CURRENT SCENERIO OF COSMETICS AND ITS LEGISLATION IN INDIA

AND AN EMERGING PUBLIC HEALTH ISSUES

Abstract:
The cosmetic market has been increasing dramatically around the globe. The important
factors like safety, efficacy, regulatory framework and marketing of cosmetic products should
take into consideration the current market trends and demands and compliance requirements.

The safety assessment of the cosmetic products is regulated by the diverse by the regulatory
bodies around the world. There are different regulatory bodies throughout the world having
their own specific rules and regulation to assess safety of cosmetic products. Major stringent
legislation exists in European Union (EU), and the United States of America (USA). The
regulation in these regulatory bodies are used as a model for the countries which are
developing. In India, cosmetic products are governed under the Drugs and Cosmetics Act
1940, rules 1945 and labelling declarations by the Bureau of Indian Standards (BIS).

As the globalization of cosmetic industry, the regulatory compliance with international

territories in the in the 1 st step towards ensuring that are safe for human use and also for
environment. Increasing uses of cosmetic products around the world increases the exposure
of variety of chemical compounds. Thus at the same time, the risk of intoxication, allergic
exposure, side effects and indiscriminate use of cosmetics triggers emerging issues of public
health. These chemicals may cause serious ill effects on skin and may also enter skin and
other organs causing carcinogenicity. So there is a need for more awareness about cosmetics
and personal care products and their adverse effects.

The aim of this review article is to provide awareness among the people worldwide about the
cosmetics and personal care products and the requirements of cosmetovigilance in Indian
legislation.

Key words: Regulatory bodies, Drugs and Cosmetics Act, BIS, Carcinogenicity,

Cosmetovigilance.
Introduction:

The word cosmetic was derived from the Greek word “kosmtikos” that means having the
ability, arrange and talent in decorating (1) Cosmetic is a very diverse product, such as cream,
perfumes, lotions, skin cleansing products, and decorative cosmetics sector (2) Cosmetics are
not only important to influence the global GDP about also give a freedom to enhance the
social lives of humans across the nations. The use of cosmetics is not new rather the roots has
already been transplanted as early as Egyptian, Greek, and Roman eras (3) The reasons to use
cosmetic, but also cosmetics are often to implicated to look attractive. Therefore, using of
cosmetics is a way to support women appearance. Cosmetics is not just a make-up, product
that called body care is also used by women to treat their body. Cosmetics industry continues
to strive to satisfy of consumers with range innovative cosmetics products to meet the
demands and needs. Those demands and needs are different will trigger the industry to create
the best product with many variant that can fulfil the marker demand. The difference of
demographics will make the industry trying harder to fulfil the demand with a special
specification (4)

Historical significance of Cosmetics

The Science of cosmetology is believed to have originated in ancient world in countries like
Egypt and India, but the earliest records of cosmetic substances and their application dates
back to Circa 2500 and 1550 B.C, to the Indus valley civilization. [9]5 An old remedy for
cracked lips is found in history. Cracked lips, besides being painful, spoil the beauty of the
face. The rind of Bel fruit (Aegle marmelos Corr.) is powdered and mixed in woman’s milk
and the paste thus prepared is applied to the cracked lips. The cracking will stop and the
cracks will heal within 10 days the Superfluous hair was considered to be a mark of disgrace
and a large number of depilatory agents were recommended to get rid of it. Dried fruits of
Aavalakatti (Emblica officinalis Gaertn.) and dried fruits of Pimpali (Piper longum Linn.)
were used. The mixture was soaked in the milky latex of Nivadunga (Cactus: Euphorbia
nivulia Ham.) This compound was applied to the desired place, the hairs from that area were
found to fall off”[5]

The use of kajal has a long history in Hindu Culture. Various beauty rituals in the present day
rituals such as colouring of hair, depilation and exfoliation find their roots in ancient
Egyptian culture[6] In earlier days, the Romans, Greeks and Egyptians used various
cosmetics which contain white Lead and Mercury[7] Oils with essence and ointments were
used to clean and soften the skin and mask body odor while dyes and natural paints were used
to colour the face, mainly for ceremonial and religious occasions.[8] There was a common
ancient belief that eye makeup could remove evil spirits and improve sight. [7]

Cosmeceuticals: hybridization of cosmetics and pharmaceuticals

As per the Drug and cosmetic act 1940, “cosmetic” means any article intended to be rubbed,
poured, sprinkled or sprayed on, or introduced into, or otherwise applicated to, the human
body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the
appearance, and includes any article intended for use as a component of cosmetic (10)

Cosmeceuticals are cosmetic products with biologically active components purporting to

have medical benefits (11,12). Cosmeceuticals classification will enable companies of
cosmetics to market their product. Cosmeceuticals can be categorized based on the product
that has the pharmaceutical reaction and it can be used on ordinary or near-normal skin. The
product must have the benefit of fewer skin disorders. Risk profile of the product must be less
than that of the skin disorder (13)

Organogram of Cosmetics Division in CDSCO:

Drugs controller general I

Joint drugs controller I

Deputy drugs controller

Assistant drugs controller

Drugs inspector

Assistand drugs inspector

Supporting staff
 Fig: 1 (9)

Different categories of cosmetics

Every person in the present era is very conscious of his/her appearance. It is for the reason
that the desire to enhance beauty and appearance and to become more attractive without
affecting the body structure or function has led to an increased use of these cosmetics.

