GPC Newsletter Nov-2022

As of 19 July 2022, the U.S. Food and Drug Administration (FDA) requested information regarding uses of fluorinated polyethylene in food contact containers. This proposal is a part of ongoing efforts to guarantee the safety of authorized food contact uses, as fluorination of polyethylene may result in the creation of per- and polyfluoroalkyl substances (PFAS). The FDA is looking for scientific evidence and information on current uses of fluorinated polyethylene in food contact, consumer dietary exposure that may arise from those uses, and safety data on chemicals that may migrate from fluorinated polyethylene food containers. 

A marketing study on fluorinated polyethylene by the Environmental Defense Fund (EDF) found that its "uses vary from packaged food and consumer goods that individuals buy to larger containers used by shops like restaurants or larger drums used by businesses to store and transport fluids." 

Following the agency's 2021 discovery of per- and polyfluoroalkyl substances (PFASs) in some fluorinated barrels, just seven comments were submitted in response to a request for information (RFI). It's unclear how the agency will move given the scant response to the data call-in, which was completed on 18 October 2022. 

On 11th November 2022, the EU parliament adopted the Corporate Sustainability Reporting Directive (CSRD) act. This act will require businesses to regularly publish information on their societal and environmental impact, which in return will make the businesses located in the EU region to be more publicly accountable. Thus, the EU's social market economy could be strengthened, and it could in the future lay the groundwork for sustainability reporting standards at the global level.   

The CSRD addresses the shortcomings found in the legislation on the disclosure of non-financial information (NFRD), which is believed to be insufficient and unreliable. The CSRD sets new standards and rules for better and more detailed reporting requirements on companies which would be in line with the EU climate goals.  

The CSRD has set requirements to ensure that companies are providing reliable information. These requirements include independent auditing and certification. Moreover, this directive will make digital access to sustainability information available. Furthermore, financial and sustainability reports will have equal conditions and investors will have comparable and reliable data. This directive will affect all large companies, whether listed on stock markets or not. Furthermore, companies which are not based in the EU will be affected if their turnover is more than €150 million euro in the EU. 

Timeline: 

It is expected that the European Council will adopt the proposal on 28 November 2022. After the approval of the proposal, it would be signed and published in the EU Official Journal. The directive will enter into force 20 days after publication. The following rules will apply to companies starting from 2024 to 2028: 

• From 1 January 2024, large public-interest companies with more than 500 employees will be subjected to the non-financial reporting directive. Moreover, companies need to submit their reports by 2025. 

• From 1 January 2025, large companies with more than 250 employees, or more than €40 million in turnover and/or €20 million in total assets will be affected by this act. Furthermore, these companies should not be presently subject to the non-financial reporting directive. If a company is categorized within this specification, their reports should be submitted by 2026. 

• From 1 January 2026, companies which are listed Small and Medium-sized Enterprises (SMEs) and other undertakings will be affected. If a company is categorized within this specification, their reports should be submitted by 2027. However, SMEs can wait to submit their report until 2028. 

 
The current rules cover 11 700 companies, compared to this the CSRD would include approximately 50 000 companies in the EU. 

Background 

Graphene is chemically defined as a single-atom-thick layer of monocrystalline graphite, a two-dimensional sheet of sp2-bonded carbon atoms arranged in a hexagonal pattern.  

Following the first isolation and characterization of graphene,  

• research and production of “graphene-related” nanomaterials (one external dimension in the nanoscale) have expanded exponentially. 

• The total forecasted global market for graphene-based materials is tens of billions and hundreds of billions of dollars for large-area graphene and bulk or flake graphene, respectively. Applications are led by the field of electronics for large-area graphene and use in filtration by both the petroleum and gas industry and the water/wastewater treatment industry for bulk/flake graphene.  

• The global market is predicted to grow considerably in the next 10 years. The current and potential applications of graphene nanomaterials are numerous including, but not limited to, use in electronics, energy storage, lighting, filtration, aerospace engineering, sensors, structural engineering composites, and health. 

Study 

In a 2020 study for the EU's Graphene Flagship project, a team from the National Graphene Institute of the University of Manchester in the UK demonstrated that a single exposure to micrometer-sized graphene oxide caused a negative reaction in rodent lungs, with inflammation lasting in some places for as long as 90 days. Animals exposed to nanometer-sized sheets, on the other hand, were totally recovered 28 days after exposure. 

The' potential for inhalation toxicity of graphene oxide sheets is significantly influenced by their width, according to a mouse study from the Manchester team. The team proposes that when building safer two-dimensional materials for commercial uses, the results, which reveal DNA damage with repeated high-dose exposure, should be taken into consideration. 

Numerous commercial products comprising composites, dispersions, or spray coatings have already been developed as a result of graphene oxide's low cost of manufacture. Other prospective uses for graphene oxide include the deposition of films on substrates in flexible electronics, solar cells, and chemical sensors. In their research paper, the experts note that there are still issues with the substance's safety profile. Although several studies have examined the genotoxic potential of graphene oxide on lung cells in vitro, there aren't many in vivo lung investigations, and the main characteristics that might contribute to toxicity are still up for debate.    

Chronic exposure  

The Manchester researchers assessed whether chronic exposure to graphene oxide could result in genotoxicity in their most recent study, which was also partially sponsored by the Graphene Flagship project:  

Animals were given high doses of graphene oxide sheets once for a maximum of 28 days or several times for a maximum of 84 days. For both exposure sets, graphene oxide sheets of equivalent thickness and physicochemical properties were employed in the micrometer- and nanometer-sized (LGO) and USGO, respectively. A low dose of 3 micrograms reflects a realistic working exposure, whereas a high dose of 30 micrograms includes the adverse circumstance. 

In contrast to an earlier study's investigation of the entire lung, the more recent study used immunostaining to pinpoint specific areas of DNA damage. Although total tissue analysis is typically the standard method, the researchers assert that it tends to produce a distorted image and underestimate local detrimental effects since nanomaterials cluster together to accumulate in various lung sections. 

Overall, the results indicate that: - 

• while LGO sheets may have long-term genotoxic effects, rodent lungs can quickly recover from exposure to USGO sheets.  

• A single high dose of LGO sheets left the rats quickly recovering, but repeated exposure led to long-term DNA double strand breakage.  

• The researcher's hypothesis that two pathways contributing to the long-term DNA damage are oxidative stress and inflammation.   

According to the researchers, the study lays some foundations for a deeper comprehension of the major elements that reduce lung injury following exposure to graphene oxide sheets. They write in the journal Particle and Fibre Toxicology that the study also “emphasises the importance of their lateral dimensions, which will be a crucial consideration for the risk classification of these materials and towards designing safer two-dimensional materials for future commercial applications."   

Research on graphene and graphene oxide is being done for the European Union Observatory for Nanomaterials (Euon). The work package on environment and health for the Graphene Flagship will be completed in 2023.

The European Food Safety Authority (EFSA) is currently evaluating its 2013 document on the risk assessment of plant protection products and bees (Apis mellifera, Bombus spp., and solitary bees).

What is the content of the guidance document published in 2013?

The objective of this Guidance Document (GD) is to outline a process by which plant protection products (PPPs) can be evaluated for their potential risk in causing unacceptable harm to groups of non-target organisms (bees). The guidance document has taken care of the potential risk in causing unacceptable harm to a group of non-target organisms (bees), maximum exposure level given by the specific protection goals (SPGs), the use of a tiered risk assessment scheme with a simple and cost-effective first tier to more complex higher tier studies under semi-field and field conditions.

Updates

In a meeting held on 17 February 2022, the Commission initiated discussions with Member States on setting specific protection goals for bumblebees and solitary bees.

The EFSA has prepared a revised draft guidance document based on the mandate, which has been submitted for public comment along with the respective data, analysis, and background data.

The EFSA launched a public consultation on 18 July 2022 on its draft guidance document on risk assessment of plant protection products and bees, covering honeybees, bumble bees, and solitary bees.

The consultation was open for 12 weeks and closed on 3 October 2022.

In addition, the Commission has asked the EFSA to ensure that all opinions and viewpoints are taken into consideration in the process.

Following the completion of the workshop with stakeholders and member states, the EFSA can finalize the revision of the guidance document.

The EU’s Green Deal Farm to Fork Strategy is moving us towards a sustainable food system.

The European Union has announced, amended, and adopted the regulations regarding biopesticides on (EU) Nos. 546/2011 and 1107/2009 (Annex II). They lay out standardized principles and criteria for assessing and authorizing plant protection products and microorganism active substances. Regulation (EU) No. 283/2013 gives the information to be submitted for active substances and the specific data requirements for micro-organisms.  Regulation (EU) No 284/2013 gives the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organism origin.

The draft was proposed on 26 October 2021. From 26 October to 23rd November 2021 was the feedback period. Now, it has been adopted on 31August 2022.

Major points were segregated in those amendments.

The term microbial active substance has been replaced by ‘Microbial Pest Control Agent (MPCA)’.

The number of requirement of studies has been reduced. In this case mostly ‘the weight of evidence’-approach with justification shall be followed.

