Malaysia Regulatory News

On 16 January 2024, the National Pharmacy Regulatory Division in Malaysia released the cosmetic notification on ‘Guidelines for Control of Cosmetic Products in Malaysia’ (Circular No. 1/2024). The...

On 16 January 2024, the National Pharmacy Regulatory Division in Malaysia released the cosmetic notification on ‘Guidelines for Control of Cosmetic Products in Malaysia’ (Circular No. 1/2024). The amendments are made to Annex II, III, IV, VI, and VII of the ASEAN Cosmetic Directive (ACD). The ASEAN Cosmetic Committee agreed to make some amendments to the ACD back in November 2023.

The amendments are as follows

Key points:

The authority has reminded the cosmetic notification holders to comply with all regulations as mentioned in Regulation 18A of the Drug and Cosmetic Control Regulations 1984 to avoid any difficulties.

On 21 December 2023, the Department of Occupational Safety and Health (DOSH) in Malaysia is opened a consultation on a proposed revision to its standards for the safe storage of packaged hazardous che...

On 21 December 2023, the Department of Occupational Safety and Health (DOSH) in Malaysia is opened a consultation on a proposed revision to its standards for the safe storage of packaged hazardous chemicals. The deadline for the consultation is 19 January 2024 . Businesses should use the DOSH website to submit comments.

Purpose of the Consultation

The purpose of the consultation is to gather views on whether the guidelines are still relevant. The DOSH wants to make sure that the existing rules are appropriate, particularly with regard to the classification and communication of chemical hazards and the storage and management of warehouses. The goal of the update is to increase workplace safety as part of the DOSH's Occupational Safety and Health Master Plan 2021–2025.

Some background

The guidelines were introduced in 2005 by the Job Safety and Health Department, Malaysian (JKKP). They were prepared by officials from the Department of Environment, the Malaysian Chemicals Department , the Fire and Rescue Department of Malaysia, the National Pharmaceutical Control Bureau, and the JKKP in collaboration with industry representatives such as the Chemical Industries Council of Malaysia and 3 M Malaysia. The guidelines are meant to assist businesses to comply with the following acts and regulations:

• Occupational Safety and Health Act (OSHA) of 1994.
• Occupational Safety and Health (Use and Standards of Exposure to Chemicals Hazardous to Health) Regulations 2000.
• Occupational Safety and Health (Control of Major Hazards in Industry) Regulations 1996.

Malaysia launched the newly redesigned MyEHS Environmentally Hazardous Substance (EHS) registration system was introduced on September 5, 2023. The website has been redesigned, and organisations can n...

Malaysia launched the newly redesigned MyEHS Environmentally Hazardous Substance (EHS) registration system was introduced on September 5, 2023. The website has been redesigned, and organisations can now register, log in, and complete the required steps. As part of the new MyEHS, companies will be asked to provide information on the production and import of chemicals that are subject to certain frameworks, mostly international treaties.

Objective of the MyEHS system

The objective of the MyEHS system is to ensure that manufacturers and importers notify the authorities about the production and import of EHS, and provide the information required for the safe and sound management of EHSs to protect the environment and public health.

Malaysian EHS Reference List

The Malaysian EHS Reference List will be established by the Department of Environment (DOE) based on data provided by industry. The list will include the names of the substance reported to DOE, their uses in Malaysia, their hazard classification, and the total amount of these chemicals sold in Malaysia. The public will have access to the data stored in this system.

The EHS Reference List contains the following list of chemical compounds that are covered by MyEHS:

• Substances included in the Rotterdam Convention's Annex III
• Chemicals regulated by the Minamata Convention on Mercury
• Chemicals listed in Annexes I and V of the EU PIC Regulation (Regulation (EU) No 649/2012) 
• Chemicals included in Annexes A, B, and C of the Stockholm Convention
• Additional substances designated by the DOE Director General as substances  of concern (such as chemicals included in the Customs (Prohibition of Import) Order 2023 and the Customs (Prohibition of Export) Order 2023)

Moreover, substances covered under the following Acts are excluded from MyEHS because the relevant authorities have previously received the information separately:

• Pesticides Act (1974)
• Poisons Act (1952)
• The Atomic Energy Licensing Act (1984)
• The Chemical Weapons Convention Act (2005)

On 6 September 2023, the Malaysian Department of Occupational Safety and Health (DOSH) published its proposed amendments to the Industry Code of Practices of Chemicals Classification and Hazard Commun...

