Department of Pharmaceutics

Academic year 2022 - 2023

Diploma in Cosmetic Preparations and Entrepreneurship

General Aspects of Cosmetics Development
Code 0601601
‫الجوانب العامة لتطوير مستحضرات التجميل‬
Lecture 1:
Introduction
Prof Labiba El-Khordagui

Thursday 13-10-2022 1

The diploma aims at:

▪ Providing up-to-date knowledge and advancing skills in

different aspects of the formulation and development of
cosmetics and personal care products at both the
laboratory and manufacturing scales including regulatory
aspects
▪ Highlighting challenges facing the cosmetics sector,
mainly innovation, sustainability and safety
▪ Enhancing business concepts of product development,
branding, pricing, launching, marketing, distribution, and
promotion
2

1
 By the end of this program, the graduate should be able to:
• Effectively use different information resources to collect
and analyze information related to new trends in cosmetic
ingredients and products
• Identify problems encountered in the formulation and
preparation of cosmetics and suggest solutions
• Recognize new challenges in cosmetics development
• Communicate information both verbally and in writing
• Integrate the specific knowledge gained with other
relevant types of knowledge in pharmacy practice.
• Demonstrate commitment to legal and ethical norms of
the pharmacy profession.
• Managing business successfully in the cosmetic field 3

Prof Dr Labiba Khalil El-Khordagui, Department of

Pharmaceutics (Course supervisor)

Dr Maha Nasra, assistant professor, Department of

Pharmaceutics

Chemist Amira Abdelrazek, Registration and Regulatory affairs

consultant

2
 Assessments

1- Assignments (oral presentation + written report) (40%)

2- Final exam (60%)

Cosmetic and personal care products are widely consumed in everyday life by people of all
ages. Young generation tends to use cosmetics for aesthetic purposes, while older generations
tend to use cosmetic products to counteract the effects of aging

3
 The cosmetic industry is an ever-growing sector that is among the most
innovative and science-driven industries

Total global sales in 2020 was $483 billion. With an annual growth rate of
4.75%, total revenue is expected to top $716 billion by 2025.

https://terakeet.com/company/ 7

Cosmetics market share

4
 Major challenges facing the cosmetics industry due to shifts in consumer
demands for:
Innovation beyond traditional formulations for better performance and safety
More environmentally friendly natural ingredients and products because of
greater awareness of the impact of extensive use of non-renewable and non-
biodegradable raw materials on the depletion of natural resources, waste
generation, climate changes, and water and air pollution. E.g., Plastic
microbeads as mechanical cleansing or exfoliating agents, silicones as
emollients or emulsifiers, or organic and inorganic sunscreen agents raise
significant pollution concerns because of their daily use
Sustainability of formulations, production practices or packaging methods less
damaging to the environment and human safety, i.e. “meeting the current
needs of the population without compromising future generations to meet their
own needs”
More local, affordable products, without compromising on quality in growing
economies like Egypt
9

10

5
 Plastic microbeads or microplastics

▪ On December 18, 2015, Congress amended the Federal Food, Drug and
Cosmetic Act (FD&C Act) by passing the Microbead-Free Waters Act of
2015.

▪ This act prohibits the manufacturing, packaging, and distribution of rinse-

off cosmetics containing plastic microbeads.

11

6
 13

14

7
 15

Sustainable cosmetics products

• Sustainable bioactive ingredients

• Sustainable additives
• Green production methods
• Sustainable packaging materials