The amended version focuses on identifying, taxonomizing, and phylogeny of the microorganism, as well as its origin, occurrence, and history of use.

It also gives clarity about dossier submission which shall be done in accordance with Part A if the active substance is a chemical substance (including both semiochemicals and extracts from biological material), or a metabolite produced by a micro-organism.

To provide information on development of resistance, in case of provision of data is required, such data may be generated in experimental studies (either in laboratories or under field conditions) or retrieved from available scientific literature. Otherwise, information already submitted for the active substance under point 3.4 of Part B of the Annex to Regulation (EU) No 283/2013 are sufficient to permit an assessment to be performed.

The goal is to reflect the specificities and use of biological substances as compared to chemical substances.

New regulations will be established for the EU for some persistent organic pollutants, according to a news release from the European Parliament on October 4, 2022. (POPs). The new regulations will make sure that EU laws support the circular economy and EU Green Deal. 

According to the European Parliament, there will be reduced limitations for: 

• POPs in waste 

• The chemical perfluorohexane sulfonic acid is a recent addition (PFHxS) 

 Companies looking to obtain and employ recycled materials for their products must consider the decision's ramifications. Waste having too high amounts of POPs must be destroyed or incinerated and cannot be recycled in order to maintain the cyclic lifespan of items. 

 With 534 votes to 25, and 66 abstentions, MEPs approved the new rule. The new regulations will go into effect six months after they are published in the EU Official Journal after being formally adopted by the council. 

 After the European Commission proposed new restrictions under the EU's POPs Regulation in 2021, Members of Parliament (MEPs) and member states temporarily agreed to modify the standards. The Council had requested higher restrictions and later application dates, although the European Parliament had initially advocated for lower limits than those put forth by the EU executive. 

The new threshold levels are:   

•  For polybrominated diphenyl ethers, 200 mg/kg (PBDEs). Five years after the law's enforcement, the new restriction will take effect. The cap is now set at 500 mg/kg, and after three years it will be reduced to 350 mg/kg. presently, it is set at 1,000 mg/kg; 

• 1 mg/kg for perfluorooctanoic acid (PFOA) and its salts, and 40 mg/kg for PFOA-related compounds  

•  Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/Fs) have a toxic equivalency quotient (TEQ) of 5 micrograms (g) per kilogramme (TEQ/kg), which will take effect one year after the regulation's effective date and have a transitional value of 10 g in the interim. PCDD/Fs are now restricted to 15 g/kg. 

• 40 mg/kg for PFHxS-related compounds and 1 mg/kg for PFHxS and its salts. Five years after they become effective, these values will be evaluated. This chemical was included during the trialogue process after being listed in the Stockholm Convention on June 9; it was earlier excluded from the Commission's recommendation. 

•  Hexabromocyclododecane (HBCDD) have a limit of 500 mg/kg, which will be reduced to 200 mg/kg five years after the regulation goes into effect; 

• 500 mg/kg for polybrominated diphenyl ethers (PBDEs), which will thereafter be reduced to 350 mg/kg three years after the regulation enters into force and again to 200 mg/kg after five years; and 

•  Short-chain chlorinated paraffins (SCCPs) are subject to a 1,500 mg/kg limit with a five-year review period. 

The vote demonstrates the European Parliament's "commitment to the implementation of the Stockholm Convention, which is clear: the only way to deal with POPs which are one of the most dangerous chemicals we know - is to work toward eliminating them," according to report author Martin Hojsk, a Renew Europe MEP.   

Products that contain Substances of Very High Concern (SVHC) fall under notification obligation to the ECHA. This means that all products imported or produced on the EU market containing SVHCs have to be notified to ECHA’s database of Substances of Concern in Products (SCIP).  

The SCIP database was developed under the Waste Framework Directive and the notification obligation for all EU countries started to apply in January 2021. The EEA countries (Iceland, Liechtenstein, and Norway) were not able to notify to the database until now since the Waste Framework Directive did not constitute a part of the EEA Agreement. However, starting from 7 November 2022 the notification for EEA countries will also become possible.  

The SCIP database is developed to enable consumers to make more informed choices and to help waste operators to reuse and recycle articles and materials. The database contains 8.7 million articles from over 8 600 EU companies. Only EU-based companies are allowed to notify to the database. In the case of exporters from non-EU countries – the importing company in the EU should do the notification. 

Ministry of Environment, Urbanisation and Climate Change (MoEUCC) in Turkey is planning measures to offer KKDIK registrants an advantage to submit dossiers before December 2023, the registration deadline, since the industry criticized significant issues with data access for an extremely low number of registrations submitted under the REACH-like regulation.

During the meeting held on the 11th of October, 2022 with industry representatives, the Ministry told that it will publish a circular soon to support registrations, alongside revised guidelines on data sharing. Until then, the Ministry has only received 504 lead dossiers which is much lower than expected. Within the scope of KKDIK, the industry forecasts that approximately 10,000 substances will be included. The data problems with KKDIK seem much more severe than those experienced in other countries such as South Korea with K-REACH. Furthermore, registrants might not increase much until the problems with data sharing were solved.  

The challenges with data access range from a general lack of understanding about where and how to acquire information inside the local sector, which is primarily made up of SMEs, to numerous administrative expenditures and costs that many businesses find difficult to deal with. To overcome data-sharing problems, the Ministry said that they would analyze the options to generate data at local labs to improve activity and capacity.

Ministry representatives made it clear that they would not postpone the KKDIK registration deadline, December 2023. On the other hand, it could be considered to set a timeframe for the lead registrant to submit completed dossiers with necessary test data.

As a result, we would recommend to complete the registration processes at the earliest time with new data sharing measures.

To learn more about latest updates, please contact GPC.  

On 2 November 2022, The Ministry of Heavy Industries of India issued a notice regarding vehicle test criteria to ensure enhanced human safety. 

According to the notice the manufacturers claiming governmental fiscal incentives under the Production Linked Incentive (PLI) Scheme and Faster Adoption Manufacture of Electric (FAME) II for vehicles need mandatory testing. 

The new tests will also apply to batteries produced under the PLI for Advanced Chemistry Cells (ACC). The ministry also stated that the new test would ensure the quality of the battery at three levels: the battery pack, battery management system, and cell levels. 

The Ministry through the notification introduced certain tests which are performed internationally and will be made mandatory from 1 April 2023. 

The notification has specified six new tests for the cells, which include an altitude simulation test to observe that the batteries do not explode or catch fire when stored at a specified absolute pressure and temperature as well as a temperature cycling test to observe the reaction of the lithium-ion cell after the chamber temperature is raised and is kept at the high temperature. 

In addition, there are five more new tests in total for the battery pack level and 11 new tests for the battery management system. 

On 24 August 2022 the Indian Ministry of Environment, Forest and Climate Change published the Battery Waste Management Rule, 2022 concerning the waste battery management in India. The new rule takes the place of the Batteries (Management and Handling) Rules, 2001. 

The rules were implemented as a transformative step for fulfilling the announcement made by Prime Minister Shri Narendra Modi in his address to the Nation on Independence Day on 15 August 2021 promoting Circular Economy in full earnest. The rules cover all types of batteries, viz. Electric Vehicle batteries, portable batteries, automotive batteries, and industrial batteries. 

Similar to the concept of Responsibility of Extended Producer Responsibility (EPR), the producers of the batteries are responsible for the collection and recycling of waste batteries and the use of the recovered materials from wastes in new batteries. It also bans disposal of the waste batteries in landfills and incineration. 

The ERP obligation also mandates the producers to engage themselves or authorize any other entity for the collection, recycling, or refurbishment of waste batteries. The rules will enable the establishment of a mechanism and a centralized online portal for the exchange of EPR certificates between producers and recyclers to fulfill the obligations of the producers. 

Online registration & reporting, auditing, and a committee for monitoring the implementation of the rules and taking measures required for removal of difficulties are salient features of the rules for ensuring effective implementation and compliance.  

Environmental compensation will be imposed for non-fulfilment of Extended Producer Responsibility targets, responsibilities, and obligations set out in the rules. The funds collected under environmental compensation shall be utilized in collection and refurbishing or recycling of uncollected and non-recycled waste batteries. 

In August 2022The Ministry of Transportation and Highways (MoRTH) issued a notification for all goods vehicles used for transporting dangerous or hazardous products. 

This notification mandated that all vehicles transporting dangerous or hazardous products must be equipped with a location tracking device, for the vehicles constructed on or after 1 September 2022.  The notification was amended because it has been brought to the attention of the government that vehicles transporting gases such as argon, nitrogen, oxygen, and goods of a dangerous or hazardous nature that do not fall under the purview of a national permit are not equipped with vehicle Location Tracking Devices. 

 
From 1 September 2022 vehicles of categories N2 and N3, in case of new models, and 1 January 2023, in the case of existing models, carrying dangerous or hazardous goods, shall be fitted with a vehicle tracking system device as per the automotive Industry Standard (AIS) 140.

