GPC Newsletter Apr-2023

On 1 April 2023, the Canadian government announced that they are taking steps to limit the potential risks associated with the use of chlorocresol in cosmetics by proposing an order to add it to the list of toxic substances. This announcement was published in the Canada Gazette. The proposed order would add chlorocresol to Schedule 1 of the Canadian Environmental Protection Act (CEPA). Stakeholders have until 31 May to provide feedback on the proposed order. After this date any subsequent risk management proposals will be subject to their own consultation process if the order is finalized. 

Chlorocresol is a biocide that is commonly used in cosmetics, non-prescription drugs and health products for skin irritations, and as a lubricant in food processing facilities. It is also registered as an active ingredient in pest control products in Canada. 

According to Health Canada and Environment and Climate Change Canada (ECCC), any potential risk management actions related to chlorocresol will focus primarily on its use in cosmetics, as this is where there is concern for Canadians. In 2019, the agencies released a draft assessment which indicated that chlorocresol, when used in moisturizers and lotions, may have adverse effects on the adrenal glands. The finding was confirmed two years later, prompting the recommendation to add chlorocresol to Schedule 1 and to include it on Canada’s Cosmetic Ingredient Hotlist as a prohibited or restricted substance. 

On 11 March 2023 the Canadian Government announced new ministerial conditions on the manufacture and import of the cosmetic and coating ingredient of 1-propanaminium, n-(3-aminopropyl)-2-hydroxy-n,n-dimethyl-3-sulfo-, n-(C12-18 and C18-unsatd. acyl) derivatives, inner salts. This substance has a variety of uses in the industry including cosmetics, adhesives and sealants, coatings, and biocides.

Based on these new ministerial conditions, importing or manufacturing of mentioned substance for use in leave-on cosmetics where the chemical is present at a concentration greater than 0.6% by weight is forbidden. This restriction applies to the company which requested this substance to be added to the domestic substance list (DSL).

Furthermore, based on the announced condition the contaminants would be also limited, which would only allow importers or manufacturers to import the substance in the two scenarios which are mentioned below.

1. The concentration of 1,3-propanediamine, n,n-dimethyl- in the substance should be less than 0.01% by weight

2. The concentration of fatty acid amidopropyl dimethylamine (amidoamine) impurities in the substance should be less than or equal to 1.5% by weight.

For further inquiries in Canada cosmetic compliance, please contact us at compliance@gpcregulatory.com

On 7 April 2023, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed lowering the "No Significant Risk Level" (NSRL) for ethylene oxide under the Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65 (Prop 65).  It was proposed to reduce the NSRL from 2 to 0.058 micrograms per day. Ethylene oxide has been identified as a known carcinogen under Proposition 65. The proposal is open for comments until May 23, 2023. 

Prop 65 requires the inclusion of warning statements when a company's product causes "exposure" to carcinogens or reproductive toxicants. There is no requirement for warnings when exposure is protected by the "safe harbour." The safe harbour for carcinogens is the "No Significant Risk Level" (NSRL), or the level of exposure that would cause no more than one additional case of cancer in a population of 100,000 exposed people, assuming exposure throughout a lifespan of 70 years. 

On 20 April 2023 the European Chemicals Agency (ECHA) published details about application dates and other information related to the new CLP Hazard Classes that came into force on that same date.

The European Commission published a Delegated Regulation on 31 March 2023, setting out new hazard classes and criteria for the Classification, Labelling and Packaging of substances and mixtures (CLP). The Delegated Regulation applies to all chemical substances and mixtures placed on the EU market under REACH. It also applies to active substances in biocidal products and plant protection products. It is binding to manufacturers, importers, downstream users, and distributors placing substances on the EU market.

The new hazard classes, their hazard statements, and hazard statement codes are as follows:

The new rules came into force on 20 April 2023 but there are transitional periods during which manufacturers, importers, downstream users, and distributors are not yet required to classify their substances or mixtures according to the new hazard classes. It is however possible to apply the new hazard classes on a voluntary basis. The transitional periods vary from 18 to 24 months for new/existing substances/mixtures. The deadlines can be seen below.

The guidance on applying the CLP criteria is expected to be updates in 2024. Until then companies and Member State Authorities can use the current guidance on identifying endocrine disruptors and assessing PBTs. The new hazard classes will be included in the IT tool IUCLID during spring 2024. After that companies can incorporate information related to the new hazard classes in their classification and labelling notifications, REACH registrations and dossiers for product and process orientated research and development (PPORD), as well as in their submissions under the Biocidal Products Regulation and poison centre notifications.

New substances must comply with the new Regulation from 1 May 2025, whereas substances which were placed on the EU market before 1 May 2025 compliant labelling is not required until 1 November 2026. For mixtures separate transition times apply. New mixtures must comply by 1 May 2026. For mixtures placed on the EU market before 1 May 20261 the deadline for compliance is 1 May 2028.

The complete text of the adopted Delegated Regulation can be found here: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R0707&from=EN

On 31 March 2023 the European Commission adopted a Delegated Act amending the Regulation on Classification, Labelling and Packaging of Chemicals (CLP). The revision of CLP, together with the planned revision of REACH is an important part of the European Commissions Chemicals Strategy for Sustainability (CSS) and the European Green Deal. The Regulation entered into force on 20 April 2023.

