REACH registration: are you concerned?
You are concerned by the REACH registration if:
- You are a manufacturer of substances and /or mixtures and /or articles
- You are an importer of substances and /or mixtures and /or articles
- Your activity concerns the European market
- Your amount of manufactured / imported substances is greater than 1 tonne per year (see below for details on the calculation method of tonnage bands)
And that
You are not exempted by the REACH regulation:
- Polymers (the monomer must be registered when its concentration is over 2 % and that the overall amount is greater than 1 tonne / year)
- Substances in Annex V of the REACH regulation
- Substances in Annex IV of the REACH regulation
- Radioactive substances (established in the Euratom directive)
- Substances Nationally exempted in the interest of defense
but also that
It is not any of the following substances:
- Non-isolated intermediates: intermediates that, during synthesis, have not been voluntarily removed from the equipment in which the synthesis has been conducted (apart from sampling).
- Substances used for Product and Process Oriented Research and Development (PPORD): These substances are exempt from registration for five years (extensions possible), if you declare your PPORD activities to ECHA.
- Substances used in animal or human foodstuffs (including use as additives or flavouring).
- Substances (active ingredients or excipient) used in medicinal products for human or veterinary use.
- Active substances used in biocidal products or plant protection products, considered as substances that have already been registered. Careful: this exception is not valid if the substance is exclusively used for this use.
The Different Tonnage Bands for REACH Registration
REACH registration is mandatory for all chemical substances manufactured or imported in quantities of 1 ton or more per year.
The information to be provided varies depending on the tonnage bands:
- from 1 to 10 tonnes/year;
- from 10 to 100 tonnes/ year;
- from 100 to 1000 tonnes/ year;
- more than 1000 tonnes/year.
What must you do after having determined the REACH tonnage bands?
After having determined your tonnage bands and determined under which band you must register, you can start the actual registration process.
Create your REACH registration dossier
The registration dossier is created in 7 steps:
- Inquiry file
- Communication in SIEF
- Joint/individual submission
- Data sharing
- CSR preparation
- File preparation
- File submission
Want to know more about REACH registration?
For more information, feel free to contact our experts.