GPC Newsletter Jun-2022

On June 8, 2022, US EPA notified WTO about the National Emission Standards for Hazardous Air Pollutants for Miscellaneous Coating Manufacturing (MCM NESHAP).

The agency currently proposes certain amendments to MCM NESHAP facilities, in accordance with the requirements of the Clean Air Act (CAA). The proposal focuses on inorganic hazardous air pollutant (HAP) standards for process vessels. This will aid the completion of the required technology review, which was originally promulgated on August 14, 2020, and enhance the protection of the environment.

Comment on this proposal is open till August 8, 2022.

About CAA: CAA is a federal law in the U.S. targeted at protecting human health and the environment from polluting emissions. The law requires U.S. EPA to set minimum national standards for the quality of air as well as ensure that the states comply with the set standards.  

The proposed action is the removal of 401 KAR 50:055 section 1(1) and section 1(4) from the Kentucky SIP, following the submission made by the Commonwealth in 2016 requesting the same. You can access the official proposal document here.

On 10 June 2022, the European Commission released a new recommendation updating the definition of nanomaterials that should inform EU legislation on the topic. A deliverable of the EU Chemicals Strategy for Sustainability, this new recommendation updates the definition established in Recommendation 2011/696/EU. Being set out in Commission recommendations, the definitions are not binding, but they orient the application of relevant legislation and can be used in binding rules and regulations.

The new definition clarifies the characteristics of particles composing nanomaterials. While the 2011 Recommendation only defined them in general terms, the new one specifies rules for particles having elongated or plate-like shapes.

The new definition also eliminates a flexibility clause relative to the threshold for the amount of particles under a certain size. In the 2011 Definition, the general rule was that nanomaterials were materials composed of at least 50% of said particles. However, in cases justified on environmental, health, safety or competitiveness grounds, lower thresholds may apply. The possibility of establishing lower thresholds is not included in the new recommendation. This is expected to minimize the potential for divergence between different legal frameworks.

While the definition is not binding, it will orient the development of the legal framework, for instance, in relation to upcoming reviews of general and product-specific chemicals legislation.

On the 15^th of June 2022, the European Commission notified its draft decision to not approve methylene dithiocyanate as an existing active substance to be used in biocidal products of product-type 12. This is in accordance with Regulation (EU) No 528/2012 of the European Parliament and the Council.

This new decision means that biocidal products of product-type 12 containing methylene dithiocyanate are not expected to meet the criteria laid down in Article 5(1) for specific points. It is quite challenging to confirm the minimum purity of the active substance and to set a reference specification for the substance considering applicants’ inability to submit data of an excellent quality to meet data requirements in points 2.7, 2.8, and 4.1.

Point 2.7: Specification of purity of the active substance in g/kg or g/l, as appropriate

Point 2.8: Identity of impurities and additives together with the structural formula and the possible range expressed as g/kg or g/l, as appropriate.

Point 4.1: Analytical methods for the determination of the pure active substance and where appropriate, for relevant degradation products, isomers, and impurities of the active substance and additives.

All these points are of Title II of Annex IIA to Directive 98/8/EC. It is also impossible to confirm that the materials used to conduct ecotoxicological studies cover the presented specifications and to conclude on the impurities’ relevance since there is no ecotoxicological data.

Additionally, an environmental risk assessment identified unacceptable risks and there is no suitable risk mitigation measure to adopt. The proposed date of adoption is September 2022 and entry into force will be 20 days from its publication in the Official Journal of the EU.

According to ECHA, there is a new intention to identify a Substance of Very High Concern (SVHC) from Belgium together with France. The substance of interest is 4,4'-sulphonyldiphenol (i.e. Bisphenol S (BPS), EC 201-250-5, CAS 80-09-1), and the following three aspects are of specific concern:

• Toxic for reproduction (Article 57c)
• Endocrine disrupting properties (Article 57(f) – environment)
• Endocrine disrupting properties (Article 57(f) – human health)

The expected date of SVHC dossier submission is set on August 4, 2022 in cooperation with France, after which the assessment process will be initiated. This is what concerned individuals need to pay close attention to.

As per Laboratory Chemical Safety Summary (LCSS) Datasheet, 4,4'-sulphonyldiphenol is categorized as bearing “irritant” and “health hazard”. It is commonly used in fast-drying epoxy glues, as a reactant in polymer reactions, or as a building block in polyethersulfone and some epoxies. Its comparable estrogen-mimicking effects to Bisphenol A (BPA) do not make it less health-threatening when it is firstly intended to replace BPA, and the use of BPS is now under greater and greater discussion.

According to ECHA, the once selected substance silver-polyethylenimine-chloride, as a new chemical to join in the biocides review programme now needs some new concerned business bodies to continue its approval process.

The original uses applied for this substance are:

• Human hygiene (product-type 1);
• Disinfectants and algaecides not intended for direct application to humans or animals (product-type 2); and
• Fibre, leather, rubber and polymerised materials preservatives 
  (product-type 9).

Biocide Products Regulation is now openly recruiting notifications till May 23, 2023 in order to keep this substance registered in the programme. Concerned individuals and those required to notify should follow up on the updates for a good understanding/convenience of future regulation and compliance issues.

Recently, the opinions of the Committee for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) were made available publicly on the ECHA website for undecafluorohexanoic acid (PFHxA). An initial proposal was made by Germany to set restrictions for undecafluorohexanoic acid (PFHxA) along with its salts and related substances (EC -, CAS -) in 2019.

Some details on the desired scope of restriction include:

• PFHxA shall not be manufactured or placed on the market as substances on their own from the enforcement of such regulation.
• From the enforcement of such regulation, PFHxA shall not be used in the production of, or placed on the market in:
  (a) another substance, as a constituent;
  (b) a mixture;
  (c) an article, in a concentration equal to or above x %.

Concerned individuals should pay close attention to updates following this adoption of the final opinions by the RAC and the SEAC, after which there would be the adoption of the restriction by the European Commission.

Following the proposal of five new Persistent Organic Pollutants (POPs), interested parties are now invited to comment on the draft regarding the respective substances listed below. These substances were proposed for listing as POPs under the Stockholm Convention. 

