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GHS Report

GPC Newsletter Oct-2022



Regulatory News

The Canadian government has proposed adding Solvent Violet 13 to the country’s list of toxic substances under Schedule 1 of the Canadian Environmental Protection Act (CEPA), which is likely to trigger risk management actions. 

The stakeholders have 60 days to comment on the proposal - until 30 November 2022. While the regulation itself does not impose regulatory requirements, it would empower the environmental and health departments to manage the potential health risks of the colorant, likely focusing on its use in cosmetics. 

Solvent Violet 13 is used in many cosmetic products, including body lotions, lipsticks, and hair dyes, along with candles, pet shampoos, and food packaging. The 2018 draft screening assessment noted that exposure to the substance from some cosmetic products is the biggest concern. 

In July 2021, Canada’s environment and health ministries suggested including Solvent Violet 13 to the Cosmetic Ingredient Hotlist, a move that would restrict the dye’s use in cosmetics placed in the country. 

In its proposal on 1 October 2022, the government said it would consider the effects of potential risk management policies and consult with stakeholders before taking further action.

 

If you have further queries regarding Canadian Regulations, please contact GPC via compliance@gpcregulatory.com. For more information regarding our services kindly visit our site https://www.gpcgateway.com

In August 2022 the US Environmental Protection Agency (EPA) has stated that it intends to expand its program encouraging federal agencies to acquire materials free of per- and polyfluoroalkyl substances (PFASs) to include a number of product groups. 

The initiative will support the agencies' efforts to purchase PFAS-free commodities, a goal established in the Biden-Harris executive order for 2021 and confirmed in implementation guidelines published in August. With an annual procurement budget surpassing $650 billion, the government has an enormous purchasing power that will encourage a wider market transition to safer substitutes for the additional product categories. 

The EPA's Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing is intended to assist federal agencies in meeting the mandate of the executive order to acquire PFAS-free products to the maximum degree practical. 

The EPA is interested in extending" the regulations to the following industries:  

  • infrastructure 

  • landscaping 

  • building and construction 

  • laboratories, and healthcare  

  • food and cafeteria services  

  • clothing and uniforms 

  • professional services. 

For the product classes mentioned previously, the suggestions will provide standard and ecolabel bodies that adhere to the organization's Framework for the Assessment of Environmental Performance Standards and Ecolabels for Federal Purchasing. 

The update is directed at product categories that are known to contain PFASs, according to the regulator. Standard and ecolabel organizations would need to demonstrate how their criteria are addressing the problem where persistent compounds present the most significant environmental and/or human health impacts in a product's lifecycle. 
  
Additionally, the EPA will assess additional standards and eco-labels for previously established procurement categories, including: office and furniture (Including copy paper), electronics (including phones, computers, imaging devices, and televisions), cleaning goods, (Including cleaners, tissues, and trash bags), and machine shop operations (particularly parts wash solution). 


The organization continued, saying that its Environmentally Preferable Purchasing (EPP) program is actively working to assess contracts to ensure that they comply with the procurement standards. 

The US, Canada, and EU are about to start a pilot project that will test a system for exchanging data on substances and provide guidance on the potential development of a global database of information on chemicals led by the OECD.

Bob Diderich, head of the OECD's environmental health and safety division, said ‘’a pilot project has been agreed upon between North American countries and the EU that will test how the database and exchange of information could work internationally while speaking at Chemical Watch's Regulatory Summit Europe, held on September 26-27.’’

The International Uniform Chemical Information Database (IUCLID) of the EU will serve as its ‘core’. The OECD and ECHA together created IUCLID, an IT system that enables organizations to record, save, manage, and exchange data on the inherent and dangerous features of chemicals.

According to Mr. Diderich, IUCLID employs the OECD's harmonized templates (OHTs), which are standard data formats for reporting data used for chemical risk assessment. These have also been incorporated into the chemical information systems of other nations.

"Because IUCLID uses OECD standards for data exchange, more and more countries are interested in using IUCLID for their own regulatory processes," he said.

‘’It would therefore make sense for it to be the core of a global information system’, he added.

Mr. Diderich said, ‘the pilot project will help the OECD determine on what form its own vision for a database could take and will attempt to provide answers to questions like whether it will be a distributed system of national databases that communicate with one another or a centralized system that everyone contributes to.’

Mr. Diderich did not confirm when the project would begin.

The idea was first floated in 2018, and has support from the industry. 

On 23 August 2022, the California State Assembly passed legislation ‘AB 2771’. The bill would ban the sale in California of any cosmetics and personal care products that contain any type of PFAS (per- and polyfluoroalkyl substances) by 2025. The bill, AB 2771, is backed by a coalition of consumer interest groups, public health groups, and environmental non-profit organizations. It prohibits the entire class of PFAS chemicals from being added to cosmetics and personal care products. 

PFAS are synthetic chemical compounds that are strongly resistant to degradation and, as a result, tend to accumulate in the environment. Characterized by the presence of strong carbon-fluorine bonds, these include perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), Gen X, and more. PFAS can present a diverse range of health risks, and their extensive use has resulted in frequent exposure in humans. Very low doses of PFAS in drinking water have been linked to increased risk of cancer, harm to the reproductive and immune system, and liver and thyroid disease. PFAS chemicals have been used in cosmetics products like dental floss, lotions, cleansers, shaving cream, lipstick, eyeliner and mascara to improve durability and texture and to condition or smooth skin or make it appear shiny. Cosmetics with the highest levels of PFAS are often marketed as waterproof, wear-resistant or long-lasting.

 

What Would AB 2247 Require?

AB 2247 requires companies that manufacture or import products (or product components) to be sold or distributed in California with "intentionally added PFAS" to publicly register the product on or before 1 July 2026. Thereafter, a manufacturer or importer must register products sold during the prior calendar year by 1 July of each year.

As states continue to consider and pass legislation regulating PFAS in cosmetics and personal care products, manufacturers and importers of these products containing PFAS will need to evaluate the scope of each state’s laws and regulations to avoid violations. Manufacturers and importers should also consider how they will comply with the regulation as the sales of these products would be banned in California by 2025.

The deadline for updating EU Safety Data Sheets (SDSs) authored before January 2021 is approaching. All SDSs compiled under EU 2015/830 must be replaced by 31 December 2022 with a new SDS authored under the Regulation EU 2020/878.