On 6 September 2023, the Malaysian Department of Occupational Safety and Health (DOSH) published its proposed amendments to the Industry Code of Practices of Chemicals Classification and Hazard Communication (ICOP), Parts 2 and 3. The consultation on the proposed amendments is open until 10 November 2023. The eighth revised edition of the UN’s Globally Harmonized System (GHS) for Classification and Labelling of chemicals served as a building block for the development of these changes.

ICOP Regulation

In order to comply with the Occupational Safety and Health (Classification, Labelling and Safety Data Sheet of Hazardous Chemicals) Regulations 2013 (CLASS Regulations), the Industry Code of Practices of Chemicals Classification and Hazard Communication, 2014 (ICOP) is a legally binding document that must be followed. Generally speaking, the CLASS Regulations provides guidance on chemical classification and hazard communication, as well as a list of chemical substances that have been officially classified.

The following four Parts along with an Appendix create the ICOP:

Part 1: Classified Chemicals List

Part 2: Chemical classification

Part 3: Hazard Communication, labelling and SDS,

Part 4: Confidential Business Information (CBI)

Amendments to Part 2 (Classification of Chemicals) of ICOP

In Part 2 of the ICOP, the main amendments to the hazard classes in terms of definitions and classification methods are as follows:

• Physical Hazards: Explosives/Flammable gases/Flammable liquids/Flammable solids/Oxidizing gases/Oxidizing solids/Gases under pressure/Self-reactive substances/Substances which in contact with water emit flammable gases/Organic peroxides/Substances corrosive to metal
• Environmental Hazards: Hazardous to the aquatic environment/Hazardous to the ozone layer
• Health Hazards: Acute toxicity/Skin corrosion or irritation/Serious eye damage or eye irritation/Respiratory sensitization/Skin sensitization/Germ cell mutagenicity/Carcinogenicity/Reproductive toxicity/Specific target organ toxicity (single exposure)/Specific target organ toxicity (repeat exposure)/Aspiration toxicity

Amendments to Part 3 (Hazard communication) of ICOP

In addition to amendments related to labelling, the guidance for the creation of Safety Data Sheets (SDS) has been amended. Some of the changes are as follows:

• Section 1: The following paragraph was added: The product identifier used for the chemical shall match with the product identifier used on the label (3.7.1.1.4)
• Section 4:  Guidance on first-aid measures was added.
• Section 6: Advice related to suitable fabric for personal protective clothing was added (3.7.6.1.2).
• Section 8:  Guidance on air monitoring procedures was added (3.7.8.1.1). ‘Exposure monitoring’ has been modified to ‘air monitoring’.
• Section 9:  Advice on the properties that should be included and the appropriate units of measure and/or reference conditions was added.
• Section 11:  Guidance on hazard information to be provided was corrected
• Section 14: Guidance on bulk transport was added

Amendments to the ICOP Appendix

In addition, with regard to Parts 2 and 3, the Appendix was also amended as follows:

• Appendix 2.2 Guidance on classification of carcinogenicity.
• Appendix 2.3 Example of Classification Record
• H315 + H320 (causes skin and eye irritation) were removed from Appendix 3.1 (List of hazards).
• Appendix 3.2 (List of Precautionary statements) several entries were deleted, replaced or amended, and new entries were added.
• Appendix 3.3 has been replaced by instructions for choosing precautionary statements for labelling.
• Appendix 3.4: Label elements for each hazard class
• Appendix 3.5: Examples of label element arrangements

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.