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ENVIRONMENTAL HEALTH MONITORING & ANALYSIS

Cosmetic Safety

According to the video clip The Story of Cosmetics by Annie Leonard, it claims that almost all

the cosmetic products in market are carcinogenic, neurotoxic and cause many health impacts to

consumers involved infants and children. Annie Leonard also said that even cosmetic products

which labeled Herbal, Natural or Organic also not safe for consumers.

The main safety concerns by consumers are skin irritation, skin sensitization, photo

irritation/ sensitization, eye tolerance, lip tolerance, systemic toxicity e.g. percutaneous

absorption, accidents (children), reasonably foreseable intake (oral hygiene, lipsticks).

Consumers are expect that cosmetics placed on the market are safe and free from banned

substances/harmful ingredients such as Hydroquinone , Tretinoin, Steroids. They also request

adequate information on cosmetics for an informed choice and correct usage that obtained from

good labeled product, appropriate/ substantiated cosmetic claims and proper packaging.

In Malaysia, cosmetics are regulated by the Drug Control Authority (DCA). The DCA

is responsible for the following activities:

1. The safety, quality and performance of cosmetics2. Providing consumers with adequate information in order to choose the best product for

themselves

3. Monitor all cosmetic products from the manufacturing process to the marketplace.

The regulatory environment for cosmetics is defined under the Control of Drugs and

Cosmetic Regulations 1984 (CDCR). This regulation provides specifications for manufacturing,

labeling, distribution and sales. Any manufacturers, importers or wholesalers of cosmetics in

Malaysia must be licensed by the DCA. The others guideline involved in control cosmetic

products are Guidelines for Control of Cosmetic Product in Malaysia, Cosmetic Advertising

Code and Cosmetic claims.

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The Control of D rugs and Cosmetic Regulationsdefines cosmetics as any substance or

preparation intended to be placed in contact with various external parts of the human body

(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 odors and/or protecting them or keeping

them in good condition.

Cosmetic manufacturers in Malaysia should meet Good Manufacturing (GMP) guidelines

and are required to list all ingredients on the product label. The ingredients should be listed

according to their International Nomenclature Cosmetic Ingredient (INCI) names. The DCA has

also established an enforcement program to ensure that cosmetic product manufacturers comply

with cosmetic regulations. As part of the program, the DCA can send out representatives to

randomly gather cosmetic products available on the market in Malaysia. These products may be

tested to ensure product safety and quality.

In conformance with the harmonization of cosmetic regulations in the ASEAN region,

this system has been replaced by a new procedure starting 1 January 2008. Instead of

registration, companies are now required to only notify / declare their compliance to the ASEAN

Cosmetic Directive to the NPCB. Post Market Surveillance will be actively conducted by

the NPCB to ensure compliance. Action will be taken against any product that is not compliant

with the Directive. The requirements of the ASEAN Cosmetic Directive has been adapted into

the Guidelines for Control of Cosmetic Products in Malaysia.

According to the Guideline for Control of Cosmetic Products in Malaysia, Annex I,

Part 6, A cosmetic product put on the market must not cause damage to the humanhealth when

applied under normal or reasonably foreseeable condition of use taking into account in

particular of the product presentation, its labeling,instruction for its use and disposal warning

statements as well as any other informationprovided by the manufacturer or his authorized

agent or by any other person responsible forplacing the product on the market.

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Responsibilities of all stakeholders of cosmectic porducts

Raw Material

Supplier1. Chemical

-Provide adequate information as to safety of ingredients-Physical/chemical/microbiological specifications-purity

-Toxicity studies e.g. Dermal absorption, Skin (mucous membrane and eye)

irritation, Photo toxicity, mutagenicity, acute and chronic toxicity

2. Botanical extracts

- Provide adequate information as to the safety of the ingredients

- Proper identification of the plant/part used- Physical/chemical/microbiological specificationspurity

- Pesticide level

- Toxicity studies e.g. Skin irritation, Photo toxicity, Mutagenicity

3. Animal extracts

-Proper identification of the animal/part used

-Physical/chemical/microbiological specificationspurity-Absence of Transmissible Spongiform Encephalopathy (TSE)

- Absence of banned ingredients beyond unavoidable traces (e.g. hormones,

antibiotics, etc)

Formulator Select safe cosmetic ingredientsCheck local tolerance of finished productSelect appropriate packagingmaintain the qualityavoid risks of misuse or accident

Manufacturer Comply to ASEAN Cosmetic GMP

Quality control (chemical,microbiological)

Appropriate labeling- presentation of the product

- instruction for use, warnings (if relevant)

Adequate complaint/ADR handling procedure

Notification Holder To ensure that manufacturer manufactures safe product

-has good system in place to ensure product safety-comply to ASEAN Cosmetic GMP requirements

Collect information on post marketing experience and transfer such

information to the manufacturer on a timely basis, determine trends and

keep adequate records Competent personnel to handle product complaint and recall

Report any Serious Adverse Event to the authoritiesRegulator To ensure public health and safety;

-PMS activities; product sampling, PIF audit

Good collaboration with industry-to investigate complaint/serious adverse events & take proper action

To remove unsafe products from the market

-product recalls, notification cancellation, media announcement

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From this video clip, it also mention on FDA Regulations to control the cosmetics safety.

The U.S. Food and Drug Administration (FDA), has no authority to require pre-market safety

assessment as it does with drugs, so cosmetics are among the least-regulated products on the

market. The FDA does not review nor does it have the authority to regulate what goes into

cosmetics before they are marketed for salon use and consumer use. In fact, 89 percent of all

ingredients in cosmetics have not been evaluated for safety by any publicly accountable

institution.

Unlike American, Cosmetic products in ASEAN are controlled by ASEAN Cosmetic

Directive (ACD). Malaysia is one of the members of ACD. All the cosmetics guidelines and

regulations are compatible with ACD. Therefore, consumers are safe when using cosmetic

products. However, they also need to be a smart consumer when choosing cosmetic products.

They need to buy products which are properly labeled and had been notified by KKM.

Conclusion

Consumer safety is a fundamental principle of cosmetic control & consumers should be provided

with substantial information to enable them to make an informed choice and proper use of

cosmetic products. Therefore, manufacturers, importers and notification holder of cosmetic

products are responsible for the safety, quality and claimed benefits of the cosmetic products.