The 7 steps to create your Registration dossier

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Pre-requirements: some key notions

7 steps to create your registration dossier

The first two waves of registration have shown that the process is quite long and can take more time than primarily expected. EcoMundo would like to present the 7 key steps to successfully create your registration dossier.
1. Know your portfolio
2. Find your co-registrants
3. Get organised with your co-registrants
4. Assess hazard & risk
5. Prepare your registration as a IUCLID dossier
6. Submit your registration dossier
7. Keep your registration up-to-date

• Prior to any registration, you have to evaluate the tonnage of your substance and the situation of your company. As part of the evaluation, you have to define which are the substances that have been manufactured or imported at more than 1 tonne per year on the European market (calculate the average tonnage for the three last years).
• EcoMundo tip: Do not hesitate to get all information you can from SDS, analysis certificates and any other documents. It will help you to save time on the long run.
  ‍Regarding the substance itself, do not forget to verify if it is exempted from the REACH registration (REACH exemptions are defined by REACH Regulation 1907/2006 in Article 2).

ECHA has produced a short video for this stage:

2) Find registrants who have the same substance

• Check the creation of any other REACH-IT account. If there is no other account, then you must create one on the REACH-it platform (fill in your address, the size of your company, your contact and so on).
• Pre-registration is mandatory in the registration process. Indeed, pre-registration will give you a number that is absolutely necessary for your registration dossier. Thus, you may want to check if your substance has been pre-registered. If you find no evidence of any pre-registration, you must opt for a late pre-registration or an inquiry process. The inquiry process intervenes when you have missed the late pre-registration deadline or if your substance is completely new on the market.

• Once you have your pre-registration/late pre-registration/inquiry number, you may start the registration process.
• As a registrant of your substance, you will join a SIEF (Substance Information Exchange Forum). There is only one SIEF for each substance. Joining a pre-SIEF will give you the opportunity to evaluate the registration situation and adapt your strategy according to three different scenarios:

1° The SIEF is empty: When a substance is completely new on the market, it occurs frequently that no other registrant has joined the SIEF yet. In that situation, you may decide whether you would like to present a joint submission or an individual one. If you decide to opt for a joint submission, you can appoint yourself as Lead Registrant. It is highly recommended to opt for a joint submission in order to anticipate the arrival of other registrants in the SIEF. Warning! Whether you decide to present a joint or an individual submission, you will have to prepare the same number of documents and data.

2° A Lead Registrant has already been appointed: If SIEF members have already appointed a Lead Registrant; you have to get in contact with him/her in order to sign the SIEF agreement. Signing the SIEF agreement will give you the right to purchase the Letter of Access which gives you access to the information of the principal dossier. Once you have paid the Letter of Access fees, the Lead Registrant will send you by email both the joint submission dossier references and the token (for your information, the token is a password). These pieces of information will allow you to enter the joint submission on the REACH-IT platform.

3° The SIEF is dormant: A SIEF is declared to be dormant when registrants have joined the SIEF but have not appointed any Lead Registrant. In this situation, you may wait for the election of a Lead Registrant or designate yourself as the Lead Registrant. If you decide to apply for the Lead Registrant role, you have to send a survey to the member registrants with all the information concerning your election. Once you have their approval, you create a joint submission on the REACH-IT platform and declare yourself as Lead Registrant. Thus, ECHA will receive a notification of your status as Lead Registrant.

3) Make sure you organise yourself within the SIEF

• The Lead Registrant acts on behalf of the other Member Registrants and has to be the first one to submit the dossier in order to allow the other registrants to have access to it. Member Registrants have to purchase a Letter of Access from the Lead Registrant in order to have the right to refer to the data of the joint submission and to add some specific information about their activity and substance.
• The table below summarises the information to be provided for both types of application:

Source : ECHA

4) Assess the risks

• Whether you act as a Lead or Member Registrant, do not forget to check the analytical data of your substance.
• EcoMundo tip: If you have followed our first tip (cf. step 1), you have anticipated the tests by gathering some upstream information about the substance. The anticipation of the laboratory tests will save you valuable time. Indeed, these laboratories are often booked up by demands and you might wait longer than expected (at least 2 months).