The Government of India has on 29 September 2022, extended the date of enforcement of the existing Quality Control Order for Ethylene Vinyl Acetate Copolymers, Maleic Anhydride, Styrene (Vinyl Benzene), Acrylonitrile, Polyethylene Material, Linear Alkyl Benzene, and Polyester yarns. Producers of this product will now have additional time to obtain Bureau of Indian Standards (BIS) certification for their products.  

The date of entry into force of the existing Quality Control Order for the following chemicals has been extended: 

As per the notifications, producers of these chemicals will now have additional time to secure BIS certification before these Orders come into force. Once these Orders come into force, both domestic and foreign manufacturers of these products will only be able to export/sell in India with a valid BIS license in place. 

To obtain such license, both foreign producers and domestic manufacturers of these products will need to submit an application to the BIS seeking certification. Furthermore, the process of certification will also require physical testing and inspection of the relevant chemicals at the factory premises as well as parallel testing by a BIS-authorized laboratory in India to verify the same. BIS certification is a time-consuming process and therefore it is recommended that interested producers make applications for certification at the earliest in cases wherein Quality Control Orders have been issued and are pending enforcement. 

For the electric vehicle (EV) batteries India’s Ministry of Road Transport and Highways has extended the deadline for implementation of mandatory standards and testing norms. 

The testing norms were supposed to come into effect from the 1st of October 2022, However, The Ministry through modifications to certain rules like the Automobile Industry Standards (AIS) Rule 156 and the AIS Rule 039 have now stipulated battery standards and testing norms to come into effect in 2 phases. The first phase is from the 1st of December 2022 and the other components are from the 31st of March 2023, in the second phase. 

In order to ensure that original equipment manufacturers (OEMs) of EV makers are well equipped to meet standards under the AIS 156 and AIS 039, the ministry stated that implementing new standards and testing norms for EV batteries has been extended. 

The Norms that will be applicable from the 1st December 2022 are the following: 

• The battery management system (BMS) shall be a microprocessor/microcontroller-based circuit. 

• BMS shall be verified for the following safety features: a) Over-charge protection, b) Over-discharge protection, c) Over-temperature protection, d) Overcurrent protection, and e) Short circuit protection 

• The charger shall have: a) charge voltage cut-off to avoid overcharging, b) soft-start function every time the battery is connected for charging, c) pre-charge function to detect deep discharge condition, d) input supply variation (230 VAC +/- 10%) protection, and e) earth leakage detection as per Class 1 of Indian Standards (IS) 12640. 

• Cells used to make batteries shall undergo a minimum 1 cycle of charge-discharge at C/3 current rate. Data of this cycling shall be maintained by the battery pack manufacturer. 

• Sufficient cell-to-cell spacing distance shall be maintained for effective heat transfer from the cell and also isolate the cells in case of thermal runaway in the battery. The inter-cell gap shall be decided based on the type of cell geometry used viz., cylindrical, prismatic, or pouch, and the capacity of the cells. 

• Battery shall have an additional safety fuse or circuit breaker in addition to the features available in BMS. 

• Each battery manufactured shall have a traceability document in which the details of the cells, BMS, and the charger used along with serial/batch number, charge-discharge data values, etc. shall be maintained with the manufacturer. 

• Adequate protection of the cells in case of regenerative braking shall be considered in the design. 

 The Norms that will be applicable from the 31st March 2023 are the following: 

• BMS shall comply with EMC (Electromagnetic Compatibility) requirements as per AIS 004 Part 3 or AIS 004 Part 3 Rev 1 as applicable at the EMC (Electromagnetic Compatibility) level. 

• This procedure is added to evaluate the ability of the battery to withstand thermal propagation which is triggered by an internal short circuit leading to a single-cell thermal runaway and subsequent thermal propagation and shall not result in fire and explosion of the battery. 

• The manufacturing date of battery cells shall be clearly visible on the cells used to build the battery pack with a clear month and year of manufacture. If the manufacturing date is in the form of code on the cells, then the manufacturer shall print the manufacturing date on the pack and shall maintain a record of the manufacturing date(s) of cells used in the assembly of the pack. 

• Cells used shall be certified as per IS 16893 Part 2 and Part 3 

• Battery must have a pressure release vent provided, to avoid building up of internal pressure and release of gases in case of an internal single cell short circuit. 

• Battery should also have active paralleling circuits for the parallel connection of strings to eliminate circulating currents. These power semiconductor devices used for interconnecting strings will also act as protection/safety switches which will detect any faulty strings and isolate them. They will allow the bidirectional flow of currents to charge and discharge the pack. The parallel strings will get isolated if it is detected to be faulty. Therefore, active paralleling circuits shall be mandatory. 

• Data on critical parameters of the battery pack shall be logged by BMS and the latest data for at least one month shall be maintained. Alternatively, the latest data can be stored on the cloud (remote server) at least for one month. 

The Director General of the Society for Manufacture of Electric Vehicle stated that “they are requesting all the EV battery manufacturers to immediately draw up a plan to implement the new standards as per the policy guidelines so as to ensure that they gear up their capabilities and capacities to ensure sufficient quantities of safer batteries to meet the exponential demand of EVs” 

According to latest Chinese cosmetic regulation, Cosmetic Supervision and Administration Rules (CSAR), cosmetic products can be exempted from registration obligation if they are sold via cross-border e-commerce platform. However, e-commerce platforms are required set to cosmetic online rules to regulate online cosmetics. Alibaba international, as the largest Chinese cross-border e-commerce platform, has published “Compliance Rules for Cosmetic Products on Alibaba.com” on the 17^th October 2022. This rule will come into force since 24^th October 2022. 

The compliance rule largely follows the requirements in CASR sets rules. These are two major parts in this rule. 

1. Compliance requirements for listing and trading cosmetic products

• All sellers who want to list cosmetics on the platform, they must strictly adhere to the "Access Rules for Category Qualifications (for Suppliers in the Chinese Mainland)". 
• It is forbideen to sell comsetic products containing cosmetic ingredients prohibited by laws and regulations. Cosmetic ingredients that are in restricted or limited use list have to comply with certain restrictions and requirements. 
• It is forbidden to sell products that are notified by domestic and foreign regulatory authorities to have violated laws and regulations, are at risk of use, or are deemed non-compliant. 
• The description of the products listed online needs to be consistent with the labels of the final products delivered. This including the packaging, labels, ingredients, and the function description of the cosmetics.                        

​​​​​​​2.Control methods 

In "Cosmetics or Cosmetic Ingredients Controlled on Alibaba.com", it mentions that Alibaba.com will comprehensively evaluate the control plan. If the compliance requirements of the same products or ingredients are inconsistent in different countries, the platform will determine the management and control methods based on the actual situation.

If sellers are found to have sold cosmetics in violation of the above-mentioned compliance requirements, penalty might be enforced. The penalty can be removing the product, deleting the product, deducting points from the product, deducting points from the store, restricting the store from using product features on the website, closing the seller's account, and restricting the sale of all products to a destination country according to the platform rules. In addition, sellers shall comply with other compliance and trading rules for products. 

If you are selling or planning to sell cosmetic products via cross-border e-commerce platform, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com for help. 

The National Institute of Environmental Research (NIER) in South Korea updates ‘the results of hazard review of chemical substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on Nov 4^th, 2022. This update is mainly on new substance.

The updates on chemical substance names are of the following 347 substances:

