Regulatory challenges of customized cosmetic products
Increasingly, consumers are personalizing their cosmetic products (i.e. choosing ingredients and concentrations) according to their skin or hair characteristics with the idea of having unique products that are as effective as possible. Whilst manufacturers must comply with the EU Cosmetics Regulation, they face significant challenges as the Regulation does not explicitly address these types of products. TSG’s Dr Helena Eixarch examines the key regulatory challenges facing companies selling customized cosmetic products.
Customized cosmetic products can be produced in many ways. One of the most common is via classical manufacturing whereby the customer completes an online questionnaire choosing their preferred properties; the product is then manufactured and shipped to the customer. The other most common way is via retail stores that offer the possibility of blending the product on-site at the moment of purchase.
Either way, the obligation to comply with the EU Cosmetics Regulation poses significant regulatory challenges as the Regulation does not explicitly address customized products.
So, what are some of the biggest challenges facing the Responsible Person in fulfilling their obligations for customized products? We take a look below.
Article 8 of the Cosmetics Regulation: Good manufacturing practice
Cosmetic manufacturing facilities must work according to good manufacturing practice; this is a general requirement that will apply to both regular and customized products. This ought not to present a challenge to products formulated or manufactured in the more traditional manner.
However, the challenge is significant when using a device to prepare the cosmetic product in situ (i.e. at the retailer’s store). In this case, the device becomes the “manufacturing facility” and should thus comply with good manufacturing practices. This means the device should be regularly calibrated and standardized in order to ensure that volumes dispensed are reliable and constant. Devices should also be kept in a good hygienic condition and people using the device should be properly trained to for both use and maintenance.
If no device is being used, but a person is preparing the product at the store, efforts should be directed towards ensuring the person is properly trained, dispensing materials are calibrated and the environment is clean.
Article 10 of the Cosmetics Regulation: Safety assessment
A safety assessment must be performed prior to placing a cosmetic product on the market. Ideally, the safety assessment should be performed before the customer takes the product home.
Responsible Persons should be able to foresee all possible combinations of ingredients their cosmetic products can have, and prepare a safety assessment for each before any product is put on the market.
This poses a big challenge if exact product composition cannot be planned in advance, and the safety assessment must be ready before the customer gets the product. If the product is shipped home, the timeframe is manageable, but if the product is blended at the retailer’s store, a good IT tool to perform the safety assessment might be the solution. Using concentration ranges for the safety assessment is an alternative, but less recommended if variable concentrations are possible for more than one ingredient as ingredient interactions become more difficult to predict.
Article 11 of the Cosmetics Regulation: Product Information File
This can be prepared after the safety assessment has been completed.
The challenge here lies in the production and storage of large amounts of documentation. If the same product label and name are used for a given concentration and combination of ingredients, then only one PIF is needed. If, on the contrary, the labels are personalized, and the product name changes for each customer despite dealing with the same formula, different PIFs will have to be generated and stored as different labels represent different products; nevertheless, the same safety assessment can be used if the formula does not change.
Article 13 of the Cosmetics Regulation: CPNP notification
As for the safety assessment, the CPNP notification must be completed prior to placing the cosmetic product on the market. If all ingredient combinations can be predicted, then product notifications can also be done in advance.
As for the PIF, if labels are the same for equal compositions, only a single notification will be needed for a given product.
But if product labels are also customized, this can pose a problem: as different labels represent different products, even for the same formula, several different notifications will be needed.
Fulfilling your obligations for customized cosmetic products can be a challenge, but with an effective strategy, non-compliance can be minimized. TSG is on-hand to help you manage all aspects of CPSR, PIF and CPNP notification requirements.
Customizable cosmetic products is just one of the topics that we will be covering at TSGE Forum’s conference The Challenges of the EU Cosmetic Regulation: Practical Advice for the Industry held on 10 July in Epsom, Surrey. Join expert speakers and gain practical advice on addressing the challenges of the EU Cosmetic Regulation. Topics include practical aspects of PAO and expiry date calculation; regulatory aspects of customizable cosmetic products; cosmetics and the microbiome; and borderline products. Follow the link to see the full programme.