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If a company established in the European Community manufactures or imports a phase-in substance which the company did not pre-register, it will have to suspend its activities involving the substances concerned and register them without delay. All manufacturing and placing on the market of such substances, between the start of the pre-registration deadline and the date of suspension of activities, may be subject to penalties according to national law. Activities involving the substances concerned can only be restarted after the substance has been successfully registered and the registration number has been received from ECHA.
To obtain a registration number, the company has to:
- Submit an inquiry according to Art. 26 of the REACH Regulation to ECHA to determine whether a registration, or an inquiry, was previously submitted for the same substance;
- Share relevant physicochemical, health and environmental data and use information in order to compile a registration dossier
- Submit a complete dossier to ECHA. Please note that the completeness includes also the payment of the fee.
If you want to know what substances have to be registered you may first consult the Guidance on Registration (Section 1.6 – What to register) http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation.
More information on how to submit an inquiry and registration dossier to ECHA is to be found at: http://echa.europa.eu/qa-display/-/qadisplay/5s1R/view/topic/reach-it/
For further information related to registration dossiers you may visit the ECHA webpage at: http://echa.europa.eu/regulations/reach/registration
For information on the Commission Regulation No 340/2008 on the fees and charges payable to the European Chemicals Agency we kindly advice you to consult the European Commission website: http://ec.europa.eu/enterprise/reach/reach/fees/index_en.htm
You can modify all information, except for the substance identity and the legal entity assigned to that pre-registration. You can update the following information:
- contact information (both internal contact of the owner and possible third party representative),
- similar substances,
- envisaged tonnage band (if applicable following the restrictions detailed below,
- the information field for the pre-SIEF if needed.
A pre-registration update is not allowed, when it involves a tonnage band change of a phase-in substance that a company manufactures or imports to the EEA in quantities:
- above one tonne per year when your substance is classified as carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, in accordance with Directive 67/548/EEC; or
- above 100 tonnes per year.
A pre-registration cannot be deleted, but it can be deactivated in REACH-IT. To deactivate the pre-registration look for your substance in the pre-SIEF section of REACH-IT and use the ‘Deactivate’ functionality.
The Status column that describes the status of your participation in the pre-SIEF will turn to ‘Inactive’. You can reactivate you pre-registration at any time by using the ‘Activate ’ functionality. If you update your pre-registration while the status is inactive, the system will automatically reactivate your pre-registration.
The deactivation of a preregistration signals to other pre-SIEF members, that you are not interested in an active participation in the SIEF discussion. Note, however, that even as a non-active participant to the pre-SIEF you may still be asked to share data in the SIEF.
Note also, that the pre-registration and potential future registration of your substance are not affected by the deactivation from the pre-SIEF forum. You can benefit from the extended registration deadline if you have a valid preregistration, irrespective of its status (active or inactive).
The ‘Deactivate’ button is disabled if a third party representative was appointed for a particular pre-registration. In this case, the deactivation can only be performed by the third party representative and not by the potential registrant.
No, downstream users should make appropriate contractual arrangements with their suppliers to ensure that they comply with REACH.
‘Read across To’ shows a list of substances that pre-registrants of the pre-SIEF have marked as similar substances.
‘Read across From’ shows a list of substances that pre-registrants of those substances have marked as similar to your substance.
Pursuant to Article 28(4) of the REACH Regulation, ECHA published a list of pre-registered substances on its website by 1 January 2009. The list includes all substances that were pre-registered by 1 December 2008. For each substance the following information is given:
- Substance identification: EC number, CAS number and name of the substance
- Substance identification of the similar substances, if applicable
- First envisaged registration deadline
This list does not mention the names of the companies who pre-registered the substances. You are invited to check the list on our website at: http://echa.europa.eu/information-on-chemicals/pre-registered-substances
If during pre-registration of your substance, you entered your substance name in a different way than the other manufacturers and importers, or if you realise during discussions on the sameness of your substance 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. Whether you find a more suitable SIEF or not, you must register your substance with the correct identifiers, which have to be consistent with the analytical data on your substance.