• "2015-4", "2015-16", "2015-17", "2015-33", "2015-35", "2015-36", "2015-37", "2015-40", "2015-76", "2015-89", "2015-93", "2015-96", "2015-101", "2016-7", "2016-12", "2016-13", "2016-21", "2016-22", "2016-34", "2016-38", "2016-41", "2016-47", "2016-59", "2016-63", "2016-67", "2016-73", "2016-78", "2016-80", "2016-81", "2016-85", "2016-103", "2016-104", "2016-106", "2016-108", "2016-109", "2016-114", "2016-116", "2016-117", "2016-118", "2016-121", "2016-122", "2016-123", "2016-124", "2016-132", "2016-143", "2016-144", "2016-145", "2016-146", "2016-147", "2016-149", "2016-151", "2016-152", "2016-153", "2016-154", "2016-155", "2016-157", "2016-158", "2016-159", "2016-163", "2016-168", "2016-175", "2016-182", "2016-183", "2016-185", "2016-190", "2016-191", "2016-195", "2016-197", "2016-201", "2016-204", "2016-208", "2016-229", "2016-233", "2016-236", "2016-242", "2016-243", "2016-244", "2016-247", "2016-251", "2016-253", "2016-254", "2016-255", "2016-256", "2016-257", "2016-258", "2016-264", "2016-265", "2016-266", "2016-267", "2016-268", "2016-270", "2016-277", "2016-280", "2016-281", "2016-286", "2016-287", "2016-289", "2016-290", "2016-292", "2016-296", "2016-297", "2016-298", "2016-299", "2016-309", "2016-313", "2016-314", "2016-315", "2016-317", "2016-319", "2016-320", "2016-328", "2016-329", "2016-338", "2016-339", "2016-350", "2016-360", "2016-361", "2016-364", "2016-367", "2016-368", "2016-372", "2016-373", "2016-378", "2016-379", "2016-380", "2016-381", "2016-382", "2016-383", "2016-384", "2016-385", "2016-386", "2016-388", "2016-389", "2016-391", "2016-393", "2016-395", "2016-396", "2016-398", "2016-399", "2016-400", "2016-401", "2016-402", "2016-403", "2016-406", "2016-407", "2016-408", "2016-409", "2016-416", "2016-421", "2016-422", "2016-424", "2016-425", "2016-432", "2016-433", "2016-435", "2016-436", "2016-437", "2016-442", "2016-443", "2016-444", "2016-446", "2016-453", "2016-455", "2016-461", "2016-463", "2016-464", "2016-469", "2016-471", "2016-478", "2016-479", "2016-481", "2016-485", "2016-488", "2016-499", "2016-502", "2016-505", "2016-520", "2016-522", "2016-523", "2016-525", "2016-526", "2016-527", "2016-529", "2016-531", "2016-538", "2016-540", "2016-544", "2016-546", "2016-547", "2016-568", "2016-574", "2016-588", "2016-600", "2016-601", "2016-615", "2016-623", "2016-625", "2016-631", "2016-634", "2016-635", "2016-640", "2016-641", "2016-642", "2016-643", "2016-644", "2016-645", "2016-666", "2016-671", "2016-698", "2016-700", "2016-740", "2016-748", "2016-754", "2016-755", "2016-759", "2016-760", "2016-764", "2016-765", "2016-782", "2016-785", "2016-789", "2016-797", "2016-807", "2016-840", "2016-871", "2016-873", "2016-874", "2016-875", "2016-876", "2016-947", "2016-948", "2016-1018", "2016-1075", "2016-1103", "2016-1104", "2016-1105", "2016-1112", "2016-1113", "2016-1129", "2017-16", "2017-19", "2017-24", "2017-26", "2017-28", "2017-29", "2017-30", "2017-38", "2017-40", "2017-41", "2017-42", "2017-43", "2017-44", "2017-48", "2017-51", "2017-52", "2017-54", "2017-59", "2017-60", "2017-62", "2017-63", "2017-70", "2017-72", "2017-73", "2017-76", "2017-77", "2017-103", "2017-104", "2017-110", "2017-111", "2017-130", "2017-132", "2017-135", "2017-137", "2017-139", "2017-140", "2017-141", "2017-157", "2017-163", "2017-165", "2017-166", "2017-195", "2017-208", "2017-214", "2017-223", "2017-230", "2017-231", "2017-232", "2017-233", "2017-236", "2017-243", "2017-255", "2017-256", "2017-257", "2017-259", "2017-261", "2017-263", "2017-268", "2017-272", "2017-279", "2017-290", "2017-291", "2017-298", "2017-300", "2017-320", "2017-321", "2017-322", "2017-325", "2017-326", "2017-328", "2017-364", "2017-369", "2017-370", "2017-376", "2017-385", "2017-395", "2017-404", "2017-410", "2017-411", "2017-412", "2017-413", "2017-415", "2017-416", "2017-417", "2017-418", "2017-419", "2017-439", "2017-443", "2017-455", "2017-463", "2017-467", "2017-470", "2017-472", "2017-474", "2017-483", "2017-489", "2017-491", "2017-495", "2017-498", "2017-519", "2017-529", "2017-537", "2017-547", "2017-559", "2017-562", "2017-589", "2017-590", "2017-591"

The amendment came into effect immediately.

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the Regulation on the subject and methods of risk assessment for the consumer chemical products’ under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on November 8th, 2022. This is to expand the subject of risk assessment based on diversified users and uses of the consumer chemical products. This makes it necessary to provide updated algorithm in order to enhance the utilization of the exposure algorithm.

The draft amendment mainly proposes revisions including:

• Add professional users to the subject of risk assessment
• Add exposure scenario by formulation to the current exposure calculation formula categorized by inhalation route and exposure route
• Update the current exposure calculation formula to enhance the utilization of the exposure algorithm
• Add general exposure factor and product exposure factor based on expanded subject of risk assessment

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

The deadline for this consultation is Nov 18th, 2022.

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea updates the Guidelines on analysis methods for cosmetic ingredients with restricted uses on October 31^st, 2022. This is for the quality improvement and safety management of cosmetics.

The main updates are:

• Addition of analysis methods applicable to products regarding 10 types of colorants that can be used in cosmetics based on “Cosmetic colorant types, standard and test methods”
  • Green No. 204, Yellow No. 4, Red No. 2, Green No 2
  • Red No. 102, Red No. 40, Yellow No. 202 (1), Red No. 103 (1), Orange No. 205, Violet No. 401

The Ministry of Food and Drug Safety (MFDS) in South Korea consults on a draft amendment of ‘Standards for Appliances, Containers and Packaging’ under Food Sanitation Act on October 14^th, 2022. It is expected that the approval for using recycled materials as raw materials for utensils, containers and packaging would be published in the near future. And this draft amendment is to specify data to be submitted when applying for the approval. In addition to this, this draft amendment is to improve some issues of the current standards that industry is facing to pursue the sustainable society.

The draft amendment mainly proposes revisions including:

• Update the standard of recycled materials made of synthetic resins
• New standard for polybutylene adipate terephthalate (PBAT)
• Update the test method

Please note that one article for the standard of recycled materials made of synthetic resins in the draft is based on the draft Enforcement Rule of the Food Sanitation Act, so it may change according to the final Enforcement Rule.

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

The deadline for this consultation is Dec 13th, 2022.

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘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 November 1^st, 2022. This is to provide updated classification on product type based on diversified and new antimicrobial and disinfectant for humidifiers. Also, this is to rationalize approval application data by specifying the approval application data.

The draft amendment mainly proposes revisions including:

• Segmentation of products such as antimicrobial and disinfectant for humidifiers
• Clarification of the submission requirements for approval application data
• Establishment of numbering standards as the expansion of approved products
• Clarification of interim measures for preservative treatment products for humidifiers

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

The deadline for this consultation is Nov 21st, 2022.

The Ministry of Environment (MoE) in South Korea added the provision to expand the definition of existing substances on Aug 12th, 2021. Based on the updated definition of existing substances, South Korea updates K-REACH registration procedure for existing substances.

The updates are as below:

For example, if an existing substance is "Mixture (reaction mass) of X+Y+(…Z)", pre-register with the existing substance X, and create new CICO with the name "Mixture (reaction mass) of X+Y+(…Z)". Also, it is necessary to put the reason as “got the approval as an existing substance from the NIER”.

*The definition of existing substances added are as follows:

• hydrate or anhydrous of existing substances
• reaction products consisting of two or more existing substances
• Isomers of an existing substance
• Other chemical substances mentioned in the attachment

The Environmental Protection Administration (EPA) of Taiwan has amended some of the articles of Regulations for the Labelling and Materials Safety Data Sheets for Toxic and Concerned Chemical Substances. The amended regulation came into force on 4 November 2022, except for Articles 3 and 4 where it will be effective from 31 October 2023.

The amendments were based on a consultation that was published on 21 July 2022 and closed on 20 August 2022. The amendment was made to align with the EU’s Regulation on Classification, Labelling, Packaging of Substances and Mixtures (CLP Regulations).

Before the amendments, companies only needed to indicate the hazardous substances presented in the mixtures. Now, companies have to list all hazardous substances on the SDS and the label. The information on hazardous substances can be labelled in two ways. Companies can include the hazard information if the testing report is available for the mixture. If there is no available testing result for mixtures, companies should follow the national standard CNS 15030 to label the substances’ hazards.

Articles 3 and 4 of the regulation concern the labelling requirements and the packaging size. See earlier news on this.

The Ministry of Land, Infrastructure, Transport and Tourism (MLIT) is the Japanese government agency responsible for the comprehensive and systematic use, development and conservation of the land, consistent development of social capital, promotion of transportation policies, development of meteorological services, and ensuring maritime safety and security.

To comply with the International Maritime Dangerous Goods Code's 41^st amendment, Japan’s MLTI has recommended that the rules for carrying and storing dangerous products aboard ships should be updated for several chemicals.

The International Maritime Dangerous Goods Code (IMDG Code) is an international code for the maritime transport of dangerous goods in packaged form, implemented to enhance and harmonize the safe carriage of dangerous goods and to prevent pollution of the environment. The Code sets out in detail the requirements applicable for each substance, material or article, covering matters such as packing, container traffic and stowage, with particular reference to the segregation of incompatible substances.

The 41^st amendment of the IMDG Code will be mandatory from 1 January 2024; however, International Maritime Organization (IMO) invites administrations to apply it from 1 January 2023. Japan also decided to adopt the IMO's suggestions and begin implementing the updated IMDG code on 1 January 2023 in order to ensure a seamless transition.

