The Institution of Occupational Safety andHealth, Southern Branch

Chemical Risk Assessment under COSHH,REACh, RoHS, DSEAR, CLP and GHS

– A Coordinated Approach

Monday 10th February 2014

• Presented by• Colin Martin CChem, MRSC, AFOH, FInstCT, MIMF• Senior Partner, ParaChem Consulting Chemists

COSHH REGULATIONS

The Control of Substances Hazardous toHealth Regulations, 2002 (as amended)

And

Approved Code of Practice and GuidanceL5 (Sixth Edition) 2013

COSHH REGULATIONS

Reg. 6 (1)“An employer shall not carry outany work which is liable to expose anyemployees to any substance hazardous tohealth unless he has-(a) made a suitable and sufficientassessment of the risk created by that workto the health of those employees and of thesteps that need to be taken to meet therequirements of these Regulations…”

• Risk assessment of substances hazardous to humans– Harmful, toxic, corrosive, irritant

• Involves consideration of– Hazardous properties– Method of use– Health effects– Exposure type, level, duration– Amount of substance– WELs– Results of health surveillance– Results of air-monitoring– Etc.

COSHH REGULATIONS

DSEAR REGULATIONS

The Dangerous Substances and ExplosiveAtmospheres Regulations, 2002

And

Approved Code of Practice and guidanceL138 (Second Edition) 2013

DSEAR REGULATION 2002

Reg. 5 (1)“Where a dangerous substance isor is liable to be present at the workplace,the employer shall make a suitable andsufficient assessment of the risks to healthwhich arise from that substance”

DSEAR REGULATION 2002

• Risk assessment of substances hazardous because of theirphysical properties• Flammable, highly flammable, extremely flammable,

oxidising, explosive• Involves consideration of

– Hazardous properties – e.g. Flash point and LFL– Method of use– Interactions of substances– Release type, level, duration– Amount of substance– Likelihood of existence / persistence of a flammable atmosphere– Effects of a fire / explosion– Etc.

Regulation (EC) No. 1907/2006 of theEuropean Parliament and of the Council of

18 December 2006

concerning the Registration, Evaluation,Authorisation and Restriction of Chemicals

“REACh”

REACH REGULATION

• To protect human health and theenvironment from the use of chemicals.

• To force manufacturers and importers tomanage the risks associated with the useof chemicals

• To allow free movement of substanceswithin the EU

REACH REGULATION AIMS

• Legislates chemicals/substances from“cradle to grave”

• Substances manufactured/imported into EUat >1 tonne pa

• Individual chemical substances

• Preparations (mixtures)

• Substances in “articles”

REACH – WHAT’S INCLUDED?

• Radioactive substances• Substances under customs supervision• Transport of substances• Non-isolated intermediaries• Waste• Naturally occurring low-hazard substances

[cf COSHH – lead, asbestos, radiation]

REACH – WHAT’S NOT INCLUDED?

• The REACh Enforcement Regulations 2008(SI 2008/2852)– Allocate responsibility for enforcement

to “Competent Authorities” “CA” (HSE,HSENI, EA, SEPA, NIEA, DECC, localauthorities)

– Provision of power to CAs– Duty of CAs to cooperate– Setting of offences and penalties

REACH IN THE UK

• Competent Authority (HSE) reports

– Since passing into law in 2009

• >70 Notices served (Enforcement orProhibition)* up to today

• 3 criminal prosecutions** by localauthorities

*Source HSE Chemicals Directorate**Source Royal Society of Chemistry

ENFORCEMENT ACTION IN UK

• Registration / Pre-registration– In nearly all cases applies to manufacturers / importers

of chemicals:- NOT to “downstream users”• How does REACH affect risk assessment of

chemicals?– HSE advice - Compile an inventory

• Include substances, preparations, substances in articles• Obtain & Audit SDS for compliance• Notify ECHA* if substance not registered on ECHA website

for their application• Downstream users– check composition of chemicals for

SVHCs

*European Chemicals Agency (ECHA)

REGISTRATION – Main requirement of REACH?

• “Downstream users are companies orindividuals who use a chemicalsubstance, either on its own or in amixture, in the course of their industrialor professional activities”

• Examples:- Formulators, End-users,Producers of articles, Re-fillers, Re-importers.

“DOWNSTREAM USER” A definition

• End-users: Use substances or mixtures but do notsupply them further downstream. Examples includeusers of adhesives, coatings and inks, lubricants,cleaning agents, solvents and chemical reagents likebleaching products.

