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Asia Update


Nearly 48,000 KKDIK pre-registrations submitted

According to the Ministry of Environment and Urbanisation (MoEU), companies have submitted nearly 48,000 pre-registrations so far under Turkey’s REACH regulation (KKDIK).

Under KKDIK, substances manufactured/imported ≥ 1 tonne/year must be pre-registered by 31 December 2020 and registered by 31 December 2023.

The MoEU has recently received funding from the EU, part of which will be used to upgrade its IT system KKS. There have previously been issues with the system, including glitches that have rendered it out of action temporarily.

7 institutions have also now been approved by the MoEU to deliver chemical assessment expert training.


New MEP Order 7 under consultation

On 9th July, the Ministry of Ecology and Environment (MEE) has published a draft regulation “Regulation on environmental risk assessment and control of chemical substances” to revise the existing “Measures for the Environmental Management of New Chemical Substances” (MEP Order 7). The Ministry is accepting public comments until 16th August 2019.

The amendment aims at tightening the rules for managing chemicals of high risk and at promoting green chemistry. The main changes are as follows:

  • R&D substances M/I < 100 kg/y: scientific research record notification will no longer be required.
  • Substances M/I < 1 t/y or polymers of low concern: record notification will be required (not requiring testing) while simplified notification will not be needed.
  • Substances M/I 1-10 t/y: Simplified notification will be required instead of Regular notification. Regular notification will still be required for substances M/I at or above 10t/y.
  • Long term toxicity tests will be required based on concerns around hazards and the exposure, and not simply on tonnage band. For example, if the substances are persistent bioaccumulative or toxic to reproduction (PBT) and there is a concern about the level of exposure.
  • The procedure for chemical assessment will also be updated and post-registration management will be implemented.

Ref: MEE announcement

MEE allows the industry to nominate substances in IECSC Before October

On 21st June 2019, Ministry of Ecology and the Environment (MEE) published an announcement regarding nominating substances into IECSC. Chinese importers/ manufacturers, foreign companies or industrial associations are allowed to nominate their substances into IECSC by 30 September 2019 if the substances meet all of the following criteria:

  • The substance was legally manufactured/imported in China before 15th Oct 2003.
  • The substance is not exempted under MEP Order 7

Industry can submit the following information to MEE to apply for the nomination:

  • Basic information about the company nominating the substance, including company name, address, contact person, telephone, fax, email, the number of substances for nomination.
  • Basic information on the substance including substance name in Chinese and English, CAS number, molecular formula and structural formula, main uses and evidence that the substance was manufactured/imported before 15th October 2003 (evidence can include invoices, import/export declarations, industry statistics, open publications)

The MEE has said it will evaluate the information in 10 working days and will publish the result on the MEE website. There are two potential outcomes of the MEE review:

  • If the substance is regarded as existing substance by MEE, it will be listed in the IECSC;
  • If there is insufficient evidence, the substance will be regarded as a new substance and so the substances would be subject to notification under MEP Order 7.

Ref: MEE notice


Japan aligns its standards with GHS Revision 6

Japan’s Ministries of Economy, Trade and Industry (METI) and Health, Labour and Welfare and (MHLW) have released new standards on the classification of chemicals, labelling and Safety Data Sheets. The below standards align to UN GHS Revision 6:

  • JIS Z 7252 – chemical classification for GHS labelling; and
  • JIS Z 7253 – hazard communication for GHS labelling and SDS

Companies have three years (until 24 May 2022) to implement the changes. Before this time, the previous versions (published in 2012 and 2014) can be used. METI is in the process of drafting guidance documents to help the industry understand the changes.

Ref: METI and MHLW announcement; Database of industrial standards

MHLW published 194 existing substances

Ministry of Health, Labour and Welfare (MHLW) publishes the quarterly Official Gazette in which 194 chemicals are designated as existing substances under the Industrial Safety and Health Law (ISHL).

The ISHL number and the English name found in the CHRIP database while the Japanese name and the ISHL number can be found in the Gazette.

Ref: CHRIP database; Official Gazette

MHLW releases revision to list of poisonous and deleterious substances

On 19th June, the Ministry of Health, Labor and Welfare (MHLW) amended the list of poisonous and deleterious substances, adding eight substances into the Deleterious Substances List and removing three from it.

