COSMETOVIGILANCE: A REVIEW

PRACTICE SCHOOL REPORT

Submitted to the

SCHOOL OF PHARMACEUTICAL SCIENCES

SHRI GURU RAM RAI UNIVERSITY

In partial fulfillment of the requirement

for the award of the degree of

BACHELOR OF PHARMACY

(2017-2021)

Submitted By

SHIVANI BAGWAN

(Enrollment No: R170632048)

(B. Pharm 7th Semester)

Under the guidance of

MrsAarti Sati

Assistant Professor

SCHOOL OF PHARMACEUTICAL SCIENCES

SHRI GURU RAM RAI UNIVERSITY,
PATEL NAGAR, DEHRADUN (UTTARAKHAND)
(2021)
 SCHOOL OF PHARMACEUTICAL SCIENCES
SHRI GURU RAM RAI UNIVERSITY, DEHRADUN

CERTIFICATE
This is to certify that the work presented in this entitled “Cosmetovigilance:A Review” is
submitted by ShivaniBagwan in the partial fulfillment of the degree of Bachelor of Pharmacy

She has worked under the supervision of MrsAarti Sati, Assistant Professor of Pharmaceutical
Sciences, Patel Nagar, Dehradun, (Uttarakhand) India.

Date:-

Place:-Dehradun

Prof. (Dr.) Alka N. Choudhary

Dean

School of Pharmaceutical Sciences,

Shri Guru Ram Rai University,

Patel Nagar, Dehradun- 248001,

(Uttarakhand) India.
 SCHOOL OF PHARMACEUTICAL SCIENCES
SHRI GURU RAM RAI UNIVERSITY, DEHRADUN

SUPERVISOR CERTIFICATE
This is to certify that the work presented in this report entitled “ Cosmetovigilance:A Review”
is submitted by Shivani bagwan in the partial fulfillment of the requirement for the award of the
degree of Bachelor of Pharmacy to School of Pharmaceutical Sciences, Shri Guru Ram Rai
University, Dehradun. She has worked under my supervision and guidance.

Date: -

Place: - Dehradun Mrs. Aarti sati

Assistant Professor

School of Pharmaceutical Sciences,

Shri Guru Ram Rai University,

Patel Nagar, Dehradun-248001

(Uttarakhand) India.
 SCHOOL OF PHARMACEUTICAL SCIENCES
SHRI GURU RAM RAI UNIVERSITY, DEHRADUN

DECLARATION
I hereby declare that the work presented in this report entitled “ Cosmetovigilance:A review” is
carried out by me under the guidance of Mrs Aarti Sati, Assistant Professor, School of
Pharmaceutical Sciences, Shri Guru Ram Rai University , Dehradun (Uttarakhand) India.

Date:-

Place:-Dehradun Shivanibagwan
ACKNOWLEDGEMENT
This piece of work would never have been accomplished without the benevolence of God. On the
very outset of this report I would like to extend my sincere and heartfelt obligation towards the
people who made it possible for me to give shape to the idea which I considered as my project. I
take this pleasant opportunity to express my regards &gratitude to Shri Devendra Das Ji
Maharaj, Mahant, Darbar Shri Guru Ram Rai Ji Maharaj and Chairman SGRR Education
mission for providing the required facilities that enabled me to complete my work.

I extend my most sincere gratitude and offer my sincere and humble thanks to my esteemed guide
Mrs. Aarti Sati, Assistant professor, SGRRU School of Pharmaceutical Sciences, Shri Guru
Ram Rai University for her help and cooperation.

I am also thankful to Prof. (Dr.) Alka N. Choudhary Dean School of Pharmaceutical Sciences,
Shri Guru Ram Rai University, for her continuous support and for providing facilities required for
my practice school work. I am also thankful to all the teaching and non- teaching staff members
for their time and support to complete my report.

Once again, I would like to extend my gratitude to all those who were directly or indirectly
involved in the successful completion of my dissertation work and helped me with their valuable
suggestions and guidance in various phases of completion of this report.

Shivanibagwan
 TABLE OF CONTENTS

S.NO CHAPTER PAGE NO

1 ABSTRACT

2 INTRODUCTION 1

3 REVIEW OF LITERATURE 16

4 CONCLUSION 22

5 REFERENCES 23
ABSTRACT

The word “pharmacovigilance” refers to the practices of collecting, detecting, assessing, tracking,
and preventing medication-related adverse reactions. The concept of “vigilance” has recently been
expanded to include the protection of herbal and cosmetic products. The word “cosmetovigilance”
was coined to describe the surveillance carried out by the cosmetics industry.

Cosmetovigilance is a relatively new term. The word has only recently been indexed. It is a form
of public health surveillance with a public health goal, as opposed to industrialists’ surveillance,
which is focused on product safety for commercial reasons, and peer surveillance (Revidal-Gerda),
which is focused on medical issues. Cosmetovigilance refers to the monitoring of cosmetics.
“Cosmetovigilance” was coined as a new word to describe industry surveillance aimed at ensuring
the protection of cosmetic products. Vigan (1997) was the first to use the term in the literature to
refer to the monitoring of cosmetic product protection. It is now accepted as a principle in public
health around the world.

A cosmetic is a product that is applied to the face, eyes, mouth, hair, or nails for the purpose of
cleansing, improving beauty, providing a good odor, or providing protection. Unlike medications,
which are used to cure or prevent disease in the body, cosmetics are believed to have no effect on
the structure or functions of the body. The distinction between drugs and cosmetics, on the other
hand, is not always apparent. Cosmetic product regulations are mainly concerned with the
protection of cosmetics that could be used by large numbers of healthy people.

