GPC Newsletter Dec-2022

The "Waste Management, Extended Producer Responsibility and Recycling Promotion" Bill No 20.920, popularly known as "The Bill" or "REP Bill," emphasizes waste generation reduction and recycling promotion. It holds importers and producers financially responsible for properly managing the waste produced by goods sold on the domestic market. The goals of the Bill are to reduce waste creation and increase garbage reuse by up to 30%. By internalizing the costs and unfavorable externalities related to waste management.  

Moreover, another bill called the Bill of Natural Resources and Environment which aims to ensure that waste producers do not escape their responsibility for their waste. The Bill establishes the concept of "Extended Producer Responsibility (EPR)," which requires importers and producers of specific goods designated as "priority products" to plan and finance the collection and treatment of the waste using a management system. 

Even though the Extended Producer Responsibility Act has been in effect since the middle of 2016, there are some provisions that, to be enforced, call for a competent authority to issue Supreme Decrees outlining the instruments intended to prevent waste production and advance its valuation. 

In 2022 the environment ministry of Chile released its biennial regulatory program, which includes plans to increase extended producer responsibility and put a special emphasis on information availability. There is no deadline for the government to disclose its Risk Assessment Resolution on the agenda. A period of 18 months was set forth by Supreme Decree 57/2021 on 9 February 2021 for the country to pass the resolution. 

The priority products covered by any supreme decree that establishes recollection objectives must be mentioned by it. This includes the classifications or subcategories it enforces, the recall objectives, the related duties, the producers it binds, and the limitations placed on an individual or collective management systems. 

According to California air standards, businesses have roughly one month to phase out perchloroethylene from dry cleaning operations, but more state- and federal-level actions over the solvent are expected soon.

The ban takes effect on 1 January 2023 and was created by a 2007 California Air Resources Board (CARB) rule. By doing so, California will become the first US state to ban the use of potential carcinogens in dry cleaning. Companies must switch to any safer alternative for this major application of perchloroethylene (PERC).

The bill banning PERC was adopted in other US states, including Minnesota, Michigan, and Maine. Minnesota will phase out PERC in 2026. In Michigan, legislators introduced a bill (HB 6511) in November 2022,  to block dry cleaners from using the compound by the end of 2028 and if approved, the legislation will ban the production and sale in 2027. The state of Maine, situated on the east-coast implements state-level National Emission Standards for Hazardous Air Pollutants (NESHAP) for the substance’s dry-cleaning applications. And the regulations of the state of New York align with a related 2008 national rule that prohibited PERC dry cleaning machines in residential buildings from December 2020.

The Environmental Protection Agency (EPA) in the US is developing a TSCA risk management rule for PERC. PERC was one of the first ten chemicals to be subject to a risk evaluation under the amended 2016 law. When the risk management rule is finalized, it may preempt certain state legislation. 

Tetrabromobisphenol A (TBBPA) is a potent flame retardant used in numerous appliances and is a major pollutant in households and ecosystems. It is the most widely used Bromophenolic flame retardant (BFR). TBBPA was thought to account for over 60% of all BFR production globally in 2004, with the yearly production in the United States, Japan, and Israel reaching about 170,000 tonnes. 

TBBPA is produced in large quantities, and as a result, it has been found in both terrestrial and aquatic environments as well as in air and inhaled dust. It has been demonstrated to have an impact on thyroid signaling, neurodevelopment, and the hypothalamic-pituitary-gonadal axis in vertebrates. Particularly at the level of transcriptome reprogramming, the molecular phenotype brought on by TBBPA exposure is only sketchily defined. 

TBBPA influences a significant number of genes, according to research from the National Museum of Natural History in Paris that applied a systems biology method to analyse experimental data on rodent stem cells. Surprisingly, they also discovered the following "hotspots of action": 

1. at the level of immune system operations  

2. at the level of neural development indicators  

The most well-known effects are related to its neurotoxicity and its impact on reproduction and the hypothalamo-pituitary-gonadal axis. Three weeks old mice exposed through maternal milk of mothers fed with high doses of TBBPA resulted in neurological and behavioral alterations. TBBPA also affects the nervous system. A high throughput toxicity test of a bank of 84 compounds identified TBBPA as a selective toxicant targeting dopaminergic neurons of midbrain-like tissues grown as organoids. 

TBBPA has the ability to impair not just the homeostatic balance of multiple endocrine pathways and neural development, but also the primary system defending body integrity from aggressors and the potential to cause cancer, hence Norway has asked Echa to designate it as a substance of very high concern (SVHC). In accordance with the Community Rolling Action Plan (Corap) of the EU, Denmark is also testing the drug for endocrine-disrupting characteristics. 

Electronic and electrical products contain several hazardous substances, including lead, mercury and other metals, flame retardants, and certain phthalates. During material extraction and manufacturing, workers and their surrounding communities may come into direct contact with hazardous chemicals. Further downstream, hazardous chemicals can be released from e-waste during disposal and recycling, directly affecting workers and entering ecosystems. 

