GPC Newsletter Jun-2023

On the 27 June 2023, the Government of Canada has announced that it will prohibit the testing of cosmetic products on animals before the end of year 2023. 

Bill C-47, Budget Implementation Act, 2023, No. 1, has brought about significant changes to the Food and Drugs Act (FDA), specifically targeting cosmetic animal testing. Under these new legislative amendments, companies in Canada are now prohibited from testing cosmetic products on animals or selling cosmetics that rely on animal testing data for safety assessments. 

The global trend towards ethical cosmetic testing has seen a remarkable reduction in the practice of animal testing, which was already infrequently conducted in Canada. By adopting these changes, Canada is aligning itself with other countries that have taken proactive measures to ban cosmetic animal testing, including all European Union member states, Australia, the United Kingdom, and South Korea. 

Moreover, Health Canada is actively collaborating with the international scientific and regulatory community to explore, validate, and implement alternative methods to animal testing, extending beyond the realm of cosmetics. The agency demonstrates its commitment to this cause by providing ongoing leadership and contributing to the efforts of various committees and organizations, such as the Organization for Economic Co-operation and Development (OECD) and the International Cooperation on Alternative Test Methods (ICATM). 

Starting from 22 December 2023, cosmetic product tests that inflict pain on animals or pose a risk to their well-being will be banned. Additionally, the new law will prohibit the sale of any cosmetic product that relies on animal testing data for safety evaluations and will prevent false labeling claims suggesting a product was not tested on animals. The updated legislation introduces several exceptions to the prohibition on animal testing, which include: 

1. Data published by the Canadian government in a scientific journal or on its website. 

2. Data that is publicly available and originates from a test not conducted by manufacturers. 

3. Data obtained from testing required under the laws of Canada or another country for a substance used or previously used in a non-cosmetic product. 

4. Data derived from a test conducted before the effective date of the ban. 

5. Cosmetics that were sold in Canada prior to the effective date of the ban. 

On June 17, 2023, the Canadian government put forward proposals to amend the regulations governing formaldehyde emissions from composite wood products. The aim of these proposed amendments is to provide clarity on the requirements for quality control testing and record-keeping. The existing requirements, which came into effect in January 2023, were designed to closely align with the regulations set out by the United States under the Toxic Substances Control Act (TSCA). Interested parties are invited to submit their comments on the proposed amendments by August 31. 

The Formaldehyde Emissions from Composite Wood Products Regulations, which were officially published in the Canada Gazette, Part II, on July 7, 2021, have been in force since January 7, 2023. The primary objective of the Regulations is to mitigate potential health risks associated with indoor formaldehyde exposure for Canadians. The regulations establish specific limits on acceptable formaldehyde emissions from composite wood products. When present in indoor air, formaldehyde can cause irritation of the eyes, nose, and throat. Moreover, evidence suggests that it may worsen asthma symptoms, particularly among children. 

To achieve the desired outcomes, the Regulations prohibit the importation, sale, or offering for sale of composite wood products that exceed the established limits for formaldehyde emissions. These measures aim to align with the provisions outlined in the Toxic Substances Control Act (TSCA) Title VI to the maximum extent possible. This alignment fosters regulatory harmonization and creates a level playing field internationally. 

The proposed amendments include the following: 

1. Removal of the accreditation requirement for laboratories conducting routine quality control formaldehyde emissions testing. 

2. Clarification of record-keeping obligations along the supply chain of composite wood products, with a focus on finished goods. This entails requiring a single manufacturer's declaration confirming the incorporation of certified panels into finished goods. 

3. Adjustment of the notification period for non-compliant lots, extending it from two days to 72 hours. 

4. Alignment with the requirements outlined in the February update to the TSCA formaldehyde emissions regulations in the United States. 

On June 17, 2023, Health Canada published its proposed Tents Regulations in the Canada Gazette which includes amendments to the Toys Regulations and the Textile Flammability Regulations. The government is seeking stakeholder comments on these proposals until August 26. 

The purpose of the Tents Regulations is to ensure the safety of individuals in Canada by addressing the risk of injuries and fatalities caused by tent fires. These regulations establish specific requirements for fire-safety labeling and flammability performance of tents. Initially, the regulations incorporated sections of an industry standard that focused on the flammability concerns related to the commonly used tent material at the time of enactment, specifically paraffin-coated cotton canvas. However, these performance requirements are no longer suitable for addressing the flammability hazards associated with the materials currently available in the market. As a result, the existing requirements may hinder the use of tent materials that are actually safe from a risk perspective, leading manufacturers to apply flame-retardant chemicals to comply with the regulations. 

Health Canada is proposing to replace the current flammability and fire-safety labeling requirements in the Tents Regulations with contemporary standards developed by the Canadian General Standards Board (CGSB). The proposed standard, entitled CAN/CGSB-182.1-2020 Flammability and Labelling Requirements for Tents, would provide updated guidelines that align with modern tent materials. Furthermore, Health Canada is suggesting the inclusion of flammability performance and fire-safety labeling requirements for children's play tents in the Toys Regulations. This would allow for separate regulation of play tents not intended for outdoor use, thereby excluding them from the Tents Regulations. Additionally, amendments to the Textile Flammability Regulations are proposed to exclude products covered by the Toys Regulations, streamlining the regulatory framework. 

This regulatory proposal aims to address various issues associated with the current requirements in the Tents Regulations under the Canada Consumer Product Safety Act (CCPSA). These issues include outdated references and methodologies for assessing the flammability performance of modern tent materials, which may lead to a reliance on flame- retardant chemicals for compliance. It is worth noting that the proposed changes do not include a prohibition on flame retardants in conventional tents and certain children's play tents, as previously considered in the 2019 proposal. 

If finalized, the new requirements would take effect immediately upon publication in the Gazette. Sellers would have one year to comply, while manufacturers and importers would have 180 days to ensure compliance.  

Legislation (S-5) to modernize the Canadian Environmental Protection Act (CEPA) received consent from the Senate and royal assent on 13 June. The provisions of Bill S-5 will come into effect immediately and the Canadian government now has two years to announce the specific requirements of the legislation.  

Bill S-5, known as the Strengthening Environmental Protection for a Healthier Canada Act, marks a significant milestone in safeguarding the well-being of both the environment and the Canadian people. The Canadian Environmental Protection Act, 1999 (CEPA), constitutes a fundamental piece of Canada's environmental legislation, aiming to combat pollution and shield the environment and its inhabitants from the detrimental consequences.   

