GPC Newsletter Jan-2023

Editors Notes:  

Dear reader, with the new year around, we are proud to share this good news with you: Our new Strategic Partner in 2023 is Chemical Watch!  

Chemical Watch is the leading global provider of independent intelligence and insight for product safety professionals managing chemicals.  

Through our combined industry expertise across sectors and nations, we look forward to new opportunities to share regulatory knowledge with our clients, and to work towards a safer chemical industry. We are excited to explore the regulatory landscape together with Chemical Watch in 2023!  

Moreover, we are honoured to announce that we are the official Knowledge Partner of the Gujarat event series by Regulatory Representatives & Managers Association (RRMA)!   

This event series on 'Chemical Regulatory Obligations and Awareness Program' takes place from 6 - 11 February 2023 across six different cities in Gujarat, India: Vapi, Surat, Ankleshwar, Dahej, Vadodara and Ahmedabad.  


Events planned:  

We are excited to announce that we are hosting our free Cosmetic Product Webinar Series in collaboration with Chemexcil and Regulatory Representatives & Managers Association (RRMA)!  

The webinars will cover Certification of cosmetic products, packaging of cosmetic product requirements, formulating and manufacturing.  

Our kick-off webinar on February 6 is dedicated to the certification for cosmetic products.   



Regulatory News

The Canadian government has unveiled three options for businesses to comply with the country's VOC (Volatile Organic Compounds) limits for household goods. These regulations, which establish concentration limits in around 130 product categories, were adopted in January 2022 and will become effective in 2024 for most products and in 2025 for disinfectants.

However, since some companies might struggle to meet the more stringent limits they can take advantage of alternative compliance paths offered by the government, which include obtaining a temporary permit, a longer-term permit, or participating in a unit trading program.

Temporary permits allow businesses to apply for a two-year permit if they can provide clear and convincing evidence that they cannot meet the VOC limit requirements for technical or economic reasons. The businesses must also present a plan to ensure compliance once the permit expires. This permit can be renewed for another two years, but the request for renewal must be submitted 90 days prior to expiration.

Long-term permits are available for products that exceed VOC concentration limits but result in lower overall VOC emissions than comparable compliant products. Manufacturers are required to disclose the estimated quantities of the product per year and provide evidence that its use results in lower VOC emissions than a compliant product in the same category. These permits are valid for four years and can be renewed 90 days prior to expiry.

Unit trading allows companies to exceed concentration limits for one product by balancing emissions with other products that have lower VOC amounts, or by purchasing compliance units from other companies. The companies must supply information on the products that exceed the limits and a plan to compensate for excess VOCs. Permit holders are mandated to submit an annual report, no later than March 1st, which should include actual quantities in Canada, compliance units used to offset the excess VOCs, and a confirmation of intent to continue manufacturing or importing the product under the permit. If emissions are not balanced for the calendar year, the permit will be revoked.

On 4 January 2023, Health Canada published the finalized version of an update to the Hazardous Products Regulations (HPR). This update was postponed earlier in 2022 because the Canadian government aimed for this update to be more in line with an update of OSHA’s Hazard Communication Standards (HazCom) underway in the US. This update brought the Canadian Globally Harmonized System (GHS) standard to the seventh revised edition of the UN GHS of classification and labeling of chemicals. It is expected that this update will affect companies that are active in the manufacturing of chemicals, plastics, and rubber industries.

 

Some of the changes in this update include:

  • Updating various definitions, including for skin corrosion and irritation, eye irritation and serious eye damage, respiratory and skin sensitisation and more
  • Acquiring a new hazard class list for non-flammable aerosols, including new subcategories for flammable gasses
  • Including a test procedure for oxidizing solids
  • Adjusting the required information on safety data sheets (SDSs)

It is expected that the new and updated HPR will further improve labeling requirements for products using small containers with a volume capacity of 100 ml or less.  Moreover, based on this update, a new physical hazard class for "chemicals under pressure," incorporated from GHS 8 is added to the HPR. This new physical hazard class is believed to bring new products into the scope of the HPR, causing new expenses for suppliers as they need to prepare new labels and SDSs for certain liquids or solids packaged in pressurized containers beside aerosol dispensers.

