Malaysia Regulatory News

On 5 February 2025, Malaysia notified the World Trade Organization of an amendment to the Food Regulations 1985 to enforce stringent food safety protocols for imported food. This amendment is in line ...

On 5 February 2025, Malaysia notified the World Trade Organization of an amendment to the Food Regulations 1985 to enforce stringent food safety protocols for imported food. This amendment is in line with existing national hygiene regulations (Malaysia Food Hygiene Regulations of 2009) to ensure the safety and quality of imported food products. 

Mandatory Food Safety Assurance Programs 
The amendment to the Food Regulations 1985 mandates that food products intended for import into Malaysia must be produced in facilities that adhere to a recognized food safety assurance program as determined by the Ministry of Health’s Food Safety and Quality Program. Such assurance systems include, but are not limited to, frameworks such as Food Safety Systems Management (FSSM), Hazard Analysis and Critical Control Points (HACCP), and Good Manufacturing Practices (GMP). 

This requirement is consistent with the provisions set of the Malaysia Food Hygiene Regulations of 2009, which mandate local manufacturers to maintain and implement validated protocols to ensure food safety within production facilities. 

The Food Safety and Quality Program has the regulatory power to conduct inspections and audits of the manufacturing facilities to ensure compliance with these standards. This could entail direct discussions with pertinent authorities in the exporting country or on-site audits of overseas production facilities. 

Importer Responsibilities  
Importers are required to provide or maintain records demonstrating that the facilities are in compliance with an approved food safety assurance program. Failure to comply may lead to regulatory actions or the rejection of imported food products. 

The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has issued Circular No. 3/2024, detailing significant updates to the "Guidelines for Control of Cosmetic Products in Malaysia". These r...

The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has issued Circular No. 3/2024, detailing significant updates to the "Guidelines for Control of Cosmetic Products in Malaysia". These revisions, effective from December 30, 2024, introduce new bans and restrictions on certain substances used in cosmetic products.

Newly Prohibited Substances

Effective November 19, 2026, the NPRA has added several substances to the list of prohibited ingredients in cosmetic products. These include:

• Benzophenone (CAS No. 119-61-9): Previously used as a UV blocker in various cosmetic formulations.

• N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid) (Pentetic acid) (CAS No. 67-43-6): Widely used for its chelating properties.

In total, 26 substances have been newly prohibited under these Directives.

Restricted Substances with Implementation Deadlines

The NPRA has also imposed specific restrictions on certain substances, with defined implementation deadlines:

• Butylated Hydroxytoluene (BHT) (CAS No. 128-37-0):

  • Mouthwash: Maximum concentration of 0.001%.

  • Toothpaste: Maximum concentration of 0.1%.

  • Leave-on and Rinse-off Products: Maximum concentration of 1%.

  • Restrictions will be enforced starting November 19, 2026.

• Homosalate (UV Filter) (CAS No. 118-56-9):

  • Facial Products (excluding propellant sprays): Maximum concentration of 7.34%.

  • Restriction will take effect on November 19, 2027.

Compliance and Enforcement

The NPRA emphasizes that all entities involved in the manufacture, sale, supply, import, or possession of cosmetic products must adhere to these updated guidelines. Non-compliance may result in regulatory action, including product recalls or penalties.

These regulatory changes are in line with decisions made at the 40th ASEAN Cosmetic Committee Meeting in November 2024, and reflect Malaysia's commitment to regional harmonization and consumer safety.

For detailed information and the complete list of affected substances, stakeholders are encouraged to consult the official NPRA directive here.

On 21 November 2024, the two-year grace period for cosmetic products to comply with the updated ASEAN Cosmetic Directive (ACD) ended. The updates were introduced during the 36th ASEAN Cosmetic Committ...

On 21 November 2024, the two-year grace period for cosmetic products to comply with the updated ASEAN Cosmetic Directive (ACD) ended. The updates were introduced during the 36th ASEAN Cosmetic Committee (ACC) meeting and its related sessions in November 2022. Products that do not meet the updated standards must be withdrawn immediately. The amendments reflect the ASEAN region’s approach to aligning with global safety standards and protecting the health of consumers in its 10 member states.

Key Updates to the ACD

• Annex II – List of substances which must not form part of the composition of cosmetic products

A consolidated list of 37 substances previously banned in the EU, has been added to Annex II of the ACD. These include entries from EU regulations (2019/831, 2019/1966, 2021/850, 2021/1902) that are not currently used in ASEAN countries. Specific compounds such as perboric acid, sodium perborate, boron compounds, octamethylcyclotetrasiloxane (D4), and p-BMHCA have also been included in Annex II.

• Titanium Dioxide Regulation

Revised safety criteria for the use of titanium dioxide as a colouring agent (Annex IV) and as a UV filter (Annex VII) have been adopted as per EU standards.

• Salicylic Acid Regulation

New limits have been introduced for salicylic acid in the Restricted Substance List (Annexes III) and in the Preservatives list (Annex VI), used in body creams, lotions, and other specific applications.

Implications for Industry

Cosmetic manufacturers, traders, and distributors were granted a two-year grace period to reformulate, test and phase out non-compliant products. With the end of this period concluded, compliance is now mandatory, ensuring that products meet updated safety requirements.

Detailed guidelines for compliance can be found here.

The Malaysian Ministry of Health has proposed amendments to the Sixteenth Schedule of the Food Regulations 1985, specifically concerning pesticide residue limits in food products.   Key Highlig...

The Malaysian Ministry of Health has proposed amendments to the Sixteenth Schedule of the Food Regulations 1985, specifically concerning pesticide residue limits in food products.

Key Highlights of the Proposal

The main changes include:

1. Introduction of New Maximum Residue Limits (MRLs):  The proposal adds MRLs for new pesticides such as famoxadone, isocycloseram, isoprothiolane, propanil, quinclorac, and others. These MRLs are designed to regulate the levels of these pesticides in various food products.

2. Expansion of Existing MRLs: The amendments also update the MRLs for existing pesticides, adding new limits for additional commodities. Pesticides such as abamectin, ametoctradin, thiamethoxam, and tebuconazole will now have MRLs for a wider range of food items.

Deviation from International Standards

The proposed MRLs are not always consistent with international standards, particularly the Codex Alimentarius, which provides globally recognized guidelines for food safety, including pesticide residue levels. Some MRLs proposed by Malaysia deviate from Codex standards or are not available internationally. For example, the MRLs for famoxadone in tomatoes, quinclorac in milled rice, and tebuconazole in mangoes differ from Codex due to differences in agricultural practices and local residue trials conducted in Malaysia and other regions.

Compliance and Prohibited Practices

The proposed amendments also clarify the definition of "pesticide" and reinforce that no food should be exposed to pesticide residue levels that exceed the limits set out in the Sixteenth Schedule. Additionally, it is prohibited to import, prepare, or sell food containing pesticide residues as follows:

• Pesticide residues exceeding the limits specified in the Sixteenth Schedule.

• Pesticide residues higher than those recommended in the Codex Alimentarius, where the pesticide is not listed in the Sixteenth Schedule.

• Pesticide residues greater than 0.01 mg/kg of if the pesticide is not specified in either the Sixteenth Schedule or Codex Alimentarius.

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.