Quality Control (inc PAO)

Quality Control (inc PAO)

According to the UK Cosmetic Regulation, the EU Cosmetic Regulation 1223/2009, GMP, and the Scientific Committee on Consumer Safety (SCCS), all products without a low-risk formulation must have results available for each batch of product released onto the market. Products are separated into two categories; products aimed at children under the age of three and/or mucous membranes, and other products.
SCCS states that microbial content limits per batch are based on Cosmetics – Microbiology – Microbial Limits EN ISO 17516:2014.

Microbial Limits stage 1
Aerobic Mesophilic Bacteria (AMB) & Yeast and Mould (Y+M) Total Viable Count (TVC)
We test cosmetic products according to their internal technical methods TM 5.4.1 & TM 5.4.2. These are based on: TM 5.4.1 – Cosmetics – Microbiology – Enumeration and detection of aerobic mesophilic bacteria BS EN ISO 21149:2017 and TM 5.4.2 – Cosmetics – Microbiology – Enumeration of Yeast and Moulds ISO 16212:2017.
Stage one allows brands and manufacturers to quantify any bacterial contaminations they may have however the test has a detectability limit of 10cfu/g. This stage provides information on the severity of contamination.

Microbial Limits stage 2
Our microbial limits stage 2 (specifics) is based on ISO 17516:2014. This stage allows brands and manufacturers to confirm if there is <1 organism per gram of product or whether growth contains any of the specified organisms.

USP 62
Where required, we can also perform a microbial limits test to USP 62 standards. This is an alternative to ISO 17516:2014 where additional organisms are tested for such as C. difficile & Salmonella. This is sometimes requested by customers, particularly those sold in the USA and for powder products.

PAO (Period After Opening)
According to EU regulations (Article 19, Reg 1223), cosmetic products with a shelf life of more than 30 months placed on the UK and EU market do not require an expiry or ‘best-before’ date, however the directive states ‘that there shall be an indication of the period after opening for which the product can be used without any harm to the consumer’ (PAO).

We can perform additional testing on products to support claimed period after opening of a product (i.e. that a product will not experience microbiological spoiling for a particular time period). We use a combination of tests, which include microbial limits, stability (real-time and accelerated), and challenge tests, as well as simulation tests, to ensure formulations are robust. This provides our customers, and the end-consumer, with data to support the maximum length of time that a product can be safely used once it has been opened.

For more information about our quality control services, please contact us.