The UN Environment Programme (UNEP) has produced guidance on how to incorporate chemical management in public procurement rules for electronics. The advice is primarily intended for decision-makers and project commissioners who establish technical specifications for the purchase of electronic items and services. The report suggests that public sector organizations clearly state how they plan to control chemicals and reduce negative effects. 

Moreover, the Strategic Approach to International Chemicals Management (SAICM), has released a new policy brief urging electronic product producers to adopt a progressive approach to chemicals of concern in e-products. According to SAICM's brief, there is currently a lack of transparency regarding the effects of chemicals on the environment, society, and human health. Hazardous chemicals in electronics and electrical products have been a priority sector within the work on chemicals in products by SAICM. The International Conference on Chemicals Management (ICCM) endorsed the addition to the Global Plan of Action of new activities related to hazardous substances within the life cycle of electrical and electronic products. 

On 1 December 2022, the Swedish Chemicals Agency (KEMI) published an announcement asking the government for more funding to ensure that Sweden can fulfil the demands of EU’s Market Surveillance Regulation. This regulation that came into force in July 2021, establishes new processes and frameworks for market surveillance, customs, and regulatory enforcement authorities from each member state to work together to take non-compliant articles off the EU market.

In the future KEMI wants to strengthen and expand market control in the chemical sector to better protect human health and the environment and create fairer competition for companies on the Swedish market

KEMI is planning to implement the following measures to make it easier for the companies to act in accordance with the regulations:

• Increase the quantity of inspections and analyses of chemicals and biocides
• Systematic follow-up of companies that have previously failed during inspections
• Increase the development of methods for controlling markets
• Develop and adapt guidance rules for the municipalities that perform parts of the market controls
• Collaborate with Swedish customs to identify companies that have not previously been inspected.

The request for extra funding is a result of the budget for 2023-2025 that was recently unveiled by Sweden’s new right-wing government. The budget allocated to KEMI was lower than expected. The budget decisions follow the government’s decision to close the Ministry of the Environment as a separate ministry.

KEMI is one of five European authorities (together with Germany, Denmark, the Netherlands, and Norway) that are preparing a restriction proposal covering all per- and polyfluoroalkyl substances (PFASs) which is expected in January 2023.

The Safe and Sustainable by Design (SSbD) is a design, development, production, and use strategy for chemicals and materials that emphasises delivering the desired function (or service) while avoiding or minimising detrimental effects on human health and the environment.  

The SSbD idea incorporates elements for the domain of chemical and material safety, circularity, and functionality, with sustainability consideration throughout their existence, minimising their environmental impact. 

The concept "Safe and Sustainable-by-Design" covers four areas: 

1. Going climate neutral 

2. Driving the circular economy 

3. Enhancing the quality of life 

4. Scaling up digital and tech 

In accordance with the SSbD concept, chemicals are produced/used in a way that maximises their benefits to society while avoiding harm to the planet and people. The production and use of safe and sustainable chemicals in Europe has become a benchmark worldwide. Chemical markets as well as chemical innovation are expected to be shaped in the future by the concept of SSbD. The concept should advance the creation of chemicals that are safe for people and the environment, provide a smaller environmental impact, and provide the expected performance and value to stakeholders along the entire value chain. It should be based on the most recent cutting-edge scientific research. 

On the 8th of December 2022, the European Commission published a “Recommendation” and an “Annex” that together constitute the long-awaited SSbD framework. The SSbD framework contains methods for assessing safety and sustainability features of chemicals.   The European Commission encourages all market stakeholders to use the “Recommendation” in their research and innovation activities. The “Recommendation” is launched at a testing phase with voluntary reporting. 

 The development is guided by the principles outlined in the Annex, which are to be used by industry and other stakeholders. For example, to prevent unfortunate substitutes, a hierarchy that prioritises safety is established. In addition, 'cut-off' criteria for the design of chemicals and materials must be established in order to encourage sustainable research and development. This would be based on the information cited in the chemical regulations of the EU as well as information that is not covered by those requirements, making the best possible use of the information on negative effects. Likewise, to assess the expected likelihood of having a negative impact on human health or the environment, every new chemical or material should be thoroughly compared to existing compounds that are structurally or functionally similar. Additionally, the supply chain should be informed of the SSbD actions taken, and all pertinent and non-confidential data should be made available in a high-quality findable, accessible, interoperable and reusable (FAIR) format for greater transparency and accountability. 

The outcomes from the current framework will direct efforts to build grading systems and standards as well as criteria for "Safe and Sustainable by Design." The Commission will begin the process of developing the criteria during the review stage of the input evaluation. The official criteria will most likely be published in 2025. 

