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The Association of Southeast Asian Nations (ASEAN) is a significant market for cosmetic products, with a combined population of over 650 million people. To ensure the safety and quality of these products, ASEAN has implemented a harmonized Regulatory framework called the ASEAN Cosmetic Directive (ACD), which aims to facilitate trade and enhance cooperation among its member states. In this blog, we shall explore the key Regulatory points and updates that cosmetic companies need to consider when entering the ASEAN market.
ACD
The ACD is a comprehensive Regulatory framework that covers various aspects of cosmetic products, including product registration, notification, labeling, and the use of prohibited and restricted substances. This directive was first implemented in 2008 and has since been updated to ensure the safety and quality of cosmetic products in the region.
Key Regulatory Points
- Product Registration and Notification:
- Cosmetic products must be registered with the relevant authorities in each ASEAN member state before they can be sold in the market.
- The company or person responsible for placing the cosmetic products on the market must notify the Regulatory authorities of the place of manufacture or initial importation of the cosmetic product before it is placed on the ASEAN market.
- Good Manufacturing Practices (GMP):
- All cosmetic products must be manufactured according to the ASEAN GMP guidelines, which lay out minimum requirements for personnel, equipment, sanitation, and hygiene to ensure safe and high-quality products.
- Labeling Requirements:
- Cosmetic products must be labeled clearly and legibly, so that customers can easily understand them.
- The labeling must include information such as the product name, list of ingredients, net weight or volume, directions for use, country of manufacturing, instructions for use and disposal, warning statements, manufacturing date, and expiry date.
- Prohibited and Restricted Substances:
- The ACD prohibits the use of certain substances, such as mercury, hydroquinone, and lead, in cosmetic products.
- The use of certain substances, such as preservatives, UV filters, and colorants, is restricted to ensure their safety and efficacy.
- Mutual Recognition System:
- The ASEAN Cosmetic Mutual Recognition Arrangements (ACMRA) allow cosmetic products that have been registered and marketed in one (01) ASEAN member state to be considered for expedited registration in another member state, thereby facilitating trade and reducing Regulatory burdens on manufacturers.
Updates and Considerations
- Full Ingredient Listing: The ACD requires a full ingredient listing on the label, which is, in fact, a significant change from previous practices. This ensures transparency and helps consumers make informed choices about the products they use.
- Post-market Surveillance (PMS): The ACD emphasizes the need for PMS, which involves continuously monitoring the safety and efficacy of cosmetic products after they are placed on the market. This shift from Pre-market Approval (PMA) to PMS is considered more effective in ensuring the safety of cosmetic products.
- Language and Cultural Considerations: ASEAN member states have different languages, cultures, and religions. Thus, cosmetic companies must ensure that their products comply with the local regulations and labeling requirements, which may vary across countries.
To conclude, the ACD is a crucial framework for cosmetic companies looking to enter the ASEAN market. Understanding the Regulatory points and updates outlined in this blog will help companies ensure compliance and successfully launch their products in the region. By aligning with international cosmetic regulations and adhering to the ACD, cosmetic companies can promote the safety and efficacy of their products in the ASEAN market.
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