Q&As

REACH

Nanoforms of substances

A. Registration obligations

Do we need to register if I generate a nanoform of a substance by milling the non-nanoforms of a substance that we purchased from an EU supplier?

If a company purchases from an EU supplier a substance in a non-nanoform and mills it down to generate a nanoform of the substance, this particular activity is considered as a downstream use of the substance, rather than as manufacturing of the substance. Therefore, as a downstream user you do not have registration obligations, but you are subject to the downstream users’ obligations set out in Articles 37 and 38. For further information please see the Q&As on Nanoforms of substances, chapter I. Downstream user 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.
Does the registration of nanomaterials concern only those that are intentionally produced?
The obligation to register nanoform(s) of a substance applies to all nanoforms meeting the definition set out in REACH, as soon as the substance is imported/manufactured in quantities of 1 tonne or more/year/registrant. This obligation applies irrespective of whether the nanoform was intentionally produced. Each manufacturer/importer is responsible for characterising its substance, and thereby identifying if the substance contains forms that qualify as nanoforms. For each form that qualifies as a nanoform, the manufacturer/importer must characterise the nanoform and report the characterisers in the registration dossier. In addition, they must ensure that a corresponding hazard dataset is submitted.
When EU distributors sell a substance as a nanoform under their own trademark, can they have the registration done by their supplier?
The answer depends on the location of the supplier of the substance. The registration obligation applies to manufacturers and importers of substances in the EU. If the substance is supplied by the manufacturer or importer and they are established in the EU, that manufacturer or importer must register the nanoform. If the supplier of the substance is based outside of the EU and the substance is imported by the EU ‘distributor’, this distributor actually qualifies as an importer under REACH. In this case, the EU distributor must register the substance, including its nanoforms.
How should the other registrants of a substance proceed if a co-registrant claims not to produce nanoforms but does not provide any proof for this?

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.

Would a change of a production line trigger a need to update our registration dossier regarding the reported nanoform , even if its characterisation parameters are not changed?

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.

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?
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.
When would a form of a substance become a new substance, e.g. based on surface modifications?

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.

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.
Does the particle size refer to the physical particle size or aerodynamic particle size?
For the purposes of determining whether you have a nanomaterial according to the REACH definition, and of reporting of particle size for fulfilling the information requirements of REACH Annex VI, you should report the physical size, not an aerodynamic size.
What is the definition of "granular form", mentioned in column 2 of endpoints 7.14 (granulometry) and 7.14bis (dustiness) under Annex VII of REACH?

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.   

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  
    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.
  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 clearly show 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, for each boundary composition describing a set of nanoforms.
 
For further information on how to report a justification for a set of nanoforms, please refer to the following support material:
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.

Do I need to submit an inquiry if I have an existing registration for a substance and I want to update it with information on nanoforms of the substance?
No, you do not need to submit an inquiry in such situation. A registration dossier update is sufficient.
Do I need to submit an inquiry if I want to register nanoforms of a substance for which I don’t have an existing registration? If so, what information should be included in the inquiry dossier concerning the nanoforms of the substance?
Yes, in such situation you should submit an inquiry for the substance in question. The information requirements, including the specific requirements for nanoforms, as specified in REACH Annex VI are applicable for the inquiry dossiers. The information included in an inquiry dossier should be sufficient for ECHA to provide the identifiers for the substance for data sharing purposes. ECHA does not check the completeness or compliance of the substance identity information provided in an inquiry dossier with the registration requirements of Article 10(a)(ii) of the REACH Regulation.
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.

When particles of a nanoform form agglomerates in micrometre size range, do we need to characterise agglomerates and/or constituent particles?

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. 

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.

