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ICE-TBDTextileTrainingCourse2010GuidoBottini–Suzhou–March18,2010SUMMARYMandatory

environmental

legislations

involving

textiles(Semi)VoluntaryenvironmentalrequirementsFuturedevelopmentsintheEUregulationConsumers’awarenessGuidoBottini–Suzhou–March18,2010Mandatory

environmental

legislationsREACH[Regulation(EC)1907/2006]IPPC(Directive2008/1/EC)ETS(Directive2009/29/EC)Ecodesign

Directive(Directive2009/125/EC)GuidoBottini–Suzhou–March18,2010REACHRegistration,Evaluation,Authorization

of

CHemicalssubstance:meansachemical

elementandits

compoundsinthenaturalstateorobtained

by

anymanufacturingprocess,includinganyadditivenecessary

to

preserve

its

stabilityandany

impurityderiving

fromtheprocess

used,but

excluding

any

solvent

whichmay

be

separated

without

affectingthestability

ofthesubstanceorchanging

its

composition;mixture(preparation):meansamixtureorsolution

composed

of

twoormoresubstances;article:means

an

object

which

duringproductionis

givenaspecialshape,surfaceordesignwhich

determines

its

function

toagreaterdegree

than

does

its

chemical

composition;GuidoBottini–Suzhou–March18,20103deadlines

for

registrationNovember30,2010:

substances>1.000t/yMay31,2013: substances100<t/y<1.000May31,2018: substances1<t/y<100GuidoBottini–Suzhou–March18,2010Function

of

an

articleTheterm“function”inthearticle

definition

should

be

interpreted

as

meaningthebasic

principle

determiningtheuse

oftheobject

rather

thanthedegree

of

technical

sophistication

determiningthequality

oftheresult.Inthis

sense,it

may

be

helpful

tolookattheresult

of

using

an

objectandpay

less

attention

tothequality

oftheresult.Shape,Surface,DesignShape

meansthethree-dimensional

form

of

an

object,like

depth,widthandheight.Surface

meanstheoutermost

layer

of

an

object.Designmeansthear-rangement

ofthe“elements

ofdesign”insuchawayas

tobestaccomplishaparticular

purpose.For

example,thedesignofatextile

may

be

determined

bythetwistof

fibresintheyarn,theweave

of

threadsinafabricandthetreatmentofthesurface

ofthetextile.GuidoBottini–Suzhou–March18,2010GuidoBottini–Suzhou–March18,2010GuidoBottini–Suzhou–March18,2010Registrationandnotification

of

substancesinarticles(Art.7)GuidoBottini–Suzhou–March18,2010Intendedreleaseof

substances

from

articlesAreleaseof

substances

from

articles

is

intended

if

it

fulfils

an

accessory

function

(to

be

differentiated

fromthemain

function

according

to

section2.1)which

is

deliberately

plannedandwould

not

be

achieved

ifthesubstance

were

not

released.e.g.inthecaseof

scented

articles,thefragrance

substances

need

to

be

releasedinorder

forthearticle

to

be

smelled.Substances

thatarereleased

because

of

ageing

of

articles,because

ofwearandtearoras

an

unavoidable

side-effect

ofthefunctioning

ofthearticle,aregenerally

considered

not

intended

releases,asthereleaseas

such

does

not

provideafunctioninitself.GuidoBottini–Suzhou–March18,2010Casesnot

considered

as

an

intendedrelease:1.Areleaseoccurs

duringprocessingofasemi-finished

article,i.e.beforemarketingasafinished

article.Example:asize

is

added

toafabric

to

improve

its

processability,whereasthesize

is

released

again

during

further

wetprocessingofthetextile.2.Areleaseoccurs

during

useormaintenance

ofthearticle,butthereleased

substancesdonot

contribute

to

any

function

ofthearticle.

Example:washing

of

clothes

bytheconsumerwhere

remnants

of

different

chemicals(dye,softener,starch,etc.)fromprocessingareremoved

oversomewashing

cycles.3.Areleaseof

substances

is

an

unavoidablesideeffect

ofthefunctioning

ofthearticle,butthereleasedoes

not

contribute

tothefunctioning

ofthearticle.