Substances added into the Deleterious Substances List

  • Aluminium chloride and preparations containing aluminium chloride (CAS 7446-70-0)
  • Cyclohex-4-ene-1,2-dicarboxylic anhydride and preparations containing cyclohex-4-ene-1,2-dicarboxylic anhydride (CAS 85-43-8)
  • Didecyl(dimethyl)ammonium chloride and preparations containing no less than 0.4% dodecyl (dimethyl) ammonium chloride (CAS 7173-51-5)
  • 2-(Dimethyl)aminoethanol and preparations containing no less than 3.1% 2-(Dimethyl)aminoethanol (CAS 108-01-0)
  • Trichloro(phenyl)silane and preparations containing trichloro(phenyl)silane (CAS 98-13-5)
  • Hexanoic acid and preparations containing no less than 11% hexanoic acid (CAS 142-62-1)
  • Heptanoic acid and preparations containing no less than 11% heptanoic acid (CAS 111-14-8)
  • Pentanoic acid and preparations containing no less than 11% pentanoic acid (CAS 109-52-4)

Substances removed from the Deleterious Substances List

  • 4-(2,2-Dicyanoethene-1-yl)phenyl=2,4,5-trichlorobenzene-1-sulfonate and preparations containing 4-(2,2-Dicyanoethene-1-yl)phenyl=2,4,5-trichlorobenzene-1-sulfonate (CAS 126980-24-3)
  • Preparations containing less than 6.4% 2-(Dimethylamino)ethyl methacrylate (CAS 2867-47-2)
  • Preparations containing less than 0.3% lithium hydroxide monohydrate (CAS 1310-66-3)

The additions to the PDSL came into effect on 1st July 2019 (with a grace period until September 30 this year), and the removals came into effect upon the release of the amendment.

Ref: Amendment to the Cabinet Order on the Designation of Poisonous and Deleterious Substances

NITE nominated decaBDE and HBCD as a low concern in consumer products

National Institution of Technology and Evaluation (NITE) concluded that the substances 1,2,5,6,9,10-hexabromocyclododecane (HBCD) and decabromodiphenyl ether (decaBDE) are of low concern for Japanese people.

Ref: NITE announcement

South Korea

Pre-registration deadline passed

30th June 2019 was the pre-registration deadline under K-REACH. Companies that pre-registered the substances by this date have been granted grace periods in which to put a K-REACH registration in place. Companies that have pre-registered must now state their intention to become the Lead Registrant, and Active Registrant or a Passive Registrant within each substance SIEF.

Companies manufacturing/importing above 1 t/y for the first time after 30 June 2019 can submit a late pre-registration through the online system and should retain evidence of the manufacture/import volumes being <1 t/y, as evidence in case of inspection. Those who imported above 1 t/y before the pre-registration deadline but who missed the opportunity to pre-register should put the registration in place immediately.

Notification of products containing Priority Control Substances starts

According to K-REACH, products satisfying one of the following criteria will need to be notified through the online system.

  • Products containing > 0.1% w/w Priority Control Substances;
  • The total amount of the substance across products is > 1 t/y.

The information required includes the name, use, content, hazard, exposure information of the substance. There are 672 Priority Control Substances, and these are divided into two lists.

  • List 1 contains 204 substance with an implementation date of 1st July 2019;
  • List 2 contains 468 substances with an implementation date of 1st July 2021.

Ref: Online notification system; Priority Control Substance List

128 substances are added to the list of substances hazardous for use in children’s products

On 8th July, the Ministry of Environment (MOE) added 128 substances to the list of substances hazardous for use in children’s products under the Environmental Health Act. There are now 263 substances on the list. The MOE will conduct risk assessments on them for their toxicity or carcinogenicity for human health.

Ref: List of substances hazardous for use in children’s products


Application for extension of data submission allowed from 2nd July

On 2nd July, EPA published an announcement on the “clock stop” process during new chemical registration and PLC confirmation.

If, during the review of new substance registrations, the EPA decides to “clock stop”, the applicant should submit the data required within 30 working days. If the relevant data cannot be submitted during this time due to technical issues, the applicant can apply for an extension by notifying the EPA. The EPA will review the application and agree to a date for data submission. Once the date is set by the authority, it cannot be changed. It is also important to note that a registrant will only have two chances to supplement the dossier.

Ref: EPA announcement


First draft of Thailand’s chemical management law is released

A proposal for Thailand’s new chemical law (B.E. No. 1/2562) has been published, which would replace the current Hazardous Substance Act. The draft intends to adopt a risk-based approach to chemical management. A national chemicals agency would support the processes required by the regulation and would provide information on how hazardous substances should be managed. The draft proposes three new substance classifications:

  • Low-risk substances: may be subject to obligations regarding import/export, manufacture, storage and disposal.
  • High-risk substances: a license must be attained in order to manufacture or import these substances, licenses will last 6 years after being granted.
  • Prohibited substances: these substances will be banned unless specific exemptions are made or if such substances are unavoidable contaminants.

The above substance classifications would replace the current type 1, 2, 3 and 4 hazardous substance classes. A national inventory of existing chemicals is expected around 2020.

Ref: First draft of Thailand’s chemical management law


NICNAS publishes common Q&As about the new regulatory scheme

NICNAS has released answers to the most commonly asked questions about the new Industrial Chemicals Introduction Scheme (AICIS).

Ref: Q&A section

New Zealand

New Zealand updates NZIoC

New Zealand’s national chemical inventory has been updated. The latest amendment adds 159 chemicals, change the status of 3 and deletes 28.

Ref: NZIoC

Contact us to discuss your requirements with one of our regulatory experts.

Authors: Tan Sun and Sophie Guinard