5) Use IUCLID 6 to prepare your registration dossier

• Once all your analytical data have been collected, you have to aggregate them into the IUCLID 6 software. The registration dossier is extracted from the software and forwarded to the REACH-IT platform where ECHA checks that all fields have been completed.

6) Submit your registration dossier

• ECHA will issue an individual invoice that you must settle within 2 months through bank transfer. If you do not achieve to pay the invoice within 2 months, you have to submit your registration dossier again and the registration fees are payable.
• Once you settled your invoice, you may find a document with a registration number on your REACH-IT account. This document proves that you have registered and that your substance is compliant with the REACH Regulation.

7) Keep your registration dossier updated

• Registration requires a continuous update of your substance especially information regarding tonnage.

Lead Registrant or Member Registrant, which status should I choose ?

Lead Registrant: his/her specific role in the REACH registration

Considering the fact that the Lead Registrant acts on behalf of other registrants, he/she has a specific role in the registration process.

• The Lead Registrant has to carry out a data-gap. A data-gap is a research of toxicological and eco-toxicological data (on the substance) available and issued less than 12 years ago. The data gap usually gives available and useful information on the product. As part of this approach, Lead Registrants and Member Registrants exchange information. Lead Registrant can purchase or negotiate some information from the Member Registrants. All in all, the data-gap gives indications on the tests that the Lead Registrant has to conduct.
• EcoMundo tip : If you are the Lead Registrant of your SIEF, you should start the toxicological and eco-toxicological tests as soon as you can.
• The Lead Registrant is the one who manages the arrival of new Member Registrants in the SIEF. Managing the SIEF includes: writing and negotiating the SIEF agreement, issuing invoices for the Letters of Access and sending the tokens to the Member Registrants. Warning ! Please bear in mind that these responsibilities are very time consuming.

The advantages of being Lead Registrant

Although being Lead Registrant is time consuming, it will give you a considerable advantage on the long run: since you are in charge of the SIEF, you will be able to complete your registration faster. Furthermore, being Lead Registrant will also give you the opportunity to conduct the toxicological and eco-toxicological tests according to your criteria. Thus, you can create the Substance Identification Profile (SIP) and make sure that the tests concern your substance and its classification. All these factors may give you a strategic advantage over other companies that are part of the same SIEF.

Member registrant: his/her specific role in the REACH registration

As the Member Registrant purchases his/her access to the common part through the Letter of Access, he/she has some different roles in the joint submission.

• The Member Registrant checks if he/she has any specific toxicological and/or eco-toxicological data for his/her substance and decides whether or not he/she wants to share them.
• By signing the SIEF agreement, the Member Registrant can purchase the Letter of Access and enter the SIEF.
• The Letter of Access gives the Member Registrant access to the SIEF and allows him/her to refer to the Lead Registrant’s dossier.

The ultimate elements to bear in mind before strating your REACH registration

What are the fees and costs of the registration ?

There are different types of costs related to the REACH registration process: the common part fees, the individual part fees and the ECHA fees.

The fees related to the common and individual part of the dossier can vary according to your situation and role in the SIEF (Lead Registrant or Member Registrant).

The ECHA fees vary according to the tonnage of your substance and the size of your company.

Ecomundo tip : If you are an SME, please bear in mind that the European Commission grants discount percentages according to the size of your structure as follows:

• 30% for medium-sized companies
• 60% for small businesses
• 90% for micro businesses.

The importance of choosing a well-adapted strategy

Registering your substance is a long and complex process that requires several steps. It is important to establish a submission strategy that fits the specificity of your situation.

Whether you choose to be Lead Registrant or Member Registrant, managing or joining a SIEF takes time. Thus, it is often better to use the services of specialized providers who can act on your behalf. The provider can give you some guidance on your strategic issues; can find laboratories to run the analytical tests and complete/submit your IUCLID 6 dossier.