Examples:wearandtear

of

materialsunderconditions

ofhighfriction,e.g.breaklinings,tyre;leakage

of

lubricant

used

toreducethefriction

between

two

moving

parts.GuidoBottini–Suzhou–March18,20104.Areleaseof

substances

formed

during

chemical

reactions

of

any

kind.Example:ozone

released

fromcopymachines,orreleaseof

combustion

products

from

articles

catching

fire.5.Areleaseinan

accident.

Example:releaseof

substances

fromathermometer

that

dropsandbreaks.6.Areleasecaused

byalong-term,extremelyintensiveuse

of

an

article.

Example:releasefromatool,whichaconsumerusesindisregard

oftherecommendationsonoperating

time

providedintheinstructions

of

use.

GuidoBottini–Suzhou–March18,2010Normal

conditions

of

use

meanstheconditions

associated

withthemain

function

of

an

article.Reasonably

foreseeable

conditions

of

use

mean

conditions

of

use

thatcanbe

anticipated

as

likely

to

occur

because

ofthefunctionandappearance

ofthearticle(even

though

theyarenot

normal

conditions

of

use).GuidoBottini–Suzhou–March18,2010Calculation

of

tonnage

ofasubstance

intended

to

be

releasedAT-shirtcontainsafragrance

substance

intended

to

be

released.Assumption:Thefragrance

substance

constitutesamaximum

of5%by

weight

oftheT-shirt,which

is

producedinan

amount

of100t/a.Thefragrance

substance

is

not

containedinother

articles

ofthesame

producer.

Conclusion:Thethreshold

of1t/ais

exceeded;theproducer

oftheT-shirtmust

registerthefragrance

substance.Not

onlytheamounts

intended

to

be

released

butthetotalamountinthearticles

needs

to

be

considered.Ifthesame

substance

is

intended

to

be

released

from

different

articles

of

one

producer/importer,thevolumes

of

this

substanceinall

those

articles

have

to

be

summedupGuidoBottini–Suzhou–March18,2010Substances

of

veryhighconcernSubstances

fulfillingthecriteria

definedinArticle57oftheREACHRegulationandcanbeputonthe“candidatelist

for

authorisation”:

carcinogenic,mutagenicorreprotoxic(CMR)substances

category1or2

persistent,bioaccumulativeandtoxic(PBT)substancesorvery

persistentandvery

bioaccumulative(vPvB)substances

substances

for

which

there

is

evidence

for

similar

concern,such

asendocrinedisruptorsSubstancesin“candidatelist”does

not

mean“banned”GuidoBottini–Suzhou–March18,2010GuidoBottini–Suzhou–March18,2010GuidoBottini–Suzhou–March18,2010GuidoBottini–Suzhou–March18,2010GuidoBottini–Suzhou–March18,2010GuidoBottini–Suzhou–March18,2010Notification

of

substancesinarticlesIt

is

required

when

all

conditions

of

Article7(2)aremet.Theobligation

to

notify

substancesinarticles

also

applies

to

packagingmaterials,which

may

be

producedorimported

separately

aspackagingof

imported

goods.Packagingis

to

be

assessed

sepa-rately

from

any

object

it

contains.Anotification

of

substancesinarticles

shall

be

madeatthelatest6months

after

it

has

been

includedonthecandidatelist

of

substances

for

authorisation,but

only

starting

from1June2011.GuidoBottini–Suzhou–March18,2010Informationto

be

notified:theidentityandcontact

details

oftheproducerorimporter

ofthearticlestheregistration

number

forthesubstance,if

availabletheidentity

oftheSVHC(thisinformationis

available

fromthecandidatelistandthesupport-ing

documentation)theclassification

ofthesubstance(thisinformationis

available

fromthecandidatelistandthesupporting

documentation)abrief

description

oftheuse(s)ofthesubstanceinthearticle(s)as

specifiedinsection3.5of

Annex

VIandoftheuses

ofthearticle(s)thetonnage

range

ofthesubstance

containedinthearticles,i.e.1-10tonnes,10-100tonnes,100-1000tonnesor≥1000tonnesGuidoBottini–Suzhou–March18,2010Obligations