Background:

On 1 January 2021, Annex II to Regulation (EU) 2015/830 was replaced by the updated Regulation (EU) 2020/878. The regulation aligned REACH Annex II with the 6th and 7th revisions of GHS and brought in several modifications to Saftety Data Sheets.

Due to this all the (M)SDS/eSDS prepared before 2021 need to be updated as per the new EU 2020/878 regulation. This implies that all new Safety Data Sheets, authored after 1 January 2021 must consider the new requirements. SDSs complying with the 2015 regulation are no longer acceptable.

However, all existing SDSs, authored before January 2021, are valid only until the grace period ends on 31 December 2022 (except for bulk mixtures requiring a UFI).  After this date, all Safety Data Sheets will need to be updated to the new requirements (EU 2020/878).

GPC can help you to update your EU Safety Data Sheets compiled before January 2021 according to the new EU Regulation 2020/878 requirements. For more information on the procedure please contact us: compliance@gpcregulatory.com 

As presented in the “Eu Strategy on Sustainable Chemicals” in 2020, the EU REACH regulation was about to be revised and updated by end of 2022 to better correspond to the sustainability plans of the EU.  

However, in the last quarter of 2022, no revision has yet been done and the announcement about its postponement keeps on coming. The reform might now be delayed to 2024. The delay is particularly concerning due to the upcoming EU Parliamentary elections that might further delay the revision. 

The delay is seen as a setback to the sustainability ambitions of the Union. Furthermore, the decision was heavily criticized by NGOs. Certain opinions see the delay as being a result of lobbying from the chemical industry. 

The delay of the revision is seen as a “life and death” matter by the members of the parliament and NGOs. After all, the revision aims to enforce the protection of human health and the environment. If not adopted before 2024, the new laws from the revision cannot come into force till 2028 which is far too late to be able to have an impact on the environmental crisis. 

The proposal to the European legislation on Food Contact Materials (FCMs) has now been opened for public consultation. The FCM legislation has been in place since 2004 and has been criticized for not being efficient, foremost by NGOs.  

In the summer of 2022, the European Commission made a review of the current regulation, and their conclusion supported the argument as the FCM legislation was called only “partially effective”. For example, the current regulation has regulatory specificity mostly for plastics but lacks it for other materials. 

An update of the regulation has been underway since 2020 but has been slow due to the complexity of the FCM legislation. The main objectives of the FCM regulation are to secure and protect human health and to ensure the functioning of the internal market.  

The proposed updated legislation is expected to be adopted in 2023. If adopted, the initiative aims to modernize the rules, to: 

  • ensure food safety & a high level of public health protection 

  • reduce the presence and use of hazardous chemicals 

  • take account of the latest science & technology  

  • support innovation & sustainability by promoting safe reusable and recyclable solutions and help reduce the sector’s environmental impact. 

The public consultation is open from 5 October 2022 to 11 January 2023. The feedback can be submitted on the website of the European Commission: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12497-Revision-of-EU-rules-on-food-contact-materials_en.  

In August the European battery industry was joined by Argentina, Australia, and the US in warning against classification of Lithium compounds under the EU’s CLP. Their statements were sent to the Competent Authorities for REACH and CLP to examine the socio-economic and supply concerns. 

In July 2021, the European Commission was requested to cover the potential impact of classification of three lithium compounds. Later in September 2021 the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) accepted a French proposal on classification of lithium salts into Category 1A (Reproductive toxicity).  

Three Lithium salts were categorized with no existing entry in Annex VI of the Classification, Labelling and Packaging regulation (CLP): 

  1.  Lithium chloride - used widely in battery production 

  1. Lithium hydroxide - used widely in battery production 

  1. Lithium carbonate - used to produce lithium salt and to manufacture aluminum 

  • Australia is the largest producer of lithium concentrate. According to a CARACAL (Competent Authorities for REACH and CLP Comment from the Australian Mission to the EU, Australia is willing to work with the European Commission to clarify that the classification of lithium salts as 1A reproductive toxicant "does not inadvertently impede our shared interest to support the development and expansion of clean energy supply chains". 

  • Argentina warned that the 1A classification could affect in many ways such as increasing regulatory uncertainty, deterring new investments, increasing the administrative burden, and increasing the costs for the whole battery supply chain. In a letter it said that "1A classification could negatively impact Argentina and the European Union’s strategic objectives regarding lithium salts and lithium batteries and their role in achieving our shared climate goals". 

  • The US department of Commerce asked the EU commission to pay attention to their concerns on "uncertainties in risk management measures, which could have adverse effects on global lithium supply chains". 

The EU listed lithium as a critical material in 2020. It is one of the most prominent minerals for clean energy transitions, according to a 2022 report on world energy investment by the International Energy Authority (IEA). IEA data suggests that demand could increase by over 40 times by 2040. 

On 3 October 2022, as a step into the Endocrine Disrupting Chemicals (EDC) blueprint that was received in June, the Belgian Federal Ministry of Economy and the Ministry of Public Health sent a survey to stakeholders requesting to derive information on Substances of Very High Concern (SVHCs). 

Belgium is exploring industry views to identify SVHCs, their uses and alternatives under its recently approved action plan on Endocrine Disrupting Chemicals. EDCs, also known as hormone disruptors, are synthetic chemicals that block, mimic, or interfere with the natural hormones in our bodies.   

The scientific project on substitution of SVHCs began in April. The aim of this project is to accelerate the elimination and replacement of SVHCs as well as advancing Belgium's economic competitiveness and status into the transition to safer and more sustainable products. 

 The objectives of the project are to develop: 

  • Methodological analysis to recognize the fundamental uses and manufacturing processes of SVHCs in Belgium and to identify priority substances.  

  • A brief list of policy measures to be proposed to support the replacement of SVHCs and for inclusion in the national replacement plan. 

  • Estimate the socio-economic impacts affiliated with the shortlisted policy  options by identifying both positive and negative aspects, along with figuring out the  potential (unwanted) consequences of each option. 

Estimating social-economic impacts will help Belgian authorities design their policies in a way that minimizes negative aspects, such as the risk of regrettable replacement, while at the same time helping to reduce the use of SVHCs and develop the market for safer substances.  

