A Year In Review: Global Chemical Regulatory Updates 2023

05 Mar 2024

Explore 2023's global chemical regulatory updates ensuring safety, management, & responsible use across borders in diverse measures & standards.

Introduction

This blog provides information on some of the key global chemical regulatory updates for the year 2023. The updates reflect ongoing developments in regulations and standards and encompass a diverse range of measures implemented by various global entities, organizations, and intergovernmental bodies to ensure safety, proper management, and responsible use of chemicals across borders.

Korea REACH (K-REACH)

South Korea's Ministry of Environment (MoE) has released an updated list of pre-registered substances under the K-REACH regulation. As of 31 December 2023, a total of 232,924 pre‑registration applications were submitted for 17,43 chemical substances, 77 being carcinogenic, mutagenic, or reprotoxic (CMR) substances. Approximately 9% of the pre‑registered substances are produced or imported at over 1,000 tons/year.

About 18% of the pre-registered substances fall within a maximum tonnage band of 100 to 1,000 tons/year, and relevant stakeholders must complete joint registration before the second registration deadline of 31 December 2024. The MoE is urging stakeholders involved with these substances to join the consortium and accelerate the registration process.

Background Information

Under K-REACH, stakeholders are given a grace period to manufacture or import pre‑registered substances before the corresponding phase-in registration deadline. The registration deadlines are set based on the maximum tonnage band:

• ≥1,000 tons/year, or CMR substances ≥1 ton/year: by 31 December 2021
• 100 to 1,000 tons/year: by 31 December 2024
• 10 to 100 tons/year: by 31 December 2027
• 1 to 10 tons/year: by 31 December 2030

Amendment of Korea REACH (K-REACH)

South Korea's parliament, the National Assembly, passed amendments of K-REACH on 9 January 2024.

K-REACH adjusted the registration standards for new chemicals to the international level and reorganized the current designation system of toxic substances to promote rational management of chemicals based on hazard characteristics.

The amendments below will be promulgated at the beginning of February 2025. Most of the above amendments will be implemented from August 2025. Attention should also be paid to the release of sub-regulations such as enforcement decree and enforcement rules of K-REACH.

1. New chemical Notification <0.1 ton per year → <1 ton per year
   (This amendment will be implemented from January 2025)
   New chemical Notification was adjusted from the current less than 0.1 ton per year to less than 1 ton per year, but it increased transparency by disclosing information on less than 1 ton per year to the public and minimized blind spots for safety by establishing a new requirement for the authority's review. In addition, substances without hazard information are assumed to be hazardous until they are confirmed to be hazardous, stipulating the entities' management responsibility for securing the safety of chemicals.
2. Three "differentiated management" for Toxic substances.
   The wording "Toxic substances" will be abolished.
   Toxic substances are classified into three "differentiated management" and reorganized to apply efficient management measures in accordance with the substance.
   
   • Human acute hazard substances (with short-term exposure);
   • Human chronic hazard substances (with repeated exposure or long-term dormant effects);
   • Environmental hazard substances (based on their effect on aquatic organisms).
3. Exemption from Registration of Chemical Substance (To export a whole quantity):
   According to the current K-REACH, for chemical substances manufactured or imported to export, only exemption or registration of the whole quantity of one chemical substance is possible. However, in the amendments, the phrase for the "whole quantity" was removed and revised to require application for confirmation of exemption for the export-exempt quantity and registration for the quantity released in the Korean market.

Korea OSHA (K-OSHA)

On 27 September 2023, the Korean Ministry of Employment and Labor (MoEL) issued an amended Enforcement Rule of the Occupational Safety and Health Act (K-OSHA). When selling chemicals to other businesses, a Material Safety Data Sheet (MSDS) must be provided. However, to protect trade secrets, alternative names and alternative content may be provided in the MSDS with the approval of the MoEL.

Until now, the use of alternative names and alternative content was permitted only in cases where products were made by "mixing" trade-secret chemicals as raw materials in Korea.

This amendment reflects industry voices and expands the permissible methods beyond "mixing" to include "physical forming and subdividing." Additionally, it allows the use of alternative names and contents in MSDSs for overseas imports that use trade-secret chemicals.