The cosmetics industry holds a great responsibility regarding the detection and study of adverse
effects related to cosmetic products. Manufacturers are responsible for ensuring that goods and
ingredients are safe before they are sold, as well as gathering evidence of adverse reactions.
Nonetheless, while manufacturers do their best to track the safety profile of their goods, there is
always the possibility of an intrinsicconflict.
INTRODUCTION

1
Introduction
The Federal Food, Drug, and Cosmetic (FD&C) Act describe drugs as “articles intended for use
in the diagnosis, cure, mitigation, treatment, or prevention of disease,” as well as “articles (other
than food) intended to influence the structure or any function of the body of man or other species”
[FD&C Act, sec. 201(g)]. Cosmetics are classified by their intended use in another segment.

Cosmetics are classified as “articles intended to be rubbed, poured, sprinkled, or sprayed on,
introduced into, or otherwise applied to the human body for the purpose of washing, beautifying,
promoting beauty, or altering the appearance” (FD&C Act, sec. 201(i)). Skin moisturizers,
perfumes, lipsticks, fingernail polishes, eye, and face makeup preparations, cleansing shampoos,
hair colors, and deodorants, screens are regulated as cosmetics, while in the United States, they
are regulated as medicines.[1]In terms of legal definitions of drugs and cosmetics, prohibitions on
the use of color additives and other ingredients, and registration standards, the requirements for
cosmetics in the United States and other countries vary. In Europe, some items, as well as any
other material intended for use as a part of a cosmetic product, are all protected by this term.[1,2]

According to the European Union’s Cosmetics Directive, a “cosmetic product” is “any material or
preparation intended to be put in contact with the various external parts of the human body
(epidermis, hair system, nails, lips, and external genital organs) or with the teeth and mucous
membranes of the oral cavity with the sole or primary intention of cleaning, perfuming, or
changing their appearance and/or correcting body odors and/or protecting them or keeping them
in good condition.[2]

Even though the word “cosmeceuticals” is sometimes applied to cosmetics containing bioactive
ingredients that are believed to have medical benefits, the Federal Food, Drug, and Cosmetic
(FD&C) Act does not recognize any such category.[3]A product may be a drug, a cosmetic, or a
mixture of the two, but the term "cosmeceutical" has no legal definition. Some cosmetics and drugs
can meet both cosmetic and drug definitions, depending on their intended use and ingredients.
Anti-dandruff shampoos, fluoride kinds of toothpaste, antiperspirant deodorants, and sunscreen
moisturizers are only a few instances. These products must fulfill the criteria for both cosmetics
and pharmaceuticals. Examples include anti-dandruff shampoos, fluoride toothpastes,
antiperspirant deodorants, and sunscreen moisturizers. These things must follow both cosmetics

2
and drug regulations. The word “pharmacovigilance” refers to the practices of collecting,
identifying, evaluating, tracking, and avoiding adverse drug reactions (ADRs). Any noxious and
unintentional reaction to a medication, including lack of effectiveness, is classified as an ADR.[4]

3
 Cosmetovigilance: A Review

NEED OF STUDY:

The concept of “vigilance” has recently extended to include the protection of herbal and cosmetic
products. (5), (6)The word “cosmetovigilance” refers to the practices of gathering, evaluating, and
tracking random reports of unfavorable incidents that occur during or after routine or fairly
foreseeable use of a cosmetic product.[7]The French health products protection agency developed
cosmetovigilance as a component of the pharmacovigilance system for
cosmetics[8]Cosmetovigilance helps us to rule out or monitor potentially harmful ingredients,
helping us to feel more at ease with the products we use.Cosmetovigilance is a relatively new term.
The word has only recently been indexed. It is a form of public health surveillance with a public
health goal, as opposed to industrialists’ surveillance, which is focused on product safety for
commercial reasons, and peer surveillance (Revidal-Gerda), which is focused on medical issues.
Cosmetovigilance refers to the monitoring of cosmetic products.Causality evaluation and reporting
categories are two issues that have yet to be resolved. Cosmetovigilance devices are credible
sources of knowledge regarding the protection of cosmetics and their ingredients. Europe should
use them to ensure that new directives have a high degree of protection. Cosmetovigilance allows
us to rule out or monitor potentially harmful ingredients, allowing us to feel more at ease with the
products we use.Cosmetovigilance is a form of health surveillance in which the aim is to protect
the public’s health. It thus varies from surveillance conducted by industry to ensure the protection
of a commodity for commercial purposes, as well as surveillance conducted for medical
reasons.[9]the cosmetic product is defined as any material or preparation that is intended to be put
in contact with the very exterior parts of the human body, such as the hairs system, lips, and
external genital system, or the teeth and mucus membrane of the oral cavity, with the sole or
primary purpose of cleaning, perfuming, changing the appearance, preserving, or maintaining them
in good condition. Cosmetics must also adhere to annexes and marketing guidelines.[10]

Cosmetics are graded according to their roles and application locations. They can be used as
hygiene and occupational products at home as well as at work. Since certain ingredients are
prohibited in annexes, any ingredient not on the list is permitted. As a result, the industry is very
innovative and always trying to develop its products; it is constantly experimenting with new
ingredients not specified in the annexes. Allergens can be present in certain ingredients. There are

4
 Cosmetovigilance: A Review

no such authorities to access the protection of cosmetic products, unlike medicines. There is no
marketing authorization with precise conditions. There is no risk-benefit analysis and no guarantee
of continuity from batch to batch. Cosmetics are not allowed to assert medicinal advantages, so
they must not damage human health when used under fairly foreseeable conditions.[11]

COSMETOVIGILANCE IN DIFFERENT COUNTRIES.