• Producers of articles: Incorporate substances ormixtures into or onto materials to form an article.Examples include textiles, industrial equipment,household appliances and vehicles (both componentsof and finished goods).

• MOST MANUFACTURING BUSINESSES AREDOWNSTREAM USERS !!!

“DOWNSTREAM USER” A definition

1. Registration

Producers or importers of articles shall submit a registration toECHA for any substance contained in those articles, if both thefollowing conditions are met:

1. The substance is present in those articles in quantitiestotalling over one tonne per producer or importer per year.

2. The substance is intended to be released under normal orreasonably foreseeable conditions of use.

DOWNSTREAM USER OBLIGATIONS

2. NotificationProducers and importers have to notify ECHA about substances if all thefollowing conditions are met:

1. The substance is present in their relevant articles above aconcentration of 0.1% weight by weight.

2. The substance is present in these relevant articles in quantitiestotalling over one tonne per year.

3. The substances are included in the “Candidate List”.

DOWNSTREAM USER OBLIGATIONS

SVHC = Substance of Very High ConcernInclusion in Candidate List = First step towards

inclusion in Authorisation List (Annex XIV)Authorisation = Industry is forced to reduce risks

from SVHCs by progressive replacement withsuitable alternatives

Substances in Authorisation List cannot be sold after“Sunset date”

Effective BanAll SVHCs to be included in the Candidate List by 2020

SVHCS, CANDIDATE LIST, and ROADMAPS

• Significant properties of SVHCs

– Carcinogenic, mutagenic or reprotoxic(CMRs)

– Persistent, bioaccumulative and toxic(PBTs)

– Very persistent and very bioaccumulative(vPvBs)

– Other substances where evidence ofendocrine disruption exists

SVHC

EXAMPLES OF SVHCS

• 1-Methyl-2-pyrrolidone,• Bis(2-ethylhexyl)phthalate• Boric acid• Cadmium compounds, various• Chromium trioxide• Cobalt compounds, various• Phenolphthalein• Sodium dichromate• Trichloroethylene• Triglycidyl isocyanurate (TGIC)

+ 164 more as of 16/12/2013

3. Communication• Producers and importers have to notify industrial

customers about substances if both of the followingconditions are met:

1. The substance is present in their relevant articlesabove a concentration of 0.1% weight by weight.

2.The substances are included in the “Candidate List”.

DOWNSTREAM USER OBLIGATIONS #4

• The Restriction of the Use of CertainHazardous Substances in Electrical andElectronic Equipment Directive (2011/65/EU)“RoHS”.

• The Restriction of the Use of CertainHazardous Substances in Electrical andElectronic Equipment Regulations 2012 (SI2012/3032)– Became law on in UK on 2 January 2013.

ROHS REGULATION

• Bans the placing on the market ofnew electrical and electronicequipment containing more thanagreed levels of six substances.

• Enforcement Authority is NationalMeasurement Office

ROHS – MAIN IMPACT ON INDUSTRY

• Enforcement and penalties similar toREACh

• Applies to manufacturers / assemblers /importers

• Proof of compliance required beforeproducts are placed on market

• Method of calculation for compliance isdifferent to REACh

ROHS – MORE DETAILS

ROHS - Restricted Substances

RestrictedSubstance

Lead Mercury HexavalentChromium

Polybrominatedbiphenyls

(PBB)

Polybrominateddiphenyl ethers

(PBDE)

Cadmium

RestrictedLimit(% w/w)

0.1 0.1 0.1 0.1 0.1 0.01

RestrictedLimit(ppm)

1000 1000 1000 1000 1000 100

• “Homogeneous” part– Uniform composition throughout, e.g.

plastics, glass, metals, alloys, resins andcoatings

– Electroplated metals separate to substrate– Passivate separate to electroplated layer

• Exemptions– Medical devices, military, telecoms, and

specific exemptions– http://www.bis.gov.uk/nmo/enforcement/roh

s-home/rohs-exemptions

ROHS – MAIN DIFFERENCES TO REACH

THE DODD-FRANK WALL STREET REFORMAND CONSUMER PROTECTION ACT

• Section 1502 – “Conflict Minerals”– Requires the identification of the origin of metals

derived from cassiterite, coltan, wolframite and theorigin of gold.

– It should be established through the supply chainthat these metals are "DRC* Conflict Free" asappropriate.