Background

Effective 16 January 2021, manufacturers or importers of Globally Harmonized System of Classification and Labelling of Chemicals (GHS) hazardous-classified chemical products must prepare and submit an MSDS to the MoEL prior to manufacture or import. If manufacturers or importers want to use alternative names and alternative content in an MSDS to protect trade secrets, approval must be attained from the MoEL and documented on the MSDS. If the product's MSDS may be transferred to Korean importers before 16 January 2021, the products are considered existing products in South Korea. The existing products will have a 5-year grace period lasting until 16 January 2026, according to the product's tonnage band (see below).

Grace period for MSDS submission and approval for Confidential Business Information (CBI) for existing products

Prepared or modified MSDSs, in accordance with the previous regulations at the time of enforcement date, must be applied for according to the following timeline:

• ≥1,000 tons/year: no later than 16 January 2022
• ≥100 to < 1,000 tons/year: no later than 16 January 2023
• ≥10 to <100 tons/year: no later than 16 January 2024
• ≥1 to <10 tons/year: no later than 16 January 2025
• <1 ton/year: no later than 16 January 2026

Turkey REACH (KKDIK)

On 03 February 2023, the Turkish Ministry of Environment, Urbanisation and Climate Change (MoEUCC) released new guidance on registration requirements under the Turkish Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (KKDIK). This new guidance makes it optional to provide importer information for the registration of a substance, and allows for chemical safety reports (CSRs) to be submitted in English provided the Turkish translation is submitted within one year from the registration deadline. In addition, under the new guidance, the "Registrant Identity" and the "Registration Number" may now be claimed as CBI.

On 23 December 2023, the MoEUCC published an amendment on KKDIK in the official gazette numbered 32408, including the details on the new deadlines of the regulation.

Background

In effect since 23 December 2017, KKDIK is a hazard-based chemical regulatory framework that requires registration of chemicals manufactured or imported in quantities of 1 metric ton or more per year in Turkey. KKDIK is modeled after the European Union's (EU's) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. While still allowing for substance pre-registrations, KKDIK has been in its registration phase since 01 January 2022, with the initial registration deadline set for 31 December 2023.

After further consultations with industry, the MoEUCC officially published the anticipated KKDIK regulation amendment on 23 December 2023. The amendment includes details such as deadline extensions according to tonnage bands and certain hazard categories, and indicates further actions to be taken by the MoEUCC. These actions include publishing new guidelines on the joint registration processes to better determine details for lead selection, bolster the Substance Information  Exchange Forum (SIEF) communications, and provide greater data access management.

The newly published amendment outlines the following the revised deadlines for the KKDIK regulation:

• 31 December 2026: Applies to (i) substances in any form (on their own, in mixtures, or in articles) produced or imported in quantities of 1,000 tons or more per year; (ii) substances classified under Aquatic Acute 1 and Aquatic Chronic 1 categories (H400, H410) produced or imported in quantities of 100 tons or more per year; and (iii) substances classified as carcinogenic, mutagenic, or toxic to reproduction (Categories 1A and 1B) produced or imported in quantities of 1 ton or more per year.
• 31 December 2028: Applies to substances manufactured or imported in quantities of 100 to 1,000 tons per year, in any form.
• 31 December 2030: A final deadline applying to substances manufactured or imported in quantities of 1 to 100 tons or more per year, in any form.

Substances are registered online through the Chemical Registration System (KKS) IT platform, which resembles the European Chemicals Agency's (ECHA's) REACH IT platform, and dossiers must be submitted in the International Uniform Chemical Information Database (IUCLID) format. Registration dossiers are submitted through the KKS platform, which has the same endpoints and sections as an older version of the IUCLID system. Registration dossiers are submitted directly to the MoEUCC via the KKS tool and cannot be extracted, unlike in IUCLID.

China

On 29 December 2022, the Ministry of Ecology and Environment (MEE), in conjunction with other Ministries, released the "List of New Pollutants for Priority Control (2023 Edition)," which was implemented on 01 March 2023.