The Delegated Act amends Annex I of the CLP Regulation and divides the hazard class for endocrine disrupting chemicals (EDCs) into two categories:

• Category 1: Known or presumed endocrine disruptors for human health/the environment

• Category 2: Suspected endocrine disruptors for human health/the environment

Furthermore, hazard classes for the following properties are introduced:

• Persistent, Bioaccumulative, and Toxic (PBT)

• Very Persistent and very bioaccumulative (vPvB)

• Persistent, Mobile, and Toxic (PMT)

• Very Persistent, very Mobile (vPvM)

Substances must be labelled in accordance with the amended Regulation from 1 May 2025. However, substances which were placed on the market before 1 May 2025 compliant labelling is not required until 1 November 2026. For mixtures the corresponding dates are 1 May 2026 and 1 May 2028.

The complete text of the adopted Delegated Act can be found here: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R0707&from=EN

On 15 March 2023 the European Chemicals Agency (ECHA) announced its Regulatory Strategy for Flame Retardants which points out aromatic brominated flame retardants as candidates for an EU-wide restriction. The Regulatory Strategy is part of the European Commission’s Restrictions Roadmap published in 2022. The roadmap is a rolling list containing large quantities of harmful chemicals which are to be prioritized for bans under the EU Chemicals Strategy for Sustainability.

• All aromatic brominated flame retardants that are or will be classified as persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) through harmonised classification or identification as substances of very high concern (SVHCs) could be covered by the scope of the restriction. This group includes polybrominated diphenyl ethers (PBDEs) known to be persistent in the environment and substances such as decabromodiphenylether (decaBDE) which is suspected of being toxic and accumulating in people and animals.
• Aliphatic brominated and some organophosphorous flame retardants (OPFRs) will be studied further to determine if restriction is necessary. ECHA suggests reassessing those groups in 2025 when more data will be available.
• Non-halogenated subgroups of flame retardants and some OPFRs are presently outside the scope of regulatory actions since no or low hazard was identified for these substances at this time. For chlorinated flame retardants regulations are already or have been initiated.
• Halogenated (including brominated) flame retardants and OPFRs account for 70 % of the organic flame retardant on the market.
• Other flame retardants will be assessed in future Assessments of Regulatory Needs (ARNs).

The European Chemicals Agency (ECHA) is calling for scientific and technical information on the use, manufacture, and placing on the market of per- and polyfluoroalkyl substances (PFAS). The information will be used to evaluate a restriction proposal prepared by the Danish, German, Dutch, Norwegian, and Swedish authorities. The consultation period will last for six months, starting from March 22, 2023, and ending on September 25, 2023. Interested parties can submit information relevant to PFAS risks, socio-economic aspects, and alternative substances. ECHA's Risk Assessment and Socio-Economic Analysis scientific committees will review the input and form an opinion on the proposed restriction.

The national authorities of Sweden, Denmark, Norway, the Netherlands and Germany submitted a proposal to restrict PFAS to ECHA on 13 January. The European Commission, together with the EU Member States is in the reviewing process of the potential restriction based on the proposal and the committees’ opinion.

On 27 February 2023 the European Commission adopted a new proposal on the voluntary digital labeling of EU fertilising products. Digital labeling has already been adopted by the EU and is being used on certain products which contain chemical substances. Based on this proposal, suppliers of fertilisers whose products meet EU health, safety, and environmental standards would be allowed to provide information on a digital label.

It is believed that this proposal could help users of fertilising products understand and use the products more safely and efficiently. Moreover, it would reduce the costs for the suppliers from €57,000 annually for a large company and €4,500 for an SME.

It should be noted that based in this proposal the fertilising suppliers are given the choice to choose which format of labelling they wish to use, meaning that the suppliers and retailer have the choice between the physical and digital format or a combination of the two.

This proposal has been sent to the European Parliament and the Council and in case of adoption, there would be a two- and half-year transaction period. This period would allow for more detailed technical rules to be decided.

The UK's Health and Safety Executive (HSE) has recently published a regulatory management options analysis (RMOA) – a technical document examining the risks posed by the use, import and manufacture of PFAS and ways to control these risks. The analysis outlines the scope of its possible restrictions on PFASs, which could target "hundreds" of substances that are most persistent and relevant to the GB market.

The HSE's RMOA focuses on a smaller number of substances than the EU's proposal, which aims to ban the entire class of chemicals. The HSE report recommends prioritizing a restriction dossier this year for PFAS use in firefighting foams.

Furthermore, there are recommendations on preparation of Annex XV dossiers under UK REACH to support restrictions on certain uses, such as firefighting foams, coatings, cleaning agents, and consumer articles. Other recommendations include further evaluation of specific substances, a review of F-gas regulations, and the development of statutory standards for PFASs in drinking water in England and Wales.

Moreover, the HSE has defined PFASs more narrowly than the EU and recommends a number of risk management measures to limit the use of PFAS and control exposures to people and the environment in the country.

