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REACH

Pre-registration

Changes to pre-registration after 1st December 2008

Is it possible to modify the data entered during a pre-registration?

A pre-registration can be modified with the exception of the Substance ID and the UUID assigned to that pre-registration. You can manually modify contact information (both internal and third party representative), similar substances, tonnage/deadline and the information in the remark field of the pre-SIEF.

Further information on how to delete, deactivate or modify a pre-registration are explained in detail in Q&A https://echa.europa.eu/support/qas-support/browse/-/qa/70Qx/view/ids/0347 and https://echa.europa.eu/support/qas-support/browse/-/qa/70Qx/view/ids/03476
Is it possible to transfer the pre-registrations already made by the importers to a newly established only representative?

No, it is not possible to transfer pre-registrations from importers to an only representative.

Further information on the general principle of legal entity change can be found in Chapter 1.5.3.1 of the Guidance on Registration at: http://guidance.echa.europa.eu

Duties following from pre-registration

What are the duties following from pre-registration?

For each substance you have pre-registered, a pre-SIEF page is set up in REACH-IT. In the pre-SIEF page, you will find the contact information of the other companies that have pre-registered with the same substance identifier (e.g. EC number).

You need to contact each other to see who will register and if your substances are the same.

In the SIEF, you will share the data you have on your substance with your co-registrants, share costs and prepare the joint registration.

The aim of a SIEF is to avoid duplicating the testing of substances and to agree on their classification and labelling. In a SIEF, companies must share animal testing studies to keep these tests to an absolute minimum. They may also share other data relevant for REACH. It is an opportunity to generate and obtain the registration information required by the REACH Regulation in a cost-effective manner.

If I pre-register do I have to maintain my production/import?

According to Article 28 of the REACH Regulation, a pre-registrant can benefit from the extended registration deadlines specified in Article 23. Pre-registration does not establish any obligation to maintain the production or import of substances. You should bear in mind, however, that other SIEF members may ask you to provide them with information required for the purposes of registration and, if you are in possession of such information, you will have to supply it.

Is the submission number proof that my substance has phase-in status?

No, it is not. Neither the receipt of the submission number nor the receipt of the pre-registration number constitutes evidence that your substance has phase-in status.

To determine whether your substance is a phase-in or a non phase-in substance, refer to Section 1.7.1 of the registration guidance available at: http://echa.europa.eu/support/guidance.

The pre-registration of a phase-in substance without an EC number does not require the potential registrant to submit documentary evidence showing the phase-in status of a substance within the meaning of Article 3(20) of the REACH Regulation in the pre-registration (see Article 28(1) of the REACH Regulation).

Nevertheless, pre-registrants have to confirm in the pre-registration that they are willing to claim phase-in status for their substance. Manufacturers/importers need to keep this information at the disposal of the enforcement authorities of the Member States at any time.

How can I use the pre-registration number?

The pre-registration number is a confirmation that the pre-registration has been received by ECHA. It is up to each pre-registrant to decide how to use this information.

Do I need to indicate the pre-registration number on safety data sheets (SDSs)?

In general, the REACH Regulation does not govern the use of the pre-registration number. As Member States are responsible for enforcing REACH, individual Member States may have national requirements concerning the communication of the pre-registration number.

However, the registration number (when eventually assigned) has to be indicated on the safety data sheet, as laid down in point 1.1 of Annex II to the REACH Regulation. More information on registration numbers can be found in Section 7.4 of the Guidance on registration available on ECHA’s website: http://echa.europa.eu/support/guidance

How will the pre-registration data be used?

ECHA will publish the list of pre-registered substances at: https://echa.europa.eu/information-on-chemicals/pre-registered-substances.

Information published will include:

  • substance EINECS and CAS number (if available) and other identity codes;
  • the first envisaged registration deadline;
  • the names and other identifiers of related substances that pre-registrants have, i.e. those for which the available information may be relevant for performing adaptation of testing requirements using read across, (Q)SARs and/or grouping of substances.

The list published by ECHA does not show the identity of the pre-registrants. This information is visible to those who have pre-registered the same substance and those who have pre-registered related substances for read-across.

Is it possible to benefit from the specific provisions for phase-in substances, if the substance was not pre-registered by 1 December 2008?

Yes. If you are a first-time manufacturer or importer, you can in principle benefit from late pre-registration. If this is your situation, you must pre-register within six months after the first manufacture or import of one up to 100 tonnes per year, and no later than 31 May 2017.

