Malaysia Chemical Regulations: EHS Notification & Registration (EHSNR) Overview

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 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.