If I already submitted my registration dossier indicating that I cover the substance as a nanoform before the release of IUCLID 6.4, do I still need to submit an update in view of the new information requirements for nanoforms?
Yes, you need to submit an update of your registration. Only IUCLID version 6.4, published in October 2019, and later versions of IUCLID contain the formats to report the information required by the revised REACH Annexes for nanoforms, such as the characterisers specified by Annex VI and the Annex VII requirement on Dustiness.
Is information on granulometry (IUCLID section 4.5) and dustiness (4.28.8) to be reported separately by each registrant, or is it part of the information to be submitted, in principle, jointly?
The information requirements on granulometry and dustiness are part of REACH Annex VII. Therefore, the corresponding IUCLID sections 4.5 and 4.28.8 should in principle be submitted by the lead registrant on behalf of the co-registrants. Alternatively, this information can be submitted separately by each registrant via the opt-out mechanism.
If I import a specific nanoform and then modify it with a surface treatment, can I register the two forms by submitting a single registration dossier?

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. 

Do registrants need to characterise and report each nanoform within a set of nanoforms, or is the justification for grouping sufficient?

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.

If information on the characterisation of a nanoform is provided in IUCLID section 1.2, is it mandatory to report this information also in section 4.28?

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.

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.
I. Downstream user obligations

What are my obligations as a downstream user purchasing, modifying or creating nanoforms?

Downstream user obligations under Article 37(4) are triggered upon receipt of a safety data sheet (SDS) with a registration number (Article 39(1) of REACH). As a downstream user, you receive an SDS with exposure scenarios attached for a hazardous substance (including nanoforms) registered above 10 tonnes/year. 
When receiving an SDS, as a downstream user you must establish whether your use and/or your conditions of use are covered by the exposure scenario information in the SDS and take action if that is not the case.

When you are dealing with a nanoform (that you have purchased or created yourself), ensuring that the use is adequately covered requires checking both the uses and conditions of use in the exposure scenario(s), and whether the nanoform you handle is covered by the extended SDS. 

When downstream users apply a surface treatment to a nanoform they purchased or create a nanoform by milling a non-nanoform (see FAQ 1838), they must check whether:
 
•    the nanoform created is covered by the SDS received (see Q&A 1831 and Q&A 1833) and
•    the use (e.g. the process of surface treatment or the milling) is covered by the exposure scenario(s) (see Q&A 1834). 

Q&A 1834 explains the actions to be taken when you conclude that your uses or the nanoform you create is not covered.
If your uses and any nanoform you create are covered in the exposure scenario, no further action under REACH is needed. Document your check and the actions you have taken to reach your conclusion and make this information available to enforcement authorities upon request. Clear documentation helps you to justify your assumptions in a transparent way and helps the authorities to better understand the criteria you have applied in your decisions.
The general duties of REACH applicable to downstream users are described in the Guidance for downstream users.
 

How do I know when I have created a new nanoform from a supplied substance?

A nanoform must be characterised in accordance with section 2.4 of Annex VI to REACH. A substance may have one or more different nanoforms, based on differences in the size distribution, shape and other morphological characterisation, surface treatment and functionalisation and specific surface area (SSA) of the particles. Variation in one or several of these characterisers results in a new nanoform. 

In practice, if you modify any of these characterisers while using the nanoform that you have purchased (e.g. by grinding, applying a surface treatment) or if you create a nanoform from a non-nanoform (e.g. by milling the non-nanoform, see QA 1838) you must check whether your supplier has covered the resulting nanoform in their extended safety data sheet (SDS) (assuming one has been received). To perform such a check, you must have enough information on the characterisers of the nanoforms you have created (See Q&A 1832).

If the nanoform you create is covered in the exposure scenario, no further action needs to be taken in this respect (but you must still check if your uses of the nanoform supplied are covered, see Q&A 1833). You must document your check and the actions you have taken to reach your conclusion and make this information available to enforcement authorities upon request. Clear documentation helps you to justify your assumptions in a transparent way and helps the authority to better understand the criteria you have applied in your decisions.
 

How do I know whether the nanoform I have created is covered by my supplier if I received an SDS with an exposure scenario attached?

As a downstream user, you receive an SDS with exposure scenarios attached for a hazardous substance (including nanoforms) registered above 10 tonnes/year. If your supplier is covering the uses of your nanoform (including where relevant the creation of a nanoform and its subsequent uses), then the SDS will indicate these uses in Section 1.2 and will include the associated exposure scenario(s) annexed that describe the conditions of that use. The supplier’s SDS must also include the nanoform characterisation information.


