Importance of Microbiological Quality to Cosmetics

06 Feb 2017

Microbial quality is one of the important factors that determine a cosmetic product to be safe for consumer use.

A number of measures can be taken to minimize microbial contamination before they are opened, for examples,

Good Manufacturing Practices
Suitable Preservative System
Sealing or Packaging
Storage Condition

THE FEQUENCY OF COSMETIC PRODUCTS BEING RECALLED DUE TO MICROBIAL CONTAMINATION

There is an increasing trend of recalled cosmetic products which were found to be contaminated by microbes between 2012 and 2016.

Importance of Microbiological Quality to CosmeticsEN17

In accordance to 2013/674/EU on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, there are three kinds of cosmetic products,

(1) Low microbiological risk products

        - Products with an alcohol content >20%
        - Products based on organic solvents
        - High/low-pH products

(2) Single-use products and products which cannot be opened

- Products for which the packaging allows dosing the product without it coming in contact with the air

(3) All other products

- Among all three kinds of cosmetic products, microbiological quality test is necessary except (1) low microbiological risk products.

QUANTITATIVE AND QUALITATIVE LIMIT IN MICROBIOLOGY

In Europe, the quantitative and qualitative limit in microbiology is given and provided in SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 9th revision (adopted on 29 September 2015, revised on 25 April 2016).

The cosmetic products are categorized into two groups, products specifically intended for children under three years of age, the eye area or the mucous membranes, and other products. In 9th revision of SCCS Notes of Guidance, the quantitative and qualitative limits are based on the European Standard EN ISO 17516:2014 Cosmetics – Microbiology – Microbiological Limits.

Types of microorganisms	Products of Category 1	Products of Category 2
Total Aerobic Mesophilic Microorganism (Bacteria plus yeast and mould)	≤1X10² CFU per g or ml	≤1X10³ CFU per g or ml
Escherichia coli	Absence in 1g or 1ml	Absence in 1g or 1ml
Pseudomonas aeruginosa	Absence in 1g or 1ml	Absence in 1g in 1ml
Staphyloccocus aureus	Absence in 1g or 1ml	Absence in 1g or 1ml
Candida albicans	Absence in 1g or 1ml	Absence in 1g or 1ml

Notes:
Products of Category 1: products specifically intended for children under three years of age, the eye area or the mucous membranes
Product of Category 2: Other products (Except Products of Category 1)

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