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The REACH Regulation states that the tonnage band is calculated per registrant per substance, including non-nanoforms and nanoforms. Thus, the registration obligation depends on the total yearly tonnage of the substance that you manufacture or import, including both non-nanoforms and nanoforms. If the overall volume of the substance is above 1 tonne per year, nanoforms within that total volume also need to be registered, even if they represent a volume of less than 1 tonne per year.
Similarly, the overall quantity of the substance, cumulating the quantity of both non-nanoforms and nanoforms, determines the applicable information requirements. The information requirements of the total volume apply to the non-nanoform and each of the nanoforms of the substance, even if their individual volumes represent a lower tonnage band.
For more information see the Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification, section 2.1 Registration obligations.
Yes, a polymer can also meet the definition of a nanoform.
The obligation to submit information on nanoforms as set out in REACH Annexes VI to X only applies to substances subject to registration. Polymers are exempt from registration. Nevertheless, any manufacturer or importer of a polymer shall submit a registration for the monomer substance(s) or any other substance(s) that have not already been registered by an actor up the supply chain, if the conditions set out in Article 6(3) of REACH are met.
For specific cases we recommend contacting our helpdesk for a more detailed reply.
Before being introduced into the polymer during the polymerisation phase, the nanoform has to be manufactured or imported. If you manufacture or import in a quantity above 1 tonne per year the substance of which nanoform is introduced in the polymer, you must register the nanoform, even if it is then used in the manufacturing of a polymer.
However, if you buy a nanoform from a supplier in the EU, you do not have to register it, but the manufacturer or importer in the supply chain must do so. In the latter case, you have to ensure that your use of the nanoform is covered by the registration of the manufacturer/importer.
Finally, if you import the polymer you must submit a registration for the nanoform if it has not already been registered by an actor up the supply chain and if the conditions set out in Article 6(3) of REACH are met (see Q&A 1674).
Each registrant is responsible for registering the nanoforms that they themselves manufacture or import. The information required by Annex VI, including the characterisation of nanoforms or sets of nanoforms, must be submitted separately by each registrant.
The information required by Annexes VII-X can be submitted jointly in the lead registrant dossier on behalf of the member registrants. Alternatively, this information can be submitted separately by each registrant via the opt-out mechanism.
If a co-registrant claims not to produce nanoforms but does not provide any proof to support their claim, the other registrants of the substance should proceed with the registration of their nanoforms following the REACH requirements.
Registrants that manufacture/import nanoforms of the substance after 1 January 2020 without a registration that covers these nanoforms are in breach with their duties under the REACH regulation, which may lead to enforcement measures by national enforcement authorities.
If none of the characterisation parameters of the nanoform(s)/set(s) of nanoforms reported in the existing registration dossier change, there is no need to update the dossier with regard to the identity of the nanoforms covered.
Note that even if none of the numerical characterisation parameters change, if the change in the production line concerns the surface-treatment process, the description of the surface-treatment process in the registration dossier may still need to be updated.
A batch-to-batch variability results from the variation of process parameters inherent to a manufacturing process that is defined by a series of parameters (e.g. starting materials, solvents, temperature, order of manufacturing steps, etc.).
If the variation in a parameter is only due to batch-to-batch variability, then these are still considered as being the same nanoform. However, if there are deliberate changes to the process parameters, then these are different nanoforms.
- The registrant reports clearly defined boundaries in terms of characterisation parameters of the nanoforms, which are part of the set
- The registrant justifies that the hazard, exposure and risk assessment of the nanoforms can be performed jointly. This justification is substantiated by supporting data on the nanoforms in the set.
The REACH Regulation defines a substance as “a chemical element and its compounds”. A substance becomes a different substance when there is a modification of the chemical element or the compounds that compose it. Following from this, the modification of the form of a substance, including its modification into a nanoform, does not make it a different substance under REACH.
