SinoApps EU REACH
FACT SHEET
What is REACH
· REACH stands for Registration, Evaluation, and Authorization of Chemicals (REACH). It is the new EU Chemical legislation, which came into force on June 1st 2007.
· REACH is to make the business that places chemicals on the market (mainly manufacturers and importers) responsible for understanding and managing the risks associated with their use. It replaces previous patchwork of European Directives with a single system.
· REACH requires every manufacturer and importer who imports or manufacturers more than 1 metric ton per year of substance of intended to be released must Register that substance with the European Chemicals Agency (ECHA) for Evaluation and Authorization.
· REACH also requires every manufacturer and importer who has a substance of very high concern (SVHC) at a level greater than 0.1% and greater than 1 metric ton per year must Notify the ECHA.
·
Failure
to Register means that the substance will not be allowed to be manufactured or
imported in the EU (“No data, No market” policy)
Key Events
Pre-Registration:
Give notice to the ECHA
(European Chemicals Agency) all substances that you intend to REGISTER. Only
pre-registered substances benefit from phase-in periods and can continue to be
sold before full registration is complet
Pre-Registration Time: June 2008 – November 2008
Registration:
Provide full information to ECHA (either by your EU importer or by your “Only Representative”) any substances covered by REACH that are intended to be released from the product.
Registration
will be phased in from June 2008 –June 2018 based on annual tonnage imported
Notification:
Notify ECHA any Substances
of Very High concern (SVHC) in any part of the product which is listed on the
ECHA Candidate List.
What is SVHC
SVHC stands for Substance of Very High Concern. SVHC will require authorization to be placed on the EU market. Currently ECHA is working on the Candidate list (“black list”) of SVHC, estimated about 1500 substance. Candidate List will be published late 2008 and notification will be required 6 months afterwards. The followings are well-know SVHCs and require authorization:
· R50-53 substance: PBTS and vPvBs. Dangerous for the environment; Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
·
CMR1/2 substance: cancer causing
substance including
Carc. Cat. 1; R45
May cause cancer.
Carc. Cat. 1; R49 May
cause cancer by inhalation.
Carc. Cat. 2; R45
May cause cancer.
Carc. Cat. 2; R49
May cause cancer by inhalation.
Mutagenicity Genetic Toxicity
Muta. Cat. 1; R46
May cause heritable genetic damage.
Muta. Cat. 2; R46
May cause heritable genetic damage.
Toxicity
to reproduction fertility
Repr. Cat. 1; R60
May impair fertility.
Repr. Cat. 2; R60
May impair fertility.
Toxicity
to reproduction development
Repr. Cat. 1; R61
May cause harm to the unborn child.
Repr. Cat. 2; R61
May cause harm to the unborn child.
Pre-registration
Why Pre-register?
If you fail to pre-register a chemical substance, you
cannot continue manufacturing or importing it after Dec 1 2008 until you have
completed a full registration with the ECHA. The benefits
of Pre-register are:
·
Transitional
registration deadline: You can establish Envisaged Registration Deadline much
later
·
Continue
manufacturing/ importing: You can continue manufacturing/importing your
products before envisaged registration deadline.
·
Obtain grace period to prepare
for
full registratio
Without Pre-registration, you
run into the risk of inquiry by ECHA and suspension of
manufacturing/importing.
Pre-registration must be done between June 1st 2008 and
November 30th 2008
What information is required in Pre-registration?
·
The name of the substance
plus its EC numbers or CAS numbers
·
The name and address
of the manufacturer or importer or person representing them.
· The weight of substance (in tonnage band) you import
Who can Pre-register?
·
EU Manufacturer
·
EU Importer
· “Only Representative” of non-EU supplier
What is “Only
Representative”?
If you are a non-European based manufacturer having an interest in importing substances on your own, in preparations or articles you will have to appoint a natural or legal person established in the Environmental Compliance Community as your Only Representative. The Only Representative will have to fulfill all obligations of the importer under the REACH Regulation. They can work with ECHA directly on your behalf to register substances.
How to Pre-Register?
If you are a non-European based
manufacturer, you need to first identify the substances need to be
pre-registered in your products and provide IUCLID 5 Pre-Registration XML about
those substances to your “Only Representative” for Pre-Register.
What is “Article”?
Article is EU REACH term, it stands for “An object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition”. Normally it represents a finished product or equipment component that you import to EU.
What is
“Substance”?
According to EU REACH, Substance is A “chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition”. Normally it’s a single chemical with CAS #.
Guideline
for EU REACH Pre-Registration Process
As REACH is a complex piece
of legislation with many aspects still to be clarified, we propose the
following guidelines for Pre-Registration:
·
Collect and store all
the substances of Intended to release on your products (See example here)
·
Generate Substance
REACH Status Report (See example here) to identify the substances to be
pre-registered.
·
Generate IUCLID 5
Pre-Registration XML file.
·
Provide
Pre-Registration XML file and work with your “Only Representative” to PRE-REGISTER between June – November 2008
·
Prepare to NOTIFY the
Chemicals Agency of any SVHC