In a notice for public comment published on 26 October 2022, the ministry proposes to:

• revise the transport requirements for cobalt (II) hydroxide powder and substances containing 10% or more of its respiratory particles
• revise the dangerous goods list's classification of UN1891 ethyl bromide from hazard class 6.1 (a poisonous substance) to main hazard class 3 (flammable liquids) and secondary hazards 6.1, as well as its allowable capacity and mass for safety measures
• remove differentiated quarantine requirements for acids and strong acids
• provide new transport guidelines for liquid compounds such as isoalkanes
• consolidate 'UN1169 fragrant liquid extract (essential oil)' and 'UN1197 fragrant liquid extract (fragrant)' as 'UN1197 fragrant extract (essential oils or fragrant)

The deadline for public comment is 28 November 2022. Late December is anticipated for promulgation, with enforcement beginning on 1 January 2023.

The International Maritime Organization (IMO) previously known as the Inter-Governmental Maritime Consultative Organization until 1982, is a specialized agency of the United Nations responsible for regulating shipping. The IMO's primary purpose is to develop and maintain a comprehensive regulatory framework for shipping and its remit today includes maritime safety, environmental concerns, legal matters, technical cooperation, maritime security, and the efficiency of shipping.

During the Chemical Materials Japan 2022 virtual conference, which took place between 17 and 28 October 2022, the Ministry of the Environment (MOE) and the Ministry of Economy, Trade, and Industry (METI) announced their intention to amend the Chemical Substance Control Law (CSCL) to prohibit perfluorohexane sulfonic acid (PFHxS), its salts, and associated compounds next year.

As per the METI, the PFHxS, its salts and related compounds are expected to be designated as class I specified chemical substances. Under CSCL, Class I Specified Chemical Substances are substances that are persistent, highly bioaccumulative, and have a risk of long-term toxicity to humans or predator animals at higher trophic levels. The manufacture, import and use of such substances are prohibited in Japan.

This action aims to bring Japan into compliance with a global ban on the material decided upon by the Stockholm Convention on Persistent Organic Pollutants (POPs) in June 2022. The Basel, Rotterdam and Stockholm conventions are multilateral environmental agreements, which share the common objective of protecting human health and the environment from hazardous chemicals and wastes.

PFHxS is a chemical compound used to make firefighting foams, non-stick cookware, carpet, paper, and fabric stain treatments. It belongs to the group of per- and polyfluoroalkyl compounds (PFASs), whose environmental persistence and presence in water have drawn increasing public scrutiny in recent years. Millions of people will benefit from the decision to prohibit PFHxS, especially firemen who are among those most exposed due to PFHxS's inclusion in firefighting foam.

The ministries of Health, Labour and Welfare (MHLW), METI and MOE will meet after November 2022 to review the strategy.

On 14 October 2022, Japan's Ministry of Health, Labour and Welfare (MHLW) announced two different public consultation notifications to add 13 more compounds that could be hazardous to the health of workers under the Labour Standards Act. The start of enforcement is anticipated for late December.

The MHLW identified ten compounds that pose a risk to workers health in a report released on 18 March 2022 that led to the proposed change to Japan's list of occupational illnesses. The findings came after an evaluation process that the MHLW started in July 2019 which covered 216 chemicals.

The list of Newly added substances and diseases are as follows:

Additionally, the amendment eliminates two medical conditions: consciousness disorder for methyl iodide and vasomotor neuropathy disorders for Nitroglycol, calcium cyanamide, and nitroglycerin.

Workers in Japan are eligible for compensation if they develop occupational illnesses linked to chemicals on the list. The Industrial Safety and Health Act (ISHA), also mandates that businesses that use the chemicals on the list put in place mandatory health and safety precautions for employees.

In Table 1-2 of the Labour Standards Act, the MHLW also recommended adding serious heart failure to the list and replacing dissecting aortic aneurysm with aortic dissection.

A subsequent assessment and discussion by the MHLW took place on 7 October 2022, and the announced its recommendations in the "Report of the Expert Review Committee on the Ordinance for Enforcement of the Labor Standards Act, Article 35."

The Ministry of Health, Labour and Welfare is currently considering a shift from legally compliant risk management to autonomous risk management in response to the growing risk management of new chemicals in the industrial sector. Chemicals and workplace safety requirements in Japan are managed by the government through a set of laws and regulations. 

On 30 September 2022, Japan released a draft notification to implement guidelines for measuring workplace exposure to certain hazardous substances as it transitions to a self-regulated risk assessment model for chemicals under the Industrial Safety and Health Act (ISHA), and the industry was given a deadline of 29 October 2022, to comment on the suggestions. 

Chemicals and workplace safety requirements in Japan are managed by the government through a set of laws and regulations. The ISHA requires workers exposed to any chemical on a designated list to be screened for occupational diseases on a regular basis.  

In the draft, the Ministry of Health, Labour and Welfare (MHLW) specifies the risk measuring requirements for the compounds like Lead, dust, specific chemical compounds, such as chlorine, ethylene oxide, and chromic acid, and organic solvents like acetone, xylene, and isobutyl acetate. 

Companies that don't follow the suggested working environment measurements for exposure threshold levels to certain chemicals, organic solvents, and lead would have to hire outside consultants to provide them advice on enhancing safety precautions. 

According to the ministry, businesses will be able to assess the overall workplace environment to better manage and control these substances by tracking samples from two or more employees who have experienced similar substance exposures and gathering sample data over the course of an entire working day. The document also outlines specifications for respiratory protective equipment. 

The MHLW suggested new, obligatory procedures in July 2021 to enhance ISHA’s chemical risk assessments and workplace safety. The rules will be published in late November, according to the ministry, and will start to be enforced on 1st April 2024. 

The draft also suggests that workplaces designated for controls under the MHLW's working environment evaluation standard, or where air exposure levels are above the limits specified in the draft, conduct personal sampling strategies — using wearable portable sample collectors — to measure substance exposure. 

On 20 October 2022, the Japanese Ministry of Health, Labour, and Welfare (MHLW), the Ministry of Economy, Trade, and Industry (METI), and the Ministry of Environment (MOE) have jointly published the 2023 schedule for companies to notify new chemical substances manufactured or imported in volumes of less than one tonne per annum (TPA), or to apply for small-volume permits under the Chemical Substances Control Law (CSCL).

An applicant code must be requested by 9 December 2022 from businesses submitting online applications for the first time. In order to fulfil the deadline for the initial online application, the ministry anticipates notifying the code on 11 January 2023.

For receiving the confirmation of manufacturing or importing small amount of chemicals substances from the Government of Japan, one can apply through following methods under the given dates:

• Online electronic submission on e-Gov website
• Optical disc by mail to METI
• Paper documents filed with the MOE

On the same day the three Ministries also published the deadline for companies to submit applications for low volume chemical permits under the Chemical Substances Control Law (CSCL) or to notify new chemical substances manufactured or imported in volumes of less than ten TPA in a separate notice.

Applicants can submit their applications for the permits via the e-Gov website, METI, or via mail that is addressed to the ministry. One month after the application deadline, the results of the applications will be made public. Detailed instructions for submissions are available on the METI website.

Companies must provide biodegradation studies and/or bioaccumulation studies to support their applications, as well as the projected amounts they anticipate to import or manufacture. The government must be able to evaluate the substance's potential for bioaccumulation, human toxicity, and ecotoxicity through biodegradation studies that provide information and analytical data on degradation products. Good laboratory practice (GLP) compliance is required for test data.

Companies who are making their first online application must have an applicant code. Companies must apply for the code by 10 January 2023 and may anticipate receiving it on 8 February 2023 in order to fulfil the first application deadline.

Applicants who want to manufacture or import the chemicals must include all the relevant details about company name, addresses, notifier or responsible person, volume, uses of chemicals to be exported, and the structural formula of the chemicals in the application. To guarantee that the overall national yearly volume is within the acceptable range for the given substance, the government will modify the authorised amounts for each application.

The Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE) and Ministry of Economy, Trade and Industry (METI) are jointly responsible for processing the applications.

The penalty for non-compliance is prison of up to one year or a maximum fine of 50 M Japanese yen.

In order to help companies, comply with the regulations for chemicals in the Pollutant Release and Transfer Register (PRTR), Japan's Ministry of Economy, Trade, and Industry (METI) has issued its 2022 Safety Data Sheet (SDS) and labelling advice. The updated guidance in Japanese was released on the METI website on 4th October 2022.

The purpose of the Japanese PRTR (Pollutant Release and Transfer Register) system is to encourage business operators to improve their management of chemical substances on a voluntary basis and to prevent any obstructions to the preservation of the environment by taking steps to confirm the release amounts, etc., of specific chemical substances in the environment.

The revised guidance provides details on the following:

• The Globally Harmonized System (GHS) and mixture classification system - The Industrial Safety and Health Act (ISHL), the Pollutant Release and Transfer Register (PRTR) Law, and the Poisonous and Deleterious Substances Control Act (PDSCL) are the three laws that govern the implementation of GHS in Japan.
• Information about the list of compounds covered by PRTR.
• Details on the necessary elements for SDSs, labels, and SDS transfer procedures.