16

8
 17

18

9
 19

Eco-friendly cosmetics packaging solutions

▪ Post Consumer Recycled Packaging

▪ Bamboo Packaging

▪ Paper Packaging

▪ Refillable Packaging

▪ Cornstarch Packaging

▪ Seaweed Packaging

▪ Beeswax Packaging
20

10
 Bamboo Biodegradable

Paper
Seaweed package
Starch
Refillable Packaging21

General Aspects of Cosmetics Development

‫الجوانب العامة لتطوير مستحضرات التجميل‬
Course description
The course aims at introducing candidates to the general aspects of cosmetic
and personal care products and their development. The course will include
national regulatory requirements for cosmetic products registration, labeling,
marketing, importing, and exporting and the role of the National Health
Regulatory Authority, cosmetics manufacturing, GMP, facility requirements,
stability, packaging, safety and testing of cosmetic products and their
ingredients.
Students will be also introduced to the emerging technologies, such as
nanotechnology and biotechnology, marine biotechnology as well as new
cosmetic actives and packaging materials for innovative and sustainable
cosmetic products increasingly demanded by consumers and manufacturers.
22

11
 23

May 2020

Biotechnology uses microorganisms and/or enzymes to obtain safer products

through fermentative processes and/or genetic engineering techniques.
Examples of these products are active ingredients, such as, kojic acid,
resveratrol, some enzymes, which are used in skin anti-aging products,
surfactants such as biosurfactants and bacterial polymers such as hyaluronic
25
acid and bacterial cellulose.

12
 26

Bacterial Nanocellulose as an Alternative to Microplastics in Cosmetics. The environmental impact of

microplastics (or plastic microbeads) (<5 mm) is nowadays of major concern, being the cosmetics and personal
care products, one of the relevant sources of primary microplastics A broad range of daily-use personal care and
cosmetic products (e.g., shampoos, toothpastes, facial scrubs, and soaps) contains microplastics that have either
a decorative or exfoliating function. Polyethylene is the main polymer used in microplastics production, but other
synthetic polymers are also used (e.g., polypropylene, nylon, polytetrafluoroethylene). These microplastics are
recalcitrant and ultimately end up in the environment, and in the marine environment, and may build up in the
food chain, ultimately causing adverse effects on human health. Over the last few years, the awareness of
consumers and the environmental policies are driving the research and industrial players to find environmentally
friendly alternatives to microplastics. 27

13
 Bacterial cellulose film

Bacterial cellulose face mask

Gentle touch, translucent appearance face mask. An
environmental-friendly green product to slow down
global warming and preserve more natural resource

Bacterial cellulose beads

28

29

14
 Waterless beauty: a sustainable
innovation
Practical and environmentally
friendly, dry and oil-based
formulas are the new trends in
cosmetics
30

Provisional assignments topics

1. Polymer-based nanoparticles in cosmetics

2. Lipid-based nanoparticles in cosmetics
3. Inorganic nanomaterials in cosmetic formulations
4. Sunscreen agents and the eco system
5. Microplastics in cosmetics
6. Probiotics and prebiotics in skin care
7. Biosurfactants in personal care products
8. Sulphate-free detergent cosmetic formulations
9. Waterless cosmetics
10. Sustainable packaging for cosmetics
11. Nanocelluloses in cosmetics
12. Artificial intelligence in cosmetics
13. Enzymes in cosmetics
14.
31

15
 Sources of information
The information science conventionally classifies sources of
information into three types, depending on the origin,
composition and function of information

Types of sources of information:

1- Primary sources
2- Secondary sources
3- Tertiary sources

32

1- Primary sources
Original reports of research and innovations in a certain field,
written carefully and completely by the author or authors
themselves and validated by peers.
Primary literature is searched when the most recent information
is needed, or the answer is not found in secondary sources
The primary literature is searched through abstracting or
indexing sources (secondary sources), search engines
(Google.com, Google scholar, Scirus.com) and databases
(MEDLINE, PubMed, etc)
Examples include research articles published in scientific
journals, conference proceedings, etc
33

16
 Sections of a research article
• Abstract
• Introduction
Background information leading to a hypothesis and the
objective of the study
• Experiments
Well designed experiment to allow testing of the hypothesis
• Results
• Discussion
• Conclusion
• References

34

2- Secondary sources

Information from any or all primary sources, which has been

modified, rearranged, condensed by someone other than the
original author(s) possibly for a specific audience or purpose
They reflect expert’s syntheses or overviews of subjects based
on the primary sources
They provide more efficient access to specific information
Examples include abstracting and indexing databases (e.g.
Medline, PubMed, etc), review articles, book chapters,
textbooks, handbooks, official compendia
Journal articles which are not original research articles, e.g.
Magazines such as: US Pharmacist, Drug Topics, etc.
35

17
 3- Tertiary sources
(Current Affair sources)

Information derived from primary and secondary sources. They

represent a composite of information from these sources. They
can be used as a source of public or patient information and to
keep up-to-date with events and developments in the
profession.
Examples include scientific articles other than research articles,
news reports in pharmacy magazines, pamphlets, newsletters,
etc.