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 is available at:
http://echa.europa.eu/information-on-chemicals/pre-registered-substances. You can also search the list of registered substance available at https://echa.europa.eu/information-on-chemicals/registered-substances.
Once you have examined the list of pre-registered and/or registered substances, the following scenarios are possible:
1) You found a more suitable pre-SIEF for your substance
You can find the lead registrant in the list of lead registrants on the ECHA website. Contact the lead to join the SIEF. If the substance is not listed or no lead is mentioned, you can use REACH-IT to update your pre-registration. If you add the more suitable substance as a similar substance you will have access to this substance pre-SIEF page. As you will not be listed as a member of this pre-SIEF, you will have to take the initiative and get in contact with the pre-registrants therein to explain that you wish to join the SIEF. It is also possible for you to set up the joint submission and to become the lead registrant. For instructions on how to update your pre-registration to view a different pre-SIEF in REACH-IT, see Q&A 1142.
2) You did not find a suitable pre-SIEF for your substance
Most likely you will have to become the lead registrant for the substance. In any case, you should include your pre-registration number in Section 1.3 of your IUCLID dossier, even though it previously corresponded to different substance identifiers (see Q&A 293)In addition, you should keep any relevant documentation that demonstrates the phase-in status of your substance in case it is requested by the enforcement authorities.
Once you have found a more suitable or more specific identifier for your substance, you can find the pre-SIEF of your substance (here bismuth tetroxide) in REACH-IT and use the functionality ‘Edit pre-registration’ to update your pre-registration (as advised in Q&A 377).
In the next step of the wizard, you should add the more suitable substance in the ‘Similar substances’ tab.
When this is done, you will be able to navigate from the pre-SIEF page of your substance to the pre-SIEF page of the similar substance using the ‘Read across to’ tab. You will not be listed as a member of this pre-SIEF, which means that you will be able to see the members of the pre-SIEF, but they will not be able to see you. For this reason, you will have to take the initiative and get in contact with them to explain that you wish to join the SIEF.
The ‘Similar substances’ functionality was designed for pre-registrants to list substances with similar chemistry, for which data may be used for grouping or read-across in the registration, in accordance with Annex XI of REACH. So not all substances listed in the ‘Similar substances’ tab concern registrants that want to refine their substance identity.
The ‘Similar substances’ functionality should not be used to fulfil the registration obligations for a substance other than the substance originally intended to be covered in the registration. The new identifier can therefore only refine the identity of the substance initially concerned; it cannot correspond to an entirely different substance.
The SFF (SIEF Formation Facilitator) is the person initiating communication with other pre-SIEF participants to start working together and ultimately submit the data in a joint submission. The SFF is visible in the pre-SIEF page in REACH-IT and is marked with the letter F for Facilitator.
To take the role of SFF, use the ‘Become facilitator’ button from the Pre-SIEF page in REACH-IT. If the button is not available, it means that someone else is already the SFF.
If you are the SFF and you no longer wish to facilitate discussions among co-registrants, you should discuss with your co-registrants if anyone is willing to take up the role of facilitator. You can delete your role as facilitator by using the ‘Stop facilitator’ button.
For further info on the tasks of the SFF, see Q&A 99.
According to Article 28(6) of the REACH Regulation, potential registrants who for the first time manufacture or import a phase-in substance in quantities of one tonne per year or more after 1 December 2008 can submit a late pre-registration within six months of first manufacturing or importing the substance above one tonne per year and at least 12 months before the relevant registration deadline.
The last registration deadline for tonnage bands between 1-100tpa is on 31.May 2018. This means that the deadline to late pre-register a new substance and benefit from the extended deadline expired on 31.May 2017.
If you are a potential registrants who for the first time manufacture or import a phase-in substance in quantities of one tonne per year or more you have submit your inquiry dossier to ECHA. For further information, see Q&A 444.