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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
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