Manufacturers are expected to implement the changes for their products before 14 December 2025. These changes include product classifications, SDSs, and labels. Furthermore, the Health Canada has announced that they will be publishing further instructions and guidelines on the transition period on the Workplace Hazardous Materials Information System (WHMIS) website: https://whmis.org/.

New York state is preparing to ban the use of PFAS chemicals in manufacturing apparel and clothing. The measure is set to take effect on the final day of 2023.

 Bill (S 6291A/A 7063A) was signed into law that would ban PFAS in clothing by December 31, 2023. The bill was passed by the state legislature last May and officially signed into law on December 30, 2022.

The restrictions come into effect as major companies like Under Armour and certifying organizations like ZDHC agree to phase out the substance class from fabrics.

Companies have until the end of 2023, to comply with the original legislation; but, under the agreement, they will have until:

  • 1 January 2025 to stop selling new common apparel with intentionally added PFASs – except protective work uniforms and heavy-duty outerwear.
  • 1 January 2027, at the latest, to stop selling items containing PFASs over a threshold to be set by the Department of Environmental Conservation (DEC).
  • 1 January 2028 to cease offering new "outdoor apparel for severe wet conditions" containing PFASs that are knowingly added or above a DEC-established amount.

Legislators are also expected to approve language that will ensure retailers won't be held accountable for an apparent violation if they can prove that they relied on a false certificate of compliance from a manufacturer. Violators of this bill will face a maximum $1,000 civil penalty for each day of offence and $2,500 per day for a repeat offence as set by the agreement.

The US Environmental Protection Agency (EPA) has informed the WTO on changes in reporting requirements for per- and polyfluoroalkyl substances (PFAS) and supplier notifications for Chemicals of Special Concern. On 6 December 2022, the WTO released a notification stating: ‘The Environmental Protection Agency (EPA) proposed a rule to add per- and polyfluoroalkyl substances (PFAS) subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA) pursuant to the National Defense Authorization Act for the Fiscal Year 2020 (NDAA) to the list of Lower Thresholds for Chemicals of Special Concern’. The reporting threshold for PFAS is already lower, at 100 pounds. The addition of PFAS to the list of chemicals of special concern will make them subject to the same reporting requirements as other chemicals of special concern. This would eliminate the use of the de minimis exemption and the option to use Form A, and limit the use of range reporting for PFAS. A more complete picture of the discharges and waste management volumes for PFAS will be obtained after eliminating the availability of these burden-reduction reporting options. In addition, the EPA is trying to remove the de minimis exemption from the Supplier Notification Requirements for all the chemicals in the list of special concerns. This step will make it possible to inform consumers who buy mixtures and brand-name items containing such compounds of their presence. 

On 2 December 2022, the US Environmental Protection Agency (EPA) released a notification for chemical substances that are the subject of premanufacture notifications (PMNs) and Microbial Commercial Activity Notices (MCANs).  The EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA). The SNURs mandate that anyone planning to manufacture (defined by legislation to include import) or process any of these chemical substances for an activity that is identified by this rule as a substantial new use, must notify the EPA at least 90 days prior to the start of that activity. The mandatory notice starts EPA's evaluation of the use within the relevant review period, under the conditions of use for that chemical substance. Nobody is permitted to start manufacturing or processing for a significant new use before the EPA has examined the notice, made an appropriate determination on the notice, and has taken the actions that are required by that determination. This new rule will be effective from 31 January 2023. 

On 17 January 2023, the European Chemicals Agency (ECHA) announced that 9 chemicals have been added to the Candidate List of Substances of Very High Concern (SVHC) because of their hazardous properties. This means that the Candidate List now contains 233 entries.

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

Under REACH there are legal obligations when it comes to substances in the Candidate List. Suppliers must give their customers and consumers information if their articles contain more than 0.1 % (weight by weight) of a Candidate List substance. Consumers have the right to ask suppliers whether their products contain SVHCs. Suppliers of substances on the Candidate List, either on their own or in mixtures, have to provide a Safety Data Sheet to their customers.

