Updates and Prospect of Influential Chemical Regulations around the World for 2020-2021

Regulation

Key Points

EU REACH

• 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.

CLP regulation

• 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;

Korea REACH

• Amended K-REACH regulation is applied to >=1t/y existing chemical substances, new chemical substances and exemption applications.
• Pre-registration for non-PEC existing substances ended on 30 June 2019. Late pre-registration mechanism is applied to qualified existing substances.
• Full registration is in progress for >=1t/y existing chemical substances to meet registration deadlines on the tonnage band basis.

UK REACH

• 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.

China REACH

• 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 more optimized.
• 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 [2019] 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 transportation requirements.
• 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.

Taiwan TCSCA

• 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 registration deadlines.
• Phase I registration (pre-registration) is applied to chemical substances < 100kg/y (not available before the amendments);

Australia AICIS

• 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.