A government gazette notice published on 20 October 2021, states that the Ministry of Economy, Trade, and Industry (METI) has raised the number of compounds included in its Pollutant Release and Transfer Register (PRTR) from 562 to 649. Under Class I, 53 chemical compounds have been added bringing the total number of chemicals listed in this class to 515. Under Class II, 34 chemical compounds have been added by the ministry, bringing the total number of chemicals listed under Class II to 134. These are substances that are specified as being harmful to humans and ecosystems and are deemed to disperse widely into the environment, or are highly likely to disperse widely into the environment at a future time. Enforcement will begin on 1 April 2023.

According to PRTR regulations, businesses are required to give SDSs to other business operators when sharing information about compounds included in the register and goods that contain them.

On 14 October 2022, Japan’s Ministry of Economy, Trade and Industry (METI), released a notice to revise the Export Trade Control Order, regarding the export approval of Decabromodiphenyl ether (decaBDE) and Perfluorooctanoic acid (PFOA), its salts and related compounds. Decabromodiphenyl ether is a technical mixture of different Polybromated Dipheny Ether (PBDE) congeners, with PBDE congener number 209 (decabromodiphenyl ether) and nonabromodiphenyl ether being the most common. It is a brominated flame retardant that was widely used in electronic plastics and fabrics. Perfluorooctanoic acid is a perfluorinated carboxylic acid produced and used worldwide as an industrial surfactant in chemical processes and as a material feedstock.

Both compounds are classified as Persistent Organic Pollutants (POPs) in Annex A of the Stockholm Convention, making it mandatory to stop using and producing them, and parties must take action to do so. The updated notification becomes effective on 21 October 2022.

The Chemical Substance and Control Law (CSCL) and the Export Control Ordinance govern the production, use, import, and export of POPs in Japan. On 19 August 2022, METI proposed revisions to the Export Trade Control Order under the Foreign Exchange and Foreign Trade Act.

Businesses must comply with the Rotterdam Convention's export limitations and get approval from the Ministry of Trade, Economy and Industry (METI) before they may export the chemicals. The Rotterdam Convention aims to improve responsibility on importing hazardous chemicals, notably through the "prior informed consent" (PIC) procedure. The PIC procedure is a method for formally obtaining and disseminating the decisions of importing parties regarding whether or not they wish to receive subsequent shipments of the chemicals listed under the Rotterdam Convention, as well as for ensuring compliance with these decisions by exporting Parties.

On 3 October 2022 the Brazilian National Health Surveillance Agency (ANVISA) published a new Technical Note 31/2022/SEI/GHCOS/DIRE3/ANVISA on the regularization of personal hygiene products, cosmetics, and perfumes which came into force directly.

On 19 September 2022, the Brazilian National Health Surveillance Agency adopted Resolution 752/2022. It entered into force on 3 October 2022. Resolution 752/2022 requires labelling adaptations which demand the addition of customer service information, particular definitions for tanning products, hypoallergenic goods, personal hygiene products, and specific wrapping features.

Resolution 752/2022 is the result of adapting several directives of the Common Market of the South (MERCOSUR). Therefore, it is an effort of the Brazilian government to standardize regulations in the region and simplify the trade of those goods within the MERCOSUR region and towards it. 

In addition to technical requirements and regularization as well as labelling and packaging procedures, the new standard defines the parameters for the microbiological control of these products. In this regard the Technical Note 31/2022/SEI/GHCOS/DIRE3/ANVISA for contains guidance to meeting the mandatory requirements for microbiological specifications of the finished product, provided for in item III of Article 8 of Resolution 752/2022.This Note points out the technical requirements and procedures concerning microbiological control. In this regard, two possible options could occur:

• if a product is keen to pollute in a microbiological dimension, the product shall comply with several parameters set in Chapter V of Resolution 752/2022.
•  if a product is potentially not a harm in a microbiological dimension such condition should be demonstrated technically under ISO29621:2017.

Existing product registration  must be adapted before 3 October 2025 and new products have to comply with the novel regulation. For more information in Portuguese visit: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2022/anvisa-divulga-orientacoes-sobre-controle-microbiologico-de-cosmeticos

On 27 October 2002, the minister of Ministry of Industry and Trade signed a new circular on amending and supplementing articles of Decree 113 published on 2017 as well as detailing and guiding articles within the Law on Chemical valid from 2008. 

The amendments are as follows: 

• A more detailed description of the roles of Vietnam Chemical Agency 

• Change in Classifying and labeling chemicals: labeling chemicals is conducted according to Decree 43/2017/ND-CP and decree 111/2021/ND-CP with instructions under Annex 8 

• Modification to make this circular coherent with changes made in Decree 82/2022  

• Change the deadline to submit annual chemical report on February 15th every year via National Chemical Database, and the recipients of the report are Vietnam Chemical Agency, local-level Department of Industry and Trade where chemicals are traded or produced 

• Change the deadline for local-level Department of Industry and Trade to report their management procedure to March 1st every year to Vietnam Chemical Agency via National Chemical Database  

• A new Annex 3 listed the forms to be used in the process of appraising and approving chemical incident prevention and response plans 

• A new Annex 5 regarding chemical activity report forms for organizations and individuals, and Ministry of Industry and Trade 

• Legal information that is removed: 

• Clause 1 in article 4 on promulgating the legal certificates and licenses for production and trading; Annex 1 detailing the legal certificates and licenses for production and trading mentioned in this clause 

• Clause 2 in article 4 on promulgating licenses to export and import industrial precursors; Annex 2 detailing the licenses to export and import industrial precursors 

• Clause 1 in article 5 on plan to prevent and respond to chemical accidents mentioned; the whole Annex 6 detailing plan to prevent and respond to chemical accidents 

• Clause 4 in article 6 on Secondary labels on chemicals 

• Clause 1 & 2 in article 8 on the custom clearance processes when import chemicals 

• Article 10 on the responsibility to conduct administrative procedure and the roles of local level Department of Industry and Trade 

• Point b clause 3 in article 11 on provoking the validation of the registration certificates and licenses before Decree 113 comes into effect 

• Part 3 of Annex 7 on the classification criteria for SOL flammable gas 

This decree will come into effect on 22 December 2022, while clause 6 article 1 regarding the annual report process and deadlines in this decree will be valid one year later. 

The second Draft of the National Technical Regulation on Thresholds for Persistent Organic Pollutants (POPs) in Articles, Products, Commodities, and Equipment was issued by Vietnam's Ministry of Natural Resources and Environment (MONRE) on 15 September 2022, and comments are now being accepted until 14 November 2022. This law would apply to companies in Vietnam that import, manufacture, trade, or use raw materials, fuels, products, commodities, or equipment that contains POPs. It is scheduled to go into effect on 1 January 2023.  

The first draft, which was released on 12 November 2021, included concentration limits for certain POPs that were allowed in plastic items, electronic devices, articles, goods, commodities, equipment, food contact materials, firefighting foam and more. It also outlined the maximum allowed values for seven different types of POPs in a variety of materials and products. 

The technical regulation would also mandate conformity assessments, compliant labelling, and government notification of any raw materials, products, goods, and equipment containing POPs before they could be sold on the Vietnamese market by businesses importing, manufacturing, trading, or using the specified products. Exporters would not be subject to the restriction.  

7 POP compounds are regulated in the second draft, each with a specific set of requirements. 

In September, the ministry of natural resources and environment open the public consultation for the second draft of the national technical regulation proposing thresholds for several persistent organic pollutants (POPs) in raw materials, materials, products, commodities and equipment. The first draft was published in November 2021, specified limits for certain POPs in different substances, covering the maximum amounts of several types allowed in plastic products, electronic devices and other products, and limits on perfluorooctanoic acid (PFOA) in food contact materials, firefighting foam and more. 

The draft of national technical regulation applies for the individuals and organizations imported POPs and raw materials, materials, products, goods, equipment that contain POPs, responsible authorities and assessing organizations involve in the importing process of POPs. According to the second draft, individuals and organizations import POPs, and raw materials, materials, products, goods, equipment that contain POPs, they need to follow the assessment procedure according to the national technical regulation, label and update the information before entering the markets. The second draft consists of the following changes compared to the first draft: 

• The procedure of assessing the POPs content in raw materials, materials, products, goods, equipment must be carried out by the following organizations:  

• Domestic testing organizations and foreign testing organizations have licensed branch or representative offices operating in Vietnam with environmental monitoring services operating eligibility certificate. 

• Foreign testing organization is accredited to the international standard ISO/IEC 17025 by a public organization admitted to be a participant in signing the mutual recognition agreement of International Accreditation Forum (IAF), Asia-Pacific Accreditation Association Ocean (APAC), International Laboratory Accreditation Association (ILAC). 

• Removing limits on tetrabromodiphenyl ether and pentabromodiphenyl ether for plastic and plastic details in electrical and electronic equipment; limits on hexabromodiphenyl ether and heptabromodiphenyl ether for plastic and plastic details in electrical and electronic equipment.  

• Adding limits for hexabromodiphenyl ether and heptabromodiphenyl ether for vehicle parts, including plastic parts, thermoplastics, and polyurethane foam in seats and cushions; and limits for PFOA for medical devices intended for implantation. 

The National Technical Regulation is expected to come into effect on 1st January 2023.

