Q&As

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REACH

NONS-Registrants of Previously Notified Substances

A. NONS, Regulatory aspects

Does an operator have to register a substance they are manufacturing or importing if it has previously been notified under Directive 67/548/EEC by another manufacturer or importer?

Yes. A notification under Directive 67/548/EEC is nominal so that only the notifier benefits from it under REACH. Therefore, any other parties manufacturing or importing the substance in quantities of more than one tonne per year, must register it, unless another registration exemption applies. 

More information on notified substances can be found in the Guidance on registration, article 24 (2) of REACH and in section 2.2.4.3- Notified substances according to Directive 67/548/EEC.

A company who notified a substance under Directive 67/548/EEC fails to claim its registration number assigned to the notified substance. Is this substance still considered as registered?

Yes. Unclaimed notifications are considered registered under REACH and therefore the notifiers are listed as registrants in the co-registrant’s page.

In accordance with Article 24 of REACH, ECHA assigned a registration number to each notification submitted under Directive 67/548/EEC and the substance is considered as registered. As for any other substance registered under REACH, both the name and the country of the registrant will be available in the co-registrant’s page. If a potential registrant submits an inquiry for this substance to ECHA, they will find this information, according to Article 26(3) of REACH.

Does the phrase "classified as [...] in accordance with Directive 67/548/EEC" in Article 23(1)(a) and (b) of the REACH Regulation refer only to substances listed with a harmonized classification in Annex I of this directive?
The wording of Article 23(1)(a) and (b) of the REACH Regulation "classified as [...] in accordance with Directive 67/548/EEC" refers to both, substances listed in Annex I with their harmonised classification and to self-classified substances.
 
It may be inferred from Articles 4 and 6 of Directive 67/548/EEC that substances shall be classified (by manufacturers/importers) according to the criteria in Annex VI of that Directive. In addition, Annex I of that Directive contains the list of substances classified by the Commission, following discussions in expert groups. As the Directive covers both situations, substances should therefore be considered as classified in accordance with Directive 67/548 not only when listed with their harmonised classification in Annex I, but as soon as they meet the criteria for classification set out in Annex VI of that Directive, i.e. also when self-classified by the registrant, should the substance not (yet) be listed in Annex I. Both situations should be considered as "classification in accordance with Directive 67/548/EEC".
 
This interpretation is borne out by the very spirit of REACH and in particular the aim and objective of the deadlines provided for in Article 23 of REACH. The aim of the earlier deadline for registration of substances with properties of very high concern is to gather earlier the necessary information on the substances, on their uses and for industry to develop and recommend appropriate risk management measures. Given the specific health and/or environmental concerns in this case the objective was not to defer the application of the REACH provisions for further years. To this end, the aim of the legislature in setting the earlier registration deadlines was clearly to cover both cases, as there is no difference in the protected public interest. Substances with non-harmonized classification are equally a ground for the same concern as substances with harmonised classification.
 
A consequence of this interpretation is that, as from 1 December 2010, as soon as a manufacturer or importer obtains evidence that his substance fulfils the classification criteria set out in Art. 23(1)(a) or (b) of REACH after that date, he will be obliged to register that substance immediately.
B. NONS, Claiming process

How do I claim a registration number for a NONS?

Registration numbers assigned to NONS notifications can be requested by the owner of the notification via REACH-IT 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. In addition, the REACH-IT database will be updated with the latest contact details of the notifiers, which will facilitate the data-sharing process.

If you provide the required information in the "Claim Notified Substances" module and it is found to match the information in the notification, you will receive:

  • A submission number: Number assigned automatically by the REACH-IT system to be used for all correspondence concerning the registration until the registration is complete.
     
  • A reference number via REACH-IT: Number assigned automatically by the REACH- IT system to the registrant once the registration of a substance is complete.

Depending on your notified roles, you will usually only receive one registration number per substance. The table below highlights the combinations of roles, the number of requests to be made, and the registration numbers received.

It is not possible to use the same ECHA Account (one UUID) to claim multiple registrations. However, it is possible to use the same company identification information (name, VAT, etc.) to create multiple accounts to claim the different registrations. Each account that you create should reflect only one role. One account for each manufacturing/importing site, and one account for each non-EU manufacturer you represent. If notification covered different roles, you need to initiate the claiming process for each account as depicted in the table above.

In case of a Sole Representative or newly appointed Only Representative, one registration number will be allocated per non-EU manufacturer represented. In REACH-IT, for each notification you will have to:

  • Declare that you have the agreement and the consent of the non-EU manufacturer to become the Only Representative under REACH and that you are entitled to claim the registration number (tick the relevant box).
     
  • Specify the non-EU manufacturer that you will represent as Only Representative for the notified substance.
     
  • Attach a letter or contract from the non-EU manufacturer that you represent in this notification. This document declares that you are entitled to become their Only Representative under REACH for the notified substance. The letter should be in PDF format and written in one of the official EU languages.

If the information specified does not match with that in the notification, ECHA will not be able to allocate the registration number to you. In this case, you are advised to contact your relevant Member State Competent Authority to resolve the situation. You can find their contacts here.  

More information on how to complete the claiming process is available at How to update your previously notified substance (NONS), point 2. Claim your registration number by 17 July 2022. 

The obligation to keep registrations up to date applies also to these registrations.

How do I verify the tonnage band of my claimed registration number in REACH-IT before my first update?