The Belgian Plan for Chemical Alternatives is part of the country's Federal action plan for a circular economy and Belgium Builds back Circular – a part of the EU's Recovery and Resiliency Plan.  

Belgium’s national action plan on EDCs 

Belgium’s action plan aims to establish a general and coherent framework to reduce exposure to EDCs in Belgium and will run for the period June 2022 to December 2026. 

The action plan is focused on: 

  1. Awareness-raising and prevention strategies, targeting the public and relevant professionals 

  1. Legislative action at national and EU levels aimed to serve EDC exposure reduction 

  1. Research and work on identification of EDCs, including biomonitoring. 

Other countries that have already taken similar initiatives including France, Denmark, and Sweden. France worked on a number of priority areas, including creating a list with the harmful substances, along with raising awareness of the associated risks.  

A seven-year extension, valid until 30 June 2027, to the exemption for the use of lead in medical equipment under the EU Directive on the Restriction of Hazardous Substances (RoHS) has been approved by the European Commission.

On 12 December 2018, the European Commission received an application for renewal of the exemption for the use of lead in medical devices. In 2020 an application submitted by the European Coordination Committee of Radiological, Electromedical and Healthcare IT Industry demanded the extension of the exemption till 30 June 2027.

The exemption covers the use of lead in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors that are used in certain medical ‘Magnetic Resonance Imaging (MRI) equipment. 

The result of technical and scientific studies, and public consultation show that older-design MRI devices are limited in quantity and highly dependent upon lead containing components compared to new lead-free versions. Although non-integrated lead-free MRI models are available, concerns are that it will require additional time to develop a lead-free integrated MRI solution. The lack of redesigned models can create a supply gap, which could affect healthcare for patients.

The exemption entry 27 in Annex IV is proposed to be approved for renewal in order to provide MRI equipment for medical services in a compatible manner and to permit the time to be taken for development of lead-free devices. Two points are added in the exemption proposal as follows -

  • MRI non-integrated coils, for which the Declaration of Conformity of this model is issued for the first time before [the date of publication in the Official Journal of the Delegated Directive + 1 day]
  • MRI devices including integrated coils, which are used in magnetic fields within the sphere of 1m radius around the isocenter of the magnetic in medical magnetic resonance imaging equipment, for which the Declaration of Conformity issued for the first time before 30 June 30 2024.

Superconductor 

Due to the lack of lead-free alternative devices on the market with properties such as ductility and electrical resistivity at low temperature, the Commission has also renewed an exemption for the use of lead in Bismuth Strontium Calcium Copper Oxide (BSCCO) superconductors for use in cables and wires, and lead in related electrical connections for other Electrical and Electronic Equipment (EEE) components. 

Lead-doped BSCCO is used to:

  • create superconducting magnetic circuits for medical devices and monitoring and control instruments
  • achieve higher resolution images for medical diagnosis or research and stable operation mode of the relevant applications

According to the EU RoHS Directive, the EU member states must adopt and publish the necessary legislation by 28 February 2023. 

The renewed exemption expires on 30 June 2027. 

 

Under the EU Directive on the Restriction of Hazardous Substances (RoHS) in Electrical and Electronic Equipment (EEE), Germany’s Öko-Institut has initiated an evaluation on exemption requests for cadmium quantum dots in lighting and display applications.

On 17 October 2022 the study will be completed. Due to the short duration, stakeholders with information are invited to contact the institute directly and stakeholder consultation will not be held. This was stated in note on 7 September 2022.

Technical and scientific support to the European Commission will be provided by the study. The study is based on an assessment of exemptions published in January 2021.

Exemption Overview-

Exemption Request No.

Exemption requests

Recommendations

Request 1018-1

“Cadmium (< 1000 ppm) in luminescent

material for on-chip application on LED semiconductor chips for use in lighting applications of at least CRI 80” requested to be valid for 5 years

 

“Cadmium in downshifting semiconductor quantum dots LED semiconductor chips for use   in display and projection applications (< 5 mg Cd per mm2 of light emitting LED chip surface)”

Annex III, Ex. 39a

“Cadmium in downshifting semiconductor nanocrystal quantum dots directly deposited on LED chips for use in display and projection applications (< 5 mg Cd per mm2 of light emitting LED chip surface)” requested to be valid for 5 years

“Directly deposited on LED semiconductor chips for use in lighting applications of at least CRI 90 (< 1000 ppm in the luminescent material) provided that applications comply with entry 72 of Annex XVII of Regulation 1907/2006.”

Annex III, Ex. 39a

“Cadmium selenide in downshifting cadmium-based semiconductor nanocrystal quantum dots for use in display lighting applications (< 0.1 mg per mm2 of display screen area)” requested to be valid until 31 October 2021

Denied

 

According to the German assessment body, the  decision  for these exemption requests is still pending and a review on the current state of the scientific and technical progress will be given by the Öko-Institute.

Because of carcinogenic, and suspected mutagenic and reprotoxic properties, cadmium is on the REACH candidate list of Substances of Very High Concern (SVHC). An exemption on cadmium is opposed by the NGO Chemical Secretariat (ChemSec). Cadmium-free technologies are widely available and major manufacturers such as Samsung, LG, Apple, and Sony have already adopted a no-cadmium policy says ChemSec’s policy adviser.

The European Parliament has actively monitored the implementation of the legal framework of Directive 2009/128/EC which specifically regulates the Sustainable Use of Pesticides (SUDP).

Timelines

On 22 June 2022, the European Commission submitted a proposal to revise the SUDP. This submission was initially scheduled for 23 March 2022, has been delayed, reportedly, due to Russia's war on Ukraine.

This proposal is part of a package of legislation on nature conservation that also includes a proposal for legally binding nature restoration rules. As part of the European Green Deal, both proposals are related to farm to fork, biodiversity, and zero pollution.

Updates: Member states shall take necessary actions on-

  • Pesticide reduction has never been an official policy objective of the SUD.

  • Encourage the development and introduction of Integrated Pest Management (IPM) and of alternative approaches or techniques to reduce dependency on the use of pesticides.

  • To ensure that the use of pesticides is reduced or banned in specific areas such as playgrounds, public parks, sports fields, or close to healthcare facilities.

  • Ban the spraying of pesticides by air.

  • Specifically, safeguard drinking water from the effects of pesticides in water.

