how to fulfill global regulatory drivers & requirements: a...

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reproduced without permission of 3E Company.

How to Fulfill Global Regulatory Drivers & Requirements:

A focus on REACH and GHS

Karen Lanka, Sr. Director, Regulatory Development & Client Services

Catherine Bland, Technical Sales Support Manager

Frankfurt - April 11, 2016



Agenda

• GHS update

• Variations between countries’ GHS implementations

• CLP and its impact on other EU legislation

• REACH eSDS for Mixtures

• Developments in methods, templates and phrases



UN GHS 5th Revision Highlights

• Published June, 2013 • Substantial part of 4th Revision was amended

– 126 pages (around 26%) of actual text is affected

• New test methods • Classification requirements are the same as the 4th Revision

– Clarification of the criteria for some hazard classes • Skin corrosion/irritation, severe eye damage/irritation, and aerosols

• Revised and simplified classification and labeling summary tables • A new codification system for hazard pictograms • New combustible dust hazard

– Categorized as “Other hazards which do not results in classification” instead of a hazard with a category

– No H code – May form explosible dust-air mixture if dispersed

• SDS changes – Section 11 and 12

• Statements similar to REACH Annex II when available data does not meet criteria

– Section 12 • Provide complete and comprehensible description for ecotox properties along with available data

https://en.wikipedia.org/wiki/File:Flag_of_the_United_Nations.svg




• Introduces many changes to Precautionary statements – Revised and further rationalized Precautionary statements

• 43 new statements • 25 changes to wording of existing statements • 8 deletions

– P Statement variation examples • P210

– 3rd Rev: Keep away from heat/sparks/open flames/hot surfaces – No smoking. – 4th Rev: Keep away from heat/sparks/open flames/hot surfaces. No smoking. – 5th Rev: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources.

No smoking.

• P282 – 3rd and 4th Rev: Wear cold insulating gloves/face shield/eye protection. – 5th Rev: Wear cold insulating gloves and either face shield or eye protection.

• P243 – 3rd and 4th Rev: Take precautionary measures against static discharge. – 5th Rev: Take action to prevent static discharges.




• New Chapter 2.17 “Desensitized explosives”

– Categories 1-4

– Definition • Solid or liquid explosive substances or mixtures which are

phlegmatized to suppress their explosive properties in such a manner that they do not mass explode and do not burn too rapidly and therefore may be exempted from the hazard class “Explosives”

– Classification criteria

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• Label elements – Signal word

• Danger – Categories 1, 2 • Warning – Categories 3, 4

– Symbol • Flame for all categories

– New hazard statements • Category 1 – H206 “Fire, blast or projection hazard; increased risk of

explosion if desensitizing agent is reduced” • Category 2,3 – H207 “Fire or projection hazard; increased risk of explosion

if desensitizing agent is reduced” • Category 4 – H208 “Fire hazard ; increased risk of explosion if

desensitizing agent is reduced”

– New precautionary statement • All categories – P212 “Avoid heating under confinement or reduction of

the desensitizing agent”

– Other existing P statements apply as well




• “Flammable Gases (Including Chemically Unstable Gases)” – This hazard has again been renamed as Flammable Gases – New Pyrophoric gas sub-category has been added

– Label elements • Signal word - Danger • Symbol – Flame • New hazard statement: H232 “May ignite spontaneously if exposed to air.” • Precautionary statements – No new statements

• STOT Single Exposure Category 3 and Aspiration Hazard – Clarifies mixture cut-off values/concentrations and relevant ingredients

• New example in Annex VII addressing labeling of small packages




• SDS Section 9 Layout – Changes to Physical & Chemical property names & order

– Allows government authorities to determine the order

– Includes guidance on the purpose of each property

• D

– Defines properties that are relevant for each hazard

• D

• d



UN GHS Versions Adopted Regulatory Body

Version of UN Adopted / Implementation Deadline

Original Update

Argentina 5th Rev 7-Oct-2015 None

Australia 3rd Rev 1-Jan-2017 None

Brazil 2nd Rev Substances: 26-Feb-2011, Mixtures: 1-Jun-2015 4th Rev Substances: 10-Dec-2012, Mixtures: 1-June-2015