REACH Annex II, which prescribes the contents of an SDS has recently been updated. Until 31 December 2022, an SDS may continue to be provided in accordance with Regulation (EU) 2015/830 or can be provided in the new format, according to Regulation (EU) 2020/878. If the supplier’s SDS has been compiled in accordance with Regulation (EU) 2020/878, then the nanoform characterisation information will be found in Section 3 (3.1 for substances, 3.2 for mixtures) or Section 9. If the SDS has been compiled in accordance with Regulation (EU) 2015/830, the supplier can include the information in Section 9 under the subsection ‘(a) Appearance’, where information on “granulometry” should be included. For further details on obligations of SDS suppliers, please see the Guidance on the compilation of safety data sheets.


If you create a nanoform as a downstream user, and the SDS you have received from your supplier contains characterisation information in terms of size, shape, surface treatment and specific surface area (SSA), you must compare it with the information on the nanoform that you have generated and decide whether or not your nanoform is covered by the supplier’s SDS. The Guidance ‘Appendix for nanoforms to the Guidance on Registration and Substance Identification’ provides details on how you can distinguish between different nanoforms. In practice, the information you receive in the SDS may refer to a single nanoform with characterisation data for each of the four characterisers (size, shape, surface treatment and SSA) (see example of possible format in Table 1 on p. 50 of the Guidance on the compilation of safety data sheets). In that case, you can consult section 4 of the ECHA Guidance ‘Appendix for nanoforms to the Guidance on Registration and Substance Identification’, in particular the subsection “Principles on the boundaries of sets of nanoforms” dedicated to each of the nanoform characterisation parameters to make a decision on whether your nanoform is covered by applying the same principles outlined in the guidance.

In the case that the supplier’s SDS refers to a set of nanoforms, the boundaries covered for each of the parameters should be specified in their SDS and allow you to decide whether the nanoform you have created is covered. In such a case, all the characterisation parameters of your nanoform must fall within the boundaries set in the SDS to ensure that it is covered. 
 

How do I know whether the nanoform I have created is covered by my supplier if: i) I did not receive an SDS or ii) I received an SDS but it does not contain exposure scenarios?

Downstream users’ obligations are triggered upon receipt of an (extended) SDS with a registration number. There may be genuine reasons where an SDS is not required to be supplied by law, e.g.  because the substance (and nanoforms) are not classified under CLP, the substance is not classified as PBT/vPvB, and/or the substance is not on the REACH Candidate List. There are also genuine reasons where there may be no exposure scenarios annexed to the SDS, e.g. because the registration tonnage is below 10 tonnes/year, or the substance is registered for use only as an intermediate under strictly controlled conditions. If you have been supplied a substance (including as a nanoform) without an SDS, or with an SDS but without an exposure scenario and you think you should have received one, it is recommended that you formally communicate with your supplier in writing to check the reason for not having received an SDS and document this action. 

Where your supplier is not required to provide an SDS, you may still have some obligations under REACH as a downstream user if you modify the nanoform you have purchased, or you create a nanoform from a non-nanoform of the substance. If, for example, the nanoform you create fulfils the criteria to be classified as hazardous (you may need testing to determine whether classification applies), you must generate an SDS for the safe use of that nanoform at company level (for your own workers) if you meet the conditions set out in Article 35 of REACH (or grant access to your workers to the same information as provided in an SDS). If you put the nanoform created on the market, becoming a supplier, you also have to provide an SDS to your customers according to Article 31 of REACH. You also need to inform upstream to your supplier, according to Article 34, that the nanoform is hazardous.

Where your supplier has provided an SDS but no exposure scenario covers your use(s), REACH gives a downstream user the right to make a use (including the creation or use of a nanoform) known to their supplier (Article 37(2) of REACH). You must provide sufficient information to your supplier to enable them to assess your use, as described in Q&A 1835. When the supplier includes that use in their REACH registration, the supplier must then create/update the SDS they provide to their downstream user customers, to enable the customers to comply with REACH Articles 35 and 31.  
 

