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REACH

Nanoforms of substances

A. Registration obligations

I am manufacturing both non-nanoforms and nanoforms of a substance. What determines the tonnage band for registration and for the hazard data?

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.

Do I need to register nanoforms which are manufactured as dispersions?
Yes, nanoforms manufactured as a dispersion must be registered.
Is it possible that a polymer is a nanoform? Does it remain exempt from registration?

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.

If a nanoform is introduced into a polymer during the polymerisation phase, do we have to register it, knowing that the nanoform is present in the final polymer without emission?

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).

If we act as downstream users of nanomaterials, e.g. making formulations, lacquers etc., do we also have to register the used nanomaterials?
If you buy a nanoform in the EU and use it without modification, you do not have to register it. However, the manufacturer or importer in your supply chain must have registered it. As a downstream user, you must ensure that your use of the nanoform is covered by its registration or prepare a chemical safety report yourself.
B. Definition of nanoforms

What is the impact of the revision of the European Commission’s nanomaterial definition on the definition of nanoform under REACH?
The revision of the European Commission’s nanomaterials definition does not impact the current definition of a nanoform used in REACH. REACH Annex VI contains a definition for a nanoform and this definition must be applied to determine the requirements applicable under REACH.
What is understood as batch-to-batch variability when a nanoform is defined?

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.

Can two nanoforms with very similar characterisers but from two different manufacturing processes be reported as one nanoform?
No. Only variations in nanoform characterisers arising from batch-to-batch variability are allowed for a particular nanoform (Q&A 1678).  However, as different manufacturing processes may result in nanoforms with almost identical characterisers, these different nanoforms can be registered as part of a set of similar nanoforms, provided that explicit conditions are meet:
 
  1. The registrant reports clearly defined boundaries in terms of characterisation parameters of the nanoforms, which are part of the set
  2. 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.
For more details, see Q&A 1681.
C. Characterisation of nanoforms

If X-ray diffraction didn't provide sufficient information to determine crystalline structure, which analytical assessment are we required to perform?
Registrants are free to choose the analytical techniques as long as the data requirement is fulfilled. For questions concerning a specific nanoform, please submit the question using our contact form.
D. Sets of similar nanoforms

How can a registrant justify a set of nanoforms?
A set of nanoforms must be based on a justification demonstrating that the hazard assessment, exposure assessment and risk assessment of the nanoforms in the set can be performed jointly. The justification must apply generically to all the applicable information requirements, including the new nanoform-specific endpoints like Annex VII point 7.14 bis Dustiness. The justification must always be substantiated by supporting data.
 
More specifically, the justification must fulfil the conditions below:
 
  1. 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.
  2. 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.  
  3. Each scientific evidence summarised in the justification must be submitted in the form of a (robust) study summary
    • The  (robust) study summary can be provided by attaching it in the section 1.2 field ‘Attached information’;
    • A reference to a (robust) study summary can also be made by linking the corresponding record in the IUCLID dossier via the section 1.2 field ‘Cross-reference’; 
    • Alternatively, references to publicly available literature may be provided instead 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. 
  4. 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 include a demonstration that the nanoforms used to generate the supporting data are representative of all the nanoforms included in the boundaries of the set.
  5. 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.
The justification provided in the field 'Justification for reporting set of similar nanoforms' and ‘Attached information’ is manually verified by ECHA staff during completeness check.
What is the impact for an already registered set of nanoforms if one or several nanoforms are added in the registration of the substance?

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.

Can I include nanoforms within one set of nanoforms, which contradict the limitations set out in Guidance, if I can justify that the hazard, exposure and risk assessment of the nanoforms in the set can be performed jointly?

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.

How can I justify a set of nanoforms if I do not have data? Do I need to generate the data on the Annex VII-X properties for each of the nanoforms in the set?

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.

E. Particle size distribution

What is the definition of a constituent particle and what is the difference between constituent and primary particle?
Please refer to the Joint Research Centre’s (JRC) report An overview of concepts and terms used in the European Commission's definition of nanomaterial, Section 2.7.
Which method should be used for measurement of particle size distribution?

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.

F. Reporting and submission

Do I need to report each nanoform separately?
In principle, each nanoform has to be reported separately. However, REACH allows reporting of a set of similar nanoforms when two conditions are fulfilled:
 
  1. The registrant reports clearly defined boundaries in terms of characterisation parameters of the nanoforms, which are part of the set;
  2. 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.
Can I register a nanoform and pass the completeness check if I lack some of the information requirements due to ongoing measurements that have been commissioned with test labs but that are not yet concluded?

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.

G. Joint Submission

How to handle joint submission of different different nanoforms of the substance?
Each registrant is responsible for registering the nanoforms that they themselves manufacture or import. Therefore, each registrant has the obligation to characterise the nanoforms (either individually or through sets of nanoforms) they manufacture/import and to ensure that a specific hazard data set is provided for each nanoform or set of nanoforms. 
 
The information required by Annex VI, including the characterisation of nanoforms, must always be submitted separately by each registrant in their IUCLID dossier. 
 
It is up to each co-registrant to identify their own nanoform(s). It is then up to the co-registrants in the joint submission to decide whether to submit the hazard data (i.e. information requirements of Annexes VII to X) on the nanoforms of the substance jointly or separately. 
 
By derogation to the obligation to provide hazard data on each single nanoform, co-registrants can identify sets of nanoforms with clearly defined boundaries if they can justify that the hazard, exposure and risk assessments can be performed jointly for the nanoforms included in the set. In this case, one set of hazard data can be submitted for all nanoforms within the set.
 
Therefore, first, registrants must decide how they want to cover the nanoforms they manufacture or import, either as single nanoforms or in a set of nanoforms (subject to the conditions described above) or both. 
 
Second, registrants must decide whether their nanoforms will be covered by the hazard information jointly submitted. In that case, they need to agree on the data to be jointly submitted. The data jointly submitted can concern single nanoforms or set(s) of nanoforms.
 
  • 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.
Do we need to update the member dossier after the lead dossier has passed the completeness check to include a link to the boundary composition(s) in the lead dossier that are relevant to our nanoforms?

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)’.

Do we need to set up a read-across approach in our member dossier for the nanoform of the substance for the endpoints where we rely on the studies on the non-nanoform submitted by the lead?

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'.

H. Annex VII-XI Information requirements

Do we need to report dustiness when the product/nanoform is manufactured as well as supplied in a water dispersion only?
According to column 2, Annex VII, 7.14.bis the study does not need to be conducted if exposure to granular form of the substance during its life-cycle can be excluded.
Do you have any recommendation on the method to measure dustiness?
The CEN standard EN 17199-1:2019 “Workplace exposure - Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles - Part 1: Requirements and choice of test methods” gives advice on the methodology and provides guidance to choose the most adequate test method. It is recommended to choose the methods more relevant to simulate the operations/tasks expected to be performed.
How to deal with data which have been generated using guidelines not revisited by either JRC or the Malta project?
Similar to non-nanoforms of a substance, ECHA will assess on a case by case basis the information provided in the endpoint study record (e.g. material and methods, characterisation of test material, raw results, conclusion) to establish the relevance and reliability of the provided information.

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