Malaysia Regulatory News

On 23 April 2025, the Department of Environment (DOE), acting as Malaysia’s Competent Authority under the Stockholm Convention, issued a reminder to industries involved in the export and import of c...

On 23 April 2025, the Department of Environment (DOE), acting as Malaysia’s Competent Authority under the Stockholm Convention, issued a reminder to industries involved in the export and import of chemicals classified as Persistent Organic Pollutants (POPs). 

Requirements for Export to Non-Party States 

Exports of POPs to countries that are not Parties to the Stockholm Convention are only permitted if the DOE issues an Annual Certification. This certification serves two essential purposes: 

• It must clearly outline the intended use of the chemical; and 

• It must confirm Malaysia’s commitment to protecting human health and the environment, in line with the Convention’s provisions. 

 
Requirements for Importing Industries  

To initiate the process, the importing industry is required to submit thorough documentation to the Department of Environment (DOE) before applying for import approval. This documentation must include: 

• A complete Safety Data Sheet (SDS) for the chemical; 

• Details on the safe handling, storage, and transportation of the substance; 

• Environmentally responsible disposal plans; 

• Compliance monitoring strategies; and 

• Worker protection measures and any public awareness efforts, if applicable. 

Following the DOE’s review and approval of these documents, the Annual Certification will be granted to the importing industry. The importing industry must then forward the certification and relevant documents to the exporting country. 

Exporting Party's Obligations 

The exporter must submit the certification to their National Authority at least 60 days before starting the export process. At present, all procedures must be carried out manually and not through the MyEHS system (Malaysia’s online environmental management portal). 

This process upholds global standards for the safe and transparent handling of hazardous substances and underscores Malaysia’s commitment to the principles of the Stockholm Convention.

Malaysia’s Department of Environment (DOE) recently published a notice on the portal of the Malaysia Environmentally Hazardous Substances System (MyEHS) outlining the country’s regulatory position...

Malaysia’s Department of Environment (DOE) recently published a notice on the portal of the Malaysia Environmentally Hazardous Substances System (MyEHS) outlining the country’s regulatory position on two persistent organic pollutants (POPs): Dechlorane Plus and UV-328.  

Stockholm Convention Signed but Not Yet Ratified
While Malaysia has signed the Stockholm Convention but has not yet ratified it. Under the Convention, both substances are subject to strict control measures that prohibit their production, use, import, and export, except under certain exemptions. These exemptions must meet the technical and procedural conditions specified in Article 4 of the Convention, including registration with the Stockholm Convention’s Secretariat and a five-year validity period from the Convention’s entry into force for the listed chemicals. 

No Plans to Register Exemptions 
However, since Malaysia has not yet ratified the Convention, the country is not eligible to register any exemptions and currently has no plans to do so. The DOE encourages stakeholders to consult the official Stockholm Convention web portal for further information on allowable exemptions. For local regulatory guidance on the production or use of these chemicals, stakeholders should contact the Chemical Management Division of the Department of Occupational Safety and Health (DOSH). 

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.