2020-2021, many countries/regions are continuously updating their chemical
regulations and many chemical regulations are expected to be issued in the
future, including EU REACH evaluation, Brexit, nanomaterials regulations, etc.
which may greatly influence a great number of enterprises which are introducing
chemical products into these countries/regions.
In addition to these regulations, enterprises also need to
give prominence to some special regulations which will be implemented in the
next 1-2 years. CIRS is summarizing the main updates and prospect of influential
chemical regulations in 2020-2021 as following:
ECHA’s focus changes into increasing
and accelerating the compliance check of the registered dossiers.
Guidance documents for registering
nanomaterials have been updated and additional information requirements have
applied since 1 January 2020.
New Poison Centre Notification (PCN) requirements
for the hazardous mixtures placed on the EU market have been applied since 1
January 2021, Unique Formulator Identifier (UFI) shall also be assigned for
classification and package;
Amended K-REACH regulation is applied to >=1t/y
existing chemical substances, new chemical substances and exemption
Pre-registration for non-PEC existing substances ended
on 30 June 2019. Late pre-registration mechanism is applied to qualified
Full registration is in progress for >=1t/y
existing chemical substances to meet registration deadlines on the tonnage
The UK withdrew from the EU on 31
January 2020. A transition period applies until 31 December 2020, unless it
is decided to extend it.
EU law continues to apply to and in
the UK during the transition period.
A new chemical regulatory framework UK
REACH is supposed to be established from 1 January, 2021 if the UK and EU do not reach a deal.
KKDIK (Turkey REACH)
Applicable substances >=1t/y can be
pre-registered before 31 December 2020 to obtain a grace period.
Substances with volume above 1t/y
shall be registered before a given deadline 31 December 2023.
All entries of KKDIK on Annex XIV Authorization List and Annex
XVII Restricted Substance List will be the similar with EU REACH list.
Russian Inventory Nomination
The inventory compilation is the preparatory
measure for the future implementation of Eurasia REACH (TREAEU041/2017).
All chemicals circulated in EAEU, present in the
concentrations of more than 0.1 % in chemical product are subject to the
inventory notification with the deadline till 1 Aug 2020.
The current China REACH regulation
(MEP Order No.7), promulgated on 19 January, 2010, will be replaced with
MEE Order No.12 since 1 January 2021.
The application type settings and data submission requirements are
The new regulation would focus more on the management and control of
high-risk new chemical substances with PBT properties.
Measures for the Administration of Road Transportation Safety of Dangerous Goods
The “Measures” (Order No.29  of
the Ministry of Transport) have come into force since 1 January 2020.
Standardize some definitions and
expressions in the Measure; penalty provisions and responsibility provisions
are indicated in more details.
Dangerous goods that meet the transport conditions of exceptional
quantity or limited quantity are expected to be exempted from some
Relevant guidance documents on limited
quantities and excepted quantities will be released in the future.
Assigned hazardous chemicals shall be
transported by corresponding special vehicles.
The "Amended Regulation of New and Existing
Chemical Substances Registration" was releases on 11 March, 2019 and the
guidance document was released in 9 June 2020.
The standard registration for first batch of
existing substances starts from 1 January, 2020 with 2- or 3-year
Phase I registration
(pre-registration) is applied to chemical substances < 100kg/y (not
available before the amendments);
The previous NICNAS is expected to be
replaced with "Australian Industrial Chemicals Introduction Scheme"
(AICIS) from 1 July 2020.
The requirements of introduction are
based on the risk level of introductions.
Australian Inventory of Industrial
Chemicals (AIIC) is established.
Chemicals (Management & Safety) Rules in India
The draft regulation is similar to the
K-REACH Regulation but it is expected to be revised in the future.
The "Draft" introduces
notification similar to pre-registration under EU REACH; Notification will be
applied to all existing substances and new substances placed in Indian
territory within the initial notification period.
The definition of “Priority substance”
is introduced under the "Draft" Full registration is required for
>=1t/y priority substances before a given registration deadlines on the
tonnage band basis.
An annual report for
notified/full-registered substances shall be submitted every year.
send an email firstname.lastname@example.org contact Ms Judy Li Judy.Li@cirs-group.com to obtain full report in Chinese or English for the “Updates
and Prospect of Influential Chemical Regulations for 2020-2021” free of charge.
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Influential Chemical Regulations for 2020-2021
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