Parties are invited to review and comment on draft risk management evaluations for:

• Dechlorane Plus (EC -, CAS 2921-88-2); and
• 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)
  (EC 247-384-8, CAS 25973-55-1).

Parties are invited to review and comment on draft risk profiles for:

• Chlorpyrifos (EC 220-864-4, CAS 2921-88-2);
• Chlorinated paraffins with carbon chain lengths in the range C14–17 and chlorination levels ≥ 45 % chlorine by weight (EC -, CAS -); and
• Long chain PFCAs, their salts and related compounds
  (EC -, CAS -).

Relevant comments should be sent by July 19, 2022. Concerned individuals should be attentive to preparation and compliance requirements for future chemical uses that involve the aforementioned substances.

The European Commission on June 1, 2022, announced its proposal to approve didecyldimethylammonium chloride (DDAC) as an active substance for use in biocidal products of product-types 1 and 2. It was proposed under the Biocidal Products Regulation (BPR) and in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council.

DDAC is approved for use in products made for human hygiene and disinfectants and algaecides that are not to be directly applied to humans or animals, product-type one and two respectively.

The proposed date of adoption is August and entry into force will be 20 days after the implementing regulation has been published in the official journal. The proposal is open for public comments until July 30, 2022. As affirmed by the Commission, this is aimed at ensuring that the EU market is harmonized on biocidal products and that human health, and the environment are highly protected.

On June 8, 2022, the European Commission published a proposal on Polyvinyl chloride (PVC) articles that contain lead and lead compounds. The draft proposal amends Annex XVII, specifically entry 63, prohibiting the use of lead and lead compounds in PVC articles.

Overall, PVC articles that contain a concentration of lead equal to or greater than 0.1% of the PVC cannot be placed on the market. However, there are quite some exceptions, some of which apply to PVC-silica separators in lead acid batteries and PVC articles that contain recovered rigid PVC. To qualify for the exemption, the recovered origin of the PVC material must be certified by an independent third party.

This new amendment is aimed at reducing lead releases and human exposure to this toxic metal while protecting human health overall. The proposed date of adoption is the fourth quarter of 2022 while its entry into force will be 20 days from when it is published in the official journal of the EU. Then the restriction on lead stabilisers’ use and placement of PVC articles containing lead on the market will be postponed for two years after its entry into force. Comment on this will close on August 7, 2022.

With the purpose to facilitate the “One substance, one assessment" process, the European Commission plans to review and improve the current way of how chemicals’ required data are gathered and disseminated under different EU laws. This proposal is expected to impact multiple regulations due in the first half of 2023.

This legislative proposal adheres to the Chemical Strategy for Sustainability (CSS), where this action aims at committing the Commission to enhance the information flow of chemical data among EU and national authorities. The current information barriers to data exchange such as intellectual property rights, data exclusivity rules, and regulatory data protection, etc., would be the focus, according to the Commission. Also at the same time, it is one of the main concerns from the industry on how to properly deal with intellectual property and the ‘free-rider’.

Disadvantaged examples of information reuse can be seen from, for instance, ECHA has no legality to reuse copyrighted data on biocidal product authorization for a REACH application authorization, nor to send it to the European Food Safety Authority (EFSA) for approving a pesticide active substance – the data generated is practically far from reusable under different regulatory processes and assessments. 

This upcoming proposal regarding data usage will address topics that include the following:

• Introduction of a data generation mechanism that could help the authorities fill information gaps – it is similar to the verification tool under the EU Transparency Regulation in some way, allowing the commissioning of additional studies in exceptional circumstances and no new data requirements is said to be introduced.  
• Requirements on business operators and laboratories to notify EFSA if they are commissioned to undertake a study – this helps the authorities keep track of new coming data, which shall be stored in an EFSA database.  
• Development of a common data platform.   
• EU repository of health-based limit values – this promotes their reuse and harmonization among risk assessors and managers; and  
• Tools to improve the uptake of academic data – this could include guidance for minimum quality of studies that will help researchers in designing and reporting them, and a search guide to help regulators and industry find and retrieve relevant academic data.  

The proposal is most likely to be formed as an “omnibus regulation” to amend provisions on data flow, dissemination and reuse in individual pieces of chemicals and product legislation. The EU executive will soon launch a call for evidence for the legislative proposal.

As aforementioned, IP concerns remain one big issue for this system-level amendment as it is one of the goals for the EU Commission to open the IP access. Pertinent problems such as data ownership and Intellectual Property (IP) rights are questioned by the industry representatives during the information session. The proposal is directed to where the industry could still be able to claim confidentiality of Confidential Business Information (CBI). As for the data ownership, the tricky part lies in determining the carrier of the cost of data used for multiple assessments yet managing the risks of free-riding to protect property.

To boost the access and reuse procedures of information sharing, the CSS prompts the Commission to establish a common data platform for chemicals. Such platform forms part of the horizontal data proposal, giving the authorities easy access to all legally accessible information, some of which will be made public. The information presented on the platform shows:

• identifiers  
• intrinsic properties  
• presence in articles and use  
• data on emissions   
• data on exposure  
• hazard and risk assessments, and  
• limit values.  

The detailed implementation plan is currently being drafted by ECHA along with other agencies and the Commission, ideally going live in 2025. A technical blueprint, operational steps, and the estimation of the resources needed for building and maintenance of the tool, are expected to be included in the implementation guidelines.

The European Commission plans to put a stop to the REACH restriction procedure for cobalt salts while focusing on setting occupational exposure limits (OELs) for the compound. This decision follows a debate on how best to manage risks for the compounds.  

This concerns five cobalt salts that were already due to become substances under REACH authorization. However, the Commission decided that it will be better and more suitable to restrict them. Therefore, cobalt salts now have a binding OEL under Osh legislation and this will protect workers better than before.

Cobalt salts are used for manufacturing chemicals, batteries, catalysts, biogas, and feed-grade materials. The fourth revision to the carcinogens, mutagens and reprotoxic substances Directive (CMRD) includes the Commission’s obligation to propose a limit value for cobalt and inorganic cobalt compounds latest by December 31, 2024.

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) consults on its opinion regarding the safety of titanium dioxide in toys until July 4, 2022.