Cosmetovigilance in Europe

Despite widespread usage of cosmetics, the incidence of adverse reactions (ARs) is poor, owing
to an underestimation of their severity. This may be due to normal self-diagnosis and self-
medication in the case of mild skin reactions. The absence of a reporting culture and a favorable
reporting atmosphere may be due, at least in part, to a lack of knowledge about the nature, number,
and severity of adverse reactions to cosmetics (ACRs).In, conclusion this survey reveals that
cosmetovigilance is treated differently in various European countries, while some countries are
attempting to establish a formal framework. [12]

Cosmetics sold in the European Union (EU) meet stringent safety and quality requirements.
Unwanted effects from natural or relatively expected cosmetic product use are unusual, and they
are generally mild and entirely reversible. Companies have protocols in place that allow them to
respond adequately to reports of unfavorable results, such as tracking, assessing, identifying the
significance of the effects, and planning for potential prevention. This is critical for companies’
post-marketing monitoring of cosmetic products and their success in the marketplace.
The EU Cosmetics Regulation (EC) No. 1223/2009, also known as the Regulation, established the
foundation for a unified approach to the management of Serious Undesirable Effects (SUEs)
caused by cosmetic use.The Regulation maintains the previous provisions of Directive
76/768/EEC regarding the inclusion of Undesirable Effects in the Product Information File and
public access to such information[13,14]. Cosmetics Europe, which represents the European
cosmetics industry, has established guidelines to encourage a standardized approach to the
management of UEs and the reporting of SUEs to Competent Authorities.It was agreed to publish
the recommendations in the open literature rather than as an industry publication to ensure that all

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 Cosmetovigilance: A Review

interested parties could easily access them. They follow the “SUE Reporting Guidelines” [15] The
current guidelines are an evolution of previous industry guidelines for dealing with unfavorable
event records. [16].

COSMETOVIGILANCE IN CANADA AND USA.

The Natural Health Products (NHP) Regulations, which went into effect in January 2004, allow
consumers and healthcare professionals in Canada to disclose any unnecessary ADRs or side
effects. The NHP is in charge of ensuring that all cosmetic products are licensed properly, that
adequate evidence for protection and effectiveness is provided, that accurate labeling is provided,
that good manufacturing practices are followed, that ADRs are recorded, that clinical trials
involving cosmetic products are kept up to date, and that all customers are informed about product
recalls.
There are notification forms for both customers and suppliers, such as the Cosmetic/Consumer
Product Incident Report. Within 15 days of the ADR, incident reports must be filed. [17]
Similar laws and agencies exist in the United States to ensure that products are used safely.
Cosmetics are overseen by the following people: Dietary Supplement and Nonprescription Drug
Consumer Protection Act, FDA, and Guidance for Industry Postmarking Adverse Event Reporting
for Nonprescription Human Drug Products Marketed Without an Apmanner.
In the United States, the FDA regulates both prescription and nonprescription cosmetics. The FDA
monitors product labeling, manufacturing, protection and effectiveness, ADRs, testing, and recalls
in the same way that the NHP does in Canada. While a cosmetic product may not be FDA-
approved, the FD&C is still responsible for ensuring that it is sold safely.
Cosmetics-related ADRs should be reported to the FDA by consumers, healthcare professionals,
and/or manufacturers. ADRs can be reported to the FDA through Med Watch by filling out an
electronic form or calling the hotline.[18]To assist with ADR files, the FDA has a customer
complaint officer. A separate report, the individual case safety report, is needed for over-the-
counter goods. Besides, the Cosmetic Safety Amendment Act of 2012 and the Healthy Cosmetics
and Personal Products Act of 2013 were also passed in the United States to fix cosmetic safety

6
 Cosmetovigilance: A Review

issues. These two acts require further ADRs to be submitted to the Secretary of Health and Human
Services within 15 days of the ADR occurring.[19]

Malaysian Cosmetic Users' Perspectives on Cosmetovigilance

Cosmetics are now considered a “must-have” commodity in most people’s everyday lives. The
National Pharmaceutical Regulatory Agency (NPRA) regulates cosmetics in Malaysia under the
Control of Drugs and Cosmetics Regulations (1984). The cosmetics industry is thought to be one
of the most important industries, not only because of its contribution to global GDP but also
because of its ability to affect the social lives of all people.[20]Cosmetic products are classified as
“any material or preparation intended to be put 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 the sole or primary purpose of cleaning, perfuming, changing
their appearance, and/or correcting b” according to NPRA in Malaysia. In light of the current
situation, a few academics have stated that customers are searching for goods that contain active
ingredients and have substantial positive effects.[21,22].In a survey of 1687 consumers aged 14
and up conducted by the FDA in 1994, it was discovered that consumers expected the product’s
effects after use to be the same as what was claimed on the packaging [23]. This means that buyers
have their own preferences and are more concerned with the effectiveness of the product they wish
to buy. Given the rising demand for cosmetics, it is the duty of cosmetic companies and industries
to ensure that their products are healthy [24,25]. Some cosmetic manufacturers, on the other hand,
are not adhering to industry guidelines when it comes to the protection of their products, since they
continue to use banned substances and chemicals as ingredients in their products while being aware
of the potential for adverse reactions [21,26,27]

