Malaysia Regulatory News

Effective 1 June 2024, Malaysia has implemented a ban on the import of two medical devices containing mercury: thermometers and sphygmomanometers which are commonly used to measure blood pressure. Thi...

Effective 1 June 2024, Malaysia has implemented a ban on the import of two medical devices containing mercury: thermometers and sphygmomanometers which are commonly used to measure blood pressure. This prohibition is part of the 'Customs (Prohibition of Imports) (Amendment) (No 2) Order 2024', which was published in the Federal Government Gazette on May 23, 2024.  

New Items Added to Import Prohibition List 

The amendment introduces 'item no 17' into the First Schedule of the 'Customs (Prohibition of Imports) Order 2023'. This category lists various prohibited items, including toxic chemicals and specific minerals that are prohibited from entering Malaysia. Mercury-containing thermometers and sphygmomanometers are now classified under this new item as 'Products under the Minamata Convention'. 

Phase-Out under the Minamata Convention 

Malaysia's decision is in line with its commitment to the UN's Minamata Convention, an international designed to protect human health and the environment from the adverse effects of mercury. The convention mandates the phase-out of certain mercury-containing products, with these specific medical devices being targeted for elimination under the treaty by 2020. 

On June 18, 2024, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) updated the list of restricted substances for cosmetics under the country’s Guidelines for Control of Cosmetic Product...

On June 18, 2024, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) updated the list of restricted substances for cosmetics under the country’s Guidelines for Control of Cosmetic Products in Malaysia. In a Pekeliling Bill 2/2024 circular, the NPRA detailed the changes to four substances, their associated concentration limits in ready-for-use preparations, and the effective dates of the revisions as follows:

The NPRA stated in its notice that companies that manufacture, sell, provide, import or own cosmetics must comply with all of the criteria. Cosmetic Notification Holders are reminded to follow all instructions and restrictions set out in Regulation 18A of the 1984 Drug and Cosmetic Control restrictions, as well as the Malaysian Cosmetic Product Control Guidelines.
The updates reflect decisions made during the 39th ASEAN Cosmetic Committee (ACC), which convened virtually on May 20 and 21, 2024. At the ACC it was agreed to amend several substances in Annex III of the ASEAN Cosmetics Directive (ACD).

The Occupational Safety and Health (Amendment) Act 2022 (OSHA 2022), which amends the Occupational Safety and Health Act 1994, will come into effect on June 1, 2024, according to a notification issued...

The Occupational Safety and Health (Amendment) Act 2022 (OSHA 2022), which amends the Occupational Safety and Health Act 1994, will come into effect on June 1, 2024, according to a notification issued by the Malaysian Department of Occupational Safety and Health (DOSH) on April 2, 2024. Although the Act was promulgated on March 16, 2022, its implementation was pending until now.  

A notice of the enforcement date of the Factories and Machinery (Repeal) Act 2022, which repeals the Factories and Machinery Act 1967, was also issued on April 2. In addition, two new regulations based on OSHA 2022 will be introduced: 

• Occupational Safety and Health (Licenced Person) Order 2024  

• Occupational Safety and Health (Plant Requiring Certificate of Fitness) Regulations 2024.  

All these Acts and regulations will come into effect on June 1, 2024. 

Occupational Safety and Health (Amendment) Act 2022 

The following are the main changes to the Act that affect employers.  

• Obtain permit from the Director-General of the Department of Occupational Safety and Health (DOSH) before constructing or operating a specified facility. Then, issue a Certificate of Fitness (refer to the guidelines below). 

• In businesses with five or more employees where the appointment of a safety and health officer is not required, a safety and health coordinator should be appointed. If an employer fails to appoint a coordinator, the employer could be fined up to RM50,000, face six months in prison or both.   

• A person must register as a competent person if he or she carries out any of the tasks listed in Appendix 5 (installation, operation, disassembly, maintenance, etc. of a plant, medical surveillance, assessment of exposure to hazardous substances, noise, etc.) 

• Occupational safety and health training is required for designated workers; details are set out in separate laws and regulations, which have not yet been published.

Occupational Safety and Health (Plants Requiring a Certificate of Fitness) Regulations 2024 

The main points of the regulation are: 

• Applies to steam boilers, pressure vessels, and lifting gear. 

• Requires inspection by a licensed individual before installation. 

• Information on the design of the installation must be submitted to the Director General of DOSH for a Certificate of Fitness, which is valid for 15 months. 

• A periodic inspection is required to renew the certificate before it expires. 

Occupational Safety and Health (Licenced Person) Order 2024 

The main content of this Order is: 

• Details the appointment and duties of licensed individuals responsible for plant inspections. 

• Lists the verification requirements for plant inspections. 

Factories and Machinery (Repeal) Act 2022 

 This The Factories and Machinery Act 1967 is to be repealed in order to maintain consistency between laws and regulations as it contains requirements similar to those in the Occupational Safety and Health Act of 1994. It will be replaced by the Factories and Machinery (Repeal) Act 2022. 

On April 2, 2024, the Malaysian Department of Occupational Safety and Health (DOSH) announced in the Federal Government Gazette that Malaysia's Occupational Safety and Health (Amendment) Act 2022 ...

On April 2, 2024, the Malaysian Department of Occupational Safety and Health (DOSH) announced in the Federal Government Gazette that Malaysia's Occupational Safety and Health (Amendment) Act 2022 (OSHA 2022) will come into effect on June 1, 2024. The Factories and Machinery (Repeal) Act 2022 and the Occupational Safety and Health (Licensed Person) Order 2024 will also come into force on the same date. 

