INTRODUCTION:

Cosmetovigilance is a term related to the collection, evaluation and monitoring of spontaneous reports of undesirable events observed during or after normal or reasonably foreseeable use of a cosmetic product. The purpose of Cosmetovigilance is to safety monitoring of medicinal products, drug safety methods, detection of adverse reactions occurring in consumers, set up and implementation of Cosmetovigilance system, Systematic monitoring the safety of cosmetics and other drug related problems. The regulations for cosmetic products primarily address the safety of products that may be used

by large populations of healthy consumers. However, the efficacy and safety of cosmetic products are not reviewed or approved by national authorities before they are sold to the public. Cosmetic is a Greek word which means to 'adorn'. It may be defined as a substance which comes in contact with various parts of the human body like skin, hair, nail, lips, teeth and mucous membranes etc. Cosmetic substances help in improving or changing the outward show of the body and also mask the odor of the body. It protects the skin and keeps it in good condition. ^{(1, 3, 10)}

Need of Cosmetovigilance in India: -

The Indian cosmetic industry is mature and growing in terms of product development and marketing because consumer’s preferences are changing from merely cosmetic to more functional, advanced and specialized products. India is fourth largest cosmetic market in the Asia pacific region after Japan, China and South Korea. The unwanted or adverse reactions due to cosmetic products are very low or go unnoticed due to lack of proper organized reporting system. In India as far as drugs are concern there is post marketing vigilance system usually focus on adverse drug reactions recently much consideration is given to medical devices, blood products, special nutritional and natural products, whereas less attention has been addressed to adverse reactions related to cosmetic products. In general, the surveillance of cosmetic products which are placed in the market is called as Cosmetovigilance. ^{(1, 2, 10)}

Cosmetovigilance Programmed Communication: -

The WHO has established the world based Cosmetovigilance centre in Sweden (Uppsala Monitoring Centre). In India the headquarter of Cosmetovigilance CDSCO is in New Delhi. The Cosmetovigilance programmed communications are discussed below in figure (1).

Reporting Process and Functions of Cosmetovigilance in India⁽¹⁰⁾: -

Cosmetovigilance system in the country to protect the population from the potential harm that may be caused by some of new cosmetics. Clearly aware the enormity of task the Central Drug Standard Control Organization has initiated a well structured and highly participative National Cosmetovigilance programmed.⁽¹⁰⁾

The Reporting Process and Functions of Cosmetovigilance in India are discussed below in figure (2).

Regulation of Cosmetovigilance in India⁽¹⁵⁾: -

In India cosmetics are regulated as per Drugs and Cosmetics Act 1940 and Rules 1945. Part XIII deals with regulations of import and registration of cosmetics. Part-XIV deals with the manufacture of cosmetic for sale or distribution. Part-XV regulates labeling, packing and standards of cosmetics. India is the fourth largest cosmetic market in Asia pacific region after Japan, China and South Korea. Unwanted or adverse reactions due to cosmetic products are either very low or go unnoticed due to lack of proper organized reporting system.

In Egypt, as early as 10,000 BC, men and women used scented oils and ointments to clean and soften their skin and mask body odor. Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. The drugs and cosmetics sold in India are safe, effective and conform to state quality standards. The related Drugs and Cosmetics Rules, 1945 contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule. The act defines cosmetic as any product that is meant to be applied to the human body for the purpose of beautifying or cleansing. The Federal Food, Drug and Cosmetic Act defines drugs, in part, by their intended use, as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals. In another section cosmetics are defined by their intended use, as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance. The products covered under this definition are skin moisturizers, perfumes, lipsticks, finger nail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, deodorants or any other substance intended for use as a component of a cosmetic product.⁽¹⁵⁾

Adverse Effects of Various Cosmetics:

Hair cosmetics:

The Preparations intended for placing in contact with the hair and scalp with the purpose of cleansing, promoting attractiveness, altering appearance and protecting them in order to maintain them in good condition. Hair cosmetics are classified two main categories:^{(2, 4, 5 )}

(a) Cosmetics with temporary effect on the hair: Shampoos, Conditioners, Sprays and Temporary colors.

(b) Cosmetics that produce permanent effect on the hair shaft: Permanent waves, Bleaches and Permanent colors.

Nail cosmetics:

Nail beautification is a big industry today with various nail cosmetics available ranging from nail hardeners, nail polishes, extensions, artificial/sculpted nails, nail polish remover and nail decorations. Adverse events may occur either during the nail-grooming procedure or as a reaction to the individual components of the nail cosmetics.