These irresponsible manufacturers often mask their counterfeit cosmetics with similar names and
packaging to the originals and market them at cheaper rates in order to benefit from low-income
customers [28] .Adverse reactions to cosmetics have recently been identified as one of the most
important aspects of cosmetics [29].Other researchers have conducted studies to determine
cosmetovigilance [29-34], and in a few of these studies, customers were the intended subjects, and
their responses were extensively used as references. Furthermore, in terms of cosmetic product

7
 Cosmetovigilance: A Review

practises, the proportion of respondents who followed correct procedures may be higher.
Education in current cosmetics procedures, methods, and practical applications should be
implemented as soon as possible so that beauty products can be used to their full potential.[35]

COSMETICS IN OTHER COUNTRIES

One of the first large-scale studies was conducted, based on reports from four companies’ hair
coloring products collected from 45 countries over four years (2003–2006). To determine the time
course, country impact, and product type, an analysis of unfavorable events was conducted. When
compared to oxidative dyes, the occurrence of allergic contact dermatitis to direct hair coloring
products was lower. Surprisingly, a history of black henna tattoos was found to be a significant
risk factor for the severity of allergic touch reactions. This was the first study to identify the risk
factors associated with the use of cosmetic hair coloring products. They concluded that it is
important to consider safety issues so that product label notices can be updated accordingly.[36]

Another wide-scale study from Europe was published the same year. The data were based on the
reports of an industrial company in France[37]They've set up their own vigilance scheme to keep
an eye on cosmetics and cleaning supplies. A total of 102,689 customers contacted the consumer
department between 2005 and 2007, with 842 (0.82 percent) reporting skin reactions. After
analyzing the results, it was discovered that 0.144 skin reaction cases per million units sold were
caused by cosmetic or household products... For obtaining reliable data, this study demonstrated
the value of quality reports and the implementation of a formal vigilance framework

The European Cosmetic Toiletry and Perfumery Association (Colipa; now Cosmetics Europe)
released the “Guidelines on Management of Unfavorable Case Reports” in 2005 as a tool for
industry harmonization regarding the compilation and assessment of adverse event reports. The
pair launch monitoring and COLIPA recommendations are intended to determine the casualty of
unfavorable Cosmetic products effects on human health.[38-40]

The regulatory regimes in the United States and Europe vary due to variations in definitions and
limitations on the use of ingredients.[41,42] A survey study with 14 countries showed that
cosmetovigilance is differently handled in European countries and suggested a need for a formal
joint cosmetovigilance system.[43]

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 Cosmetovigilance: A Review

Another study from Europe was carried out in Italy.[44] In a study conducted in Turkey,
pharmacists reported that the safety and effectiveness of cosmetics sold in pharmacies were their
top concerns and that they expected manufacturers to respond and take responsibility if an ADR
occurred.[45]Group pharmacists in Naples, Italy, interviewed 4373 people about cosmetic side
effects.[46]

Another research in Brazil found that 38% of participants had an ADR with a beauty product they
had used in the previous two years.[47] The majority of mild to moderate side effects were said to
be caused by soap, shampoo, and deodorants. Just about a tenth of the ADRs were serious.

In a recent survey of 600 people in Ethiopia, 61 percent said that the cosmetics they use have
caused them problems (allergies, acne, and hirsutism).[48]

COSMETOVIGILANCE IN INDIA

The Drugs and Cosmetics Act describes “cosmetics” 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 washing, beautifying, promoting beauty, or altering the appearance, and includes any
article intended for use as a portion of cosmetics,” according to Section 3(aaa).[49,50] Cosmetics
in India are governed by the Drugs and Cosmetics Act 1940 and Rules 1945. Parts XIII (cosmetic
import and registration), XIV (cosmetic manufacturing for sale or distribution), and XV (cosmetic
manufacturing for sale or distribution) (regulates labeling, packing, and standards of cosmetics).
The use and import of arsenic and lead-containing compounds are prohibited by rules 145 and 135
respectively
The jaws 135A and 145 D make it illegal to use cosmetics that contain mercury. Import of
hexachlorophene-containing cosmetics is prohibited under Rule 134-A. Cosmetic goods must
contain paint, dye, or pigment as defined by schedule Q and the Bureau of Indian Standards,
according to Rule 134. Notification in the Gazette Skin products (which are further subdivided
into ten subcategories: products for skin care, washing, removal of body hair, body hair bleach,
body odor corrective products, products for shaving (pre or aftershave), products for makeup,
perfume, products for heat, among self-tanning, and others) and hair and scalp products (which are
further subdivided into four subcategories: cleansing, removal of body hair, body hair bleach, body
odor corrective products, products for shaving and other nail and cuticle care products), as well as

