Malaysia Regulatory News

On July 4, 2023, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published Circular 2/2023, Guidelines for Control of Cosmetic Products, which outright prohibits 19 ingredients, limit...

On July 4, 2023, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published Circular 2/2023, Guidelines for Control of Cosmetic Products, which outright prohibits 19 ingredients, limits three others, and allows the use of two more.

The Guidelines for Control of Cosmetic Products in Malaysia are periodically reviewed and updated to reflect changes made to the ASEAN Cosmetic Directive (ACD) by the National Pharmaceutical Review Agency (NPRA). Both the 36th ASEAN Cosmetics Committee (ACC) meeting, which was conducted electronically on November 30 and December 1, 2022, and the 37th ACC meeting, which took place on May 8 and 9, 2023, had previously agreed to update some of the substances listed in Annex II (List of prohibited substances), III (List of restricted substances), VI (List of preservatives), and VII (List of UV filters) on the ACD.

In Circular 2/2023 19 substances are added to Annex II (Appendix A), i.e. banned.  The full list that is quite similar to EU Amendment to Annex II (DLI 2019/831, EU 2019/1966, and EU 202J/850).can be found here (in Malay). Cosmetics containing components that have been notified are allowed to be sold until May 8, 2025.

Beginning on May 8, 2025, the revision also permits the usage of two additional substances listed in the table below. The two substances have been added to the List of permitted preservatives (Annex VI) and the List of UV filters (Annex VII) respectively.

The updated list of ingredients with restricted concentration allowed in cosmetics as per Annex VI and VII

Three more chemicals, together with their concentration requirements and restrictions, were added to the list of prohibited substances (Annex III) by the NPRA:

For Salicylic acid, as of November 21, 2024, conditions of use and warnings must be stated on product labels.  Methyl-N-m ethyIanthranilate used in leave-on products is restricted from 8 May 2025. The restriction does not apply to products that make claims about secondary UV protection, such as moisturizing and skin-lightening products. Use of ammonium silver zinc aluminium silicate, which is allowed in deodorant (both spray and non-spray types) and foundation is restricted to 1% from 8 May 2025.

The updated list of ingredients with restricted concentration allowed in cosmetics as per Annex III (Appendix B)

All Cosmetic Notification Holders are recommended to make thoughtful arrangements to prevent any potential problems. The holders of cosmetic notifications are reminded to follow all guidelines and legal requirements as outlined in Regulation 18A of the Drugs and Cosmetics Control Regulations of 1984 and the Guidelines for Control of Cosmetics Products in Malaysia.

The Department of Occupational Safety and Health (Dosh) in Malaysia is planning to update the instructions on how to create and submit chemical registers. Under the Occupational Safety and Health Act,...

The Department of Occupational Safety and Health (Dosh) in Malaysia is planning to update the instructions on how to create and submit chemical registers. Under the Occupational Safety and Health Act, manufacturers, suppliers, and users who process, produce, or store hazardous substances at the workplace are required to submit a register to the Director General of DOSH.

The proposed amendments to the Guidelines for the Preparation of a Chemical Register include a requirement that the register be submitted no later than 31 March of the year after their effective date and then each calendar year after that. When enforcement will begin is not known yet, according to the government. Moreover, they make it clear that the following details are necessary: list of chemicals; each chemical's most recent safety data sheet (SDS); average amount processed, generated, or stored per month or year; and chemical's physical state (liquid, gas, or another); the location where it is generated, processed, or stored; chemical hazard categorization; supplier information, and name and address.

The recommendations include a new suggested format in Appendix 1 of the guidelines. This refers to the dissemination of extra information, such as:

Information about the business, the person in charge of creating and approving the register, and a statement from top management that all personnel who could be exposed to hazardous substances would have access to the register.

They should be refreshed consistently, however, no time period was given.

The modifications, which were dependent upon a public discussion from 10 February to 10 March, plan to adjust the rules to the country's Occupational Safety and Health (Classification, Labelling and Safety Data Sheet of Hazardous Chemicals) Regulations, 2013, (CLASS Regulations 2013).

The Occupational Safety and Health (Use and Standard of Exposure Chemical Hazardous to Health) (USECHH) Regulations 2000 set compound substance openness norms to guarantee working environment wellbeing under the Occupational Safety and Health Act 1994 (OSHA 1994).

On 9 December 2022 the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published revised cosmetics control regulations, including new product categories and labelling requirements. The Co...

