” Since February 2023, France and Italy have started to implement their control strategies, verifying REACh restriction compliance at customs checkpoints for products entering the EU. As a result, many cosmetic brands have been blocked at customs for failing to demonstrate compliance with REACh. “

Executive Summary

In 2019, the REACH Enforcement Forum of ECHA (European Chemical Agency) conducted an examination of consumer products across all sectors to assess their compliance with the REACh Regulation (EC No 1907/2006), which governs chemical legislation in the European Union.
The commission’s findings revealed that a significant number of products, particularly those imported from outside the EU, were not meeting the legal requirements. This lack of compliance was attributed to inadequate enforcement by EU member states and a limited number of REACH oriented controls for consumer products.

In response, the Enforcement Forum of ECHA developed a new “REACh Enforcement project” announced in November 2022 which mandates EU member states to enforce strict adherence to the REACh Regulation. Specifically, this project will investigate how companies fulfil the registration, authorisation and restriction obligations for products and chemicals they import from outside the EU. The project will be done in 2023-2025 and will require close cooperation between REACh enforcement and national customs authorities in the Member States. Each member state must develop its own enforcement plan. This plan concerns all consumer product, including cosmetics.

Introduction

As a cosmetic company, you are likely aware that in order to import or sell your products in the EU, compliance with the EU cosmetic regulation (EC No 1223/2009) is mandatory. Non-EU brands, in particular, require an EU Responsible Person such as Biorius to ensure compliance. However, compliance with the REACh regulation is equally important, and it applies to cosmetics as well. In this article, we will explain what REACh is, how it pertains to cosmetics, and how to comply with it – especially if you are a non-EU company. Additionally, we will discuss why REACh has become a pressing concern for cosmetics companies. Do not risk non-compliance with REACh regulations; read on to learn everything you need to know to ensure your cosmetics business is fully compliant.

What is REACh?

REACh, short for Registration, Evaluation, Authorisation, and Restriction of Chemicals (EC No 1907/2006), is a chemical regulation that governs chemical substances. Unlike the cosmetic regulation, which specifically regulates finished cosmetic products, REACh is concerned with the regulation of chemical substances. Additionally, REACh considers not only the hazards to human health but also hazards to the environment, which are not included in the cosmetic regulation. Therefore, a cosmetic product must not only be compliant with the cosmetic regulation but also comprise a mixture of chemicals, each of which must comply with the REACh regulation. REACh is a complex regulation that encompasses various aspects and regulatory processes. However, in this article, we will focus on the obligations related to regulated substances and substance registration.

Ensuring compliance with REACh is essential for your cosmetics business to avoid legal and reputational risks. By understanding the regulations and taking necessary steps, such as substance registration, you can ensure compliance with REACh and avoid potential consequences.

a. Regulated substances lists

There are two primary lists to consider under REACh – the Authorization List (Annex XIV of REACh)
and the Restriction List (Annex XVII of REACh).

The Authorization List can be deceptive, as it is actually the “Substance Submitted to Authorization”
list. It comprises the most harmful substances, and once a substance is on this list, it cannot be put
on the market or used without obtaining authorization. However, it is incredibly difficult to obtain
authorization, and it is impossible to get one for a cosmetic use. For example, Karanal, a well-known
fragrance molecule, is on this list and will be prohibited from August 2023.

You may have heard of the “Candidate List.” It serves as the antechamber of the Authorization List.
While the obligations related to the substances present on this list are few and mainly concern
communication, these substances will eventually be either included in the Authorization List or
strongly regulated through another means, such as restriction. The Polysiloxanes D4, D5, and D6
are typical examples of substances used in cosmetics and present on the Candidate List.

Finally, the Restriction List is a bit more complex as it encompasses various kinds of restrictions. In
general, it includes both a substance (or a group of substances) and an associated use, unlike the
Authorization and Candidate Lists, which do not refer to usage. A well-known restriction in the
cosmetic world is the limitation of 0.1% of D4 and D5 in wash-off cosmetic products. It can also be
more generic restrictions like Pentachlorophenol, which cannot be used at more than 0.1% in any
mixture (including cosmetics). It can even be very extensive restrictions, like the restrictions that
ban thousands of substances for textiles or tattoo inks or even the ongoing PFAS restriction.

It is essential to be aware of these lists and their implications for your cosmetics business. Noncompliance with the regulations can result in legal and reputational risks, including product recalls, fines, and damage to brand reputation.

b. Substances Registration

One crucial aspect of REACh is the registration obligation, which applies to any company that manufactures or imports over 1 ton per year of a substance, whether it is a pure substance or a mixture like a cosmetic product. This means that when importing a cosmetic product into the EU, every substance present in it must be registered if it exceeds the 1 ton per year threshold. Even if the import volume is below 1 ton per year, it is still important to be able to demonstrate and justify the import volumes of each substance to prove that registration isn’t required.