  • Develop programmes to raise public awareness of the potential dangers associated with the usage of pesticides.

European Court of Auditors Recommendations

To ensure compliance with the SUDP requirements, the European Commission conducts audits in the Member States (MSs).

  1. The Commission should make sure the MSs have converted the general principles of IPM into practical and measurable criteria, (verified on farms by 2022), and incorporate these measurable IPM criteria into the 'conditionality' of the post-2020 common agricultural policy (CAP). 

  2. By 2023, the Commission must address the following to improve statistics and environmental monitoring: First, the restrictive aggregation requirements for Plant Protection Product (PPP) statistics should be removed so that more useful statistics can be published (such as low-risk PPPs and active substances with specific properties), and second, the EU statistics on agricultural use of PPPs should be clarified, improved and harmonised to make them more useful, comparable and accessible. 

  3. The Commission should develop new (harmonised risk indicators) HRIs, or improve the existing ones, by 2023.

From 1 October 2022, Rechargeable Electric Energy Storage Systems (REESS) and electric vehicle makers would need to comply with new amendments to specific technical requirements for REESS or batteries for electric vehicles of categories ‘M’ and ‘N”.  ‘M’ denotes electric four-wheel motor vehicles used for carrying a passenger and ‘N’ denotes electric four-wheel motor vehicles used for carrying both goods and passengers. These amendments were announced on 1 September 2022, by India’s Ministry of Road Transport and Highways. Earlier the ministry through a draft notification issued on 25 August 2022, had announced the amendments to the Central Motor Vehicle Rules 1989.

These amendments provide for additional safety requirements related to battery management systems (BMS), onboard chargers, battery pack design, and thermal propagation due to internal cell short circuits leading to fires, based on the report by an expert committee constituted by the Road Transport Ministry.

Amendment 2 to Automotive Industry Standard AIS 156 comprises specific requirements for motor vehicles of the L category- motor vehicles with less than four wheels and an electric power train.

Amendment 2 to AIS 038 Rev.2 lists specific requirements for electric power trains of M category vehicles and N category motor vehicles.

The ministry also issued draft notification GSR 659 (E) to amend Sub-rule 4 of Rule 124 of Central Motor Vehicles Rules (CMVR) 1989 for mandating Conformity of production for traction batteries used in electric power train vehicles.

On 14 September 2022, the Ministry of Commerce and Industry of India published Notification No.32/2015-2020. This notification permits the import of PET Flakes. However, there are certain conditions.

The import of PET flakes has been permitted subject to NOC (No Objection Certificate) from the Ministry of Environment, Forest, and Climate Change (MoEFCC) and authorization from the Directorate General of Foreign Trade (DGFT).

This was in connection with the ban on all plastic imports as notified in the ‘Hazardous and Other Wastes (Management & Transboundary Movement) Amendment Rules, 2019’ by the MOEFCC.

In March 2019 the Ministry of Environment Forests and Climate Change imposed a ban on the importation of PET bottles to India, along with other electronic items. The ban aimed to strengthen the waste management infrastructure and prevent the country from turning into a global dump yard. Additionally, the ministry’s Hazardous Substance Management (HSM) Division banned the import citing that India has enough waste which can be processed by recyclers.

Once upon a time, India was one of the largest importers of PET bottle scrap, after China. India imported large volumes of PET scrap from the USA, Europe, and the Gulf countries. The booming recycling industry heavily relied on PET imports, i.e. nearly 70-80% of the demand was fulfilled by imports. However, this led to the waste generated locally being left unaddressed.

In the wake of the National Green Tribunal directions, the MoEFCC took an action to effectively ban the import of all types of plastics, household waste, and electronic waste into India. The three-year ban was, however, partially lifted in March 2022, allowing only PET flakes to be imported. Since the import was opposed by many stakeholders, including Recycle India Foundation and Mumbai-based Pandit Deendayal Upadhyay Smiriti Manch (PDUSM), the issue was referred by the environment ministry to a technical review committee which has now recommended the import with certain specific conditions. The ministry accepted the recommendations, allowing the import of 95,105 tonnes of PET flakes, on August 24, 2022.

India’s Department of Chemicals & Petrochemicals published the Gazette Notifications for Quality Control Orders (QCOs) of three Chemicals: Trimethyl Phosphite, 1, 3 Phenylenediamine and Rubberseed Fatty Acids. According to the orders, manufacturers and importers should conform to the corresponding Indian Standards and include the Standard Mark under a license from the Bureau of Indian Standards (BIS) from October 2022 (See table below). The notification for QCOs of these three chemicals were published in April 2022.

 

No.

Chemical

Date of Gazette Notification

Date of entry into force

1.

Trimethyl Phosphite

05.04.2022

03.10.2022

2.

1, 3 Phenylenediamine

27.04.2022

24.10.2022

3.

Rubberseed Fatty Acids

27.04.2022

24.10.2022

 

Read more on BIS compliance.  

India’s Department of Chemicals & Petrochemicals (DCPC) has delayed the implementation of the Quality Control Orders (QCOs) for six chemicals. The notification came on October 21, 2022, and according to the amended QCOs these orders will be in place in 24 April next year.

These six chemicals are mainly used in soup and other personal care. The chemicals are:  

  1. Lauric Acid

  2. Acid Oil

  3. Palm fatty Acids

  4. Rice Bran Fatty Acids

  5. Coconut Fatty Acids

  6. Hydrogenated Rice Bran Fatty Acids 

The delays are mainly due to revisions to some Indian standards and travel bans of factory auditing due to Covid pandemic. This is in particular the cases for foreign manufacturers.  

 

Recently, the Ministry of Industry and Information Technology of China (MIIT) published a plan about making a national mandatory standard -- Regulations on the Preparation of Chemical Safety Labels. They are seeking input from industries to give comments on this new draft regulation. 

According to MIIT, the enforcement of regulations on the preparation of chemical safety labels will replace the current GHS labelling standard GB15258. However, it will take sixteen months to revise the standard and the new GHS labelling standard is expecting to come into force in 2024. 

The current GB15258 specifies the relevant definitions, content, preparation requirements and application methods for preparing precautionary labels for chemicals in China.

For more information regarding China GHS requirements, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com. 

National Institute of Environmental Research (NIER) in South Korea provides a guideline to prepare biocidal product approval submissions. Under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR), manufacturers and importers of biocidal substances and biocidal products must get approval.

