ASEAN Cosmetics Notification

The Association of Southeast Asian Nations (ASEAN) consists of 10 countries, including,

• Brunei;
• Cambodia;
• Indonesia;
• Laos;
• Malaysia;
• Myanmar;
• Philippines;
• Singapore;
• Thailand; and
• Vietnam.

In 2003, these countries agreed to harmonize the requirements for cosmetic products in order to facilitate the movement of goods and decrease the trade barriers within the region. The new common cosmetics legislation came into force in 2008. This legislation is called the ASEAN Cosmetic Directive (ACD). ACD is modelled after the EU Cosmetic Directive and the EU Cosmetic Regulation 1223/2009 that followed.

The ASEAN Cosmetic Directive provides the following definition: "A cosmetic product shall mean any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition".

In the ASEAN region, each country requires a separate notification. The company or person responsible for placing the cosmetic products on the market in each individual ASEAN member country must be located in that country and has to complete the product notification with the local regulatory authority of that country. And the product information file must be kept readily accessible to the regulatory authority as well.

Vietnam

There is no special distinction between the registration and sales of general cosmetics and functional cosmetics in Vietnam, and cosmetics are managed in accordance with the "Notice on Cosmetics Management" No. 06/2011/TT-BYT issued by Vietnam Food Safety Authority. Cosmetics need to obtain a cosmetics notice with a product announcement number issued by the Drug Administration of Vietnam (DAV) under Vietnam Food Safety Authority before being sold and launched. Overseas enterprises need to establish a company or authorized agent locally to be responsible for product registration and listing.

Vietnam Cosmetics Notification refers to the declaration by a company to the government that the cosmetics will be sold in the Vietnamese market, confirming that the advertised cosmetics meet all the requirements of ASEAN cosmetics and its attachments and appendices. The validity period of cosmetic notification is 5 years.

Materials required for registration:

• Product registration application form;
• Business license of the import company (cosmetic business qualifications is required);
• Authorization letter issued by the manufacturer;
• Free Sale Certificate (CFS) issued by the product country;
• COA and inspection analysis report; and
• Product Composition Table (International Nomenclature Cosmetic Ingredient, contents, and functions).

Registration cycle: approximately 2 to 3 months

Indonesia

The cosmetics registration process in Indonesia is regulated by Badan Pengawas Obat dan Makanan (BPOM). Indonesian law requires all cosmetic products circulating in the Indonesian market to be registered with the BPOM and obtain a marketing license before they can be launched. The validity period of the license is 3 years.

The applicant should be a local cosmetics production enterprise in Indonesia, which owns import rights for cosmetics, or has obtained production authorization/license.

Materials required for registration:

• Importer application form, business license, tax card, and official stamped declaration by the responsible person;
• Import identification number API;
• Manufacturer's GMP certificate;
• Certificate of Free Sale;
• Product Composition Table;
• Finished product COA and inspection analysis report;
• Label that meets the requirements;
• Import Authorization Letter; and
• HS code of imported cosmetics.

Registration cycle: approximately 3 to 4 months. Note: Once a BPOM notification is issued, all registered products should be produced or imported for sale within six months to maintain the effectiveness of the cosmetic notification.

Thailand

Cosmetics manufacturers or importers must obtain the notification issued by the Thailand Food and Drug Administration (TFDA) before production or import. Overseas enterprises need to establish a company locally or appoint a Thai agent to be responsible for product registration and listing. The validity period of cosmetic notifications is 3 years.

Materials required for registration:

• Information about the applicant, such as the name and address of the manufacturer, importer, or warehouse;
• Cosmetic information, such as name, brand name (product name), category, and ingredients;
• Import Authorization Letter; and
• Notification form.

Registration cycle: approximately 1 to 3 months.

Malaysia

According to the requirements of the ASEAN Cosmetics Directive, all cosmetics sold in Malaysia must meet the requirements of the ASEAN Cosmetics Directive and be notified in the Quest3+system of the National Pharmaceutical Regulatory Agency (NPRA), a government regulatory agency. After the government agency approves the application documents, a notification (NOT) will be issued. The applicant for cosmetics NPRA registration must be a company registered in Malaysia. For overseas enterprises, it is necessary to designate a local agent as the Cosmetic Notification Holder (CNH). CNH is responsible for placing the product on the market. CNH must be a locally registered company or legal entity with a permanent address and registered with the Malaysian Companies Committee (its business scope is related to the health/cosmetics products listed in our company's Memorandum and Articles of Association). All documents and materials submitted to NPRA must be in Malaysian or English. The validity period of the notification certificate is 2 years.

Materials required for registration:

• Product information: product name, model, purpose, and product introduction;
• Manufacturer's name and address. Note: For foreign manufacturers, a GMP certificate (or similar certificate) is required;
• The name, address, contact phone number, and email address of CNH;
• Name and contact phone number of CNH representative employees;
• Importer's name and address;
• List of ingredients for the product (note: if the ingredients used in the product are not in the database, approval from NPRA is required);
• Authorization letter or entrusted processing contract. Note: In cases where the CNH is not the product owner, a Letter of Authorization (LOA) must be issued. The product owner authorizes the CNH to report the product to NPRA and follow up on all product notification matters. The authorization letter should include a list of the product and brand. When there is a situation of commissioned processing of products, a commissioned processing contract should be issued, which includes the roles and responsibilities of both parties, as well as a list of products/brands; and
• Product labeling.

Registration cycle: approximately 2 to 3 months.

Singapore

Health Sciences Authority (HSA) is the regulatory body responsible for importing drugs, cosmetics, and other goods in Singapore. The product should notify the HSA and apply through the online system PRISM (https://goo.gl/dErV2c). Enterprises need to apply for Client Registration and Identification Services (CRIS). Market activities can only be carried out after confirmation by HSA. Overseas enterprises need to establish a company locally or appoint a Singapore agent to be responsible for product registration and listing.

Materials required for registration:

• Brand and product name;
• Product type and specifications; and
• Manufacturer's name, address, and contact phone number.

Registration cycle: approximately 1 to 2 months

Philippines

Any company engaged in the following businesses within the Philippines needs to apply for a License to Operate (LTO) issued by the Food and Drug Administration of the Philippines: Import, Export, Wholesale Trading, Distribution, Manufacturing. To operate different categories of products, it is necessary to apply for LTO separately. Cosmetics also need to obtain a Notification of Cosmetics Products (NCP) from the Food and Drug Administration of the Philippines before being launched. Overseas enterprises need to establish a company locally or appoint a Thai agent to be responsible for product registration and listing. The NCP is valid for 1 to 3 years.

Materials required for registration:

• Manufacturer's certificate;
• Certificate of Free Sale;
• Certificate of Good Manufacturing Practice;
• The name, function, and percentage of each component in the product formula;
• Product packaging and labeling; and
• Expense substantiation.

Registration cycle: approximately 3 to 4 months.

Our Services

ASEAN Cosmetics Notification

ASEAN Cosmetics Formula/Label Review

ASEAN Cosmetics Regulatory Compliance Consultation