Gazette notification G.S.R 426 (E) divides cosmetics into 4 gross categories that are
described in table 1.(14)

Division
Skin products
Hair and scalp products
Nail and cuticle products
Oral hygiene products
Subdivision
Products for skin care, cleansing, removal of
body hair, body hair bleach, body odour
corrective products, products for shaving,
products for makeup, perfumes, products for
sun and self-tanning and others (2).
4 subcategories- 1. Cleansing and care
products 2. Products for hair colouring, hair
styling products 3. Products for hair 4.
Other products for scalp care (2).
Nail varnish and remover, product for nail
glue removing and other products for nail
and cuticle care (2).
Tooth care, tooth whiteners, mouth wash
and breath spray and other products for oral
hygiene (2).

Cosmetics Regulation: legal authorities

As the world seemingly strives to become a more globalized and better-connected
environment, where new trade agreements are signed between nations and the internet
presenting itself as a powerful tool to reach the end consumer, it becomes increasingly
important to understand that cosmetic products are part of a regulatory landscape that is
far from homogenous. In fact, significant differences between cosmetic legislations and
technical requirements can be a source of major challenges for companies who wish to
begin an international venture [15]
United States and European Union are the two largest markets in the world for cosmetic
products. The cosmetics market in India is growing at 15-20% annually, twice as fast as that
of the United States and European market. It is therefore important for a cosmetic
manufacture to understand the difference in regulatory system in India when compare to
USA and EU[16]
USA Regulation:
United States of America (USA) The cosmetics are defined as “articles intended to be applied
to the human body for cleansing, beautifying, promoting attractiveness, or altering the
appearance without affecting the body’s structure or functions” in the US. The most
commonly known cosmetic products are fingernail polishes, lotions, skin creams, lipsticks,
toothpastes, deodorants, perfumes, shampoos, eye and facial makeup preparations, hair
colors and permanent waves. Soap goods consisting chiefly of an alkali salt of fatty acid and
making no label state other than that the cleansing of the human body are not considered
cosmetics under the law (U.S. Food and Drug Administration, 2014). As divergent to drugs,
cosmetic products do not involve confirmable, compulsory fulfillment before they can be
commercialized. In the United States, utilizing the Voluntary Cosmetic Registration Program
(VCRP) is minimum expected from the manufacturers, packers and distributors of
ornamental goods that are in profitable distribution. VCRP provides FDA with the finest data
obtainable in relation to the cosmetic products and its factors, their fabrication and
distribution and their frequency of exercise. The manufacturer, packer or distributor should
file a report known as Cosmetic Product Ingredient Statements (CPIS) in the United States,
for every product that the firm has introduced into the market (Deepthi and Sudheer, 2013).
As per the law of administration, the FDA may perform investigations and examine the
products and the establishments in which products are manufactured or held, misbranded
(incorrectly or deceptively labeled or filled) or seize adulterated (harmful) cosmetics.
Cosmetics and Personal Product Act of 2013 is planned to give the US FDA power to make
sure those personal care products are fully exposed and without harmful constituents.
The cosmetics regulation which concerns misbranded and adulterated cosmetics is
amended in the Federal Food, Drug, and Cosmetic Act in such a manner that it requires:
1. Once a year registration of any enterprise occupied in promotional material,
fabrication, or distributing cosmetics 2. Expense of amount to give for oversight and
fulfilling of regulations of cosmetics, 3. Need revelation of information and labeling
of ingredients and 4. Reporting of adverse event.
The Act calls for the secretary to set up a record of banned ingredients and a record of
components that are safe and sound without limits for purpose of use in cosmetics and
determine the minimum data necessities and test protocols to be practiced by producers to
estimate the safety of the cosmetic components. The Act also sets forward requirements
related to nanotechnology in the manufacturing of cosmetics, mandatory and voluntary
recall of cosmetics and alternatives to testing of animal. The Act constitutes the
“Interagency Council on Cosmetic Safety” to share the data and as well as the support
association on cosmetic safety with federal authorities. A cosmetic that fails to convince the
labeling requirements under this human activity is held to be misbranded (Federal Food,
Drug, and Cosmetic Act, 2013). The Fair Packaging and labeling Act is to guarantee that
package and their labels should offer consumers with precise data to facilitate value
comparisons and contents quantity details (15 U.S. 1451-1460). This includes inserts, labels,
display packs, risers, promotional literature, booklets or any other printed or written
information disseminated with manufactured goods (Cosmetic Labeling Guide, 2015) under
the law the label statements must emerge on any outside container or wrap and on the
inside. The main demonstration panel (section of the label most clearly displayed under the
customary surroundings of exhibit for sale), must display the product name, identify by
illustration the function or nature or descriptive name of the product and display correct
report of the net amount of cosmetic contents in the package in terms of measure, weight,
numerical count, or a combination of numerical count. The announcement must be
different, located in the bottom field of the panel in line usually corresponding to the floor
on which the package rests and in a type size commensurate with the size of the container.
All label statements essential by regulation must be in English terminology and must be set
on the label with such prominence and conspicuousness that they are readily observed, and
read by consumers under customary conditions of purchase (labeling of cosmetics in the
USA).
European Union (EU)
European Union defines the cosmetics as “any substance or preparation intended to be put
in touch with the various external functions of the human body (epidermis, hair system,
nails, lips and external genital organs) or with the 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 maintaining
them in safe shape”. EU Regulation 1223/2009 (Cosmetics Regulation) reinforces the safety
of cosmetic products and streamlines the structure for all operators in the sector. The
regulation simplifies procedures to the tier that the internal market of cosmetic products is
now a foregone conclusion. The cosmetics regulation adopted in 2009 is replaced by
Directive 76/768/EC and substantially updated on numerous occasions. The Cosmetics
Regulation provides a robust, globally recognized regime, which reinforces product safety
taking into consideration the latest technical developments including the attainable use of
nanomaterials (European Commission, 2015). The most significant changes experienced by
the cosmetics regulation include: • The Producers are asked to produce a product safety
report previous to inserting a product along the grocery store. • Only cosmetic products
for which a natural or legal person is appointed within the EU as “responsible individual” can
be placed along the cosmetic industry. The new cosmetics regulation allows the exact
recognition of who the responsible person is and clearly outlines the responsibilities.
The manufacturer will inform its product only once via the EU cosmetic products notification
portal (CPNP). A responsible individual will bear an obligation to notify serious unwanted
effects (SUE) to competent national government agencies. The agencies will also garner
information from health professionals and users, and will be appreciative to share the data
with other EU Member States. More data on reporting of SUE (European Commission. 2013)
is being included. EU Rules are combating misleading information and putting safer
cosmetics on EU shelve. Preservatives, colorants and UV filters, including those that are
nanomaterials, must be openly authorized. Products containing other nanomaterials, not
controlled by the Cosmetics Regulation will be the object of full safety measurement at the
EU stage. In the list of ingredients nanomaterials are labeled with the word ‘nano’ in
brackets e.g., “titanium dioxide (nano)” (European Commission, 2015). The trade name and
address of registered office of the producer or of the person employed for marketing the
cosmetic product within the Community should be mentioned. It should also carry volume
or weight of ware and several safety bars and a distinct recognition of the product reference
or number batch number.