REACH also specifies that the surface treatment of a nanoform does not lead to the creation of a new substance, but a new nanoform of the substance concerned. Each nanoform must be specifically characterised and reported in the registration dossier.
There is no definition for the term “granular form" in REACH. However, this can be interpreted to mean "particles".
All nanoforms, by definition, will have at least 50% of their particles by number below 100 nm, and all nanoforms will be "granular" when available as a dry powder. However, some nanoforms are available only in suspensions, or are incorporated into a matrix throughout their entire lifecycle. In this case, there may be no exposure to the dry powder, or the granular form in general.
- The justification must address separately each characteriser listed in section 2.4 of Annex VI. To this end, it must follow the structure of the text template available in the IUCLID section 1.2 field 'Justification for reporting set of similar nanoforms' and address all applicable points in it.
- The justification must be substantiated by scientific evidence addressing the physicochemical, environmental fate, ecotoxicity and toxicity properties of nanoforms that are within the boundaries of the set of nanoforms. For each characteriser, the justification must summarise the supporting data.
- Each scientific evidence summarised in the justification must be submitted in the form of a (robust) study summary
In all the above cases, the findings from these studies and the characterisers of the nanoforms used in the studies must be summarised in accordance with the points listed.
- The (robust) study summary can be provided by attaching it in the section 1.2 field ‘Attached information’;
- When the (robust) study summary is reported elsewhere in the IUCLID dossier, e.g. in IUCLID section 4-7, a reference to it can also be made by linking it via the section 1.2 field ‘Cross-reference’;
- Alternatively, references to publicly available literature may be provided instead of a robust study summary.
- For each characteriser, the justification must explain how the scientific evidence demonstrates that all the nanoforms in the set can be assessed jointly. This explanation must clearly show that the nanoforms used to generate the supporting data are representative of all the nanoforms included in the boundaries of the set.
- The justification must always be provided in full in the field 'Justification for reporting set of similar nanoforms' or in the field ‘Attached information’. The justification cannot refer to explanations provided elsewhere in the dossier.
If the registration will be updated to cover additional nanoforms, the decision needs to be made whether the nanoforms will be registered (i) on their own as separate nanoforms; (ii) as a new set of nanoforms; or (iii) by modifying the already registered set of nanoforms.
If the nanoforms are added to the registration as separate nanoforms or as a new set of nanoforms, they will not impact the already registered set of nanoforms. Similarly as for the existing set, they need to be registered by including in the dossier the appropriate characterisation of the set, the set justification and the Annex VII-X information corresponding to the set.
If the nanoforms are added to the registration in an existing set of nanoforms, you need to ensure that the nanoforms fit within the clearly defined boundaries of characterisers of the existing set. If this is not the case, you need to analyse whether the boundaries of the set can be expanded without affecting the joint hazard assessment, exposure assessment and risk assessment of all the nanoforms covered by the set. This analysis must be reflected in the provided justification for the set.
The principles described in the Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification for forming a set of nanoforms give advice to the registrants on how to build a set of nanoforms. Following the principles in the Guidance reduces the need for development of complex justifications for the set.
The limitations for the formation of sets of nanoforms are based on presumptions resulting from a scientific consensus. The stronger the consensus, the stricter the limitation. For the strictest restrictions (e.g. fibres and sphere shapes must be addressed in different sets of nanoforms), the scientific consensus is such that the presumption is considered not rebuttable.
For other restrictions, deviating from the principles set in the Guidance will increase the complexity of a justification as well as the supporting evidence required, and this will increase the level of scrutiny given to the justification.
In any case, for each set of nanoforms a robust justification that the hazard, exposure and risk assessment can be performed jointly for all nanoforms in the set must always be provided. It is the responsibility of a registrant to develop the justification and provide the data supporting the justification.
The completeness of the justification is checked during the technical completeness check and its compliance in a potential compliance check.