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

The uses of the nine new entries to the Candidate List are for example in flame retardants, paints and coatings, inks and toners, coating products, plasticisers, and in the manufacture of pulp and paper. The substances are for example very persistent and very bioaccumulative (vPvB), carcinogenic, toxic for reproduction,  or have endocrine disrupting properties. The new entries included on 17 January 2023 are listed below.

 

Substance name

EC number

CAS number

Reason for inclusion

Examples of use

1,1'-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene]

253-692-3

37853-59-1

 

 

Very persistent and very bioaccumulative 
(REACH Article 57 e)

While the substance itself is not registered under REACH, identification as an SVHC can be seen as a measure to avoid future regrettable substitution. 

2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol

201-236-9

79-94-7

Carcinogenic 
(Article 57 a)

As a reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxy coated circuit boards, printed circuit boards, paper and textiles.

4,4'-sulphonyldiphenol

201-250-5

80-09-1

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

In the manufacture of: pulp, paper and paper products, textile, leather or fur and chemicals.

Barium diboron tetraoxide

237-222-4

 

 

13701-59-2

Toxic for reproduction
(Article 57 c)

In paints and coatings.

Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof

-

-

Very persistent and very bioaccumulative (Article 57 e)

As a flame retardant and as a plasticiser for flexible polyvinylchloride and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings and adhesives.

Isobutyl 4-hydroxybenzoate

224-208-8

4247-02-3

Endocrine disrupting properties 
(Article 57 f – human health)

In the manufacture of substances and in the following products: coating products, fillers, putties, plasters, modelling clay and inks and toners.

Melamine

203-615-4

108-78-1

Equivalent level of concern having probable serious effects to human health (Article 57 f – human health); 
Equivalent level of concern having probable serious effects to the environment (Article 57 f – environment)

In polymers and resins, coating products, adhesives and sealants, leather treatment products, laboratory chemicals.

Perfluoroheptanoic acid and its salts

-

-

Toxic for reproduction 
(Article 57 c); Persistent, bioaccumulative and toxic (Article 57 d); 
Very persistent and very bioaccumulative (Article 57 e); Equivalent level of concern having probable serious effects to human health (Article 57 f – human health);
Equivalent level of concern having probable serious effects to the environment (Article 57 f – environment)

While the substance itself is not registered under REACH, identification as an SVHC can be seen as a measure to avoid future regrettable substitution.

reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine

473-390-7

-

Very persistent and very bioaccumulative (Article 57 e)

Used in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites and in manufacturing.

 

A proposal to restrict per- and polyfluoroalkyl substances (PFASs) under the European Union's chemicals regulation, REACH, has been submitted to the European Chemicals Agency (ECHA) by the national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden . 

The detailed proposal will be published by ECHA on February 7th, 2023. This proposal comes after the five authorities identified risks in the manufacture, placement on the market, and use of PFASs that need to be addressed throughout the EU and European Economic Area. ECHA will run the necessary administrative checks before the proposal and supporting documents are made available. 

The next steps include a scientific evaluation by ECHA's scientific committees for Risk Assessment and Socio-Economic Analysis in March 2023, followed by a six-month consultation starting on March 22nd, 2023. The final opinions will be sent to the European Commission and EU Member States for a decision on a potential restriction.  

The Model Regulations address consignment processes, the usage, building, testing, and approval of packing and portable tanks, as well as the categorization of dangerous commodities and their listing (marking, labelling, placarding and documentation). They seek to provide a high degree of safety by preventing incidents involving people, property, and the environment while in transit, while also offering a standardised regulatory framework that may be used globally for national or international transport using any method. 

Recycled plastics are made from plastic that has been cleaned and processed into new packaging from previously used industrial packaging. The particular characteristics of the recycled material used to make new packaging must be guaranteed and routinely documented as part of a quality assurance procedure approved by the appropriate authorities. 

The industry organisations had previously proposed changes to the Model Regulations during a conference in July in order to encourage the use of recycled plastic, including easing limitations on doing so. However, the subcommittee stated that it would prefer to modernise current provisions, therefore the meeting did not approve these ideas.  

