Regulatory Services for Chemical Products & Mixtures 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 drug/OTC/general consumer products/drug/cosmetic and medical devices. Surface disinfectants to be used on the non-porous surface are regulated by National Pharmaceutical Regulatory Agency and require registration. Detergents and household cleaning products are categorized as general consumer products and do not require registration/notification however 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 regulations like the Occupational Safety and Health (Classification, Labeling and Safety Data Sheet 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 classification 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 changing global Regulatory dynamics for chemical products, Freyr can extensively support and provide the end-to-end scientific and chemical Regulatory services in Malaysia.

Categories

Biocide/ Disinfectant

Detergents

/Cleaning products

General consumer Products

Chemicals

Regulation

NPRA registration (National Pharmaceutical Regulatory Agency)

  • 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 EHS list (environment hazard substance)

 

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 Requirement

Yes (voluntary)

No

No

Yes  (currentvoluntaryary)

Process in Brief

Online (The submission is by appointment only)

N/A

N/A

Online (company can notify the My EHS system online for chemicals)

Local Representative

Yes

N/A

N/A

Yes

Key Data Requirements

Efficacy/ chemistry and toxicology requirements.

Safety Information about the product, Biodegradability, and phosphate content.

Safety Information about the product.

Required information (Substances on 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

 

Timeline

4 - 6 months approximately

N/A

N/A

5 working days

H.S. Code

Multiple

Examples: Disinfectant 3808, 3307

3401 and 3402

Multiple

Multiple

Examples:

3903, 29, 38

The Occupational Safety and Health (Classification, Labelling and Safety Data Sheet of Hazardous Chemicals) Regulations 2013 (CLASS Regulations) officially introduced GHS into Malaysia and required mandatory notification of hazardous chemicals.

Expertise

Freyr Expertise

  • Product classification and Regulatory guidance
  • Regulatory strategies for market access/product launch
  • Product notification/chemical product registration strategies.
  • Regulatory applicability review and interpretation
  • Prepare technical data files (specifications, MSDS, etc.), including chemical product registration Malaysia/notification dossiers
  • Application preparation and submission for relevant introductions and renewals
  • Sustainability and packaging solutions
  • Regulatory intelligence
Freyr Advantages
Advantages

Freyr Advantages

  • Local presence in the market with relevant expertise and experience.
  • End-to-end Regulatory consultation
  • Easily navigate 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 Regulatory services for chemicals in Malaysia