Cosmetic products

The European Cosmetic Regulation states that designating a Responsible Person (RP) is mandatory for manufacturers.

Manufacturers of cosmetics must have a Responsible Person in the EU if they want to sell their products in the EU market. EU manufacturers can act as their RP or designate one. Non-EU manufacturers cannot act as their RP and must designate an EU-based Responsible Person. Their importers can act as their RP, or alternatively they can designate an RP established in the EU or EEA.

The RP is responsible for ensuring that all the obligations related to product conformity have been carried out before placing the product onto the European Market. The RP also acts as the Cosmeto-Vigilance contact point in Europe for the cosmetic product they are responsible for.

One of the main requirements of Regulation EC 1223/2009 is the pre-market notification. Pre-market notifications are done through a notification to the CPNP, the Cosmetic Products Notification Portal.

The designated Responsible Person can only complete the notification after the Product Information File (PIF) encloses all evidence of conformity. The notification of a cosmetic product indicates that:

• A Responsible Person has been designated to the product
• The Product Information File (PIF) holds all evidence of conformity
• The product is ready to be placed on the EU market from a compliance point of view

A cosmetic product notified to the CPNP – a one-time notification – can be placed on any of the EU markets provided that the labelling conforms with the respective country’s language requirements. No national notifications are necessary anymore.

The Safety Report is essential when building a cosmetic product’s Product Information File (PIF). The Safety Report always includes two parts:

• Part A: Safety Information
• Part B: Safety Assessment

The Safety Information, identified in Annex I of the Regulation, is to be obtained from the suppliers of the raw materials and the producers of the finished product (easily accessible when producing according to Good Manufacturing Practices) and with the support of laboratory tests.

The Safety Assessment, identified in Annex I of the Regulation, is to be completed by the “Safety Assessor”, a qualified person with a European degree in pharmacy, medicine, toxicology, or a related discipline. When the qualification degree diploma is not obtained from a European university, the Safety Assessor must have it recognised by the appointed national bodies within one of the EU Member States. A unique safety assessment needs to be issued in case the products are:

• Intended for use on children under three years old.
• Intended exclusively for use in external intimate hygiene.

Mandatory EU Safety Testing

According to the EU Cosmetics Regulation, the mandatory tests for cosmetics are stability, compatibility, and preservative efficacy. However, some additional testing may be required based on the characteristics of the products, such as the patch test.

Compatibility Testing

The compatibility test aims to evaluate the migration of chemicals between the cosmetic product and its container. Packaging can directly affect finished product stability and safety because of the possible physical and chemical interactions between the product, the package, and the external environment.

There are no standard protocols for the compatibility testing of cosmetic products. An appropriate assessment may be made based on the knowledge of the formulation and primary packaging materials as well as experienced expert judgment.

This test analyses the potential migration of small substances from the primary packaging material to the formulation. It is carried out before placing the cosmetic product on the market.

Challenge Testing

Challenge testing is mandatory for all cosmetic products for which there might be a risk of microbial growth during normal conditions of storage or use. Preservatives are included in most cosmetic product formulations to protect them from microbiological contamination during regular consumer use. The challenge test aims to verify the reliability of the preservative system during the shelf and usage life of the cosmetic product.

The test should be done in at least two phases:

1. During the development of the product – after adding the preservative system.
2. At the end of the stability testing and/or formulation compatibility test with the packaging material (as an evaluation of the protective efficacy in intact, in-use or in-ending cosmetic products).

The conclusions report of the Challenge Test shall contain the following:

• Identification of the lab conducting the testing
• Identification of the product
• The packaging material used in the test
• A description of the methodology used – the protocol
• Study conditions
• The result of the study
• The signature of the person responsible for the study

Stability Test

Stability testing ensures that the cosmetic product maintains its intended physical, chemical, and microbiological quality, functionality, and aesthetics when stored under appropriate conditions.

Each manufacturer, given its knowledge of the formulation and the product’s intended use, may draft and argue the best-suited conditions to evaluate the stability of the product. The elements to be considered when preparing the protocol of a stability test:

1. Identify the conditions that will “accelerate and predict” the effects of standard conditions of storage and use. Where relevant, consider stresses, including temperature, that will enable the assessment of product integrity under anticipated product exposure conditions.
2. Consider evaluating critical aesthetic properties such as colour, fragrance, texture, and flow, particularly after exposure to conditions that stress each property.
3. Consider variations in the process conditions.
4. Consider the impact of the primary packaging on the formulation and any effects the product might have on the packaging.

The EU regulatory framework for cosmetics is regularly updated with new restrictions and bans of ingredients. Such changes may require beauty brands to reformulate their products if they want to keep placing their products on the EU market.

Importers of cosmetic products from outside the European Union automatically assume the role of their Responsible Person. As stated by the EU Cosmetics Regulation, importers who take the role of Responsible Person are fully responsible for ensuring that the products meet the law requirements.

However, importers can designate by a written mandate another EU-based company as the Responsible Person for the products they import.

Distributors of cosmetic products also assume the role of Responsible Person in case the distributor:

• Sells the products under their name or trademark, or
• Changes the product in a way that the regulatory compliance may be affected, for example, by changing packaging, labels, or product name.