​​​​​​For a handful of NONS notifications, the tonnage band may be incorrect in REACH-IT and the system may be unable to accept an update of the registration dossier or might issue a wrong invoice.

Under REACH there are three possible registration types: standard registration, transported isolated intermediate, and on-site isolated intermediate. For each one of them there is a different registration fee.

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 and have the same tonnage band for standard and transported isolated intermediate. 

It is extremely important and very easy to check that the tonnage band of your notification is correctly indicated in REACH-IT after claiming your registration number and before you submit any update of your registration dossier. You should make sure that the maximum tonnage band displayed under ‘Dossier type’ and ‘Payment information’ matches the tonnage of your NONS notification.

Information on the tonnage band of a registration is displayed in the reference number page. 


 

If you see any mistake in the tonnage band shown in reference number page, you should follow the instructions of Q&A 0689.

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

You need to contact your relevant Member State Competent Authorities. They will in turn confirm that an amendment is necessary and provide ECHA with the correct information.

You can find the contact details of all the Member State Competent Authorities here.

C. NONS, Update of NONS

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

Detailed information on the update process for NONS registrations can be found at How to update your previously notified substance (NONS), point 4. Migrate your scientific information to IUCLID 6. 

In which cases shall I update my NONS registration?

The registration dossier must be updated if one or more of the update reasons for registrations under REACH applies (Article 22 and Article 24(2)). For example, a change in the composition of the substance, the status of the registrant, the classification and labelling, or if the annual quantities manufactured or imported reach the next tonnage band. 

It is important to verify the information available for your notification in REACH-IT before you start the dossier update. For more details, see How to prepare registration and PPORD dossiers, Annex 4. Minimum information required for updating a registration under previous Directive 67.

Find more information on dossier updates at Keeping your dossier up to date.

What will happen after I submit an update to my NONS dossier?

Your dossier will undergo a series of initial administrative checks called "business rules". ECHA accepts a dossier for processing only if all the relevant business rules are satisfied. 

Once your dossier has been submitted: 

  • It will be allocated a submission number.
  • It will undergo a completeness check.
  • You will receive an invoice if there the tonnage band has been upgraded or if you have added chargeable confidentiality claims not made under Directive 67/548/EEC. 

It will be regarded as complete once ECHA has verified the completeness of the information you submitted and received the payment of the relevant fee (Article 20(2) of REACH).

In the case of an update of a registration to comply with an evaluation decision issued in accordance with Article 135 of REACH, 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.

D. NONS, Classification and Labelling

Do substances notified under Directive 67/548/EEC (NONS) have to be classified, packaged and labelled in accordance with the CLP criteria and notified to the Classification and Labelling Inventory?

Yes, substances notified under Directive 67/548/EEC (NONS) need to be classified, labelled and packaged in accordance with the CLP Regulation. CLP repealed this Directive with effect 1 June 2015 (Article 60).

These substances are regarded as registered under REACH. Therefore, their classification and labelling information must be included in the C&L Inventory. After a registration number has been claimed by the NONS notifier, the respective registration dossier must be updated with the CLP classifications without undue delay, and a separate notification to the Inventory is not required.

For NONS notified below one 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 submitted if the substance is classified as hazardous and is placed on the market. So, if the annual volume of the NONS substance remains below one tonne, the company must submit a C&L notification. When the annual volume has reached or exceeds the one tonne threshold, an update in the form of a registration dossier is required. 

E. NONS, Dissemination and Confidentiality

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

Yes. REACH requires that certain information on chemical substances is made available to the public. This concerns the information specified in Article 119 of REACH. You can search for publicly available information on NONS at the information on chemicals database

On the ECHA website NONS dossiers can be recognised by their purple background while other registration dossiers have a blue background.

For further information, see Dissemination and Confidentiality under the REACH Regulation, Chapter 2.5, Publication and confidentiality of NONS, page 16.

Confidentiality under NONS and under REACH. What can be claimed confidential?

Under the NONS Directive you could claim confidentiality on:

  • Tonnage band;
  • (Robust) Study summary; and
  • IUPAC name of the substance.

Confidentiality claims accepted under Directive 67/548/EEC remain valid under REACH, in as far as the information has in the meantime not become available in the public domain. ECHA will assess the confidentiality claim and will – if the information is found to be publicly available – request further information before rejecting the claim. 

You do not need to pay for claims that were already made under Directive 67/548/EEC. For more information, see How to update your previously notified substance (NONS)

For the case where confidentiality of the IUPAC name was requested under Directive 67/548, but the IUPAC information in the meantime is already available in the published EC Inventory or at any other publicly available source, ECHA assumes the request to be expired, unless the registrant provides a full justification that includes a valid reason why the information should still be kept confidential despite of the public availability.

Under REACH, it is foreseen that also the following information is published on the ECHA website, unless claimed confidential: 

  • Information contained in the safety data sheet (including name of the notifier, registration number, uses and uses advised against);
  • 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.

Further information is available in the manual on Dissemination and Confidentiality under the REACH Regulation.

ECHA gives the same possibilities to NONS notifiers as to other REACH registrants for claiming confidentiality. Therefore, if your company considers that this information should not be published on the ECHA website, you can introduce the relevant confidentiality claims. These confidentiality claims need to be justified and ECHA will charge a fee for each claim, in accordance with Article 119(2).

ECHA will assess the confidentiality claim and will – if the information is found to be publicly available or if the claim is not sufficiently justified – request further information before rejecting the claim.  

Further information can be found in the NONS Question and Answers.