At that conference it was advised to co-ordinate efforts with an ISO working group that is examining the requirement for recycled plastics in packaging for dangerous products (ISO 16103:2005). Additionally, a remark in the current definition states that the ISO standard "must be followed." As the present version of the standard is based on experience from 20 years ago and only applies to drums and jerrycans, this has been modified to "may be followed". 

The UN Sub-Committee of Experts on the Transport of Dangerous Goods (SCETDG) met in December and decided to provide the update. It was the result of two proposals, one from Belgium and the other a collaboration between the International Confederation of Plastics Packaging Manufacturers (ICPP) and the Intermediate Bulk Container Associations (ICIBCA). 

According to the current definition, each batch of recycled plastic material has to pass a quality control procedure. The word "batch" is "undefined and it has taken on numerous connotations," according to the ICPP/ICIBCA proposal. It was said that this has an impact on the recycling industry's economic sustainability by raising expenses for lower batch sizes. Therefore, the definition will be changed to specifically state that a batch is "of homogenous composition". 

The update includes a clarification that intermediate bulk containers (IBCs) can be constructed from recycled plastic and will accept plastic from other sources if it complies with specified specifications. 

IBC tanks play a part in providing businesses' products with tough and long-lasting packaging. Its resilience demonstrates its reusability. The function of IBC tanks in circular sustainability implies that intermediate bulk containers can endure use and other circumstances for extended periods of time, so that you do not need to acquire additional lower-quality storage cans or plastics. IBC tanks are manufactured from dependable and sturdy materials. The IBC tanks have the great quality of being reusable. This immense significance is crucial to the circular economy's viability. And among these roles are: 

  • Pollution Elimination 

  • Compactness. 

  • Energy Conservation 

The revision will be included in the Model Regulations' 23rd amended version, which will be released this year and will take effect in January 2025. 

On 23 January 2023 the European Chemicals Agency (ECHA) announced that they will start checking both new registrations and updates to existing registrations of chemicals under REACH against revised requirements recently amended by the European Commission. The amended checks will take effect on 1 May 2023. Since the checks will apply to both new and existing registrations, registrants should prepare for the changes because existing registrations may no longer pass the completeness check.

The changes to the completeness checks concern the following areas:

  • Substance identity: ensuring correct and consistent identification of a substance’s boundary composition and its constituents and additives based on clarifications made to Annex VI.
  • Standard information requirements based on Annexes VII-XI: supporting registrants in reporting information for endpoints concerning mutagenicity, degradation and aquatic toxicity based on Annex VII-XI information requirements. Registrants adding a new weight-of-evidence adaptation will be prompted to provide arguments for the approach in a more structured format.

Registrants are encouraged to use the IUCLID validation assistant to check their registrations before submitting them to ECHA. The new version of IUCLID which will be released at the end of April 2023 will include the amended completeness check rules.

On 16th December 2022, the Ministry of Environment, Urbanization, and Climate Change, Turkey announced that the terminology table with English-Turkish equivalents of terms related to chemicals management regulation has been updated.

 

With the registrations going forward to meet the deadline of December 2023 under KKDIK, this table would be helpful for the preparation and submission of the technical dossiers. It is recommended by the Ministry to use the translations in the terminology table in Chemical Registration Dossiers, Chemical Safety Reports, and Safety Data Sheets prepared by companies and certificated specialists.

 

The deadline for KKDIK registration, 31 December 2023, is not expected to be postponed. We suggest that industry representatives should complete the process as soon as possible since substances not registered after the deadline will not be able to enter the Turkish market.

 

If you want to learn more about this, and the table, please contact GPC.

The directorate of the Revolving Fund of the Ministry of Environment, Urbanization, and Climate Change has published the 2023 KKDIK registration fees.

Compared to 2022, the fees have increased by 121% on average in TL. In 2022, the joint submission fee was lesser than the individual submission. The registration fee currently varies from 130 TL/€7 (for SME companies that jointly register 1-10 tonnage) to 26,700 TL/€ 1346 (for large size companies that individually register 1000+ tonnage substance) depending on the tonnage band, the size of the company, and whether it is a joint or individual submission. This indicates the importance of joint registration for companies. If you haven't pre-registered your substances yet, kindly do, so you can be part of SIEF and also participate in joint registration.