– Inhumane mining practices– Proceeds fund illegal militia

*Democratic Republic of Congo

THE CONTROLLED DRUGS (DRUGPRECURSORS) REGULATIONS, 2008 (x 2)

• Controlled drug and precursor chemicallicence– Licence may be required if a company or

individual deals in or uses chemical thatare known to be used in themanufacture of illegal drugs

– Licences issued by Home Office DrugsLicensing & Compliance Department

– Aim to to stop the supply of precursorchemicals to manufacturers

CHEMICAL RISK ASSESSMENT

Chemical IdentificationNames and numbers

Hazard Classification – Old and NewCHiP, GHS, CLP

Substances of Very High ConcernSVHCs, CMRs, PBTs, vPvBs

CHEMICAL IDENTITY

CH3CO2H

Ethanoic acid

Ethylic acid

Methanecarboxylicacid

Essigsaeure

C2H4O2

Demonstrates the need for standard names….

Ethanoic acid - Simple example, what about more complexchemicals…

α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol

[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride

1,3,5-tris[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione

(all correct IUPAC names)

STANDARDISED NAMING SYSTEM

STANDARDISED NAMING SYSTEM

• Spot the difference…

[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride

[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] diethylammonium chloride

• Need easier ID system???

NUMERICAL ID SYSTEMS

• α,α-Bis[4-(dimethylamino)phenyl]-4(phenylamino)naphthalene-1-methanol

• [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride

• 1,3,5-tris[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione

• 229-851-8 786-83-0

• 219-943-6 2580-56-5

• 423-400-0 59653-74-6

• “EC Number” “CAS Number”

• European Commission Number EC Number– Chemicals are assigned unique numbers and no two

substances have same number

– IUCLID Database• http://esis.jrc.ec.europa.eu/index.php• International Uniform ChemicaL Information Database

– Assigned to substances for regulatory purposes in the EU - >100,000 substances

EC NUMBERS

CAS NUMBERS

•Chemical Abstracts Service (CAS) CAS Number–Division of American Chemical Society–CAS Registry

•> 71 million substances assigned individual registrynumbers known at 1957 onwards

•> 64 million proteins and DNA sequences

•All given unique numbers and no two substances havesame number

•First Registry number “50-00-0” Formaldehyde

• Chemicals classified under “CHiP” (Chemicals (HazardInformation) in Packaging) Regs under outgoingsystem– Based on Approved Supply List (ASL)

• 2009 Onwards New System is “CLP / GHS”. GloballyHarmonised System of Classification and Labelling ofChemicals– Based on IUCLID

• Now until 2015 (2017 for some) – Transition period –Both systems used

HAZARD CLASSIFICATION

• Corrosive

• HighlyFlammable,ExtremelyFlammable

• Toxic

• Harmful

• Irritant

• Oxidising

HAZARD CLASSIFICATION UNDER CHiP

• Risk Phrases– State the risk associated with a substance

• R10 Flammable• R35 Causes severe burns• R51 Toxic to aquatic organisms• R42/43 May cause sensitisation by inhalation and

skin contact• R48/20/21/22 Harmful: danger of serious

damage to health by prolonged exposurethrough inhalation, in contact with skin and ifswallowed

CHiP – “RISK PHRASES”

• Classification, Labelling and Packaging ofSubstances and Mixtures (CLP Regulation) fromEuropean Union, adopts

• Globally Harmonised System of Classificationand Labelling of Chemicals (GHS)

• Classification and Labelling of HazardousSubstances will be universal (They hope)

GHS AND CLP

CHiP TO CLP – ICONS TO PICTOGRAMSSome convert logically

This pictogram refers to less serioushealth hazards such as skinirritancy/sensitisation and applies tomany circumstances where theCHIP symbol is applied.

This pictogram reflects seriouslonger term health hazards suchas carcinogenicity andrespiratory sensitisation

CHiP TO CLP – ICONS TO PICTOGRAMSand some don’t

Risk Phrase–R35

Causes severe burns

–R12Extremely flammable

Hazard Statement• H314

Causes severe skin

burns and eye damage

• H224Extremely flammable

liquid and vapour

CHiP TO CLP– Risk Phrases to Hazard Statements

Safety Phrases and Precautionary Statements

Safety Phrase–S 2

Keep out of reach ofchildren

–S20When using do not eator drink

–S25Avoid contact witheyes

PrecautionaryStatement

• P201Keep out of reach of children

• P264Wash thoroughly after

handling

GHS –EXAMPLELABELLING

CHEMICAL DATA AUDITING – ACOORDINATED APPROACH FOR ALLCHEMICAL REGULATIONS

•Draw up an inventory of all chemicals on site

•Obtain Safety Data Sheets (SDS) for all

•Audit Safety Data Sheet (SDS)–Is the SDS REACh/CLP Compliant?