according

to

Article33Theinformationis

to

be

provided

totherecipients

automatically,i.e.as

soon

asthesubstance

has

been

includedonthecandidatelist

for

authorisation.Notethattheterm“recipients”refers

toindustrialorprofessional

usersanddistributors,but

not

to

consumers.Informationavailable

tothearticle

supplier

necessary

to

ensure

safe

use

of

an

article

has

to

be

provided

also

to

consumers

upon

request(Article33(2)).Consumers

have

to

be

provided

with

thisinformationwithin45days

oftherequest,freeof

charge.GuidoBottini–Suzhou–March18,2010Obligations

according

to

Article33(follows)There

is

notonnagetrigger

for

these

obligations(i.e.they

also

apply

below1tonneperyear).Apackagingis

always

to

be

treated

as

an

articleseparatefromthecontents

ofthepackaging.Therefore,theobligations

to

communicateinformationonsubstancesinarticles

also

apply

topackagingmaterials.Thesubstance

concentration

threshold

of0.1%(w/w)applies

tothearticle

as

supplied.Likeinthecontext

of

substance

notification,it

does

not

relate

tothehomogeneous

materialsorparts

of

an

article,but

tothearticle

as

such.Theobligations

also

apply

to

articles

which

were

producedorimported

beforethesubstance

was

includedinthecandidatelistandaresupplied

aftertheinclusion.Thus,thedateof

supply

ofthearticle

istherelevantdatehere.GuidoBottini–Suzhou–March18,2010Calculation

oftheaverage

concentration

ofaSVHCinan

articleAchair

consists

ofawoodenpartandaplasticpart.Theweight

ofthechair

is2.001kg.Thewoodenpartofthechair

contains10mgof

anSVHC.Theweight

ofthewoodenpartis2kg.Theplasticpartofthechair

contains1mgofthesameSVHCandweighs1g.Theconcentration

oftheSVHCinthechair

is

calculated

usingtheformulaabove.Conclusion:Theaverage

concentration

oftheSVHCinthechair

does

not

exceed0.1%(w/w).Obligations

according

to

Article7(2)and33donot

apply.GuidoBottini–Suzhou–March18,2010Calculation

ofthetotalamount

ofaSVHCindifferent

articlesAcompanyimports20000pairs

of

shoes,3000belts,and60000bagsperyear

intotheEEA.Apair

of

shoes

contains0.05%(w/w)ofaSVHConthecandidatelist,abelt

contains0.15%(w/w),andabagcontains2%(w/w)ofthesameSVHC.Theweights

of

these

articlesare0.7kgperpair

of

shoes,700gperbeltand1kgperbag.Theconcentration

oftheSVHCinthebeltsandbags

is

above0.1%(w/w).Thetotalamount

oftheSVHCineach

article

type

producedand/orimportedperyear

withaconcentration

oftheSVHCabove0.1%(w/w)is

calculated

usingtheformulaabove.GuidoBottini–Suzhou–March18,2010Summingupthevalues

obtained

for

each

article

type,thetotalamount

oftheSVHCinall

articles

producedand/orimported,which

containmorethan0.1%(w/w)ofthesubstance,is

obtained.Conclusion:Thetotalamount

oftheSVHCinall

articles

producedand/orimported,which

containmorethan0.1%(w/w)ofthesubstance

is

over

one

tonneperyear.Hence,thecompanyhas

to

submitanotification

fortheSVHCinthebagsandthebelts.Furthermore,thecompanyhas

to

provideinformationfor

boththebeltsandthebags

according

to

Article33oftheREACHRegulation.GuidoBottini–Suzhou–March18,2010Informationto

be

suppliedAsaminimum,thename

oftheSVHCshall

be

provided.Article33(2)requiresthesame

type

ofinformationto

be

forwarded

to

consumers

upon

request.What

otherinformationshall

be

provided?