Canada 3rd/5th Rev 1-Jun-2016 None

Chile 5th Rev 27-Aug-2016 None

China 2nd Rev 1-Feb-2009 4th Rev 1-Nov-2014

European Union 2nd Rev Substances: 1-Dec-2010, Mixtures: 1-Jun-2015 4th Rev Substances: 1-Dec-2014, Mixtures: 1-Jun-2015

Hong Kong Not specified No official adoption; accepts GHS

India Not specified No official adoption; accepts GHS

Indonesia 2nd Rev 15-Nov-2009 4th Rev Substances: 12-July-2013, Mixtures: 31-Dec-2016

Japan 2nd Rev Dec-2006 4th Rev 1-Jan-2017

Kazakhstan Not specified 24-Oct-2007 None

Korea 2nd /3rd Rev Substances: 1-Jul-2010, Mixtures: 1-Jul-2013 None

Malaysia 3rd Rev 17-Apr-2015 None

Mexico 3rd Rev 4-Jun-2011 None

New Zealand 2nd Rev 1-Jul-2006 None

Philippines 4th Rev Mid-Mar-2015 None

Russia 2nd Rev 1-Jan-2009 4th Rev 1-Aug-2014

Serbia 3rd Rev Substances: 1-Oct-2012, Mixtures: 1-Jun-2015 None

Singapore 2nd Rev Substances: Feb-2012, Mixtures: mid 2015 4th Rev Substances: 4-Feb-2014, Mixtures: Mid-2015

South Africa 3rd Rev Substances: 2012, Mixtures: 2016 None

Switzerland 3rd Rev Substances: 1-Dec-2012, Mixtures: 1-Jun-2015 None

Taiwan 3rd Rev 31-Dec-2008 4th Rev 24-Jan-2015

Thailand 3rd Rev Substances: 2013, Mixtures: 2017 None

Turkey 3rd Rev Substances: 1-Jun-2015, Mixtures: 1-Jun-2016 None

United States 3rd Rev 1-Jun-2015 None

Ukraine Not specified 1-Jan-2010 None

Uruguay 4th Rev Substances: 31-Dec-2012, Mixtures: 31-Dec-2017 None

Uzbekistan Not specified 11-Nov-2008 None

Vietnam 3rd Rev Substances: 30-Mar-2014, Mixtures: 30-Mar-2016 None



GHS Status per Country

Source: 3E Ariel WebInsight



EU/Serbia/Turkey GHS

Flammable Liquids

Flammable Gases (Including Unstable)

(Flammable) Aerosols

Acute toxicity

Skin corrosion/irritation

Serious eye damage/irritation

Aspiration hazard

Aquatic Acute

Aquatic Long-term

Ozone Hazard

Cat 1A

Cat 1

Cat 1

Cat 1

Cat 1B

Cat 2

Cat 2

Cat 1C

Cat 3

Cat 2

Cat 3

Cat 4

Cat 4

Not adopted by EU/RS/TR

Cat 1

Cat 1

Not adopted by RS/TR

Cat 2 Cat 3 Cat 4

Cat 5

Cat 3

Cat 2

Cat 2 Cat 3

Cat 1 Cat 2 Cat A Cat B

Cat 1 Cat 2 Cat 3

Cat 1 Cat 2 Cat 2A

Cat 2B

Cat 1



EU/Serbia/Turkey GHS

EU Serbia

Turkey

Substance Effective Date 1 Dec 2010 1 Oct 2012 1 Jun 2015

Mixture Effective Date 1 Jun 2015 1 Jun 2015 1 Jun 2016

Classification Basis 4th ATP/4th UN 2nd ATP/3rd UN 2nd ATP/3rd UN

R Phrase Translation table Y Y Y

H Statement Deviations Y Y Y

Supplemental Hazard Statements Y Y Y

P Statement Deviations Y N Y

Substance GHS Classification list 7th ATP 2nd ATP 4th ATP

Classification Abbreviations, SCLs, M Factors and Notes Y Y Y

P Statement Reduction Allowance Y Y Y

Symbol Size Requirement Y Y Y

Optional corrosive to metals symbol to consumer Y N N

Requires Nationally Certified Preparer N N Y

Hybrid SDS Template for Mixtures N N Y

Component Classification in Section 3 Y Y Y

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://www.flagmakers.co.uk/buy-flags/serbia/&ei=kWeIVazfJ9baoATQ_ZVI&psig=AFQjCNHMIKCDyYgY9touuV0GO9LJFTHEgQ&ust=1435089141986825