On 29 November 2022, the UK government published the results of a consultation process on extending the UK REACH deadlines. This consultation was conducted from 5 July to 1 September this year by the Department for Environment, Food and Rural Affairs (DEFRA). In total, 289 responses were submitted to the consultation, with the majority coming from the industry. One of the major concerns by the stakeholders was the registration deadline. The DEFRA had put forward the following three options for the consultation:

• Baseline – do not change the current submission deadlines (27 October 2023, 27 October 2025, and 27 October 2027)
• Option 1 – extend all the current submission deadlines of each tonnage band by 3 years to October 2026, October 2028, and October 2030
• Option 2 (option preferred by the government) – extend the first submission deadline by 3 years to October 2026, the second by 2 years to October 2027, and the third by 1 year to October 2028

82% of respondents selected Option 1, which would mean that the three registration deadlines (October 2023, 2025, and 2027) should be extended by 3 years.

The DEFRA acknowledges that Option 1 could lessen burdens on SMEs and downstream users without reducing levels of protection of human health and the environment. The next step is a request for administration consent and introduction legislation on extension of the submission deadlines across all tonnage bands by 3 years.  

Because most of household waste generated in Russia ends up on the landfills, the Russian authorities are now developing updated legislative mechanisms such as extended producer responsibility (ERP) for waste. The EPR policy for waste has been in place in Russia since 2014, however it didn't concern that packaging material that corresponds to 50% of all generated waste. 

Starting from January 1, 2025, all manufacturers and importers of packaging material will be obliged to recycle 100% of the packaging waste. In cases where the recycling rates won’t be met by the manufacturer, a penalty eco-fee will be applied. The eco-fee will be calculated as the difference between the standard and the accumulated volume of recycled waste times two.  For products and containers that are difficult to recycle, the eco-fee rate will be higher. Furthermore, according to the draft law, the recycling of waste will be more controlled. The update EPR for waste implies placing responsibility for package recycling from manufacturers and importers of products (4 millions) to only those manufacturing packages and importing them (2 500 only). This will make it much easier to keep track of how well companies are complying with the update EPR.  

In the upcoming year 2023, the Indian Department of Chemicals and Petrochemicals (DCPC) is expected to commence workplace training in the use of international chemical safety cards (ICSCs). A non-binding memorandum of understanding (MoU) for the use of ICSCs was signed on 27 July 2022 between the DCPC and WHO’s International Labour Organization (ILO) during a seminar on the safe use of chemicals at the workplace. On the same day an information note about the cards was published on the DCPC website. 

The safety cards have been developed by the World Health Organization (WHO) and the ILO in collaboration with the European Commission.  They will be used to provide workers with concise safety, hazard and health information on chemicals used at the workplace.    

This training program will be carried out with assistance from the ILO, which includes the training  of trainers to ensure the initiative is sustainable for the long-term. The program will be delivered to the industrial workers at all levels. 

The training-language can be the barrier for some workplaces. Even though a full set of safety cards can be accessed in the English language, only some cards are available in two Indian languages-Hindi and Urdu. The translations into other languages will depend on the demand of the Ministry.  

The International Labour Organization will use the DCPC’s network of industry associations to educate workers at small and medium enterprises (SMEs) on chemical safety and health risks. It is the plan of the organization to run mock safety drills, conduct participatory risk assessments, and teach staff about the practical applications of the ICSCs. 

On 13 December 2022, the Bureau of Indian Standards (BIS) organized a Stakeholders Consultation Meeting with industry associations and manufacturers of Chemical products in New Delhi.

BIS Certification is a national standard based on the Bureau of Indian Standards Act established in 2016.  The aims of the BIS Act include harmonious development of the activities of standardization, conformity assessment, and quality assurance of goods, articles, processes, systems, and services.

BIS Certification is required by every manufacturer (Indian or foreign) who is manufacturing products under Compulsory Certification. Currently, 63 chemicals require or will require BIS certification in the first half of 2023. 

In addition to the chemicals previously announced by the BIS, at this meeting, the BIS proposed a list with a total of 93 chemical products that are under consideration for compulsory certification. The list contains a wide range of products from respiratory protective devices, disinfectant fluid, ready mixed paint, cement paint, baby toilet soap, textiles (polyster textured yarns), shoe polish paste, and many others.

A list can be expected to be published after the stakeholders meeting. For further details on BIS compliance, see here or contact GPC at compliance@gpcregulatory.com 

On 23 November 2022, the National Medical Products Administration (NMPA) in China released a new supplementary test method ‘BHJ 202203 Determination of 16alpha-hydroxiprednisolone in Cosmetics’. The test specifies the qualitative and quantitative determination method of the ingredient 16alpha-hydroxyprednisolone in creams, lotions, and liquid cosmetics.

16alpha-hydroxyprednisolone (CAS number of 13951-70-7), is used in the production of steroids such as budesonide and ciclesonide.  According to the EU classification, prolonged or repeated exposure to the substance can cause skin sensitization reactions, impair the fertility of unborn babies, and cause harm to breastfed children. It is banned for use in cosmetics in China.