Bill S-5 is the first significant set of amendments to CEPA in over two decades since it came to force in1999. The aims to: 

1. Enhance protection for vulnerable communities that bear the brunt of pollution's impact. 

2. Advance Indigenous reconciliation by explicitly confirming the implementation of the United Nations Declaration on the Rights of Indigenous Peoples, encompassing the principles of free, prior, and informed consent, as well as recognizing the invaluable role of Indigenous knowledge in environmental and health-related decision-making. Moreover, these amendments introduce new reporting requirements. 

3. Mandate the development of a new Plan of Chemicals Management Priorities, strengthen the assessment of cumulative effects resulting from exposure to multiple chemicals, and establish a Watch List to facilitate the transition toward safer alternatives. 

4. Foster the development and adoption of scientifically supported alternative testing methods and strategies, reducing reliance on animal testing in favor of more humane approaches. 

5. Embed an environmental purpose within the Food and Drugs Act (FDA), facilitating the effective management of environmental risks associated with pharmaceuticals and establishing a modernized regulatory framework for drugs within an environmental context. 

The government now has until June 2025 to develop a comprehensive new plan that prioritizes chemicals for risk assessment and potential risk management. This plan will replace the chemicals management plan (CMP) from 2006, which has largely fulfilled its purpose of evaluating over 4,300 chemicals out of the 23,000 currently present in Canadian commerce. 

As per the new legislation, the government also has a two-year timeframe to establish a framework that outlines how it will incorporate the right to a healthy environment into its implementation of CEPA. This framework will encompass important concepts such as environmental justice and intergenerational equity. 

On 19 May 2023, Environment and Climate Change Canada (ECCC) and Health Canada published their draft state of per-and polyfluoroalkyl substances (PFAS) report. The report signifies a significant development by the Canadian government in acknowledging the potential risks posed by PFASs to human health and the environment. This collaborative effort between Environment and Climate Change Canada (ECCC) and Health Canada moves the government closer to considering regulatory measures to restrict these persistent compounds. 

Based on the findings outlined in the report, which align with the toxicity criteria specified in section 64 of the Canadian Environmental Protection Act (CEPA), the government intends to recommend adding the group of over 4,700 PFASs as a class to Schedule 1 of CEPA. This schedule lists toxic substances within the country, and if confirmed in the final report, it will pave the way for potential regulatory and non-regulatory controls on the use of PFASs, particularly in firefighting foams. The government also aims to explore avenues for reducing exposure to PFASs from other sources and products, while seeking alignment with actions taken by other jurisdictions. 

The draft report indicates the possibility of future regulatory actions not only targeting PFASs in firefighting foams but also addressing their wide usage in cosmetics, food packaging, and other products. This underscores Canada's commitment to intensifying efforts in addressing PFASs comprehensively. The country already regulates the manufacturing, import, use, and sale of specific PFASs such as perfluorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA), and long-chain perfluorocarboxylic acids (LC-PFCAs). By adopting a class-based approach, Canada aims to align its actions with those of the United States, including initiatives in Maine, as well as with the European Union's proposal to address a broader range of PFASs. In the accompanying risk management scope, the Canadian government expresses its intent to consider alignment with jurisdictions such as the EU, US, Australia, New Zealand, and others. 

Interested parties have the opportunity to provide comments on the draft report and risk management scope until 19 July. 

On 15 May 2023, a legislation (the Toxic-Free Cosmetics Act, HB 1047) was signed by Washington Governor Jay Inslee to ban per- and polyfluoroalkyl substances (PFAS), phthalates and several other chemicals from personal care products. This is considered the strongest law in the United States on the regulation of cosmetics and personal care products.

The following chemicals which are intentionally added in cosmetic products will be banned from 1 January 2025. Retailers will be allowed to sell existing noncompliant products until 2026.

The following two main modifications to the House bill have been adopted by the US Senate in April 2023.

• By May 2024, an initiative is to be taken to assist independent cosmetologists and small businesses in transitioning to safer products.

• The Washington State Department of Ecology is required to build up a list of products giving off formaldehyde or formaldehyde releasing agents which may subject to restriction.   

The European Chemical Agency (ECHA) recently organized a workshop on New Approach Methodologies (NAMs) with over 500 participants to discuss ways to replace animal testing in the hazard assessment of industrial chemicals while at the same time ensuring a high level of protection of human health and the environment.

The workshop aimed to achieve a common understanding of what short and long-time goals can be realized with NAMs. Some issues discussed at the workshop were:

• Potential areas where NAMs could be used to reduce regulatory dependence on data generated with animal tests.

• How to accelerate the regulatory acceptance of NAMs.

• The potential of NAMs to accelerate the pace of assessment while taking ethical values into consideration.

The concluding remarks from the Director for Prioritisation and Integration, Ofelia Bercaru, indicated that ECHA opens the way for animal testing-free chemicals regulation in the future: “ECHA is committed to supporting the development of new methodologies to replace testing on animals. We also want to contribute to future EU chemicals regulation which would not rely on animal testing. This workshop gave us new views and a better understanding on how we can move forward, while implementing horizonal regulations such as REACH and CLP." 

Prior to the workshop ECHA published its fifth report on the use of alternatives to testing on animals for the REACH Regulation. The report finds that progress is being made in the increased use of alternatives to gather data on the properties of substances, in place of animal testing. An example is that there has been a significant increase in the use of in vitro test methods. These are methods that involve studies with cell, tissues, or organs which are used to obtain data for skin corrosion/irritation, serious eye damage/eye irritation and skin sensitisation. Approximately 50% of the studies conducted for skin and eye irritation in the period 1990-2022 were performed in vitro. For new studies conducted in 2019-2022, this percentage rises to approximately 90%.

The report reveals opportunities and challenges associated with moving away from animal testing in the regulatory assessment of chemicals. Additionally, it presents the initiatives made by ECHA to promote non-animal testing and to increase the acceptance and uptake of NAMs.

On 14 June 2023, the European Chemicals Agency (ECHA) added two chemicals to the Candidate list of Substances of Very High Concern (SVHC).

SVHCs are substances that can have serious and often irreversible effects on human health and the environment. A substance that is identified as an SVHC will be added to the Candidate List for eventual addition to the Authorisation list. With the new additions the Candidate list now has 235 entries, some are groups of chemicals, so the overall number of impacted chemicals is higher. The Authorisation list has 59 entries. If a substance is on the Authorisation list, its use is prohibited unless the European Commission grants authorisation for continued use.

