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Vinay Kumar Singh
General Manager-Technical,
Mikasa Cosmetics Limited,
Ahmedabad, Gujarat

A contaminant is a substance that is where it shouldn't be and is at high enough levels to have a negative effect on our health or on the health of animals or plants. A contaminant is any potentially undesirable substance (physical, chemical or biological). It usually refers to the introduction of harmful human-made substances.

Heavy metals are found as elements naturally present in rocks and soils. Some metals are essential for life at low levels, for example iron and zinc, while others, such as cadmium, mercury, and lead are toxic to most living things at relatively low levels. Metals tend to accumulate in specific parts of the body. For example, lead accumulates in the bones, mercury and cadmium accumulate in kidney and liver, and the form of mercury known as methyl mercury accumulates evenly throughout the body.

Cosmetics are anything that we apply to our bodies including soap, toothpaste, shampoo, mouthwash, deodorant and shaving cream. When you put a coating of cream or shaving gel on your face, these chemicals penetrate the skin and get inside the body, but not everything you put on your skin is actually going to be absorbed. Some molecules are too large to get in, but some are very tiny and can stay in the body for many days.

Everyone used to think the skin is the perfect barrier, but one of the transport systems that takes these harmful ingredients into the body is the hair follicle.

Contamination can occur from the cleaning of the plants or from the solvents they use. Unwanted impurities in cosmetic products can be manufacturing residuals, breakdown products from cosmetic ingredients, environmental contaminants in the case of plant-derived ingredients, or what are called “unreacted monomers,” the small building blocks of the large polymer ingredients common in cosmetics.

Heavy metals are naturally occurring, are present in the environment and can make their way in trace quantities into raw materials. These substances end up in the products we consume and use every day. Dermal exposure is expected to be the most significant route for cosmetic products since the majority of cosmetics are applied to the skin. Dermal absorption of heavy metals is typically low, with absorption of individual elements influenced by a number of factors including physical-chemical properties of the mixture.Oral exposure can occur for cosmetics used in and around the mouth, as well as from hand-to-mouth contact after exposure to cosmetics containing heavy metal impurities. Inhalation exposure is expected to be negligible.

Heavy metals like lead, arsenic, mercury, aluminum, zinc, chromium and iron are reported to have been found in a wide variety of personal care products including lipstick, whitening toothpaste, eyeliner and nail color. Some metals are intentionally added as ingredients, while others are contaminants. Exposure to metals has been linked to health concerns including reproductive, immune and nervous system toxicity.

While some metals are contaminants of the chemical combining process, others come from colorants. For instance, chromium is used in a very small number of products as a colorant, and iron oxides are common colorants in eye shadows, blushes and concealers. Some aluminum compounds are colorants in lip glosses, lipsticks and nail polishes. In addition, some color additives may be contaminated by heavy metals like arsenic, lead and mercury.

Mercury, Arsenic, Cadmium, Lead and other heavy metals are banned from use in cosmetic products. However, they are naturally occurring elements and minute traces may be carried into the product during manufacture.

Lead exerts adverse effects on numerous organs and systems including the central nervous system (CNS), the kidneys and on the hematopoietic (blood forming) system. Exposure to lead is typically greater in children, who are also more susceptible to the effects of lead than adults. Children are particularly at risk for the subtle adverse effects of chronic low-dose lead exposure, as are pregnant women/fetuses. Children absorb about 50% of ingested lead.

Arsenicexerts adverse effects due to a pronounced affinity for skin and keratinizing structures including the hair and nails. Therefore, symptoms of acute overexposure include a variety of skin eruptions, alopecia and characteristic striation of the nails. Arsenic does not act as a sensitizer, due to poor skin penetrating ability of its naturally occurring compounds. The health effects of arsenic in humans vary depending on the compound and form. Metallic arsenic is not absorbed by the gastrointestinal tract and does not have any known adverse health effects. Carcinogenicity has been observed only in its inorganic form. Inorganic arsenic compounds are more acutely toxic than environmentally occurring organic arsenic (for example dimethylarsinate). Dermal uptake is expected to be very limited. One study predicted that dermal exposure to arsenic may contribute less than 1% of the exposure from ingestion.