Substance registration is generally a straightforward process for cosmetics since most substances already have an existing registration dossier, and it is a matter of joining it. However, it becomes much more complicated for “new substances.” Additionally, like cosmetic registrations, substance registration can only be carried out by an EU legal entity. Therefore, if you are a non-EU company, you will need to have an EU legal representative, known as an Only Representative (OR), who is responsible for REACh regulation compliance instead of cosmetic regulation compliance, similar to a Responsible Person (RP).

How to be REACh compliant for cosmetics?

To ensure compliance with REACh, it is important to verify whether each substance present in your products appears on the candidate, authorization, and restriction lists, as well as checking for any more generic restrictions. This can be a challenging task, given the vast number of different substances that may be present in your product portfolios.

The registration process is even more complex, as it involves determining the composition and annual
import volumes of each of your products, and calculating the import volume for each substance, taking
into account that the same substance may be present in multiple products. If you import more than 1
ton/year of a substance, it must be registered.

However, there are some substances that are exempt from registration, and some raw material
volumes may not need to be included depending on what your raw material supplier has done. To
ensure compliance, it may be helpful to work with an Only Representative (OR) who can handle
registration and other REACh compliance requirements on your behalf if you are a non-EU company.
What does it mean in practice for cosmetic companies?

For an EU company:

• For the raw material you are sourcing in EU you should ensure that your supplier has registered the substance or is exempted.
• For the raw material you are importing from out of Europe, you must track the annual volumes.
• If your products are formulated out of EU, you must track annual volume of each substance.
• If the annual volume of a substance is over 1 ton/year, you must register it.

For a non-EU company:

• You must track the annual volume of each substance you are exporting to Europe.
• You should nominate an EU Only Representative.
• You must register any substance exported at more than 1 ton/year.

Why it is urgent to be REACh compliant?

Compliance with REACh regulations for cosmetics is not new; it has been in existence since the creation
of REACH in 2006. However, for a long time, the chemical sector was primarily dealing with it, and
mixtures, especially those with dedicated regulations like cosmetics, were not a priority for authorities
responsible for controls.

However, the European Chemicals Agency (ECHA) conducts regular investigations on specific REACh
aspects under the REACh Enforcement Forum. Based on the conclusions, ECHA can decide, together
with national authorities, to focus controls on specific aspects, known as REACh enforcement projects.

In the November 2022 meeting, the Enforcement Forum of ECHA agreed to investigate how companies comply with the registration, authorization, and restriction obligations for products and chemicals they import from outside the EU. The project will be carried out from 2023 to 2025, requiring close cooperation between REACh enforcement and national customs authorities in the member states. This means that compliance with REACh regulations for products, and not just raw materials, will be
increased. Customs will perform most of the checks since imported products are a major target.

France is the first country to launch this campaign by adding a section to its customs form specifically
for REACh restriction compliance. We have already received reports of cosmetics being blocked by
French customs due to non-compliance, indicating that cosmetics are indeed included in the project.
Furthermore, we got the confirmation in March that Italy started to perform customs controls
following the French practices. These first two initiatives are just the beginning, as more countries will likely implement similar procedures. It is also possible that the controls may extend beyond restriction compliance.

Conclusion

While most cosmetic brand overlooked REACh compliance up until now, maybe at the exception of the
restriction very specific to cosmetics like D4 & D5 in wash-offs, it is now urgent to ensure REACh compliance.
Biorius has a department dedicated to REACh compliance. We can help you analyze your portfolio for
the regulated lists compliance of your products and deliver certificate attesting it. On the registration side, we can calculate your annual substances import volume, define your responsibilities and devise a compliance strategy and act as your Only Representative in EU if you are a non-EU company. We can also help you with substance registration if needed.

One last word, don’t forget UK! While this article was about EU-REACh, since Brexit, UK is not in EU but they have their own UK-REACh which is very similar. It means that that they have their own regulated lists, your import volumes in the UK must be calculated separately and if you are a non-UK company (even an EU company) you also need a UK Only representative. Biorius having offices in UK we can also assume the role of your UK Only Representative.

For more detailed information, we invite you to check some articles on the subject present on our
website and visit our REACH for cosmetics services webpage:

• REACh for beginners
• Did you know that cosmetic products have REACH obligations? part 1
• Did you know that cosmetic products have REACH obligations? part 2
  

Dr. Philippe Azam

Director Safety & Regulatory Affairs – Chemistry
Contact us at info@biorius.com