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REACH

Dichiaranti NONS di sostanze precedentemente notificate

How do I prepare IUCLID 6 dossier in case of a NONS update?

A distinction should be made between updates due to a tonnage band change, becoming a lead of a joint submission and other updates.

For a NONS registration update due to increase in the tonnage band or becoming a lead of a joint submission, a complete dossier in IUCLID 6 format has to be submitted to ECHA like for any other standard or transported isolated intermediate registration.

For other NONS updates, certain information is not required and may be waived until the next tonnage threshold is reached, provided that explanatory derogation statements are included in the dossier header.

In order to successfully update your registration dossier you should follow the steps outlined below:

  1. Migrate the SNIF file to IUCLID 5.6 and then import it to IUCLID 6 You can request your notification migrated into IUCLID format (IUCLID substance dataset) from your relevant Member State Competent Authority, or migrate it yourself using the SNIF migration plug-in tool available on the IUCLID web site http://iuclid.echa.europa.eu/.
  2. Update the substance dataset according to the REACH requirements. Please note that all registration updates undergo a technical completeness check according to the requirements of Article 20(2) of the REACH Regulation. You are advised to first check your tonnage band in REACH-IT, as described in Q&A 686.

    To be considered as complete, your dossier should be filled-in as specified below:
    • When updating a dossier due to an increase of tonnage band or becoming a lead of a joint submission, the registrant must be aware that the updated dossier must fully comply with all REACH information requirements. The update should not only contain the information required by REACH which corresponds to that higher tonnage threshold, but also any information which corresponds to lower tonnage thresholds. If your update involves a registration at or above the 10 tonnes threshold, a complete chemical safety report (CSR) should be included in section 13 of your IUCLID 6 dossier unless the conditions for not submitting a CSR as set out in Article 14(2) of the REACH Regulation are met (in which case a justification should be provided in section 13 instead).

      For further information please consult the manual "How to prepare registration and PPORD dossiers" at: http://echa.europa.eu/manuals.

    • For updates to include the classification and labelling according to the CLP Regulation. You have to update your registration dossier to include the classification and labelling according to Regulation (EC) No 1272/2008 (‘CLP Regulation') in case you manufacture or import your NONS substance in a volume of more than or equal to 1 tonne per year. For NONS notified below 1 tonne under Directive 67/548/EEC and for which no tonnage band update has been done, a separate notification to the Inventory will have to be made, and the registration dossier does not need to be updated.
    • If you only need to update the classification and labelling but your tonnage band remains unaltered, you only need to provide a minimum of information as explained in Annex 4 of "How to prepare registration and PPORD dossiers" manual " available at: http://echa.europa.eu/manuals.

    • For updates to the joint submission status of the claimant, select an appropriate dossier template for your submission.

      The lead of a joint submission uses a standard template accordingly to the tonnage band covered by the joint submission. The tonnage band of the lead registrant is indicated in the dossier header.

      Members of a joint submission need to select a special template for a joint submission member. Two different kinds of member templates exist: general registration and intermediate registration. Intermediate template is used if the member registers only an isolated intermediate (transported or on-site).

      When creating the dossier, the tick box ‘Joint submission' must be ticked in the dossier header. When submitting the dossier in REACH-IT, the submitter must select ‘joint submission:' and provide the name of the joint submission.

    • For other types of updates, Other updates concern all other cases indicated under Article 22(1) of the REACH Regulation and updates following a decision made by the MSCA according to Article 16(1) or 16(2) of Directive 67/548/EEC. For such updates, the dossier does not need to include information requested under the REACH Regulation that was not required under the previous legislation (i.e. Directive 67/548/EEC).. The minimum information which needs to be submitted in these types of updates (when the tonnage band remains unaltered) is provided in Annex 4 of "How to prepare registration and PPORD dossiers" manual " available at: http://echa.europa.eu/manuals.
    IMPORTANT NOTE:
    • In Section 1.3 ‘Identifiers' of your IUCLID 6 dossier, do not forget to specify your notification number under Directive 67/548/EEC, as well as your reference number under the REACH Regulation (the one you received when claiming your NONS via REACH-IT).
    • In Section 1.7 ‘Suppliers' of your IUCLID 6 dossier, do not forget to attach all necessary contractual agreements if you are representing a non-Community manufacturer.
  3. Update your confidentiality claims.