Cadmium is classified as a human carcinogen by the National Institute for Occupational Safety and Health (NIOSH). Absorption of cadmium through the skin is low (0.5%) and would be of concern only in situations where concentrated solutions would be in contact with the skin for several hours or longer. Significant dermal exposure can cause irritant dermatitis

Hexavallent Chromium (Cr+6) is corrosive and allergic to the skin. Cr+6compounds are enlisted as carcinogens by the International Agency for Research on Cancer (IARC). Adverse effects of the Cr+6 on the skin may include ulcerations, dermatitis, and allergic skin reactions.

Nickel can cause allergic reaction when it comes in contact with the skin. Studies on animals show that if consumed in high amounts, it affects kidneys, stomach and liver.

Mercury is a neurotoxin. Mercury has been used by many names such as “mercurous chloride”, calomel, mercuric, mercurio or mercury. The prolonged use of products containing mercury can lead to inflammation of the liver, kidneys and urinary tract. Presence of mercury in Skin Creams has become a global public health problem. Mercury compounds are readily absorbed through the skin on topical application and have the tendency to accumulate in the body. They may cause allergic reactions, skin irritation or neurotoxic manifestations.

Mercury intoxication from cosmetics has been featured in numerous news stories in recent years. Distribution of mercury-containing creams and soaps is banned in the European Union.

Overexposure to antimony and its compounds can adversely affect the skin, lungs, cardiovascular system and liver. Because antimony is found naturally in the environment, the general population is exposed to low levels, primarily in food, drinking water, and air.

Other metals(for example, selenium, barium and chromium) may be present as impurities in cosmetic products; however the toxicological properties and corresponding risk associated with these substances are considered less significant than for lead, arsenic, cadmium, mercury and antimony. Accordingly, impurity limits in cosmetics have not been developed for these metals.

Cosmetics products in India are regulated under the Drugs and cosmetics Act 1940 and Rules 1945 and Labeling Declarations by Bureau of Indian Standards (BIS). BIS sets the standards for cosmetics for the products listed under Schedule ‘S’ of the Drugs and cosmetics Rules 1945.

Bureau of Indian Standards (BIS) has provided the specification for various Products. e.g. Skin Creams and Lipstick has Indian Standards as  (IS) 6608:2004 and 9875:1990 respectively.

The Dyes colors (pigments & lakes) if used in the manufacture of skin creams and lipstick shall comply with IS 4707 (Part I) subject to the provision of Schedule Q of Drugs and Cosmetics Act and Rules, issued by the Government of India, and as amended from time to time.

Other ingredients shall comply with the provisions of IS 4707 (Part 2).

Rule 134 of Drugs and Cosmetics Rules has laid down restrictions on use of cosmetics containing Dyes, Colors and Pigments other than those specified by the Bureau of Indian Standards (IS: 4707 Part 1 as amended) and Schedule Q.

The permitted Synthetic Organic Colors and Natural Organic Colors used in the Cosmetic shall not contain more than:
• 2 ppm (parts per million) of Arsenic calculated as Arsenic Trioxide.
• 20 ppm of lead calculated as lead.
• 100 ppm of heavy metals other than lead calculated as the total of the respective metals.

These coloring agents are generally recognized as safe (GRAS). For some of these, purity requirements are mentioned as laid down in the EEC directive of 1962. Maximum concentration in finished products is mentioned in some. Rule 145 of the Drugs and Cosmetics Rules prohibits use of lead and arsenic compounds in cosmetics for the purpose of coloring. Rule 135 prohibits import of cosmetics in which a lead or arsenic compound has been used for the coloring purpose. Rule 145 D and 135 A prohibits manufacture and import respectively of cosmetics containing mercury compounds.

As per the Drug and Cosmetics Act 1940, India prohibits the manufacture and import of any cosmetic products containing hexachlorophene, lead, arsenic or mercury compounds.

The amount of heavy metals in cosmetic shall not exceed:
2 parts per million of arsenic calculated as arsenic trioxide.
20 parts per million of lead calculated as lead.
100 parts per million of heavy metals other than lead calculated as the total of the respective metals

Though it is the responsibility of manufacturer to offer safe product to consumer, it is the duty of FDA to ensure the same.



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