BJH 202203 is a supplementary test that is a supplement to the conventional test methods specified in the national cosmetic standards and technical specifications. The supplementary tests are established for banned ingredients in cosmetics that lack testing methods and are used in adulterated products. Supplementary testing methods are important for regulators and law enforcement inspecting cosmetics post-market especially when combatting illegal additions.

For further information about the NMPA supplementary tests check the following links:.

• NMPA supplementary tests, 2021 (in English)
• NMPA supplementary test method for 16α-hydroxyprednisolone in cosmetic products (Mandarin)

For more information regarding China regulatory compliance solutions, please contact us at compliance@cn.gpcregulatory.com

The Ministry of Environment (MoE) in South Korea plans for the public consultation on the draft list of substances subject to permission under the Act on Registration and Evaluation of Chemicals (K-REACH). The MOE published 11 potential substances subject to permission on Novebmer 23^rd, 2022.

These substances subject to permission are:

Additionally, they are going to publish hazard information and other relevant data on December 12^th, 2022. This would include 1) hazard information, 2) main use and exposure information, 3) distribution volume in Korea, 4) types of people who may be exposed in the process of handling chemicals and etc.

If you have any opinion on this draft, please write your opinion and submit it via www.chemnavi.or.kr.

This public consultation opens from Dec 15^th, 2022 to Feb 13^th, 2023.

The National Institute of Environmental Research (NIER) in South Korea updates ‘the Designation of toxic substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH) and Chemical Control Act (CCA) on December 7^th, 2022.

The main updates are:

• Revision of chemical substance name: substances with unique number “97-1-91”, “97-1-92”, “97-1-271”, “97-1-311”, “97-1-315”, “97-1-334”, “97-1-345”, “97-1-436”, “97-1-451”, “97-1-472”, “99-1-499”, “2000-1-509”, “2001-1-515”, “2001-1-516” and “2008-1-577”
• Addition of chemical substances: substances with unique number from “2022-1-1096” to “2022-1-1109”

The amendment will come into effect in a month. However, ‘Handling standards of hazardous chemicals’ and ‘Preparation and submission of chemical accident prevention management plan’ under the Chemicals Control Act will be implemented in 3 months. In addition to this, ‘Arrangement, installation and management standards of handling facilities’ and ‘Hazardous chemical business license’ under the Chemicals Control Act will be implemented from January 1^st, 2025.

The National Institute of Environmental Research (NIER) in South Korea updated the ‘Regulation on chemical substance classification and labelling’ under the Act on Registration and Evaluation of Chemicals (K-REACH) and the Chemicals Control Act (CCA) on December 7^th, 2022.

The main updates are:

• Revision of toxic substances: substances with unique number “97-1-91”, “97-1-92”, “97-1-271”, “97-1-311”, “97-1-315”, “97-1-334”, “97-1-345”, “97-1-436”, “97-1-451”, “97-1-472”, “99-1-499”, “2000-1-509”, “2001-1-515”, “2001-1-516” and “2008-1-577”
• Addition of toxic substances: substances with unique number from “2022-1-1096” to “2022-1-1109”
• Revision of restricted substances: substances with unique number “06-5-5”, “06-5-6” and “06-5-10”
• Revision of substances requiring preparation for accidents: substances with unique number “1”

The amendment came into effect immediately.

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea provides a Guideline to prepare functional cosmetics report submission under the Enforcement Rule of the Cosmetic Act on December 1^st, 2022. This guideline is to provide details of report submission and requirement.

This guideline mainly includes:

• Report submission process
• Common categories for all reports for functional cosmetics type 1-3
• Details of the report for functional cosmetics type 1
• Details of the report for functional cosmetics type 2
• Details of the report for functional cosmetics type 3

If you are planning to prepare and submit functional cosmetics report, please refer to the guideline for the details.

The Ministry of Environment (MoE) in South Korea updated the ‘Enforcement Decree of the Chemical Control Act (CCA)’ on November 15^th, 2022. This update is mainly on import reporting procedures for substances categorized as both restricted substances and toxic substances.

Before the update, if a substance categorized as both restricted substances and toxic substances, importers of the substance should get import permit for restricted substances (based on CCA Article 20-1) and import reporting for toxic substances (based on CCA Article 20-2), respectively. After the amendment, if importers get import permit for restricted substances, it can be exempted from import reporting for toxic substances. This is to reduce the burden on chemical importers from dual import procedure.

The amendment came into effect immediately.

The National Institute of Environmental Research (NIER) in South Korea updates the ‘Regulations on the Approval for Consumer Chemical Products Subject to Safety Verification’ under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on December 12, 2022. This is to provide updated classification on product type based on diversified antimicrobial and disinfectant for humidifiers. Also, this is to update approval application data by specifying the approval application data.

The main updates are:

• Change the product type from ‘antimicrobial and disinfectant for humidifiers’ to ‘disinfectant and preservatives for humidifiers’
• Provide definition of ‘preservation treatment product for humidifiers’
• Clarification of the submission requirements for approval application data on ‘disinfectant and preservatives for humidifiers’ and ‘preservation treatment product for humidifiers’
• Establishment of numbering standards as the expansion of approved products

The amendment came into effect immediately.