This guide provides details of preparation methods and submission requirement regarding ‘Comprehensive safety data (comprehensive evaluation data)’ in under Article 6 (1) of the .

The contents are as follows:

1. Application for biocidal product approval

          a. Preliminary stage of application for biocidal product approval

          b. Preparation for biocidal product approval application data

2. Preparation for comprehensive evaluation data

          a. Summary and evaluation results

          b. Evaluation results on biocidal product information and safety

          c. Comprehensive data results on safety

If you are planning to prepare biocidal product approval submissions, please refer to the guideline for the details.

The National Institute of Environmental Research (NIER) in South Korea updates ‘the Regulations on preparation methods for registration application dossier and hazard review methods’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on September 30th, 2022.

 

The main updates on new substances are as follows:

  • Addition of definitions of hazard review methods: In vivo somatic chromosome aberration test, In vitro chromosome aberration test, Non-test data, Read-across, WoE (Weight of Evidence)
  • Addition of non-test data and its requirements: QSAR data, Read-across, WoE
  • Addition of methods to submit opinions to the president of the NIER if a person who received the result of hazard review disagrees with it (Article 35)
  • Addition and specification of exemption conditions for each test category

 

The amendment came into effect immediately. However, the amendment of the Article 35 will come into effect from October 15th, 2022.

The National Institute of Environmental Research (NIER) in South Korea updates ‘the Designation of toxic substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on October 6th, 2022.

 

The main updates are:

  • Revision of chemical substance name: substances with unique number “97-1-5”, “97-1-21”, “97-1-45”, “97-1-46”, “97-1-80”, “97-1-96”, “97-1-119”, “97-1-132”, “97-1-163”, “97-1-182”, “97-1-198”, “97-1-209”, “97-1-212”, “97-1-218”, “97-1-240”, “97-1-268”, “97-1-277”, “97-1-278”, “97-1-376”, “97-1-410”, “97-1-411”, “97-1-432”, “2010-1-611”, “2010-1-646” and “2012-1-688”
  • Addition of chemical substances: substances with unique number from “2022-1-1085” to “2022-1-1095”

 

The amendment will come into effect in a month. However, for 1) handling standards of hazardous chemicals, 2) preparation and submission of chemical accident prevention management plan, 3) arrangement, installation and management standards of handling facilities, and 4) hazardous chemical business license under the Chemicals Control Act, it will be implemented in 3 months.

The National Institute of Environmental Research (NIER) in South Korea updated the Regulation on chemical substance classification and labelling under the Act on Registration and Evaluation of Chemicals (K-REACH) and the Chemicals Control Act on October 6th, 2022.

 

The main updates are:

  • Revision of toxic substances: substances with unique number “97-1-5”, “97-1-21”, “97-1-45”, “97-1-46”, “97-1-80”, “97-1-94”, “97-1-96”, “97-1-114”, “97-1-119”, “97-1-132”, “97-1-136”, “97-1-137”, “97-1-139”, “97-1-145”, “97-1-148”, “97-1-163”, “97-1-165”, “97-1-167”, “97-1-182”, “97-1-183”, “97-1-198”, “97-1-200”, “97-1-203”, “97-1-209”, “97-1-218”, “97-1-240”, ““97-1-274”, “97-1-277”, “97-1-313”, “97-1-359”, “97-1-376”, “97-1-381”, “97-1-382”, “97-1-384”, “97-1-405”, “97-1-406”, “97-1-407”, “97-1-409”, “97-1-410”, “97-1-411”, “97-1-432”, “98-1-479”, “99-1-492”, “99-1-506”, “2001-1-520”, “2001-1-525”, “2006-1-556”, “2010-1-604”, “2010-1-610”, “2010-1-611”, “2012-1-640”, “2012-1-644”, “2012-1-645”, “2012-1-646”, “2013-1-666”, “2013-1-668”, “2014-1-685”, “2014-1-688”, “2014-1-700”, “2018-1-824” and “2020-1-982”
  • Addition of toxic substances: substances with unique number from “2022-1-1085” to “2022-1-1095”
  • Revision of restricted substances: substances with unique number “06-5-4” and “06-5-13”
  • Revision of substances requiring preparation for accidents: substances with unique number “3”, “4”, “11”, “26”, “35”, “40”, “42”, “43”, “45”, “47”, “49”, “52”, “54”, “62”, “65”, “66” and “73”

 

The amendment came into effect immediately.

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) on October 6th, 2022. This is to disclose chemical substance name due to the cancellation of data protection.

 

The draft amendment mainly proposes revisions including:

  • Information disclosed based on the results of hazard review: 347 of new substances
  • Information disclosed due to the termination of data protection period

 

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

The deadline for this consultation is Oct 26th, 2022.

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea consults on a draft amendment on the Guidelines for Clinical trials on cosmetics that alleviate hair loss symptoms on October 14th, 2022. This is to clarify required fields to be included in the clinical trial report.

The guidelines mentions that the clinical trial report should follow the “Regulations on the demonstration of cosmetic labeling and advertising”. The clinical trial report is recommended to include the following criteria:

  • Title of the test
  • Testing institute information
  • Test and control substance information
  • Subject control and test method
  • Test results
  • Methods of synthesizing results
  • Data reliability
  • Side effect and measurement details

 

If you have any opinion on this draft amendment, please write your opinion in the provided format and submit it to Korea Cosmetic Association.

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

The Ministry of Environment (MoE) in South Korea consults on a draft amendment of ‘the Rules on Approval of Chemical Safety Information Exception’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on October 18th, 2022. Currently, there is a risk that trade secret approved for non-disclosure under other regulations may be exposed through the K-REACH registration number (or report number), since K-REACH registration number (or report number) is not subject to non-disclosure. Therefore, this amendment aims to protect trade secret by including K-REACH registration number (or report number) as non-disclosure.

 

The draft amendment mainly proposes revisions including:

  • In case of approval for non-disclosure under other act, K-REACH registration number (or report number) is included as non-disclosure
    • The information on whether a substance is registered or reported will be still marked to show its compliance under K-REACH

 

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

The deadline for this consultation is Nov 7th, 2022.