Considering the classification of titanium dioxide in the EU as a category 2 carcinogen via inhalation, SCHEER had to evaluate available products to ascertain the level of safety in using the substance in toys and toy materials. The conclusion of their evaluation says toys containing titanium dioxide are considered safe if manufacturers prove that the products contain no ultrafine particles.

Titanium dioxide is a substance used in white pigments and inhalation exposure can occur with products that release particles. Therefore, when ultrafine particles are present in the products, SCHEER suggested that safe use should not be indicated for casting kits, chalks, and powder paint. However, the use of titanium dioxide as a colouring agent for polymers in toys poses no risk since the pigment for such is locked in. But if it is not embedded in polymer, substance release is highly possible.

For finger paints, white colour pencils, lipstick and lip gloss, SCHEER do not affirm them as safe for use for children. The hazard characterization for immunotoxic, genotoxic, and carcinogenic activity is highly uncertain.

The European Commission opens consultation till July 8, 2022, on the exemption of hexavalent chromium usage. According to the proposal, the exemption of the use of hexavalent chromium as an anticorrosion agent in gas absorption heat pumps (GAHPs) will end on December 31, 2026.

This consultation is under Annex III of the Directive on the restriction of hazardous substances (RoHS) in electronic and electrical equipment. The exemption is due to the unavailability of other anticorrosion agents. Also, other heat pumps that are available have less energy efficiency.

The Commission evaluates that with this exemption, about 38g of hexavalent chromium will be used per GAHP and around 1,400 kg would be placed on the market annually.

Generally, some hazardous substances are restricted in Electrical and Electronic Equipment (EEE) under the Directive of RoHS. However, specific, and time-limited exemptions can be granted for substances when requested by stakeholders, as long as the request/substance meets the necessary criteria.

On June 22, 2022, the European Parliament and Council reached an agreement on a proposal by the European Commission to review Annexes IV and V of Regulation (EU) 2019/1021, on persistent organic pollutants (POPs). The allowable limits were discussed and lowered which means tightened global limits for six substance groups and one for the newly listed substance perfluorohexane sulfonic acid (PFHxS). 

The presence of POPs in waste is a barrier to the development of a circular economy – one of the major objectives of the European Green Deal – and the Commission’s proposal sought to introduce limits for new POPs and to tighten acceptable maximums for several POPs that are already in the regulation.

The agreement sets threshold levels of the following limits according to a June 21 Council of Ministers' press release:

• 200mg/kg for polybrominated diphenyl ethers (PBDEs). The new limit will apply five years after the entry into force of the legislation. Until then, the limit is set at 500mg/kg, which will be lowered to 350mg/kg after three years. The current limit is 1,000mg/kg.   
• 1mg/kg for perfluorooctanoic acid (PFOA) and its salts, and 40mg/kg for PFOA-related compounds. 
• 5 microgram (μg) toxic equivalency quotient/kilogram (TEQ/kg) for polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/Fs), with some transitional measures, where the current limit for PCDD/Fs is 15μg/kg. 
• 1mg/kg for PFHxS and its salts and 40mg/kg for PFHxS-related compounds - after the entry into force, these values will be reviewed five years; furthermore, though this substance was not initially included in the Commission’s proposal, it was supplemented during the trialogue procedure, following its listing in the Stockholm Convention on June 9.
• 500mg/kg for hexabromocyclododecane (HBCDD), which will be lowered to 200mg/kg five years after entry into force of the regulation. 
• 500mg/kg for polybrominated diphenyl ethers (PBDEs), which will be lowered to 350mg/kg three years after entry into force of the regulation, with another reduction to 200mg/kg after five years, and  
• 1,500mg/kg for short-chain chlorinated paraffins (SCCPs), with a review clause five years after the entry into force.   

In May, Parliament voted for stricter limits to accelerate the transition towards a circular economy. It also proposed that the Commission would consider amendments to EU waste legislation clarifying that waste containing POPs above their allowed concentration limits is hazardous waste.

Legislation proposals need the agreement of both Parliament and Council to become law. After having held negotiations, both institutions have reached an informal agreement. It includes some new POPs in the regulation (including some not initially proposed by the Commission) and updates the concentration limits for others. The agreed text is a compromise between the high ambition of Parliament and the demands for higher limits and slower timelines put forward by the Council.

Additionally, the amendments will require the Commission to assess the convenience of amending waste law in line with Parliament’s proposal.

While an informal agreement has been reached, this will not yet become law. Both the Parliament and the Council will now launch formal proceedings to adopt the agreed text, which will enter into force once both institutions have endorsed it. A final vote is scheduled in the European Parliament this autumn to decide on the provisional agreement.

Consolidated versions of UK REACH and Classification, Labelling and Packaging (CLP) legislation were published, including the incorporation of amendments made to EU regulations covering post-Brexit national laws. The concern about the effectiveness brought by consolidated texts used in legislation prompted the new versions of legislation release.

To increase the legislation readability for different stakeholders, the “re-organized" UK REACH text is updated by the National Archives on the UK government legislation website. This regulation entered into force on January 1, 2021, compiling five Statutory Instruments (SI) that amends the EU REACH regulation. The updated version successfully merged several amendments into a single piece of legislation.

The newly published text on April 28, 2022, is expected to make it more accessible and available for concerned readers to check the regulation without any required consultation. In a similar fashion, GB CLP and the British cosmetics law, which referred to the EU Regulation for cosmetics products, also have their consolidated texts published.

On June 14, 2022, the United Kingdom’s Secretary of State implemented Statutory Instruments (SIs) which impose the ban on some chemicals in cosmetics and toys. This is in accordance with the EU decision and based on the assessments done by the scientific advisory body that was set up after Brexit.

The new SIs adds some carcinogenic, mutagenic, or reproductive toxicants (CMRs) to Annex II (the list of prohibited substances in cosmetic products) of the cosmetic regulation in the UK. Deoxyarbutin is banned and salicylic acid is added to Annex III of the cosmetics regulation, although restricting its uses to being used as a preservative at the following concentrations:

• Maximum 3% in rinse-off cosmetics
• Maximum 0.5% in body lotion, eye shadow, mascara, eyeliner, lipstick, and roll-on deodorant
• Maximum 2% in other products

The amendment also limits the use of aniline and formaldehyde in toys meant for children under 36 months and other toys that might get placed in the mouth. The rule regarding salicylic, aniline, formaldehyde, and deoxyarbutin and salicylic acid in cosmetics are expected to come into force on December 15, 2022. While other rules in the SIs will enter into force on October 15, 2022.