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 Cosmetovigilance: A Review

oral hygiene products (tooth care, tooth whiteners, mouth wash, and breath spray and other
products for oral hygiene).[50]
The distinction between drugs and cosmetics, on the other hand, is not always apparent.[51]
Cosmetics can have negative side effects, much like medications. In a five-year retrospective study
of 1609 participants, 12.2 percent experienced negative effects from cosmetics and toiletries, with
63.3 percent of women and 36.7 percent of men. Itching (70.9%), dry skin (63.3%), and a burning
feeling in the skin were the most popular complaints (50 percent ). There were rhagades, scales,
blisters, streaks, and redness on the skin, as well as no noticeable changes. Eye discomfort,
manifested by itching and watery eyes, shortness of breath after perfume spray, local lymph node
swelling after deodorant use, sneezing after aftershave application, and nausea after perfume
application were among the other symptoms. The most commonly affected areas were the face and
hands.[52]
Tenderness, swelling, scratching, and bumps were the most common adverse drug reactions
(ADRs) following permanent makeup procedures in the United States. Suffering lasted anywhere
from 5.5 months to 3 years.[53]Sensitization to many allergenic components has increased as a
result of increased cosmetic use.[54] In India, hair dye is one of the most common causes of contact
dermatitis.[55]kumkum dermatitis was very common in India's southern states. The use of sticker
bindis has also been discovered to be a significant risk factor for contact dermatitis.[56] Certain
cosmetic ingredients, in addition to the active ingredient, have been linked to negative reactions
after using cosmetics.[57] Even though there are many ADRs at the population level, regulatory
authority reporting is very limited. The majority of patients with contact dermatitis reported having
negative reactions to cosmetic products, according to a review.
They discovered that many patients with contact dermatitis had good outcomes in cosmetic patch
examinations, and they concluded that cosmetics are significant etiological factors for contact
dermatitis incidence.[58]

Cosmetics that have been mislabeled or are counterfeit

Cosmetics that are misbranded or fake are normal, just like drugs. The provisions of the Drugs and
Cosmetics Act 1940 and the Drug and Cosmetics Law 1945 describe misbranded and spurious
cosmetics. If a cosmetic contains an unprescribed color, improper labeling, or false/misleading

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 Cosmetovigilance: A Review

product details, it is referred to as misbranded. Cosmetics are branded as spurious whether the
name resembles another cosmetic, the product resembles another cosmetic, or the manufacturer
information is false, fake, or non-existent, which may lead to consumer deception.[59] In the
Indian industry, there has been a lot of talk about fake cosmetics. Cosmetics in labeled bottles have
been discovered being sold to parlors and salons. Officials from the Food and Drug Administration
confiscated a large number of cosmetic items with no license number shown on the label during a
raid on beauty parlors in Pune. [60] Many cosmetic items have been found to contain high levels
of lead.[61]Hairstylists in salons and parlors are exposed to chemicals in cosmetics, and hand
dermatitis is a common ailment among them. Fertility disorders and poor pregnancy outcomes are
especially prevalent among female hairstylists, which is a cause for concern. As a result of their
sensitivity to ammonium persulfate, hairstylists are more likely to develop asthma.[62]In contrast
to US samples, 43 percent of India samples of sindoor exceeded the level of lead content in sindoor,
according to Shah et al. To ensure the lead-adulterated sindoor is not available for sale, public
health initiatives should concentrate on primary prevention.[63]Lead levels have been found in
also widely used "kajal." Minimum (Pb3O4) and galena are two lead-containing compounds
present in kajal (PBS). Zincite (ZnO), magnetite (Fe3O4), and amorphous carbon are among the
other compounds discovered. These compounds in high concentrations can be harmful to the
human body, particularly pregnant women.[64]
Cosmetics and Pregnancy are two topics that come up often.
Another problem that needs to be addressed with caution is cosmetic use during pregnancy and its
developmental effects. There is no easy solution to this dilemma. Except for hydroquinone and
topical retinoids, the risk of malformations and other side effects does not seem to be increased
when using cosmetics.[65]Trichloroacetic and salicylic acid are two chemical peeling agents that
should be avoided or used with caution. Another problematic subject is the use of botulinum toxin.
Sclerotherapy should also be used with caution, particularly during the first trimester and after 36
weeks of pregnancy. During the lactation period, fat transfer and sclerotherapy are not
recommended.[66] Couto et al. discovered a correlation between the use of hair dye or hair
strengthening products during the first trimester and the development of acute lymphoblastic and
acute myeloid leukemia in their children.[67]While no such effects were found in later trials, it is
advisable to prevent such care during pregnancy.[68]

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 Cosmetovigilance: A Review

In India, there is a need for cosmetic vigilance.

India has a large population, and its cosmetics industry is similarly large. In India, contact
dermatitis and other dermatoses are normal, and cosmetics have been linked to them. Traditional
agents, such as kajal and kumkum dermatitis, are also widely reported to cause adverse reactions.
The Drugs and Cosmetics Act, Section 135 B, makes it illegal to import cosmetics that have been
tested on animals in India. Cosmetic-related illnesses, like other diseases, result in
pharmacoeconomic losses
Hence besides proper regulation of these agents, a proper vigilance system is also required to
protect the health of the Indian population. Going with the words of Vigan and Castelain, 2014[69]

ADVERSE EFFECTS OF COSMETICS

An empirical analysis of adverse cosmetic reactions: The need to put the Cosmetovigilance method
into effect
Cosmetics are an important part of people’s everyday lives through centuries, and they are used
for a variety of purposes.[70] Cosmetics are classified as “articles for beautification, cleansing, or
altering physical appearance” by the US Food and Drug Administration (FDA).[71] Cosmetics are
described by the Saudi FDA as "any product containing one or more substance intended for use
on the outer parts of the human body (skin, hair, nails, lips, and the outer parts of the genital),
teeth, and the mucous lining of the oral cavity for cleaning, perfuming, to protect or keep the good
condition, to change or improve appearance, or to change or improve the smell of the
body.[70]Similarly, cosmetics regulations vary in the United States and Saudi Arabia: in the
United States, certain personal care products are classified as OTC drugs, while in Saudi Arabia,
they are classified as cosmetics.[70,71]
The majority of cosmetic users are more concerned with the short-term effects of cosmetics on
appearance than with the long-term effects on the whole body. Such goods are thought to have an
acceptable level of protection and tolerability.[72] According to the reports, exposure to different
chemical compounds used in cosmetics is harmful to one’s health.[73-74] Headache, dizziness,
tiredness, and nausea were the frequently reported adverse reactions associated with prolonged
exposure to heavy makeup.[75-77] The Middle East’s beauty and personal care industry is

