ghs implementation training 6:- implementation & issues arising 1 william g. machin manager;...

1GHS Implementation Training 6:- Implementation & Issues Arising

William G. Machin

Manager; Classification and Hazard Communication

Cefic

European Chemical Industry Council

Brussels


GHS Implementation & Issues Arising


Module 6 – Contents

6.1 General Issues

6.2 Chemical Categories

6.3 REACH Interface

6.4 SME’s and Mixtures

6.5 International Inventories

6.6 CAS Numbers


6.1 Implementation General Issues


IssuesGHS is political compromise between existing systems Substances

Health and Environment Criteria

Lot of commonality with EU supply scheme

Less robust in some areas e.g. C & R

Some more severe criteria e.g. STOT

Physical Hazards Criteria

Existing UN Transport system Mixtures (Preparations)

Generally more severe than existing EU supply system Safety Data Sheets – basically same as existing EU system Downstream legislation – Seveso Directive, Waste


GHS & Substance Classifications

• GHS Aim; One Substance, One Global Classification

• GHS Intended to be a Self-Classification System

• No Global Inventory of Substance Classifications

• Therefore no Forum for agreeing Classifications

• GHS Annex VI/C&L Inventory could become a de facto Global Inventory


Workability of Implementing REACH/GHS

GHS Implementation restricted to equivalent to current EU system

Avoid duplication of work

• REACH Registration should begin with GHS classification

Phased Implementation of GHS is proposed

• Classify substances first – 3 years is being proposed

• Classify mixtures after – further 4½ years is being proposed

De minimis levels for REACH Title XI are required

Downstream legislation needs to be addressed in the interim

* Resource will be an issue if EC wants REACH and GHS together


6.2 Chemical Categories


Chemical Categories• The properties of a compound are likely to be

similar or follow a regular pattern as a result of structural similarity

• Exploit structure-activity relations

- for either structural alerts or non-alerts

- use information for waiving of studies


○●●○Activity 3

●○○●Activity 2

○●○●Activity 1

○●●○Property 3

●○○●Property 2

○●○●Property 1

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxStructure

Chemical 4Chemical 3Chemical 2Chemical 1

● Existing data point ○ Missing data point

SAR/Read-across

SAR/Read-across

Extrapolation

Interpolation

Extrapolation

Interpolation

Chemical Categories


Chemical Categories• Advantages

- identifying data gaps and structural alerts- filling data needs

> by read-across, trend analysis, (Q)SAR,…> interpolation or extrapolation to other chemicals, reducing

need to test for every endpoint for every chemical

- better consideration of the biological plausibility of grouping the chemicals within a category


Chemical Categories• Limitations

- Problems to identify/define category

> Endpoint-related subcategories may emerge

> You need sufficient evidence for a common mode of action

- Any hypothesis needs to be debated and needs to

be open to experimental validation


Chemical Categories• C&L

> Some members of the category meet the criteria for one hazard classification for the particular endpoint, whereas other members of the category meet the criteria for another.


6.3 REACH

Interface


European Commission view on the GHSExplanatory memorandum to the amendment to

Directive 67/548/EC, 29-10-2003; 2003/0257(COD): “it is the intention of the Commission to propose the

introduction of the internationally agreed GHS into Community law as soon as possible”

“the Commission will come forward with the necessary proposals for having it adopted at the same time as the final adoption of the REACH legislation”

European Commission will coordinate activities across servicesi.e. Supply and Transport

European Commission GHS web sitehttp://europa.eu.int/comm/enterprise/reach/ghs_en.htm


REACH and the GHS – Scope comparison

REACH GHS

R,E,A,Ch Classification, Labelling, SDS

Risk Hazard

Substances Produced Substances/Mixtures

Hazardous and Non-Hazardous Hazardous

> 1 Tonne per Manufacturer Any volumes

Harmonised Classifications Self Classification

CMRs at EU Level

Other Endpoints - Industry

European Union Global

Supply Supply and Transport


REACH Classification ProvisionsREACH Classification Related Objectives

Classification & Labelling Inventory Title XI, Articles 112-116

Harmonised Substance Classifications Title XI, Article 115

REACH Classification Related Provisions

Pre-Registration Title III, Article 28

Classification not required

Registration Title II, Article 10

Classification required

Classification & Labelling Inventory Title XI, Articles 114

Classification of Marketed Substances notified for Inventory


European Commission GHS Draft ProposalInterface with REACH

• SDS to remain in REACH

• Title XI of REACH will move to the GHS Regulation

• Harmonised Substance Classifications will go into Annex VI of GHS

• Transitional period for substances 3 years, but this expires 30/11/2010 (REACH Tier 1 Registration deadline)