Hygiene Purpose:

Hygiene is defined as the many practices that help people be and stay healthy. In society cleanliness is an important issue poor hygiene is seen as unacceptable and unhealthy. Good hygiene includes thoroughly and regularly washing one's body (especially hands), washing one's hair, brushing and flossing teeth and caring for gums. These grooming habits will reduce the threat of bacteria that constantly reside on the body. While a certain amount of bacteria are harmless and even beneficial to the body, a build-up of bacteria can harm a person's health. For hygienic purpose various cosmetics used such as Controlling body odor, deodorants, antiperspirants, perfumes, colognes, and scented soap.

Health Hazardous associated with chemicals used in formulation of cosmetics:- ^{(6,
9, 14)}

Heavy Metals in Cosmetics: Heavy metals which can get accumulated in the body over a period of time are known to cause various health problems. Some of the health risks associated with heavy metals in cosmetics are cancer, reproductive and developmental disorders, neurological problems, cardiovascular, skeletal, blood, immune system, kidney and renal problems, headaches, vomiting, nausea and diarrhea, lung damage. They may also cause contact dermatitis and brittle hair and hair loss. Some heavy metals are hormone disruptors while others are respiratory toxins. They can enter the body through ingestion or absorbed through the broken skin.⁽¹¹⁾

Lead acetate:

Hair color restorers may contain lead acetate. It appears to be safe when used as directed, as there's no evidence significant quantities of lead are absorbed into the blood stream. Once a common ingredient in products such as Grecian Formula, lead acetate was banned in Europe and Canada and many products have been reformulated with safer but less effective bismuth citrate and silver-based salts.⁽¹¹⁾

Mercury:

Mercury is a common ingredient found in skin-lightening soaps and creams. It is also found in other cosmetics, such as eye make-up, cleansing products and mascara. Mercury in cosmetics exists in two forms: inorganic and organic. Inorganic mercury (e.g. ammoniated mercury) is used in skin-lightening soaps and creams. Organic mercury compounds (ethyl mercury and phenyl mercuric salts) are used as cosmetic preservatives in eye make-ups, cleansing products and mascara. The main adverse effect of the inorganic mercury contained in skin lightening soaps and creams is kidney damage. Mercury in skin-lightening products can cause skin rashes, skin discoloration and scarring, as well as a reduction in the skin’s resistance to bacterial and fungal infections. Other effects include anxiety, depression or psychosis and peripheral neuropathy.⁽¹¹⁾

Phthalates:

Phthalates are used as plasticizers and solvents and can be found in fragrances, hair products, skin lotions, nail polish and nail hardeners. They have been found to have endocrine disruption effects, have been linked with endometriosis and early puberty in girls, reproductive organ abnormalities and reduced fertility in males. They can also act on the thyroid and have been linked with obesity.

Talcum Powder:

Talcum powder applied to the genital area might get into the fallopian tubes and onto the ovaries and cause inflammation which in turn could cause ovarian cancer. The main risk factors for ovarian cancers are being overweight, having endometriosis, hormone replacement therapy, smoking and gene mutations.

Formaldehyde:

Formaldehyde is used as a preservative that can irritate skin, eyes, nose, respiratory tract, trigger heart palpitations and can cause cancer among those with high levels of exposure. Small amounts are permitted for use in cosmetics and it's mainly found in hair straighteners and nail polish/hardeners. Extended exposure to formaldehyde may cause joint pain, allergies, depression, headaches, chest pains, ear infections, chronic fatigue, dizziness and loss of sleep. It can also aggravate coughs and colds and trigger asthma.

Coal Tar Dyes:

Coal tar is a made up of many chemicals obtained from petroleum. The p-phenylenediamine is a common coal tar dye used in many hair dyes. Phenylenediamine is found more in darker hair dyes than lighter colours. Adverse reactions caused by p-phenylenediamine are stinging sensations, with an erythromatous rash, swelling, blisters, and surface oozing. Most cases have sneezing, runny nose, cough, and shortness of breath instead of skin reactions. Some colourings have been banned in certain cosmetic products in various countries and have also been banned in soaps and shampoos in Europe and some Asian countries.

Triclosan:

Triclosan is used as a preservative and antibacterial agent found in personal care products such as antiperspirant, soap, hand wash and toothpaste. Tests on mammals and other animals have shown endocrine disruptor effects.

Resorcinol:

Resorcinol is used as an antiseptic and disinfectant found in topical treatments for acne, seborrhoeic dermatitis, eczema, psoriasis, corns and warts. It's also found in hair dyes. It can irritate skin and has been linked with thyroid dysfunction when used in large quantities on broken skin over a long period of time.

Toluene:

Toluene found in some nail polishes that cause short-term neurological effects such as dizziness, euphoria, hallucinations and headaches and used high concentrations may affect a developing foetus in pregnancy. ⁽⁸⁾

Sodium Lauryl Sulfate and Sodium Laureth Sulfate: These foaming agents are found in almost all shampoos, shower gels, toothpastes and other foamy products. Strong evidence shows that both Sodium Lauryl Sulfate and Sodium Laureth Sulfate are irritants to skin, eyes and the respiratory tract.