The Ministry of Environment, Urbanization and Climate Change of Turkey has developed a new website to search for information regarding the inventory of chemicals called Chemicals Data System (KIMVES). While the system resembles the substance search features of ECHA’s website, only the data regarding CLP notification is currently available.

Users can search substances by name, CAS number or EC number and view the notified classification and labeling information provided by the manufacturers or importers of the substance. Information such as how many companies have notified in a specific classification or non-classification group, and how many different categories of companies have notified for the specific substance is available on the system.

It has been a question in the previous years whether the Ministry would publish any information regarding the notifications and registrations under KKDIK and CLP regulations like ECHA does, and this website seems to be the answer to such questions. Although currently, only CLP notification information is available, there hasn’t been any mention in the announcement about what other data might be published in this system and if it’s only limited to CLP notification or not.

The system is only accessible from Turkey, however, it is expected to be accessible worldwide shortly. You can check the website out yourself from the link here: https://kimves.cevre.gov.tr/KIMVES

On May 20, 2022, the Indian Ministry of Environment, Forest, and Climate Change released a new regulation draft that will replace the current E-Waste (Management) Rules, 2016. In addition to information technology and telecommunications equipment and consumer electrical equipment, the target goods now include large and small electrical equipment, electrical tools, and medical equipment. Furthermore, the collecting goal (recycling target), which is one of the producers' responsibilities, will be partially offset by the purchase of EPR certificates, and environmental penalties will be imposed if the standards are not met. For FY2024  onwards, the recycling target has been set at 80%, and EPR certificate transactions and yearly report submissions are implemented and maintained through an online portal supplied by the Central Pollution Control Board (CPCB). Note that the Producer Responsibility Organization (PRO) provisions have been removed. The plan is open for public comment for 60 days, and no implementation date has been set.

Target products 

• Information technology and telecommunication equipment [Item code: ITEW 1 to 25]
• Consumer Electrical and Electronics and Photovoltaic Panels [Item code: CEEW1-18]: Screens, monitors, video cameras, video recorders, audio amplifiers, solar panels, etc.
• Large and Small Electrical and Electronic Equipment [Item code: LSEEW 1-29]: Large cooling appliances, freezers, clothes dryers, dishwashers, electric cookers, electric stoves, electric hot plates, electric fans, vacuum cleaners, irons, smoke detectors, thermostats, etc.
• Electrical and Electronic Tools (With the exception of large- Scale Stationary Industrial Tools) [Item code: EETW 1-8]: Drills, saws, sewing machines, tools for mowing or other gardening activities, tools for welding, soldering, or similar use, etc.
• Toys, Leisure, and Sports Equipment [Item code: EETW 9-14]: Hand-held video games consoles, video games, sports equipment with electric or electronic components, Computers for biking, diving, running, rowing, etc.
• Medical Devices (except for all implanted and infected products) [Item code: MDW 1-10]: Radiotherapy equipment, cardiology equipment, dialysis equipment, pulmonary ventilators, laboratory equipment for in vitro diagnosis, analysers, MRI & ultrasound equipment, etc.

EPR certificate transactions (Article 20): A producer can buy EPR certificates up to the amount of their current year's EPR responsibility plus any residual liability from previous years plus 10% of the current year's liability. The webpage will provide information on the EPR certificate's availability, requirements, and other data. At the time of filing quarterly returns, all transactions must be recorded and filed on the internet portal by the producers/recyclers.

Environmental Compensation (Article 28):

Environmental compensation must be paid if the regulations are broken. Payment of environmental compensation does not relieve producers of their EPR obligations under these rules. The unpaid EPR obligation for a given year will be carried forward to the following year, and so on, for a maximum of three years. If the EPR duty gap is resolved within one year, 85 percent of the imposed environmental compensation will be refunded to the producers. If the EPR obligation shortfall is addressed after two years, 60 percent of the environment compensation levied will be returned; if the shortfall is addressed after three years, 30 percent of the environment compensation levied will be returned; and if the shortfall is addressed after four years, no environmental compensation will be returned to producer. The CPCB will draft standards for environmental compensation separately.

Recycling targets (Schedules III and III (A)):

Schedule III:

Note: The importers of used electrical and electronic equipment will have 100% EPR obligation for the imported material after end of life, if not re-exported.

Schedule III (A): Extended Producer Responsibility targets for producers, who have started sales operations recently, i.e., number of years of sales operations is less than average life of their products mentioned in the guidelines issued by Central Pollution Control Board from time to time.

A draft standard was issued by the Bureau of Indian Standards (BIS) on May 6, 2022, for tooth whitening and bleaching products. The authorities invite comments till July 5, 2022. 

The standard prescribes requirements and test methods for external tooth whitening and bleaching products, especially for direct, professional use on the outer surfaces of the teeth. Under the regulation of this draft, caution marks are required on the packaging of tooth bleaching products applicable not to be used on a person under the age of 18 and to be sold only to dental practitioners.

For other requirements, please refer to the table below.

Page Industries, an Indian textiles firm, has established a restricted substances list (RSL) as part of its chemical management strategy, which will be enforced by enterprises throughout its supply chain.

According to the corporation, it was published in May and will go into effect in January of the following year. Throughout the fiscal years (FY) 2022, 2023, and 2024, the RSL will be rolled out and monitored along the supply chain in three phases.

The company did not disclose any additional information on this, but it did state that by March 31, 2025, it hopes to have eradicated all items on the RSL from its supply chain.

It stated that hazardous dyes have already been replaced in its in-house manufacturing, and that it plans to phase out per- and polyfluoroalkyl substances (PFASs) from the supply chain by 2024. It also intends to phase out bisphenols and alkylphenol ethoxylates (APEOs), although no deadline has been set.