The first new substance is diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (TPO) which is identified as toxic to reproduction in accordance with Article 57(c) of the REACH Regulation. TPO is primarily used in inks and toners but also in a wide range of products such as photo-chemicals, adhesives, sealants, and polymers. Between 10,000 and 100,000 tonnes are manufactured or imported in the European Economic Area (EEA) every year.

The second new substance is bis(4-chlorophenyl) sulphone (BCPS) which is a very Persistent and very Bio-accumulative (vPVB) substance according to Article 57(e) of the REACH Regulation. BCPS is used industrially to produce polymers, rubbers, and other chemicals. It is manufactured and imported in the EEA in the range of 10,000 to 100,000 tonnes per year.

Under REACH there are legal obligations when it comes to substances in the Candidate List:

• Suppliers must give their customers and consumers information if their articles contain more than 0.1 % (weight by weight) of a Candidate List substance.

• Consumers have the right to ask suppliers whether their products contain SVHCs. Suppliers of substances on the Candidate List, either on their own or in mixtures, have to provide a Safety Data Sheet to their customers.

• Importers and producers of articles that contain a substance from the Candidate List must notify ECHA within six months from the date the substance has been added to the List.

Furthermore, under the Waste Framework Directive, companies have to notify ECHA if the articles they produce contain SVHCs in a concentration above 0.1 % (weight by weight).

On 8 June 2023 the European Commission added 24 new entries for substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR) to the REACH Restricted Substance List (Annex XVII). The list of substances was published in an Annex to the Commission Regulation 2023/1132 in the Official Journal of the European Union on 9 June. The Commission Regulation can be found here. The restrictions will come into force on 1 December 2023.

The 24 new substances are classified as Category 1A and 1B CMR substances. Category 1A contains chemical substance for which there is scientific evidence based on humans that the substance is CMR. For Category 1B the scientific evidence is based on animals. Under the REACH regulation substances that are categorised as CMR 1A and 1B cannot be placed on the market or used.

The substances added to Annex XVII include the following:

Furthermore, five existing substance entries in Annex XVII have been amended.

The extension of the UK REACH registration deadlines is now official! The legislation necessary to implement the extension was laid in Parliament by the Department of Environment, Food & Rural Affairs (DEFRA) on 20^th April 2023 and the Statutory Instrument (S.I.) 2023 No. 722 that brings it into force was made available from 28^th June 2023. The S.I. 2023/722 will come into force on 19^th July 2023. 

Extensions to the current UK REACH Registration deadlines are as follows:

More information on the extensions can be viewed by visiting the S.I 2023/722 here: The REACH (Amendment) Regulations 2023 (legislation.gov.uk)

The UK Government recently informed Parliament that they will no longer grant licenses for animal testing of chemicals that are exclusively intended for use in cosmetic products. The licensing ban came into force on 17 May 2023.

The UK Government is fully committed to minimizing the use of animals in scientific research, whenever scientifically viable, and holds strong confidence in the capabilities of the UK science sector and industry to provide alternative solutions.

This move has positioned the UK at odds with the EU, as the European Chemicals Agency (ECHA) mandates the testing of cosmetics-only ingredients on animals as a last resort to ensure worker and environmental safety within the framework of REACH.

Regarding cosmetic regulations, manufacturers are obligated to demonstrate the safety of their products for consumer use. In 1998, the UK implemented a ban on animal testing for consumer safety of cosmetics and their ingredients, which remains in effect to this day.

However, under the chemicals regulations, known as the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regime, chemical manufacturers and importers must prove the potential hazards of the chemicals they place on the market to human health and the environment. This requirement encompasses chemicals utilized as ingredients in cosmetics. In certain instances where no validated alternatives exist, animal testing has been employed as a last resort in the past.

It's important to note that the REACH regime operates separately from consumer cosmetics regulations, serving a distinct purpose. This distinction has allowed for the possibility of animal testing when it comes to chemicals used in cosmetics production. As a result, a limited number of time-limited licenses were issued between 2019 and 2022. The government acknowledges the public's concerns regarding animal testing of cosmetic ingredients and recognizes the newfound opportunities to diverge from the EU testing regime.

Recently, the UK High Court dismissed a legal challenge brought forth by an animal rights organization, which claimed that the government had neglected to communicate its alignment with the EU's approach.

On 8 June 2023 UK’s Health and Safety Executive (HSE) published its recommendation to restrict the use of hazardous substances in ink used for tattooing and permanent make-up (PMU) in Great Britain.  The recommendation follows the publication of the final risk assessment opinion in February 2023 and a 60-day public consultation on the draft socio-economic (SE) opinion which ended on 14 April 2023. The Secretary of State for the Department of Environment, Food & Rural Affairs (DEFRA) and the Welsh and Scottish ministers will now have to decide if the restriction should be brought into law.

The proposed restriction aims to protect people from potential harmful effect that can be caused tattoo and PMU ink.  It targets substances with the following classifications:

• CMR (carcinogenic, mutagenic, and reprotoxic)

• Skin sensitisation

• Skin corrosion

• Serious eye damage

The restriction, however, includes a derogation for 19 pigments including Pigment Blue 15:3 and Pigment Green 7. The fact that HSE’s review of these 19 pigments did not find evidence indicating that they are unsafe if used in tattoo or PMU ink combined with the lack of identified alternatives means that it was deemed appropriate to allow the continued use of these 19 pigments. Originally the derogation also included Pigment Red 83 and Solvent Violet 13, but these two substances were removed because the review identified data indicating potential concern for skin sensitisation for these substances.

In the EU restrictions apply to more than 4000 hazardous chemicals contained in mixtures for tattoo inks and permanent make-up since 4 January 2022 and exactly one year later the ban on Pigment Blue 15:3 and Pigment Green 7 came into force.  

This recommendation of restriction is the first made by the HSE after it became the authority in charge of UK-REACH in Great Britain when the UK left the EU. The HSE recommends a transition period of two years to give manufacturers and suppliers time to adapt to the new legal requirements and to test new inks. Furthermore, artists will have one more year to use up old stock and switch to new inks.

It is important to check with the new definitions to see if the previous definitions are still met by the company. Therefore, companies could complete their fee payments according to the size of the business during the KKDIK registration process. 

A new code of practice for safeguarding employees from chemical airborne pollutants in the workplace is being discussed in India. 

In May 2023 the Bureau of Indian Standards (BIS) published the draft Indian Standard, Work Environment Monitoring (Airborne pollutants) - Code of Practice and is accepting comments on it until 23 July 2023. The draft contains standards for monitoring data of chemical variables responsible for airborne pollutants, frequency and kind of sample collection, and data interpretation. The complete draft can be found here. 