This list addresses the environmental risks of toxic and harmful chemical substances. It includes a total of 14 key controlled pollutants, including:

• Ten Persistent Organic Pollutants (POPs)
• Two toxic and harmful pollutants
• One environmental endocrine disruptor
• Antibiotics

Most new pollutants listed in the 2023 edition are prohibited from manufacture, processing, use, import, or export, and the very few exemptions will be under extremely strict monitor management.

Until now, there are around 50,000 chemicals listed in Inventory of Existing Chemical Substances in China (IECSC). Comparing with number of 86,000+ in TSCA in USA and 100,000+ in EU inventories (EINECS/ELINCS/NLP) respectively, this indicates a huge potential on new chemicals' regulatory compliance request in China. Enterprises aiming to import and/or domestically produce new chemical substances shall prepare their registration in advance to ensure the smooth entry of their products into Chinese market.

There are three types of registrations under MEE Order 12:

Registration Type	Scope of Application
Regular Registration	>10 tons/year New chemical substances to be manufactured or imported above the annual volume of ten tons.
Simplified Registration	1-10 tons/year New chemical substances to be manufactured or imported above the annual volume of one ton and no more than ten tons.
Filing (Record)	New chemical substances with an annual tonnage of less than one ton. Monomers of new substances, polymers containing less than 2% w/w new substances. Polymers of low concern

In addition to the registration requirements for new substances mentioned above, substances listed on the IECSC list with new use management (i.e. use for other non-permitted industrial uses) still need to be registered according to actual import/produce volume.

On 25 January 2024, China's Ministry of Industry and Information Technology, the Ministry of Commerce, and the General Administration of Customs jointly issued a notice on simplifying the import and export control over mixtures containing low concentrations of triethanolamine(CAS No. 102-71-6), which will take effect on February 1, 2024.

According to the notice, products with low concentrations of triethanolamine, including non-medical disinfectants, synthetic detergents, cosmetics, and inks, are no longer subject to the import & export control for triethanolamine (HS code: 2922150000), and triethanolamine mixtures (HS code: 3824999950) listed in the Catalogue of license for dual-use items and technologies.

Remark: Previously, these products must obtain the Import & Export License for Dual-use Items and Technologies.

European Union

1. New update to Candidate List of substances of very high concern

   On 14 June 2023, ECHA released the new Candidate List of substances of very high concern (SVHCs). With the addition of two new substances, the current list now contains 235 substances.

   Entries added to the Candidate List on 14 June 2023

   #	Substance Name	EC Number	CAS Number	Reason for Inclusion	Examples of Use(s)
   1	Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide	278-355-8	75980-60-8	Toxic for reproduction (Article 57c)	Inks and toners, coating products, photo-chemicals, polymers, adhesives and sealants and fillers, putties, plasters, modelling clay
   2	Bis(4-chlorophenyl) sulphone	201-247-9	80-07-9	vPvB (Article 57 e)	Manufacture of chemicals, plastic products, and rubber products
   CAS = Chemical Abstracts Service; EC = Enzyme Commission; vPvB = very persistent and very bioaccumulative.

2. Proposed Toy Safety Regulation would increase protection from "harmful chemicals"

   On 28 July 2023, the European Commission (EC) announced a proposed Toy Safety Regulation that would revise the current rules to protect children from potential risks in toys. The proposal would update the safety requirements for toys to be marketed in the EU, whether they are manufactured in the EU or elsewhere. According to the EC, the proposal will:

   • Increase protection from harmful chemicals. The proposal would maintain the current prohibition of CMR substances and expand it to other harmful chemicals in toys. It would target chemicals that are particularly harmful to children, such as endocrine disruptors, chemicals affecting the respiratory system, and those toxic to a specific organ.
   • Strengthen enforcement. All toys would be required to have a digital product passport, which would include information on compliance with the proposed regulation. Importers would have to submit digital product passports for all toys at EU borders, including those sold online. A new IT system would screen all digital product passports at the external borders and would identify the shipments that need detailed controls at customs.