    In case you wish to keep confidential the information which was accepted as such under Directive 67/548/EEC, you are required to write in the justification field adjacent to each confidentiality flag the text ‘Claim previously made under Directive 67/548/EEC'. This will allow ECHA to invoice correctly and validate the claims already presented under Directive 67/548/EEC. confidentiality

    Please note that ECHA will only charge a fee for those confidentiality claims associated with new information submitted, or new confidentiality claims for existing information. This means that there will be no fee for confidentiality claims successfully made under Directive 67/548/EEC, provided that this is confirmed by the registrant in their dossier as indicated above.

    Please note that the information listed below could not be claimed confidential under Directive 67/548/EEC.

    • The name of the notifier (which under REACH is considered to be part of the information contained in the safety data sheet).
    • The information contained in the safety data sheet (including registration number, uses and uses advised against).
    • The trade name of the substance.
    • If essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous.

    For these claims, a full justification needs to be provided and the claim will be subject to the corresponding fee under REACH.

    Please be aware that dissemination of information listed in Article 119(1) of the REACH Regulation includes the IUPAC names of substances included in Annex I to Directive 67/548/EEC and that, as a general rule, information listed both in Articles 119(1) and 119(2) of the REACH Regulation will be disseminated.

    ECHA will not disseminate the information listed in Article 119(2) for which a party has submitted a justification, accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned.

    More information about the confidentiality claims which are possible under REACH is available in the document "Dissemination and confidentiality under the REACH Regulation" at: http://echa.europa.eu/manuals.

    You are able to simulate which information from your dossier will be made available on the ECHA website by using the dissemination tool available in IULID 6

  4. Create the IUCLID registration dossier

    Once you have prepared your substance dataset, you need to create your registration dossier. To do this:

    • Choose the correct IUCLID Template. Make sure that the template selected corresponds with the intended submission Further information in "How to prepare registration and PPORD dossiers " manual available at http://echa.europa.eu/manuals.
    • Complete the dossier header information. For the specific case of NONS registration updates, you have to fill in the dossier header in IUCLID in the following way (see also screenshot below):
      • Tick the box "Is the submission an update?".
      • Indicate the submission number in the "Last submission number" field (the one you received when you claimed your registration number via REACH-IT) .
      • Tick the box "Spontaneous update".
      • Select the justification of the update. If there is more than one reason for your spontaneous update (e.g. change of tonnage band and change of classification and labelling), you should create several repeatable blocks under ‘Spontaneous update'.
      Please remember that in case of NONS substances notified below 1 tonne and for which no tonnage band update has been done, you need to submit a ‘C&L notification' instead of an update of your registration dossier.

Please remember that in case of NONS substances notified below 1 tonne and for which no tonnage band update has been done, you need to submit a ‘C&L notification' instead of an update of your registration dossier.

Other types of updates. In case of other types of spontaneous updates, you will have to select the proper justification. If you select ‘other', indicate clearly the reason for updating in the adjacent field.

For the specific case of an update according to Article 135 of the REACH Regulation (Transitional measures regarding notified substances), select ‘other' in the justification field and indicate the new information that you are updating in the free text field: "Article 135 of REACH – submission of test (specify test)".

Specific Submissions

Once you have created your IUCLID dossier, you need to submit it through REACH-IT. See Instructions in "How to prepare registration and PPORD dossiers" manual at: http://echa.europa.eu/manuals.

In the case that you are an Only Representative representing several non-Community companies under the REACH Regulation you need to submit a separate updated registration for each of the non-Community manufacturers you represent.

For a tonnage band increase (and only in this case). Before you submit your registration update you are required to inform ECHA of the additional information you would need to comply with the information requirements for the new tonnage level (Article 12(2) of the REACH regulation). In order to facilitate this process, you are required to submit an inquiry to ECHA. Upon receipt of this information, ECHA acts as in the inquiry process (Article 26(3) and (4) of the REACH Regulation) and will inform the registrant of the names and addresses of any previous registrants (and any potential registrants) and of any relevant study summaries already submitted by them. The purpose for this is to share existing data and to ensure that studies on vertebrate animals are not unnecessarily repeated. The inquiry for a tonnage band increase should be submitted according to the procedures outlined in the manual "How to prepare and submit an inquiry" at: http://echa.europa.eu/manuals.