India
In India, as per as Drug and Cosmetic Act 1940 and Rules 1945, the cosmetics have been
defined as “any article intended to be rubbed, poured, sprinkled or sprayed on, or
introduced into, or otherwise applied to, the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the appearance, and includes any article
intended for use as a component of cosmetic” (Drugs And Cosmetics Act and Rules, 1945).
Lack of accomplishment guidelines of the Drug and Cosmetic Act for regulators for issues
related to cosmetics such as contradictory approach across authorities in the interpretation
of particular issues (Indian Regulatory Scenario, 2013). Cosmetics market is one of the
fastest rising retail segments in India, and the booming Indian cosmetics market offers
talented opportunities for the US brands. The Indian cosmetic market, which was
conventionally a stronghold of a few major players like ponds and Lakme, saw a lot of
distant entrants to the market within the last two decades. India allows access of imported
cosmetics without any restrictions. India’s import of cosmetics, intermediate raw materials
and beauty products such as essential oils is presently around $400 million (Phookan, 2011).
According to Drug and Cosmetics Act in India, both the inner and outer labels should bear
the name of cosmetics and manufacturing address. For small size containers the name of
principal place of manufacturing and pin code are enough. The outer label should enclose
the contents of ingredients used in the manufacturing. The directions to be followed for safe
use, warning indications, names and quantities of poisonous or hazardous ingredients
should be mentioned on the inner label. The label should also carry a characteristic batch
number and it’s marked by the letter “B” and for soaps the month and year of the
manufacturing shall be given in place of the mark “B”. This is not relevant to cosmetics
weighing 10 g or less for solids or semisolids and 25ml or less for liquid products. On the
label, the letter “M” specifies the manufacturing license number (Drugs and Cosmetics Act
and Rules, 2013).
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