Regulatory Considerations Of Producing Bespoke Cosmetics In Store

Regulatory considerations of producing bespoke cosmetics in store

In recent years, the availability of personalised cosmetic and personal care products created in-store has been growing. This trend has evolved so quickly, that there is no specific regulation for these ‘point of sale’ (POS) cosmetics – instead, multiple laws apply. What’s more, meeting the requirements of UK and EU Cosmetic Regulations, specifically Good Manufacturing Practice (GMP), is much more challenging compared to the traditional method of production in a factory.

So, to stay compliant and ensure the safety and quality of products, here’s a comprehensive guide of what to consider when creating products at the point of sale (POS).

• Labelling.

Ensure product labelling complies with Article 19 of Regulation (EC) No 1223/ 2009. In indelible, easily legible, and visible lettering, labelling should include: the name of the Responsible Person (RP), a batch code and unique batch number, nominal content, the date of minimum durability or period after opening (PAO), the product’s function, and ingredient list. The use of a loose leaflet is not accepted if there is enough space on the packaging itself.

• Preparation, cleaning, and training.

Ensure the preparation of bespoke products is completed by fully trained personnel only, in a dedicated area compliant with the requirements of GMP.  This zone must be cleaned following a predetermined and documented process (Standard Operation Process), which details the cleaning protocol, frequency, and training.  Minimise cross contamination by allowing only trained personnel access to the area.

Training must include how to prepare products to the requirements of GMP and be recorded in a guide for each employee.

• Ingredients.

Where products are made from several ingredients, are the individual components cosmetic products in their own right or chemicals? The mixing of ingredients that can be considered cosmetic products is preferential since the use of raw materials (chemicals) in bespoke products is very complex – and unlikely to be appropriate for an in-store setting. Additionally, enhanced training and documentation are also required to ensure worker safety.

• Filling, refilling, and storage.

Tightly monitor the filling of product into packaging and perform regular controls and audits to ensure quality control. Filling directly into customers’ pre-used empty containers is not recommended, due to contamination risks. However, it is acceptable to exchange a pre-used receptacle for an industrially cleaned one to refill at the POS.

Packaging used for filling should be stored to protect from contamination prior to filling. Refill batches should never be mixed, and the expiry/PAO dates must be respected.

• Safety.

The very nature of bespoke products means that many similar versions are created – and each one must be compliant. Due to the cost and impracticability of commissioning testing for every combination of ingredient, the production of microbiological high-risk products is not recommended. All possible combinations of the product must be considered during safety assessments. In certain cases, read-across data for preservative efficacy (challenge) testing and stability studies may be acceptable.

• Traceability.

Each product must contain a batch code and a traceability document should also be kept updated showing concordance between incoming refill-bulk, packaging materials, and the sold finished product. Ensure each unique combination of ingredient has an individual notification and Product Information File (PIF).

Additionally, any product returned to store must be documented and held centrally by the RP to ensure any safety-related reports, trends in the poor performance of the product or durability are identified and addressed quickly.

For further information or advice, please contact us.