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Scope of China
REACH 2010 |
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“New” chemical substances, i.e. those
that are not listed in the Inventory of Existing Chemical Substances
(IECSC) |
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Chemical substances
used as raw materials and intermediates of pharmaceuticals,
pesticides, veterinary medicines, cosmetics, food, food additive,
feed additive |
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Chemical substances intentionally released from articles in their
normal use |
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Chemical substances
produced, imported, processed or used in the People’s Republic of
China, including bonded areas and export processing areas |
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MEP regulation of new
chemical substances |
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Producer/importer
must submit a notification prior to the
production or import of the substance |
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The notifier must
be an institution registered in China |
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CRC must issue a registration certificate before the
substance can be produced, imported, processed or used (about 80 to
90 days) |
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Registration
certificate for the substance will indicate its registered purpose,
quantity grade, risk management category and the risk control
measures required by the MEP |
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Registrant must file first activity report
within 30 days of first production or delivery of the substance |
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CRC will follow the substance for a five-year period during which
the registrant must file annual reports and a final report of actual
activity |
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Substances are
listed in the IECSC five years after the date of first production or
import |
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Three types of notification, based on annual tonnage |
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Regular notification – one tonne
annually or more |
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Includes material
safety data sheet (MSDS), safety classification, precautionary
labeling/statements, hazard assessment, environmental and health
risks, exposure scenarios and risk control methods |
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Requires test reports of physicochemical, toxicological and
eco-toxicological properties, including eco-toxicological testing
conducted in China on a Chinese test species |
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Four "quantity
grades" have increasing testing requirements: 1 tonne (Grade 1), 10
tonnes (Grade 2), 100 tonnes (Grade 3) and 1,000 tonnes (Grade 4) |
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Must file a new notification if quantify grade increases |
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Simplified notification - less than one
tonne annually |
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Requires a
simplified notification form and eco-toxicological testing conducted
in China on a Chinese test species |
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Filing notification – less than 0.1
tonne annually used for scientific research (or eco-toxicological
testing on a Chinese species) |
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Submit filing form
only |
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Three "management
categories" for new chemical substances |
|
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General – hazardous properties in
substance are below specified values (or haven’t been found yet) |
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Hazardous – substance contains
physicochemical, human health or environmental hazard properties
above specified values |
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Priority environmental management
–
substance is persistent, bio-accumulative and hazardous to human
health or the environment |
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Must follow "major
risk control measures" such as discharge monitoring during
production, processing and use; appropriate delivery equipment to
prevent accidents; hazardous waste disposal provisions |
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Must file delivery
report within 30 days of each delivery to a customer |
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Must file new
notification if registered purpose changes |
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Publication of
records |
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Notifier may
request confidentiality for business and technical secrets |
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Information
involving hazards to human health or environmental safety may not be
kept confidential |
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MEP will post all
certificates of registration on its website, as well as the
"registration contents” of regular notifications |
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Registrant must
keep notification and actual production records for at least 10
years |
