The European Union and its Regulation on Cosmetic Products, a not-so-“common” regulation

As it is well known, Regulation 1223/2009 is the legal framework that cosmetic products must comply with in the territory of the European Union (EU). All this is in place to ensure a unified and regulated market under the same regulations, regardless of the EU territory where the product is marketed. However, with the passage of time, there have been changes that have made the unified market of the European Union increasingly less unified, complicating the task. A clear example is the United Kingdom’s (UK) exit from the European Union, where regulatory paths have already started to diverge.

On the other hand, there are certain points within Regulation 1223/2009 that are left to the discretion of the member states. Some states have chosen to take specific actions regarding certain ingredients or to regulate internally with their own domestic regulations, which further complicates the initial or ideal common market. Let’s now explore some of the particularities that we have encountered within the disunited Union.


United Kingdom and Brexit

An important change is the shift in the responsible person (RP) for cosmetic products. Previously, a single responsible person within the EU territory could market their product throughout the EU, including the United Kingdom. However, after the split, it is now necessary to have an RP located within the United Kingdom to market products in that territory, and another RP for marketing within the EU. This is a clear example of the duplicity that we may encounter throughout the separation process, along with other specificities and differences with the European regulation.

Another example of this separation is that previously, a single notification to the Cosmetic Products Notification Portal (CPNP) was valid for the entire European territory. However, now an additional notification must be made for the United Kingdom through the Submit Cosmetic Product Notification (SCPN) process.

On the other hand, the creation of the Scientific Advisory Group on Chemical Safety in Consumer Products (SAGCS) in the UK is another example of the divergence between the EU and UK regulations. The SAGCS serves as the equivalent of the EU’s Scientific Commitee on Consumer Safety (SCCS). The SCCS provides opinions on ingredients used in cosmetics, their safety or potential risks, and specific conditions of use based on different populations, among other factors. With the establishment of the SAGCS, opinions issued by this group may differ from those provided by the SCCS, highlighting the gradual separation of these two regulatory systems.

In addition, there are further particularities. The Annexes of Regulation 1223/2009, which contained information on prohibited and restricted substances, preservatives, colorants, etc., have been transposed into British legislation. However, subsequent updates to Regulation 1223/2009 have not been incorporated into the UK Cosmetic Regulation. This means that certain substances that have been regulated or prohibited in the EU can still be used without restrictions or prohibitions in the UK market. For example, Methyl-N-methylanthranilate was regulated in the EU by Regulation 135/2022, and the restriction on its use came into effect on August 31,2022.

However, this has not been the case in the UK. As of today, the UK has notified the WTO of the modification to its regulations, and the indicated deadlines suggest that the restriction will not be applicable until 2024. These examples clearly demonstrate how the United Kingdom and the European Union are gradually diverging, requiring increased attention to regulatory differences when wishing to market products in these regions.

Particularities within the EU Territory

As mentioned at the beginning of the article, there are also certain particularities within the EU territory. Certain aspects of Regulation 1223/2009 are left to the discretion of the member states, and some member states have chosen different paths despite being part of the EU’s common market.

Among the aspects left to the member states by Regulation 1223/2009 is the designation of the competent authority responsible for market surveillance in that territory, as well as the management of cosmetics vigilance and reported adverse effects. Other notable points include the language of the Product Information File (PIF) and labeling requirements.

There are also particularities that go beyond these “bureaucratic” aspects and can affect the product depending on the market of commercialization. One example is found in French legislation, as authorities in the country (ANSM)  intended to restrict the use of Phenoxyethanol but were unsuccessful. Instead, they issued labeling guidelines that require manufacturers to specify on the labeling of rinse-off cosmetic products containing Phenoxyethanol (excluding deodorants, hair styling products, and makeup) that they cannot be used in the diaper area of children under 3 years old. This creates a particularity in the French territory that is not required in the rest of the European territory. Legal proceedings have been initiated against this labeling guideline, but so far, no decision has been made to remove or eliminate it.

Another particularity of the French market is related to the use of nano ingredients in cosmetic products. Although it is not a regulation directly imposed by Regulation 1223/2009, if a cosmetic product includes nano ingredients, a notification must be made.

The French market also pays special attention to certain claims made about cosmetic products, and a guide has been developed that provides recommendations to follow.

Another example of divergence in the French market is the recent proposal of a national regulation that will govern the sale of bulk products, affecting the cosmetics industry.

Another notable particularity in the industry is the German market. Regulation 1223/2009, in Article 17 on traces and impurities, does not specify maximum limits for these substances. However, the German government, through the Federal Office of Consumer Protection and Food Safety (BVL), published a study providing guidance on maximum limits for heavy metals in cosmetic products. These limits are taken into account by German authorities in market surveillance. For example, lead is limited to 2 ppm in makeup products, while cadmium and mercury are limited to 0.1 ppm, among other limits. These are points that need to be monitored in our products if they are to be marketed in the German market.

We won’t delve into the topic of packaging and mandatory symbols in this article, as it is beyond its scope. However, it’s important to note that there are individual legislative actions in each territory of the EU, resulting in cosmetic product labeling differing in each country of commercialization, particularly in terms of symbols for packaging and recycling. This aspect will become increasingly important until the European Commission establishes a unified regulation for the entire community in this regard.

With this brief article, we aim to highlight that although there is a single common regulatory framework in the EU market, there may be slight differences between territories that can impact the commercialization process in one country or another. It is essential to be aware of these differences to avoid any complications.