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The new EU CLP Regulations and GHS Overview G. Malinverno - SOLVAY SA Chairman of CEFIC REACH Management Team

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Title: The new EU CLP Regulations and GHS Overview G. Malinverno - SOLVAY SA Chairman of CEFIC REACH Management Team


1
The new EU CLP Regulations and GHS Overview
G. Malinverno - SOLVAY SA Chairman of CEFIC
REACH Management Team
CEFIC- ICCA - WORKSHOP Zagreb 3-4 December
2009
2
Content
  • The CLP Regulation - State of Play
  • REACH links to Classification and Labelling ( CL
    )
  • The Classification and Labelling Inventory
  • The Notifications to the CL Inventory some
    technical considerations
  • GHS Major Hints

3
The CLP Regulation State of Play
  • Entry into force on 20 January 2009
  • Transitional period 2010-2015
  • Both classification systems to be used
  • Repeal of old directives (67/548/EEC
    999/45/EC) on 1 June 2015
  • Annex I of Directive 67/548/EEC deleted on 20
    January 2009
  • Annex I of Directive 67/548/EEC replaced by CLP
    Annex VI (up to 29th ATP)
  • Downstream legislations reviews

ATP Adaptation to Technical Progress
4
The CLP Regulation Next
  • Proposed 1st ATP to CLP
  • transfer of 30th 31st ATP to 67/548/EEC
  • Published 5th of September 2009
  • Review Annex I of REACH (CSA/CSR)
  • Review Annex II of REACH (Safety Data Sheets)
  • Fees to be determined by the Commission
  • Request for use of an alternative chemical name
    (Art.24 CLP )
  • industry proposal for harmonised classification
    (Art.37(2) CLP)
  • RIP 3.6 Guidance on Classification and
    Labelling

5
REACH Links to Classification and Labelling
  • REACH does NOT include CRITERIA for CL
  • It refers
  • to substance classification Dir 67/548/EEC
  • to preparation classification Dir 1999/45/EC
  • CLP updates REACH
  • But REACH has links to CL
  • Registration
  • Information in the supply chain
  • CL Inventory
  • REACH Title XI deleted
  • CLP Title V   Harmonisation of Classification
    and Labelling of substances and the
    Classification and Labelling Inventory  

6
The Classification and Labelling Inventory
  • The CL Inventory under CLP (Title V, Chapter 2)
    replaces the CL Inventory under REACH (Title XI)
  • It will be a database established and maintained
    by ECHA with CL information on substances
  • The CL Inventory has several purposes
  • Allow public access to basic information on the
    classification and labelling of substances
  • Encourage the harmonisation of classification and
    labelling (one of the principal aim of SIEFs)
  • Reference tool for hazard communication and risk
    management (authorisation and restrictions
    processes under REACH )

7
Which substances are subject to CL Inventory ?
  • All substances subject to REACH Registration (gt 1
    tonne/y)
  • All Substances not subject to REACH Registration
    but
  • Are within the scope of CLP
  • Are classified as hazardous under CLP
  • Are placed on market on their own or in a mixture
    classified as hazardous under CLP
  • Irrespective of the tonnage

8
REACH Substances
  • REACH Registrant(s) do not need to notify the CL
    information of their substance(s) if already part
    of a REACH registration before the CLP
    Notification deadline (CLP Art 40(1) para 2)
  • A notification is required when the substance has
    been pre-registered but not registered before the
    Notification deadline
  • However, it seems that substances regarded as
    being REACH registered such as ELINCS
    substances, active plant protection substances,
    active biocidal substances and classified may
    also need to be notified

9
Non REACH substances
  • Many substances exempted from REACH Registration
    fall within the scope of CLP such as
  • Substances below 1tonne/y,
  • Many substances exempted under REACH Annex V,
  • Polymers
  • Ingredients used to produce medicinal and
    veterinary medicinal products
  • They will be subject to notification (CLP
    conditions to apply)

10
Who needs to notify ?
  • Only manufacturers or importers, or group of
    manufacturers or importers, who places on the
    market (Art 40(1))
  • Downstream users, including formulators of
    mixtures, distributors and producers or importers
    of articles do not need to notify
  • REACH Registrant(s) do not need to notify the
    substances classification information if already
    part of a registration before the Notification
    deadline

11
What is the notification deadline ?
  • Does it mean two deadlines ?
  • Obligatory ? One month after the placing on the
    market
  • 1 January 2011 (inclusive)
  • substances in commerce on 1 Dec 2010
  • substances placed on the market for the first
    time on 1 Dec 2010
  • On a case by case, one month from the date of the
    placing on the market
  • Voluntary ?
  • Before 1 December 2010 for substances placed on
    the market before 1 December 2010
  • Article 40(3) of CLP
  • Substances placed on the market on or after 1
    December 2010 shall be notified in accordance ()
    within one month after their placing on the
    market
  • However, substances placed on the market before 1
    December 2010 may be notified in accordance ()
    before that date

