REACh is a VERY complex European regulation (yes, another one!) and we will try to explain this complex Chemical European regulation easily.
What is REACh exactly and what is its purpose:
REACh stands for: Registration, Evaluation, Authorization, Chemicals and is the Largest European Chemical regulation.
- The objective is to improve the protection of human health and the environment from the risks that can be posed by chemicals.
- As of May 31, 2008, the European REACh (regulation EC No 1907/2006) applies to all chemical substances produced or imported within the European Union (all chemical substances contained in all products).
- It applies to almost all types of products including Cosmetics, Detergents, Biocides, Room fragrances, paints, etc…. (Medicinal, Food or Feed products are excluded)
- In order to be sold on the European market, substances (ingredients or raw materials) indeed have to comply with this regulation EC No 1907/2006. This means that only substances registered by the manufacturer or importer under this regulation are authorized for sale on the European market.
- As an importer of a finished product, you are considered an importer of all ingredients/substances contained in it and you may need to register them. Companies must indeed identify and manage the risks linked to the substances they market in the EU.
- It mainly addresses those who manufacture substances and put them on the market BUT a brand putting a product on European market also has to ensure that each substance contained in his product is registered.
- REACh indeed concerns any substances manufactured, imported, put on the market or used in Europe and is completely mandatory for all substances manufactured or imported at more than 1 ton per year.
- Every company must indeed know the tonnage of each substance they are responsible for in Europe and if it concerns more than 1 ton/year of a substance, the REACh registration is completely mandatory.
- In this regulation, the by default responsible company is the first “EU company of the supply chain” like for cosmetics.
- Non-EU companies can of course also nominate an EU Only Representative (OR) (equivalent to responsible person for cosmetics) which means that their downstream users are free of responsibility and are relieved of REACh registration obligations.
It wasn’t really a problem in the past because the controls and sanctions of national authorities were delayed for quite some time BUT this situation is now changing quickly and more and more importers of foreign brands have started to refuse the import of products for which the supplier does not assume REACh registration responsibilities itself.
The core principle of the REACh regulation is “no data, no market”, therefore products whose REACh traceability has not been approved can be refused (and this can of course have a significant damaging impact on compagnies).
REACh impacts on a wide range of companies across many sectors, even those who may not think of themselves as being involved with chemicals. Another problem is that a lot of companies do not always realize that they do indeed produce and distribute 1 ton every year of substances present in their various products (which can go very fast).
The REACh regulation has an impact on most companies across the EU:
- Manufacturer: If you make chemicals (to use yourself or to supply), then you will very probably have some important responsibilities under REACh.
- Importer: If you buy anything from outside Europe, you are likely to have some responsibilities under REACh. It may be related to chemicals, mixtures or finished products (including Cosmetics, Detergents, Biocides, Room fragrances, paints, etc…).
- Downstream users: Most companies use chemicals (sometimes even without realizing it), therefore you need to check your obligations if you handle any chemicals in your company, you might indeed have some REACh responsibilities.
In summary, if the products you will sell in Europe contain more than a ton/year of some substances, than a REACh registration will indeed be mandatory. Even if you export less than 1 ton/year, the importer will ask for you to take responsibility of your tonnages.
Biorius can of course help you with the REACh Regulation (BIORIUS indeed offers a complete support to assess and fulfill REACh obligations):
- Check compliance with REACh restriction
- Making SDS (Safety Data Sheet)
- Become EU REACh Only Representative (OR) and thus cover the risks.
- By taking responsibility for your tonnage (even for substances at less than 1 ton/year)
- Making REACh registrations of substances exceeding the exempted threshold of one ton per year.
- New restrictions usually comes out every few months and we are and we remain completely up to date with the REACh regulation.
- Biorius can help you assess and manage your REACh responsibilities for your finished products (and/or communicate with other members of the supply chain) in order to ensure regulatory compliance.
- Brexit UK has its own REACh regulation, tonnage and registration must be done separately and Biorius can also become UK Only Representative (OR) and thus cover the risks.
For more information, do not hesitate to contact your Account Manager, if you are already a Biorius’ client or to contact us at email@example.com.