• Transitional period for mixtures 4½ years starting 1/12/2010

• Estimated 30,000 Marketed substances subject to REACH to enter into the Inventory +

• Other substances to enter into the Inventory


Phase in Substance volume per

Manufacturer or Importer

Pre-Registration Date Registration Date

> 1000 Tonnes p.a. 1/06/2008 to 30/11/2008

1/06/2008 to 30/11/2010(includes > 1 Tonne p.a. R50/53 & CMR Cat. 1 or

2 substances)

> 100 Tonnes p.a. 1/06/2008 to 30/11/2008 1/06/2008 to 30/11/2013

> 1 Tonnes p.a. 1/06/2008 to 30/11/2008 1/06/2008 to 30/11/2018

EU implementation of the GHS - TimingREACH Timing Provisions

REACH Entry Into Force Date is 1/06/2007


6.4 Implementation Mixtures & SMEs


Enterprise Size Companies Employees

TypeNumber ofEmployees

Number ofCompanies

% of TotalNumber ofEmployees

% of Total

Large > 250 1039 3.8 864,400 63.0

Medium 50 - 249 2844 10.4 312,900 22.8

Small 10 – 49 6316 23.1 143,300 10.4

Micro 1 - 9 17088 62.6 52,100 3.8

Mixtures IssuesEU Chemical Industry Structure (2004)

NOTE: - 1 The above figures exclude Pharmaceuticals2 Only 6317 SMEs (24%) produce substances

96% of Enterprises are SMEs

> 75% of SMEs are formulators only

> 55% of SMEs are not members of a Trade Association


Impact on Mixtures of GHS Implementation Mixtures are not just Mixtures of Substances Most mixtures contain Intermediate Mixtures Mixtures can contain multiple layers of Intermediate Mixtures Substances may be common to Final Mixture &

Intermediates

Example; Paint(i) Paint can contain Colour Dispersion, Resin, Solvent (Driers)

(ii) Colour Dispersion can contain Resin, Solvent(iii) Resin can contain Solvent, Driers

(iv) Driers can contain Solvent and Substances In many cases substances in intermediates are speciality chemicals Speciality chemicals may not be manufactured on a regular basis It could take a long time for a change in classification of a substance

at the lowest level to feed through to the final mixture


SUBSTANCE composition of Paint

manufacturer (a)

manufacturer (g)

Importer (b)Some substances are considered to be below cut-off concentration due to dilution in the

manufacturing process

Colour dispersionResinSubstances B P K L N M O Y

ResinDrierSubstances A C M X

DrierSubstance A F S P

Substance A (Solvent)Manufacturer(a) > 1000 t/aImporter (b) > 1 t/aImporter (c) > 0.1 t/a

Substance P (Co Comp.)

Manufacturer(a) > 100 t/aManufacturer(g) > 1 t/aImporter (k) > 0.1 t/a

PaintColour DispersionResinSubstances A B C D

ResinSubstances P Q U X Z

A, C, D, P, N, O, S,

Importer (c)

Importer (k)


Impact on MixturesImportance of knowing Substance Chemical Identities

Using the previous Paint Example

Drier contains 0.1% of a substance classified as a CMR Cat.2 (EU)

Therefore Drier classified as a CMR Cat.2

Resin contains > 0.1% Drier (> 0.0001 CMR Substance)

Therefore Resin classified as a CMR Cat.2

Colour Disp. contains > 0.1% Resin (> 0.0000001 CMR Substance)

Therefore Colour Dispersion classified as a CMR Cat.2

Paint contains > 0.1% Colour Disp. (> 0.0000000001 CMR Sub.)

Therefore Paint classified as a CMR Cat.2


Mixtures ClassificationGHS 1.3.2.3 Hierarchy of data for mixtures classification

(a) Where test data are available for the complete mixture, the classification of the mixture will always be based on that data;

(b) Where test data are not available for the mixture itself, then bridging principles included and explained in each specific chapter should be considered to see whether they permit classification of the mixture;

In addition, for the health and environmental classes,

(c) If

(i) test data are not available for the mixture itself, and

(ii) the available information is not sufficient to allow application of

the above mentioned bridging principles,

then the agreed method(s) described in each chapter for estimating the hazards based on the information known will be applied to classify the mixture.