The guidelines state that: 

• Environmental monitoring in a plant shall take place under normal process conditions and ideally every day and throughout the day. 

• Airborne contaminants shall be identified by monitoring all situations where it is possible that a person can be exposed.  

• The total duration of a process shall be estimated when a process or operation is carried out repeatedly. 

• When two or more contaminants are present simultaneously, they shall be monitored individually and simultaneously. 

The draft suggests that the exact threshold limit value for individual contaminants may be obtained from relevant literature such as the American Council of Governmental Industrial Hygienists' (ACGIH) list of chemical pollutants' threshold limit values (TLV).  

The Bureau of Indian Standards (BIS) asked for comments until 2 June 2023 on a new revised standard for vinyl acetate monomer, which is used in adhesives, emulsion paints, wood coatings, lacquers, and inks. 

The standard for vinyl acetate monomer was originally published in 1988. The revision incorporates alternate methods for determination of aldehyde, distillation range and specific gravity. 

The chemical should be stored in mild steel drums, according to the updated draft, which also suggests the required use of "dangerous goods" labels coupled with visual markings (in accordance with Indian Standards 1260). Additionally, the container must clearly state that it contains "vapours and liquid dangerous to eyes." 

The BIS updated standard establishes the following precise specifications for the substance: 

Additionally, substance containers must be marked with manufacturing information including the name of the material, the manufacturer's name, the product's gross and net weight, the month and year it was made, and its shelf life.    

On 23 May 2023 the Central Government of India published a notice in the Indian Gazette delaying the start date for the Quality Control Orders (QCOs) for vinyl acetate monomer, methyl acrylate, and ethyl acrylate. The initial enforcement date for the substances was 31 May 2023 and the new enforcement date for all three substances is 29 February 2024.

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 15 May 2023 the Indian Ministry of Health and Family Welfare (MHFW) published a notification in the Gazette of India concerning amendments of the Cosmetic Rules, 2020. The MHFW is accepting comments for 45 days, i.e. until 29 June 2023.

The following are some of the changes proposed in the amendment:

The Cosmetic Rules, 2020 came into force on 15 December 2020 but an 18-month extension was granted to comply with the rules. The Rules are a part of the Drugs and Cosmetics Act, 1945.

The notification can be found here: https://egazette.nic.in/WriteReadData/2023/245904.pdf

On 18 May 2023 the Indian Standards Bureau (BIS) published a draft revised standard regarding polyethylene terephthalate (PET) bottles for packaging of edible oils. PET, a plastic resin formed by poly-condensation reaction of ethylene glycol with either terephthalic acid or dimethyl terephthalate, is a commonly used material for FCM. BIS will be accepting comments on this draft until 17 July 2023. 

In India Food Contact Materials (FCMs) are regulated under Food Safety and Standards Act (2006) and its related regulations such as Food Safety and Standards (Labelling and Display) Regulations (2020) and Food Safety and Standards (Packaging) Regulations (2018). Last year, the authority also published a Direction regarding the use of recycled plastics. In addition to the FCM regulations, the Indian government also uses BIS standards to address individual materials used for packing food or have direct contact with food.  

The draft revised standard prescribes the requirements and methods of sampling and testing for PET bottles up to 5 kg or 5 liters of edible oil and has a total migration limit for all compounds of 60 mg/kg,  

Additionally, the updated draft sets the following precise limitations for heavy metals and the phthalate DEHP: 

According to the specification, PET material must be virgin grade and in compliance with Indian Standard (IS) 12252:2017. For bottles to be recyclable, additives for biodegradability or compostability must be avoided. High density polyethylene (HDPE) or another virgin food-grade polymer must be used for plastic bottle caps. The IS 15495 standard must be followed for all printing inks and coating chemicals used on labels, and all inks, coatings, glues, and adhesives must be bisphenol-free. 

The Ministry of Industry and Information Technology of China (MIIT) published a notification calling for public opinions on twelve national mandatory standards which includes four chemical related standards. 

• Safety and Technical Guidance on Transportation Package of Hazardous Chemicals and Packaging which Contains Several Hazardous Chemicals 

This Guidance gives information about the classification of dangerous goods and packaging, packaging coding and marking, shipping marks and shipping labels, packaging requirements, special requirements for limited quantity packaging and excepted quantity packaging. 

• Transport packaging for dangerous goods - Safety technical specifications for salvage packaging

This Guidance specifies the classification of dangerous goods and packaging, packaging coding and marking, transport marks and transport labels, and general requirements.

• Rules for Classification and Labeling of Chemicals Part 1: General Rules

This document specifies the terms and definitions related to chemical classification and labeling, as well as chemical hazard classification, labeling and chemical safety data sheets.

This document is applicable to the classification and labeling of chemicals according to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (hereinafter referred to as GHS). Drugs, food additives, cosmetics, and pesticide residues in food, etc., are excluded from the label coverage of this document when ingested intentionally. However, if there is a possibility of worker exposure, or potential exposure during transportation, the provisions of this document still need to be followed.

• Rules for Classification and Labeling of Chemicals Part X: Desensitized Explosives

This part of GB 30000 specifies the terms and definitions, classification criteria, decision logic and guidance, and labeling of desensitized explosives.

This part applies to the classification and labeling of desensitized explosives according to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (hereinafter referred to as GHS).

The consultation period is until 16^th August. All the above standards will be enforced a year after it is being officially published. If you need any help regarding China REACH, please conduct GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com  

On 5^th June, China National Institutes for Food and Drug Control (NIFDC) published a notification including nine guidelines on cosmetic products and cosmetic new ingredients registration process. 

Cosmetic products and cosmetic new ingredients are under the overarching framework of Cosmetic Supervision and Administration Regulation (CSAR) based on the risks. The nine guidelines cover the following areas: 

• Registration and approval of new cosmetic raw materials with higher risks;
• Approval of amended registration for domestic special cosmetic products;
• Approval of first registration of domestic special cosmetic products; 
• Renewal of registration and approval of domestic special cosmetic products; 
• Approval of deregistration of domestic special cosmetic products; 
• Approval of amended registration of imported special cosmetic products; 
• Examination and approval of first registration of imported special cosmetic products; 
• Approval of renewed registration of imported special cosmetic products; and
• Approval of deregistration of imported special cosmetic products.

