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Cosmetic Case Study

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Regulatory aspects of cosmetic products in Malaysia
Definition
According to ASEAN Cosmetic Directive, cosmetic product is defined as ‘ any substance or preparation intended to be placed in contact with various external parts of the human body, for example, epidermis, hair system, nails, lips and external genital organs) or with 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 a good condition.’
The external parts of our body includes the following:
1. Epidermis
2. Hair system
3. Nails
4. Lips
5. External genital organs
6. Teeth oral cavity
Cosmetic products have the following …show more content…

This product notification process will allow National Pharmaceutical Control Bureau (NPCB) to collect enough information on the cosmetic products that are placed in the local market. Under Control of Drugs and Cosmetics (amendment) Regulations 2007, to place a cosmetic product in the local market, the person responsible or the company must notify the Director of Pharmaceutical Services (DPS) through National Pharmaceutical Control Bureau (NPCB) prior to product manufacture or importation. Under CDCR 1984, Regulation 18A (1): No person shall manufacture, sell, supply, import, possesses any cosmetics unless the cosmetic is a notified cosmetic. According to the regulation, it is an offence if anyone conduct the activities without prior notification to the DPS. The chart below shows the flow of notification process. Besides that, the notification should also be made online through NPCB website …show more content…

Particulars of person representing the company of cosmetic notification holder
5. Name and address of importer
6. Full product ingredients
7. Letter of authorisastion
8. Label of product
Safety requirements
A cosmetic product should not cause any damage of adverse side effect to human helath when placed on the market. The cosmetic notification holder should ensure that safety assessment has been conducted for each product.
Cosmetic ingredients
The cosmetic products that are going to be marketed should not contain substances that are listd in the poison list, Annex II Part 1, Annex III Part 1, colouring agents other than those listed in Annex IV Part 1 with the exception of cosmetic product containing colouring agents intended solely for hair colouring, preservatives other than those listed in Annex IV Part 1, UV filters other than listed in Annex VII Part 1. The Annex as mentioned above can be referred from www.npra.com.my.
Labelling requirements
The information of the cosmetic products should be clearly labelled in English or Bahasa Malaysia. The labelling also must comply with the labelling requirements as defined in Annex I part 7: Cosmetic labelling requirements.
Cosmetic

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