 

How do I claim a registration number for a notified substance?

According to Article 24 of the REACH Regulation all notified substances under Directive 67/548/EEC (NONS) are considered already registered under the REACH Regulation at the relevant tonnage band.

A notification under Directive 67/548/EEC is nominal so that only the notifier benefits from his notified substance as being considered registered (Cf. Section 1.6.5.3 of the Guidance on Registration available at: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation).

In principle, any other parties intending to manufacture or import a notified substance but who have not notified such substance themselves cannot be assigned a registration number under Article 24 of the REACH Regulation. Such parties should submit an inquiry and subsequently register the substance in accordance with the provisions of the REACH Regulation. The European Chemicals Agency (ECHA) has assigned registration numbers to all notifications made in accordance with Directive 67/548/EEC.

These registration numbers can be requested from ECHA by the owner of the notification via the REACH-IT system using the "Claim Notified Substances" module. This procedure will confirm to ECHA the identity of the notifier and to whom the registration number should be sent to. In addition, the REACH-IT database will be updated with the latest contact details of the notifiers, which will also enhance the data-sharing process.

If the claimant's details specified in REACH-IT match those for the notification, ECHA will provide the registration number. If the claimant's details do not match, ECHA will not be able to allocate any registration number and the notifier is advised to contact its relevant Member State Competent Authority (MSCA) to resolve this issue. Claimants need to sign-up in REACH-IT for each type of role they had under Directive 67/548/EEC for the notified substance in question.

There are four potential types of claimant (role) that may request a registration number for a notified substance:

  • The claimant was a Domestic Manufacturer under Directive 67/548/EEC (i.e. the Manufacturer was established within EU).
  • The claimant was an Importer under Directive 67/548/EEC.
  • The claimant was a Sole Representative under Directive 67/548/EEC.The claimant is a newly appointed Only Representative and will take the duties of a previous notifier (Sole Representative). Note that Only Representatives must sign up in REACH-IT for each non-community manufacturer they represent and submit a claim using the appropriate account.

    It is not possible to use the same legal entity object (having the same company UUID) for multiple accounts, but it is possible to use the same company identification information (name, VAT, etc.). In case of a Sole Representative or newly appointed Only Representative, one registration number will be allocated per non-Community manufacturer represented. The claimant will have to submit, in REACH-IT, written evidence of the validity of his request. This provision is in line with the implementation already in place for an Only Representative in case of registration.

 

How do I request a registration number for my notified substance?

Once you have signed-up in REACH-IT and specified your company details, you can proceed with the request of your registration number. The distribution of registration numbers by ECHA will be made following your request via the "Claim Notified Substance" module in REACH-IT.

  • Log-in to REACH-IT >> Menu >> Registration >> Claim notified substance
  • Put the Notification number (standard format) without the 2 last digits corresponding to the version of the notification (you should specify XX-XX-XXXX in REACH-IT). And Put the ELINCS number of the notified substance and follow the wizard

If all the information specified is correct and matches with that in the notification dossier:

You will instantly receive a submission number, and a reference number via REACH-IT. You can request for the notification to be migrated in IUCLID 6 format from your relevant Member State Competent Authority. You can find their contacts at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities.

If the information specified does not match with that in the notification, ECHA will not be able to allocate the registration number to you. You are advised to contact your relevant Member State Competent Authority to resolve the situation. You can find their contacts at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities.

How many NONS registration numbers will I receive for my role(s)?

Depending on your role(s), you will usually only receive one registration number. The table below highlights the combinations of roles and indicates the corresponding number of requests and registration numbers received.

combination of roles

What must I do in case of change of legal entity and transfer of my NONS notification to another company?

A notification under Directive 67/548/EEC is nominal so that only the notifier benefits from being considered registered according to Article 24 of the REACH Regulation. Cf. Section 1.6.5.3 of the Guidance on Registration available at: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation

Nevertheless, it may happen that a company with a legal personality that has notified a substance has transferred the responsibilities for manufacture and import of that substance to another company. In such circumstances the original notifier may have transferred its notification to the company that has taken over the original notifier's activities relating to the manufacture or import of the notified substance. Such an event may happen for example after a merger of two companies or, the company splits.