On 27 September 2022 South Korea’s Ministry of Environment (MoE) published a notification on updating the requirements for two Persistent Organic Pollutants (POPs). The requirements are added to the rules for chemical compounds exported on prior informed permission of the Chemical Control Act (CCA). The new requirements are up for consultation under South Korea’s Ministry of Environment (MoE) until 17 October 2022. 

The Consumer Chemical Products and Biocides Safety Act (K-BPR) regulates both  compounds listed in the recent notification. The two POPs are:  

  • decabromodiphenyl ether (decaBDE) which is used as a flame retardant in a variety of products, including thermoset resin plastics, textiles, and adhesives. 

  • perfluorooctanoic acid (PFOA) and its salts and related compounds. PFOA and its salts are widely used as processing aids in the production of fluoro-elastomers and fluoropolymers, with Polytetrafluoroethylene (PTFE) being an important fluoropolymer. PFOA-related compounds are used as surfactants and for the manufacture of side-chain fluorinated polymers. Due to the surfactant properties of both PFOA and its related non-polymeric surfactants, applications exist for the use of these substances, e.g., fire-fighting foams, wetting agents, and cleaners. 

According to the proposed regulations, companies planning to export these chemicals would need to get permission from the MoE and submit an export notification to the ministry in English before proceeding. 

Companies exporting the compounds would also need to supply handlers in importing nations with safety data sheet (SDS) information as well as mark hazardous information on the packaging or containers of the substance.  

The recommendation comes after the UN’s decision to include these two compounds in the Rotterdam Convention in June 2022. The countries receiving products containing these chemicals must be informed of their import and have the option to reject them under the Prior Informed Consent (PIC) procedure of the Convention. 

Both compounds are included in the Stockholm Convention's list, which obliges nations to stop using and producing them. Nevertheless, some particular uses are still momentarily permitted. 

On 15 September 2022, the Ministry of Health, Labour, and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of Environment (MOE) jointly released a Notice to seek hazard information on three default candidate substances. The notice sets a deadline of 30 November 2022. Interested companies planning to conduct tests should notify the ministries and complete them by 31 December 2023.

A 'default candidate substance' is a general chemical substance for which the ministries have insufficient hazard data to conduct a screening assessment to designate it as priority assessment. The substances are: 

  • tricyclo[5.2.1.0(2.6)]dec-3-en-8-yl acetate
  • N, N-Dipolyoxyalkylene (C=2, 3)-N-alkyl (C8-18, normal chain) amine;
  • polyoxyalkylene (C 2-4,8) monoalkyl(or alkenyl) (C 1-24) ether (n=1-150)

The three ministries have requested the following data:

  •  algae growth inhibition
  •  daphnia acute immobilisation
  •  fish acute toxicity

 

If the collected information is found to be insufficient or received and verified, but cannot be used for the screening assessment without test notifications, the ministries will classify the default candidate substance as:

  • default hazard class I: for substances that potentially have an effect on the ecosystem
  • default hazard class II: for substances that potentially have an effect on health

 

On the basis of hazard and toxicity levels, the substance’s hazard and exposure class will be estimated by the joint ministerial council to decide if it should be designated as a 'default priority assessment chemical'.

With the objective to help manufacturers comply with the Ministry of Health, Labour, and Welfare’s (MHLW) risk control requirements and to keep abreast of new regulations being introduced under the Industrial Safety and Health Act (ISHA), Japan is going to launch a platform on chemical management.

The information portal will be set up on a test basis in the financial year 2023 which runs from 1 April 2023 to 31 March 2024 and will be updated later with the feedback received from user experience. Japan has implemented the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) through its ISHA regulatory framework. 

The Japan National Institute of Occupational Safety and Health (JNIOSH) is responsible for creating, running and upgrading the platform as per governmental policy on occupational safety and health. 

Currently, the website is under construction and will provide detailed information on:

  • News on revisions to ISHA and enforcement schedules which includes updates on risk management provisions under the Act, such as changes to SDS, labelling and exposure limit requirements. 
  • Chemical risk management requirements for consultants and managers 
  • Risk assessment tools
  • Guidelines for monitoring workers’ health

On July 15, 2022, the Ministry of Health, Labor, and Welfare (MHLW), the Ministry of Environment (MoE), and the Ministry of Economy, Trade, and Industry (METI) announced that they have revised the guidance documents to "rationalise and expedite classifications of substances for risk assessment and management". Revised technical guidance and related documents were expected to be published in September 2022, however, to date (October) nothing has been published

The Japanese Chemical Substances Control Law (CSCL) defines the risk assessment for Priority Assessment Chemical Substances (PACS) as, “the assessment to determine whether there exists a risk of damage to human health or to the population and/or growth of animals and plants in the human living environment, due to environmental contamination attributable to chemical substances.”

This risk assessment enables the Minister of Health, Labor and Welfare, the Minister of Economy, Trade, and Industry and the Minister of the Environment to determine the necessity for their exercise of regulatory authority such as the “Designation as Class II Specified Chemical Substances” and the “Rescission of Designation as Priority Assessment Chemical Substances” under the Japanese Chemical Substances Control Law.

As of April 1 2022, Japan has added 4 substances and removed of another 13 from its PACS list under the country's Chemical Substances Control Law (CSCL). Currently, there is a total of 218 substances on the PACS list, according to METI.

The guidance documents in the following list have been revised. These documents were previously revised in 2019:

  • The basic concept of screening assessments for PACS
  • Screening assessment methods
  • The basic concept of risk assessments for PACS
  • The methods of risk assessment

The sections of the Technical Guidance on Risk Assessment for PACS under the CSCL listed below have also been revised: 

  • Assessment criteria for the removal of substances with no risk concerns from the PACS list
  • Methods for prioritizing chemicals for risk assessment
  • Evaluating risk from mutagenic substances using carcinogenicity test results or existing quantitative information 
  • Screening requirements for mutagenic and hazardous substances using in vivo test results

While evaluating PACS, METI gathers detailed information from the industry regarding their production and uses. Based on the collected information the ministry then performs a risk assessment (Tier 1) to decide whether to reclassify the substance, cancel its PACS designation, or prioritise it for further environmental exposure studies and a follow up risk assessment (Tier 2). In some cases, the government might also request toxicity studies of the substances before a final risk assessment.