AUSTRALIA

AICIS extends temporary recordkeeping provisions for NICNAS introducers to 01 April 2024

On 13 September 2023, the Australian Industrial Chemicals Introduction Scheme (AICIS) announced that recordkeeping provisions for introducers that transitioned from the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to AICIS will continue to be available until 01 April 2024.

AICIS notes that these arrangements apply only to "eligible introducers who are still importing or manufacturing chemicals that were previously on the NICNAS Inventory"—‍arrangements that were originally set to end on 30 November 2023. Introducers must meet the following requirements to be eligible to use the temporary recordkeeping provisions:

• The introducer imported or manufactured (introduced) a chemical under NICNAS before 01 July 2020;
• The chemical introduced was listed on the NICNAS Inventory and the introducer continued to introduce the same chemical under AICIS after 01 July 2020; and
• The introducer does not know the chemical's Chemical Abstracts Service (CAS) name or CAS Registry Number.

AICIS states that it has been exploring ways to resolve challenges businesses have faced to comply with AICIS recordkeeping obligations under the Industrial Chemicals (General) Rules 2019 (the Rules). As a result, it developed a suite of proposed changes to the Rules around recordkeeping requirements, and "will soon announce a public consultation on these proposed changes, along with others relating to AICIS categorisation and reporting obligations."

CANADA

Canada's Revised Canadian Environmental Protection Act, 1999 (AKA CEPA 2023)

In Canada, Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act received Royal Assent on 13 June 2023. This bill, which amends the Canadian Environmental Protection Act, 1999, focuses on recognizing a right to a healthy environment as provided under the Act and on strengthening Canada's chemicals management regime.

In a statement, the government stated that the bill would "encourage businesses to transition to the production and use of chemicals that are safer for the environment and human health." Under the bill, Environment and Climate Change Canada (ECCC) will develop a new plan of chemical management priorities, replacing the categorization provisions and the Priority Substances List provision that were added to CEPA 1999. This integrated, multi-year plan will set timelines for assessing substances already in commerce in Canada. The plan will also focus on the activities and initiatives that support chemicals management, such as information gathering, risk management, risk communications, and research and monitoring, and implement a strategy to promote the development and timely incorporation of scientifically justified alternative methods and strategies in the testing and assessment of substances to replace, reduce, or refine the use of vertebrate animals.

More information can be found in our blog: CEPA Reform 2023 (intertek.com).

Canada issues mandatory information request for 850 chemical substances

Canada published a notice in the Canada Gazette on 24 June 2023, announcing that it is collecting information on 850 substances for the purpose of prioritization, risk assessment, and risk management. The government is gathering information from Canadian manufacturers, importers, and users on the commercial status, facility information (e.g., releases), and uses of these substances in Canada, pursuant to Section 71 of the Canadian Environmental Protection Act, 1999 (CEPA).

According to the notice, the Minister of the Environment requires the information to assess whether the listed substances are toxic or are capable of becoming toxic, and to assess whether to control, or the manner in which to control, the listed substances. The persons described in the notice must provide the specified information that may be in their possession or to which they would reasonably be expected to have access. Responses are due 17 January 2024.

Canada's per- and polyfluoroalkyl substances (PFAS) state and report

Per- and polyfluoroalkyl substances (PFAS) are a class of over 4,700 human-made substances. These substances have a wide range of uses in products available to consumers, industrial applications, and other specialized applications. The widespread use of these substances and their extreme persistence in the environment, propensity for accumulation, and mobility has led to PFAS being commonly detected in the environment and in humans. Despite data having largely been generated on a limited suite of well-studied PFAS, there is a growing body of evidence that exposure to other PFAS can lead to adverse effects on the environment and human health. Cumulative effects from co-exposure to multiple PFAS may also occur.

PFAS are Persistent, Bioaccumulative and Toxic and are considered to be environmentally persistent and mobile within the environment. These substances do not readily biodegrade under normal conditions and within organisms, and have been detected in humans, wildlife, and environmental media worldwide.

While these substances do not occur naturally, certain PFAS have been detected in wildlife and humans around the globe and can remain within humans and wildlife for years. Research has shown some PFAS are readily absorbed into the body and can accumulate and persist in the body for years. Once absorbed into tissue, they can move up the food chain.