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 Cosmetovigilance: A Review

expanding at twice the rate of the rest of the world. [78] In the Kingdom of Saudi Arabia, economic
and cultural developments affect cosmetic use habits.[76,79] Since the Kingdom’s rapid growth
in cosmetics, the Saudi Food and Drug Administration (SFDA) has been in charge of regulating
cosmetics and issuing guidelines to ensure their safety. SFDA introduced an electronic system
called Cosma to control the production, importation, and marketing of cosmetic goods. Also, the
SFDA established a single call Centre number for questions about the safety of food, medicines,
and cosmetics. Despite these efforts, there is a research gap in the Saudi population regarding
cosmetics use habits and cosmetics-related adverse reactions[70]

Contact Allergy to Fragrance and Cosmetics in Children

Fragrances aren’t just for cosmetics; they’re also in topical medications, toys, food, and detergents.
Cosmetic products, according to the European Union (EU), are "any substance or preparation intended to
be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips,
and external genital organs) or with the teeth and mucous membranes of the oral cavity with the sole or
primary purpose of cleaning, perfuming, changing their appearance, and/o" Cosmetic goods must also
adhere to the applicable EU regulation's annexes and labelling guidelines.[80].Cosmetics are distinct from
medications to treat disease and medical devices that are often used for medical purposes in that there
is no risk–benefit analysis for cosmetic products. Soaps, body washing products, wet wipes, creams,
shampoos, toothpastes, and perfumes are the most popular beauty products for young children. Wet
wipes, for example, may cause sensitization to methylisothiazolinone, a cosmetic ingredient.[81]Cosmetic
ingredients are not unique; they can be used in detergents, toys, and industrial goods as well. Some
products are "cosmetic like"—they appear to be cosmetic products based on the term, but they do not
meet the requirements set forth in the regulation's annexes. Black henna tattoos, for example, are only
meant to affect the appearance of the skin, but they can actually cause paraphenylenediamine
sensitization because they do not meet the requirements in Annex III of the regulation regarding this
ingredient.[82]

A survey of adverse reactions to cosmetics and the Notification System in Health Surveillance

13
 Cosmetovigilance: A Review

The word “cosmetics and hygiene products” refers to products that are intended to provide
protection and beauty and are divided into four categories: hygiene products, cosmetics in general,
perfumes, and products for children.[83] It is possible to assume that its application is universal,
and such goods are thought to have an acceptable level of protection and tolerability. Even though
the majority of adverse reactions (AR) to cosmetics are minor and typically involve the skin, there
have been a few serious cases recorded in the literature involving perfumes, fragrances, and hair
dye. Several compounds, including para-aminobenzoic acid, cinnamate, essential oils, p-
phenylenediamine, and preservatives, have been identified as the most common causes of allergic
reactions to cosmetics.[84]The Brazilian Health Surveillance Agency (Anvisa) began investing in
the strengthening of post-use surveillance/commercialization of health surveillance goods,
including cosmetic surveillance, in 2005.[85]

Nail Products: Their Safety and Efficacy

Nails, which have been used as a defensive structure for centuries as a survival tool, have evolved
into a fashion accessory over time. Items for nail cosmetic treatment have increased in popularity
over the last few decades. More and more items to improve the cosmetic appeal of nails are being
commercialized, ranging from nail hardeners to nail polish to artificial nails. The United States
and European countries have attempted to regulate the standard of nail cosmetics. The Federal
Food, Drug, and Cosmetic Act were enacted by the US Food and Drug Administration (FDA),
while Cosmetics Regulation No. 1223/2009 was enacted by the European Union Commission.
Manufacturers and distributors must provide ingredients and safety details for cosmetic products
under these regulations. The FDA’s Federal Food, Drug, and Cosmetic Act identifies a cosmetic
product, regulates product labeling, and also prohibits the use of compounds with known adverse
effects. It also necessitates prominent warning statements on items that could pose a health risk or
whose protection has yet to be decided [86] In the case of cosmetic allergies, both US and European
law prohibits the use of such allergens if adequate patch test data and literature are available.[87]
The FDA has a scheme in place called the Voluntary Cosmetic Registration Program that helps
them to assess cosmetics that are currently on the market. The Cosmetic Ingredient Review
Advisory Panel of the FDA is a private-sector-funded group of scientists and experts that evaluates
cosmetic products for ingredient protection.[88]The most popular nail products are nail polish and

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 Cosmetovigilance: A Review

artificial nails, and the most common safety issue is allergic contact dermatitis caused by
sensitizers including TSFR and methacrylates. Furthermore, prolonged artificial nail use has been
linked to chemical and mechanical damage to the nail. There is also concern about the consumption
of items like nail primers, nail polish removers, and nail glue removers, which may cause serious
morbidity a Health effects such as eye and throat irritation, asthma, and even neurocognitive
changes can be observed as a result of compound aerosolizing. Methacrylates have numerous
systemic consequences, including respiratory discomfort, neuropathy, altered mental state,
gastrointestinal irritation, and fetotoxicity, in addition to allergic and irritant contact
dermatitis.[89]