 

Until the 11 October 2022 the Australian Chemicals Introduction Scheme (AICIS) is consulting on proposed alterations to the Industrial Chemicals (General) Rules 2019, regarding certain lower risk chemicals when introduced in small quantities (10 kg or less in a registration year).

The AICIS has divided the proposed changes into two parts:

  1. Changes to the record-keeping requirements for listed introductions at 10 kg or less in a registration year.
  2. Changes to categorize introductions of chemicals at 10 kg or less in a registration year as reported.

The proposed changes intend to simplify the record-keeping obligations for manufacturers or importers who might have difficulties getting confidential or commercially sensitive information such as CAS number and name of a chemical from the overseas supplier. Instead, the AICIS would require the introducers of low-volume chemicals to “keep information that they should have or should be able to easily access”.

The proposed changes would mean that introducing volumes of 10 kg or less in a registration year of lower risk substances that meet the eligibility criteria of the AICIS could be categorised as reported.

Chemicals of higher concern, such as carcinogenic, fluorinated or persistent, bioaccumulative and toxic to the environment, would not meet the criteria for these changes.

You can submit your feedback on the proposed changes by 11.59 pm AEDT on the 11 October 2022 on https://www.industrialchemicals.gov.au/have-your-say-about-our-consultation-chemical-introductions-10-kg-or-less

On 5 September 2022, the Brazilian Chemical Industry Association (Abiquim) signed , in the Brazilian capital, Brasília, a protocol of intent with the Ministry of the Environment. This document intends to collaborate, among other issues, in the elaboration of the National Climate Change Mitigation Plan and chemical management.  

This happens in the context of draft bill 6.120/2019 which was approved on 6 December 2021 by the Environment Committee of the Brazilian Chamber of Deputies. The intent of this is to set inventories, risk assessments, and authorization requirements for chemicals to protect human health and reduce environmental damage. This entails the production, importation, and use of chemicals in the Brazilian territory. If the protocol is approved in the parliament,  a database would be established in the country with all the industrial chemicals used in Brazil with a quantity of more than one tonne per year. 

In this context, Abiquim and the Ministry of Environment are advancing in the Brazilian management of chemical substances.  This is already in progress through Bill 6.120/2019 whose enactment was paused under Bolsonaro’s government. However, a representative of Abiquim expects that this bill will be approved and believes that its effects will be positive for the chemical industry in Brazil.  

The United Nations has funded a project with the cooperation of the Brazilian Ministry of the Environment, to monitor hazardous chemical substances in order to establish and create a national chemical inventory. It is estimated that this project will start in early 2023. Currently, the Bill is waiting to be approved by all committees of the Brazil National Congress, and after the final approval, it will be sent to the Brazilian senate. 

On August 19, 2022, Vietnam Ministry of Industry and Trade (MOIT) released a draft circular on distinguishing food-grade and non-food-grade alcohol based on the national technical regulation for alcoholic beverage. The purpose of this circular is to prevent the use of non-food-grade alcohol in manufacturing alcoholic beverages. MOIT proposed the use of coloring agents, flavoring agents, and warning signs to make industrial and food-grade alcohol distinct.   

This circular is applied to organizations and individuals related to manufacturing, trading, and or using industrial alcohol in Vietnam.  

Industrial alcohol according to the definition of MOIT is ethanol (C2H5OH), consisting of harmful ingredients that does not meet the requirements for food-grade alcohol according to QCVN 6-3:2010/BYT, the national technical regulation for alcoholic beverages.  

The requirements of the coloring and flavoring agents adding to industrial alcohol:  

  • Should not be listed in Decree 113/2017/ND-CP (implementation guidelines on licenses, classification, plans/measures for chemical incident, safety training, declaration) 

  • Should not create chemical reactions with industrial alcohol and other substances in alcohol-containing mixture  

  • Should not produce toxins affecting health  

  • The solution after adding coloring agent must create distinctive color to differentiate from food-grade alcohol  

  • The solution after adding flavoring agents must have horrible distinctive taste of industrial to differentiate from food-grade alcohol  

The information of added coloring and flavoring agents in the solution must be added on labels and safety data sheet. In the safety data sheet, industrial alcohol must be clearly stated as “do not drink”.  

The differentiation industrial and food-grade alcohol by using warning signs is guided according to the appendix of the circular draft before entering the market. 

The circular draft will receive comment until October 17, 2022.

New restrictions on Hazardous Substances (RoHS) in Electrical and Electronic Equipment (EEE) have been suggested by Vietnam’s Ministry of Industry and Trade (MoIT) to conform with the directives of the EU. The discussion on the draft regulation will continue until 17 October 2022.

On 19 August 2022 a National Technical Regulation on the Restriction of Hazardous Substances in Electrical and Electronic Equipment (EEE) was published by the MoIT. Four phthalates: Bis(2-Ethylhexyl) phthalate, Benzyl butyl phthalate, Dibutyl phthalate, and Diisobutyl phthalate would be added to Vietnam’s list of restricted substances in EEE.

According to the regulation draft-

  • 0.1% or 1000 mg/kg will be the maximum use limit for every new substance in EEE.
  • A certificate of conformity with three years validity will be necessary.
  • The certificate must be obtained from a registered testing organization before placing certain EEE on the market.

Inclusion of the four phthalates would align the hazardous substance restrictions for EEE of Vietnam with the EUs RoHS Directives.

On 1 January 2026 the regulation will come into effect after getting approval. It would replace Vietnam’s existing RoHS regulation, Circular 30/2011/TT-BCT.

On 21 January 2022, the Philippine Food and Drug Administration (FDA) has issued Circular No. 2021-011-A which allows the extension of the transition period of HUHS products (Household/Urban Hazardous Substances). The FDA Circular No. 2021-011-A replaces and repeals Circular No. 2020-025. The new Circular specifically extends the transitory period by a further two years from the initial due date of 31 December 2021 for the products in Categories III and IV. This indicates that until 31 December 2023, the registration and labeling requirements of the FDA Circular No. 2020-025 will not apply to such items.

In the Philippines, there are five categories into which HUHS products are categorized. The circular applies to products in categories III and IV, which include deodorizers, fresheners, and cleaners respectively.