On 18 October 2022, the deputy prime minister signed and passed the new Decree 82/2022/ND-CP amending and supplementing articles of Decree 113 published on 2017 as well as detailing and guiding articles within the Law on Chemical valid from 2008. 

These are the significant changes Decree 82/2022/ND-CP has on Decree 113/2017/ND-CP: 

• The process of declaration and custom clearance via National Single Window Portal in article 27. 

• Dinitro monoxide, cyanide compounds, mercury and mercury compounds are added to point a, clause 4, article 27 as hazardous chemicals needed to be controlled when being declared for import.

• 16 chemical substances are added to the Annex I (list of chemicals subject to conditional production or import) of Decree 113. 

• The substance no. 231, Table 1 (list of hazardous chemicals for which chemical incident prevention and response plans are required) Annex IV of Decree 113 changes from Mercury fulminate to Mercury and mercury compounds. 

• 6 chemicals are added to Annex V (list of chemicals subject to be declared) of Decree 113: Pentachloro benzene (PeCB); Hexabromocyclododecane (HBCD); Polychlorinated naphthalene (PCN); Decabromodiphenyl ether (DBDE); Perfluorooctanoic acid (PFOA) and its salts and PFOA - related compounds; Perfluoro hexane sulfonic acid (PFHxS), its salts and PFHxS - related compounds.  

• Replace Annex II (list of industrial chemicals restricted from production and trading) and Annex VI (Licenses and Certificate) of Decree 113 by Annex II and Annex VI of Decree 82.  This indication associates Vietnam with its obligations under Rotterdam and Stockholm conventions. 

This decree will come into effect on 22 December 2022, while clause 14 article 1 in this decree will be valid one year later. 

In September 2022, two chemical control order (CCO) drafts were published by the Department of Environment and Natural Resources (DENR) of the Philippines for benzene and vinyl chloride. The draft order adds vinyl chloride to chemical substances to be regulated under CCOs, to reduce the risk of its exposure to human health and the environment. Both CCOs will go into effect 15 days after they are announced in a major publication.

Benzene is used in the production of many polymers and plastics including polystyrene, thus the draft order is applicable to all sectors of its use. If this order gets approved company sectors from importers, distributors, manufacturers and industrial users, commercial users, transporters, to treatment, storage, and disposal (TSD) facilities should register the substance on the Philippines Online Permitting and Monitoring System (OPMS). They will receive the certificate after submitting the necessary documents. For the import of the substance, importers must apply for import clearance via the same system and the clearance will be valid for six months.

The use of benzene will be prohibited if no technically and economically feasible alternatives can be found, in paints, varnishes, coatings, solvents and thinners, glues, cement and rubber goods, solutions for textiles, fabrics, and leathers, inks and dyes and in cleaning and degreasing agents.

In February 2022 the first draft CCO for vinyl chloride was published by the DENR. Vinyl chloride is used to manufacture polyvinyl chloride (PVC), which is used to make many plastic products including pipes, wire and cable coatings, and packaging materials. So, in the second draft of the CCO for vinyl chloride, there is an addition of the prohibited uses section which stipulates that the substance will be banned in aerosols as a propellant or an ingredient. Also, In the chemical management plan, some slight changes have been made relating to registration requirements which include which documents are necessary and what additional details of the chemical are needed.

 The “Regulation of the Minister of Industry No. 13 of 2021 on the Recommendation of the Importation of Hazardous substances” came into force in Indonesia on 13th of July 2021.  

The regulation concerns two categories of importers of hazardous substances; 1) “manufacturers and importers” (API-P) and 2) “general importers” (API-U). In the case of “Manufacturers and importers”, these types of importers have no right to further distribute hazardous substances on the Indonesian market. In the case of “General Importers” group, only state-owned companies will be granted the recommendation letter to import hazardous chemicals and distribute them on the Indonesian market. However, if one of the “General importers'” buyers does not comply with the regulations, the buyer will be banned from purchasing hazardous chemicals. 

According to the new regulation, the API-P type of importers of hazardous substances must get a recommendation letter from the Ministry of Industry. To obtain the letter, the importer must first verify itself through a third-party organization and then submit its application to the Ministry of Industry through the “State Industrial Information System (SIINas)”.  After the recommendation letter is obtained, the importer must submit an import result at least once a month to the Director General in charge through SIINas. 

The documents required for verification are as follows (for API-P only):  

• Company Registration Number (NIB) 

• Industrial business license or expansion business license Import plan 

• Hazardous substances inventory list owned by the company 

• List of types and quantities of major equipment used and production process flow 

• List of workers 

• Safety data sheets (SDS) for hazardous substances 

• Production capacity and types of products to be produced 

• Production performance reports for the last 3years 

• Hazardous substances utilization report for the last 3 years 

• Production plan and hazardous substances requirements for one year of production. 

After the verification by a third party, the company is supposed to apply for the recommendation letter through SIINas: https://siinas.kemenperin.go.id/.  The application must include reports on the verification results. Furthermore, the importer should provide:; 

• Identification information of the company 

• The business license of the company 

• The CAS number of the hazardous substances to be imported 

• The HS tariff number/item of the hazardous substances to be imported 

• Intended use of hazardous substance 

• Recommended import quantity 

• Country of origin, country of loading 

• Port of destination 

• The recommendation letter's validity period 

Definition:  

According to the regulation, the definition of hazardous substances is the following: Hazardous substances are components, chemicals, and biological materials in the form of single substances or mixtures that are toxic, carcinogenic, teratogenic, mutagenic, corrosive, and irritant that may pose a risk to health and the environment, directly or indirectly. 

Every two years manufacturers and importers of dangerous substances have to notify the environmental authority. The first notification deadline due on February 2024. 

Any manufacturer or importer of a substance as such and any importer of a dangerous substance contained in quantities equal to or greater than one tone per year (TPA) must notify the environmental authority in the Substance Notification System, through the Single Window of the Environmental Authority portal. As it is stated in art 294 of Decree 57, the notification must be made every two years, with a deadline of 30 August, considering what was manufactured and imported in the previous two calendar years.   

However, the first notification must be made until February 2024, for substances for industrial use and in the fourth year for substances for non-industrial use. The information to be provided should include elements such as: 

• name, address, telephone, and email address  

• name of the substance and number of the American Chemical Society  

• hazard classification(s) of the substance indicating the class and category of hazard 

• amount of substance manufactured or imported per year expressed in mass ranges 

• intended uses.  

In the case of substances contained in mixtures, the corresponding use of the mixture must be indicated.   

Once the notification has been made, the Ministry of the Environment will issue a Resolution with all the notified substances, until 31 December of that same year. This is part of a current new regulation that the Chilean government is implementing, and its process is ruled by Title VI of Decree 57 which is the result of the country’s commitments as an OECD party. These harmonized labelling and classification of chemicals are obligations that Chile is complying with to facilitate international trade and protect human health and the environment.  

Chile approved the uniformized Regulation on Classification, Labelling and Notification of Hazardous Chemicals and Mixtures by Decree 57 on 26 November 2019. In publishing Decree 57 Chile formally accepts the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals. Under article 270 of Decree 57, the supplier of a hazardous substance or mixture must provide its recipient with a Safety Data Sheet (SDS). Title V of this Decree describes its requirements and obligations, as well as specifies what information must be included in each section of the registration.   

From May 31, 2022, manufacturers and importers in Colombia have three years to register chemical substances for industrial use in the new digital application.  

Colombia released a registration platform for companies to submit information on the use of chemicals in their industrial activities. The deadline is May 30, 2025.  

Decree 1630 of November 30, 2021, aims to regulate the comprehensive management, including risk management of chemical substances for industrial use that are classified as hazardous within the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) created by the United Nations.  

The Colombian Ministry of Commerce enacted Circular 018/2022 of May 31, 2022, which initiated three years to register chemical substances for industrial use as it is stated in Decree 1630. This is an obligation to register chemicals in Colombia's new National Registry of Industrial Chemical Substances. It is mandated to manufacturers and importers whose chemical substance volumes exceed 100 kg and voluntary to those below 100 kg.   

Information required:  

• annual production and import amount 

• substance identification, including CAS number 

• risk assessment and classification according to the GHS 

• identified substance uses 

Additional compliance steps include:  

• follow SDS and label standards 

• submit information to the national inventory 

• design, implement and make public risk reduction and management actions programs 

Circular 018/2022 establishes the digital application and its filing instructions to register the information requested by the National Inventory of Chemical Substances for Industrial Use, as pointed out in Decree 1630. From the date of its enactment manufacturers and importers have a three-year period to comply with the new registration duties.  

For more information please visit: https://www.mincit.gov.co/getattachment/7ad4c91f-afe6-4c7d-8366-cd2837acf081/Circular-018-del-31-de-mayo-de-2022.aspx  

On September 29, 2022, Argentina enacted Provision 7809/2022 which puts in force the MERCOSUR Technical Regulation on labelling for personal hygiene products, cosmetics and perfumes. This is a step towards the uniformization of technical requirements for cosmetics and personal care products in Argentina, Brazil, Paraguay, and Uruguay. This regulation establishes the essential information that must be included on the labels of personal hygiene products, cosmetics, and perfumes regarding their use, as well as any necessary indication regarding the products. 