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 Cosmetovigilance: A Review

REVIEW OF LITERATURE

16
 Cosmetovigilance: A Review

REVIEW OF LITERATURE

Choursiya S, et.al, (2021)(90) declares a genuine way of collecting information on the protection
of cosmetic products and their ingredients is through a Cosmetovigilance scheme. Given the
complexities of formulating for a technologically advanced market, cosmetic formulation is
becoming increasingly complex. The paper is intended for cosmetic chemists, scientists,
dermatologists, and formulators who must consider a broad range of issues in order to develop
successful novel skin care products for a diverse population.

Sharma A, et.al, (2021) (91)stated that the cosmetics cause excessive exposure to chemicals and
indirect ingestion, resulting in health problems such as allergy, hypersensitivity, and even
carcinogenic effects in certain cases. Many pieces of scientific evidence have supported the
existence of phthalates, coal tar, heavy metals, parabens, and other chemicals in cosmetics.This
study is a selection of data from the cosmetics literature that has been reviewed. More stringent
safety assessment guidelines, the prohibition of such hazardous substances, an end to industry-
wide animal cruelty, and the use of more natural products and herbal formulations should all
bepromoted.

Sebastian J,et.al, (2020)(92)stated that, there are no standardized, accurate monitoring programs
in place, such as cosmetovigilance, the number of adverse effects recorded with cosmetics is
extremely low. Self-diagnosis, self-use, and the lack of medical consultation are all factors that
contribute to this underestimation, as they do not understand or pay attention to these mild and
moderately harmful incidents. National cosmetovigilance initiatives can be developed to remedy
cosmetic problems. These programmes should be continuing because there are many misbranded
and spurious items on the market that have the potential to cause serious and non-serious adverse
incidents.

Toklu HZ,et.al ,(2020)(93) suggested to increase theresidents’ understanding of the adverse

reactions caused by the use of cosmetic products, primary care physicians should integrate
“cosmetovigilance” into their post-graduate curriculum, as well as promote good reporting
behaviour.

17
 Cosmetovigilance: A Review

HadiH, et.al,(2020)(94) stated the severity of the Adverse reactions in the Europe. He gather
information on post marketing (respect to AR), from other countries who were members of
European union and common European Economic space, by his end of the study about 16 months
after the mailing( June 2004) , he received responses from countries to which the survey was sent.
According to his research, the post-marketing vigilance method for cosmetics differs by region. In
particular, when it comes to AR notification. According to his research, cosmetovigilance is
viewed differently in different European countries

Khan AD, et.al(2019) ( 95) stated the necessity of making citizens aware of the different adverse
effects of cosmetics and chemicals used in cosmetics that has become a requirement. The global
cosmetic industry is estimated to be worth about $20 billion dollars today. The increasingly drawn
of using beauty and personal care items as consumers. However, these items, which are meant to
make us feel good and look good, have a dark side. Various harmful additives and dangerous
chemicals commonly used in cosmetics have been found to be present in quantities that exceed
reasonable limits. These chemicals may have serious side effects on the skin, as well as invade the
skin and other organs and cause cancer.

AK Mohiuddin, et.al (2019) ( 96) discussed cosmetics safety concerns, cosmetics contain a variety
of chemicals to which we are constantly exposed. All cosmetics were divided into three groups:
rinse-off (shower gel, shampoo,private soap, shaving foam), leave-on (body cream, face cream,
hand cream, antiperspirant, sunscreen, astringent), and make-up (face cream, face cream, hand
cream, antiperspirant, sunscreen, post-shaving astringent) (lipstick, nail polish).Because of their
toxicity at higher concentrations, a large number of these compounds are allowed to be used under
strict limits. Every ingredient used in cosmetics complies with certain regulatory requirements.
Nonetheless, he stated because of their toxicity at higher concentrations, many chemicals are
allowed to be used under strict limits.

KoseO,et.al,(2018) (97) aimed was to evaluate skin irritation potentials of cosmetics by Epiderm
model.Sixty commonly used cosmetic items were gathered from various markets and cosmetic
stores. Just one shampoo was found to be a strong/severe skin irritant/possible corrosive among
hair care products, while 22 shampoos were moderate skin irritants and 11 shampoos were mild to
moderate skin irritants. One skin care product was found to be a moderate to mild skin irritant out

18
 Cosmetovigilance: A Review

of a total of six. Suggested that alternative in vitro experiments be used to monitor both ingredients
and final cosmetic formulations on a regular basis.

VS Bhuvaneswari , et.al (2018)(98) includes a brief overview of the method of evaluating a

cosmetic product’s protection. Cosmetics do not have a large systemic absorption rate due to skin
penetration, although certain items are designed to be applied to the mucous membranes or the
skin surrounding the mucus membrane.

Arora H ,et.al (2017) (99) aimed to summaries and analyses the available data on popular nail
products, as well as their protection and efficacy. Case studies and studies have shown that nail
goods like nail polish, nail polish removers, and artificial nails have certain negative effects.To
evaluate the safety of these compounds and the chemicals inside them, further long-term
retrospective studies and randomized controlled trials were needed. The effectiveness of nail
cosmetics has not been well studied, and it should be a future research subject.