https://en.wikipedia.org/wiki/File:Flag_of_Turkey.svg



US/Canada GHS Comparison

Acute toxicity

Skin corrosion/irritation

Aspiration hazard

Aquatic Acute

Aquatic Long-term

Ozone Hazard

Cat 1A

Cat 1

Cat 1A

Cat 1B

Cat 2

Cat 1C

Cat 3

Cat 2

Cat 4

Cat 3

Cat 5

Cat 2

Not adopted by US or CA but required for substances in a formulation

Not adopted by US or CA

Cat 1

Cat 1

Cat 1

Not adopted but allowed by US & CA

Cat 2 Cat 3

Cat 2 Cat 3 Cat 4



US/Canada GHS

US Canada

Effective Date 1 Jun 2015 1 Jun 2017

Classification Basis 3rd UN 3rd UN

H & P Statement Basis 3rd UN 5th UN

H Statement Deviations Y Y

P Statement Deviations Y N

Substance GHS Classification list N Y

Pyrophoric Gases Y Y

Simple Asphyxiants Y Y

Combustible Dusts Y Y

Biohazardous Infectious Materials N Y

Upon contact with water, releases a gas that is acutely toxic Y Y

Products that undergo vigorous polymerization N Y

Hazards Not Otherwise Classified (HNOCs) Y Y

Dual Languages Required N Y

Carcinogenicity Category 2 Label Cutoff % 1% 0.1%

https://en.wikipedia.org/wiki/File:Flag_of_the_United_States.svg



Authority Classification Lists

Listing Approx. # Substances

Status

Canada HPR Schedule 4 40 Mandatory for Canada

China SAWS 3300 Mandatory for China

EU CLP Annex VI 4500 Mandatory for EU

Korea MOE 900 Mandatory for Korea

New Zealand HSNO CCID 4900 Mandatory for New Zealand

Malaysia ICOP 230 Mandatory for Malaysia

Australia HSIS 4500 Advisory

Canada Quebec WHMIS CSST/SRT 1000 Advisory

Korea KOSHA 6500 Advisory

Japan NITE 2900 Advisory

South Africa SANS 670 Advisory

Taiwan CLS 3300 Advisory



Substance Classification Challenges

• Conflicting information from different suppliers

• Availability/Reliability of data

• In-house expertise, particularly with regard to criteria

• Interpretation of data

• Very time consuming

• Automated classification platforms can only do so much



CLP Annex VI – ‘harmonised’ classifications • Only the hazard classes mentioned in Annex VI are

harmonised; these are often properties of the highest concern (i.e. CMR & Respiratory sensitisation) or other properties if there is need for EU-level action.

• Minimum classifications are sometimes given for certain hazard classes, including acute toxicity and STOT RE, because classifications were derived from criteria in Directive 67/548/EEC and translation to CLP did not correspond directly.

– Manufacturer/importer/DU has obligation to consider all data available and apply more stringent classification if applicable.

• Hazard classes not included in Annex VI entry must be self-classified and labelled accordingly.



CLP: C&L Inventory notification

• Scope = Article 39, CLP

– All substances subject to registration under REACH

– Substances which are classified as hazardous according to CLP (without deminimus)

– Substances in a mixture which results in the classification of the mixture as hazardous

• Obligation = Article 40, CLP

– Any manufacturer/importer who places a substance (either on their own or in a mixture) on the market shall notify ECHA the hazard C&L of the substance(s)

– Updates by notifier(s) => • Whenever new scientific or technical information is generated which

results in a change to the C&L of the substance



Substance harmonisation of C&L

1

• Competent Authority may submit proposal to ECHA (for new substance or revision of an existing harmonised classification)

• or; Manufacturer/Importer/DU may submit a proposal to ECHA (provided substance not already covered by CLP Annex VI) + fee

2 • Public consultation (45 days) on the proposal for harmonised

classification and labelling (CLH).

3

• ECHA Committee for Risk Assessment (RAC) will adopt an opinion on any proposal submitted within 18 months and forward this opinion to the EU Commission.

4

• EU Commission decides if harmonisation of the substance C&L is appropriate at EU level; if so, the substance will be added to Annex VI of CLP (subject to scrutiny) without undue delay via ATP

4 –

5 y

ears



No single SDS or label can be used globally!

