RAPEX alerts in the cosmetics industry: Wake-up calls for producers and consumers

Cosmetic products must be safe for use. But who checks this in the EU? And what happens when a product turns out NOT to be safe?

Who checks cosmetics safety in the EU?

In the EU, the so called ‘competent authorities’ are tasked with checking whether cosmetic products are safe. These authorities function on an EU member state level, which means that each country has their own competent authorities.

For example, in the Netherlands this is the Dutch Food and Goods Authority (NVWA).

In which cases, exactly, are cosmetic products checked?

Cosmetics are checked by the Competent Authorities for safety. But when do they do this? In the EU, there are 2 different control systems that Authorities may use.

  • A pre-market control system
  • An in-market control system

Cosmetics are regulated by the in-market control system. This means that in order to sell a cosmetic product, you do not need to submit a registration dossier to the authorities beforehand.

This is unlike other product categories such as medical devices and drugs, which require pre-market approval.

Instead, cosmetic products are only checked after they have already been placed on the market.

There are several reasons for this.

Average life cycle of cosmetics

The average life cycle of a cosmetic product is around 3 years. This would mean that, every 3 years, you would need to register a product all over again.

This would be a large bureaucratic burden for the Authorities and would really delay new cosmetics products being introduced to the EU market. In essence, it would hamper innovation of new concepts.

Having to be able to enact changes

Having pre-market control would also mean that no changes can be made to products that are on the market. If a change has to be made, then the product would have to go through the entire registration process again.

This is currently the case for medical devices, where any change must be re-evaluated. With in-market control, changes can be done on the fly, keeping products on the market.

This continuously puts the responsibility of the product back on the company that put the product on the market.

Since Authorities don’t stand in the way of a product launching and solely control the product safety when it is on market, it’s really up to the company to continuously ensure their products are safe and compliant.

What are the reasons for the Authorities to check cosmetics, then?

In this in-market control system, the reasons for checking cosmetics are:

  1. Random checks
  2. Cosmetovigilance and UHEs
  3. Public complaints

Random checks

Similar to police conducting random driver’s license checks, Competent Authorities also conduct random checks on cosmetic products.

They do this by analyzing product samples (e.g., buying the product and analyzing it in a laboratory) or by visiting the Responsible Person at the address stated on the product packaging.

However, they do not just show up at your doorstep. By law, Authorities must announce their inspection at least 72 hours in advance.

This gives the Responsible Person ample time to prepare for the visit and ensure all necessary information is readily accessible, which will facilitate a smooth inspection process (the Authorities also appreciate smooth cooperation).

If any issues are found during the inspection, the Authorities typically indicate what needs to be corrected and set a new date for the next visit.

Cosmetovigilance

Although it may sound like “Batman goes Beauty”, cosmetovigilance actually refers to the Responsible Person ensuring that the product remains safe when it is put on the market.

Any health complaints from consumers using the product must be handled adequately. These health complaints fall into two categories:

  1. Undesirable (health) effects, or UEs
  2. Serious undesirable effects (SUEs)

As you can imagine, SUEs are extremely severe. This can lead to hospitalization or possibly irreversible damage from using the product. When an SUE occurs, the Responsible Person must communicate this with the Competent Authorities.

If the product is sold in multiple countries, the Competent Authorities will communicate with each other. Together with the Responsible Person, they can work on a plan, such as issuing a product recall.

Public complaints

Competent authorities can also receive complaints or tips directly about a product. If the issue is serious enough, it may warrant an inspection of the product. This occurs more frequently in certain countries.

For example, the Netherlands is known for its self-regulatory culture. There are committees, such as the Reclame Code Commissie and KOAG-KAG, that focus on product claims, while other committees and NGOs focus on different areas.

In addition, it’s common for competitors to report non-compliance. Although this may seem harsh, it helps maintain high standards, which is necessary for market control.

Without such standards, unregulated products could end up being sold on the market.

What happens if the Authorities detect a non-compliant product?

In the majority of cases, cosmetic products are safe and compliant when checked by authorities. However, there are instances when a product does not meet the necessary standards. The severity of non-compliance determines the course of action taken. For minor mistakes that do not pose a threat to safety, the Responsible Person usually receives a warning and is given time to rectify the issue. On the other hand, if the non-compliance poses a high risk to public health, control measures will be severe, such as:

  • Warning
  • Fix in the next batch
  • Marketing ban
  • Stop of sale
  • Direct recall
  • Public recall

Competent authorities may also impose a fine and increase company control measures in response to the non-compliance.

The European Rapid Alert system: RAPEX

In cases of serious health effects where direct action is required or when the Responsible Person fails to correct the mistake within the given timeframe, Competent Authorities use a specific information system called the Rapid Alert system RAPEX.

This system records information about the product, the noncompliance, and the control measures taken. Since it is a publicly accessible tool, anyone can check these RAPEX notifications.

All product categories use this system, so you can also find RAPEX alerts on clothing, electronic power banks, and many more. But of course, you can filter on cosmetics (as well as date and country) to immediately see which products were noncompliant.

For the most part, noncompliance falls into one of these categories:

  • Incorrect labeling (no instructions for use or the product contains ingredients that are not declared on the packaging)
  • Forbidden substances (high heavy metals content, medicinal drugs, etc.)
  • Microbiological contamination
  • Product that looks like food and is therefore a choking hazard
  • Incorrect formulation, such as a pH that is too low, leading to skin burns

Some of these issues have to do with importing products from outside of the EU, where different legislation and therefore different forbidden substances may exist.

or instance, some bleaching or skin whitening products that are accepted in Ivory Coast and parts of Asia are forbidden in the EU.

Importers may not be aware of these different legislative frameworks and restricted ingredients, leading to products that are rejected at the EU border.

Mistakes during manufacturing or during the sourcing of raw materials can also lead to product contamination. This may be due to a lack of quality standards in the factory.

Sometimes, the Responsible Person is unaware that there is a cosmetic regulation and that they need to be able to prove that their products are safe for use with a Cosmetic Product Safety Report (CPSR), which should be compiled by a Safety Assessor.

These mistakes can be damaging not only to product brands but also to public health. It’s crucial that cosmetic products should be safe and compliant at all times so that consumers can trust that their cosmetics are safe without a second thought.

Want to know more about the RAPEX system?

At SkinConsult, we know exactly what its influence is on your cosmetics business.