With KKDIK registration deadline, 31 December 2023 approaching, we encourage companies to complete their registration process as soon as possible and not to take the risk of jeopardizing the trade.

If you would like to learn more about 2023 KKDIK registration fees, please contact GPC.

On 20 December 2022 the Indian Department for Promotion of Industry and Internal Trade (DPIIT) issued a notice for bringing 50 products under the 16 categories of mandatory quality control orders (QCOs) by the second quarter of 2023-24. 

According to the notice the QCOS comes into force next year and the items under this order need to be certified as compliant with the standards set by the Bureau of Indian Standards (BIS) and cannot be produced, sold, traded, imported, or stocked unless they are marked by the BIS denoting the quality certification. 

In case of imported goods, the BIS states that orders applicable to domestically produced goods shall apply to imported products and they will be subjected to the same mandatory compliance. Thus, for these imported products, manufacturers in foreign country will be required to obtain a license from the BIS under the Foreign Manufacturers Certification Scheme (FMCS) of the standards organization. 

Any person who violates the provisions of the QCOs will be punishable with fine, imprisonment, or both under the BIS Act. 

The QCOs are: 

  • Aluminium and Aluminium Alloy Products (Quality Control) Order 2023 

  • Bolts, Nuts and Fasteners (Quality Control) Order 2023 

  • Ceiling Fan Regulator (Quality Control) Order 2023 

  • Conduits and Fittings for Electrical Installation (Quality Control) Order 2023 

  • Copper Products (Quality Control) Order 2023 

  • Deepwell Handpumps and Components (Quality Control) Order 2023 

  • Drum and Tin (Quality Control) Order 2023 

  • Fire Extinguishers (Quality Control) Order 2023 

  • Hand Tools (Quality Control) Order 2023 

  • Hinges (Quality Control) Order 2023 

  • Household and similar Electrical Appliances (Quality Control) Order 2023 

  • Laboratory Glassware (Quality Control) Order 2023. 

  • Solar DC Cable and Fire Survival Cable (Quality Control) Order 2023 

  • Steel Wires/Strands, Nylon/Wire Ropes and Wire Mesh (Quality Control) Order 2023 

  • Valves and Taps (Quality Control) Order 2023 

  • Welding Wires, Rods and Electrodes (Quality Control) Order 2023. 

On 23 and 26 Dec. 2022, National Medical and Pharmaceutical Administration of China (NMPA) released two tests, BJH 202204 and BJH 202205, to detect six hazardous chemicals in cosmetic products. Both of the test methods use qualitative and quantitative methods to determine the hazardous substance contained in cosmetic products. 

Test BJH 202204 is for detecting the presence of the following hazardous chemicals in cream, liquid, gel and wax-based cosmetics:

  • tetrahydroimidazoline;  
  • naphazoline;
  • oxymetazoline;  
  • antazoline; and  
  • xylometazoline.  

Test BJH 202205 is for cream, liquid, gel and film cosmetics to detect the presence of dehydroandrographolide succinate half ester.

Both test methods are created to strengthen the conventional testing methods through targeting prohibited ingredient. Entities who wish to submit a supplementary test themselves can do so via the NMPA Technical Guidance for Research and Drafting Cosmetics Supplementary Testing Methods. 

For more information regarding China cosmetic regulation and REACH compliance, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com. 

On 12 Jan. 2023, National Medical Products Administration of China (NMPA) published the final Measures for the Administration of Sampling and Testing of Cosmetics. This new rule will come into force from 1 Mar. 2023. 

According to the new rule, the following cosmetic products will be the key products of sampling and testing: 

(1) Children's cosmetics and special cosmetics.

(2) Cosmetics using new raw materials.

(3) Many problems are found in supervision and inspection, case investigation, adverse reaction monitoring, safety risk monitoring, complaints and reporting, and public opinion monitoring process.

(4) The unqualified rate of previous sampling inspections was relatively high.

(5) Those with a wide range of circulation and high frequency of use.