6.5 International Inventories


Inventories and EU GHS ImplementationInventoriesEU REACH/GHS proposals will establish an InventoryUN RTDG Chapter 3.2 is an Inventory of Substance classificationsJapan has Inventory of 1423 GHS Substance classificationsNew Zealand has Inventory of 5655 GHS Substance classifications

Transport Regulatory StructureUnited NationsUN Recommendations on the Transport of Dangerous Goods

International Conventions (Global & between EU Countries)

Sea Transport IMDG Code (Binding Convention)Air Transport ICAO T.I.Rail Transport RID (not global but wider

than EU)Road Transport ADR (not global but wider

than EU)


HazardTDG Classified

Not EU ClassifiedEU Classified

Not TDG ClassifiedAcute Tox. 136 70Corrosivity 28 58Explosive 11 22Oxidising 13 2

Flammable 85 20

Inventories and EU GHS ImplementationClassification and Labelling Comparison

Supply v Transport

994 Substances Common to TDG & EU Inventories

340 Substances have differing classifications


Inventories and EU GHS ImplementationClassification and Labelling Comparison - EU Supply v Transport

Supply Transport

4,4’-Diaminodiphenylmethane (MDA)UN2651, Division 6.1 Packing Group II

612-051-00-1; R45, R68, R39/23/24/25, R43, R48/20/21/22, R51/53

PhenolUN1671 (Solid), UN2312 (Molten), Division 6.1 Packing Group II

604-001-00-2; R68, R23/24/25, R34, R48/20/21/22

Supply Transport


GHS & Substance Classifications

CMR Substances

GHS v EU Categories Comparison

EU Category 1 = GHS Category 1A

EU Category 2 = GHS Category 1B

EU Category 3 = GHS Category 2


GHS & Substance ClassificationsExample GHS Classification; Phenol

Endpoint EU Classif. Japan Classif. N.Z. Classif. TDG Classif.

Carcinogen (No) (No) (No) Not ApplicableMutagenicity Cat.2 Cat.1B Cat.1B Not ApplicableReprotox. (No) Cat.1B Cat.2 Not Applicable

Corrosive Cat.1 Cat.1 Cat.1 (No)ToxicityAcute Oral Cat.3 Cat.3 or 4 ? Cat.2 ? Cat.2 (Route?)Acute Dermal Cat.3 Cat.3 or 4 ? Cat.2 ? Cat.2 (Route?)Acute Inhal. Cat.3 Cat.3 or 4 ? Cat.2 ? (No)Target Organ Cat.2 Cat.2 ? Cat.1 Not ApplicableEnvironmentWater (No) ?? Cat.3 ??Soil Not Applicable ?? Cat.4 Not ApplicableInvertebrates Not Applicable ?? Cat.2 Not Applicable


Concentration LimitsHydrogen Peroxide

EU Directive 67/548/EEC Annex I

Index Number 008-003-00-9

Classification R5, R8, R20/22, R35

Concentration Limits C > 70% R20/22, R3550% < C < 70% R20/22, R34

UN RTDG Chapter 3.2

UN2015 C > 60% Class 5.1, Class 8, PGI

UN2014 20% < C < 60% Class 5.1, Class 8, PGII


6.6 Implementation CAS Numbers


Inventories and EU GHS Implementation

CAS Number IssuesThe use of CAS Numbers in 2 Inventories/Databases EU Dangerous substances Directive (DSD) Annex I A North American web-site database

PHOSPHORUSRed Phosphorus in North American web-site CAS 29879-37-6Red Phosphorus in EU 67/548/EEC Annex I CAS 7723-14-0White Phosphorus in North American web-site CAS 7723-14-0White Phosphorus in EU 67/548/EEC Annex I CAS 12185-10-3

TDI (Toluene diisocyanate)2,6-TDI in the North American website CAS 91-08-72,6-TDI in EU 67/548/EEC Annex I CAS 584-84-92,4-TDI in the North American website CAS 584-84-92,4-TDI in EU 67/548/EEC Annex I CAS 91-08-7


Challenges Awareness creation SMEs – how to reach them and train them Preparing in companies for the changes the GHS will bring Implementing REACH and GHS at the same time is a complex

operation with significant implications Resource will be a limiting factor for implementing REACH and

GHS at the same time Training for all involved in using or applying the GHS GHS Guidance – RIP 3.6 Timing between jurisdictions is an issue – Catch 22 situationOther IssuesPackaging - Transport has a packaging testing and certification regime - National/Regional supply legislation packaging provisionsTiming of the introduction and updating of the GHSDownstream Legislation

ghs implementation training 6:- implementation & issues arising 1 william g. machin manager;...

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