12
What information to notify and how ?
  • The identity of the notifier(s)
  • The identity of the substance(s)
  • The classification of the substance(s)
  • The reason for non-classification
  • Specific concentration limits or M-factors
  • The labelling elements for the substance
  • The format shall be specified by ECHA and
    submitted via REACH IT

13
The content of CL Inventory
  • It will contain
  • CL information on notified and registered
    substances
  • The list of harmonised classifications (Annex VI)
  • ECHA will add
  • Whether there is a harmonised CL at Community
    level (Annex VI ) for a particular entry
  • Whether the entry is a joint entry between
    registrants of the same substance
  • Whether the entry is agreed by two or more
    notifiers or registrants
  • Whether the entry differs from another entry for
    the same substance
  • Public access for most of the CL Inventory
    (REACH Article 119(1))
  • Other parts only accessible to notifiers and
    potential REACH registrants (who have
    pre-registered)

14
The Notifications to the CL Inventory some
technical considerations
  • The Notification deadline is very close to the
    first registration deadline for phase-in
    substances
  • The estimated number of notifications is expected
    to be huge may be up to 5 million (vs. 2,8
    million of pre-registrations)
  • Scope of the CLP regulation
  • Lack of threshold
  • The content of the notification is more complex
    compared to the information required to submit
    pre-registrations

15
The Notifications to the CL Inventory some
technical considerations (2)
  • Which format ?
  • IUCLID 5 mainly for REACH registrations not for
    CLP
  • Which submission system ?
  • Single upload, webforms ?
  • Need to have a bulk notification
  • How to ensure that a group of manufacturers or
    importers ( Art. 40(1)) can notify the CL of
    the substance to ECHA ?
  • How to achieve a harmonised classification when
    it involves registrants by 1 December 2010,
    potential registrants after 1 December 2010 and
    non registrants ?

16
GHS What are the Issues?
  • Not Straightforward
  • Overload of Chemical Legislation e.g. REACH in
    the EU
  • implementing REACH and CLP/GHS at the same time -
    complex operation with significant implications
  • GHS Global Implementation in parallel
  • Substances more severely classified and more
    classified mixtures
  • Downstream consequences different in EU from rest
    of the world
  • Safety Data Sheet formats changing New Labels
    significant changes
  • Estimated 30,000 substances subject to REACH
    other substances outside of REACH to enter the
    Inventory
  • Estimated approximately 2,000,000 mixtures
    marketed in EU alone

17
Why GHS Necessary?
  • Example Different risk phrases used for a
    substance with an Acute Oral
  • Toxicity LD50 257 mg/kg/day
  • EU Harmful (St Andrews Cross)
  • US Toxic
  • CAN Toxic
  • Australia Harmful
  • India Non-toxic
  • Japan Toxic
  • Malaysia Harmful
  • Thailand Harmful
  • New Zealand Hazardous
  • China Not Dangerous
  • Korea Toxic
  • GHS. Danger (Skull Cross Bones)

18
General Principles of UN GHS
  • Focus on intrinsic hazards (not exposure or risk)
  • Self-classification (not by regulatory
    authorities)
  • Best scientific practice and judgment applied to
    existing data
  • Building block approach to facilitate
    implementation
  • Not intended to reduce current level of
    protection in any country - Competent Authorities
    decide which elements to implement
  • However
  • Flexibility non-uniform implementation
  • around the world!

19
GHS Global Implementation Expected by 2010 !
Ongoing Activities
In Preparation
Implemented
SOLVAY
SOLVAY S.A. / CC-GPA G. Malinverno September
2009
18
20
Global Implementation Summary - 1
Australia
Varies by State Expected Implementation -
2010 for Substances, 2015 for Mixtures
China
Expected Implementation - March/April 2010
26 Classification standards published.
Step By Step Implementation. Will have a
mandatory List
Hong Kong
Expected Implementation - 2009. Expected
Compliance - 2010
India
Expected Implementation - 2009. Expected
Compliance - 2010
Indonesia
Implemented Feb. 2008 for pure substances only.
Compliance Deadline end 2009 for
pure substances only. Draft of Indonesian
Presidential Regulation on GHS still
pending for approval. Implementation date unknown
Japan
Implemented Industrial Safety and Health Law
(MHLW) implemented Dec. 1, 2006 GHS
Classifications published - Non binding until
2010
http//www.safe.nite.go.jp/ghs/list.html
Korea
Implemented Compliance deadline June
30/2010-single substances ( postponed from
June 2008) June 30, 2014-mixture. Non Binding
classification list for 2,500 substances
Malaysia
Implementation Exact date not know but possibly
Dec. 2010
New
Implementation 2006, SDS compliance deadline
Jun 30/2008, but labels (full GHS
Zealand
compliance) is not required until Dec. 31/2010
Philippines
Expected Implementation - 2009. Expected
Compliance - 2010
Singapore
Manufacturers Suppliers 2 years for single
substances till end 2010 4 years for
mixtures till end 2012. End users 3 years for
single substances till end 2011 5 years
for mixtures till end 2013

