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 cosmetics 2. 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.

The Control of Drugs and Cosmetic Regulations defines 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 human health 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 information provided by the manufacturer or his authorized agent or by any other person responsible for placing the product on the market.

Responsibilities of all stakeholders of cosmectic porducts Raw Material Supplier 1. 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) Select safe cosmetic ingredients Check local tolerance of finished product Select appropriate packaging maintain the quality avoid risks of misuse or accident 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 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 authorities 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

Formulator

Manufacturer

Notification Holder

Regulator

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.