In order to create a set of nanoforms, you need to clearly define the boundaries of your set of nanoforms, and provide a justification to demonstrate that the hazard assessment, exposure assessment and risk assessment of the nanoforms in the set can be performed jointly for all nanoforms included in the set, without exceptions. This demonstration may require you to test some of these nanoforms. Indeed, this justification must be substantiated by scientific evidence addressing the physicochemical, environmental fate, ecotoxicity and toxicity properties of nanoforms that are within the boundaries of the set of nanoforms. Each scientific evidence summarised in the justification should correspond to a (robust) study summary. For further information on how to justify a set of nanoforms, refer to Q&A 1681.
Once a set of nanoforms has been established and scientifically justified, the complete Annex VII-X information must be provided for the set of nanoforms. It is not necessary to generate data on the Annex VII-X properties for each nanoform included in the set. Indeed, as mentioned above, the justification for the set of nanoform must prove that the hazard, exposure and risk assessments of the nanoforms can be performed jointly for all nanoforms in the set. However, the data provided for each information requirement must be representative for the whole set of nanoforms.
For every information requirement as per Annex VII-X, the registrant must submit either (i) studies performed on the nanoforms concerned; or (ii) studies on other forms of the substance accompanied by endpoint-specific justifications as to why this information is adequate for assessing the nanoforms concerned; or (iii) relevant adaptations as foreseen by Annex XI of REACH or Column 2 of the relevant Annex VII-X.
As explained in chapter G. Joint submission, the Annex VII-X information can be submitted by the lead registrant on behalf of the other assenting registrants, or separately by co-registrants via the opt-out mechanism.
The legal requirement under Annex VI of REACH is to report the number-based particle size distribution with indication of the number fraction of constituent particles in the size range within 1-100 nm. You are free to choose the measurement method as long as the data requirement is fulfilled. We recommend using at least one electron microscopy technique.
If laser diffraction can provide that information, it can be used. In many cases, this may not be the case. All the measured particles must be taken into consideration when the number fraction of constituent particles is determined.
The requirement in REACH Annex VI is to report the number-based particle size distribution with indication of the number fraction of constituent particles in the size range within 1-100 nm. This is the case even if the constituent particles of the nanoform you manufacture/import form agglomerates. This information is reported by each registrant in sections 1.2 and 1.4 of IUCLID .
Information on the size of the agglomerates shall be reported in IUCLID section 4.5 “Particle size distribution (Granulometry)”. The information in section 4.5 is normally submitted jointly by the lead registrant on behalf of the co-registrants. Nevertheless, it can be submitted by a member registrant via the opt-out approach, especially if the information submitted is specific to him and considered confidential.
- The registrant reports clearly defined boundaries in terms of characterisation parameters of the nanoforms, which are part of the set;
- The registrant justifies that the hazard, exposure and risk assessment of the nanoforms can be performed jointly. The justification must be supported by data on the nanoforms in the set. For more information on the set justification, refer to Q&A 1681.
The completeness check ensures that all the required information is reported in the dossier. Therefore, you cannot pass the completeness check by providing placeholders for missing information, even if the tests have been commissioned. If you cannot address the information requirement with available data or an adaptation (or, in the case of Annex IX-X information requirements, with a testing proposal), you will not pass the completeness check for this information requirement.
If you fail the completeness check, you will be given a standard deadline of four months to provide the missing/incomplete information. Therefore, if you fail the completeness check at first attempt and in the meantime obtain the test results, you can amend the dossier and pass the completeness check at second attempt. The submission date will correspond to the submission of your first attempt.
For advice on how to report unfinished tests that were commissioned in response to an ECHA (draft) requesting you to carry out a test, please refer to the document Information on manual verification at completeness check, chapter 2.
You can only submit one registration dossier per substance. Therefore, all the forms, including nanoforms, of the same substance must be covered by one single registration dossier. This means that you will have a single registration number for the registration of the substance, covering both the non-nanoform and nanoform(s).
