Regulation

Helena Eixarch
Consultant

TSG Consulting

United Kingdom

Personalisation of cosmetic products is a popular trend whereby consumers can choose ingredients in the product to suit their specific needs. Reaching full regulatory compliance poses several challenges in the EU and the UK, where cosmetic products must comply with the requirements of Regulation 1223/2009 (1) and the equivalent UK Cosmetics Regulation (2), respectively (the Regulations). 

What are the regulatory requirements? 

The Responsible Person (RP) placing a cosmetic product on the market must ensure the product is compliant with the relevant obligations set out in the Regulations, the cornerstone objective being consumer safety. Compliance with the Articles addressing ingredient restrictions, animal testing ban, claims compliance and access to information on the product can be easily achieved and will therefore not be reviewed. 

On the contrary, compliance with the Articles listed below may be challenging. 

Good manufacturing practice (GMP) 

Cosmetic manufacturing facilities must work according to GMP, which implies, among other requirements: appropriate documentation and precisely described protocols of the manufacturing process; relevant training of people involved in the manufacturing process; calibration of manufacturing devices; and maintenance of hygienic conditions of the manufacturing facilities.  

Safety assessment 

A safety assessment must be performed prior to placing a cosmetic product on the market. For this, the composition of the product must be known, as well as any data that may have an impact on the product’s safety (e.g. microbiological quality). 

Product Information File (PIF) 

The PIF includes the above-mentioned safety assessment, therefore the same limitations apply. The generation of large amounts of documentation, which must be properly stored and be accessible, can be challenging, especially if customising product labels: one formula may be commercialised using different product names (and labels); each one will be considered a different product and will therefore require a dedicated PIF. This difficulty is common to all possible ways of manufacturing personalised cosmetics and will not be individually discussed.  

Sampling and analysis 

The challenge here is logistic, as there are space and capacity limitations if a sample of each manufactured batch must be kept. 

Portal notification 

The notification must be completed prior to placing the cosmetic product on the market, therefore, data on the formulation must be known in advance. 

As with the PIFs, the possibility of customising product labels might increase the number of notifications required, even if products share the same formula.   

Labelling 

Cosmetic products must include the following items in the product label: RP details, country of origin (if outside the EU or the UK), nominal content, date of minimum durability or Period After Opening, precautions and directions for use, batch number, function of the product and list of ingredients. 

Communication of serious undesirable effects (SUEs) 

In the event of a SUE the affected consumer will most probably contact the RP or the sale point where the cosmetic product was purchased, who must then notify it to the competent authority. Standard operating procedures should be in place to facilitate dealing with these issues. 

Can personalised cosmetics comply with the regulations? 

Products manufactured in regular facilities 

One typical model is where customers choose their preferences for the cosmetic product through an online questionnaire. After this, the product is manufactured and shipped home. 

Regulatory compliance is achievable: the product’s characteristics are well known before the final product reaches the consumer and therefore the production process is the same as for any other regular cosmetic product. 

Sampling and analysis may be slightly problematic. Each manufacture for every single customer may be a different batch, therefore, numerous small batches of the product will be produced. If a sample of each batch must be kept then the question is whether there will be enough storage space? 

Products blended using domestic devices 

Domestic devices are available on the market which mix the contents of several cartridges containing base creams and cosmetic actives in the optimal proportion according to the customer’s skin characteristics. The mixing concentrations are designed before the cartridges are sent to the client. Therefore, these products can be considered cosmetic kits and regulatory compliance can be assessed as such. 

Safety assessment (and PIF collation), as well as portal notification, can be performed before the product reaches the consumer. Samples of the resulting finished product are not required as the ready-to-use product (freshly prepared) will never be stored as a finished product at home. For the same reason, no final product labelling will be  necessary. 

GMP compliance is the biggest challenge. The device used, which is the “manufacturing facility”, should be designed to ensure dispensing accuracy and hygiene when manipulated by the consumer at home. Clear and accurate directions for use should be provided to the consumer to ensure the manufacturing process results in a safe cosmetic product. 

Products blended on-site 

Some retail stores offer the possibility of blending the product at the point of purchase. Compliance with the Regulations might not be fully achievable. 

If a device is used, it becomes the “manufacturing facility” and must thus comply with GMP as described in the previous example. If no device is being used, efforts should be directed towards ensuring that the person blending the product is properly trained, dispensing materials are calibrated, and the environment is clean. 

As the exact product’s composition is not known in advance, completing a safety assessment (and PIF) and portal notification before the product reaches the consumer is an issue. In order to do this, the RP should be able to foresee all possible ingredient combinations; the use of concentration ranges is an alternative, but less recommended for the safety assessment if variable concentrations are possible for more than one ingredient, as ingredient interactions become more difficult to predict. Microbiological quality of the product is problematic: due to practical reasons, it will most probably not be checked, and it is questionable if a safety assessor will consider a product is safe if these data are lacking. 

Sampling and analysis can also pose logistical drawbacks due to the need of a large storage space. 

Labelling must be done in situ, which means assigning a batch number, an expiry date and personalising directions for use and warnings, if necessary, at the moment of purchase. Ingredients must also be correctly listed, according to the product’s composition. The correct IT tool might facilitate this. 

Enrichment of base creams 

Some personalisation can be achieved by adding boosters to regularly used cosmetic products. 

As the resulting final product will be freshly prepared and not stored, sampling and analysis are not required, nor is a product label needed.  

The safety assessment and portal notification for the enriched product is not an issue when both boosters and base creams are manufactured by the same brand, as all information is available in advance. Nevertheless, this is not possible when mixing products from different brands and therefore this option must be discarded. 

Summary and conclusion 

Marketing personalised products can be challenging from a regulatory point of view, and only those products for which compliance and safety is achievable should be placed on the market. Online purchase and the use of domestic devices allow a higher degree of control over product composition and the timely performance of safety assessment and product notification. On the contrary, on-site manufacturing (at the retail store) poses higher compliance and safety challenges and use of boosters is only encouraged if it can be ensured that all products to be mixed will be manufactured by the same brand.