Environmental Engineering Reference
In-Depth Information
(reformatted).text,.and.hundreds.of.pages.of.guidance,.with.the.latter.igure.expected.
to.grow.considerably.as.more.guidance.is.issued.
The. core. of. REACH. is. its. registration. requirement,. which. mandates. that. all.
chemicals. manufactured. or. imported. into. the. EU. in. quantities. of. 1. metric. ton. or.
more. per. year. be. registered. with. the. newly. created. European. Chemicals. Agency.
(ECHA).
.The.registration.obligation.applies.to.legal.entities.—.all.manufacturers.
and.importers.of.“substances”.on.their.own.or.in.“preparations”.(i.e.,.mixtures),.and.
all.producers.and.importers.of.“articles”.meeting.certain.criteria.—.that.are.estab-
lished.within.the.EU.and.that.meet.the.1-metric-ton-per-year.threshold.
Registration. will. entail. the. generation. of. substance-speciic. health. and. safety.
data;.preparation.of.a.technical.dossier;.and.for.those.substances.manufactured.or.
imported.in.quantities.of.10.metric.tons.or.more.per.year,.an.assessment.of.the.risks.
posed.by.the.substance,.including.relevant.exposure.scenarios,.and.the.development.
and.communication.of.appropriate.risk.management.measures.[56].
For.“phase-in.substances,”.which.include.existing.chemicals,
.the.registration.
process.will.proceed.in.phases..To.beneit.from.the.extended.registration.deadlines.
—. 3½,. 6,. and. 11. years. from. June. 1,. 2007,. depending. on. the. annual. volume. and.
hazard.of.the.substance.—.manufacturers.and.importers.(as.well.as.producers.and.
importers. of. certain. articles). must. pre-register. their. substances. between. June. 1,.
2008,.and.December.1,.2008.
.Pre-registration.will.enable.a.company.to.continue.
manufacturing.or.importing.the.substance.until.the.extended.registration.deadline.
is.reached.
For.most.entities,.the.initial.step.under.REACH.will.be.the.pre-registration.of.
phase-in. substances.. Pre-registration. will. entail. the. electronic. submission. to. the.
ECHA.of.certain.basic.information.on.the.chemical.and.the.pre-registrant.[57,.58]..
By. January. 1,. 2009,. the. ECHA. intends. to. publish. on. its. website. a. list. of. the. pre-
registered.substances..The.list.will.not.identify.the.pre-registrants,.but.this.informa-
tion.will.be.available.to.all.companies.that.have.pre-registered.the.same.substance.
[58]..The.companies.will.then.be.required.to.participate.in.a.Substance.Information.
Exchange.Forum.(SIEF).for.the.substance,.with.the.aim.of.the.SIEF.being.to.facili-
tate.the.sharing.of.existing.data.on.the.chemical,.the.collective.identiication.of.data.
gaps,.and.cost-sharing.with.respect.to.the.generation.of.any.new.data.[59,.60].
.See.REACH.Art..5-7..Under.Article.5,.the.non-registration.of.a.substance.that.is.required.to.be.reg-
istered.means.that.the.substance.cannot.be.manufactured,.imported,.or.otherwise.placed.on.the.EU.
market..This.REACH.principle.is.often.referred.to.as.the.“no.data,.no.market”.principle.
.See.REACH.Art..3,.6-7;.see.generally.ECHA,.Guidance.on.Registration.(June.2007).at.19-21,.avail-
able.at.http://reach.jrc.it/03_rdds_web_content/.registration_en/registration_en.pdf..Deinitions.of.the.
key.REACH.terms.appear.in.Article.3.of.the.regulation.
.The.term.“phase-in.substance”.is.deined.in.REACH.Article.3(20).
See.REACH.Art..23,.28;.see.generally.Guidance.on.Registration.at.41-44,.52..Final.guidance.on.the.
pre-registration.process.is.expected.soon.
.See.REACH.Art..21(1),.23(1)-(3);.see.generally.Guidance.on.Registration.at.52;.ECHA,.Guidance.on.
Data. Sharing. (Sept.. 2007). at. 20,. available. at. http://reach.jrc.it/docs/guidance_document/data_shar-
ing_en.pdf..Pre-registration.is.not.required;.but.for.a.phase-in.substance.that.is.not.pre-registered,.the.
company.cannot.legally.manufacture.and/or.import.the.substance.subsequent.to.June.1,.2008,.until.
3.weeks.after.it.has.submitted.a.complete.registration..See.Guidance.on.Registration.at.52;.Guidance.
on.Data.Sharing.at.23.
