Environmental Engineering Reference
In-Depth Information
Unless.they.import.the.chemicals.they.utilize,.downstream.users.(DU).of.chemicals.
(e.g.,.formulators.of.mixtures,.users.of.chemicals.in.industrial.activities).do.not.have.reg-
istration.obligations.under.REACH..Each.DU,.however,.must.identify,.apply,.and,.where.
suitable,.recommend.appropriate.risk.management.measures,.and.may.have.certain.risk.
assessment,.communication,.and.notiication.obligations.under.the.regulation.
Under.the.REACH.authorization.provisions,.“very.high.concern”.chemicals.will.
be.included.on.a.list.of.candidate.chemicals.that.the.ECHA.is.expected.to.publish.
in.late.2008.[61]..Eventually,.approximately.1500.“substances.of.very.high.concern”.
(SVHCs).are.expected.to.be.taken.from.the.candidate.list.and.included.in.REACH.
Annex. XIV,. the. list. of. substances. that. will. be. subject. to. REACH. authorization..
Once.included.in.Annex.XIV,.authorization.from.the.European.Commission.(EC).
will.be.needed.before.the.substance.can.be.marketed.or.used. An.application.for.
authorization.must.include.an.analysis.of.alternatives.and.a.substitution.plan.where.
a.suitable.alternative.exists.[62]..Thus,.the.REACH.authorization.system.is.designed.
to.“assur[e].that.….[SVHCs].are.progressively.replaced.by.suitable.alternative.sub-
stances.or.technologies.where.these.are.economically.and.technically.viable”.[63]..
It. is. widely. anticipated. that. some,. perhaps. many,. of. the. manufacturers. of. SVHCs.
will.cease.manufacturing.them,.forcing.DUs.either.to.reformulate.their.products.or.
cease. producing. those. products. in. the. absence. of. viable. substitutes.. Some. uses. of.
chemicals,.moreover,.may.be.limited.under.the.REACH.restriction.provisions,.and.
authorization.for.those.uses.would.not.be.granted.
As.the.EU.authorities.have.explained,.“REACH.is.very.wide.in.its.scope”.[64].
and. “applies. to. all. substances. with. a. few. exemptions”. [65].. Exemptions. from. all.
aspects.of.REACH.exist.for.radioactive.substances,.substances.under.customs.super-
vision,.non-isolated.intermediates,.the.transport.of.dangerous.substances,.and.waste. .
There.is.no.explicit.exemption.for.nanoscale.materials..Partial.exemptions.exist.for,.
inter alia ,.substances.listed.in.Annex.IV.(minimum.risk.substances).or.covered.by.
Annex.V.(e.g.,.incidental.reaction.products,.byproducts,.natural.substances).and.re-
imported. substances. [66,. 67],. and. “[a]. number. of. other. substances. are. exempted.
from.parts.of.the.provisions.of.REACH,.where.other.equivalent.legislation.applies”.
[65,.68].
Although.nano-speciic.provisions.in.REACH.were.explicitly.considered.when.
developing.REACH,.they.were.ultimately.rejected..As.noted,.however,.there.is.no.
question.that.REACH.applies.to.nanoscale.substances..What.is.less.clear.is.whether.
the.ECHA.will.consider.each.nanoscale.substance.as.equivalent.to.the.macroscale.
version..If.so,.registrants.would.be.required.to.develop.the.necessary.data.set.required.
under.Article.10.for.the.dossier.and.provide.guidance.on.the.safe.use.of.these.materi-
als.as.a.condition.of.pre-market.approval.[69].
.See.REACH.Art..31-39;.see.generally.ECHA,.“Downstream.Users,”.available.at.http://reach.jrc.it/down-
stream_users_en.htm..Note.that.only.EU.entities.are.DUs.under.REACH..See.REACH.Art..3(13)
..See.REACH.Art..56..Annex.XIV.will.specify.for.each.SVHC.a.date.after.which.the.placement.on.
the.market.and.use.of.the.substance.will.be.prohibited.unless.an.authorization.is.granted..See.REACH.
Art..58(1)(c)(i).
.See.REACH.Art..2(1)-2(2);.see.generally.ECHA,.Guidance.for.the.Navigator.(June.2007).at.7-9,.
available. at. http://reach.jrc.it/03_rdds_web_content/navigator_en/navigator_en.pdf.. Given. that. all.
aspects.of.the.regulation.are.inapplicable,.it.is.probably.more.accurate.to.state.that.these.substances.
are.excluded.from.REACH.
 
Search WWH ::




Custom Search