–Sec. 1.2 Relevant identified uses of the substance ormixture and uses advised against?

–Sec. 2 Classification?

–Sec. 3 Composition – Chemical Identity?

Draw up an inventory of all chemicals on site

Is the SDS REACh/CLP Compliant?

Sec 1.2 - Relevant identified Use:Sets out application for which a chemical substancemay be used.Producers (manufacturers) can only use a chemical inthe method describedOther methods of use will require the manufacturer toregister their method of use with ECHA.

Uses advised against:Effective prohibit particular uses of a chemicalsubstance

SDS AUDIT UNDER REACH

Relevant identified Uses – ECHA Guidance• Suppliers must indicate the relevant identified

use(s) of a substance using a brief(understandable) description of what the substanceis intended to do. Uses advised against andreasons why must be given if applicable

• At least the identified uses relevant for therecipient(s) of the substance or mixture shall beindicated. This shall be a brief description of whatthe substance or mixture is intended to do, such as“flame retardant”, “anti-oxidant”.The uses whichthe supplier advises against and why shall, whereapplicable, be stated. This need not be anexhaustive list

Relevant identified Uses – Examples received

• Peelable mask, aerosol cleaner, manufacture ofprinted circuits, adhesive, semiconductors,electrical and electronic applications, additivefor paints, grease, manufacture of substances,machine oil, uses in coatings, other consumeruses, water treatment, “blank”, metal markingink, cleaner, etc. etc.

Sec. 3 Composition – Chemical Identity?

• “All Substances Report”

– Lists all constituents of all consumables infactory

– CAS and EC Numbers– % age composition of substances in

proprietary products– Shows the chemical products they are

contained in– Key to compliance with all Regs that require

identification of chemicals

CHEMICAL INVENTORY TO “ALLSUBSTANCES REPORT”

STRUCTURE OF “All Substances Report”

Chemical Inventory All Substances Report

Chemical XNickel sulphateSulphuric acidBoric acid

Chemical YSulphuric acid2-Butoxyethanol

Chemical ZAmmonium persulphateSulphuric acid2-Butoxyethanol

2-ButoxyethanolChemical YChemical Z

Ammonium persulphateChemical Z

Boric acidChemical X

Nickel sulphateChemical X

Sulphuric acidChemical XChemical YChemical Z

ALL SUBSTANCES REPORT

• Need to know composition of manufactured article– All chemicals used in factory – “All Substances

Report”• Next Step…

– Base materials – Request to supplier– Bought-in components - Request to supplier– Free-issue customer parts - Request to supplier– Surface finishes - Request to supplier

ADDITIONAL DATA COLLECTION

• Obtain information on SVHCs present in;– Base materials, bought-in components, free-issue

customer parts and ANYTHING ELSE THAT ISINCLUDED IN FINISHED PRODUCT

• When to obtain information

• Needs to be recorded (and kept for 10 years)

INVENTORY OF NON-CHEMICALS

• On completion of compilation and the inventoriesof chemical and non-chemical consumables

• We have identified any SVHCs, RoHS bannedsubstances, Conflict Minerals and PrecursorChemicals present

• Can now look at thresholds for disclosurerequirements where applicable

• May be able to exclude SVHCs present oninventory, but not present in finished product,such as…

CONSOLIDATED INVENTORY

• 1-Methyl-2-pyrrolidone– CAS 872-50-4, EC 212-828-1 is SVHC

– Used in “Hermitite Gasket Remover”– Used in maintenance department– Not in finished product– No duty to disclose

EASY EXCLUSIONS?

EASY EXCLUSIONS?

• Phenolphthalein– CAS 77-09-8, EC 201-004-7 is SVHC

– Used in chemical analysis– Not in finished product– No duty to disclose

EASY INCLUSIONS?

• Chromium trioxide CAS 1333-82-0 is SVHC

– Used in chromate conversion coating on zincplated components

– Is in finished product – Calculation required– (Easy non-exclusion)

EASY INCLUSIONS?

• Di-sec-octyl phthalate

– Real ID Bis(2-ethylhexyl)phthalate or DEHP– CAS 117-81-7, EC 204-211-0

– Used in bought-in article (plastic components)

– Supplier questionnaire and possibly calculationrequired.

• Do we need to design out SVHCs, RoHS bannedsubstances, Conflict Minerals and PrecursorChemicals ?– Differences in exclusion criteria

• Do we need to seek alternative (SVHC/RoHS etcfree) materials?

DESIGN & PROCUREMENT CONSIDERATIONS

Thank you for attending and listening

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