A surface-treated and a non-surface treated nanoform are two separate nanoforms that you will need to characterise and report separately in your registration dossier, with a corresponding hazard dataset for each nanoform.
If you use the approach to register individual nanoforms via a set of nanoforms, it is important to note that where both surface-treated and non-surface-treated nanoforms are covered by a registration, surface treated and non-surface-treated nanoforms must a priori not be included in the same set of nanoforms.
To be able to build the set(s) of nanoforms, you may need to characterise the individual nanoforms in order to allocate them in the appropriate set and provide an adequate justification.
If nanoforms are included in a set of nanoforms, you are not expected to report information on the characterisation of all the nanoforms in the set in the IUCLID dossier. Instead, when registering nanoforms via a set of similar nanoforms, you must clearly report the boundaries of the set for each of the characterisers and provide a justification for the set, per characteriser.
To register a nanoform of a substance, you must report its characterisation parameters in sections 1.2 and 1.4 of IUCLID, as defined by REACH Annex VI. The information reported in these sections refers to the identification of the compositions/forms of the substance within the scope of the registration. It is submitted separately by each registrant.
The Annex VII-X information requirements for the nanoform are then reported in sections 4-7 of IUCLID. This information can be submitted jointly by the lead registrant on behalf of the co-registrants; or separately by co-registrants via the opt-out mechanism.
While IUCLID section 4.28 contains the templates for reporting (robust) study summaries of certain physicochemical properties for nanomaterials, the only sub-section in 4.28 that corresponds to a mandatory Annex VII-X information requirement is section 4.28.8 – Nanomaterial dustiness. The remaining sub-sections under 4.28 do not need to be provided as part of a registration dossier.
- If the information is jointly submitted, the co-registrant only has to identify his nanoform(s) under Annex VI, but he does not have to submit himself the hazard data that cover his nanoform(s). Instead, the co-registrant must link in his registration dossier his nanoform(s) to the corresponding hazard data submitted in the lead dossier. To this end, the co-registrant must refer to a boundary composition record of the lead dossier in the field ‘Reference to related composition(s)’ of each section 1.2 legal entity composition record. This boundary composition must be relevant to the co-registrant’s nanoform or set of nanoforms, and must be linked to the Annex VII-X information submitted to cover the information requirements for it.
- Note that if the jointly submitted information concerns a set of nanoforms, the co-registrant must ensure that his own nanoform(s) fall within the characterisers reported for a boundary composition for a set of nanoforms in the lead dossier, and that the justification provided for the set of nanoforms in this same boundary composition covers his nanoforms.
- If the information is submitted separately by the co-registrant, he must ensure that a specific hazard data set is provided for his nanoform(s) via an opt-out, as foreseen in Article 11(3) of REACH. In this second case, the co-registrant must submit all the hazard data required for his nanoforms in sections 4-7 of IUCLID.
If you have submitted your member dossier but rely on the lead dossier for Annex VII-X information for your nanoform of the substance, ECHA could not verify the completeness of this data. Therefore, ECHA reserves the right to assess the completeness of your dossier in relation to the information on the Annex VII-X requirements, whenever this information is submitted by the lead registrant.
Once the lead registrant has submitted their dossier, you must update your registration to link your nanoforms with the relevant Annex VII-X information in the lead dossier. This is done by referring to the corresponding boundary composition name(s) of the lead dossier, in the section 1.2 Legal entity compositions of your own dossier by using the field ‘Reference to related composition(s)’.
Yes. Due to the differences between non-nanoforms and nanoforms you need to demonstrate for each endpoint and each nanoform why the information generated on the non-nanoform of the substance is adequate for assessing the nanoform, i.e. that the prediction from the non-nanoform to each nanoform is reliable and accurate, and does not underestimate the hazard.
To report the read-across in your dossier, follow the advice given in the manual “How to prepare registration and PPORD dossiers”, chapter 9.6.3 ‘How to report read-across in IUCLID'.