On 9 December 2022 the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published revised cosmetics control regulations, including new product categories and labelling requirements. The Control of Drugs and Cosmetic Regulations (CDCR) 1984 rules have outlined some standards that the companies who produce, market, sell, import, or keep the products are required to adhere to all those standards.

The following amendments are included in the update:    

• Three new cosmetics product categories have been added: hand sanitisers, sunscreen products, as well as essential oil for skin, hair, and nails.
• Before products may be marketed in Malaysia, they must be labelled in accordance with the regulations. Products in the vials or ampoules must be labelled "for external use only."
• A Halal logo may be used on a notified cosmetic product, but it must be approved by the Malaysia Department of Islamic Development (Jabatan Kemajuan Islam Malaysia, JAKIM), or any Islamic entity recognised by JAKIM.
• In addition, the list of approved components for UV filters, preservatives, and colouring agents has been eliminated.
• The guidelines for Good Manufacturing Practise (GMP) have also been amended. New regional producers and manufacturing lines will now be inspected by the NPRA before being notified under the CDCR.
• The production facility's layout must be established and constructed in accordance with GMP guidelines.
• Manufacturers from other countries will need documentation of GMP compliance from an authorised body.
• Requirements for claims, product recalls and complaints are now included in the updated guidelines.

Acetyl tributyl citrate (ATBC), a common substitute for phthalates when producing plastics, has been found to be a thyroid disruptor during in vivo studies performed by researchers in Malaysia.   ...

Acetyl tributyl citrate (ATBC), a common substitute for phthalates when producing plastics, has been found to be a thyroid disruptor during in vivo studies performed by researchers in Malaysia.  

ATBC has endocrine-disrupting potential in zebrafish and Japanese medaka according to scientists. ATBC is already used in a wide range of applications, including PVC.  

That ATBC may induce abnormal embryo development and disrupt thyroid hormone activity was reported in a paper published in the Journal of Hazardous Materials Advances. In a study fertilized eggs were exposed to ATBC at various concentrations for up to 11 days throughout hatching and the early development phases. After assessing the toxicological endpoints, it was observed that ATBC inhibited thyroid-related gene expression and led to the swim bladder inflating incorrectly. This indicates the potential of ATBC for thyroid hormone-disrupting activity in fish. 

ATBC is a non-phthalate plasticizer that tends to decrease thyroid gene expression whereas, phthalate plasticizers tend to increase it. Phthalates are quite different from ATBC in their molecular structure thus genes are affected differently.  

The relationship between chemical structures and thyroid-related gene expression is not clarified yet according to researchers. Additives such as lead, cadmium, and phthalates that are used in PVC are already banned but the alternative additives also raise concerns due to a lack of data. 

On 6 July 2022 Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has restricted the use of three substances in cosmetics, banned one substance and allowed the use of three others under the...

On 6 July 2022 Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has restricted the use of three substances in cosmetics, banned one substance and allowed the use of three others under the guidelines of the country for Control of Cosmetic Products.

The Circular states that restrictions were put on the use of three chemical substances in cosmetics. It includes climbazole, dihydroxyacetone, and titanium dioxide and will take effect on 11 November 2023. Furthermore, Deoxyarbutin was banned and the ban will take effect on 11 May 2023. The Circular allows the use of the two preservatives climbazole and hydroxyethyl phenyl butanone. The update aligns with changes incorporated in the Asean Cosmetic Directive (ACD) during the 35th Asean Cosmetic Committee virtual meeting held on 25-27 May 2022. 

Restricted Substances:

• Climbazole:

IUPAC name: 1-(4-chlorophenoxy)-1(imidazole-1-yl)-3-3dimethylbutan-2-one

Used in: Rinse off anti-dandruff shampoo (maximum concentration 2 %), Rinse off anti-dandruff conditioner (maximum concentration 0.5 %) as a biocide

Amendment takes effect on: 11 November 2023

• Dihydroxyacetone:

IUPAC Name: 1,3-dihydroxy-2-propanone

Used in: Non-oxidative hair dye products (maximum concentration 6.5 %), self-tanning products (maximum concentration 10 %),

Dyeing eyelashes and eyebrows (Banned)

Amendment takes effect on: 11 November 2023

• Titanium Dioxide:

Used in: Sunscreen and UV blocking pigments, The use of the pigmentary form of the substance is restricted to 25 % in face products containing loose powder, and 1.4 % in hair aerosol spray products intended for use by general users. For products aimed at professional users, the limit is 1.1 %. Manufacturers cannot use the substance in other applications that may lead to lung exposure or inhalation.