Implementing the RSL

The Zero Discharge of Hazardous Chemicals Manufacturing RSL (ZDHC MRSL) was utilised as a starting point for the RSL Page Industries' own list. This was developed by the Roadmap to Zero Programme, a non-profit organisation, and it covers chemicals that are prohibited from being used at facilities that process textiles and footwear rather than products.

The RSL implementation process is built on assuring the right approach at every stage by using ZDHC MRSL compliant inputs and implementing the best chemical management practises to ensure that the chemicals are selected, stored, transported, and used appropriately.

Page Industries has hired BluWin, a service provider, to oversee the RSL's implementation. Through capability building, due diligence testing, audits, and other methods, the company, which promotes sustainability, will verify all supply chains for RSL chemicals.

India holds a public consultation on a draft standard for carbon tetrachloride, which is widely used as a solvent and diluent. The deadline is June 28.

The chemical is also used to make chlorofluoromethane refrigerants, as well as grain fumigants, fire extinguishing mixtures, and moth control.

If approved, this would be the third version of Indian Standard (IS) 718, which was published by the Bureau of Indian Standards (BIS) in April. The draft lays forth the requirements, sampling techniques, and testing procedures for carbon tetrachloride. Because carbon disulphide (CS₂) is no longer utilised, it has been removed from the requirements.

Given the BIS's findings that carbon tetrachloride is one of the most hazardous solvents, all handling must adhere to a variety of different Indian regulations, including IS 5311:1969, the substance's code of safety.

The proposed standard says that it must be chlorine-free, and it must be used in accordance with the following guidelines:

• Maximum non-volatile matter content of 0.002 percent by mass.
• maximum moisture content of 0.01 percent by mass and
• maximum methyl chloride, methylene chloride, and chloroform content of 0.025 percent by mass – used alone or in combination.

It also advises against storing in plain steel or cast-iron drums, preferring galvanised or epoxy-lined mild steel containers or high-density polyethylene (HDPE) drums. The following information must be written on these:

• name of the material.
• name of the producer and, if applicable, its recognised trademark.
• month and year of manufacture.
• lot or batch number.
• net weight and
• any additional legal requirements

If the draft is accepted, products that meet the requirements will be certified by the BIS and labelled with the conformity mark.

The Ministry of Industry and Information Technology (MIIT) in China made an announcement explaining China’s plan to make stronger its restriction of hazardous substances in electrical and electronic products under its RoHS-like regulation (RoHS2) within the next three years.

China plans to add four phthalates to the scope RoHS2 covers. These four phthalates are DEHP, BBP, DBP, and DIBP. China proposes adding four phthalates to RoHS2 and to this effect, the ministry will start revising the requirements of GBT 26572-2011 on restricted substances and their concentration limits in electrical and electronic products. The revision will start in July 2022 all through to November set as the deadline to complete the revision.

Compliance with regulations for these substances means that companies must label the products that contain the phthalates, and the substances must not exceed the concentration limits. Products also have to be labelled according to the marking standard SJ/T11364-2014 which specifically explains the marking requirements for hazardous substances in electrical and electronic products, recyclability and the environmental protection use period. Seeing as a consultation opened on March 15 and closed on March 25, 2022, a significant change is expected regarding the addition of the four phthalates. A revised version of this standard is expected to be published in November 2022. While waiting for this new revision to be published in November 2022, the MIIT has started to draft a policy document to widen RoHS2 substances control to include the new addition, and there will most likely be a 180-day transition period after its publication.

Following the “One enterprise, one chemical product, and one QR code” principle, China’s new Hazardous Chemical Registration Comprehensive Service System was launched on February 16, 2022. It supports registry of hazardous chemicals with the automatic generation of QR codes – the Hazardous Chemical Safety Information Codes.

The original chemical management plan turned out to be overly ambitious after its launching, seeing the difficulties in production and supply chain paralysis which resulted from COVID-19 as well as the insufficient supports given from the legislation. The Guangdong pilot project that started on October 1, 2021, has delivered promising results. It mandated Hazchem Codes on labels, packaging, containers, and vehicles before hazardous chemicals leave the factory or warehouse in Guangdong, and the concerned authorities is planning to expand this project to involve more cities at an even larger scale.

For the time being, information supplementation in the new system gains more focus. There are more entries on information about the enterprise and chemicals that have to be filled out in the new system. For example, the identification number (passport number) of the legal person of the enterprise, hazard identification, classification report, dangerous goods classes, storage methods, and storage locations of chemicals, etc.

The local registration offices of different provinces are urging enterprises registered in the old system to supplement such information, where the deadlines are set respectively. The QR code cannot be generated until the registration information is complete, which makes information supplementation in the new system a necessary step for a smooth roll-out of this QR code policy. Currently, no penalty is imposed for failing to supplement the information in time; however, it is highly recommended for the enterprises to respond to the suggestion from their local registration offices.

Despite the high engagement with the national-level promotion of legislation, more time is still needed to finalize the supporting documents. For instance, GB 15258-2009 General Rules for Preparation of Precautionary Label for Chemicals is planned to be revised to incorporate QR code requirements in 2022. As for the draft of the Law of the People’s Republic of China on Safety of Hazardous Chemicals, it aims at establishing a hazardous chemicals information management system and implementing electronic identification as well as the whole life cycle information management of hazardous chemicals. All to be ready for the first reading at the 2022 Legislative Work Plan of the NPC Standing Committee.

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the results of hazard review of chemical substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH).

The draft amendment mainly proposes revisions including:

• Notification of the results of hazard review of registered chemical substances
• Revision of 15 notified chemical substances by adding additional information and correcting wrong information
• Notification of information on classified substances: the name of chemical substances, CAS no., toxic substance designation, main hazard, classification and labeling, etc

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

The deadline for this consultation is June 20th, 2022.