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the Designation of Existing Biocidal Substances for Approval Deferment’ under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on December 13th, 2022. This is to designate additional existing biocidal substances for approval deferment based on hazard and risk of the substances, as well as to cancel the designation of existing biocidal substances for approval deferment due to the cancellation of reporting.

The draft amendment mainly proposes revisions including:

• Addition of biocidal product type for the designated biocidal substances: 5 substances
• Designation cancellation of existing biocidal substances for approval deferment: 110 substances
• Designation cancellation of biocidal product type of existing biocidal substances for approval deferment: 106 substances
• Additional designation of existing biocidal substances for approval deferment: 12 substances

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

The deadline for this consultation is Dec 23rd, 2022.

In Thailand, the Ministry of Industry (MOI) is a cabinet ministry responsible for promoting and regulating industries. To ensure consumer safety, and safeguard human health, Thailand has published Thai Industrial Standard (TIS) 2622-2556 (2013) that will restrict the amount of lead and cadmium in fluoropolymer coatings for metal utensils used for cooking with heat. The standard will enter into force on 2^nd April 2023.

The standard only applies to utensils formed from a metal substrate where the side in direct contact with food is coated with a fluoropolymer and is to be used for cooking with heat. Cooking utensils and electric appliances that cook with electrical heating are excluded. The Fluoropolymer coated utensils in contact with food must comply with the Thai Industrial Standard (TIS) 2622-2556 (2013) (Fluoropolymer-coated utensils in contact with food), that outlines the migration limits for lead, cadmium, and certain volatile substances which must not exceed 100mg/kg.

The specifications also list the utensils’ coating materials, including polytetrafluoroethylene, tetrafluoroethylene/hexafluoropropylene, and perfluoro-alkoxyalkane. Furthermore, the standard TIS 656 must also be used to test leachable chemicals for heavy metals and substances that react with potassium permanganate.

In addition, the notification also specifies the requirements related to limitations on container evaporation, packaging and product labeling, properties of the surface, the hardness of the coating, and abrasion resistance.

As required under the Hazardous Substance Act B.E. 2535 (1992), the Ministry of Industry of Thailand's Department of Industrial Works opened the first draft notification for the public hearing procedure on 20 May  2021. It has perfluorooctanoic acid (PFOA) included as part of the primary revision. On 3 May 2019, more than 180 nations decided to prohibit the manufacturing and use of PFOA, its salts, and PFOA-related chemicals at the international Stockholm Convention on Persistent Organic Pollutants (POPs) 

However, as unintended trace contamination is possible, to calculate this the Department of Industrial Works evaluates European Union Regulation (1019/1021) 

 The draft specifies the following exemptions under Type 4 (banned chemicals):

In the manufacturing of fluoropolymers, PFOA (a synthetic perfluorochemical) is produced as a byproduct. A class of substances known as perfluorochemicals (PFCs) is used to create fluoropolymer coatings and goods that withstand heat, oil, stains, grease, and water. For instance, PFOA was used in the manufacture of polytetrafluoroethylene (PFTE) better known as Teflon. People are most likely exposed to PFOA through the consumption of tainted water and perhaps through the use of PFOA-containing items. Compared to the general population, perfluorochemical industry workers may be exposed to higher levels of PFOA. 

Other PFOA-related chemicals on Thailand's List No. 5.1(Hazardous Substance Act's Annex 5) now have different classifications: Substances 523-533 are now Type 3 hazardous substances when certain conditions or exemptions apply, while Substances 534-541 are now Type 4 hazardous substances when such conditions or exemptions are not present, such as when the concentration is below 0.0000025% w/w. Industrial chemicals, chemical waste, discarded electrical and electronic equipment, and chemical weapons convention chemicals are all regulated by Annex 5. 

In addition, the first draft notification has two additional compounds with more accurate classifications: 

The classification of benzyl cyanide (Cas RN 140-29-4) has been changed from Type 1 (hazardous substance) to Type 3. Triethanolamine (Cas RN 102-71-6), which is already a Type 3 substance, has also had a threshold limit of > 30% w/w applied in accordance with list 3B (precursors) annexed to the Chemical Weapons Convention. 

The Ministry of Health, Labour and Welfare (MHLW) is a cabinet-level ministry of the Japanese government which provides services on health, labour and welfare.  

The MHLW published a proposal on 21 October 2022, to categorise carcinogenic compounds as Category 1 for carcinogenicity (excluding ethanol), in accordance with national criteria. The industry was given a deadline of 19 November 2022, to comment on the proposal. Early December is anticipated for promulgation, and the first day of enforcement will be 1 April 2023. 

The proposal is in line with the government's hazard classification of chemical substances conducted in accordance with the Japanese Industrial Standard (JIS) Z 7252 classification method which is based on the sixth revised edition of the Globally Harmonized System (GHS) of classification and labelling of chemicals implemented on 24 May 2022.  

