How to Fulfill Global Regulatory Drivers ... - Verisk...

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How to Fulfill Global Regulatory Drivers & Requirements:

A focus on REACH and GHS

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

Heather Collins, Manager, Authoring Production & Customer Care

Pittsburgh – November 1, 2016


Agenda

• UN GHS update • Variations between North America countries’

GHS implementations • CLP and its impact on other EU legislation • REACH eSDS for Substances and Mixtures

• Developments in methods, templates and phrases


GHS Update

3


UN GHS 4th Revision Highlights

• Published 2011 • Renamed Flammable gases (Including Chemically unstable gases)

– Categories A and B – New hazard statements

• Renamed Flammable Aerosols – Added Category 3 for non-flammable – New hazard statement

• Gases under pressure – No longer applicable to aerosols

• Rewording of Precautionary statements throughout the guidance

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


UN GHS 5th Revision Highlights • Published 2013 • Substantial part of 4th Revision was amended

– 126 pages (around 26%) of actual text is affected • New test methods referenced • 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

• Guidance on combustible dust hazard – Recognized as “Other hazards which do not results in classification”

not a hazard with a class as in US / Canada – Recommended statement “May form explosible dust-air mixture if

dispersed” – No H code



UN GHS 5th Revision Highlights • 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.



• Published 2015 • 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”



UN GHS 6th Revision Highlights • 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


UN GHS 6th Revision Highlights • “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 – Includes guidance on the purpose of each property

• D

– Defines properties that are relevant for each hazard • D • d


UN GHS Versions Adopted (1/2)

Regulatory Body

UN Revision Adopted / Implementation Deadline

Original 1st Update 2nd Update

Argentina 5th Sub: 15-Apr-2016, Mix: 1-Jan-2017

Australia 3rd 1-Jan-2017

Brazil 2nd Sub: 26-Feb-2011, Mix: 1-Jun-2015 4th Sub: 10-Dec-2012, Mix: 1-June-

2015 5th Draft / TBD

Canada 3rd/5th 1-Jun-2017

Chile 5th 27-Aug-2016

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

European Union 2nd Sub: 1-Dec-2010, Mix: 1-Jun-2015 4th Sub: 1-Dec-2014, Mix: 1-Jun-2015 5th 1-Feb-2018

Hong Kong No official adoption; accepts GHS

India No official adoption; accepts GHS

Indonesia 2nd 15-Nov-2009 4th Sub: 12-July-2013, Mix: 1-Jan-2017

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

Korea 2nd /3rd Sub: 1-Jul-2010, Mix: 1-Jul-2013 3rd/4th 6-April-2016

Malaysia 3rd 17-Apr-2015

Mexico 3rd 4-Jun-2011 (voluntary) 5th 1-Oct-2018


UN GHS Versions Adopted (2/2)

Regulatory Body

UN Revision Adopted / Implementation Deadline

Original 1st Update 2nd Update New Zealand 2nd 1-Jul-2006 5th Draft / Estimated Mid-2017

Philippines 4th Mid-Mar-2015

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

Serbia 3rd Sub: 1-Oct-2012, Mix: 1-Jun-2015

Singapore 2nd Sub: Feb-2012, Mix: mid 2015 4th Sub: 4-Feb-2014, Mix: Mid-2015

South Africa 3rd Sub: 2012, Mix: 2016

Switzerland 3rd Sub: 1-Dec-2012, Mix: 1-Jun-2015

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

Thailand 3rd Sub: 2013, Mix: 13-Mar-2017

Turkey 3rd Sub: 1-Jun-2015, Mix: 1-Jun-2016

United States 3rd 1-Jun-2015

Uruguay 4th Sub: 31-Dec-2012, Mix: 1-Jan-2018

Vietnam 3rd Sub: 30-Mar-2014, Mix: 30-Mar-2016


GHS Status per Country

Source: 3E Ariel WebInsight


A Comparative Analysis of GHS in US, Canada & Mexico

https://www.youtube.com/watch?v=vIJAP_Sav50


US/Canada/Mexico GHS

Desensitized Explosives

Flammable Gases

Aerosols

Acute Toxicity

Skin Corrosion/irritation

Aspiration Hazard

Aquatic Acute

Aquatic Long-term

Ozone Hazard

Cat 1A

Cat 1

Cat 1

Cat 1B

Cat 2

Cat 1C

Cat 3

Cat 2

Cat 4

Cat 1

Cat 1 Cat 2 Cat 3 Cat 4

Cat 3

Cat 2

Cat 2 Cat 3

Cat 1 Cat 2 Pyro Gas

Cat A C.U.

Cat 1 Cat 2 Cat 3

Cat 1

Cat 5

Not adopted by US or CA but data must be taken into account for mixture classification

Not adopted by US, CA or MX but allowed Not adopted by US or CA

Not adopted by US, CA or MX

Cat 1 Cat 2 Cat 3 Cat 4

Cat B C.U.