For instruction on the steps to take please consult "Practical guide 8: How to report changes in identity of legal entities" available at: http://echa.europa.eu/practical-guides

How do I verify the information recorded in REACH-IT for my notification

In a handful of cases, the New Chemicals Database (NCD) has not been adequately updated to reflect the current details for some notifications, in particular, for tonnage bands. As a result, this information may appear incorrectly in REACH-IT and the system may be unable to correctly accept a potential update of the registration dossier.

It is extremely important and very easy to check that the tonnage band of your notification is correctly indicated in REACH-IT before you submit any update of your registration dossier to ECHA to avoid potential delays in the submission process as a result of a business rules failure.

To confirm that the correct tonnage is indicated in REACH-IT:

  • Log in to REACH-IT >> Menu >> Search>>Reference numbers >> Search reference number using the criteria displayed Click on the Reference number link >> Tonnage band info is displayed under "Dossier type".

There are several tonnage bands mentioned in REACH-IT because under the REACH Regulation there are three possible registration types: standard registration, transported isolated intermediate (TII), and on-site isolated intermediate (OSII). Under Directive 67/548/EEC there was no such specific distinction and only one type of standard notification was required. All NONS notifications are initially regarded as standard registrations in REACH-IT. Therefore, your notified substance will initially not include any tonnage for isolated intermediates.

In the ‘Reference number' page you will also find under "Payment information" the tonnage band information which will be taken into account for invoicing purposes ( i.e. "Maximum tonnage band" and "Maximum transported isolated intermediate")

Paymrnt Information

Initially, here you will see the same tonnage bands indicated for the standard registration as for the transported isolated intermediate (TII). This is to ensure that ECHA does not charge fees for tonnage band updates in cases where this would not be legitimate.

In case you submit an update of your registration for a tonnage band that is different to what is reported in REACH-IT, you should select in your dossier header that the reason for the update is a change of tonnage band.

Who do I contact if the information in REACH-IT is not correct?

In case the information recorded in REACH-IT for your substance does not match with what was indicated in your notification, you will need to make a request for an amendment. This is achieved by contacting your relevant Member State Competent Authority, who will in turn confirm that an amendment is necessary and provide ECHA with the correct details.

You can find the contact details of all the Member State Competent Authorities at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities

How is the NONS information transferred from SNIF to IUCLID 5

Information for a notification under Directive 67/548/EEC was initially submitted to the Member State Competent Authority in the Summary Notification Interchange Format (SNIF). Thereafter, all the SNIF files were transmitted to the former European Chemicals Bureau (ex-ECB) at the Joint Research Centre. This information, stored in a central database called the new chemicals database (NCD) at the ex-ECB, was migrated into IUCLID 5 format and distributed back to the responsible Member State Competent Authority in 2 formats (read-only and editable).

Claimants (owners of the notification) should contact their Member State Competent Authority to receive their files in IUCLID 5 format. The editable format will enable them to fulfil their obligations under REACH, in particular when they need to update their registration in the case where the next tonnage threshold is reached.

The tool developed to migrate the SNIF file to IUCLID 5 format is also available to industry as an add-on to IUCLID 5 on the IUCLID web site http://iuclid.echa.europa.eu/. Please note though, the SNIF migration plug-in can only be used with IUCLID version 5.1.

In order to migrate to IUCLID 6, first migrate to IUCLID 5.1 and then import to 5.6 and after import to ICUID 6.

Please pay attention to the migrated file results and check the generated IUCLID 5 substance dataset carefully (e.g. Legal entity, confidentiality claims, endpoint study records, classification and labelling…) before using it for updating your registration via REACH-IT.

In which cases shall I update my NONS registration?

The registration dossier must be updated if at least one of the cases described in Article 22 or Article 24(2) of the REACH Regulation applies. This would also include any update referring to the inclusion of the information required under Article 40 of the CLP Regulation (notification to the Classification & Labelling Inventory).

It is important to verify the information available for your notification in REACH-IT before you start the dossier update. When updating a NONS registration, the following three scenarios have to be taken into account:

  • Tonnage band update
  • Update to become the lead or a member of a joint submission
  • Other updates

For more details please continue to Annex 4 of the "How to prepare registration and PPORD dossier" manual at: http://echa.europa.eu/manuals/.