The Japanese Industrial Standards (JIS) are the standards used for industrial activities in Japan, coordinated by the Japanese Industrial Standards Committee (JISC) and published by the Japanese Standards Association (JSA). The JIS Z 7252 standard covers the chemical classification for GHS labelling and JIS Z 7253 covers the hazard communication for labelling and safety data sheets (SDSs).  

To ensure workers' safety and health in the workplace, companies handling carcinogenic substances are required to keep records of safety measures implemented in response to risk assessment results, the status of workers' exposure to the substance, and interviews with workers for three years. They must also keep records of each worker's name, job description, work schedule, worker exposure status, and other information for 30 years under the Industrial Safety and Health Act (ISHA). However, companies handling the chemicals on a transitory basis are exempt from following the requirements. 

The Industrial Safety and Health Act (ISHA) is the main law implementing the Globally Harmonized System (GHS) of the classification and labelling of chemicals in Japan. 

In Japan, companies must notify new chemical substances manufactured or imported in volumes of less than one tonne a year or apply for small-volume permits. Companies are also required to submit applications for new chemical substances manufactured or imported in volumes of less than ten tonnes per year under the Chemical Substances Control Law (CSCL). The CSCL aims to reduce the risks that chemicals pose to human health and avoid environmental degradation.

The Ministry of Economy, Trade, and Industry (METI) has recently published a manual to assist companies in submitting the necessary data online when applying for authorization to manufacture or import new chemicals. The manual guides through how to set up an e-Gov account, confirm browser settings, install and setup e-applications, and gives instructions for providing information online.

According to METI, all applications should be submitted online by 2025.

On 21 November 2022, the Japanese Ministry of Health, Labour, and Welfare (MHLW) published an interim report on worker exposure measuring requirements, in order to assist businesses in getting ready to comply with proposed changes to the Industrial Safety and Health Act (ISHA). The report includes mandatory personal sampling for certain substances 

The ISHA will be updated by 31 March 2023 to match the suggested measuring requirements contained in the report. The recommendations from the "Panel of Experts on Chemical Substance Management Interim Report" include information on the requirements for measuring worker exposure for the short-term (15 minutes) and long-term (8 hours), sampling location, and evaluation of data for risk assessment. They are intended to ensure that businesses comply with the ministry's allowable concentration limits under the ISHA.  

Recommendation from the 'Panel of Experts on Chemical Substance Management Interim Report'   

Japan approved the revisions to ISHA in May 2022. The revision includes the recruitment of workplace risk assessment managers and safety equipment specialists. Furthermore, modifications to the standards for safety data sheets (SDS) and labelling were included. These changes are expected to be implemented gradually over the following two years 2023-2024. 

MHLW also plans to provide more technical details on requirements for respiratory protective equipment, sample collection and risk assessment methods. 

On 16 November 2022 the Australian Industrial Chemicals Introductory Scheme (AICIS) announced that 8 substances have been added to the Australian Inventory of Industrial Chemicals (AIIC) because 5 years have passed since the assessment certificates for the chemicals were issued. This is in accordance with Section 82 of the Industrial Chemicals Act 2019. Obligations to provide information about the new substances apply. The AICIS must be informed within 28 days if the circumstances of the introduction (importation or manufacture) are different to their assessment.

The substances added to the AIIC are:

On the same day the AICIS announced that the inventory listing for the following substance was changed since the approval to treat the proper name of the substance as confidential business information (CBI) had been revoked:

1,3-Benzenedicarboxylic acid, polymer with (2E)-2-butenedioic acid, 2,2-dimethyl-1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and hexanedioic acid, (octahydro-4,7-methano-1H-indenyl)methyl ester (CAS number: 2093197-30-7)

On 15 November 2022 the Australian Industrial Chemicals Rules 2019 has been amended regarding introductions of 10 kg or less. The amended rules, Industrial Chemicals (General) Amendment (Introductions of 10 kg or Less) Rules 2022, is a result of a consultation held by the Australian Chemicals Introduction Scheme (AICIS) in October 2022.

For listed introductions (import or manufacture) it is now possible to choose to keep a simple set of records, if the introduced chemical is listed in the Australian Inventory for Industrial Chemicals (AIIC) and the combined volume of the chemical that is introduced in an AICIS registration year (from 1 September to 31 August) is 10 kg or less. This means that if the introducer of the chemical knows the CAS number to the chemical, they must keep a record of the CAS number and the CAS name (or INCI) name. If the introducer does not know the CAS number, they must keep a record of the CAS name, IUPAC name, or INCI name as well as records to indicate that the chemical is listed on the inventory. This information could be obtained for the chemical supplier.  