US/Canada/Mexico GHS

US CA MX

Effective Date 1-Jun-2015 1-Jun-2017 1-Oct-2018

Classification Basis 3rd UN 3rd UN 5th UN

Label Element Basis 3rd UN 5th UN 5th UN

H Statement UN Deviations Y Y N

P Statement UN Deviations Y N Y

Symbol Precedence UN Deviations Y Y Y

Signal Word UN Deviations N N Y

Prescribed Classification list N Y N

Pyrophoric Gases, Simple Asphyxiants, Combustible Dusts, Upon contact with water, releases a gas that is acutely toxic Y Y N*

Products that undergo vigorous polymerization Y/N* Y N*

Biohazardous Infectious Materials N Y N

Hazards Not Otherwise Classified (HNOCs) Y Y N*

Printing of H&P Codes N N Y

Symbol Size Requirements N N Y

Dual Language Requirement N Y N

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


Authority Classification Lists


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 – ‘Harmonized’ Classifications • Only the classifications in hazard classes included in

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

• Properties not addressed under the Annex VI entry must be self-evaluated, classified and labelled accordingly

• Minimum classifications are given for certain substances, typically acute toxicity and STOT RE – Manufacturer/importer/DU has obligation to consider all data

available and apply more stringent classification if available


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 Harmonization Annex VI

1

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

labeling (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 harmonization 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 ye

ars


No single SDS or label can be used globally!

http://www.starwarsdatabase.com/


Regulation of Chemicals Within the EU

23


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 recognized 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

Manufacture Transport Use Dispose/Re-use R&D Raw Material Inputs


Relation of CLP to Other EU Legislation

• REACH (EC) No. 1907/2006 Changes to classification criteria in CLP impact on applicability of requirements

– Registration dossiers, – Exposure assessments and risk characterization within CSA, – Obligations to provide SDS, – Classification as CMR category 1A or 1B, or as a PBT or vPvB could cause the

substance to be added to the SVHC list

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

may preclude approval as an active substance


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


PC Reporting Requirements

• Poison Centers (PC) – 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), recently approved by member states

Mixtures for: Consumer use 2020 Professional use 2021 Industrial use 2024 If info on hazardous mixtures already submitted before deadline date

no need to comply with this regulation until ??? Waiting for confirmation

Unless changes to the mixture arise, in which case must comply with this Annex

before placing the changed mixture on the market


PC Reporting Requirements

PC N

otifi

catio

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 harmonized product categorization 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 minimize exposure, which in turns reduces the risk of harm being caused


Recent REACH Developments

31


REACH: Important Deadlines


REACH: Enforcement

• Who? – Enforced at a national level by competent authorities – Activities coordinated by ECHA Enforcement Forum

which also covers CLP and PIC – Series of Reach En-Force (REF) projects

• What? – REF-5 scope covers the communication of key

information on safe use in the supply chain, namely extended Safety Data Sheets (eSDS), exposure scenarios (ES), risk management measures (RMM) and operational conditions (OC)


REACH: Enforcement

• When? – Training for national coordinators Q4 2016 – Inspections in 2017, Report issued in 2018

• How? – Joint inspections with authorities responsible for

occupational safety and health inspections • Availability of the eSDS to DU • Compliance with the regulations

– Completeness – Consistency within SDS – Language requirements met


REACH Requirements: Exposure Scenario

REACH, Annex I: “An exposure scenario is the set of conditions, that

describe how the substance is manufactured or used during its lifecycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These sets of conditions contain a description of both the risk management measures and operational conditions which the manufacturer or importer has implemented or recommends to be implemented by downstream users.”


REACH Requirements: Exposure Scenario

Registered under REACH Chemical Safety Report (CSR) is available

Defined as hazardous


Communication Tool: eSDS for Substances

eSDS = SDS + nES(s) Extended Safety Data Sheet = eSDS Exposure Scenario(s) = ES(s) n – number of ES(s) = number of processes/uses


Substance eSDS Requirements

Exposure scenario (ES) must be attached to the SDS and be an integrated part of the SDS (paging, languages)* SDS must be consistent with the ES (Sections

1.2, 5, 6, 7, 8, 9, 13)**

•See Annex II of the REACH, Part A - 0.3.2. •See p. 20, Table 1 on p. 109-110 in the guidance: http://echa.europa.eu/documents/10162/13643/sds_en.pdf

http://echa.europa.eu/documents/10162/13643/sds_en.pdf


REACH Requirements: Downstream Users

REACH, Article 31 (7) Paragraph 2: “Any downstream user shall include relevant

exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses.”


REACH Requirement: Mixtures

Formulators Mixture is classified as hazardous according to

CLP Contains hazardous substances registered

under REACH Timelines:

• 6 months from the substance registration to DU • 12 months to incorporate it into eSDS mixture


Determination of Safe Use Information

• Industry-Specific =“Bottom-up” approach – Sector groups have developed Safe Use of Mixtures

Information (SUMI) • Compare substances against existing RMM/OC • 20 methodologies under development • Use-oriented so they can be used for multiple products • Multiple SUMIs can be pertinent to a product

– DUCC defined format • Universal =“Top-down” approach

– Identification of the “Lead Component(s)” (LCID) • The only recognized/recommended methodology

– Requires ESs for each component that triggers classification of the mixture

– Safe Use Information for Mixtures (SUI)


Communication Tool: eSDS for Mixtures

Attach ES for substances to SDS

Include information in 16 section SDS

Append Safe Use information to

SDS

ES(s) for all relevant substances are attached, may vary according to intended uses. (eSDS = SDS +nES*N)

Information consolidated from ES(s) for component substances is integrated into the within main body of mixture SDS. (eSDS = SDS)

Append safe use information for the mixture derived from the exposure scenarios of the component substances or product as a whole (eSDS = SDS + nSUMI/SUI)


DUCC SUMI Format


Sample eSDSs for

Mixtures


Reminder

REACH is not over in 2018! All actors need to continue

learning from the experiences and leading to improve

processes and efficiency.

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