|
What is
REACH?
REACH
is short for the Registration, Evaluation and Authorization of Chemicals.
Regulation (EC) 1907/2006
The following
summary is intended to familiarize you with the key concepts in REACH and provide a
broad framework for understanding this exceedingly complex piece of
legislation.
The
purposes of REACH:
(as set forth in the
131 recitals of the preamble)
|
§ |
Establish a
comprehensive and detailed database
of the chemical substances in the European Community: manufactured,
placed on market, imported or used |
|
§ |
Motivate companies
to develop cost-effective and safer
alternatives to hazardous substances by requiring the
evaluation of all substances (not just new ones) |
|
§ |
Shift
responsibility for testing and risk
evaluation from government and regulatory authorities to
the manufacturers or importers of the substances, producers of
articles and downstream users |
|
§ |
Establish
graduated requirements for
testing and risk evaluation based upon the likelihood of causing
harm to human health or the environment: |
| |
i.e. increasing
quantities
of the substance
(manufactured, imported or used) increase the likelihood of harm |
| |
i.e. substances having
certain dangerous
characteristics (carginogenic, mutagenic, toxic to reproduction;
persistent, bioaccumulative and toxic or very persistent and very bioaccumulative; very toxic to aquatic organisms; probable serious
effects) increase the likelihood of harm |
|
§ |
Reduce duplication
of testing (especially on vertebrate animals) through mandatory
information sharing, with
cost sharing required in the
first twelve years |
|
§ |
Establish a
mechanism for controlling or restricting
the use of hazardous substances (the provisions for evaluation of
substances, authorization & restrictions) |
|
§ |
Establish an
independent agency (ECHA) to manage the
regulation of chemical substances |
The
focus of REACH
is on substances:
It is
the substance rather than the finished product
that is subject to the requirements of REACH.
Each substance in the
product should be considered for registration, notification, classification,
etc. (although many will meet the criteria for exemption). Under REACH,
substances are defined as being either 'in themselves', in a preparation, or
in an article, with different criteria applying to each.
|
§ |
Substance 'in
itself': a chemical element and its compounds, including
additives necessary to preserve stability and impurities derived
from processing |
|
§ |
Preparation: a mixture or solution
composed of two or more substances |
|
§ |
Article:
an object whose function is determined by its shape, surface or
design rather than by its chemical composition |
The
requirements
of REACH:
(these function
independently of each other, and exemption from one requirement does not
necessarily mean an exemption from the others)
|
REGISTRATION of SUBSTANCES: |
| |
Applies to
manufacturers/importers of substances 'in themselves' or in
preparations. Also applies to producers/importers of substances in
articles that are 'intended to be released'. |
| |
Registration is required when quantity
of substance is 1 tonne
or more per year in the European Community. One metric tonne
equals 1000 kg or about 2204 lbs. |
| |
Chemical safety
assessment is required for manufacturers/ producers/importers with 10 tonnes or more.
Testing requirements increase with tonnage. |
|
|
Effective
date was June 1, 2008. However,
registration deadlines for 'phase-in' substances that were pre-registered
in 2008 are
staggered over the next decade:
|
|
|
Dec 1, 2010:
1 tonne if carcinogenic/mutagenic/toxic reproduction
Dec 1, 2010:
100 tonnes if very toxic to aquatic organisms
Dec 1, 2010:
1,000 tonnes
June 1, 2013:
100 tonnes
June 1, 2018: 1
tonne |
|
SAFETY DATA SHEET: |
| |
Applies to
manufacturers/importers of
substances 'in themselves' or in preparations.
|
| |
Safety data sheets must be provided to
recipient of substance/ preparation when the substance has certain 'dangerous'
characteristics. There is no quantity threshold. |
| |
Effective date was
June 1, 2007. |
|
DOWNSTREAM USERS: |
| |
Applies to
commercial/industrial users (in the EU) of substances 'in themselves'
or in preparations. |
| |
Downstream users report to ECHA is
required for any use of a
'dangerous' substance that is not identified by supplier's SDS (or
is advised against). There is no quantity threshold. |
| |
Chemical
safety assessment is required when
user's total quantity is 1 tonne or more and supplier's quantity is 10 tonnes
or more. |
| |
Effective
date was June 1, 2008. |
|
CLASSIFICATION and
LABELING: |
| |
Applies to
manufacturers/producers/importers of substances
'in themselves', in preparations and in articles. |
| |
Notification to ECHA is required for
'dangerous' substances of the substance's identity, hazard
classification & hazard label.
There is no quantity threshold; separate notification is not needed
if registration is required. |
| |
Effective
date
is December 1, 2010.
|
|
SUBSTANCES of VERY HIGH CONCERN: |
| |
Applies to
producers/importers of articles. |
| |
Safe use
information must be provided to recipient of article when
SVHC is present.
There is no quantity threshold. |
| |
Notification to ECHA is required when
quantity of SVHC is over 1 tonne and concentration in
articles is
above 0.1%. Separate notification is not needed if registration is
required. |
| |
Effective date is
June 1, 2011. Notification is required
six months after the SVHC is added to the 'candidate list'. |
|
RESTRICTED SUBSTANCES: |
| |
Applies to
manufacturers/producers/importers of substances
'in themselves', in preparations and in articles. |
| |
Use
of a substance listed in
Annex XVII must comply with the
conditions specified in the annex. No report to ECHA is
required. |
| |
Effective
date was June 1, 2009. |
|
AUTHORIZATION: |
| |
Applies to
manufacturers/producers/importers of substances
'in themselves', in preparations and in articles. |
| |
Each separate use of
a substance listed in
Annex XIV must
be authorized by the European Commission (not ECHA).
Authorizations
usually include conditions of use and a specified review period. |
| |
Effective
date was June 1, 2008. However, Annex
XIV is currently empty. |
This summary is
intended to give you an easy-to-understand overview 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.
If you need assistance
in implementing or managing your company's REACH compliance, we stand ready
to help you. Just
email
us or give us a call at 972-679-8996 for a quick and personalized
response.
top
Copyright ©
2009 -- All Rights Reserved
RSJ
Technical Consulting
PO Box 867705, Plano, Texas 75086
|