SOLVAY
SOLVAY S.A. / CC-GPA G. Malinverno September
2009
19
21
Global Implementation Summary - 2
Taiwan
Implementation - Jan. 2007 Compliance deadline
Dec 31/2009-substances on CLA
Dangerous Goods/EPA TCCL lists only.
Thailand
Implementation Dec. 2008. Compliance Deadline
end 2009 for pure substances only.
Expected compliance for mixtures - Dec. 2011 Not
all endpoints included at this time
Vietnam
Implemented January 2009 - transition to 1
July 2009 postponed - but final date
unknown
EU
Implementation 2009. Substance compliance - Dec
1, 2010, Mixture compliance - Jun 1,
2015.
Russia
SDS and CLP standard published in Russian,
Implementation for 2010
South
Regulation Planned for 2008/9 - no update
National Standard (GHS) (SANS 10234)
Africa
was published in 2007- essentially implementing
the UN GHS Supplement with list
reclassified substances due end 2008 - not yet
aware of the list being published
Brazil
South American and MERCOSUR countries discussion
ongoing
Implementation expected by 2010 Transition by
2013 possibly
Mexico
Possible GHS implementation in Mexico Jan 1,
2010, but nothing confirmed yet
Canada
Expected implementation 2009-date looks
doubtful.
USA
DOT/IMDG/ICAO adopted GHS class 3 6 criteria
for transport in 2007 and GHS class 9
criteria for aquatic toxicity in 2009. OSHA
likely to be another year
CPSC is just beginning to investigate GHS
implications for consumer products. US
implementation likely to be staggered across
all 4 agencies ranging between 2007-
2012
SOLVAY
SOLVAY S.A. / CC-GPA G. Malinverno September
2009
20
22
Global Implementation Challenges for Companies
  • How to keep up to date
  • UN website not current
  • Need Global Regulatory Information
  • SMEs disadvantaged
  • Industry is working together, but information is
    limited
  • Biennium update of UN GHS when can the new
    guidance be used
  • 3rd Edition July 2009
  • Japan Implemented 1st Ed translated 2nd Ed,
    Industry can use 3rd Ed
  • Korea Chemical Law to be amended before use 3rd
    Ed
  • South America translated 1st Ed GHS to be
    implemented with 1st Ed
  • EU updated by ATP to CLP Regulation but when can
    new guidance
  • actually be used for self-classification

23
Global Implementation Challenges for Companies
  • Building Block Approach
  • Varies by Country
  • Leads to different labels
  • Global IT (M)SDS systems need to be amended to
    handle this do not underestimate the problems
    that this will cause

24
Building Block Approach leads to Global
Disharmony
Health and Environment
Japan/Taiwan/
Human Health and Environmental follow criteria
and endpoints outlined by UN.
South Africa
China
Human Health Aspiration hazard not adopted
Korea/
Human Health Acute Oral Cat 5 not adopted. Eye
irritation - Cat. 2A only (MOL)
Cat 2 (2A2B) (MOE) so varies by Ministry
Singapore
Environment Acute Cat. 2 - No (MOL) Yes
(MOE)
EU
Human Health Cat. 5 Acute Toxicity, Cat 3 Skin
irritation, Cat 2b Eye Irritation,
Cat 2 Aspiration hazard are not adopted
Environmental Aquatic Acute 2 3 not adopted
Hazardous for Ozone layer (R59) maintained
MOL Ministry of Labour MOE Ministry of
Environment
SOLVAY
SOLVAY S.A. / CC-GPA G. Malinverno September
2009
23
25
Building Block Approach leads to Global
Disharmony
Health and Environment
New Zealand
Human Health CMR Categories 1A 1B and 2 are
now Cat 1 and Cat 2
Environmental 3 additional terrestrial endpoints
(Categories have unique numbering scheme and a
searchable database available for
classifications) Note NZ only accepts GLP data!
Australia
Human Health Cat. 5 Acute Toxicity not likely
to be adopted
Environmental Not in scope
United States
Human Health Will vary with Agency CPSC will
allow risk-based labeling
Environmental Unlikely to be required by OSHA
but allowed, may be adopted by
EPA
Canada
Human Health Cat 4 and 5 Acute Toxicity,
Aspiration Hazard and STOT under
discussion
Environmental Under discussion
SOLVAY
SOLVAY S.A. / CC-GPA G. Malinverno September
2009
24
26
GHS Implementation Challenges for Companies
  • GHS designed to permit self classification (UN
    GHS1.1.4.)
  • Differences in knowledge and expertise in
    applying GHS criteria
  • Different regional interpretation of the
    guidelines
  • Different rules on data acceptance
  • Difference between REACH and GHS data
    requirements for
  • phys-chem hazards. The REACH methods
    (references test methods from Directive EC
    440/2008) sometimes differ greatly from the test
    methods as required by GHS (which references the
    UN Manual of Tests and Criteria)