The Government of Canada has published a report stating the state of PFAS in Canada and the next steps to control or limit their introduction into the Canadian Marketplace. You can view the report at: https://www.canada.ca/en/environment-climate-change/services/evaluating-existing-substances/draft-state-per-polyfluoroalkyl-substances-report.html.

UNITED STATES

2024 is going to be an active year for U.S. chemical regulations.

In the first quarter, the Toxic Substances Control Act (TSCA) notification fees were published. The increase for Pre-Manufacture Notices (PMNs) will be from $19,020 to $37,000 USD. Also in this quarter, the new Persistent, Bio-accumulative and Toxic (PBT) rules will likely be published.

Later in the year, we have the Per- and Polyfluoroalkyl Substances (PFAS) reporting rule opening in November and the Chemical Data Reporting (CDR) occurring from June to September.

Looking beyond, we can expect the Environmental Protection Agency's (EPA) call for greater transparency resulting in stricter substantiation rules for claiming material as Confidential Business Information (CBI). Moreover, as the EPA continues to apply conservative risk assessments, we will likely see new Significant New Use Rules (SNURs) before year-end.

NEW ZEALAND

New Zealand Environmental Protection Authority confirms overseas regulators for hazardous substance assessments

On 16 August 2023, the New Zealand Environmental Protection Authority (New Zealand EPA) announced it has confirmed which international regulators it can draw on for information used in some hazardous substance assessments. The regulators are from Australia, Canada, the EU, the UK, and the U.S., "all of which regulate hazardous substances in a similar way to our own system," according to the New Zealand EPA. The New Zealand EPA will use information from the recognized international regulators to assess and reassess hazardous substances through two new pathways aimed at streamlining the processes:

• Approving a substance via a rapid assessment if the same use has been approved by a recognized international regulator, unless it will have significant cultural, environmental, and/or human health effects; and
• Amending the hazard classifications or rules for use of an existing substance to align with recognized regulators.

The change will come into force on 01 October 2023. The New Zealand EPA states that it will work with relevant industries to develop guidance for the new pathways and information requirements.

LATIN AMERICA

Latin America's chemical regulation landscape has been developing quickly over the last 2 years, with recent developments in three countries in particular. It is anticipated that even more change is coming (for example, Argentina, Brazil, Honduras, and others).

Chile:

In 2022, Chile published its modern chemical regulation, Decree 57, Regulation on Classification, Labeling, and Notification of Hazardous Chemicals and Mixtures. Based loosely on the Organisation for Economic Co-operation and Development (OECD) and EU models, Decree 57 and its implementing standards, including Resolution 777/2021, aim to make a holistic change to the way chemicals are regulated. Decree 57 sets out both Chile's Globally Harmonized System of Classification and Labelling of Chemicals (GHS) for industrial and consumer products, as well as its version of the REACH Regulation.

Colombia:

Colombia joined Chile as the second country in Latin America to enact its comprehensive chemical regulation under Decree 1630/2021. The new REACH-inspired decree applies to industrial chemicals identified as hazardous by the GHS that are manufactured or imported in quantities over 100 kg per year. 

Brazil:

In a recent bill, Brazil also took an important step towards enacting a framework national chemical law inspired by EU REACH and Canada's Chemicals Management Plan (CMP). With approval from the head of the Committee in the Chamber of Deputies, the bill will make important changes that bring Brazil's chemical law closer to an earlier version developed by the country's much-admired agency, the Comissão Nacional de Segurança Química (CONASQ).

National Chemicals Inventory Laws

Country	Type of Proposal	Status	Proposal
Argentina	Legislative	Pending Congress	Bill 4339-D-2019
Brazil	Legislative	Pending Congress	PL 6120/2019
Chile	Agency Action	Enacted	Decree 57/2021 Resolution 777/2021
Colombia	Agency Action	Enacted	Decree 1630/2021
Mexico	Legislative	Not yet drafted
Peru	Legislative	Drafted – not yet presented in Congress	Not available

For more information, please visit our blog: The regulatory landscape in Latin America is changing fast! (intertek.com).