If you have any questions regarding China cosmetic compliance, or you would like to have to the full text of these guidelines, please contact GPC via compliance@cn.gpcregulatory.com.

In South Korea, the government has decided to break down uniform chemical regulations for small and medium-sized companies by unifying multiple ministries' double approval process to resolve corporate site difficulties significantly. 

On the 7th of June, the government held an "Economic Regulatory Innovation Task Force" meeting presided over by the Deputy Prime Minister and Minister of Strategy and Finance, Choo Kyung-ho, at the Government Complex Seoul and announced the "5th Economic Regulatory Innovation Plan" and the "Small and Medium Business Chemical Regulatory Innovation Plan." 

The burden of customs administration such as certification and reporting of import and export companies is also expected to decrease. Suppose an approved exporter for each item acquires certification rights for several new items. In that case, the validity period of the certification varies depending on the time of acquisition. Still, the validity expiration date of the certified items is integrated into one date. 

Regarding the regulation of chemicals in small and medium-sized enterprises, the enforcement regulations of the Chemical Substance Control Act will be revised to extend the validity period of the technical personnel standard that meets the criteria for completing the curriculum by five years from December this year to December 2028. In addition, when evaluating the qualifications of hazardous chemical managers, it was decided to additionally recognize surface treatment and precision industrial chemical qualifications that deal with the safety management of hazardous chemicals. 

If the Ministry of Employment and Labor approves the import of banned substances by revising the Enforcement Rules of the Ministry of Employment and Labor's Occupational Safety and Health Act, the import licensing system will become one, recognized as a permitted import license by the Ministry of Employment and Labor (MOEL).

The government will also revise the Act on Registration and Evaluation of Chemical Substances in the first half of 2024 and strengthen the protection of trade secrets by allowing "EU-style generic names" for trade secrets when transferring or transferring mixed products. 

To this end, based on the management system reform plan discussed by the public, industry, and government at the Chemical Safety Policy Forum in December 2022, a revision to the Chemical Substance Control Act and the Act on Registration and Evaluation of Chemical Substances will be prepared by August 2023 by related ministries, including the Ministry of Environment,

During the second half of 2023, the government will also push for revisions of the Act on Registration and Evaluation of Chemical Substances and the Chemical Substance Control Act, including the establishment of a management system based on the harmfulness, handling volume, and risk of chemicals. 

On June 12, 2023, the National Institute of Environmental Research (NIER) released an announcement regarding the contents of the amendment of the Regulations on Consumer Chemical Products and Biocides Safety Control Act. 

The amendment focuses on Article 10, Paragraph 6 of the " Consumer Chemical Products and Biocides Safety Control Act," as well as Article 6 of the Enforcement Decree and Article 6 of the Enforcement Rules of the same Act. The following are the key contents of the amendments to the "Regulations on Approval of Consumer Chemical Products Subject to Safety Verification."  

Key Amendment Contents: 

A. Mandatory labelling: The approved disinfectants for surface use now require the inclusion of a label that states the "Prohibition of air disinfection when using air disinfection devices such as aerosol disinfectants and high-pressure spray disinfection." This addition clarifies the usage instructions and dosage, emphasizing that these approved disinfectants do not possess air disinfection properties. 

B. Elaboration on protective clothing: The revised rule specifies the necessary protective clothing for operators working with disinfectants and pesticides. It states that when using the product, the operator must wear appropriate protective clothing, including a suit with upper and lower parts, protective gloves, and work shoes suitable for the situation. In addition, they should utilize designated respiratory protective equipment, such as respirators with face filtration or powered air-purifying respirators, as well as facial protective equipment like safety goggles and face shields. This amendment aims to provide specific details regarding the required protective clothing for operators. 

On 8 June 2023, the National Institute of Environmental Research (NIER) in South Korea partially revised the result of the hazard assessment of chemical substances and enforced it on the same date. 

• Notification of the results of hazard assessment of registered chemical substances: 37 new substances 

• Revision of notified substances: 30 new substances

- Dioctylbis(2,4-pentanedionato-.kappa.O2,.kappa.O4)tin (54068-28-9)

- Carbomonocycle carboxylic anhydride polymer with alkyl(C=2~6)-(substituted alkyl(C=1~5))-alkane(C=3~6)ol and alkyl(C=1~5)alkan(C=4~8)oic acid

- 'Dichlorodimethylstannane(753-73-1) mixt. with trichloromethylstannane(993-16-8) (78643-41-1)

- 'Matte, lead (84195-51-7)

- 1,5-Diisocyanatopentane homopolymer, 2-ethyl-1-hexanol-blocked (1976005-08-9)        

- Trialkyl(C=12~14) phosphite (93686-48-7)

- Reaction product of 1,1'-biphenyl, formaldehyde, aniline and maleic anhydride 

- 'B-Benzo[b]naphtho[2,3-d]furan-1-ylboronic acid (2261008-21-1)

- Biphenyl[(diheteropolycyclic)phenyl]phenyl heteromonocycle

- Tetrahydro-1-[4-(2-methoxyethoxy)-1-naphthalenyl]thiophenium, 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1) (1359824-38-6)

- [(Phenyl)-carbopolycyclic]-heteropolycycle

- N,N-Bis(2-ethylhexyl)isooctadecanamide (1616494-50-8)

- Phenol polymer with hydro-alkano(C=1~5)-carbopolycycle, glycidyl ether polymer with alkyl(C=1~5)-alkenoic(C=3~7) acid and hydroisoheteropolycyclic-dione

- Carbomonocycle carboxylic acid anhydride reaction product with substituted carbomonocycle, oxybis[alkanol(C=2~6)] and alkane(C=3~7)triol

- Fatty acids, (C=14~18) and (C=16~18)-unsatd., esters with neopentyl glycol (85116-81-0)

- Fatty acids, (C=12~16), esters with neopentyl glycol (85186-95-4)

- Mixture of fatty acids(C=15~21) and (C=16~21)-unsatd. polymers with alkyl(C=1~8) peroxide alkyl(C=1~7) alkyl(C=1~4) alkenoate(C=2~6)-linseed-oil fatty acids-alkyl(C=1~4) alkenoic(C=2~6) acid-alkenyl alkyl(C=1~4) carbomonocycle polymer, conjugated sunflower-oil fatty acids, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, linseed-oil fatty acids and hydroxyalkyl(C=1~4) alkane(C=2~6)ol, ammonium salts and linseed-oil polymer with aldo heteromonocycle, polyethylene glycol, alkyl(C=1~4) ether and polymd. linseed-oil

- 'Iron sinter (65996-66-9)