Amendment takes effect on: 11 May 2024

Banned Substance:

• Deoxyarbutin, tetrahydropyranyloxy phenol:

IUPAC Name: 4-[(tetrahydro-2H-pyran-2-yl)oxy]phenol

Used in: Skin lightening agents used in cosmetics

Amendment takes effect on:  11 May 2023

Allowed use of Preservatives:

• Climbazole:

IUPAC Name: 1-(4-chlorophenoxy)-1(imidazole-1-yl)-3-3dimethylbutan-2-one

Used in: Hair lotions and face creams (maximum concentration 0.2%) and rinse-off shampoo and hair conditioner (maximum concentration 0.5 %).

Amendment takes effect on:  11 November 2023

• Hydroxyethylphenyl butanone:

IUPAC Name: 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one

Used in: Cosmetics (maximum concentration 0.7 %)

 All the companies which manufacture, sell, distribute, and import cosmetics must comply with all the requirements needed under the guidelines and should notify Malaysia’s National Pharmaceutical Regulatory Agency (NPRA).

Malaysia’s Department of Occupational Safety and Health (DOSH) is consulting on amendments to its health and safety regulations. The main purpose behind this is to align the regulations with the eig...

Malaysia’s Department of Occupational Safety and Health (DOSH) is consulting on amendments to its health and safety regulations. The main purpose behind this is to align the regulations with the eighth revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 8). The proposal has public consultation between 15 August and 15 October 2022. The DOSH of Malaysia has yet to provide an official proposed implementation date. Moreover, it is currently unclear whether a transitional period will be in place.

The DOSH is a department under the Ministry of Human Resources. This department is responsible for ensuring the safety, health, and welfare of people at work as well as protecting other people from the safety and health hazards arising from work activities.

The Occupational Safety and Health (Classification, Labelling, and Safety Sheets) Regulations 2013 will be impacted by the suggested modifications. They fall under the Occupational Safety and Health Act of 1994 (OSHA) that entered into force on 12 October 2013 in which the agency implements to regulate workplace safety.

These regulations are also known as CLASS. The regulations were published in the Federal Gazette (http://www.federalgazette.agc.gov.my/) on 11 October 2013. They are based on the 3rd revised edition of the GHS (GHS 3). The nation aims to start enforcing its modified OSHA as of 13 June 2022.  as part of its national goal to increase safety for individuals managing chemicals in the workplace.

Among other changes, the DOSH of Malaysia plans to introduce the following changes to its previous GHS implementation following the building-block approach:

• Subcategorization for flammable gases, category 1 in 1A and 1B.
• Addition of new hazard categories, pyrophoric gases, and chemically unstable gases, within the hazard class flammable gases.
• Addition of category 3 to the Aerosol classification.
• Addition of the desensitized explosive hazard classification.
• Implementation of Skin irritation, category 3.
• Subcategorization of Eye irritant, category 2 in 2A and 2B.
• Subcategorization of Respiratory/Skin sensitization category 1 in 1A and 1B.

The Department of Environment (DOE) in the Ministry of Environment and Water, Malaysia launched a new website in April 2021. This new website called ‘MyEHS’ was launched after the department clo...

The Department of Environment (DOE) in the Ministry of Environment and Water, Malaysia launched a new website in April 2021. This new website called ‘MyEHS’ was launched after the department closed its Environmental Hazardous Substance Notification and Registration (EHSNR) system.

MyEHS allows the registration of Environmentally Hazardous Substances (EHS) and the search of registered substances list, usage manuals, FAQs, among others. It will also establish a Malaysian reference list where information will be available on the substances notified to DOE, substance usage in Malaysia, hazard classification, and the accumulated quantity in the Malaysian market. All these information are available to the public. The system was formerly operating as ‘EHSNR’ and since 2009, chemical manufacturers/importers have registered their substances voluntarily on the website. 596 chemicals have been registered and 1,365 companies are recognized for EHS notification.

The objective of this system is to provide necessary information on EHS while ensuring that manufacturers/importers notify their substances. All these are aimed at protecting human health and the environment. Notifiers are expected to notify on MyEHS before or on 31^st January of the following year.

Last Update: 2022-02-03