Cosmetic
& Personal Care

A cosmetic is defined as a product which is used to; Clean, perfume, change the appearance of, protect, keep in good condition or correct body odours and it is used on external parts of the body eg skin, hair, nails, the mouth or the external genitals.

Borderline products

Care must be taken to ensure that the product being marketed meets the definition of a cosmetic. Many products are on the borderline of cosmetics but are regulated as medicines (MHRA), biocidal products (HSE, Biocidal Product Regulation) or Aromatherapy products (General Product Safety Regulation).

Products that are ingested, inhaled, injected or implanted are not defined as cosmetics.

Regulations

All cosmetic products placed on the market in the UK must comply with Schedule 34 of the Product Safety and Metrology Statutory Instrument Regulation which details the amendments to the EU Cosmetic Regulation (EC) No 1223/2009.

EU Cosmetic Regulation (EC) No 1223/2009 makes it an offence to supply a cosmetic product that may cause damage to human health or contains specific restricted or prohibited substances. It is an offence to supply an incorrectly labelled cosmetic product.

The main requirements are that each product must have a Cosmetic Product Safety Report (CPSR) and a Product Information File (PIF), must be correctly labelled, a notification must be submitted to the Office for Product Safety and Standards via the UK SCPN Portal (CPNP in Europe) and the product must not contain prohibited raw materials. This ensures that the cosmetic product is deemed ‘safe’ for the end user.

Testing Requirements

Melbec Microbiology is one of the leading, UKAS 17025 accredited microbiology laboratories in the United Kingdom for the testing of Cosmetics and Personal Care products so you can be confident your products have been tested to ensure full compliance with the current legislation and regulations. Melbec Microbiology prides itself on being committed to the highest standards of excellence and customer service and this is paramount to our success as a laboratory. Our bespoke facility has a laboratory solely dedicated to meet the needs of the cosmetic and personal care industry, and now includes the expanding pet care industry. Our extensive team of highly skilled and experienced microbiologists test and quality assure the microbiological needs of beauty, cosmetic and hygiene products for today’s growing global industry.

Melbec offers a flexible range of testing and quality control to suit your needs. We can ensure that your products reach the UK or international consumer market at the highest standards and meeting the required regulations.

So, whether you require the full package or specific testing, we can accommodate to suit what is appropriate for your product with our completely integrated and seamless in-house approach.

There are three main tests which are required to ensure your product complies with the Cosmetic Regulation:

PET is carried out at the product development stage and is used to demonstrate that the preservative is effective in the cosmetic formulation. There are a number of PET methods eg BS EN ISO 11930, European Pharmacopoeia (EP), British Pharmacopoeia (BP) and US Pharmacopoeia (USP).

The only one which is written specifically for cosmetic products is BS EN ISO 11930 and Melbec are UKAS accredited to carry out this test.

All PET methods follow the same principles. The first stage is to add microorganisms to the cosmetic product and then the numbers of surviving microorganisms are determined at defined timepoints eg 7, 14 and 28 days. The reduction in organism numbers required at each time point is specified in the standard being followed and are termed the acceptance criteria.

For BS EN ISO 11930 the acceptance criteria are:

Log Reduction Values
Microganisms
Bacteria
Candida Albicans
Aspergillus
Brasiliensis
Sampling Time (Days)
7
14
28
7
14
28
14
28
Acceptance Criteria A
≥3
≥3 & NI
≥3 & NI
≥1
≥1 & NI
≥1 & NI
≥0
≥1 & NI
Acceptance Criteria B
-
≥3
≥3 & NI
-
≥1
≥1 & NI
≥0
≥0 & NI

NI No increase in numbers from previous test time point

EP (European Pharmacopoeia) & BP (British Pharmacopoeia) – topical products are tested at 48h, then at 7, 14 and 28
days and oral products are tested at 14 and 28 days.

USP51 (United States Pharmacopoeia Chapter 51) – topical products are tested at 14 and 28 days.

Stability testing assesses the formulation only and is carried out in glass jars whereas compatibility testing assesses the product in the final packaging.

The data obtained from the testing is used to determine the date of minimum durability of the product. The date of minimum durability is expressed as a ‘best used before end of’ date and uses the ‘egg timer’ symbol. If a product has a minimum durability greater than 30 months a ‘period after opening’ is used and the symbol for this is the ‘open jar’.

Stability tests involves incubating products at a variety of temperatures and light conditions to mimic transportation and storage conditions which may be encountered during warehousing, retail and with the consumer. These tests ensure that the characteristics of the products, including the fragrance, colour, texture, appearance and formulation do not change when subjected to these conditions.

Compatibility testing is similar to stability but would also include an assessment of packaging functionality and stability, label stability and determine if there are any interactions between product and packaging.

Most stability and compatibility testing is carried out at elevated temperatures as an accelerated shelf life study.

The incubation conditions chosen for the test will depend upon several factors including how the product is to be warehoused, how it is to be transported and where in the world it will be marketed etc.

Melbec Microbiology have a range of ambient humidity incubators, environmental chambers and simulated light chambers and hence can cover most testing requirements with respect of temperature, humidity, simulated light and freeze thaw.

Products are assessed at each time point and assessment includes organoleptic properties, viscosity, specific gravity, weight loss, functionality and pH.

Standards used for stability and compatibility include CIPAC, PD ISO/TR 18811, IFSCC and ‘in-house’ customer specific methods.

After manufacturing, cosmetic products should be assessed for microbial levels prior to release to market. Microbial contamination in cosmetic products may enter during the manufacturing procedure, from the process water or from raw materials/components.

QC/batch release testing should include Enumeration of Aerobic Mesophilic Bacteria and Yeasts and Moulds. In addition, presence or absence of specified organisms should be determined. Specified organisms include Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli and Candida albicans.

Batch release testing ensures you are confident that your product is of the highest quality, free from contamination and compliant with the requirements for microbial limits in cosmetics when it reaches your customer.

Melbec Microbiology is UKAS 17025 accredited for QC/batch release testing.

The standards we use to test cosmetics for batch release include:

  • BS EN ISO 21149 Cosmetics – Microbiology – Enumeration and Detection of Aerobic Mesophilic Bacteria
  • BS EN ISO 16212 Cosmetics – Microbiology – Enumeration of Yeasts and Moulds
  • BS EN ISO 18415 Cosmetics – Microbiology – Detection of Specified and Non-specified Organisms
  • BS EN ISO 22718 Cosmetics – Microbiology – Detection of Staphylococcus aureus
  • BS EN ISO 22717 Cosmetics – Microbiology – Detection of Pseudomonas aeruginosa
  • BS EN ISO 21150 Cosmetics – Microbiology – Detection of Escherichia coli
  • BS EN ISO 18416 Cosmetics – Microbiology – Detection of Candida albicans

The microbial limits for cosmetic products are specified in the standard, BS EN ISO 17516 Cosmetics – Microbiology – Microbiological Limits. This standard states that specified organisms must be absent in 1g of product and the total number of bacteria, yeasts and moulds should not exceed either 1 x 102 cfu/g or 1 x 103 cfu/g depending on the intended user and the site of application.

Product Information File (PIF)

The information required for the PIF is specified in the EU Cosmetic Regulation (EC) No 1223/2009.

The information includes:

  • A description of the cosmetic product
  • The Cosmetic Product Safety Report (CPSR)
  • A description of the manufacturing method and a statement of compliance with Good Manufacturing Practice (GMP)
  • If relevant, any proof of claims made for the cosmetic
  • Data on any animal testing performed by the manufacturer, agents or suppliers

Useful links:

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