The next stages of regulatory action will be set out in the UK REACH work program for 2023-24, followed by a detailed risk assessment and legislative proposal.

Belarus has approved updated rules (Decree N.71) for the transport of dangerous goods on inland waterways, replacing a 2009 decree. The new rules, which take effect from 1 July, align with the UN Model Regulations, and several chapters have been revised to reflect this. The United Nations (UN) Model Regulations defines dangerous goods as "substances or articles which are capable of posing a risk to health, safety, property, or the environment and which are shown in the list of dangerous goods in these Regulations or which are classified according to these Regulations".

The decree includes requirements for stakeholders involved in transport, emergency planning procedures, port responsibilities for loading and unloading, placement of cargo onboard vessels, conditions for vessels carrying dangerous goods, and documentation requirements. Specific provisions are included for oil tankers.

In April 2023 the Central Government of India published two notices in the Indian Gazette delaying the start date for the Quality Control Orders (QCOs) for the 10 substances listed in the table below. The initial enforcement date for the substances was 24 April 2023 and 20 May 2023.

The Quality Control Order is the regulation that requires concerned substances to carry the certification mark of the Bureau of Indian Standards (BIS).

For further information on BIS compliance, visit GPCgateway or contact GPC at compliance@gpcregulatory.com

On 23 March 2023, The Gazette of India published that the Indian Department of Chemicals and Petrochemicals (DCPC) has delayed the implementation of the quality control order (QCO) for ethylene glycol until 28 June 2023. It’s the second time the QCO for ethylene glycol has been delayed. 

Ethylene glycol is used in manufacturing cosmetics, paints, ballpoint pens, solvents, and hydraulic brake fluids. The substance was among five that the Bureau of Indian Standards (BIS) categorized as specialty chemicals covered by QCOs, originally scheduled to enter into force in December 2021.  

The implementation is delayed in the public interest and to prevent dislocation in manufacturing and trade.  

Due to staff shortages, BIS inspectors have been unable to conduct inspections in overseas manufacturing plants exporting materials into India.  

Manufacturers, importers and the traders are obliged to obtain a quality certificate from the BIS under the QCO rules. This process is to be done every two years and the manufacturers, importers, and traders cannot conduct any business using the substance without QCO certificate. 

On 21 March 2023, a draft proposal was released by India’s Central Pollution Control Board (CPCB), that specifies the average lifetime of products under the E-Waste (Management) rules, 2022. On 1 April 2023, this came into force.

E-waste management refers to the process of properly disposing of electronic waste, which includes any electronic device or component that has reached the end of its useful life. Some strategies of E-Waste management are as follows:

• Reduce: The first step in e-waste management is to reduce the amount of electronic waste generated.

• Reuse: Reusing electronic devices and components is another way to reduce the amount of e-waste.

• Recycle: Recycling is the most common and effective method of managing e-waste. It involves extracting useful materials such as metals, glass, and plastics, which can be used to manufacture new products.

• Disposal: If electronic devices cannot be reused or recycled, they should be disposed of properly.

In short, e-waste management is crucial for protecting the environment and human health. Byreducing, reusing, recycling, and properly disposing of electronic devices, we can minimize the negative impact of e-waste and create a sustainable future.

From 2023 onwards, Producers must comply with the E-Waste recovery targets set up by the E-Waste (Management) rules and the average lifetime of products is used to calculate these targets. Below is the recycling rate given which the producers are required to reach:

The average life for 85 categories of EEE items is proposed. A few examples are given below and the complete list can be found here: link: openpdffile.php (cpcb.nic.in)

E-Waste recycling target is calculated as per the rules by multiplying sales volume of EEE item in year (Y) and E-waste recycling rate.

Example: Recycling target for the above EEE item “scanners” in 2023 can be calculated as follows:

1. E-Waste recycling rate in 2023: 60 %;

2. The average life of a scanner: 5 years;

3. The sales volume in 2018 (2023 – 5): 1500 kg;

4. E-Waste recycling target for the scanner: 1500 kg X 60% = 900 kg

On March 6, 2023, the Indian government issued the guidelines 'IS 18149:2023— Transportation of Dangerous Goods—Guidelines', which have been formulated under the Transport Services Sectional Committee, SSD 01, of the Bureau of Indian Standards (BIS). 

The aim of the Guidelines is to standardize the transportation practices and to ensure safety when transporting of dangerous goods and hazardous goods that pose threat to the public safety, properties and environment. The Guidelines provide detailed precautions which are to be taken for packaging, handling and transportation of the hazardous goods. They apply to all stakeholders including vehicle owners, transport agencies, contractors, consignors, consignees, operators, and drivers. 

The BIS has provided guidelines on classification, packaging, labelling and marking, handling, documentation, role of stakeholders, training, transportation, emergency action, and provisions for segregation.  

The dangerous goods referred in the standard include explosives, gases, flammable liquids, flammable solids, oxidizing substances and organic peroxides, poisonous and infectious substances, radioactive substances, corrosive substances and other miscellaneous dangerous substances. 

