This document discusses controversial ingredients commonly found in cosmetics. It summarizes the key ingredients of parabens, dioxane, formaldehyde liberators and provides details on their use, health concerns, regulations and alternatives. Parabens are widely used preservatives that some research links to cancer and hormone disruption. Dioxane and formaldehyde releasing chemicals are contaminants and preservatives respectively that are classified as carcinogens. The document outlines the potential health effects of these ingredients and regulations around their use in cosmetics.

1. CONTROVERSIAL
INGREDIENTS OF COSMETICS
Prepared by, M.PHARM
(PHARMACEUTICS)
1. SHUBHAM YADAV
(VP21PHAR0100006)
2. AMAN KUMAR CHOUDHARY
(VP21PHAR0100008)
Under the guidance of,
Dr. G.V. Radha

2. Parabens
• Parabens are a set of chemicals which are extensively used as preservatives especially
in cosmetics.
• They can be discovered in shampoos, industrial moisturizers, shaving gels,
topical/parental preparations, tanning solutions, toothpaste, and also in food additives.
• Parabens are used to prevent microbial growth of the bacteria in cosmetics to maintain
the customers health and maintain the integrity of the product.
• Common parabens used are: methyl paraben, propyl paraben, ethyl paraben and butyl
paraben.
• Parabens are controversial due to the following factors given by American drug society
and FDA:
• According to research, it is found that it is relatively safe, posing only a negligible risk
to the endocrine systems.
1. Allergic reactions
2. Breast Cancer
3. Estrogenic Activity
4. Sun exposure

3. Chemistry of Parabens
• Parabens are derived from para-
hydroxybenzoic acid which is
found in many fruits and
vegetables. Ex:- Blueberries,
carrots and onions.
• Parabens can mimic hormones in
the body and disrupt functions of
endocrine system.
• Parabens can enter in your body
through your skin when you
applied it on your skin.

4. Parabens
Parabens Chemical
Formula
Chemical Name Molecular
Weight (g/mol)
Structure
Methyl Paraben C8H8O3 Methyl-4-
hydroxybenzoate
152.15
Ethyl Paraben C9H10O3 Ethyl-4-
hydroxybenzoate
166.18
Propyl Paraben C10H12O3 Propyl-4-
hydroxybenzoate
180.20
Butyl Paraben C11H14O3 Butyl-4-
hydroxybenzoate
194.23

5. A popular skin cream containing parabens, and a newer one that is paraben-free.

7. Side Effects of Parabens
1. Allergic Reactions
• Parabens will cause a range of reactions to those with allergies. They are notable
to cause skin irritation and dermatitis, that could be a serious form of skin
inflammation characterized by rashes, blisters and burning skin.
• Parabens deeply penetrate the skin and disrupt the conventional functioning
of hormones.
2. Estrogenic Activity
• It’s potential that parabens will increase estrogen production, resulting in
estrogen-positive carcinoma and male physiological state problems.

8. 3. Premature Ageing
• The alkyl group kind of paraben is particularly damaging to the skin and will
increase sensitivity to the sun. Applying paraben-containing product before
going outdoors will cause your skin cells to die quicker than normal once
exposed to ultraviolet rays. Skincare product should not damage the skin.
4. Breast Cancer
• Parabens are known to be xenoestrogen, i.e. endocrine-disrupting chemicals,
also known as hormone-mimicking chemicals, which is said by Kindred. Which
means that the paraben like a hormone. For example, parabens may act like
oestrogen.

9. 5. Early puberty and decreased sperm count
• The parabens are known as endocrine disruptors are those substances that
adversely have an effect on the endocrine system.
• The system releases hormones into the blood and is concerned during a variety
of functions associated with waste elimination, digestion and metabolism.
Endocrine disruptors like parabens will result in early adolescent in both girls
and boys.
• Parabens can even have an effect on the male genital system.

10. Regulations
• The European Scientific Committee on Consumer Safety (SCCS) stated in 2013
that methyl paraben and ethyl paraben are safe at the maximum authorized
concentration [upto 0.4% for one ester or 0.8% used in combination].
• They concluded that the use of butyl paraben and propyl paraben as
preservatives in finished cosmetics products is safe to the consumer.
Alternatives for Parabens
• Phenoxyethanol used in the EU at upto 1.0% in all product categories.
• Sodium benzoate in combination with potassium sorbate, upto 2.5% in rinse
off products, 1.7% in oral care products, 0.5% in leave-on products.
• Benzyl alcohol upto 1.0% and dehydroacetic acid upto 0.6%.

11. Dioxane
• The compound 1,4-dioxane is a trace contaminant in some cosmetic products. It is not
used as an ingredient in cosmetics, but may be present in extremely small amounts in
some cosmetics.
• 1,4-dioxane forms as a byproduct during the manufacturing process of certain cosmetic
ingredients.
• These ingredients include certain detergents, foaming agents, emulsifiers, and solvents.
• The compound is formed through a process called as ‘Ethyoxylation’, in which
ethylene oxide, a known breast carcinogen is added to other chemicals to make them
harsh.
• Example:
• Sodium laurel sulphate:- a chemical that is harsh on the skin, is often converted to the
less harsh chemical sodium laurel sulphate.
• The conversion process can lead to contamination of this ingredients with 1,4-dioxane.