How to check if my use and the conditions of use are covered by the exposure scenario received?

The process of checking the uses and conditions of use is not different for nanoforms and non-nanoforms. Be careful that you check the uses applicable to your nanoform (in case the safety data sheet (SDS) covers several (nano)forms of the substance). Details on how to perform the check (on whether your uses and conditions of use are covered by the provided exposure scenario) are provided in section 4.2 of the Guidance for downstream users. The check includes three steps:

  • Checking the use(s): compare your use(s) with the “identified use(s)” in SDS Section 1.2 and the title section of the attached exposure scenarios;
  • Checking processes/activities of the exposure scenario: compare your processes/activities with those described in the exposure scenario to ensure that the way you use the substance has been covered in the supplier’s assessment;
  • Checking the conditions of use: compare your onsite operational conditions and risk management measures (including their effectiveness) with those described in the exposure scenario(s).

If you conclude that your use is covered by the exposure scenario received, no further action under REACH is needed. You should nevertheless document your check and any action you take to guarantee your compliance with the conditions of use in the exposure scenario.
 

What do I need to do if my nanoform/uses are not covered by my supplier?

If you conclude that the nanoform you have created or its uses are not covered by the information in your supplier’s safety data sheet (SDS), there are three options available to you:

  • Stop the uses and the creation of the nanoform that is not covered.
  • Ask your supplier to include the nanoform you have created, as well as the use(s) or conditions of use in their chemical safety report and to provide you with an exposure scenario for it (see Q&A 1834). In this case, you must make sufficient information available to your supplier to enable them to make an assessment. In the case that you are requesting a new nanoform to be covered, this information should normally include the characterisation of the nanoform (Annex VI characterisers) unless your supplier agrees to generate this information for you. If new hazard data needs to be generated, you may agree with your supplier on who is performing the testing and/or covering the costs. 
    If your supplier refuses to cover your uses/ your nanoform or if the supplier advices against your use/ your nanoform, you can try to find another supplier that covers your uses/ nanoform. When looking for a possible supplier that can cover your nanoform, it may be useful to consult the ECHA dissemination web pages to check whether your nanoform is covered by the registration dossier of the substance to get an idea on how likely it is to find a supplier that covers your nanoform.
  • Alternatively, you can cover the nanoform or uses yourself. In this case, you must carry out your own chemical safety assessment and prepare your own downstream user chemical safety report (DU CSR) for your uses and conditions of use, unless exemptions apply (Article 37, (c) use <1 tonne/year or (f) PPORD use). When you perform a DU CSR, or you are relying on exemptions, you must notify this to ECHA (see Q&A 1837).

More information on how to handle exposure scenarios can be found in:  Practical guide 13: “How downstream users can handle exposure scenarios”.
 

What should the downstream user chemical safety report contain?

Practical Guide 17: “How to prepare a downstream user chemical safety report” contains practical information on how to perform a downstream user chemical safety report (DU CSR). When you perform a DU CSR for a nanoform, it is advisable to follow the steps detailed in the guide, taking into account the specificities for nanoforms detailed below to determine which of the three approaches explained you should follow.

The content of the DU CSR would depend on whether you need to assess and describe:

  • a new nanoform (created from bulk or modified from a nanoform), or
  • only new uses or new conditions of use of a nanoform already covered by an exposure scenario, or
  • both a new nanoform and new uses and conditions of use.

Whenever there is a new nanoform, it is likely that you will have to follow Approach C in the Practical guide (which includes reviewing the hazard assessment).

Information on the nanoforms

If you conclude that the nanoform you created is covered by the information in your supplier’s safety data sheet (SDS), you can follow the advice of the section below (information on uses and conditions of use).

If you conclude that the nanoform you have created is not covered and you intend to assess it by yourself, you must determine whether the hazard assessment performed by your supplier is applicable to your nanoform.