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://www.evangelistrjbrown.com/id17.html&ei=olfFVOmzH8uIsQTxk4Fg&psig=AFQjCNHAhLuv5a0XQ0f03EJBZRQhDwAwQQ&ust=1422304862594726



Export of Hazardous Chemicals from EU

• Does the ‘ship to’ country have its own chemical hazard classification and labelling system in place? – Yes – use it. Need to consider that chemicals that are non-

hazardous under CLP may not be considered non-hazardous under criteria of system in target country

– No – business decision on which classification system to use: CLP or UN Purple Book

• EU CLP = easiest option, but risk of not covering all hazards relevant to target users. Also decide on which workplace exposure controls to promote in Section 8 of the SDS.

• UN GHS = widely recognised scheme, but adds cost/effort to SDS/label generation and application

• PIC Regulation No 649/2012 Article 17 – implements the Rotterdam Convention

– Substances & Mixtures that have labelling obligations under Regulation No. 1272/2008 and are intended for export shall be subject to these provisions unless they would conflict with any specific requirements of the importing country

– Information on the label and SDS shall be given in the official language(s) of the destination country or area of intended use, as far as practicable

– Exempt: R&D samples if less than 10kg to each importing country per calendar year



Product Life Cycle • All participants impacted

– Each stage needs to effectively communicate GHS information downstream

– Users = Industrial, Professional, Consumer



Relation of CLP to other EU legislation

• REACH = No. 1907/2006 – Updates in CLP impact upon registration dossiers, exposure assessments

and risk characterisation within CSA, and obligations to provide SDS. Also classification as CMR category 1A or 1B, or as a PBT or vPvB could cause the substance to be added to the SVNC list

• Plant Protection Products & Biocides = No. 1107/2009 (PPPR) & No. 528/2012 (BPR) – Under the new Regulations certain classifications (e.g. CMR Cat 1A or 1B)

may preclude approval as an active substance

• Transport – Information available for transport classifications via UN Model Regulations

and related Modal regulations, especially for physical hazards, can aid CLP classification for named substances/mixtures



Downstream legislation to CLP

• Seveso = Directive 96/82/EC Directive 2012/18/EU

• Workplace exposure Directives – Chemical Agents at work = 98/24/EC

– Carcinogens & Mutagens at work = 2004/37/EC

– Young People at work = 94/33/EC

– Pregnant & Breastfeeding women at work = 92/85/EEC

– Health & safety signs at work = 92/58/EEC

• Cosmetic products = Directive 76/768/EEC Regulation No. 1223/2009

• Toy Safety Directives 88/378/EEC & 93/68/EEC Directive 2009/48/EC

• Detergents Regulation No. 648/2004 ……

• Export & Import of dangerous chemicals (PIC) = Regulation No. 689/2008 Regulation No. 649/2012

• Hazardous Waste = Directive 2008/98/EC Regulation No. 1357/2014

Directive 2014/27/EU



Seveso (III) Directive updated

=> control of major-accident hazards involving dangerous substances

• This Directive “lays down rules for the prevention of major accidents which might result from certain industrial activities and the limitation of their consequences for human health and the environment.“

– Directive 96/82/EC has been repelled and replaced by Directive 2012/18/EU, effective date June 1, 2015

– Key changes include: • Annex I list of substances updated and aligned with CLP hazard

classes and categories

• Transition arrangements for MAPPs and Safety Reports – June 1, 2016 for existing upper-tier establishments

– June 1, 2017 for ‘other’ establishments

• Stronger requirements for publicly available information, even for lower-tier establishments, and stronger requirements for authority inspections



Seveso III • Categories of dangerous substances

– Health hazards (Acute toxicity, STOT SE)

– Physical hazards (all CLP except Corrosion to Metals, Flammable Solids, Chemicals under pressure, Chemically Unstable Gases)

– Environmental hazards (Acute & Chronic toxicity)

– Other hazards (EUH014, Contact with water emits flammable gases, EUH029)

• Evaluation as a lower-tier or upper-tier establishments – q 1 /Q U1 + q 2 /Q U2 + q 3 /Q U3 + q 4 /Q U4 + q 5 /Q U5 + … is greater

than or equal to 1

– For mixtures, use the maximum concentration of the substance

• New CLP hazard classes may impact Seveso Directive, and hence tier assignments, in the future



• Waste is defined in Directive 2006/12/EC and is not a substance, mixture or article within the meaning of CLP

• Directive 2008/98/EC – ‘Hazardous waste’ means waste displaying one of more properties listed in

Annex III

• However: – Regulation No 1357/2014 replaced Directive 2008/98/EC Annex III on June

1st 2015 to align waste definitions with CLP. Renamed hazardous properties to HP 1 - HP 15 to avoid confusion with CLP H statements.