Only the Certificate of Product Registration (CPR) is impacted by the extension; the License to Operate (LTO) is unchanged. Until 31 December 2023 goods containing HUHSs that are currently on the market but have not been registered may continue to be sold.  However, an LTO is a requirement for all companies participating in or planning to participate in HUHS operations. A copy of the circular and an LTO may be used in place of a CPR for any customs-related activities, including advertising and sales promotions, according to the FDA, The following products come under categories III and IV.

    • Category   III (Cleaners, Air Fresheners and Deodorizers)
  • Bleaches
  • Cleaners (i.e., corrosive, multi-purpose, surface, etc.)
  • Deodorizers
  • Dishwashing and laundry detergents/soaps
  • Disinfectants (for surfaces)
  • Fabric conditioners/softeners and ironing aids
  • Air fresheners (i.e., room, car, etc.), aromatics, diffusers
  • Moisture-absorbing agents (i.e., desiccants)
  • Polishes
  • Pool chemicals
    • Category IV (Do-It-Yourself and Hobby Items)
  • Adhesives, glues, and sealants
  • Care and repair products for automobiles, furniture, and jewellery
  • Button batteries
  • Colouring materials
  • Fabric dyes, tattoo dyes
  • Paints, varnishes, and thinners
  • Paint stripper
  • Rust remover/degreasers

 

 

 

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).

Malaysia’s Department of Occupational Safety and Health (DOSH) is consulting on amendments to its health and safety regulations. The main purpose behind this is to align the regulations with the eighth revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 8). The proposal has public consultation between 15 August and 15 October 2022. The DOSH of Malaysia has yet to provide an official proposed implementation date. Moreover, it is currently unclear whether a transitional period will be in place.

The DOSH is a department under the Ministry of Human Resources. This department is responsible for ensuring the safety, health, and welfare of people at work as well as protecting other people from the safety and health hazards arising from work activities.

The Occupational Safety and Health (Classification, Labelling, and Safety Sheets) Regulations 2013 will be impacted by the suggested modifications. They fall under the Occupational Safety and Health Act of 1994 (OSHA) that entered into force on 12 October 2013 in which the agency implements to regulate workplace safety.

These regulations are also known as CLASS. The regulations were published in the Federal Gazette (http://www.federalgazette.agc.gov.my/) on 11 October 2013. They are based on the 3rd revised edition of the GHS (GHS 3). The nation aims to start enforcing its modified OSHA as of 13 June 2022.  as part of its national goal to increase safety for individuals managing chemicals in the workplace.

Among other changes, the DOSH of Malaysia plans to introduce the following changes to its previous GHS implementation following the building-block approach:

  • Subcategorization for flammable gases, category 1 in 1A and 1B.
  • Addition of new hazard categories, pyrophoric gases, and chemically unstable gases, within the hazard class flammable gases.
  • Addition of category 3 to the Aerosol classification.
  • Addition of the desensitized explosive hazard classification.
  • Implementation of Skin irritation, category 3.
  • Subcategorization of Eye irritant, category 2 in 2A and 2B.
  • Subcategorization of Respiratory/Skin sensitization category 1 in 1A and 1B.

On February 10, 2022, the Regulation of the Minister of Trade No. 7 of 2022 Concerning Distribution and Control of Hazardous Substances was enacted in Indonesia and came into effect on the same day. This regulation is about regulating the distribution of certain hazardous substances. 

Businesses working with such chemicals are required to get a business permit in order to handle those substances, label hazardous substances, attach SDS to hazardous substances, and to report the results of distribution. Since there is enforcement of this regulation, the existing Regulations of the Minister of Trade No. 44 of 2009 and No. 47 of 2019 are invalidated. 

Hazardous substances refer to chemical substances, biological substances, and substances in the form of pure substances or mixtures that are toxic, carcinogenic, teratogenic, mutagenic, corrosive, and irritating and that may directly or indirectly endanger human health and the environment. 

The specific list of hazardous substances can be found in attachments of this particular regulation. 

Distribution requirements for hazardous substances 

Distribution of hazardous substances is only possible by registered hazardous substances distributors, companies that are dealing with hazardous substances, and registered importers of such hazardous substances: 

  • Registered hazardous substances distributors: 

This consists of large-scale commercial enterprises handling hazardous substances that hold a business identification number under the Indonesia Standard Industrial Classification No. 46653 for hazardous substances distribution. 

  • Industrial companies handling hazardous substances: 

This consists of local people that work in chemical industries in Indonesia and handle hazardous substances as part of their work in accordance with the industrial sector regulations. 

  • Registered hazardous substances importers: 

This consists of enterprises that possess a business identification number valid as an import identification number and that are engaged in the import and distribution of hazardous substances. 

Registered hazardous substances distributors are supposed to obtain a business permit to handle hazardous substances from the Minister of Trade for the distribution of hazardous materials. The application for the permit shall be made online at https://oss.go.id/

The documents that are required along with the application are as follows: 

  • a letter of appointment from an industrial company that handles hazardous substances 

  • a written description of the storage, and a document indicating possession of an emergency response system 

  • For industrial companies handling hazardous substances and registered hazardous substances importers, only a business permit in accordance with the law is required. 

 

For hazardous substances listed in Attachment I, among the regulated hazardous substances, industrial companies handling hazardous substances or registered hazardous substances importers may distribute hazardous materials directly to businesses that use them as raw substances. Alternatively, they may be distributed through registered hazardous substances distributors as the intermediary. Hazardous materials listed in Attachment II must be distributed directly from industrial companies handling hazardous substances or registered hazardous substances importers to businesses that use them as raw substances. In other words, registered hazardous substances distributors cannot handle these hazardous materials. 

When hazardous substances are distributed, it is an obligation to attach a Safety Data Sheet (SDS) and label on packaging. The label must contain the following points: 

  • Type of hazardous materials. 

  • Name and address of registered hazardous substances distributors, industrial companies handling hazardous substances, or registered hazardous substances importers packing the hazardous substances. 

  • Net weight or volume of the hazardous substances. 

  • Application, hazard pictogram/symbol, signal words, and hazard statement 

 

Reporting of hazardous substances distribution results 

Registered hazardous substances distributors, industrial companies handling hazardous substances, and registered hazardous substances importers are required to report the distribution results of hazardous substances online at https://sipt.kemendag.go.id/

Registered hazardous substances distributors are supposed to report the number of hazardous substances obtained from industrial companies handling hazardous substances or registered hazardous substances importers. 

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