Reported introductions of 10 kg or less now have reduced reporting and record-keeping obligations compared to other reported introduction types. A pre-introduction report (PIR) must be submitted if the chemical to be introduced is in the reported category and is not on the AIIC or if it is on the AIIC, but the introduction is outside the parameters of the defined scope of assessment. Introducers must keep records for 5 years including written or electronic record of the chemical names provided in the PIR, the names of any products containing the chemical that has been imported into Australia, and records showing that the criteria for reported introduction 10 kg or less are met.

Other changes made as a result of the feedback the AICIS received during the consultation:

• The definition of GHS has been changed so that it now refers to the GHS edition in use by SafeWork Australia. This signifies that the Industrial Rules 2019 will not need to be amended when SafeWork Australia updates its GHS edition.
• Introductions can be classified as reported as long as the introducer does not hold information to suggest that the chemical does not satisfy the criteria for germ cell mutagenicity, carcinogenicity, or reproductive toxicity hazards classes in the GHS.

Normative Instruction 11 of October 17, 2022, replaces Normative Instruction 5, of May 17 2010.  This new regulation adjusts the registration obligation of remedial products, prior consent for importation, and authorization to carry out research and experimentation. These procedures are adopted by the Brazilian Institute for the Environment and Renewable Natural Resources. 

The Instruction enters into force on November 1, 2022. The National Council for the Environment will update its classification (Resolution 464 of 2014) of environmental remedial products concerning their nature: chemical or physical-chemical remediators, bioremediators, phytoremediators, biostimulators, and physical process agents. Currently, the last three are exempt from registration. 

Failure to comply with the provisions of this Normative Instruction and other legal rules applicable to activities involving remedial products will subject violators to the sanctions provided for in Act 9,605/1998. 

For more information please visit: https://www.gov.br/ibama/pt-br 

To access Normative Instruction 11 of October 17, 2022, in Portuguese please visit: https://tratamentodeagua.com.br/instrucao-normativa-ibama/  

To access to the list of remedial products in Portuguese, visit: https://ibamagovbr-my.sharepoint.com/:x:/g/personal/07612330679_ibama_gov_br/EbFO464p94VPqAkXPgOwBHwBAL2tckoEl4hM5LzfBqBWqg?rtime=77NBCWHN2kg 

In the circular 17/2022, the Ministry of Industry and Trade informed that the current date for enterprises to submit their annual report has changed from January 15th to February 15th. Additionally, organizations no longer have to submit hard copies of their annual report, instead they can submit the digital version by filling in the form in the national chemical database. 

The annual report is mandatory for organizations that have trading activities with chemical substances belongs to the following lists according to current law, decrees and circulars: 

1. Chemicals subject to conditional production and trading 

2. Restriction chemicals 

3. Prohibited chemicals 

4. Industrial precursors 

5. Chemicals requiring incident prevention plan 

6. Chemicals subject to declaration  

Chemicals belonging to the first and second lists also require import permission certificate from Vietnam chemical agency. The permits are valid for 6 months. 

Any organizations wanting to import any chemicals in the above lists have to register themselves to become a legal entity and have their business registration certificate to obtain their tax number in Vietnam. The tax number is used for the trading activities as well as an account on Vietnam national chemical database system to submit their annual report. 

The United Nations Environment Programme (UNEP) will collaborate with small to large enterprises involved in textiles manufacturing in Bangladesh, Indonesia, Pakistan, and Vietnam to manage and reduce hazardous chemicals and to prevent workers from risks associated with the handling of hazardous chemicals.

The programme which is known as the 'Reducing uses and releases of chemicals of concern in the textiles sector' has a budget of $43m. The objective is to eradicate the most hazardous chemicals from manufacturing of textiles.

 The development of processing mills to take charge of chemicals according to best practice is difficult    due to lack of understanding and technical skills.

 This project is seen as beneficial not just to the above mentioned countries but it also encourages partner countries to bring about plan of action towards chemical management as well as occupational health and safety, thus to make efforts in order to create an environment relieved of harmful chemicals which also consist of  per- and polyfluoroalkyl substances ( PFAS) .

Since this project has capitalization from the Global Environment Facility (GEF) and is supported by the Basel & Stockholm Convention Regional Centre South-East Asia and the Natural Resources Defence Council (NRDC),it can avail stakeholders to predict and take measures in accordance to this project so as to extract maximum profit , both in terms of finance and environmentally

The "Waste Management, Extended Producer Responsibility and Recycling Promotion" Bill No 20.920, popularly known as "The Bill" or "REP Bill," emphasizes waste generation reduction and recycling promotion. It holds importers and producers financially responsible for properly managing the waste produced by goods sold on the domestic market. The goals of the Bill are to reduce waste creation and increase garbage reuse by up to 30%. By internalizing the costs and unfavorable externalities related to waste management.  

Moreover, another bill called the Bill of Natural Resources and Environment which aims to ensure that waste producers do not escape their responsibility for their waste. The Bill establishes the concept of "Extended Producer Responsibility (EPR)," which requires importers and producers of specific goods designated as "priority products" to plan and finance the collection and treatment of the waste using a management system. 