Bilal Al, et.al (2017) (100) Concluded that a higher percentage of cosmetic consumers said they
had experienced at least one negative reaction. The number of cosmetic products used and the
frequency at which they were used were both significant predictors of adverse events. This means
that safety issues about cosmetic use must be considered. Awareness-raising campaigns and the
promotion of the idea of cosmetovigilance among cosmetic vendors, consumers, and other
stakeholders may be used to resolve such issues.

Udupa N , et.al (2016)(101) stated that because of a lack of a well-organized reporting system, the
number of unintended or adverse reactions to cosmetic products is very poor or goes unnoticed. In
India, there is a post-marketing vigilance scheme that focuses on adverse drug reactions. More
recently, medical devices, blood products, biologics, special nutritional and natural products have
received more attention, while adverse reactions to cosmetic products have received less attention.
Furthermore , he stated in his study that India may be the first country to implement a structured
cosmetovigilance scheme.

Dias MFRG, et.al (2015)(102) examines the formulas and modes of action of hair cosmetics such
as shampoos, conditioners, hair straightening products, hair dyes, and henna, as well as the
prescription and safety of these products. The dermatologist's understanding of hair care products,

19
 Cosmetovigilance: A Review

their use, and potential side effects will extend to an understanding of cosmetic resources, allowing
dermatologists for better manage hair and scalp conditions based on hair type.

Vigan M,et.al(2014)(103) access definition, regulation, and application “in practice” of

cosmetovigilance it’s a form of public health surveillance with a public health goal, as opposed to
industrialists’ surveillance, which is focused on product safety for commercial reasons, and peer
surveillance (Revidal-Gerda), which is focused on medical issues.

Bocca B ,et.al (2014) (104) suggested that cosmetics may have several exposure scenarios and
high level of metals can give to the cosmetic a potential intrinsic hazard.Cosmetics companies
are not required to disclose impurities of this kind, so customers are unaware of their own risk.The
concentrations of metals in various forms of cosmetics produced and sold around the world, as
well as data on metals’ dermal penetration and systemic toxicology, were reviewed in this paper.

Salverda JGW , et.al (2013)(105) overviewed the negative effects that cosmetic products have
been linked to, as well as described the ingredients that are involved. To allow consumers to report
unfavorable results, a website and public awareness campaign were launched as a result makeup
and moisturizers were the most commonly mentioned cosmetic products, and isothiazolinones and
fragrance ingredients were the most frequently detected allergens.

Huf G, et.al (2013) (106) aimed to explain the population’s perspective on the prevalence of
Adverse Reactions (AR) and details about the surveillance system were examined.The aim of the
study was to look into the quality of cosmetic products and to assess the cosmetic surveillance
system.

Watkins S , et.al (2012) (107) Examine the most common allergens found in cosmetics, as well as
the types of cosmetics that contain them. Sensitization to many allergenic components has
increased as a result of the increased use of cosmetics , concluded that dermatologists may be able
to recognize touch allergies to cosmetic ingredients and help patients avoid the offending items
with adequate education and patch examination.

Ruggiero S , et.al (2012) (108) stated that Control Centres (PCCs) offer specialized and timely
information to customers and health practitioners to ensure that incidents related to exposures to
various agents, including Cosmetics, are managed appropriately., findings call for more attention

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 Cosmetovigilance: A Review

to this form of hazard, particularly for children under the age of four, since exposure frequency
appears to be more likely to indicate product availability and accessibility to ingestors.

Bozzo P , et.al ( 2011)(109) detected the lead levels in commonly used "kajal". Two lead-
containing compounds contained in kajal are minimum Pb3O4 and Galena. Other compounds
discovered include zincite, magnetites, and amorphous carbon. In his study he also stated the high
concentrations of these compounds can be harmful to humans, particularly pregnant women.

Gosavi S.S , et.al ( 2010)(110) investigated that the naiil cosmetics are used to improve the
appearance of fingernails, but there is a lack of detailed knowledge about the products and
chemicals used in them. And allergic contact dermatitis, which is caused by sensitizers like
methacrylate, is the most common safety concern. Long-term artificial nail use has also been
linked to chemical and mechanical damage to the nail.

Hyde KD, et.al (2010) (111)concluded that Anti-aging, anti-oxidants, skin revitalising, skin
whitening, and hair products are some of the cosmetics that contain fungi. The mushrooms
currently in use have long been known to contain medicinal compounds, and as a result, they were
the first to be used in cosmetics. There are, however, a slew of other mushroom species that have
yet to be evaluated, identified, or cultivated, but have enormous potential for use in cosmetics.
Some fungi are also used in biotransformation, and products like lactic acid and ceramides may be
used in cosmetics in the future.

CONCLUSION:

Cosmetovigilance is a recent approach in cosmetic product safety control. It may be considered an

integral part of public health efforts. If post marketing monitoring of cosmetics becomes more

21
 Cosmetovigilance: A Review

common across the world, issues associated with these products can be detected and resolved,
ensuring product protection. A key task for family medicine physicians and primary care
practitioners is to identify ADRs caused by cosmetic products and encourage patients to report
them. Raising recognition of this emerging paradigm would be a significant contribution to global
public health.Cosmetics safety control is referred to as cosmetovigilance. It is a component of
public health activities. In the near future, pharmacists should be more aware of this issue. To
bolster the results even further, a prospective national prevalence analysis that analyses causality
and reports to the country’s pharmacovigilance framework could be performed.

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 Cosmetovigilance: A Review

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23
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