(6) Other products with relatively high safety risks.

But if cosmetic products meet the following situations, then it can be exempted from sampling and testing requirement: 

(1) The product is only for export.

(2) The product has been opened, damaged or contaminated, which may affect the inspection results.

(3) The remaining validity period of the product is less than 6 months, except for products with a validity period less than 6 months.

Overseas manufactures who exported their cosmetic products to China shall ask their Chinese agent to help them with the sampling and testing requirement which will be enforced from 1 Mar 2023. For more cosmetic and REACH compliance in China, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com

The National Institute of Environmental Research (NIER) in South Korea notifies conditions for submission of hazard data for 31 biocidal substances that have been evaluated internationally. This is to maintain reliable biocide approval system by clarifying the management methods of hazard information of biocidal substances that have been evaluated internationally. This will enable efficient implementation of the biocide approval system for existing biocidal substances subject to get the approval by 2024.

 

Scope:

- 31 biocidal substances that have been evaluated internationally among existing biocidal substances subject to get the approval by 2024

- exclusion: 15 substances under evaluation or unable to confirm evaluation information

 

Conditions for data submission:

① Prioritizing the substances that completed 2nd international evaluation: For the same biocidal substance, if the hazardous data submission condition for the first evaluation and second evaluation is different, the data submitted for the second evaluation will be prioritized.

② Additional data submission: Test data (CMR, PBT, EDCs, etc.) of major approval category (approval criteria, determination of valid date, etc.) may be required additionally during the approval evaluation to enhance the reliability of the data.

③ Submission of retained data: For the substances that completed 2nd international evaluation, it is possible to submit retained data to enhance the reliability of the data. If it is a reliable data, the data submitted by an applicant will be prioritized (only applicable for individual submission).

④ Risk Assessment: Applicants should confirm risks index and submit risk assessment result including risk reduction plan.

⑤ Ensuring completeness: Completed data with substance manufacturer certificate (including manufacturing site), component analysis report (including impurities), representative product sample, etc should be submitted (till June 2023).

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 Dec 21st, 2022.

 

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

The main updates on new substances are as follow:

1) Updates on chemical substance name, etc: "2015-84", "2016-15", "2016-284", "2017-169", and "2021-87"

2) Removal of chemical substance: "2015-45"

3) Updates on hazard information: "2016-87", "2016-153", "2016-196", "2016-235", "2016-502", "2016-540", "2016-668", "2016-990", "2017-245", "2017-448", "2017-450", "2017-490", "2017-952", "2018-175", "2018-260", "2018-533", "2018-694", "2019-107", "2019-348", "2019-889", "2020-170", "2020-176", "2020-223", "2020-229", "2021-19", "2021-61", "2021-161", "2022-43", "2022-122", "2022-131", "2022-134", "2022-149", "2022-161", and "2022-162"

4) Addition of chemical substances: from "2022-224" to "2022-279"

 

The main updates on existing substances are as follow:

1) Updates on unique number: "2020-020", "2021-058", and "2021-166"

2) Updates on toxic substance unique number: "2022-207", "2022-208", "2022-209", "2022-210", "2022-211", "2022-212", "2022-213", "2022-214", "2022-215", "2022-216", "2022-218", "2022-219", "2022-220", "2022-221", and "2022-222"

3) Updates on hazard information: "2021-051", "2021-052", "2021-053", "2021-054", "2021-069", "2021-088", "2021-094", "2021-115", "2022-203", "2022-204", "2022-205", and "2022-207"

4) Addition of chemical substances: from "2022-312" to "2022-338"

 

The amendment came into effect immediately.

On 15 December 2022, the Ministry of Labour, Health and Welfare (MHLW) released a document containing a plan to introduce workplace exposure limits for 860 chemical substances under the Industrial Safety and Health Act (ISHA). Companies will need to implement risk assessments and take the necessary measures to keep workers’ exposure to those substances within allowable limits.