Even though the Extended Producer Responsibility Act has been in effect since the middle of 2016, there are some provisions that, to be enforced, call for a competent authority to issue Supreme Decrees outlining the instruments intended to prevent waste production and advance its valuation. 

In 2022 the environment ministry of Chile released its biennial regulatory program, which includes plans to increase extended producer responsibility and put a special emphasis on information availability. There is no deadline for the government to disclose its Risk Assessment Resolution on the agenda. A period of 18 months was set forth by Supreme Decree 57/2021 on 9 February 2021 for the country to pass the resolution. 

The priority products covered by any supreme decree that establishes recollection objectives must be mentioned by it. This includes the classifications or subcategories it enforces, the recall objectives, the related duties, the producers it binds, and the limitations placed on an individual or collective management systems. 

In November 2022, the East African Standards Committee (EASC)  released a Draft East African Standard (DEAS 1114:2022) that specifies the requirements, sampling, and test methods for insecticidal aerosols. This draft aims to categorize a standard for insecticides and pesticides as per ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) standards. The Draft Standard covers the following countries in East Africa: Burundi, Kenya, Tanzania, Rwanda, and Uganda.

In keeping with the standards, the insecticidal aerosol needs to fulfill the following requirements:

• The final formulation of the insecticidal aerosol will be in solution or emulsion form of insecticides with the required number of propellants, deodorants, and other ingredients.
• The aerosol must be a non-staining and light-colored liquid without any obnoxious odor while spraying.
• The essential active ingredients will be pyrethrin or artificial pyrethroids with low mammalian toxicity with some other effective pest management product with low residual impact and without unacceptable risks posed to mammals subjected to non-stop inhalation of that product.
• The active ingredient used in the aerosol must be approved by the responsible national authority.

• All the active components used for formulation must be compatible, and the solvents or other diluents shall be inert.

• The insecticidal aerosol must not contain CFCs (chlorofluorocarbon).

Specific Requirements for insecticidal aerosol shall abide by obligations stipulated in Tables 1 and 2 when tested by the method prescribed therein. Annex A to F can be found in the DEAS 1114:2022.

Table 1: Biological efficacy of insecticidal aerosol

 Table 2: Other specific requirements for Insecticidal aerosol

The active ingredient content shall be declared on the labels and comply with the tolerance limits in Table 3.

Table 3 — Tolerance limits

The insecticidal aerosols must be packed in closed containers for quality protection. The nozzle of the aerosol

 must be packed in the following way:  

1. 1. 1. Protected against puncturing/activation with a cap or seal manufactured from a suitable material that does not react with the product
      2. Hermetically sealed at the bottom
      3. Equipped with a discharge button or spray cap
      4. The materials used for the valve and button shall be inert.

While labeling aerosol each package shall be decipherable and indelibly labeled in English or other official languages. The name of the product must be mentioned as “insecticidal aerosol” with all proper indications like “used for flying insects or crawling insects”. Other basic information like the name,  common name of active ingredients with their percentage, manufacturer name, net content, batch number, and other essential details should be properly mentioned on the label. Special indications like safety signs and hazard pictograms, and flammability categories must be indicated. Before moving into the market, the insecticidal aerosol must complete all the quality checks.

The revision of the Mandatory Standard SI 562 part 3 was published in the Israel Official Gazette Section of Government Notice no. 10401 “ISO 8124-3:2020 Safety of toys — Part 3: Migration of certain elements “on 17 November 2022 and entered into force immediately, allowing for a transition period until 16 April 2023. During this time, products may be tested according to the old or the new standards.

The Israel Government circulated the official Gazette which specifies the maximum acceptable levels and the methods of sampling, extraction and determination for the migration of the certain elements from toy materials and from parts of toys.

Israel updated standard also follows the EU standard EN 71-3:2019 (Safety of Toys-Part 3: Migration of certain elements) which gives the requirements and test methods for the migration of 19 elements as well as a method for determining the migration level of chromium VI from scraped-off toy materials such as paint.

Standard SI 562 specifies requirements and test methods for the migration of coatings of paints, varnishes, lacquers, printing inks, polymers, paper/paperboard, textiles, glass/ceramic/metallic materials, pliable modelling materials, among others. The standard applies to toys and components of toys which are intended to come in contact with the mouth. It also applies to food toys, cosmetic toys, and writing material. Moreover, it includes toys for children under 72 months of age, as well as liquid, pastel, and gel paint or modelling compound.
Packaging materials are not included, unless they form part of the toy or have intended play value.

The standard includes requirements for the migration of chemical elements. Certain of the toy materials are listed under 3 categories (Category I - Dry, crisp, powder-like substances , Category II - subordinates liquid or sticky substances , Category III - Materials that can be removed by scratching ) which specifies requirements and test methods for the migration of the following elements: aluminum, antimony, arsenic, barium, boron, cadmium, trivalent chromium, hexavalent chromium, cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium, tin, organic tin, and zinc