What are cosmetics regulations and what is their purpose?
Cosmetics regulations constitute a framework specifying the specific requirements associated with cosmetic products, both for their development and for their marketing.
This framework includes strict measures to be respected on the composition of the product’s formula, manufacturing, risk assessment, conditions of use, prohibited substances, information displayed and labelling of its cosmetic packaging… Overall, regulations on cosmetics are complex and constantly evolving.
In this article, we base our documentation on the European cosmetics regulation 1223/2009/EC.
Regulations are developed on a country-by-country or geographical zones basis. For instance:
- Cosmetic products marketed within the European Union must comply with the European Regulation (EC) n°1223/2009, which is applicable to all Member States.
This Regulation imposes clear and detailed rules to cosmetic products, in particular for composition, labelling and marketing expectations such as safety assessment and vigilance on undesirable effects. In addition, it prohibits animal testing on both ingredients intended for cosmetic use and end products in order to meet the requirements of regulations on cosmetics. It is made clear that this Regulation establishes rules to be compliant with for any cosmetic product made available on the European market, whether manufactured in Europe or imported from third countries.
- In France, cosmetic products are also governed by specific provisions from the Public Health Code (Code de la Santé Publique – CSP), including provisions to adapt to EU legislation.
- Still in France, establishments that manufacture and package a cosmetic product must be declared to the French National Agency for the Safety of Medicines and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé – ANSM).
These rules apply to any cosmetic product as defined in the Cosmetic Regulation 1223/2009/EC to be compliant with in order to ensure the functioning of the internal market and a high level of protection of human health.
EU legislation ensures that legal requirements are implemented at the same time throughout the Community.
In case of non-compliance or violation of these rules, penal sanctions have been defined on the L. 5431-2 to L.5431-9 CSP articles which do not give room for diverging transposition by Member States. They shall take all measures necessary to ensure that related rules in force are implemented.
Let’s take a look at the key elements that must be taken into account to go to market in compliance.
When shall cosmetics regulations be integrated into a cosmetic development project?
Beyond the innovation, efficacy, texture and sensorial aspects, placed at the heart of a cosmetic product, it is essential to take into account the regulatory requirements linked to the project from the start.
There are several key steps to successfully develop skin care products, including ones that comply with cosmetics regulations. These are actually determined when the product specifications are being drawn up.
Placing a cosmetic product on the market in full compliance imposes precise requirements, including for operators who import finished products into the European territory.
European Cosmetics Regulations’ 7 key requirements to place on the market:
Responsible Person designation
According to the European Cosmetic Regulation, it is usually the brand ensuring the marketing; or in the case of importation, the Responsible Person, who must be located in Europe, is a European representative after establishing a written contract. The Responsible Person ensures compliance with all safety and labelling requirements, including notification obligations and corrective actions.
Product claims and information on substances according to European Regulation 1223/2009/EC
It imposes either bans or restrictions on certain compounds, while specific ingredients (cosmetic preservatives, UV filters or dyes) are included in specific must lists or annex. Cross-cutting requirements exist for ingredients such as the ban on animal testing or the identification of nanoparticles for subsequent labelling. The whole formulation must take all these parameters into account.
Before any cosmetic product is placed on the market, the Responsible Person shall ensure that its safety is assessed in order to demonstrate its safety for human health and that a toxicological certificate is drawn up.
Product Information File (PIF):
It gathers the key information specific to a cosmetic product and must be established for each new product placed on the market. The PIF must be regularly updated and made available to the authorities by the Responsible Person.
Compliance with Product and packaging labelling
They must show a certain number of indelible, legible and visible indications. Claims are strictly regulated so that they are reliable and useful to consumers, allowing them to make an informed choice.
In addition, information on the label must comply with both cosmetic regulatory requirements and more transversal provisions such as those in France via the AGEC law, which specifies, for instance, the conditions of use of the Triman logo, details relating to waste sorting.
Online notification on the Cosmetics Products Notification Portal (CPNP)
It allows to declare online the placing on the European market of a cosmetic product before it is marketed. This declaration is a prerequisite of Regulation 1223/2009/EC of the European Parliament and of the Council on cosmetic products.
Compliance with Good Manufacturing Practices
Among the requirements of the cosmetic regulation, complying with good manufacturing practices is mandatory and it applies to production carried out through the structuring of a quality organisation in accordance with the ISO 22716 standard.
Regulatory monitoring is key to place on the market in compliance
The frequent updating of regulations on cosmetics products requires regular monitoring of the ingredients and the evolving associated requirements. In addition, other regulations need to be taken into account as they may bring new requirements for cosmetics, e.g. the AGEC law in France.
If it is essential to foresee a regulatory approach in an overall cosmetic development, it is necessary for a cosmetic company, wanting to place on the market, to be accompanied by an external actor handling cosmetics regulations processes.
For example, the regulatory affairs department of the cosmetics manufacturer ALPOL Cosmétique enables cosmetic brands placing products on the market to:
- develop cosmetic products that comply with the regulatory expectations of the marketing areas. Regulatory monitoring is materialized thanks to its membership to professional unions, enabling ALPOL Cosmétique to advise or alert its clients to regulatory changes.
- help them gain in productivity and devote themselves to their business development. This can be achieved thanks to the recognised regulatory expertise of the manufacturer’s teams, which allows them to move forward with confidence on the overall regulatory monitoring of their cosmetic development (except for points specifically related to the marketer).
- gain in flexibility and consistency. When a cosmetics brand does not have a well-staffed regulatory affairs department, ALPOL Cosmétiques’ support provides clear and detailed support on these topics.