Mineral Oil and Petroleum Jelly:

Petroleum is commonly used to coat the skin like plastic wrap, but by doing so, the skin’s natural immune barrier is disrupted and the skin then loses its ability to breathe and release toxins which can then promote acne and other skin disorders, including diaper rash. This process also slows down skin function and normal cell development, causing the skin to prematurely age. ⁽⁷⁾

Perfume:

Perfume is a mixture of essential oils or aromatic compounds and solvents used to give the human body, animals, food, objects and living-spaces a pleasant scent. It is found usually in liquid form and used to give a pleasant scent to an individual’s body. Perfumes are also used in cosmetics. Many of the compounds in fragrances are carcinogenic and affect the central nervous system, causing depression, hyperactivity and other behavioral problems and symptoms related to fragrance sensitivity include headaches, dizziness, rashes, skin discoloration, violent coughing and vomiting and allergic skin irritation.⁽¹²⁾

Cyclomethicone and Siloxanes:

Cyclomethicone and siloxanes widely used in moisturisers, makeup and hair care products, these silicone-based compounds are used to soften, smooth, and hydrate. They make hair products dry more quickly and deodorant creams slide on more easily. They are also used extensively in moisturizers, facial treatments, medical implants and lubricants but these chemicals are thought to build up toxicity in the liver and gastro intestinal system and are also toxic to wildlife.

Diethanolamine, Monotaholamine and Tiethanolamine:

These foam boosters are found in shampoos, hair styling products, facial cleansers, soaps and shower gels all can cause contact dermatitis. They are easily absorbed through skin to accumulate in body organs, even the brain. Repeated use can result in major increases of liver and kidney cancer.

Colour Pigments:

Found in lipstick, mascara, eye shadow, blush and other facial makeup many colour pigments cause skin sensitivity and irritation Absorption of certain colours can cause depletion of oxygen in the body and even lead to death in some rare cases. Synthetic colours from coal tar contain heavy metal salts that deposit toxins in skin, causing skin sensitivity and irritation.

Butylated hydroxyanisole and Butylated hydroxyl toluene:

Butylated hydroxyl anisole and butylated hydroxyl toluene are closely related synthetic chemicals used as preservatives in moisturizers and lipsticks among other cosmetics. Butylated hydroxyl anisole and butylated hydroxyl toluene can cause allergic reactions in the skin. Some lipsticks contain the preservative butylated hydroxyanisole which is carcinogenic in high doses.

Polyethylene Glycols:

Polyethylene glycols are compounds based on petroleum that are widely used in creams as thickeners, solvents, softeners and moisture-carriers. PEGs also show some evidence of genotoxicity and can cause irritation and systemic toxicity if used on broken skin.

SUMMARY AND CONCLUSION:

Cosmetovigilance refers to the post marketing surveillance of any health related undesirable effects possibly due to the use of cosmetic products. The purpose of Cosmetovigilance is to collect, analyze and assess the adverse reactions occurring in consumers to identify any potential health risks, thus guaranteeing a further strengthened safety for consumers. Cosmetovigilance is the ongoing and systematic monitoring of the safety of cosmetics in terms of human health. The aim of the paper is to review of detection adverse effects of cosmetic products and to prevent adverse effects by taking appropriate measures. Regulations for cosmetic products primarily address the safety of products that may be used by large populations of healthy consumers. The identification and analysis of adverse effects related to cosmetic products is a process that is currently still, to a large extent, industry driven. It is the responsibility of manufacturers to determine that products and ingredients are safe before they are marketed and then to collect reports of adverse reactions. Products range from hair, skin, and oral care products to lipsticks, nail polishes, deodorants, body powders and aerosols, to cosmeceuticals which are quasi-pharmaceutical over-the-counter products such as antiperspirants, dandruff shampoos, wrinkle reducers, antimicrobial soaps, acne treatments or sun screen products. The unwanted or adverse reactions due to cosmetic products are very low or go unnoticed due to lack of proper organized reporting system. In India as far as drugs are concern there is post –marketing vigilance system usually focus on adverse reactions of drugs, recently much consideration is given to medical devices, blood products, biologics, special nutritional and natural products, whereas less attention has been addressed to adverse reactions related to cosmetic products.

ACKNOWLEDGEMENT:

This review work was kindly supported by the faculty of Pharmacy Mrs. Pragya Sharma in Ujjain Institute of Pharmaceutical Science, Ujjain. The author would like to their collages for their support and give valuable time.

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Received on 18.11.2020 Modified on 28.12.2020

Asian J. Res. Pharm. Sci. 2021; 11(1):86-91.

DOI: 10.5958/2231-5659.2021.00014.X