Thailand published some new requirements regarding Food Contact Materials (FCMs) which will enter into force on January 3, 2023. The Thai Industrial Standards Institute (TISI) published these five mandatory standards in the Royal Gazette on April 8, 2022 to  replace some previous voluntary standards as described below:

• Plastic utensils for food part 1 – polyethylene, polpropylene, polystyrene, poly (ethlene terephthalate), poly (vinyl alcohol) and poly (methyl pentene) – TIS 655 Part 1-2553 (2010) 
• Plastic utensils for food part 2 – poly (vinyl chloride) polycarbonate polyamide and poly (methylmethacrylate) – TIS 655 Part 2-2554 (2011) 
• Plastic utensils for food part 3 – acrylonitrile-butadiene-styrene and styrene-acrylonitrile – TIS 655 part 3-2554 (2011) 
• Plastic food containers for microwave oven part 1 – for reheating – TIS 2493 Part 1-2554 (2011) and 
• Plastic food containers for microwave part 2 – for single reheating –TIS 2493 Part 2-2556 (2013). 

Details on the types of plastics permitted in the FCMs utensils and containers are provided in all five standards, and they have as well specified migration limits for ingredients used. The date of entry is the deadline for concerned companies to ensure the products’ compliance with the new standards. A product conformity assessment process is necessary, after which the conformity mark shall be placed on labels and packaging, once certified.

Without a conformity mark, the products will be banned from the market introduction and/or importation to Thailand. Fabricated marks – namely, products with marks without a legally approved conformity assessment are considered non-compliant and liable to penalties.

Japanese standards on chemical classification, labelling and safety data sheets (SDSs), JIS Z 7252 and JIS Z 7253, have been aligned with the Globally Harmonized System (GHS) Rev.6.Until May, 24, 2022, chemical suppliers were given the time to arrange and update relevant SDSs and labels to adapt to new requirements. GHS labels and SDSs are mandatory for the chemicals regulated by the three main clauses for chemicals in Japan, that is, the Industrial Safety and Health Law (ISHL), the Pollutant Release and Transfer Register (PRTR) Law and the Poisonous and Deleterious Substances Control Law (PDSCL).

Whereas for other chemicals falling outside these regulatory categories, implementation of GHS classification and hazard communication elements is encouraged. Despite their different applicable scopes, these laws overall convey the same standards on the criteria for classification, labeling and SDS preparation for:

• JIS Z 7252:2019 Classification of chemicals based on GHS of Classification and Labelling of Chemicals, and
• JIS Z 7253:2019 Hazard Communication of Chemicals Based on GHS - Labelling and Safety Data Sheet.

The notable revision after these standards were published in May 2019, was the incorporation of an additional hazard class for desensitized explosives with new H statements, H206 to H208, into the standards. A sub-hazard category (i.e., Pyrophoric gas) was also introduced for flammable gases.

Noteworthily, the 3-year grace period expired on May 24, 2022. Therefore, individuals have to follow up with the new requirements to ensure compliance within the industry.

On the 30^th of May 2022, Australia published some evaluations under section 78 of the Industrial Chemicals Act 2019. The draft versions of these evaluations were initially published for public consultation and closed on the 28^th of March 2022.

The concerned chemicals and new evaluations are as follows:

From June 1-3, 2022, the Latin America Regulatory Cooperation Forum (LARCF) hosted a two-day event to exchange information and progress toward sound management of chemicals across the region. LARCF has been front running with events and cooperation partnerships in Latin America, bringing together more than 100 regional industry members.

In the Virtual Annual Meeting, attendees learned more about the steps, challenges, and implementation of diverse instruments across several countries. To summarize a few, the meeting addressed the following:

• Colombia's fresh chemical framework implementation and the support from the National Industry Association (ANDI) in the development of chemical policy.
• Chile’s recent chemical regulation and chemical classification process aligned with their policy implementation.
• Insights from the chemical management in Asia-Pacific Economic Cooperation (APEC), including a regulatory convergence proposal.
• Peru’s chemical proposal has been updated and this indicates that it will soon be submitted to the executive power and there will be additional chemical efforts regarding international chemical instruments implementation.
• Past and future work performed by the Intergovernmental Network on Chemicals and Waste for Latin America and the Caribbean, aligned with United Nations Environment Programme support.
• Further capacity building and activities performed together with Strategic Approach to International Chemicals Management (SAICAM) and United Nations Institute for Training and Research (UNITAR) – tools, documents, and training programmes.

Latin American countries are aware of the importance of chemical instruments to trade, environment, and safety. Such meetings are crucial to strengthening management implementation and cooperation in the region.

It was also announced that LARCF plans to publish guidelines for chemical prioritization later this year, besides the Roadmap for Sound Management of Chemicals and Chemical Inventory Guidelines published in April 2021 and March 2022, respectively.

In May 2022, the Brazilian National Health Surveillance Agency (ANVISA) modified the procedures for low-risk sanitizers issuing Resolution of the Collegiate Board (Resolução da Diretoria Colegiada -RDC) 692 . The change is intended to facilitate the process and reduce paperwork.

Referred to as "risk 1" sanitizers, the low-risk sanitizers are now required to notify the agency exclusively through the online notification system. In addition, risk 1 sanitizers are exempted from registration, and their notification is exempted from revalidation. The declaration of interest for continued commercialization lasts ten years.

Accordingly, "Risk 2" sanitizers had their registry validity extended for a similar period. The validity period of registration granted before is October 16, 2019, which is accordingly extended to 10 years, counted from the granting of the registration.

Risk 1 sanitizers differ from risk 2 sanitizers in the absence of corrosive characteristics, antimicrobial activity, disinfestation action, and they are not based on viable microorganisms, while these attributes are used for risk 2 sanitizers classification. In addition, risk 1 sanitizers may not contain inorganic acids [Hydrofluoric (HF), Nitric (HNO3), Sulfuric (H2SO4)] in their formulation or release related salts during product usage.

Accordingly, ANVISA updated the list of permitted preservative substances for the formulation of sanitizing products. The Normative Instruction (Instrução Normativa – IN) 153/2022 displays 46 substances by chemical name, CAS number, and maximum permitted concentration limit.

On June 10, 2022, the Organisation for Economic Cooperation and Development (OECD) approved specific roadmaps for States accession, after the first steps for accession discussions in January 2022. From the original list, Brazil, Bulgaria, Croatia, Peru, and Romania were accepted; Argentina, unfortunately, was not accepted.

The roadmap has specificities for each country's ascension and establishes the process and defines the conditions for such. OECD will conduct technical examinations in areas such as trade, investment, anti-corruption, environmental information, and SME & Entrepreneurship.