whatthedownstreamlife-cycle

stages

ofthearticleareupto

final

disposal(transport,storage,uses)

whatthepotential

routes

of

exposureareduring

each

of

these

life-cycle

stages

whatthehazards

oftheSVHCarefor

human

healthandtheenvironment

what

types

of

exposure

control/personalprotection

measuresarelikely

to

beappropriateduring

each

ofthelife-cycle

stagesinorder

forthehandling

ofthearticle

to

be

considered

safe.GuidoBottini–Suzhou–March18,2010Formatfor

provision

ofinformationREACHdoes

not

specifyaformatPossible

formats:

existing

documents,such

as

instructions

for

useandpackaging;informationonlabels;linktoawebsitewithup-to-dateinformation(suchalinkalonewould

not

be

sufficient

sincetheinformationwould

then

not

be

readily

available);standardcommunication

formats

developed

by

industry

sector

associations.GuidoBottini–Suzhou–March18,2010Illustration

ofthedecision

processExample:Cloth

with

lemon

scent(D-limonene)AreyouthefirstEUproducerorimporter

oftheobject?YES.Is

your

object

an

article?YES.Thecompanyimports

cloths

whicharearticles,becausetheshape

determines

their

function.Is

there

an

intendedreleaseof

substances

fromthearticle?Substancesarereleased

duringtheuse

ofthearticle.Thereleaseis

an

additional

quality

oftheclothandthereleaseis

therefore

intended,otherwisethearticle

would

not

smell.GuidoBottini–Suzhou–March18,2010Doesthearticle

containaSVHCincludedinthecandidatelist?Astheimporter

hasnoinformationexcepttheresults

fromthechemical

analysis

he

coulddothefollowing:1)Collectinformationonsector

knowledgeandtypical

content

of

substancesinthis

type

of

article,e.g.standards.He

wouldcomparethatinformationwiththecandidatelist

for

authorisationandmay

have

doubts

whether

hecanexcludethepresence

ofSVHC.He

does

not

findinformationonthefragrances

intended

to

be

released.2)Checkthesupply

chain

requesting

if

any

ofthesubstancesonthecandidatelist

is

includedinthearticleorthesubstances/mixtures

used

toproducethearticleorreceive

confirmation

thatSVHCarenot

presentinthearticle.Checkthesupply

chainandask

ifthesupplier

ofthefragrance

substancescanbe

identified.Ifyes,theimporter

of

cloths

may

try

to

obtainasafetydatasheet.GuidoBottini–Suzhou–March18,20104)Check

if

identified

substancesarelistedonthecandidatelist(Theemissiontestrevealedthepresence

of

compounds

classified

withR50/53andR51/53.These

compounds

may

potentially

fulfilthecriteria

asPBT/vPvB

substances,andthus

be

identified

asSVHC).5)Calculatetheamount

of

substances

identifiedinthescreeninganalysisandassess

whetherthetonnage

threshold

for

registration

could

be

exceeded.Workprocess

for

calculatingtheamount:Isthetotalvolumeof

articles>1t/a(all

articles

should

be

consideredandsummedup)?YES.1million

cloths,each

cloth

with2gof

parts

containing

fragrance

makesatotalvolumeof

articles

ofatleast2t/a.GuidoBottini–Suzhou–March18,2010Isthetotalamount

ofthefragrance

mixture>1t/a(all

such

articlesinacompanyshould

be

considered)?YES.Thetotalvolumeof

fragrance

is

approx.2t/a.Identify

each

substance

intended

to

be

released

fromthearticle.Atotalof11fragrance

compounds

were

identified

to

be

containedinthecloth.Duringtheemissiontestvarious

compounds

were

detectedandsomeofthedetected

compounds

were

identified