- 4,4'-Oxybis[3-(trifluoromethyl)benzenamine] (344-48-9)

- '4'-[2-(4-Aminophenoxy)ethoxy][1,1'-biphenyl]-4-amine (2014385-51-2)

- Fatty acids, tall-oil reaction products with ethanolamine, ethoxylated (61791-19-3)

- (Heteropolycycle-yl)bis[hydroxypoly[substituted(alkyl(C=1~5)-alkane(C=2~5)yl)]]

- Vinylbenzene polymer with alkyl(C=2~6) acrylate, alkyl(C=1~5) alkyl(C=1~5)-alkenoate, hydroxyethyl acrylate, alkyl(C=1~5) aminoalkyl(C=2~6) alkyl(C=1~5)-alkenoate, alkyl(C=3~7) phosphate, oxiranylalkyl(C=1~5) alkyl(C=1~5) alkenoate, hexamethylene diisocyanate, phenylalkyl(C=1~5)amine and substituted alkanoic(C=6~10) acid lactone, homopolymer [(alkyl(C=1~5)-oxo-alkenyl)oxy]alkyl(C=2~6) ester

- 'N-1-Dibenzofuranylspiro[9H-fluorene-9,9'-[9H]xanthen]-2'-amine (2641673-05-2)

- 'Chromium nitride (24094-93-7)

- '9-Ethenyl-9H-carbazole (1484-13-5)

- N,N’-{Dialkyl(C=2~6)-bis(alkyl(C=1~5)carbomonocyclic)-[alkyl(C=1~5)bis(alkyl(C=1~5)carbomonocyclic)iminocarbopolycyclic-alkyl(C=2~6)-dialkyl(C=1~5)anilinocarbomonocyclic-alkyl(C=1~5)carbomonocyclic]diammonium}tungstophosphate

- Reaction mixture of 2-(1,1-dimethylpropyl)anthraquinone and 2-(1,2-dimethylpropyl)anthraquinone

- 'Mill scale (ferrous metal) (65996-74-9)

- 2-(4'-Bromo[1,1'-biphenyl]-4-yl)benzo[b]thiophene (2641700-97-0)

- 'Bis(acetato-O)phenyliodine (3240-34-4)

- '2-(2-Naphthalenyl)-4-[7-(2-naphthalenyl)-1-dibenzofuranyl]-6-phenyl-1,3,5-triazine (2706591-68-4)

- Bicarbomonocyclic-(carbopolycyclicbenzofuranyl)-diphenylheteropolycyclic-diamine

- Di(carbomonocyclic)-(carbopolycyclic-benzofuranyl)-heteromonocycle

- '2-Bromobenzo[b]naphtho[2,3-d]furan (1627917-16-1)

- 'Iron ores, agglomerates (65996-65-8)

- N,N’-{Dialkyl(C=2~5)-bis(alkyl(C=1~4)carbomonocyclic)-[alkyl(C=1~4)bis(alkyl(C=1~4)carbomonocyclic)iminocarbopolycyclic-alkyl(C=2~5)-dialkyl(C=1~4)anilinocarbomonocyclic-alkyl(C=1~4)carbomonocyclic]diammonium}tungstophosphate

On 1 June 2023, the National Institute of Environmental Research (NIER) in South Korea publicly notified the Designation of Toxic Substances under the Act on Registration and Evaluation of Chemicals (K-REACH). 

Earlier this year, NIER consulted on a draft amendment for this matter, and the main proposed revisions included the following:  

• The new designation of toxic substances for which hazard assessment has been completed: CAS 2713-34-0, CAS 872-93-5, CAS 91742-16-4, CAS 79-00-5, CAS 1976005-08-9, and CAS 84988-61-4.

• Revise the name of toxic substances: DMAB; Dimethylamine borane; CAS 74-94-2, CAS 68-11-1 and mixtures containing more than 1%, CAS 126-98-7 and mixtures containing more than 1%, Selenium [CAS 7782-49-2] or its compounds and 1% a mixture containing the above. However, selenium, cadmium sulfoselenide orange (CAS 12656-57-4), cadmium sulfoselenide red (CAS 58339-34-7), except that it contains less than 25 % of CAS 10026-13-8 and mixtures containing it more than 1%, CAS 102-82-9 and mixtures containing it more than 1%, and CAS 1702310-11-9.

• Regulate newly designated toxic substances on import declaration & business license under Chemical Control Act (CCA), labeling hazardous chemicals, and transitional measures for handling. 

On June 1st, 2023, the National Institute of Environmental Research (NIER) in South Korea revised the regulation on chemical classification and labeling, including pictograms, hazard statements and precautionary statements, and classification mark lists, and enforced it on the same date. 

Earlier this year, NIER consulted on a draft amendment of this matter, and this was to notify the classification and labeling of newly designated toxic substances, as well as existing hazardous chemicals for which hazard reviews have been completed. 

• New classification and labeling for newly designated toxic substances 

- 6 substances including 3,5-difluorophenol. 

- CAS 2713-34-01 and mixtures containing more than 5%, CAS 872-93-5 and mixtures containing more than 25%, CAS 91742-16-4 and mixtures containing more than 25%, CAS 79-00-5 and mixtures containing more than 25%, CAS 1976005-08-9 and mixtures containing it more than 1%, and CAS 84988-61-4 and mixtures containing it more than 5%. 

• Revise classification and labeling for existing hazardous chemicals 

1) 28 toxic substances 

2) 2 substances requiring preparation for accidents. 

In April 2023, the National Institute of Environmental Research (NIER) in South Korea was consulted 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 was to update the regulation based on updated international chemical regulations, including OECD’s animal alternative test methods. 

On the 2nd of June 2023, according to Article 14 (1) of the Chemical Substances Registration Evaluation Act and Article 5 (1) 1 of the Enforcement Rules of the same Act, 11 items were revised to reflect the latest chemical test methods (122 items). Test methods for chemical substances were partially revised, 9 test items in the field of health effect test and added 2 new items.  

clause 4 - Eye irritation and serious eye damage test 

clause 5 - Skin Sensitization Test 

clause 14 - Toxicokinetic test 

clause 27 - In vitro skin irritation test (human skin model test) 

clause 33 - Skin hypersensitivity test (regional lymph node test, LLNA) 

clause 34 - Skin sensitization test (regional lymph node test, LLNA: DA) 

clause 36 - Chemical skin sensitization test (peptide binding test, amino acid derivative binding test, dynamic peptide binding test) 

clause 54 - Estrogen receptor transcriptional activity test 

clause 66 - Eye irritation test using Vitrigel. 

clause 71 - Skin sensitivity test (Defined Approached: 2 out of 3 methods) 

clause 72 - In vitro human skin model (RhE) phototoxicity test  

In a notice published in the official government gazette Kanpo on 26 May 2023, Japan’s Ministry of Health, Labour and Welfare (MHLW) added 3-Aminopropan-1-ol (CAS number 156-87-6) and mixtures thereof with a concentration of 1% or more to its list of poisonous and deleterious substances. The MHLW designated the substance, used in electronics, cosmetics, textiles, synthetic resin and pharmaceuticals, as 'deleterious' and the designation came into force on 1 June 2023.