36

EndNote
EndNote is a multiplatform software tool that helps you search
for millions of research papers and journal articles, manage the
process of writing and preparing research papers. EndNote will
manage PDF and other research files, automatically compiling
key information from your files for easy reference and citation
building.
In addition to using EndNote on your smartphone, tablet, or
desktop, you also have access to the EndNote website, where
you can connect with your University library system to search
for millions of research papers and journal articles.

37

18
 38

39

19
 40

Information Sources for cosmetics

Books
▪ Consumer Information Handbook on Cosmetic Products (FDA)
▪ Harry’s Cosmeticology
▪ Handbook of Nonprescription Drugs, APhA.

Periodicals:
▪ Cosmetics
▪ International Journal of Cosmetic Science
▪ Journal of Cosmetic Science
▪ Clinical, Cosmetic and Investigational Dermatology
▪ Journal of Cosmetic Dermatology

Internet sites
• FDA: www.fda.gov
• Skin care forum. www.scf.com
• Skin Therapy Letter. www.skintherapyletter.com
• Happi. www.happi.com
• Makingcosmetics.com 41
• Lotioncrafter.com

20
 42

Cosmetics databases:
• The European Commission database for information on cosmetic
substances and ingredients (CosIng)
https://ec.europa.eu/growth/sectors/cosmetics/cosing_en

• The cosmetic ingredients and suppliers database (Coptis)

https://www.coptis.com/en/coptis-ingredients
https://www.coptis.com/en/full-list-suppliers

• EWG data base for ingredient and product safety

https://www.ewg.org/skindeep/

• Cosmethics: A dynamic cosmetic product database

https://cosmethics.com/

• SpecialChem INCI directory (International Nomenclature of Cosmetic

Ingredients) 43
https://cosmetics.specialchem.com/inci-names

21
 Cosmetic societies and associations

Cosmetic Europe Association, the European trade association

for the cosmetics
. and personal care industry

44

45

22
 46

Personal Care Products (PCPs)

Products intended to keep the skin and hair clean and fresh
smelling. They include mainly:
• Skin care products (e.g. emollient, moisturizer,
sunscreen, antiperspirant, deodorant products) and
• Hair care products, (e.g. shampoos, conditioners, hair
loss products, etc…)

PCPs are classified as cosmetics or cosmetic products

possessing medicinal or drug-like benefits (non-
prescription or OTC drugs) or cosmeceuticals

47

23
 1. Cosmetics
FDA legal definition of "Cosmetics"
The FD&C Act defines cosmetics 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. Included in this definition are
products such as skin creams, lotions, perfumes, lipsticks,
fingernail polishes, eye and facial make-up preparations,
shampoos, permanent waves, hair colors, toothpastes, deodorants,
and any material intended for use as a component of a cosmetic
product. Soap products consisting primarily of an alkali salt of fatty
acid and making no label claim other than cleansing of the human
body are not considered cosmetics under the law. 48

2. Cosmetics that are also drugs

(Cosmeceuticals or OTC drugs)
Cosmetics that are also intended to treat disease (anti-acne) or
prevent disease (anti-caries fluoride toothpaste) or affect the
structure or functions of the human body (antiperspirants,
antidandruff shampoos, skin care products and lipsticks with SPF
number) are considered also drugs and must comply with both of
the drug and cosmetic provisions of the law. These are OTC drugs.
Under the FD&C Act, a drug is product intended to diagnose,
mitigate, treat, or prevent disease, or to affect the structure or
function of the body. The term “cosmeceuticals” was coined in 1962
as a fusion of cosmetic and pharmaceutical to cover a new class of
products able to achieve aesthetic and drug-like benefits.
FDA does not recognize the term “Cosmeceuticals” 49