On 31 March 2023, Indian government published a Gazette Notification regarding the BIS requirements and the related implementation dates of six chemicals. According to the published Quality Control Orders (QCO), below chemicals will require BIS certificates from July and October 2023.

For further information on BIS compliance, visit GPCgateway or contact GPC at compliance@gpcregulatory.com

China’s National Center for Food Safety Risk Assessment (CFSA) has called for industry feedback on draft national safety standard on food contact materials to include more polymers and food ingredients.  

The current enforcing standard for food contact materials is GB 4806.1-2016: General Safety Requirements on Food Contact Materials and Articles. It specifies the definitions, basic requirements, restrictions, compliances, test methods, traceability, and product information requirements for food contact materials. Specifically, it clarifies the overarching definition of “food contact material” which excludes any outer packaging or material, unless it comes into direct contact with food.

The new revision to this regulation was published on 19^th April 2023. It proposed that materials such as plastics, rubber, silica gel, paints, adhesives, and oil paints which are already permitted in China can be blended for use in food contact materials on condition that there are no chemical reactions. In addition to this, any substance which already has been approved for use as food ingredients in China, if it meets concerned standards, it can be used in the manufacture of FCMs. 

The consultation period is until 15^th May 2023. If you have any opinions, you are welcome to contact GPC via compliance@regulatory.cn. We will help you to submit your opinions to the authority. 

On 1 March 2023, to align national standards and requirements with the UN Model Regulations, the Standardization Administration of China (SAC) published draft revisions of two transport regulations for public consultation.

The two concerned national mandatory standards are GB 6944 Classification code of dangerous goods and GB 12268 List of dangerous goods. These two standards were first released in 2005 and revised in 2012. 

The classification Code introduces the definition, categories, and numbering and naming rules of dangerous goods. Compared to the previous version, the new standard had made several changes to classification methods and determing packing groups in the UN model regulations. The List of Dangerous Goods proposed to add 59 items to the list. Both the two standars help to standardize the system for dangerous goods transportation, storage, distribution, and other related activities in China. 

There will be a 12 months transition period after finish publishment. The public consultation period is until 8 May 2023. If you have any opinion or want to know more about chemical compliance in China, please contact GPC via compliance@gpcregulatory.cn.

On 4^th April 2023, NMPA published a notice announcing the new regulation on cosmetic online service operators -- "Measures for the Supervision and Administration of Cosmetics Online Operations". This measure is expected to come into force from 1^st September 2023. 

Prior to the announcement of this new measure, there is no special rules governing cosmetic online operationists. And the online service providers are exempted from the application of CSAR regulation. This new measure includes five chapters governing all cosmetic e-commerce operators, including cosmetics e-commerce platform operators, cosmetics operators on the platform, and e-commerce operators who operate cosmetics through self-built websites and other network services. However, those who engaged in cross-border e-commerce retailing of imported cosmetics are exempted from the application of this new measure. 

NMPA and local MPA will be responsible for the administration and supervision of this new measure. E-commerce operators shall require platform cosmetic operators to provide address, ID and contact information. Such information shall be updated every 6 months. And operators’ information shall be kept for at least three years after they exit the platform. Regular checking recording shall be kept for at least 2 years since the recoding is made. 

E-commerce platform operators shall ensure that the products sold by them are in line with those which are registered under NMPA and keep relevant information. If any cosmetic products are identified as not complied, then the operators shall stop selling concerned products. For the other batches of the same variety, if the operator wants to continue selling it online, then it shall publish the result for a year. 

For more information, regarding China cosmetic regulation compliance, please contact GPC via compliance@gpcregulatory.cn. 

On 27 March, NMPA published a notification on optimizing cosmetic ingredients registration procedures and some adjustment to the transitional measures. The following points were addressed in the notification. 

1. Content of existing cosmetic ingredients submission 

Cosmetic ingredients safety information mainly includes ingredient quality, safety risk evaluation and related safety information. Under IECIC published by NMPA, it specified all the existed cosmetic ingredients. Cosmetic products producers shall ask ingredients provides to provide all the safety information. If ingredient submission code is available, the cosmetic product producers should connect the code, without repeating the safety information by filling it in the system. 

2. Ways of ingredient submission 

Since the publishment of this notification, registrants can submit by the following ways: 

• If ingredient submission codes are available, then ingredient submission codes are preferred. But cosmetic product registrants shall still ask ingredient providers to share ingredient’s safety information for the purpose of backing up. 
• If ingredient submission codes are not available, then cosmetic product registrants shall fill and upload the ingredients safety related information by themselves.
• For the same cosmetic products, if only some of the ingredients obtain ingredient submission codes, then the above two ways can be adopted at the same time. 

3. Adjustment to transitional measures

• The deadline for submitting ingredients safety information was delayed from 1 May 2023 to 1 January 2024. 
• If the registration was done before 1 May 2021, then ingredient’s safety information shall be submitted before 1 January 2024. 
• For cosmetic products which used special cosmetic ingredients and the registration was done between 1 May 2021 and 31 Dec 2023, then the ingredients safety information shall be filled before 1 January 2024. 