Late pre-registration also applies to phase-in substances in articles imported for the first time for which registration is required. Only representatives are also entitled to late pre-registration if the substance of the non-EU manufacturer is imported for the first time in the EU (Guidance on data sharing, section 3.1.1).

This is further described in the section "Pre-registration of phase-in substances" of the Guidance on data sharing in: http://echa.europa.eu/guidance-documents/guidance-on-reach.

I am a first-time manufacturer or importer. How can I pre-register my substances and is there a format to be respected?

Late pre-registrations can only be submitted using the REACH-IT portal by direct encoding of the information on the REACH-IT website (online pre-registration). 

How much is the pre-registration fee?

There is no fee for pre-registration.

How is it possible to find out whether a substance is pre-registered?

The list of pre-registered substance is published on ECHA’s website. This list does not contain the names of the pre-registrants. Thus, to find out whether a substance has been pre-registered in a particular supply chain, downstream users should ask their suppliers or other actors further up their own supply chain. The list is available at:
http://echa.europa.eu/information-on-chemicals/pre-registered-substances

What are phase-in substances?

Substances that fulfil at least one of the following criteria may be considered as phase-in substances in accordance with Article 3(20) of the REACH Regulation:
 

  • Substances listed in the European Inventory of Existing Commercial chemical Substances (EINECS);
  • Substances that have been manufactured in the EU (including accession countries on 1 January 2007) but have not been placed on the EU market after 1 June 1992;
  • Substances that qualify as a so-called ‘no-longer polymer’.

Detailed information can be found in Section 1.7.1.1 – Phase-in substances of the Guidance on

registration at: http://echa.europa.eu/web/guest/support/guidance-on-reach-and-clp-implementation.
Which are the different registration deadlines?

Article 23 of the REACH Regulation provides for a scheme with different registration deadlines for so-called ’phase-in substances’, depending on the tonnage band and hazards of the substance.

The respective deadlines to submit a registration dossier to ECHA are as follows:

  • 30 November 2010 for CMR (Classified as carcinogenic, mutagenic or toxic to reproduction, categories 1 and 2, in accordance with Directive 67/548/EEC.) ≥ 1 tonnes/year, R 50-53 (Classified as very toxic to aquatic organisms and may cause long-term adverse effects in the aquatic environment (R50-53) in accordance with Directive 67/548/EEC.) ≥ 100 tonnes/year and other substances ≥ 1 000 tonnes/year; or
  • 31 May 2013 for other substances ≥ 100 tonnes/year; or
  • 31 May 2018 for other substances ≥ 1 tonne/year.
How do I calculate the tonnage to determine the respective registration deadline?

The actual amount of production and/or import, the forecasted tonnages and how hazardous the substance is will define the relevant registration deadline. The envisaged yearly quantity has to be calculated per calendar year.

Detailed guidance and practical examples are provided in the Guidance on Registration (Section 1.6.2 – Calculation of volume to be registered and Article 3 (30) of the REACH Regulation) http://echa.europa.eu/web/guest/support/guidance-on-reach-and-clp-implementation.

Is there a pre-registration number that is distributed to the pre-registrant?

Yes, every successfully pre-registered phase-in substance receives a pre-registration number. This number is unique for every company and pre-registered substance.

 

The structure of the pre-registration number:

<TYPE>-<BASE-NUMBER>-<CHECKSUM>-<INDEX-NUMBER>

Example: 05 - 1234567890 - 49 - 0000

Where:

  • 05 is the pre-registration type
  • 1234567890 is the random unique 10-digit number
  • 49 is the calculated checksum (changeable 2-digit number)
  • 0000 is the index number

This structure is of the same basic format as the other registration and notification numbers that REACH-IT will provide.

Can I, as a downstream user, check the pre-registration number online and see if my supplier pre-registered?

No, there is no functionality in REACH-IT that would accommodate and distribute this information as it could be considered confidential business information. Downstream users are advised to make appropriate contractual arrangements with their suppliers to ensure that they comply with REACH and that pre-registration has taken place within the pre-registration period.

 

If you are in doubt and need verification, please contact your local enforcement authority for more information. 

Does a downstream user have pre-registration obligations?

A downstream user who is not manufacturing or importing substances is not required by the REACH Regulation to pre-register a phase-in substance. However, after the publication of the list of pre-registered substances by ECHA (by 1 January 2009), a downstream user of a substance that does not appear on the list may notify ECHA of their interest in the substance, their contact details and the details of their current supplier. ECHA can then provide contact details of the downstream user to a potential registrant.

The ECHA website provides public information and documents from REACH processes such as the list of pre-registered substances or downstream users’ notifications as they become available at: https://echa.europa.eu/information-on-chemicals.