You cannot simply presume that your nanoform is covered by the hazard assessment performed by the supplier. You must have a justification on why this is the case, document your conclusion and make it available to enforcement authorities upon request (see principles below).

The Guidance ‘Appendix for nanoforms to the Guidance on Registration and Substance Identification’, provides advice in section 4 on a set of principles that helps to define the boundaries of a set of nanoforms, where variation (in the characterisation parameters in 2.4.2 to 2.4.5 of REACH Annex VI) within these boundaries does not affect the hazard assessment. The same principles could be applied by a downstream user (you) to determine whether the nanoform you have created and its hazard assessment falls within the boundaries of your supplier’s nanoform/ hazard assessment. The Guidance also gives some indication of what must be considered to justify that the hazard assessment performed by the supplier covers your nanoform.

If, after following the above principles, you cannot conclude that the hazard assessment from your supplier is applicable to your nanoform, you must perform a hazard assessment for your nanoform. Though not an explicit requirement, the information requirements as specified under Annexes VII to X would be expected to be followed in order to perform the hazard assessment on the nanoform.

You have the possibility to apply read-across or other adaptations to address hazard endpoints related to your nanoform. The ‘Appendix R.6-1 for nanoforms applicable to the Guidance on QSARs and Grouping of Chemicals’ gives advice on how to justify the use of hazard data between nanoforms and/or sets of nanoforms, and the non-nanoforms (bulk) of the same substance.

If the information required to conclude on the hazard assessment can only be obtained by testing, you should follow the advice provided in the three nano-specific appendices to the Guidance on IR&CSA (endpoint specific Guidance), Chapter R.7a, R.7b and R.7c. Where this information can only be obtained by testing for Annex IX and X standard information requirements you must submit a proposal for a testing strategy to the Agency in accordance with Article 38.

Information on use and conditions of use

If, when checking the uses identified by your supplier or the conditions of use applicable to the uses, you conclude that (some) are not covered (see Q&A 1833) you must perform this step. This involves the identification of uses and conditions of use that are not covered by the information in your supplier’s SDS and the generation of exposure scenario for these uses.

The advice in the Practical Guide 17: “How to prepare a downstream user chemical safety report” can be followed. However, attention should be paid to the following:

  • When the uses have been identified and assessed by the supplier but you have determined that your nanoform is different, you cannot assume that the exposure potential/ (e.g. dustiness) of the nanoform you have created is the same. The exposure estimation may need refinement.
  • When performing the exposure estimation step, it should be noted that the method adopted (either direct measurement or an exposure estimation modelling tool) must be applicable to the nanoforms.
How do I report to ECHA that I have performed a downstream user chemical safety report (or I am relying on an exemption)?

If you need to prepare a downstream user chemical safety report (DU CSR) or you rely on the exemptions in Article 37(4)(c) or (f), then you must report certain information to ECHA.

A downstream user of nanoforms can report information to ECHA via IUCLID, as described in the manual on How to prepare a downstream user report.

The reporting comprises the following required information (the corresponding IUCLID section is indicated in brackets):

  1. Identity of the downstream user, i.e. name, contact details (REACH-IT account and IUCLID section 1.1 Identification);
  2. Identity of the substance and characterisation of the nanoform as specified in section 2.4 of Annex VI to REACH (IUCLID sections 1.1 Identification and 1.2 Composition)
  3. The registration number(s) as communicated to the downstream user by their suppliers (IUCLID section 1.3 Identifiers);
  4. Identity of the manufacturer(s), importer(s) or other supplier, i.e. name, contact details (IUCLID section 1.7 Suppliers);
  5. Site(s) of use (IUCLID section 3.3 Sites);
  6. A brief general description of the use(s) (IUCLID section 3.5 Life Cycle description) including the information on the conditions of use(s);
  7. If appropriate according to Article 38(2)(f), a proposal for additional testing on vertebrate animals (relevant endpoint study record(s) in IUCLID section 5-7);
  8. An indication of the type of report (including any exemptions relied upon), and an explanation for why the report was required, including why the issue could not be resolved through the supplier (IUCLID Section 14).