If you are interested in China NMPA CSAR regulation, please contact GPC via zhengmin@cn.gpcregulatory.cn for more information. 

The National Institute of Environmental Research (NIER) in South Korea is consulting on a draft amendment of the Regulation on chemical substance classification and labelling under the Act on Registration and Evaluation of Chemicals (K-REACH). This is to notify classification and labelling of newly designated toxic substances, as well as existing hazardous chemicals for which hazard reviews has been completed.

The draft amendment mainly proposes revisions including:

• New classification and labelling for newly designated toxic substances
  • 6 substances including 3,5-difluorophenol
  • From 2023-1-1110 to 2023-1-1115
• Revise classification and labelling for existing hazardous chemicals
  • 28 toxic substances
  • 2 substances requiring preparing for accidents

If you have any opinion on this amendment, please write your opinion and submit to the NIER.

The deadline of this consultation is May 15th, 2023.

The National Institute of Environmental Research (NIER) in South Korea is consulting on a draft amendment of Designation of Toxic Substances under the Act on Registration and Evaluation of Chemicals (K-REACH).

The draft amendment mainly proposes revisions including:

• New designation of toxic substances for which hazard reviews has been completed: from 2023-1-1110 to 2023-1-1115
• Revise the name of toxic substances: 97-1-41, 97-1-68, 97-1-71, 97-1-1134, 97-1-213, 98-1-480, 2014-1-692
• Regulate newly designated toxic substances on import declaration & business license under Chemical Control Act (CCA), labeling hazardous chemicals, and transitional measures for handling

If you have any opinion on this amendment, please write your opinion and submit to the NIER.

The deadline of this consultation is May 15th, 2023.

The National Institute of Environmental Research (NIER) in South Korea is consulting on a draft amendment of the Regulation on test methods for chemical substances under the Act on Registration and Evaluation of Chemicals (K-REACH). This is to update the regulation based on updated international chemical regulations including OECD’s animal alternative test methods.

The draft amendment mainly proposes revisions including:

• Add 2 categories in the test on human health part: OECD TG 497, OECD TG 498
• Revise 9 categories in the test on human health part: OECD TG 405, OECD TG 406, OECD TG417, OECD TG 439, OECD TG 429, OECD TG 442A, OECD TG 442C, OECD TG 455, OECD TG 494

If you have any opinion on this amendment, please write your opinion and submit to the NIER.

The deadline of this consultation is May 8th, 2023.

The National Institute of Environmental Research (NIER) in South Korea plans to evaluate biocidal products for the approval of biocidal substance and biocidal products under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR). Regarding this evaluation, an update on test methods for determining the shelf life of biocidal products was provided on April 12^th, 2023.

Applicants for the approval must submit complete physical and chemical stability test data proving that the quality (content, effect, efficacy, etc.) of the biocidal product is stable during the shelf life. Long-term storage test, acceleration storage test, and low-temperature stability test (liquid) are mandatory, but it can be exempted under certain conditions.

New case with the stability test

• Testing Institute: Recommended to submit data produced by testing institutes that comply with international standards. Example: ISO 9001, ISO/IEC 17025, GLP, etc.

• Test data: Long-term storage test and acceleration storage test data that conform to the shelf life of biocidal products must be submitted, but test data can be selectively submitted depending on the shelf life and storage temperature & conditions.

Submitting existing test data

• Scope: Limited to products that have been approved by submitting stability test data as daily use consumer chemical product subject to safety verification and approval.

• Approval: Resubmit the stability test data that was submitted and got approval as the daily use consumer chemical product subject to safety verification and approval, and the shelf life given at the time of approval would be accepted.

The National Institute of Environmental Research (NIER) in South Korea provides a summary for the Approval application documents based on the updates on disinfectant and preservatives for humidifiers on April 10^th, 2023. This is based on the updated classification on product type based on diversified disinfectant and preservatives for humidifiers under the ‘Regulations on the Approval for Consumer Chemical Products Subject to Safety Verification’ on December 12, 2022.

According to the summary, the Approval application documents for the antimicrobial and preservatives for humidifiers remains the same, but some of the Approval application documents for the preservation treatment product for humidifiers can be exempted. The provided summary for the Approval application documents is as below:

• The scope of document submission of standard and test method review

• The scope of document submission of stability & effectiveness review

○: Mandatory documents to be submitted

△: Documents that may be exempted

-: Documents that don’t need to be submitted

The Ministry of Food and Drug Safety (MFDS) in South Korea consults for the draft amendment of the Cosmetic Act on March 22^nd, 2023. The Cosmetic Act prohibits advertisements that might mislead the public for cosmetics as medicines, functional cosmetics, natural cosmetics or organic cosmetics. This amendment is to clarify the scope of the prohibited subject related to the misleading advertisement.

The main amendments are:

If you have any opinion on this draft amendment, please write your opinion in the provided format and submit it to Korea Cosmetic Association.

The deadline for this consultation is April 14^th, 2023.

On 24 March 2023 Taiwan’s EPA published the updated Guidance for New and Existing Chemical Substance Phase One Registration and Guidance on Chemical Substances Hazard and Exposure Assessment. The updated guidelines aim to help companies to meet their dossier submission obligations under the Toxic and Chemical Substances of Concern Control Act (TCSCCA). 