12. Health Concerns
1. Cancer:
• Research shows that 1,4-dioxane readily penetrate the skin. It is considered as a
probable human carcinogen by the U.S Environment Protection Agency.
• It is listed as an animal carcinogen by the National Toxicology Program by US.
• It is include on California’s proposition 65 list of Chemicals known or suspected
to cause cancer or birth defects.
• It is also leads to cause organ toxicity.

13. • Vulnerable Population:
• Infants
• Teenagers
• Pregnant women
• Regulations
• As per regulations, it is found that limit for dioxane safe for human is 10 ppm in
products.

14. Alternatives for 1,4-dioxane
There are several ways to avoid the formation of 1,4-dioxane in the ingredients:
• The FDA does not require 1,4-dioxane to be listed as an ingredients on product
labels because the chemical is a contaminant produced during manufacturing.
• Without labelling, there is no other options to know for certain whether a product
contains 1,4-dioxane, making it difficult for consumers to avoid it.
• Alternative processes to ethoxylation do not exists but many companies don’t
take advantage of them.
• Vacuum stripping can remove 1,4-dioxane from an ethoxylated product.
• Organic standard do not allow ethoxylation and some conventional companies
such as Johnson and Johnson have agreed to alter the process that results in this
combination.

16. Formaldehyde Liberators
• Formaldehyde is a colorless, strong smelling gas used in a wide range of industries and
products including building materials, cabinets furniture, walls and personal care
products.
• Formaldehyde and formaldehyde releasing preservatives are found in many personal
care products, particularly in shampoos, liquid baby soaps, nail polish, nail glue, hair
gel and etc.
• Health concerns:
• Cancer
• Skin irritation
• Vulnerable populations
• Infants
• Hair salon workers
• Nail salon workers
Formaldehyde

17. • FOUND IN: Nail polish, nail glue, eyelash glue, hair gel, hair- smoothing
products, shampoo, body soap, body wash, color cosmetics.
• WHAT TO LOOK FOR ON THE LABEL:
• quaternium-15,
• DMDM hydantoin,
• imidazolidinyl urea,
• diazolidinyl urea,
• polyoxymethylene urea,
• sodium hydroxymethylglycinate,
• bromopol and glyoxal.

18. Health Concerns
1. Cancer
• Formaldehyde is considered as a known human carcinogenic by many experts
and government bodies.
• A 2014 study found that formaldehyde initiates and promotes tumour formation.
• It enters into a body through an inhalation of formaldehyde containing
formulations leads to cause cancer.
2. Irritation
• Formaldehyde, in the 2015 by American contact dermatitis society considered as
contact allergen of the year.
• It also results in occurrence of sensitivity.

19. Regulations
• Banned from use in cosmetics and toiletries in Japan and Sweden.
• EU allows the use of quaternium-15 upto 0.2% as preservatives in cosmetics
products till 2017. But in new cosmetic rules in 2017 EU banned quaternium-15
and formaldehyde.
Alternatives for Formaldehyde Liberators
• Skin hair smoothing products especially those sold in salons, as salon based
products are exempt from labelling laws.
• Don’t use expired cosmetics products or store cosmetic products in the sun
because this can cause more formaldehyde to be released.
• Choose nail products that are labeled formaldehyde free or toxic free
(formaldehyde, toluene and Dibutyl Phthalate).

20. • Quaternium-15
a) It is a quaternary ammonium salt used as a surfactant and
preservatives in many cosmetics and pharmaceutical
products.
b) It is the most sensitizing of FRP and is found in mascara,
lotion and shampoo.
• Glyoxal
a) Glyoxal is the smallest dialdehyde and organic compound
which is yellow colored liquid that evaporates to give a
green colored gas.
b) It is found in conditioner, lotion, nail polish, etc.
c) CIR (Cosmetic ingredient review) expert panel has
declared that glyoxal is an skin allergen.

21. Allergy due to Quaternium-15

22. DMDM Hydantoin
• DMDM hydantoin is an antimicrobial formaldehyde releaser
preservative with the trade name Glydant.
• DMDM hydantoin is an organic compound belonging to a
class of compounds known as hydantoins.
• DMDM hydantoin works as a preservative because the
released formaldehyde makes the environment less
favourable to the microorganisms.
• DMDM Hydantoin is found in lotion, sunscreen and make-
up remover and is one of the least sensitizing of the FRPs.

23. Imidazolidinyl urea, diazolidinyl urea and
polyoxymethylene urea
• Imidazolidinyl urea, diazolidinyl urea, and polyoxymethylene urea are found in
shampoo, conditioner blush, eye shadow, and lotion and are all known human
allergens.
• Imidazolidinyl urea is one of the most common antimicrobial agents used in
personal care products and is often combined with parabens to provide a borad
spectrum preservative system.

24. Imidazolidinyl Urea
Diazolidinyl Urea

25. Sodium Hydroxymethylglycinate
• Sodium hydroxymethylglycinate is found in shampoo, moisturizer, conditioner,
and lotion.
• In Animal studies have shown that sodium hydroxymethylglycinate has the
potential for sensitization and dermatitis.

26. Bronopol
• It is found in nail polish, makeup remover, moisturizer and bodywash.
• It is safe in concentration less than 0.1%.
• Mixing Bronopol and amines produce nitrosamines which have been found to
penetrate to skin and cause cancer.

27. THANK YOU