
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Symbols replaced by pictograms
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New Terminology
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Classes
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Categories/Divisions/Groups
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Pictograms
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Mixtures
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Hazard statements
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Precautionary statements
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Changes
Indication of danger (= Signal word)
EU - IRRITANT
CLP – WARNING
Risk Phrase (= Hazard statement)
EU - Irritating to eyes
CLP - Causes severe eye irritation
Safety phrase (= Precautionary statement)
Keep out of reach of children
Do not breath dust
In case of contact with eyes, rinse immediately with water and seek
medical advice
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Symbols
Pictograms
DSD and DPD
CLP / GHS
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Risk Phrase
Hazard statement
Safety phrase
Precautionary statement
Source: Introductory Guidance on the CLP Regulation, ECHA, 2009
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‘Old’ C&L
Pictogram
Symbol
Indication of
danger
GHS/CLP
Explosive
Extremely/very flammable
Oxidising
Very toxic/toxic
Corrosive
Harmful/irritating
Dangerous for the
environment
Risk phrase
R##
Safety phrase
S##
Signal word
Danger
Warning
Hazard
statement
H###
EUH###
Precautionary
statement
P###
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CLP Hazard Classes and categories
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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)
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Health Hazards
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–
–
–
–
–
–
–
–
–
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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
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Structure of the CLP Regulation
Legal 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
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TITLE VI – Competent Authorities and Enforcement
TITLE VII – Common and Final Provisions
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Structure of CLP -Annexes
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Annex I: Classification and labelling for substances and mixtures
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Annex II: Special labelling rules (EU phrases)
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Annex III: Hazard (H) statements (23 languages)
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Annex IV: Precautionary (P) statements
– general; prevention; response; storage; disposal
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Annex V: Hazard pictograms
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Annex VI: Harmonised classifications
– 3.1 CLP; 3.2 ‘old’ Annex I of 67/548/EEC
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Annex VII: Translation table (DSD/DPD => CLP)
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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
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Roles and obligations
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Downstream users:
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–
–
–
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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
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Roles and obligations
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Distributors (including retailers)
–
–
–
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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
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Producers/importers of articles not placed on the market but which require registration or
notification under REACH should classify in accordance with CLP
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Key deadlines
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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
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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)
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Timelines for CLP and REACH
1 Jun 2007
REACH entry
into force
1 Jun – 1 Dec 2008
Pre-registration
period
20 Jan 2009
CLP entry into
force; repeal of
Annex I to DSD
1 Dec 2010
1st Phase
registration deadline
1 Dec 2010*
Obligation to
apply CLP to
substances
*derogation for already placed on the market:
- substances until 1.12.2012
- mixtures until 1.6.2017
1 Jun 2013
2nd Phase
registration deadline
1 Jun 2018
3rd Phase
registration deadline
1 June 2015*
Obligation to
apply CLP to
mixtures
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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.
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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
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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
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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
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Process of classification for substances
•
Options
– Harmonised classification
– Self classification
• Start form scratch
• Use translation tables
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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
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Harmonised classification Annex VI
Index No
International
Chemical
Identification
EC No
001-00100-9
hydrogen
215605-7
003-00100-4
lithium
003-00200-X
CAS No
Classification
Suppl.
hazard
inform.
Code(s)
Lab
ellin
g
Cod
es
Specific
Conc.
Limits,
Mfactors
Classificatio
n Annex I
Dir
67/548/EEC
Hazard Class
Code(s)
Hazard
statement
Code(s)
1333-740
Flam. Gas 1
H220
231102-5
7439-932
Water-react. 1
Skin Corr. 1B
H260
H314
EUH014
F; R14/15
C; R34
n-hexyllithium
404950-0
2136964-2
Water-react. 1
Pyr. Sol. 1
Skin Corr. 1A
H260
H250
H314
EUH014
F; R14/1517
C; R35
004-00200-2
beryllium
compounds
with the
exception of
aluminium
beryllium
silicates, and
with those
specified
elsewhere in
this Annex
-
-
Carc. 1B
Acute Tox. 2 *
Acute Tox. 3 *
STOT Rep. 1
Eye Irrit. 2
STOT Single 3
Skin Irrit. 2
Skin Sens. 1
Aquatic. Chronic
2
H350i
H330
H301
H372 **
H319
H335
H315
H317
H411
006-00300-3
carbon
disulphide
200843-6
75-15-0
Flam. Liq. 2
Repr. 2
STOT Rep. 1
Eye Irrit. 2
Skin Irrit. 2
H225
H361fd
H372 **
H319
H315
F+; R12
A
Carc. Cat.
2; R49
T+; R26
T; R2548/23
Xi;
R36/37/38
R43
N; R51-53
F; R11
Repr. Cat.
3; R62-63
T; R48/23
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Xi; 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
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Annex VII – transitional tables
Classification under Directive 67/548/EEC
Physical state of the
substance when relevant
Classification and hazard statements assigned under this Regulation
Classification
E; R2
Hazard statement
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
H400
H410
N; R51-53
Aquatic Chronic
N; R59
Additional EU classification
H411
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EUH059
Self classification using Annex 1
•
Four basic steps:
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Gather available information
•
•
•
•
•
•
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Examine information and ensure it is adequate and reliable
•
–
May require expert judgement
Evaluate available information against classification criteria specified in Annex 1
•
•
•
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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
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
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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)
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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. Dilution
2. Batching
3. Concentration of highly toxic mixtures
4. Interpolation within one toxicity category
5. Substantially similar mixtures
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Hazard Communication
• Labels
CLP
• Safety Data Sheets
(SDS/ MSDS)
REACH
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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)
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CLP Label
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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);
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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 homepage
http://guidance.echa.europa.eu/docs/guidance_document/clp_en.htm
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