Phase one registration is required for existing chemical substances manufactured in or imported to Taiwan with the quantity above 100 kg. Registrants that completed Phase One Registration will receive a Registration Number. Based on the issued date of this number, companies need to submit dossier in following date:

• Phase One Registration received before 31 December 2019 and the tonnage reaches 1 TPA, companies should complete dossier submission by 31 December 2024.
• Phase One Registration received after 1 January 2020 and the tonnage reaches 1 TPA in the same year, companies should complete dossier submission within 5 years.

For inquiry on Taiwan TCCSCA, contact compliance@gpcregulatory.com

On 12 March 2023 Thailand's Food and Drug Administration (FDA) has announced plans to outlaw the use of 13 per- and polyfluoroalkyl substances (PFASs) despite the fact that none of the 13 substances are currently used in cosmetics products in Thailand.

The FDA proclaimed in a draft gazette notification (B.E. 2566–2023) that the country's Cosmetics Committee had authorised the intervention. The FDA asserted that after gazing over cosmetics that that had been registered as being manufactured and imported for sale in Thailand, it unearthed and none of them contained the components noted below. Before releasing a final version, the Authority needs authorization from the Minister of Public Health.

The 13 per- and polyfluoroalkyl substances listed in the draft are:

1. Perfluorooctane sulfonate (PFOS)

2. Potassium perfluorooctanesulfonate (potassium heptadecafluorooctane-1 -sulfonate)

3. Diethanolamine perfluorooctane sulfonate

4. ammonium perfluorooctane sulfonate (ammonium heptadecafluorooctanesulfonate)

5. Lithium perfluorooctane sulfonate (lithium heptadecafluorooctanesulfonate)

6. Perfluorooctanoic acid (PFOA)

7. Ammonium pentadecafluorooctanoate

8. Nonadecafluorodecanoic acid

9. Ammonium nonadecafluorodecanoate

10. Sodium nonadecafluorodecanoate

11. Perfluorononanoic acid (PFNA)

12. Sodium heptadecafluorononanoate

13. Ammonium perfluorononanoate 

In a notice published on 27 March 2023, the Japanese Ministry of Economy, Trade and Industry (METI), the ministries of Health, Labour and Welfare (MHLW) and Environment (MOE) announced that they will monitor the manufacturing and importation volumes of eight substances to consider their removal from the Priority Assessment Chemicals (PACs) list.

The substances are: 

• tritolyl phosphate – used in vinyl plastics, as a lubricant additive and in waterproofing materials;  
• aniline – used in dyes and intermediates, photographic chemicals, urethane foams (pictured), pharmaceuticals, explosives and petroleum refining;  
• nitrilotriacetic acid – used in cleaning products, personal care products and pesticides;  
• 2-(tert-butylamino)-4-(cyclopropylamino)-6-(methylthio)-1,3,5-triazine – used as an anti-fouling agent in paints and as a biocide;  
• trioctylamine – used in fuel production;  
• salt of N,N-diethyl-N-methyl-2-[(2-methylprop-2-enoyl)oxy]ethan-1-aminium – used in pharmaceuticals and medical articles;  
• 4,4'-diamino-3,3'-dichlorodiphenylmethane (also known as 4,4'-methylenebis(2-chloroaniline)) – used as a curing agent for polyurethanes and epoxy resins; and  
• mixture of bicyclo [2.2.1] heptane-2,5(or 2,6)-diyl dicyanide – a compound. 

In a separate notice, published in the official government gazette Kanpou on 3 April 2023, the Japanese Ministry of Economy, Trade and Industry announced the classification of six substances as PACs under the country's Chemical Substances Control Law (CSCL).

The six substances are as follows:

• sodium salt of 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetic acid; 
• alpha,alpha'-[(alkyl(C=8-18, normal chain)azanediyl)bis(ethane-2,1-diyl(or ethylethane-2,1-diyl))]bis{omega-hydroxypoly[oxyethane-1,2-diyl/oxy(methylethane-1,2-diyl)]} (The repeating number of repeating unit is an integer 1 or more.) (Limited to the number-average molecular weight of the polymer that is less than 1,000.);
• salt of {ester of 2-hydroxy-N-(2-hydroxyethyl)-n, n-dimethylethan-1-aminium and [saturated fatty acid(C=10-18, normal chain)(or unsaturated fatty acid(C=18, normal chain))]} or salt of {ester of 2-hydroxy-n-(2-hydroxypropyl)-n,n-dimethylpropan-1-aminium and [saturated fatty acid(C=10-18, normal chain)(or unsaturated fatty acid(C=18, normal chain))]}; 
• alpha-(alkyl(C=6-18))-omega-hydroxypoly[oxyethane-1,2-diyl/oxy(methylethane-1,2-diyl)](Limited to the number-average molecular weight of the polymer of less than 1,000.); 
• alpha-hydro-omega-[(3-methylbut-3-en-1-yl)oxy]poly(oxyethane-1,2-diyl) (The repeating number of repeating units is an integer 1 or more.) (Limited to the number-average molecular weight of the polymer of less than 1,000.); and
• [alpha-(alkanoyl(C=8-18, normal chain))-omega-methoxypoly(oxyethane-1,2-diyl) or alpha-(alkenoyl(C=8-18, normal chain))-omega-methoxypoly(oxyethane-1,2-diyl)] (The repeating number of repeating unit is an integer 1 or more.) (Limited to the number-average molecular weight of the polymer of less than 1,000.). 