The ministry will publish a list of 120 compounds with exposure limits that will be in effect for the current financial year, which ends on 31 March 2023, following the last expert conference on 30 January 2023. The MHLW is expected to list 170 substances in the financial year 2023, 180 substances in the year 2024 and 390 substances in the year 2025 and after. Once public comments have been received, ISHA will be amended and the exposure limits will be in force. The ministry did not provide a date for its amendment.

On 30 November 2022, Japan informed businesses that in cases where air exposure levels for organic solvents and other compounds have exceeded authorized concentration limits, occupational risk assessments must be conducted using personal sampling techniques. Enforcement begins on 1 April 2024.

The MHLW is not intending to establish workplace exposure limits for the regulated compounds included on the designated chemical substances list at this time. The Ordinance on Prevention of Hazards Due to Specified Chemical Compounds establishes precise guidelines and precautions for certain substances to avoid exposure.

On 12 December 2022, Ministry of Economy, Trade and Industry (METI) of Japan notified the WTO of the proposal to reduce the use of fluorocarbons in air conditioners and meet global warming potential (GWP) targets. Companies are required to meet GWP objectives specified for certain goods by a target fiscal year under the Act on Rational Use and Proper Management of Fluorocarbons. Global warming potential is the heat absorbed by any greenhouse gas in the atmosphere, as a multiple of the heat that would be absorbed by the same mass of carbon dioxide (CO2).

Fluorocarbons are fluorinated carbon chain polymers, and they belong to the class of per- and polyfluorinated compounds (PFCs). PFCs are used in refrigerants and solvents and have been recognized as chemicals of concern for some time because of their persistence and ecological toxicity.

Following are the newly listed products and their targets:

Products

GWP target

Fiscal Year Target

Facility air conditioners

750

2027

Central air conditioner

750

2027

Gas engine heat pump air conditioners

750

2027

Automobile air conditioners

150

2029

Refrigerator and freezer

150

2029

The enforcement of the proposed changes is anticipated to begin in March 2023 after a 60-day comment period, with the exception of the labelling regulations, which would take effect in October 2023.

Japan establishes GWP targets for the sectors with the highest environmental effect and where non-fluorinated refrigerants or other low-GWP compounds are commercially accessible and energy efficient.

On 10 January 2023 a number of changes to the Australian Inventory of Industrial Chemicals (AIIC) were announced by the AICIS.

After an evaluation under Part 4 of the Industrial Chemicals Act 2019, the AICIS has decided to remove the inventory listings of two Persistent Organic Pollutants (POPs) from the AIIC. The conclusion of the evaluation was that the risks to the environment from the introduction or use of the two substances cannot be managed with the existing regulatory framework. The following two substances will therefore be removed from the AIIC on 8 February 2023.

CAS Number

Chemical Name

118-74-1

Hexachlorobenzene (HBC)

608-93-5

1,2,3,4,5-pentachlorobenzene (PeCB)

The above-mentioned evaluation also resulted in variations to inventory listings for two substances. The variation means that an obligation to provide specific information to the AICIS will be added to the terms of listing for the to following compounds from 8 February 2023.

CAS Number

Chemical Name

84434-22-0

3-(1,1-dimethylethyl)-1,5-dimethyl-2,4-dinitro-benzene

145-39-1

1-(1,1-dimethylethyl)-3,4,5-trimethyl-2,6-dinitro- benzene

Furthermore, the following industrial chemicals were added to the AIIC because 5 years have passed since the assessment certificates for these compounds were issued. Obligations to provide information about the new substances apply. The AICIS must be informed within 28 days if the circumstances of the importation or manufacture (introduction) are different to their assessment.

CAS Number

Chemical Name

2871677-90-4

 

1,3-Benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate and 1,3-isobenzofurandione, benzoate

2870701-51-0

Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with N1-(2-aminoethyl)-1,2-ethanediamine, 1,4-cyclohexanedimethanol, dimethyl carbonate, 1,6-hexanediol, hydrazine and 1,1′-methylenebis[4-isocyanatocyclohexane], compd. with N,N-diethylethanamine

1881248-50-5

2-Propenoic acid, 2-methyl-, C16-18-alkyl esters, polymers with 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate, 1,1-dimethylpropyl 2-ethylhexaneperoxoate-initiated

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