Pre-registration, late pre-registration, inquiry: what should I consider?
Pre-registration: over since December 2008
In force since 2007, the REACH Regulation imposes the registration, evaluation, authorization and restriction of manufactured chemicals on the European Market.
- Registration is mandatory for all substances produced and/or imported in more than 1 ton per year
- Until the registration is not effective, it is not possible to produce and/or import a substance that has not been pre-registered
Starting from the implementation of the REACH Regulation on the 1st of June 2008, companies importing or producing more than 1 ton of a substance per year had 6 months to pre-register their substances. The pre-registration specifies the intention to register the substance within the deadline related to the annual tonnage of the producer. This process gave companies the opportunity to benefit from a transitory period which meant that they could continue to produce/import their substance as long as the registration was done before the end of the deadline. Companies would usually get a pre-registration number (starting with 05) that is mandatory for the registration dossier compilation.
Considering that the pre-registration process is over since December 2008, if you haven’t pre-registered your substance, you have to submit a claim for a late pre-registration process.
What are the 3 conditions for a late pre-registration?
- The substance shall be “phase-in” (meaning that it should be registered in the EC inventory)
- There shall be at least one year before the end of the deadline related to the annual tonnage (the last deadline is the 1st of June 2017)
- You must have produced/imported the substance in more than one ton per year within the last 6 months.
The three conditions must be met otherwise it is not possible to launch the late pre-registration process.
When should I consider the inquiry process?
- When the deadline for the late pre-registration is overdue
- When the substance is not in the EINECS inventory.
Late pre-registration, inquiry: what should I do?
How to prepare the late pre-registration dossier?
The main facts about the late pre-registration dossier are as follows:
- You must submit it through the REACH-IT portal
- It gives you access to the SIEF
- It will allow you to benefit from a transitional period for your registration
- It is free of charge
- It does not exempt you from the registration
- It gives you a number starting with 17, mandatory for the REACH registration
How to proceed with the inquiry?
You have to submit your inquiry application in the form of an IUCLID 6 dossier on the REACH-IT portal. Through its 7-step approach, ECHA gives you some guidelines on how to proceed with the inquiry.
The inquiry dossier must consist of the following information:
- Identity of the registrant (through the REACH-IT portal),
- Identity and composition of the substance
- Analytical data
- Information requirements.
Once you have submitted your inquiry dossier, ECHA has around 20 business days to give you an answer. As soon as ECHA accepts the inquiry process, you will be given an inquiry number (starting with 06). This number is mandatory for the REACH registration but it also gives you some insights onto other dossiers that have been submitted for the same substance. It will guide you towards the right SIEF and will help you to choose whether you submit jointly or individually).
Please bear in mind that ECHA does not give information on an existing SIEF that has not yet submitted.
As SIEF manager, we handle the registration dossier from A to Z, organize cost sharing and take care of the SIEF continuity until 2018. Nevertheless, alongside with the internal timeframe of ECHA, the registration process takes time.
What are the deadlines for each process?
Late pre-registration
Before 2018, the dossier for the late pre-registration has to be submitted within the 6 months following the production and/or import of the substance over 1 ton. Moreover, your claim should be submitted no later than the 31st of May 2017.
Due to the short timeline, our experts strongly recommend you to start the late pre-registration process as soon as possible. After the 31st of May 2017, the inquiry process will be mandatory if you want to register your substance.
Inquiry
As for the inquiry, there is no deadline; you may submit your inquiry dossier at any time.
How much does it cost?
Late pre-registration
The late pre-registration process is completely free. It is important to underline that it does not commit you to register your substance.
Constitution of the inquiry dossier
While the late pre-registration process is free, the costs for the inquiry dossier include:
- Analytical tests (from 2,000 to 3,000€ for classic ones) required for the inquiry dossier. This data can be used for most registration dossiers (except for “intermediate” substance registration, cf. explanation below).
- For intermediates, please be aware that inquiry data is not mandatory for the registration dossier as a member of the joint submission:this means the data will be only produced for the inquiry process.
- Possible labor costs for the compilation of the IUCLID 6 dossier if you decide to go through a service provider.
Thus, you have less than 6 months to submit your late pre-registration dossier and to save costs relating to the inquiry process.
To conclude, the late pre-registration or the inquiry process is mandatory for the REACH registration as you have to include your pre-registration or inquiry number in your dossier.