Priority Assessment Chemicals (PACs) are substances that are believed to be hazardous to the environment or human health. Companies must submit annual reports to METI for these substances when manufacturing or importing them in volumes of one tonne or more a year.

On 6 March 2023, Japan’s Ministry of Health, Labour and Welfare (MHLW) published a draft of its latest revised positive list for food contact materials (FCMs) which includes substances for listing requested by companies, and revised use requirements for some substances under table 1 and 2. Table 1 consist of base materials like dichloromethylphenylsilane, 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane, [n-2-(aminoethyl)-3-aminopropyl]dimethoxy methylsilane, etc. and Table 2 consists of for example triallyl isocyanurate, triester of benzoic acid and 2-ethylhexanoic acid with trimethylolpropane.

The first draft of the positive list for FCMs was published in August 2019 under the amended Food Sanitation Act. Currently, the positive list consists of:

• Approximately 300 base polymer resins
• 750 additives
• 180 base polymer resin additives
• 50 trace monomers

The revision follows a consultation phase from 26 April 2022 to 15 July 2022, where businesses were asked to provide comments and list suggestions to the MHLW. Enforcement of the new revision is expected to begin on 1 June 2025.

The Japan Food Contact Material Safety Centre gave companies advice at the end of March to review the list of compounds, the Ministry's policies based on company comments, and the revised use restrictions for some substances.

On 14 February 2023, Japan’s Ministry of Environment (MOE) announced its plan of drawing up proposals to designate poly(oxyethylene) nonylphenyl ether (NPE) as class II specified chemical substance.

Class II specified chemicals are those that have been discovered (or are soon anticipated to be discovered) in significant amounts in the environment and are believed to represent a risk of long-term harm to persons and/or the ecosystem. Currently, there are 23 substances in this class, including trichloroethylene, tetrachloroethylene, carbon tetrachloride, and triphenyltin N,N-dimethyldithiocarbamate. Class II specified substances are regulated under Japan’s Chemical Substances Control Law and require mandatory reporting of present and anticipated production quantities.

In Japan, NPE is widely used as:

• wetting agent, emulsifier, and dispersant in textile processing.
• detergents, dishwashing liquids, and floor cleaners in household and industrial cleaning products.
• defoaming agent in the production of paper and pulp.
• emulsifier and wetting agent in the production of pesticides and herbicides.
• emulsifier and surfactant in cosmetic products such as shampoos, body washes, facial cleansers, etc.

By the end of 2023, the MOE plans to inform the WTO and launch a public consultation on the recommendations.

On 31 January 2023, Japan’s Ministry of Health, Labour and Welfare (MHLW) published a draft notification to begin measuring workers’ exposure to 15 specified chemical substances, dust and organic solvents, using personal sampling, under the Industrial Safety and Health Act (ISHA).

Owing to their high toxicity, the specified chemical compounds are subject to preventative actions under the MHLW's Ordinance on Prevention of Risks Due to Specified Chemical Substances.

The Specified Chemical Substances are listed below:

• Benzene
• Acrylonitrile
• Formaldehyde
• Ethylene oxide
• Auramine
• Ortho-toluidine
• Dimethyl sulfate
• Propylene oxide
• Magenta
• Diantimony trioxide
• Dimethyl-2,2-dichlorovinyl phosphate (DDVP)
• Refractory ceramic fiber
• Methyl bromide
• Naphthalene

The changes to ISHA were anticipated to be completed in March 2023, and go into force on 1 October 2023.

In the report “Expert Committee on Chemical Substance Management Financial Year (FY) 2022”, the MHLW also suggested workplace environment concentration standard values (exposure limits) and testing techniques for 67 compounds. Moreover, it lists substances due for assessment in the upcoming financial years. The report was released on 10 February 2023.

On 23 March 2023 the Australian Industrial Chemicals Introduction Scheme (AICIS) opened consultation on 17 draft evaluation statements covering 1768 industrial chemicals. The deadline for comments is 19 May 2023. This type of consultations has been held by the AICIS on three prior occasions, first in October 2021 (1387 substances), in May 2022 (157 substances) and in October 2022 (187 substances).

Under Australia’s Industrial Chemicals Act 2019, any chemical that meets the definition of an industrial chemical (or class of industrial chemicals) may be subject to evaluation. Evaluations can cover a single chemical, a class or group of chemicals, a specific use, a specific hazard, a specific exposure, or specific circumstances of a chemical introduction.