United Kingdom

UK authorities recently published information regarding the "Alternative Transitional Registration model (ATRm)" in relation to UK REACH regulation and data requirements.

Due to concerns from the UK industry about additional costs of accessing data to register under UK REACH, the UK authorities have been seeking alternative options for data submission.

Following an extensive review of the way UK REACH is implemented, the authorities determined that UK regulators do not need to hold a complete copy of all registration data on all chemical substances currently held under EU REACH in order for UK REACH to undertake its regulatory work. The authorities intend to take a much more targeted approach by using information already available to them and building on work done previously by the EU and global jurisdictions to tackle emerging risk and focus the UK regulatory priorities accordingly.

The aims will therefore be focused on ensuring that industry is using chemicals as safely as possible with regulators assessing the level of exposure and risk that chemicals present in Great Britain and taking targeted regulatory actions where those risks are deemed unacceptable.

The UK has made some progress in developing proposals on which they will consult with the industry in early 2024. The below highlights may result in significant cost savings for companies required to submit UK REACH registrations.

• Refining the "use and exposure" information UK registrants will need to provide.
• Reducing, as much as possible, the "hazard" information required for transitional registrations and intermediates—‍in general, UK REACH registrants will not need to access and pay for data packages held by EU industry consortia.
• Significantly reducing the estimated £2 billion costs to the industry associated with buying or accessing EU hazard information.
• Improving regulator powers so they can require and quickly receive data from registrants for regulatory or risk prioritisation purposes, ensuring timely response to new or emerging risks.
• Reviewing the existing fee structure for UK REACH to ensure a more sustainable funding model, including exploring reductions in the current fee levels for UK REACH registrations.
• Revising the UK REACH restriction processes to allow quick action where risks have been identified, drawing on work by UK regulators and other sources.

These changes constitute an ongoing process, and the industry will be invited to consult on the authorities' proposals in 2024.

The registration deadlines are still set as below.

Deadline (last date for dossier submission)	Tonnage	Hazardous Property
27 October 2026	1,000 tonnes or more per year	Carcinogenic, mutagenic or toxic for reproduction (CMR) - 1 tonne or more per year Very toxic to aquatic organisms (acute or chronic) - 100 tonnes or more per year Candidate List substances (as at 31 December 2023)
27 October 2028	100 tonnes or more per year	Candidate List substances (as at 27 October 2026)
27 October 2030	1 tonne or more per year

Conclusion

Developments in chemical regulations, like the ones above, aim to ensure the safety, efficacy, and proper use of chemicals across various industries. These updates often revolve around other legislative changes, advancements in scientific understanding, and evolving global standards for chemical management. If you have questions about the global regulatory chemicals control landscape, contact us at chemicals.assuris@intertek.com or visit us online at https://www.intertek.com/assuris/chemicals/.

The content of this blog is provided for general information purposes only and is not intended to be relied upon. This blog should not be used as a substitute for seeking appropriate professional advice on the requirements of the regulations, and independent advice should be sought, as appropriate, in relation to regulatory compliance. To receive regulatory advice, please contact Intertek directly.

References

• https://tksd.org.tr/tr-TR/duyurular-detail/gorus-talebi-
• https://www.resmigazete.gov.tr/eskiler/2023/12/20231223-9.htm
• https://kimyasallar.csb.gov.tr/kayit-dosyalarindaki-bilgi-gereklilikleri/365
• http://english.nmpa.gov.cn/2021-12/30/c_739582.htm
• https://echa.europa.eu/-/echa-adds-two-hazardous-chemicals-to-candidate-list
• https://ec.europa.eu/commission/presscorner/detail/en/ip_23_4010
• Temporary record-keeping provisions for NICNAS introducers extended to 1 April 2024 | Australian Industrial Chemicals Introduction Scheme (AICIS)
• Canada Gazette, Part 1, Volume 157, Number 25: GOVERNMENT NOTICES
• https://www.epa.govt.nz/news-and-alerts/latest-news/epa-confirms-overseas-regulators-for-assessment-information/