Safety In Cosmetic Products

Safety is the most fundamental consideration when it comes to taking care of consumers. If consumers can’t believe in a product and rely on it to do what it says, then nothing else matters.

Product safety is the top priority of cosmetics and personal care products companies, and everything they do is grounded in the best science available.

In the U.S., cosmetics and personal care products are regulated by the Food & Drug Administration (FDA) under the Food, Drug & Cosmetic Act  (FD&C Act) and the Fair Packaging & Labeling Act (FPLA). Similarly, each country follows their own regulation for consumer safety.

Civilizations have used cosmetics- though not always recognizable compared to today’s advanced products- for centuries in religious rituals, to enhance beauty, and to promote good health. Cosmetics usage throughout history can be indicative of a civilization’s practical concerns, such as beginning with the Ancient Egyptians in 10,000 BCE through modern development in the world.

The Cosmetics Directive [Regulation (EC) No. 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products] defined a “cosmetic product” as any substance or preparation intended for placing in contact with the various external parts of the human body,

  1. Epidermis,
  2. Hair system,
  3. Nails,
  4. Lips and
  5. External genital organs
  6. Teeth and the mucous membranes of the oral cavity

with a view exclusively or principally to cleaning them, perfuming them or protecting them in order to keep them in

►good condition,

►change their appearance or

► correct body odours.

Product categories in the cosmetic industry:

Cosmetic product categories. While there are thousands of cosmetic products on the market, they can all be sorted into major 5 distinct categories.

҂ Skincare products. …

҂ Hair care products. …

҂ Colour Cosmetics. …

҂ Fragrances. …

҂ Personal Care products. …


General Properties of Cosmetics:

The types and main properties of cosmetics and beauty products are,

  1. Analgesic,
  2. Antibacterial,
  3. Anti-inflammatory,
  4. Antispasmodic,
  5. Antioxidant,
  6. Antiseptic,
  7. Astringent,
  8. Soothing,
  9. Emollient,
  10. Moistening/moisturising,
  11. Nourishing,
  12. Regenerating,
  13. Relaxing
  14. Toning

Some of the safety concerns that may be associated with cosmetics and personal care products include:

∞ Eye infections.

∞ Spreading bacteria on the skin.

∞ Irritation and scratches on the eye.

∞ Fire hazards, in the case of aerosol products.

∞ Allergic reactions or sensitivity to ingredients.


Microbiological risk analysis:

Cosmetic products can be categorised for microbial risk based on the following consideration (reference: IS 14648:2011)

  1. Water Activity (less than 0.6%)
  2. pH [ less than 3.0 i.e. highly acidic or more than 10 i.e. highly alkaline)
  3. Alcohol content (more than 20%)
  4. Filling temperature ( more than 65°C)
  5. Raw materials which create a hostile environment
  6. Strong oxidising or reducing agents
  7. Solvents such as ethyl acetate,
  • Oxidising dyes
  1. Aluminium chlorohydrate and related salts.
  2. Combined factors

Cosmetic formulations falling into any of the above categories can be treated as microbiologically low risk products, hence can be exempted from microbiological testing.


Microbiological Limits for Cosmetics Finished Products (ref. IS 14648: 2011)


Product                                Microbiological Limit [CFU / gm (for solid) or CFU /ml (for Liquid)]


Shampoos,                                                        Total Microbial Count: 1000, maximum

Powder, Lipcare                                             Yeast and Mould Count: 100, maximum

Skin cream and lotion,                                 Gram Negative Pathogens: Absent

Toothpaste and toothpowder


Baby Products                                                Total Microbial Count: 200, maximum

Yeast and Mould Count: 100, maximum

Gram Negative Pathogens: Absent


Eye Products                                                   Total Microbial Count: 100, maximum

Yeast and Mould Count: 100, maximum

Gram Negative Pathogens: Absent


All other products requiring                            Total Microbial Count: 1000, maximum

Microbiological assessment                           Yeast and Mould Count:  100, maximum

Gram Negative Pathogens: Absent


Harmful Toxic Chemicals in Cosmetics:

  • Coal Tar. Coal tar is a carcinogen that comes from burning coal. …
  • Lead, Arsenic, Cadmium, Mercury and other Metallic impurities …
  • Carcinogens (forbidden dyes, PAH : Polycyclic Aromatic Hydrocarbons). …
  • Ethanolamines (MEA, DEA, TEA) …
    1. MEA :   Monoethanolamine
    2. DEA :   Diethanolamine
    3. TEA :  Triethanolamine
  • Parabens (artificial preservatives) …
  • Antioxidants
    1. BHA : Butylated hydroxyanisole
    2. BHT : Butylated hydroxytoluene
  • Formaldehyde: This is one of the most deadly chemicals that can be featured in beauty products. It is used in the making of nail polishes and eyelash glue. Formaldehyde is a dangerous toxin that can be inhaled and can lead to irritation of the skin as well as of the respiratory tract.


General Tips for safe use of Cosmetics:

҂ Read the Product label carefully. E.g. Hair colourants can cause severe allergic reactions. Read and follow instructions.

҂ Wash hands before using the product.

҂ Do not share makeup.

҂ Keep the containers clean and tightly closed when not in use, and protect them from temperature extremes.

҂ Discard cosmetics. if there are changes in colour or smell.

҂ Not to use cosmetics after the expiry of shelf life.

҂ Use aerosols or sprays cans in well-ventilated areas.


Cosmetic Safety is ensured Worldwide:

Throughout the world, cosmetic and personal care product manufacturers work to create and market safe and elegant products that help consumers to look and feel their best.

To further ensure the safety of cosmetic products, different countries employ different measures to achieve this goal.

However, the stringent regulations governing cosmetics in each country or jurisdiction, have one common goal: To protect the consumer by ensuring safe ingredients and finished products.

Neelikon Food Dyes and Chemicals Ltd. is the only Colour manufacturing company that has adopted the global concept “One world One Quality” for consumer health & safety.



1. IS 14648: 2011 (Indian Standard) : Microbiological Examination of Cosmetics and cosmetic raw materials-methods of test.

2. ISO 21148 : 2017 : Cosmetics — Microbiology — General instructions for microbiological examination.

3. The Cosmetics Directive [Regulation (EC) No. 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products].

4. ISO 22716 : 2007 : Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices.

5. Microbiological quality of Cosmetics – Legal requirements, test methods and risk assessment- Demand and Legal requirements by Dr. Bernhard Fellenberg.

6. United States Pharmacopeia, 2007.

7. United States (U.S.) Food & Drug Administration (FDA) under the Food, Drug & Cosmetic Act (FD&C Act) and the Fair Packaging & Labeling Act (FPLA).


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