Cosmetic and personal care products must comply with this requirement within 36 months from the mentioned date.  This means that importers, manufacturers and others will have to finalize their product registration until September 29, 2025. This regulation states general labelling requirements for personal hygiene products, cosmetics and perfumes which entails minimum mandatory data depending on the type of container used. It also indicates specific requirements for: 

• Aerosols 

• Neutralizers, waving and straightening products 

• Hair lightening agents and hair dyes 

• Bleaching agents for hair/body hair 

• Dye for hair/body hair 

• Depilatories and epilatories 

• Toothpaste and mouthwashes with fluoride 

• Antiperspirant products 

• Tonics/hair lotions 

• Activators/cccelerators of tanning 

• Self-Tanners/tan Simulators 

• Oral care products suitable for sensitive teeth 

• Products for intimate hygiene 

• Hypoallergenic products 

MERCOSUR, also known as the Southern Common Market, is an international integration body where Argentina, Brazil, Paraguay and Uruguay are full members. Bolivia, Chile, Colombia, Ecuador, Guyana, Peru and Surinam are associated countries. Bolivia is currently undergoing an adherence process to join MERCOSUR.  

The Global Environment Facility (GEF) project for the “Development and Sustainable Management Mechanism for POPs in the Caribbean” is an initiative born from obligations risen in the Stockholm Convention. Its objective is that the Caribbean Countries implement inventories for Persistent Organic Pollutant (POP) chemicals, establish management mechanisms for demonstration sites, train personnel, and promote new national programs and regulations to assist the countries to meet their commitments and obligations under the Convention. 

Eight Caribbean nations, all parties to the Stockholm Convention, participated in this mission. These are Antigua and Barbuda, Barbados, Belize, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname, and Trinidad and Tobago. Under the initiative, all of the countries inventoried their POP chemicals, including the allegedly most dangerous Dichlorodiphenyltrichloroethane (DDT) and Polychlorinated biphenyls PCB. This initiative is leading other countries to eliminate PCBs from their territories.  

Some other of the key results of this project are: 

• Standard Operating Procedures stated for complying inspectors 

• Alertness-raising plans and a communications toolkit  

• A local lab with competencies to analyze POPs  

• Preliminary evaluations and risk calculations of highly polluted sites 

• Evaluations and references for lab kits and proficiency building 

• The possibility of implementing waste differentiation in some countries would contribute to limiting the generation of POPs by landfill fires  

The project was formally closed on 3 October 2022, but it led the way to other initiatives such as the ISLANDS programme, implemented by the United Nations Environment Program (UNEP) and funded by the Global Environment Facility (GEF). Its total funding is 47,041,860 USD. 

South Africa has adopted a modified version of the United Nations' Globally Harmonized System (GHS) for classifying and labeling chemicals in its industrial sector.

The Regulation comes into force on 29 September 2022. Companies have 18 months to meet the new requirements. From September 2022 onwards, manufacturers and importers of hazardous chemicals will be required to comply with the requisites silhouetted in the Regulation of Hazardous Chemical agents (RHCA)

On 29 March 2021, the Department of Labor published a regulation that is part of South Africa's umbrella legislation on worker safety—the Occupational Health and Safety Act 1995. The update to this law comes as its twentieth-anniversary approaches.

The GHS establishes requirements for classifying and labeling chemicals, including providing safety data sheets (SDSs) to accompany each shipment of a chemical. However, it does not apply in cases where the hazardous properties are less than those classified under section 4 of Schedule 1

The UN Globally Harmonized System Revision 8, South Africa's firsthand regulation that oversees GHS, is the ground rule for the Regulation of Hazardous Chemical agents. This regulation aligns with the UN Globally Harmonized System Revision 8.

It also requires employers to:

• Train all employees on properly using hazardous chemicals and safety practices, comprehending conditioning them to understand GHS labels, signs, and SDSs.
• Furnish the applicable personal protective equipment (PPE) to employees
• Perform air monitoring to check for exposure to substances in the workplace, ensuring that they don't exceed a specified threshold.

The GHS only details requirements for the industrial sector. However, South African departments responsible for agriculture, transport, and consumer health have announced that they will also implement it in those areas.

Violating the regulation is an offense that can lead to imprisonment or fines.

Nonetheless, the regulation does not require the classification of certain types of hazardous materials:

• Explosives – all categories,
• Extremely toxic (oral, dermal contact, inhalation), category 5
• Skin irritation, category 3
• Eye damage/eye irritation, category 2B
• Hazardous to the aquatic environment short-term (acute), category 2 and 3
• Category 3 and category 4 substances that are dangerous to the environment if allowed to enter water supplies

In October 2022 the National Environment Agency (NEA) of Singapore presented a list of 26 chemicals and chemical groups it proposes to control as hazardous substances under the Environmental Protection and Management Act (EPMA) and the Environmental Protection and Management (Hazardous Substances) (EPM(HS)) Regulations. Previously, these 26 substances have been regulated by Singapore Customs under the Chemical Weapons (Prohibition) Act (CWPA) and Chemical Weapons (Prohibition) Regulations (CWPR). However, the NEA intends to strengthen the regulatory controls over the import, export, manufacture, offer for sale, transport, purchase, storage and/or use of these chemicals to ensure that they are managed in an environmentally sound manner.

The presentation comes after a three-week public consultation that took place during summer 2022. The respondents were generally supportive of the proposed control of the 26 chemicals as hazardous substances. The NEA intends to announce the regulatory changes formally by December 2022 and the changes are expected to be implemented 6 months later by June 2023.

Stakeholders must possess a valid hazardous substance license or permit to perform the specified activities involving the chemicals proposed to be controlled by June 2023. The licenses and permits will be available from 1 January 2023. Companies that wish to import/export, store, use, and/or supply any hazardous substance controlled under the EPMA must apply for a Hazardous Substance License. Any person that wishes to purchase, store, and/or use any hazardous substance controlled under the EPMA must apply for a Hazardous Substance Permit.

The substances on the list include neurotoxins such as Sarin, Samon, Saxitoxin, and Ricin and other warfare agents such as lewisites but also substances with industrial usage. In order to balance the regulatory burden on the industry with the environmentally sound management of the hazardous substances, the NEA is presently examining the possibility to grant exemptions from regulatory controls when the substances are present in low concentrations or as impurities. Companies may submit data such as safety data sheets and analytical data relevant to the examination to the NEA.

The list of hazardous chemicals proposed to be controlled include some chemical groups such as lewisites and nitrogen mustards. It is therefore more than 26 distinct chemicals that will be controlled as hazardous substances. The NEA will provide a list of the chemicals and their CAS Registry numbers that belong to these groups. As the list will not be complete, companies may consult with the NEA if more information is needed.

During the month of September 2022, the National Environment Agency of Singapore has proposed regulations on hazardous substances on 2 different occasions.

On 23 September 2022 the following three substances/groups of substances were regulated as hazardous substances under the Environmental Protection and Management Act (EPMA) and the Environmental Protection and Management (Hazardous Substances) (EPM(HS)) Regulations.

• decabrominated diphenyl ether (decaBDE)
• pentadecafluorooctanoic acid (PFOA), its salts and PFOA-related compounds
• perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds

Import and export of the compounds has been prohibited, except for specific uses allowed under the Stockholm Convention. From 22 October 2022 DecaBDE and PFOA were adopted into Annex III of the Rotterdam Convention. This signifies that the import and export for specific uses as allowed under the Stockholm Convention is now subject to the Prior Informed Consent (PIC) procedure of the Rotterdam Convention. Therefore, prior approval from the Chemical Control and Management Department (CCMD) must be obtained for every export of these chemicals and their products.

PFHxS (including its salts and PFHxS-related compounds) are listed in Annex A of the Stockholm Convention. The manufacture, import and export of PFHxS, its salts and PFHxS-related compounds, as well as products containing these chemicals, will not be allowed in Singapore from 17 June 2023. Companies that have stocks of the chemicals and/or their products that were imported before 17 June 2023 are allowed to deplete their stocks locally.

On 26 September 2022, just three days after the previous announcement, the NEA publicized that another five chemicals will be controlled as hazardous chemicals under the EPMA and the EPM(HS) Regulations starting on 1 March 2023. The five chemicals are:

• Amitrole
• Nonylphenol and Nonylphenol Ethoxylates
• Iprodione
• Dechlorane Plus
• UV-328

Of these five chemicals, Amitrole, nonylphenol/nonylphenol ethoxylates, and iprodione are listed under the Rotterdam Convention while dechlorane plus and UV-328 are listed under the Stockholm Convention on Persistent Organic Pollutants (POPs).

Companies that manufacture, import, export, or sell these compounds must require a Hazardous Substance License while end-users that purchase, store and use them must obtain a Hazardous Substances Permit. Traders are required to use the appropriate Harmonized System and Product Codes from 1 March 2023 when declaring their import and export. All applications will be processed and approved by the Chemical Control and Management Department (CCMD).