The MHLW has classified 3-Aminopropan-1-ol as Category 1 Skin corrosion/irritation as well as serious eye damage/eye irritation in line with the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) standards established in Japan. These hazard classes are the primary considerations in selecting Deleterious Substances.

The amendment also includes the following changes, valid from 26 May 2023, to the list of Deleterious Substances:

• The concentration cut-off is changed from 10% to 15% for 2-Isobutoxyethanol (CAS number 4439-24-1), currently designated as a Deleterious Substance. 2-isobutoxyethanol mixtures with less than 15% are excluded from the list.
• Removal of diantimony tetraoxide (CAS number 1332-81-6) and its mixtures from the list of deleterious substances.

Manufacturers, importers, and distributors of Poisonous and Deleterious Substances have the obligation to register their substances with the MHLW and will be subject to SDS and labelling requirements. According to the government's Chemical Risk Information Platform (CHRIP), there are currently 585 substances on the poisonous and deleterious substance list.

On 1 June 2023, the Ministry of Land, Infrastructure, Transport, and Tourism (MLIT), the Ministry of Health, Labour, and Welfare (MHLW), and the Ministry of the Environment (MOE) of Japan jointly announced the proposal to add cybutryne to the list of hazardous substances that need permission when dismantling a ship. Cybutryne is a biocide used in antifouling paints. The action comes after cybutryne was added to the standards for creating an inventory of hazardous elements in April 2023 by the International Maritime Organisation's subcommittee on pollution prevention and response.

The enforcement is anticipated to begin in the middle of July, and public comment is ongoing until 2 July 2023.

It becomes mandatory for ship owners to provide an inventory of any hazardous materials discovered in the ship's machinery and structure in accordance with the country's Proper Implementation of Ship Recycling and Dismantling Act. This act aspires to align with the Hong Kong International Convention for the Safe and Ecologically Sound Recycling of Ships (HKC). The HKC was adopted by the International Maritime Organisation (IMO) in 2009 and will enter into effect 24 months after 15 states have signed it and other prerequisites have been satisfied. The HKC is aimed at ensuring that ships, when being recycled after reaching the end of their operational lives, do not pose any unnecessary risk to human health and safety or to the environment.

On 29 March 2023, Japan’s Ministry of Economy, Trade, and Industry (METI), the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Environment (MOE) released the classification results for classifying substances under the UN Globally Harmonised System (GHS) of classification and labelling of chemicals.

The list includes classification outcomes for substances that have been reclassified several times in prior years, and it covers 3,281 different substances. The justifications for each substance's classification are listed separately.

The outcomes can be used by businesses as a guide for creating GHS labels or safety data sheets (SDSs). However, according to the National Institute of Technology and Evaluation (NITE), it is not mandatory to provide the classification result on a label or SDS for Japan.

In May 2019, METI, MHLW and MOE jointly released the Japanese standards on chemical classification, labelling, and safety data sheets (SDSs) that are in line with the sixth revised version of the Globally Harmonised System (GHS). The standards are:

• JIS Z 7252: Classification of chemicals based on GHS 6 classifications and labelling
• JIS Z 7253: Hazard communication of chemicals based on GHS 6 labelling and SDSs

On 9 June 2023, the Australian government announced that because of a historic agreement reached at a national summit of environment ministers, strict new government regulations governing packaging will soon be implemented to reduce waste and increase recycling. With the aid of these new regulations, packaging waste may be reduced while also being utilised in places where it can be recovered, reused, repurposed, or reprocessed. To limit the use of toxic chemicals in food packaging, the regulations will include required package design criteria and objectives, as well as requirements for recycled material. 

Manufacturers must now meet new design requirements and must prioritize waste reduction from the start of the packaging process. These guidelines will cover several factors, including the use of recycled materials. In addition, consumer health and environmental protection laws will be introduced to ensure the safe and sustainable use of chemicals in food packaging. 

Voluntary targets set by environment ministers in 2018 to be completed by 2025. The targets set in 2018 and the completion status of the targets can be seen in the table below. In addition, single-use plastic packaging, which is harmful and unnecessary, should no longer be used by 2025.   

The pledge follows a report from the Australian Packaging Organization (APCO) published on April 20, which concluded the nation was not on target to meet its public packaging targets by 2025 and called for clearer guidance. 

On 20 June 2023, the Australian Industrial Chemicals Introduction Scheme (AICIS) posted information on their website that the rules for importation and exportation of decabromodiphenyl ether (decaBDE), perfluorooctanoic acid (PFOA), its salts, and PFOA-related compounds in Australia will be amended in the near future. The changes will be made because these chemicals were added to Annex II of the Rotterdam Convention in October 2022. The amendments will affect Division 1, Part 2 of Chapter 6 of the Industrial Chemicals (General) Rules 2019.

The AICIS has furthermore published a Call for Information asking current and previous importers and exporters of the above-mentioned chemicals to submit information about their import or manufacture. The call is open until 15 September 2023 and the information can be submitted here.

For current importers of decaBDE, PFOA, its salts and related compounds the new rules will mean that they must cease any new import or export of the chemicals. All current and new importers must apply to the AICIS for import or export authorisation and can only resume import or export once the authorisation has been received. It will be and offence to import or export these chemicals without authorisation and penalties apply.

The full list of chemicals that will be subject to the new import/export authorisation rules can be found here.

The Constitution, Justice, and Citizenship Commission (CCJC) of Brazil on 9^th of May 2023, granted their approval to the preliminary Draft Law of National Inventory of Chemical Substances (PL6120/19), also known as the Projeto de Lei do Inventário Nacional de Substâncias Químicas. As part of the legislative process in Brazil, the Federal Senate, or Senado Federal, will now undertake the discussion and evaluation of the Law. If the Law is approved by the Federal Senate and enacted into law, Brazil will join Chile, Colombia and Peru as South American nations that have implemented some form of national chemical management scheme.

