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What's on the REACH Authorization List?
Regulation EU 125/2012
Regulation EU 143/2011
On February 14, 2012,
the European Commission amended
REACH Annex XIV to include
an additional eight substances, bringing the total to 14. These are very
toxic substances whose use is generally prohibited after the "sunset
date" unless an "authorization for use" has been obtained by the
manufacturer/importer.
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Substance name: |
Property: |
Application: |
Sunset date: |
1.
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5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)
EC # 201-329-4, CAS # 81-15-2 |
vPvB
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Jan 21, 2013
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Jul 21, 2014
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2.
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4,4'-Diaminodiphenylmethane
(MDA)
EC # 202-974-4, CAS # 101-77-9 |
Carcinogen
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Jan 21, 2013
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Jul 21, 2014
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3.
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Hexabromocyclododecane (HBCDD)
EC # 247-148-4,
221-695-9
CAS # 25637-99-4,
3194-55-6
Alpha-hexabromocyclododecane
CAS # 134237-50-6
Beta-hexabromocyclododecane
CAS # 134237-51-7
Gamma-hexabromocyclododecane
CAS # 134237-52-8 |
PBT
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Jan 21, 2014
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July 21 2015
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4.
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Bis(2-ethylhexyl)phthalate
(DEHP)
EU # 204-211-0, CAS # 17-81-7 |
ToxicRepro
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Jul 21, 2013
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Jan 21, 2015
* |
5.
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Benzyl butyl
phthalate (BBP)
EC # 201-622-7, CAS # 85-68-7 |
ToxicRepro
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Jul 21, 2013
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Jan 21, 2015
* |
6.
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Dibutyl
phthalate (DBP)
EC # 201-557-4, CAS # 84-74-2 |
ToxicRepro
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Jul 21, 2013
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Jan 21, 2015
* |
7.
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New
Diisobutyl phthalate (DIBP)
EC # 201-553-2, CAS # 84-69-5 |
ToxicRepro
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Aug 21, 2013
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Feb 21, 2015
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8.
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New Diarsenic trioxide
EC # 215-481-4, CAS # 1327-53-3 |
Carcinogen
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Nov 21, 2013
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May 21, 2015
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9.
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New Diarsenic pentaoxide
EC # 215-116-9, CAS # 1303-28-2 |
Carcinogen
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Nov 21, 2013
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May 21, 2015
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10.
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New Lead chromate
EC # 231-846-0, CAS # 7758-97-6 |
Carcinogen
ToxicRepro |
Nov 21, 2013
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May 21, 2015
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11.
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New Lead sulfochromate yellow
(C.I. Pigment Yellow 34)
EC # 215-693-7, CAS # 1344-37-2 |
Carcinogen
ToxicRepro
|
Nov 21, 2013
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May 21, 2015
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12.
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New Lead chromate molybdate
sulphate red (C.I. Pigment Red 104)
EC # 235-759-9, CAS # 12656-85-8 |
Carcinogen
ToxicRepro
|
Nov 21, 2013
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May 21, 2015
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13.
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New Tris (2-chloroethyl)
phosphate (TCEP)
EC # 204-118-5, CAS # 115-96-8 |
ToxicRepro
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Feb 21, 2013
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Aug 21, 2015
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14.
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New 2,4-Dinitrotoluene (2,4-DNT)
EC # 204-450-0, CAS # 121-14-2 |
Carcinogen
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Feb 21, 2014
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Aug 21, 2015
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* Uses in the
immediate packaging of medicinal products are exempted |
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Authorizations are granted by the European Commission, not ECHA.
A separate authorization must be obtained for each specific use of a substance by
each manufacturer/importer with that use. Exception: you may
rely upon an authorization granted to your immediate downstream
user or to an actor up your supply chain. |
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Manufacturers/importers who wish to continue
using the substance after the sunset date must submit an
application at least 18 months in advance. The deadline for
current users to submit an application is known as the
"application date". |
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An application
for authorization requires an extensive dossier with a high
burden of proof. Applicants
must demonstrate one of the following: |
 |
The risk to
human health or the environment is adequately controlled per
Annex I, Section 6.4 |
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The benefits of use
outweigh the risks to human health or the environment (as
demonstrated by a
socio-economic analysis) |
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Note:
socio-economic analysis is required if the substance is PBT/vPvB
or if safe use thresholds cannot be determined |
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Authorizations
are granted for a limited time,
usually with conditions of use (including monitoring), and
are subject to review. |
This summary of REACH Priority Substances is designed to provide you with an accurate, easy-to-understand
overview of the topic and does not constitute legal advice. The actual
standard in the original language should be reviewed and used for all
business, legal, and product compliance purposes.
RSJ provides a number of
REACH compliance services that can be tailored
to the needs of your company.
We provide awareness training, BOM scrub, compliance program
implementation, compliance software evaluation, product risk assessment,
and REACH reporting services. We are here to help you!
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