Part I
I recently started working for Biorius with the responsibility of managing chemical regulations questions. I quickly noticed that there was a question for which there are many divergent opinions around, a lot of hearsay and very little substantiated answers. And this question was: How the REACH regulation applies to cosmetics? While you’ll find the answer to the question in this article you will also notice that this answer raises other questions. So, I decided to write a series of articles about REACH and cosmetic products to help you understand what you must do and how to do it!
Chemicals in cosmetics are also regulated by REACH
In Europe, chemicals at large are regulated mainly by two big regulations which are the REACH regulation and CLP regulation. Because finished cosmetic products have their very own regulation to ensure their safety and correct labelling you might think that they are not concerned by chemical regulations. Unfortunately, this is wrong! While it is true that cosmetic products are not submitted to the CLP regulation, they are not exempted of the REACH regulation.
REACH is a beast of a regulation
Even for Europe REACH is a huge and ambitious regulation; first but not last of its kind in the world, its aim is to ensure the safe use of all chemicals in Europe. This goal is achieved through four main steps which can be found in the name of the regulation: Registration, Evaluation, Authorisation and Restriction.
The main specificity of REACH, compared to many other chemical regulations around the world, is that not only does it apply to new substances, but it also applies to all existing substances as well.
The parts of REACH that you have to live with
The cosmetic industry has an almost negligible influence on the evaluation, restriction, and authorisation of substances. However, your products can be impacted by the outcome of these regulatory processes.
The evaluation happens when a substance needs to be studied further because of potential concern. Restriction and authorization steps are processes aiming to limit the use of substance presenting a very high concern (SVHC). The way to do it ranges from restricting their utilization in some uses (restriction) to reserving their utilization to the most critical uses only (authorisation). These steps are the responsibility of authorities (ECHA, Member states, European commission) and the industry input is quite small. However, if a substance enters the candidate list or is submitted to authorisation, the related obligations will also apply to your cosmetic products.
Registration is the heart of the matter
The first step of the REACH process is registration which falls under the Industry responsibility. The core principle of registration is that all producers or importers of a chemical in Europe should ensure that it is safe. Indeed, this is easier said than done, to do it you’ll need to know three main parameters: How much of the substance you are manufacturing or importing? what is its toxicity? and how it is used to ensure that it is done in a safe way. All of these elements will have to be presented in a registration dossier by each of the companies importing or manufacturing more than one ton a year of a chemical in Europe. However, on the bright side, some substances are simply exempt from registration, as would be the case of substance known as safe, like water, some naturally occurring substances (but under conditions) and polymers (for now because it will change soon). In addition, and very importantly, articles and substances in articles are exempted of registration (but not of REACH).
All of this is very interesting… but what about my lipstick?
I mention above that some articles are exempted of registration so your lipstick or tube of cream should be exempted, right? The answer is Yes…. and No….
The most important point to understand is that when you import cream in a tube for example, the tube is indeed an article, but the content is considered as a mixture. In this case, it’s considered as an “article with intended release of a substance/mixture”. And while articles are exempted from registration, substance in a mixture are not. Importing a mixture is like importing each and every one of its components individually. Therefore, when you do import a finished cosmetic product you are actually importing both an article and a mixture of many different substances. Each of these substances may have to be registered under REACH! This interpretation was undoubtedly confirmed by the French REACH Helpdesk in their answer to the question number 33414.
This is just the beginning
Now you know that you may have to register under REACH the components of your finished cosmetic products. The question then becomes, who should register and how to do it? These questions seem straightforward at first, but like everything in regulations, it is not as obvious as it could or should be!
You’ll find the answers to these questions in the next parts of this series on REACH and cosmetic products! Or you can ask Biorius and we’ll be glad to help you define and fulfill your responsibilities concerning REACH.
A bit about me
In addition, I’d like to use this first article to introduce myself. I am a Senior Toxicologist experienced in human health and environmental toxicological and risk assessment. I have a successful track record in chemical registrations and product regulatory compliance on various markets acquired mainly during my ten years in Solvay. I have served in several business environments, including cosmetics, with a worldwide scope and I actively contributed to European committees.
I started my career with a Ph.D. on skin sensitization methods completed by a postdoctoral fellowship at the University of California. I then took on the role of a non-clinical assessor in LFB, a biotech company, before joining Solvay and more recently Biorius with the mission of developing chemical regulations services. If you want to know more about me, here is my LinkedIn page.
