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.
Rules to calculate REACH registration tonnage bands
The different REACH tonnage bands
There are four different tonnage bands in which the deadlines vary:
- from 1 to 10 tonnes/year;
- from 10 to 100 tonnes/ year;
- from 100 to 1000 tonnes/ year;
- more than 1000 tonnes/year.
How to calculate your tonnage bands for REACH registration?
Tonnage bands are very easy to calculate: all you need to do is calculate the average tonnage of the last 3 years.
Let’s take an example: an acetone manufacturer that also uses it as a solvent to formulate paint will have to register the acetone as a manufacturer if he produces more than one tonne a year.
2014 2015 2016 Average per year over tree years Acetone 0.5 tonne 1.5 tonnes 0.5 tonne 0.83 tonne
Its average over 3 years is 0,83 tonne per year. Hence, he won’t have to register his substance.
Deadlines: what to do if you have missed them?
If you have missed the registration dates, you must immediately go through the inquiry process (cf. below). Once you have the results, you must register the substance straight away to be compliant and avoid potentially severe penalties in case of a control.
What must you do after having calculated the REACH tonnage bands?
After having calculated your tonnage bands and determined under which band you must register, you can start the actual registration process. There are two options possible: pre-registration and inquiry.
The 3 conditions for late pre-registration:
- The substance must be phase-in (registered in the EC inventory)
- There must be at least one year before the corresponding tonnage deadline
- You must have produced/imported the substance at more than 1t/year for less than 6 months.
The 3 conditions must all be met, without which the late pre-registration cannot take place. As soon as late pre-registration is no longer possible, you must consider the inquiry process.
When must I consider an inquiry?
- When the late pre-registration deadline has been missed,
- When the substance is not in the EINECS inventory.
- When the substance has been manufactured or imported for more than 6 months.
Once the pre-registration or inquiry number has been received, you can start the registration dossier constitution.
Create your REACH registration dossier
The registration dossier is created in 7 steps:
- Identifying the substances subject to registration;
- Finding co-registrants;
- Getting organised with the co-registrants;
- Assessing the risks and dangers;
- Preparing your registration in IUCLID 6 format;
- Submitting your registration dossier;
- Keeping the registration up-to-date;
You want to know more on REACH registration?
For more information, do not hesitate to contact Renaud Germain-Thomas or one of our experts via our contact form, indicating the purpose of your inquiry.