The Factories and Machinery (Repeal) Act 2022, provides general guidance for the handling and storage of chemicals and equipment in the  workplace. The Occupational Safety and Health (Licenced Person) Order 2024, outlines the duties and obligations of the licensed person who inspects premises to ensure that  equipment and working conditions meet the required standards.  

Amendments in OSHA 2022 

The current OSHA 1994, which covers only ten industries, i.e. manufacturing, mining and quarrying, construction, and agriculture—will be amended by OSHA 2022. OSHA 2022 was passed in Parliament on March 16, 2022, and as mentioned above, will enter into force on June 1, 2024. 

In order to increase worker safety, OSHA 2022 will apply to all industry sectors and all places of work throughout Malaysia. Among the amendments are:  

• Inclusion of a new provision to enhance the protection for employees, allowing them to remove themselves from danger (Section 26A) 

• Compulsory risk evaluations aimed at  identifying suitable risk control strategies.;  

• Ensuring protection and well-being of labourers throughout the storage and transportation of chemicals. 

• Providing knowledge, guidance, education, training, and oversight to safeguard employees'’ health and safety (Section 31A). 

• Establishing a secure working environment to protect employees'’ health.

• Establishing and carrying out of emergency protocols 

• Designating a coordinator for workplace health and safety (Section 29A).  

• Revised fines for non-compliance. Employers can be fined a maximum penalty of RM 500,000 as opposed to RM 50,000 under OSHA 1994. Fines for employees will also increase from the current RM 1,000 to a maximum of RM 2,000.  

On 16 January 2024, the National Pharmacy Regulatory Division in Malaysia released the cosmetic notification on ‘Guidelines for Control of Cosmetic Products in Malaysia’ (Circular No. 1/2024). The...

On 16 January 2024, the National Pharmacy Regulatory Division in Malaysia released the cosmetic notification on ‘Guidelines for Control of Cosmetic Products in Malaysia’ (Circular No. 1/2024). The amendments are made to Annex II, III, IV, VI, and VII of the ASEAN Cosmetic Directive (ACD). The ASEAN Cosmetic Committee agreed to make some amendments to the ACD back in November 2023.

The amendments are as follows

Key points:

The authority has reminded the cosmetic notification holders to comply with all regulations as mentioned in Regulation 18A of the Drug and Cosmetic Control Regulations 1984 to avoid any difficulties.

On 21 December 2023, the Department of Occupational Safety and Health (DOSH) in Malaysia is opened a consultation on a proposed revision to its standards for the safe storage of packaged hazardous che...

On 21 December 2023, the Department of Occupational Safety and Health (DOSH) in Malaysia is opened a consultation on a proposed revision to its standards for the safe storage of packaged hazardous chemicals. The deadline for the consultation is 19 January 2024 . Businesses should use the DOSH website to submit comments.

Purpose of the Consultation

The purpose of the consultation is to gather views on whether the guidelines are still relevant. The DOSH wants to make sure that the existing rules are appropriate, particularly with regard to the classification and communication of chemical hazards and the storage and management of warehouses. The goal of the update is to increase workplace safety as part of the DOSH's Occupational Safety and Health Master Plan 2021–2025.

Some background

The guidelines were introduced in 2005 by the Job Safety and Health Department, Malaysian (JKKP). They were prepared by officials from the Department of Environment, the Malaysian Chemicals Department , the Fire and Rescue Department of Malaysia, the National Pharmaceutical Control Bureau, and the JKKP in collaboration with industry representatives such as the Chemical Industries Council of Malaysia and 3 M Malaysia. The guidelines are meant to assist businesses to comply with the following acts and regulations:

• Occupational Safety and Health Act (OSHA) of 1994.
• Occupational Safety and Health (Use and Standards of Exposure to Chemicals Hazardous to Health) Regulations 2000.
• Occupational Safety and Health (Control of Major Hazards in Industry) Regulations 1996.

Malaysia launched the newly redesigned MyEHS Environmentally Hazardous Substance (EHS) registration system was introduced on September 5, 2023. The website has been redesigned, and organisations can n...

Malaysia launched the newly redesigned MyEHS Environmentally Hazardous Substance (EHS) registration system was introduced on September 5, 2023. The website has been redesigned, and organisations can now register, log in, and complete the required steps. As part of the new MyEHS, companies will be asked to provide information on the production and import of chemicals that are subject to certain frameworks, mostly international treaties.

Objective of the MyEHS system

The objective of the MyEHS system is to ensure that manufacturers and importers notify the authorities about the production and import of EHS, and provide the information required for the safe and sound management of EHSs to protect the environment and public health.

Malaysian EHS Reference List

The Malaysian EHS Reference List will be established by the Department of Environment (DOE) based on data provided by industry. The list will include the names of the substance reported to DOE, their uses in Malaysia, their hazard classification, and the total amount of these chemicals sold in Malaysia. The public will have access to the data stored in this system.

The EHS Reference List contains the following list of chemical compounds that are covered by MyEHS:

• Substances included in the Rotterdam Convention's Annex III
• Chemicals regulated by the Minamata Convention on Mercury
• Chemicals listed in Annexes I and V of the EU PIC Regulation (Regulation (EU) No 649/2012) 
• Chemicals included in Annexes A, B, and C of the Stockholm Convention
• Additional substances designated by the DOE Director General as substances  of concern (such as chemicals included in the Customs (Prohibition of Import) Order 2023 and the Customs (Prohibition of Export) Order 2023)

Moreover, substances covered under the following Acts are excluded from MyEHS because the relevant authorities have previously received the information separately:

• Pesticides Act (1974)
• Poisons Act (1952)
• The Atomic Energy Licensing Act (1984)
• The Chemical Weapons Convention Act (2005)