withaCASnumberandclassification.Theoutputfromtheanalysis

wasthesubstance

name

only.TheC&L

inventory

to

be

established

should

be

consultedinorder

to

obtainaCASnumberandclassification.Further

stepsinthiscasearefocusedonD-limonene,which

was

identifiedinthechemical

analysis.GuidoBottini–Suzhou–March18,2010Substances

exempted

from

registration?NO.Check

for

existing

registration

for

that

use.Thesubstance

has

not

been

registered.Determinetheamount

of

each

substance

intended

to

be

released(all

such

articlesinacompanyshould

be

consideredandsummedup)Basedonthechemical

analysis,thecontent

of

D-limonene

intended

to

be

released

is

determined

to

be800mg/kgintheinnerpartofthecloth.Thecontent

of

D-limoneneinthecloth

is1.6mgastheweight

oftheinnerpartwas2g.Totalamount>1t/a?It

is

assumed

that

this

cloth

istheonly

article

containing

D-limoneneandimported

bythecompany.Theannual

amount

of

D-limonene

is

calculated

to

be1.6kg/a,which

is

below1t/a.Registration

of

D-limoneneinthecloths

is

not

required.GuidoBottini–Suzhou–March18,2010Example:DEHPinbath

mattressesAreyouthefirstEUproducerorimporter

oftheobject?YES.Is

your

object

an

article?YES,thebath

mattress

is

an

article.Is

there

an

intendedreleaseof

substances

fromthearticle?NO.Conclusiononregistration:Noneed

for

registration.GuidoBottini–Suzhou–March18,2010Doesthearticle

containaSVHCincludedinthecandidatelist?YES.DEHPhas

been

includedonthecandidatelist.Determinetheconcentration

oftheSVHC,whichinthis

example

isDEHP.To

determinetheconcentration

limitthecompanyasked

its

supplier

forinformation.Thesupplier

informed

thattheconcentration

ofDEHPwas30%(w/w)inthemattresses.Notestprotocols

were

available

fromthesupplier

to

confirm

concentration

levelsandthecompanydid

not

find

any

reason

to

questiontheinformationgiven

bythesupplier.Concentration

above0.1%(w/w)?YES.Theconcentration

ofDEHPinthebath

mattresses

exceedsthethreshold

limit

of0.1%GuidoBottini–Suzhou–March18,2010Conclusion

after

this

step:communicateinformationaccording

toArt.33.Asthebath

mattress

containsmorethan0.1%DEHPandis

distributed

to

retailers

withintheEEA.Thecompanyhas

to

giveinformationto

allow

safe

use

ofthearticle.Informationto

be

considered

as

important

isthefollowing:

Substance

name:di(ethylhexyl)phthalate

CAS.No:117-81-7

RegistrationNo:not

available

forthetime

being

Classification:R60-R61,thesubstance

is

classified

as

toxicandtoxic

to

reproduction,i.e.thesubstance

causes

reduced

ability

to

reproduceanddamage

totheunborn

child

Exposure

control:Avoidlongterm

dermal

contact

by

childrenorpregnantwomen

GuidoBottini–Suzhou–March18,2010IstheSVHCintended

to

be

released?NO.Hasthesubstance

already

been

registered

for

that

use?NO.It

is

assumed

thatDEHPis

not

registered

for

that

use.Determinetheamount

oftheSVHC(DEHP)presentinall

articles?TheDEHPconcentrationinthemattresses

is>0.1%andtherefore,thetotalamount

ofDEHPbrought

intotheEEAinthemattresses

has

to

be

considered.Thetotalamount

ofDEHPperyearinall

imported

mattresses

is:Theimportof

mattressestheyear

before:150,000items

Theweight

of

one

mattress:900gThemaximumDEHPconcentrationinamattress:30%(w/w)Thetotalamount

ofDEHP:(30⋅0.1)⋅(900⋅10-6)⋅150,000=40.5t/aGuidoBottini–Suzhou–March18,2010Isthetotalamount