The evaluations are a part of Australia’s evaluation roadmap for 2024 and beyond, published in September 2021 and the accompanying rolling action plan for prioritizing chemicals for evaluation. Both were implemented to accelerate the risk assessment process for industrial chemicals that can be used in the country. The aim of the evaluation roadmap is to evaluate at least 20 % of the chemicals on the Australian Inventory of Industrial Chemicals (AIIC) for which a current risk assessment is not available by 30 June 2024. This would be approximately 4200 chemicals.

The list of draft evaluation statements provides an overview of the evaluations including the proposed outcomes for each chemical. For example, benzaldehyde is evaluated in order to provide information on human health risks, focusing on the risk to public health from the use of the chemical in e-cigarettes (vaping products). Another example is 1-chloro-4-(trifluoromethyl)-benzene where evaluation selection analysis has indicated a potential human health risk and the AICIS proposes to vary terms of the Inventory for this substance. Most of the substances (approximately 1500 of the 1768) are not considered for in depth evaluation since they are no longer commercially active in Australia.

On 17 March 2023 the Brazilian Institute of the Environment and Renewable Natural Resources (IBAMA) published the Regulatory Instruction No. 10 of March 17, 2023, that establishes an updated list of classification of harmful or dangerous substances according to the risk they produce when coming into contact with water. The standard conforms to the International Code for Chemical Products in Bulk (ICCPB) adopted by Annex II of the International Convention for the Prevention of Pollution by Ships (ICPPS) of the Committee for the Protection of the Marine Environment of the International Maritime Organization (IMO).

This regulation classifies chemical products according to the medium or moderate risk to human health or the environment and grants the Brazilian Institute of the Environment and Renewable Natural Resources, as the authority in the case, the power to classify the products in the corresponding category of the International Code of Chemical Products in bulk or in another category resulting from the risk assessment of the mixture of harmful  substances. To do this, the institute must consider the best technical information available at the time of the evaluation.

The Argentinian government has published the fees for registration, importation, notification, fines and tariffs for 2023 regarding the Registry of Chemical Precursors created by Law 26.045 of 8 June 2005. The fees are summarized in the following table: 

To make the payment there are several options available. The first option is to make a transfer or deposit that corresponds to the fee that needs to be paid or the value of the tariff that is required for the compensation of tariffs that were acquired before the Resolution 647/2021 of 30 December 2019 (Procedures within the National Registry of Chemical Precursors) came into effect. 

Another option is to complete the form found on the website www.entecooperador.org.ar/informar-pago.html. Once the payment has been made, it is necessary to wait for the receipt of an electronic invoice, which will be emailed within 48 hours of the next business day after the transfer or deposit was made. 

If the invoice has not been received after 72 business hours, it is important to inform the National Registry to the email: pedidos@entecooperador.org.ar. 

The Mexican government has expressed its interest in promoting the application of a national policy on chemical substances, considering the life cycle of such substances. The General Health Council, responsible for the health sector in Mexico, has stated that the new policy will ensure the safe management of chemical substances throughout their entire life cycle, from production to disposal, to protect the health of people and the environment.  

To support this initiative, Aniq, a working group consisting of representatives from different companies, has been formed to develop a conceptual proposal for the management of chemical substances in Mexico. The proposal aims to align with international regulations and avoid trade barriers. However, there is no official document that includes the proposal at this stage.  

The potential impact of this new regulatory framework has generated curiosity and concern among other organizations. As a result, a telephone conference was held with officials from other representative organizations of the chemical industry, including the International Council of Chemical Associations (ICCA) and the American Chemistry Council (ACC) to share the information that is currently available regarding this project in Mexico. During the conference, representatives from Aniq expressed their intention to generate information that serves as a basis for position documents related to the regulation of chemicals, such as those that take place at summit meetings on international agreements and conventions on safety and the environment, such as the Strategic Approach to International Chemicals Management promoted by the United Nations.  

To further advance this initiative, a new conference call will be scheduled with the counterparts of Aniq in Latin America to comment on the matter and define a joint agenda that allows the chemical industrial sector to improve the management of chemical substances. Representatives of ICCA and ACC suggested a cooperation strategy for the regulation of chemical substances in Latin America. This strategy is based on the participation of Latin American Chemical Associations, coordinated by ICCA, for the exchange of information and experiences in the matter, including training courses for both companies and governments in the region.  

Aniq plans to participate in this strategy by holding monthly conferences with those involved to define the steps to follow. The participation of international organizations would also be sought, as well as the participation of an expert adviser financed by ICCA.  

Overall, the goal of the proposed regulatory framework is to ensure the safe management of chemical substances in Mexico and Latin America, protect human health and the environment, and align with international regulations. The involvement of various organizations and the cooperation strategy suggested by ICCA and ACC will facilitate the exchange of information and experiences in the matter, ultimately leading to the effective regulation of chemical substances in the region. 

Uruguay’s Ministry of Livestock, Agriculture and Fisheries is proposing a resolution to ban import, registration, and renewal of pesticide products that include the following active ingredients:  Carbofuran, Methyl Parathion, Trichlorfon, Dichlorvos, and Cyhexatin. The Draft Resolution contains only two pages information (in Spanish) (View here). The resolution is available for public comment for a period of 60 days from 12 May 2023. The resolution is expected to enter into force 6 months from the date of publication.