• E.g. H 5 (‘harmful’) renamed to HP 5 ‘STOT / Aspiration toxicity’

– Mixing of hazardous waste with other waste is not allowed

– Waste producers must retain information on their waste and make it available to authorities

– Treatment and disposal of hazardous waste requires a permit.

Hazardous Waste Disposal



PCC Reporting Requirements

• Poison Control Centres (PCC)

– CLP Article 45: “mixtures placed on the market and classified as hazardous on the basis of their health or physical effects”

– requirements outlined in draft Annex VIII to CLP (December 2015), pending adaptation

Mixtures for:

Consumer use July 2019

Professional use July 2020

Industrial use July 2023

If info on hazardous mixtures already

submitted before deadline date

no need to comply with this regulation

until January 2025

Unless changes to the mixture arise, in

which case must comply with this Annex

before placing the changed mixture on the

market



PCC Reporting Requirements

PC

C n

oti

fica

tio

n

Before placing mixture on the market – must notify each MS individually & in official language (i.e. no central database)

Via XML format, provided by ECHA

Intended use of mixture to be declared via harmonised product categorisation system

Group submissions possible if all mixtures have identical health & physical hazards and very similar compositions

UFI = Unique Formula Identifier

To be on label and SDS

Consumer/professional use: Declare types and sizes of packaging

Full composition disclosure, even non-hazardous components – complex logic



The Role of Effective HazCom

Hazard = the degree of a chemicals capacity to harm depending upon its intrinsic properties

Risk = the likelihood of harm occurring if/when exposure to a chemical takes place

Hazard x Exposure = Risk

Successful hazard communication alerts the user to the presence of a hazard and the need to minimise exposure, which in turns reduces the risk of harm being caused



REACH: Important Deadlines



REACH: Deadlines & Enforcement

• Announcement at the Enforcement Forum

– Authorities will start focusing on eSDS review and existing dossiers

– During audit, authorities will be checking

• Availability of the eSDS to DU

• Its compliance with the regulations, especially its completeness and consistency (including language requirements)

• Accountability

– ECHA is taking actions to discourage free-riders

– Will send back dossiers if they believe the data has been unofficially used



What is an eSDS?

• Aims =>

– REACH = safe use communication in the Supply Chain

– SDS = hazard based (upon CLP) to cover all end users

– eSDS = SDS + nES; risk based and specific ES per registered use; intention is to provide user with detailed information for safe use

• Risk Management Measures (RMM)

• Operating Conditions (OC) • Exposure Scenario (ES) = the set of conditions , including the OCs and RMMs,

that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposure to humans and the environment. The ES may cover one specific process or use or several processes or uses.



eSDS for Substances

• eSDS should already be in place if Substance is:

– Registered under REACH

– Above 10 tonnes per year

– Defined as hazardous under CLP criteria

• A Substance eSDS from the M/I could contain multiple ES

– One ES per registered use • Each registered use has Contributing Scenarios (i.e. tasks/activities

outlining how the environment, worker or consumer may become exposed) and RMMs (i.e. boundaries for use to mitigate exposure)

– Must provide within 6 months of substance registration to DU

• A DU would select the ES(s) for the uses relevant to their customers when preparing an eSDS to pass down the supply chain



Mixture DU Communication

• DU communication of ES is required for mixtures meeting the following criteria

– Classified in accordance with CLP

– Containing one or more registered substances for which an eSDS has been received by formulator

• Must incorporate within 12 months of receipt and provide to DU

• Methods for Determining Mixture Safe Use Information 1. Exposure Scenario approach – “Top down”

• Uses ES’s for each component

• Consolidates information from all the ES’s

• Frequently done by identification of the ‘Lead Component(s)’ (LCID)

2. Existing controls approach – “Bottom up”

• Uses existing information on operating conditions and risk management measures that currently allow safe use of mixtures

• Sector groups have developed generic exposure scenarios based on intended uses

• Existing controls are checked against those recommended in component ES’s



Communicating safe use information

Attach ES as Annex to SDS

Most suitable approach when

communicating to formulators

Attach all relevant Substance ES to the

Mixture, without consolidation

Potentially very long Annex – many

pages

Within main body of SDS

Suitable for end user communication only

Summarise RMMs and OCs from Substance

ES and include details into body of SDS

e.g. DNEL / PNEC for substances, uses

covered, etc.