oftheDEHP>1t/a?YES.Thetotalimported

amount

ofDEHPis40.5t/a.This

amount

exceedsthethreshold

limit

of1t/a.Canexposure

be

excluded

during

normalorreasonable

foreseeable

conditions

of

use?Thefunction

ofthesubstanceinthearticles:Plasticisersarenot

permanently

bound

tothePVCpolymer,andphthalatesaretherefore

released

fromplasticproducts

throughout

their

lifetimes.Theuse(s)ofthearticle:Normal

use(s):Inbath

mattresses

for

adults.Reasonably

foreseeable

use(s):It

is

very

likely

thatthemattresses

also

will

be

used

by

childrenorfertilewomen.GuidoBottini–Suzhou–March18,2010Potential

for

emission

during

use(s)anddisposal–Lookingattheroutes

of

exposure:Dermal

exposure

could

be

considered

to

bethemost

likelywayof

exposure.It

could

be

assumed

that

naked

skin

often

would

beindirect

contact

withthearticle

during

use.Exposure

through

inhalation

may

occur

ifthearticle

is

used

in-doors.Exposure

through

ingestion

is

also

possible

as

it

could

be

considered

to

be

reasonably

foreseeable

that

children

might

suckonthemattress,althoughduetothesizeandshape

oftheproduct

exposure

through

ingestion

is

regarded

as

limited.Furthermore

astheproduct

is

mainly

usedindirect

sunshineattemperatures

above20degreesthetemperatureofthematerialcould

be50degrees,which

could

contribute

toaconsiderable

emission

ofDEHP.Canexposure

to

humansortheenvironment

be

excluded?NOConclusion:Notification

is

required

GuidoBottini–Suzhou–March18,2010Why

is

important

to

supplyinformationonsubstances?Chemical

analysis

of

substancesinarticles

theoretically,substances

containedinarticlescanbe

identifiedandtheir

concentrations

quantified

by

applying

analytical

methods.

chemical

analysis

may

thus

bea“lastresort”

chemical

analyses

may

yield

ambiguous

resultsand/orbe

very

costlyandarethus

not

recommended

asthepreferred

instrument

for

obtaininginformation.

articles

may

be

very

complexandcomposed

of

different

partsandmaterials.It

is

therefore

dif-ficult

tocreateasamplefortheanalysis

that

representsthewhole

article

substances

thatareincludedinthearticle

matrix

may

have

to

be

extracted

from

it

various

analytical

methodsareavailable

to

screen

fortheexistenceandidentification

of

differ-ent

substancesinasampleGuidoBottini–Suzhou–March18,2010But

mainly

because:

obligations

to

registerornotify

substancesinarticles

identified

as

describedinchapters3and4donot

applyincertain

casesaregistrationornotification

ofasubstanceinarticles

is

not

required,ifthesubstance

has

already

been

registered

for

that

use(i.e.theuse

by

whichthesubstance

is

includedinthearticles)Asubstance

is

considered

to

have

already

been

registered

foraparticular

use,if

two

conditionsarefulfilled:

thesubstanceinquestion

isthesame

asasubstance

that

has

already

been

registeredtheuseinquestion

isthesame

as

one

oftheuses

describedinaregistration

of

this

substance

that

was

already

madeanddoingsowill

notstopyour

ownbusiness!!!GuidoBottini–Suzhou–March18,2010Notification

is

not

required

iftheproducerorimporter

of

articlescanexclude

exposure

to

humansortheenvironment

during

normalorreasonably

foreseeable

conditions

of

use,including

disposal.Weareworkingonit

but

it

is

not

simple!GuidoBottini–Suzhou–March18,2010EXPOSURESCENARIOSUSEDESCRIPTORSYSTEMBasedon4elements:Sectorof

Use(SU)

chemical

Product

Category(PC)

PROcess

Category(PROC)

Article

Category(AC)Thelist

of

Article

Categoriescoverboth

article

with

intendedreleaseof

substancesandarticle

with

not

intendedrelease.GuidoBottini–Suzhou–March18,2010GuidoBottini–Suzhou–March18,2010GuidoBottini–Suzhou–March18,2010GuidoBottini–Suzhou–March18,2010PARTSOFTHEREACHREGULATIONOFPARTICULARRELEVANCEArticle3(3)providesthedefinition

of

an

article

forthe

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