For Brazil and Peru, the acceptance came as a recognition of their efforts to adhere to and align the countries’ standards with international best practices. Brazil confirms 112 adhered instruments out of 257 requested by the Organization, while Peru ratified its continuing endeavors.

What does it mean for chemicals?

While Latin American countries have been progressing towards sound management of chemicals, OECD has been a relevant influence in the region. Four Latin American countries – Chile, Costa Rica, Colombia, and Mexico – are already part of the organization, and not by coincidence, Chile and Colombia are the only ones to have recently enacted a chemical framework.

Even when considering non-OECD members, countries in close relation with the Organization are ahead. This is the case, for example, of Argentina, Brazil, and Peru, whereas all these countries have at least a draft of chemical management regulations that have been accessed by their respective legislators.

In relation to chemicals, OECD requires members states to comply with core principles, which are highlighted in the following examples:

• Acceptance of the Mutual Acceptance of Data and in accordance with the Principles of Good Laboratory Practice and Test Guidelines
• Harmonization of chemical and safety policies
• Implementation of a systematic and comprehensive industrial chemicals management system

Consultation on the proposed amendments to the Vietnamese rules on their restricted chemical licences, labelling, management logbooks, and annual reporting deadlines is currently ongoing until June 26, 2022. The approved changes would accordingly be applied to the existing chemicals law in Vietnam, Decree 113/2017/ND-CP.

The Draft Circular published on April 28, 2022, by the Ministry of Industry and Trade (MoIT) mainly proposes revision on several of the requirements stated in Circular No. 32/2017/TT-BCT Providing Guidelines for Implementation of the Law on Chemicals and the Decree No 113/2017/ND-CP.A key change seen in the proposals is that for hazardous chemicals called out in the chemicals law, companies concerned are obliged to prepare Safety Data Sheets (SDSs) before chemicals use and/or circulation in the market. To fulfill this requirement means to have information prepared according to Appendix 9 in the instructions.

It also proposes an amendment to the submission deadline for industrial annual reports which is to be altered from January 15 to February 15 for those activities relevant to chemicals. This includes where the dangerous chemical ingredients with a maximum concentration of 0.1% for mixtures would also have to be listed. Noteworthily, this does not apply to exempted chemicals in Annex II (i.e. the list of restricted chemicals) of the chemical law. Another highlight of the draft is the stipulation of the expiry date for the issuance or renewal of manufacturing or trade licences for restricted chemicals, which would be modified as “5 years from the issue date”. For the case of re-issued licences, the original expiry date will apply.

At the same time, guidance on management logbook preparations for manufacture, trade, and use of industrial precursors is brought up. Requests for chemical labelling to comply with effective regulations for goods as well as warning signs for dangerous chemicals transportation to comply with rules are also seen in the draft. The current progress of the Draft Circular could serve as a reminder to either the manufacturers or the importers of restricted chemicals that, upon the approval of the draft, compliance with the latest amendments would be crucially necessary.

On May 31, 2022, the Colombian Ministry of Commerce (MINCIT) officially launched the Online Portal for Chemical Substances for Industrial Use. The Online Portal will be the main instrument for the industry to submit chemical information to the authorities, as foreseen in the recently approved chemical framework (Decree 1630/2021).

Decree 1630 is Colombia's most recent and comprehensive chemical policy, enacted in November 2021. The creation of a National Chemical Inventory is among the future instruments intended to improve chemical management. The Inventory, in turn, will be populated with existing chemicals and their respective characteristics.

Manufacturers and importers dealing with chemicals identified as hazardous by the GHS in amounts over 100 kg per annum will be required to submit data to the Online Portal, referred to as the notification process. Necessary information comprises the manufacturer/importer details, substance name, CAS number, hazard classification, uses, and specific amounts. The deadline for chemical notifications is May 30, 2025.

In this first notification deadline, manufacturers/importers shall submit information related to chemicals and amounts for the years 2022, 2023, and 2024. From 2025, manufacturers/importers will be required to submit information for the previous fiscal year, i.e., chemical amounts produced or imported into Colombia. This means that manufacturers/importers must submit updates every once a year, where the notification for 2026 is related to the amount of produced or imported chemicals in 2025.

Further details about the Online Portal and the notification process are available once the business registers into the notification portal. Unfortunately, the notification portal is currently only accessible for those businesses with tax identification numbers in Colombia.

On 6 July 2022 Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has restricted the use of three substances in cosmetics, banned one substance and allowed the use of three others under the guidelines of the country for Control of Cosmetic Products.

The Circular states that restrictions were put on the use of three chemical substances in cosmetics. It includes climbazole, dihydroxyacetone, and titanium dioxide and will take effect on 11 November 2023. Furthermore, Deoxyarbutin was banned and the ban will take effect on 11 May 2023. The Circular allows the use of the two preservatives climbazole and hydroxyethyl phenyl butanone. The update aligns with changes incorporated in the Asean Cosmetic Directive (ACD) during the 35th Asean Cosmetic Committee virtual meeting held on 25-27 May 2022. 

Restricted Substances:

• Climbazole:

IUPAC name: 1-(4-chlorophenoxy)-1(imidazole-1-yl)-3-3dimethylbutan-2-one

Used in: Rinse off anti-dandruff shampoo (maximum concentration 2 %), Rinse off anti-dandruff conditioner (maximum concentration 0.5 %) as a biocide

Amendment takes effect on: 11 November 2023

• Dihydroxyacetone:

IUPAC Name: 1,3-dihydroxy-2-propanone

Used in: Non-oxidative hair dye products (maximum concentration 6.5 %), self-tanning products (maximum concentration 10 %),

Dyeing eyelashes and eyebrows (Banned)

Amendment takes effect on: 11 November 2023

• Titanium Dioxide:

Used in: Sunscreen and UV blocking pigments, The use of the pigmentary form of the substance is restricted to 25 % in face products containing loose powder, and 1.4 % in hair aerosol spray products intended for use by general users. For products aimed at professional users, the limit is 1.1 %. Manufacturers cannot use the substance in other applications that may lead to lung exposure or inhalation.