More information on the obligations of downstream users is available in 22 EU languages in the Guidance for Downstream users. Please change the language in the top right corner at: http://guidance.echa.europa.eu.

Can a downstream user participate in a SIEF and share data?

Yes they can, and are encouraged to do so if they hold significant data that will be valuable for registrants when compiling their registration dossiers. In practice, downstream users have to submit certain information (substance identification, contact details) to ECHA to be recognised as a data holder for a substance, after which ECHA puts them in contact with the potential registrants.

Data holders are entitled to be compensated for their data used for registration. More detailed information is available in the Guidance on data sharing, Section 3.2.3.2. https://echa.europa.eu/documents/10162/13631/guidance_on_data_sharing_en.pdf

What should I do if I am in the wrong pre-SIEF?

If you entered your substance name in a different way than the other manufacturers and importers when pre-registering, or if you realise during discussions about the sameness of your substances that you do not have the same substance as the other pre-registrants in the pre-SIEF, you may want to look for and join another SIEF.

A useful tool when looking for a more suitable SIEF is the list of pre-registered substances. This list contains all pre-registered substances, with the available identifiers such as EC number, CAS number and chemical name with synonyms. The list can be found at: https://echa.europa.eu/information-on-chemicals/pre-registered-substances

Once you have found a more suitable or more specific identifier for your substance (which is then considered as “another” substance by REACH-IT), you can use REACH-IT to view the pre-SIEF of this “other” substance. For this, you need to update your pre-registration by adding this “other” substance in the “similar substances” tab, which can be found under “Edit pre-Registration”.

From the pre-SIEF page of your substance, you will then be able to navigate to the pre-SIEF page of this “other” substance. You will not be listed as a member of this pre-SIEF, so you have to take the initiative and get in contact with the pre-registrants to explain that you wish to join the SIEF.

What should I do if nobody in the pre-SIEF replies to my emails?

A pre-SIEF might have many participants, but it is possible that most of them are undecided about registration or have decided not to register. The status ‘Inactive’ in the pre-SIEF indicates that the company will not register, but not all companies use it.

If companies do not reply to your emails, you might want to try contacting them in another way (if their email address is outdated). You might limit this to companies you are familiar with and who you think might be registering.

It will also be helpful to download the pdf file of pre-registrants at regular intervals to see if any changes to contact details have been made. Please note that communications might be filtered out as spam.

If further communication attempts remain unanswered, document the attempts made and prepare to register your substance alone. Communicate your progress by email to the others in the pre-SIEF. Think about becoming the SIEF Formation Facilitator (SFF) so you can indicate in the pre-SIEF how others can contact you.

If your substance is a complex substance, consider the possibility that other manufacturers/importers of the substance used other identifiers for the substance and are in a different pre-SIEF. Look in the list of pre-registered substances for pre-SIEFs you could potentially merge with.

How do you merge a pre-SIEF?

To merge pre-SIEFs, you will need to do the following:

  • Contact the other pre-SIEF;
  • Establish which pre-registrant should be the lead registrant of the joint submission;
  • The lead registrant should create a joint submission in REACH-IT for the substance;
  • The lead registrant should use the pre-registration number to create the joint submission only if the identity of the substance as specified in the pre-registration specifically and correctly identifies the substance to be registered;
  • Every member of the joint submission should use the same chemical identifiers used by the lead registrant to create the joint submission in REACH-IT;
  • Members of a joint submission, as any other registrant, should individually provide the information on the identity and compositions of their own substance. This information should correspond to their substance as manufactured. Members of a joint submission should therefore not provide generic compositions or duplicates of compositions provided by other registrants, as appropriate.
How do you split a pre-SIEF?

To split a pre-SIEF, you will need to do the following for each substance covered by the pre-SIEF:

  • Establish, among those pre-registrants having the same substance, which pre-registrant should be the lead registrant of the joint submission.
  • The lead registrant should create a joint submission in REACH-IT for that substance;
  • The lead registrant should ensure as far as possible that a distinction can be made between the identity of the substance as defined in the joint submission and the other substances also covered by the pre-SIEF. For this purpose, the lead registrant may need to enter manually the correct and specific identity of the substance rather than use the pre-registration number;
  • Every member of the joint submission should use the same chemical identifiers used by the lead registrant to create the joint submission in REACH-IT;
  • Members of a joint submission, as any other registrant, should individually provide the information on the identity and compositions of their own substance. This information should correspond to their substance as manufactured. Members of a joint submission should therefore not provide generic compositions or duplicates of compositions provided by other registrants, as appropriate.