24
 50

51

25
 Cosmetics, defined by the current European regulation on
cosmetics (European Commission, 2015), as any substance or
mixture intended to be placed in contact with the external parts of
the human body (e.g. epidermis, hair system, nails, lips) 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, protecting them, keeping them in good condition
or correcting body odors. These products are regulated at
European level to ensure the highest level of consumer safety while
promoting the innovation and the competitiveness of this sector

52

1. The Voluntary Cosmetic Registration Program (VCRP) (FDA) for

products marketed in US.
2. Cosmetic Product Notification Portal CPNP (EU)
Manufacturers are responsible for the safety of their products, and
must ensure that they undergo an expert scientific safety
assessment before they are sold. All products to be marketed in
the EU must be registered in the cosmetic products notification
portal (CPNP) before being placed on the market and after
having fulfilled all of the provisions of the Regulation.
3. Egyptian Requirements for Cosmetic Product Registration
(ERCPR)
53

26
 Labeling means all labels and other written, printed or graphic
matter on or accompanying a product. The label statements must
appear on the inside and any outside container or wrapper.

The label must :

▪ State the name of the product
▪ Identify by descriptive name or illustration the nature or use of the
product,
▪ The net quantity of contents in terms of weight, measure, numerical
count, or a combination of numerical count and weight or measure.

54

▪ The name and place (street address, city, state, and zip
code) of business of the firm marketing the product
▪ If the distributor is not the manufacturer or packer, this
must be stated on the label "Manufactured for ......" or
"Distributed by ......" or similar, appropriate wording.
▪ Cosmetics bearing false or misleading label statements
may be considered misbranded (making false or
misleading claims) and may be subject to regulatory
action.

55

27
 Cosmetic labeling must be truthful and not misleading. Products
intended for a therapeutic purpose, such as treating or preventing
disease, are subject to regulation as drugs.

Claims made for cosmetic products:

"Alcohol Free"
"Cruelty Free"/"Not Tested on Animals"
"Hypoallergenic“ (produce fewer allergic reactions than other
cosmetic products)
"Organic” (must comply with both the US Department of Agriculture
(USDA) regulations for the organic claim and FDA regulations for
labeling and safety requirements for cosmetics
56

The Federal Food, Drug, and Cosmetic Act does not specifically require the use
of animals in testing cosmetics for safety, nor does it subject cosmetics to FDA
premarket approval. However, FDA has consistently advised cosmetic
manufacturers to employ whatever testing is appropriate and effective for
substantiating the safety of their products

57

28
 According to the FDA,
The ingredients of cosmetic products must be listed on the label
in a descending order of predominance (concentration or
amount)
If the product is both a cosmetic and OTC drug product, the
active ingredients must be listed on top of the ingredients list
followed by inactive ingredients
Ingredients with less than 1% concentration are listed in any
order
58

59

29
 Ordinary soap (alkali metal salts of fatty acids, true soap, e.g.
sodium stearate or palmitate) with no added active ingredients
does not require ingredient labeling.

If a cosmetic claim is made on the label of a soap or cleanser

such as moisturizing or deodorant, the product is a cosmetic
product and the label must list all ingredients.

If a drug claim is made on a soap or cleanser such as

antibacterial, antiperspirant or anti-acne, the product is a drug
and the label must list all active ingredients.
60

According to the FDA, cosmetics manufacturers are not required

to print expiration dates on the label of cosmetic products, but
cosmetic firms have a responsibility for the safety of their
products
A minimum shelf-life of 18 to 24 months is suggested according to
voluntary shelf-life guidelines
The shelf-life of eye-area products and those containing plant-
derived substances is more limited than for other products

61

30
 62

63

31