OC & RMM originating from ES must be clearly identified

Attach info as Annex to SDS

Used when wide range of uses &

different conditions of use

Safe use information identified as

originating from ES and consolidation of

RMMs

Format = SUMI or industry-sector

specific

Common problems: • Not all Substances have eSDS yet • Manual work – difficult to automate

Pre

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ed b

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Pre

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nd u

ser




• Downstream Users of Chemical Co-ordination group (DUCC) – Represents companies that use chemicals to formulate mixtures as finished

products for end users – Developed a communication format in the context of the following actions of the CSR/ES Roadmap

• Action 4.4: Further develop the methodology to link the substance-related safety advice in the exposure scenarios with the communication on safe use of (substances in) mixtures.

• Action 5.1: Analyse the information needs of the different end-user groups and improve the presentation of information on safe use of mixtures in the safety data sheet (either in exposure scenarios or in the main body of the document).

• “Bottom-up” versus “Top-down” Methodology – Original “top-down” approach

• Starting point is the information from the substances that constitute the mixture • Less practical for mixtures for end-users

– Members developing the “bottom-up” approach • Starting point the information on the uses of the mixtures • Two main elements – One SUMI for each SWED

– SUMIs – Safe Use of Mixtures Information – SWEDs – Sector-specific Workers Exposure Descriptions, which are the basis of the SUMIs content




• SUMI – Intended to include simplified and tailored Information on the Safe

Use of Mixtures – Appended to or incorporated in a Safety Data Sheet – Simple 1-2 page format for end users – Because they are use-oriented, they can be used for multiple

products – Multiple SUMIs can be pertinent to one product

• Some SWEDs will be developed for the whole use and other SWEDs will be developed for a single activity

• Same product can be used in different ways

• DUCC proposed formats – DU Sectors: Safe Use of Mixtures Information (SUMIs), May 2015 – Finalized December 2015 – Formally announced January 2016



DUCC SUMI Formats



Sample eSDS with ES and SUMI



ES Phrase Library

• ESCom Standard Phrase Catalogue

– Version 2.1 made available for download January 2016

– ECHA Guidance version 3.0 – Chapter R.12 on Use Description published December 2015

• Currently only one vendor option for multi-lingual translation package

– Known throughout the industry

that issues with quality exist



Reminder

REACH is not over in 2018!

All actors need to continue learning from the experiences

and leading to improve processes and efficiency.



3E Solutions

• Substance/Base Chemical Library – Compiled by experienced 3E Regulatory Experts and

Toxicologists • Extensive experience with Global GHS Classifications

– Methodology • Analysis of available data

• Consideration of existing independent reviews

• Avoids potential infringement of copyright data

– Provides not only classification but also supporting documentation for each material

– Electronic data set for upload to client authoring platforms

• Consultancy – How to interpret CSR and ES



3E Solutions

• Authoring Services – eSDS

• Substances • Mixtures

– Including identification of relevant ingredients of the mixture – Extraction of the required information from the applicable ESs – Choice of the most appropriate approach (industry sector specific, if such

exists, or otherwise universal/general approach)

– SUMI • Information provided on safe use of mixture is concise, readable, and

understandable

– Authoring platform options • Outsourced Authoring, i.e. our authors create a complete eSDS in all

requested languages in our authoring platform • Co-sourced Authoring, i.e. our authors create a complete eSDS in

English in customer’s authoring platform



3E Solutions

• ESCom Standard Phrase Catalogue – High quality alternative

– Provided by certified translators; not auto generated

– Based on Version 2.1 Phrase Catalogue

– Electronic upload to Authoring Platforms

• MSDgen Authoring Software – SDS, eSDS, ES, SUMI Document Templates

• Complies with the requirement that ES must be an integrated part of the SDS and have continuous paging

• Ease of authoring – Author once, associate to many – Option to import of GES from 3E Authoring system for direct

association to client’s materials

– Multi-lingual libraries for SDS, ES

how to fulfill global regulatory drivers & requirements: a...

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