What will happen after I submit my NONS dossier?

Your dossier will undergo a series of initial administrative checks called "business rules". A dossier is accepted for processing by ECHA only if all of the relevant business rules are satisfied. Once your dossier has been accepted for processing:

  • Your dossier will be allocated a submission number.
  • Your dossier will undergo a completeness check.
  • You will receive an invoice, if applicable, for an appropriate fee (for tonnage band upgrades and chargeable confidentiality claims not made under Directive 67/548/EEC).
  • Your dossier will be regarded as complete once ECHA has verified the completeness of the information you submitted and received the payment of the relevant fee in accordance with Article 20(2) of the REACH Regulation.
In the case of an update of a registration in accordance with Article 135 of the REACH Regulation, the submitted information will be evaluated by ECHA pursuant to Article 42 or by the requesting MSCA pursuant to Article 48, depending on the legal basis of the original request of the MSCA under Directive 67/548/EEC.

Will ECHA publish information from my NONS dossier on the website?

Yes. REACH requires that certain information on chemical substances, which is kept in ECHA's databases, is made available to the public, free of charge, over the internet. This concerns, in particular, information specified in Article 119 of REACH. ECHA is already providing public access via the internet to such information from registration dossiers on its website at:http://echa.europa.eu/information-on-chemicals/registered-substances.

Information from NONS notifications will be released in a stepwise approach in order to allow NONS registrants to adapt the content of their dossiers to the REACH format, and insert adequate confidentiality claims if required. NONS registrants who have claimed their notification are being individually informed of the timelines for publication and the actions they need to take in relation to their dossier via a message in REACH-IT.

Please refer to chapter 2.5 of "Dissemination and confidentiality under the REACH Regulation" manual at: http://echa.europa.eu/manuals.

I notified as a Sole Representative under Directive 67/548/EEC and I will take up the duties of the Only Representative under REACH, what are the next steps?

Any Sole Representative agreements are invalid after 31st May 2008. Where the intention is to appoint an Only Representative under REACH, new documentation/contract from the non-Community manufacturer(s) you represent needs to be drawn up.

The company claiming the registration number must indicate in REACH-IT that he/she is entitled to act as the Only Representative.

Please note that Only Representatives have to sign-up in REACH-IT for each and every non-Community manufacturer they represent for the same notification and submit a claim for NONS using the appropriate accounts.

Once you have indicated the notification specifics in the ‘Claim notification module' follow the wizard and:

  • Declare that you have the agreement and the consent of the non-Community manufacturer to become the Only Representative under the REACH Regulation and that you are entitled to claim the registration number (tick the relevant box).
  • Specify the non-Community manufacturer that you will represent as Only Representative for the notified substance.
  • Attach the following documentation from the non-Community manufacturer you represent:
  • Individual letter(s)/contract(s) from the non-Community manufacturer declaring that you are entitled to become their Only Representative under the REACH Regulation for the notified substance. The letter(s) should be in PDF format and written in one of the official Community languages.

 

If all the information specified is correct and matches with that in the notification:

You will instantly receive a submission number, and a reference number for the non-Community manufacturer you represent via REACH-IT.

You can request for the notification to be migrated in IUCLID 6 format from your relevant Member State Competent Authority. You can find their contacts at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities .

If the information specified does not match with that in the notification, ECHA will not be able to allocate any registration number to you.

You are advised to contact your relevant Member State Competent Authority to resolve the situation (http://echa.europa.eu/contacts-of-the-member-state-competent-authorities).

I notified as a Sole Representative AND as a Domestic Manufacturer AND/OR Importer under Directive 67/548/EEC, what are the next steps?

Once you have indicated the notification specifics in the ‘Claim notification module':

You must first sign-up in REACH-IT for each type of claimant you are (role) for the notified substance in question under Directive 67/548/EEC and submit a claim for NONS using the appropriate REACH-IT account.

In addition, as a former Sole Representative you have to sign-up in REACH-IT for each non-Community manufacturer you represent and submit a claim for NONS using the appropriate accounts.

You should then first request your registration number as a domestic Manufacturer AND/OR Importer (see Q&A 683).

Then you should request your registration number as a Sole Representative (see the process described before).

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