27
Classifications may vary by country (Example of a
Metal Powder)
Jurisdiction
Future Proposed GHS Classification
Pictograms
Notes
UN GHS Self-
Serious Eye Damage/Eye Irritation Category 2B
Classification based on
Classification
Hazardous to the Aquatic Environment
thorough review of
(Acute Chronic) Category 1
Eye Warning
available data
phrase only
EU GHS Self-
Serious Eye Damage/Eye Irritation Category 2
Not all endpoint
Classification
Hazardous to the Aquatic Environment
categories have been
(Acute Chronic) Category 1
adopted
New Zealand
Eye Irritation 6.4A, Aquatic Effects 9.1A
Terrestrial data needs to
be evaluated to make
classifications
Australia GHS
Serious Eye Damage/Eye Irritation Category 2B
Eye Warning
Environmental
phrase only
classification not
mandatory
Japan GHS
STOT Single Exposure Category 3
Japanese NITE
(Lung) STOT Repeated Exposure
Classification followed
Category 1 (Liver) Chronic Hazards to
UN approach, but used
the Environment (Category 4)
unreliable data.
SOLVAY
SOLVAY S.A. / CC-GPA G. Malinverno September
2009
26
28
GHS Implementation Challenges for Companies
  • Country Classification Lists
  • Not Mandatory (Japan (2010?), Korea, Taiwan etc)
  • Mandatory China
  • Data sources can be limited (RTECS MERC SAX
    online databases) or direct implementation of
    IARC classifications
  • Mandatory - EU CLP Annex VI Industry may have
    newer data and therefore classify differently
    outside of EU
  • updating Annex VI has to go via Member States
    making a REACH Annex XV dossier slow process!
  • EU CLP Inventory - Industry (agreed)
    Self-Classifications
  • Use of GHS to harmonise various regulatory lists
  • OECD to review in PIC substances

29
GHS Implementation Challenges for Companies
  • EU Inventory issues how to prepare
  • No detailed process
  • Needs to be simple (note recital 55 CLP requires
    the Agency to study the possibilities for further
    simplification of the notification procedure in
    particular taking into account the needs of
    SMEs), but need to allow several options
  • Maybe up to 5 million notifications
  • Propose to agree a limited exemption up to a 300
    kg threshold for RD substances
  • Propose to agree on a Small Volume Limit of 20 kg
  • No further burden on fees

30
What Should Industry Do?
  • Get information sources and understand CLP/Global
    GHS and its implications
  • for your business
  • Train staff
  • Note that change of classification in the EU can
    lead to a change of duties under REACH and impact
    other duties under Downstream Legislation under
    review keep track
  • Develop inventory of substances (and/or as
    mixtures) regardless of volumes, and territory
    that require assessment for classification.
  • Gather hazard data and assess substances
  • In EU those to be registered before 1 Dec 2010
    and those subject to notification by 1 Dec 2010
  • Most regions working to 2010 deadline
  • In the EU plan for working towards an agreement
    of classification both under REACH and outside of
    scope of REACH

31
Conclusion CLP Major points
  • Get prepared now !
  • CL Notifications apply to all hazardous
    substances
  • placed on the market under REACH
  • and outside of REACH scope
  • by end 2010 !
  • Implementing REACH and CLP/GHS at the same time
    is a complex operation with significant
    implications (overlap with GHS )
  • Change in EU classification
  • impact other REACH duties ?
  • impact other duties in Downstream legislations
    ?

32
Conclusion GHS
  • Reality
  • GHS implementation around the world including the
    EU may result in differing classifications for
    identical substances - this is contrary to the
    intent of the UN
  • Challenges
  • Acquiring the good quality data necessary to
    assign appropriate classification
  • Using the correct system within a jurisdiction to
    make the
  • classification
  • Maintaining consistent classifications within
    business units and across industry
  • Agreeing industry classifications' for
    notification in the EU (overlap with CLP)

33
Thanks for your attention!
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