With a concise length of only eight pages, the preliminary Law leaves various aspects open for further development. Nonetheless, the fourteen Articles provide significant insight into the government's perspective on the management of chemical substances. The "Rationale" section, located at the end of the draft Law, extensively elaborates on these viewpoints. While acknowledging chemical substances as the fundamental building blocks of life and the key components used in manufacturing products, Brazil also recognizes the potential dangers and risks associated with these substances if not properly managed. Despite the presence of multiple chemical substance registries in the country, Brazil highlights the absence of a comprehensive analysis regarding the potential risks posed by each substance. Consequently, an all-encompassing inventory and registration mechanism should be established.

From this standpoint, the government advocates for a comprehensive approach to managing chemical substances in the country, with an emphasis on knowledge-based prevention throughout their life cycle. The Law also aims to reduce fatalities and illnesses caused by hazardous chemical products, enhance water quality by minimizing exposure, provide training to the healthcare sector on managing poisonings and related illnesses, promote the correct use of these products, and address several other aspects. Finally, the government outlines three specific areas of action to be achieved through the implementation of the Law:

• Acquiring missing information about substances entering the country, particularly those intended for industrial use.
• Facilitating interaction among existing information systems to prevent redundancy in efforts by citizens and the government.
• Establishing a comprehensive mechanism for assessing hazardous substances that integrates a technical perspective on environmental care, health, and production.

You can check the full document here: Compliance Library of Brazil Regulatory Region | GPC Gateway

In Vietnam, it is mandatory to register the use of controlled substance under Decree No. 06/2022/ND-CP on Reduction of Green House Gas Emissions and Protection of Ozone Layer enacted by the Government on January 7,2022. On the same day the Ministry of Natural Resources and Environment (MONRE) also enacted Circular No. 01/2022/TT-BTNMT providing Detailed Regulations on implementation of Climate Change Response in the Law on Environmental Protection. On March 2, 2023, the Climate Change Bureau of the MONRE published a list as document no 237/BDKH-GNPT which consist of all the companies that have submitted applications for the registration of the use of controlled substances.

The substances that are present in the decree No. 06/2022/ND-CP as controlled substances are as follows:

• Bromochloromethane
• Carbon tetrachloride (CTC)
• Chlorofluorocarbon (CFC)
• Halon
• Hydrobromofluorocarbons (HBFCs)
• Hydrochlorofluorocarbons (HCFCs)
• Bromomethane
• Trichloroethane
• Hydrofluorocarbons (HFCs)

A company carrying out business that concerns manufacturing of controlled substances, import, export, reuse, recycling of controlled substances, manufacture or import of any product that is made up of or contain controlled substances has to register its use with the MONRE by January 15 of each year.

On the 28th of June, Chilean authorities delivered an important update via webinar on the progress of implementing Chile's regulation, based on the Decree 57/2021. The focus of this update centered around the introduction of some requirements to register hazardous industrial substances, known as "Notificación de substancias," on the country's online platform. The announcement highlighted crucial information regarding registration requirements, deadlines, and key updates from the recent event. 

Under the GHS regulation in Chile, manufacturers and importers of a substance, as well as importers of a substance contained within a hazardous mixture, are obligated to notify the new system with the required information. This notification process applies to substances or mixtures with quantities equal to or exceeding 1 ton per year. However, for substances contained within mixtures, notification is solely necessary for those posing risks to the environment and human health, provided their concentrations surpass the specified values outlined in Regulation, Art. 291. 

To facilitate a smooth transition, the Chilean authorities have set phased-in deadlines for registration based on different substance categories. The deadlines are as follows: 

• Industrial Substances – August 30, 2024 

• Industrial Substances Contained in Mixtures – August 30, 2027 

• Non-Industrial Substances – August 30, 2025 

• Non-Industrial Substances Contained in Mixtures – August 30, 2029 

It is important to note that the initial registration for industrial substances will encompass information from the preceding two-year period, in this case the years 2022 and 2023. 

At present, the GHS registration system in Chile does not accommodate foreign manufacturers' participation. The absence of provisions for foreign manufacturers, even through the involvement of local agents such as the Colombia's OR, designed to protect Confidential Business Information (CBI), necessitates potential reforms to the Chilean regulation (Decree 57/2021) to enable such participation. 

During the event, Chilean authorities also unveiled other updates regarding the implementation of the GHS regulation: 

• In an effort to ensure an efficient and effective registration process, the government plans to conduct a new Beta Test of the revised online platform. This test is scheduled to take place in the later months of 2023, allowing industries to engage with the system, test its functionality, and provide valuable feedback. 

• Accessible Substance Registration Database: By the end of 2023 or the beginning of 2024, the substance registration database is expected to be accessible to all. This database will serve as a comprehensive repository of registered hazardous substances, facilitating easy access to vital information. 

You can find more info at: GHS - Chile - Ministerio de Salud

In May 2023 the New Zealand Environmental Protection Agency (EPA) issued new guidance and assessment criteria for the import of bulk hydrofluorocarbons (HFCs). The updated guidance provides detailed information for the application process to assist companies in obtaining special import permits. Special import permits are a requirement under the Ozone Layer Protection Regulations.  

The regulation of bulk hydrofluorocarbons (HFCs) in New Zealand is governed by the Ozone Layer Protection Act 1996 and the Ozone Layer Protection Regulations 1996. These regulations control the import, export, and transshipment of HFCs. New Zealand imposes an annual limit on the quantity of new bulk HFCs that can be imported, and this limit gradually decreases over time.  

Under the current import limit, a significant portion of up to 80% is allocated through grandparented import permits. These permits are exclusively available to individuals or entities that meet the criteria for grandparented eligibility. The remaining portion of the import limit is made available for allocation through special import permits. The EPA has discretion when granting these special permits. In assessing applications for special import permits, the EPA considers the provisions outlined in the Ozone Layer Protection Act and Regulations, as well as New Zealand's international obligations to phase down HFC usage.  

In summary, New Zealand sets a limit on the importation of bulk HFCs, with up to 80% of the imported product allocated through grandparented permits and the remaining balance through special permits. 

For more information click here: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.epa.govt.nz%2Fassets%2FUploads%2FDocuments%2FHazardous-Substances%2FKigali%2FHow-to-apply-for-a-special-permit-to-import-new-bulk-hydrofluorocarbons-HFCs-.docx&wdOrigin=BROWSELINK%C2%A0