Amendment takes effect on: 11 May 2024

Banned Substance:

• Deoxyarbutin, tetrahydropyranyloxy phenol:

IUPAC Name: 4-[(tetrahydro-2H-pyran-2-yl)oxy]phenol

Used in: Skin lightening agents used in cosmetics

Amendment takes effect on:  11 May 2023

Allowed use of Preservatives:

• Climbazole:

IUPAC Name: 1-(4-chlorophenoxy)-1(imidazole-1-yl)-3-3dimethylbutan-2-one

Used in: Hair lotions and face creams (maximum concentration 0.2%) and rinse-off shampoo and hair conditioner (maximum concentration 0.5 %).

Amendment takes effect on:  11 November 2023

• Hydroxyethylphenyl butanone:

IUPAC Name: 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one

Used in: Cosmetics (maximum concentration 0.7 %)

 All the companies which manufacture, sell, distribute, and import cosmetics must comply with all the requirements needed under the guidelines and should notify Malaysia’s National Pharmaceutical Regulatory Agency (NPRA).

Two Non-Governmental Organizations conducted tests on toys and other consumer products found on sale in African and Arab countries. A report published on May 24, 2022, shows that the tests discovered about 20% of the sampled products contain high levels of toxic flame retardant chemicals and brominated dioxins, including substances that are banned under international agreements.

The concerned products that tested positive for the highest concentrations of brominated flame retardants (BFRs), brominated dioxins, and other toxic chemicals include:

1. Toys; a toy car and two other toys purchased in Jordan and a toy purchased in Ethiopia
2. A kitchen knife, purchased in Tunisia
3. Office supply: a cup for pencils purchased in Tanzania
4. Hair accessories; two purchased in Morocco and three purchased in Kenya

According to the Association de l'EducationEnvironnementale pour les Futures Générations (AEEFG), studies have shown that these chemicals cause cancer, infertility, and harm to children’s brain development among other serious health problems. Knowing that plastics can destroy the circular economy, there is a need for stricter POPs limits in the world. Some other tests were also done, all of which confirmed the existence of toxic substances in the products. All the tested products are made from recycled plastics and are present in 11 countries across the two regions. The 11 countries include Burkina Faso, Cameroon, Egypt, Ethiopia, Gabon, Jordan, Kenya, Morocco, Syria, Tanzania, and Tunisia.

There is currently no limit for BFRs content in products and waste in African and Arab countries. There is however an urgent need to set a regulating limit in place.

IPEN and Arnika together with eleven other organizations produced this study and their recommendations include:

1. To apply stricter low POPs Content Levels (LPCLs) to waste; this will prevent the flow of e-waste and End-of-Life Vehicles (ELVs) plastic into the new products that are made from recycled plastics.
2. To ban e-waste and ELVs plastics that contain a high level of toxic flame retardants from the recycling chain.
3. To stop listing BFRs as individual substances and make them a class under the Stockholm Convention. Listing them individually will keep putting human health at risk.
4. To add brominated dioxins to the list of unintentionally produced POPs that are regulated by the Stockholm Convention.

On the 10^th of June 2022, Singapore published an addendum proposing the control of chemicals under review by multilateral environmental agreements. The notified measure is expected to enter into force by March 1, 2023.

In February 2022, the National Environment Agency (NEA) of Singapore had notified WTO about their intention to control five new chemicals as Hazardous Substances (HS) and importers/manufacturers/distributors of the five chemicals and products containing the chemicals will have to apply for a HS licence/permit to import, sell, store, export, and use the chemicals.

These five chemicals are identified by the Stockholm and Rotterdam Conventions for review. The identification is as follows:   

These five substances are identified for their potential to cause harm to human health and the environment. The step taken by Singapore to control them is aimed at protecting the environment as well as preparing themselves for their obligation to the Stockholm Convention and Rotterdam Convention. The Stockholm Convention is a global treaty on Persistent Organic Pollutants (POP) while the Rotterdam Convention is a global treaty for the international trade of specific hazardous chemicals.

The Saudi Standards, Metrology and Quality Organization (SASO) published the Technical Regulation for Restriction of Hazardous Substances in Electrical and Electronic Equipment (SASO RoHS) in 2021 to take effect from July 4, 2022. The initial implementation date was January 5, 2022, which was later changed to July 4, when the implementation will now be done in stages.

Although several countries around the world raised concerns about SASO RoHS causing obstacles to trade, Saudi Arabia has set plans requiring conformity assessments under its regulation indicating that the assessments will help raise the quality level of their national industry and also enhance the safety of goods imported to the country. To this effect, the Saudi Arabian government published the assessment procedure guidelines and the documents required for submission by companies.

SASO RoHS is similar to the EU’s Directive on the restriction of hazardous substances (RoHS) in electrical and electronic equipment (EEE).  However, unlike EU RoHS, it stipulates that both domestic manufacturers and importers need to obtain a certificate proving the conformity of their products with the regulation. The certificate must also be from an approved organisation. For suppliers to get certified, they have to provide a test report of the complete product. If not available or possible, they can provide a report for a minimum of three critical parts, which should be selected based on a risk assessment.

In the regulation, there are six categories of EEE that must meet their relevant requirements before they can enter and be placed in the Saudi market. The substances and their limits are:

The categories of EEE covered by the regulation have different enforcement dates that should be noted from now. For electrical home appliances (for small and large appliances), the enforcement date is July 4, 2022, and October 2, 2022, respectively. The regulation regarding Information and communication technology equipment will be enforced from December 31, 2022, and lighting equipment will be enforced from March 31, 2023. For electrical and electronic tools and equipment, enforcement of the regulation will start on June 29, 2023, and September 27, 2023, for games, entertainment devices, and sports equipment. Lastly, the directives for monitoring and control tools will be enforced from December 26, 2023.

Who will be affected?

The regulation, SASO RoHS, applies to manufacturers and importers of household appliances (both small and large), equipment for information communication technology and lighting, monitoring and control tools, and equipment for leisure, recreation, and sport.

Anyone who fails to comply is liable to fines, penalties, and the possibility of complete removal of such products from the market.

Who is exempted?

The exempted products are medical devices, military equipment, large-scale industrial stationary machinery, large-scale fixed installations, and aerospace equipment.