Chemical Registration in Malaysia


Chemical Registration in Malaysia - Overview

Cleaning and disinfectant products are called/identified and regulated differently across countries and regions, making it very challenging for the industry to place these products in different markets.

In Malaysia, these products are classified differently as per the claims/user instructions and raw materials and may fall under drugs/OTC/general consumer products/cosmetics and medical devices. Surface disinfectants to be used on the non-porous surface are regulated by National Pharmaceutical Regulatory Agency (NPRA) and require registration. Detergents and household cleaning products are categorized as general consumer products and do not require chemical registration/notification. However, they require compliance with standards like MS 2633:2018 (Household laundry detergent powder – Specification).

In addition to that, chemicals associated with product formulation/mixture are subject to other chemical regulation in Malaysia like the Occupational Safety and Health (Classification, Labeling, and Safety Data Sheet (SDS) of Hazardous Chemicals) Regulations 2013 and the Department of Environment MyEHS chemical notification. These cover all substances that are not covered by other notification or registration system in Malaysia and fulfilling the criteria for classification according to GHS and further does not cover substances for which notification is already performed.

Furthermore, regarding disinfectant active ingredients, they must be listed under Appendix I of this NPRA guidance or recognized by relevant authorities such as the European Chemical Agency (ECHA) and Environmental Protection Agency (EPA).

Keeping abreast with the stringent and dynamic chemical regulation in Malaysia, Freyr can extensively support and provide end-to-end scientific and chemical Regulatory services in Malaysia.

Table 1: Chemical Regulation in Malaysia - Overview

CategoriesBiocide/ DisinfectantDetergents/Cleaning productsGeneral Consumer ProductsChemicals
Regulation National Pharmaceutical Regulatory Agency (NPRA) Registration.
  • The Consumer Protection Law 1999 (Act 599).
  • Environmental Quality (Prohibition on the Use of Controlled Substance in Soap, Synthetic Detergent, and Other Cleaning Agents) Order 1995 and its Subsequent Amendment.
CONSUMER PROTECTION ACT 1999.

Department of Environment -Environment Hazard Substance (EHS) List.

 

Occupational Safety and Health (Classification, Labelling and Safety Data Sheet of Hazardous Chemicals) Regulations 2013.

 

The Industry Code of Practice on Chemical Classification and Hazard Communication 2014.

Registration RequirementYes (voluntary).NoNoYes (currently voluntary).
Process in BriefOnline (The submission is by appointment only).N/AN/AOnline (The company can notify the MyEHS system online for chemicals).
Local RepresentativeYesN/AN/AYes
Key Data RequirementsEfficacy/Chemistry and Toxicology Requirements.Safety Information About the Product, Biodegradability, and Phosphate Content.Safety Information About the Product.

Required Information (Substances on the EHS Reference List):

  • Substance identification information: (CAS number, EC number. or Code number).
  • Annual tonnage.
  • Use of the substance.
  • Concentration range of the substance in raw material or finished products.
  • Country of export (if imported).

 Required information (Substances not on EHS reference list):

  • All documents required by basic notification.
  • Molecular formula, molecular weight, & molecular structure information.
  • Physical and chemical properties.
  • Physical and chemical category.
  • Hazard information to human health.
  • Hazard information to the environment.
  • GHS classification.

 

Timeline4 - 6 months approximately.N/AN/A5 working days.
H.S. Code

Multiple

Examples: Disinfectant 3808, 3307, etc.

3401 and 3402Multiple

Multiple

Examples:

3903, 29, 38, etc.

The Occupational Safety and Health (Classification, Labeling, and Safety Data Sheet of Hazardous Chemicals) Regulations 2013 (CLASS Regulations) officially introduced GHS in Malaysia, which required mandatory notification of Hazardous Chemicals.

Freyr Expertise

  • Product Notification, Product Classification, and Regulatory Guidance.
  • Regulatory Strategies for Market Access/Product Launch.
  • Classification of Hazardous Chemicals.
  • Regulatory Applicability Review and Interpretation.
  • Prepare Technical Data Files (specifications, MSDS, etc.), including Chemical Product Registration/Notification Dossiers.
  • Application Preparation and Submission for Relevant Introductions and Renewals.
  • Sustainability and Packaging Solutions.
  • Regulatory Intelligence Services.

Freyr Advantages

  • Local presence in the market with relevant expertise and experience.
  • End-to-end Regulatory consultation for chemical registration in Malaysia.
  • Easily navigate the complexities of Regulatory Authorities.
  • Support for region-specific Regulatory complexities.
  • A structured and cost-effective approach to ensure compliance in multi-market scenarios.
  • Quick turnaround and faster time-to-market.
  • Expert advice on hazardous chemical regulations.

Our Location in Malaysia

Suite 163E, Level 16,
Gurney Paragon Office Tower,
Jalan Kelawei, 10250 George Town,
Pulau Pinang, Malaysia

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