# Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances (Text with EEA relevance), Division 3: Annex VI to Regulation (EC) No 1907/2006 is amended as follows:

Extent: E+W+S+N.I.

(a) The subtitle and the introductory text under the current subtitle ‘Guidance note on fulfilling the requirements of annexes VI to XI’ are replaced by the following:
‘NOTE ON FULFILLING THE REQUIREMENTS OF ANNEXES VI TO XI
Annexes VI to XI specify the information that shall be submitted for registration and evaluation purposes according to Articles 10, 12, 13, 40, 41 and 46. For the lowest tonnage level, the standard requirements are in Annex VII, and every time a new tonnage level is reached, the requirements of the corresponding Annex have to be added. For each registration the precise information requirements will differ, according to tonnage, use, and exposure. The Annexes shall thus be considered as a whole, and in conjunction with the overall requirements of registration, evaluation and the duty of care.
A substance is defined in accordance with Article 3(1) and identified in accordance with section 2 in this Annex. A substance is always manufactured or imported in at least one form. A substance can also occur in more than one form.
For all nanoforms covered by the registration certain specific information items shall be provided. Nanoforms shall be characterised as provided for in this Annex. The registrant shall justify why the information provided in the joint registration, covering the information requirements for the registered substances with nanoforms, is adequate for assessing the nanoforms. Information relevant to cover information requirements for such a substance can also be submitted separately by individual registrants, where justified in accordance with Article 11(3).
More than one dataset may be required for one or more information requirements whenever there are significant differences in the properties relevant for the hazard, exposure and risk assessment and management of nanoforms. The information shall be reported in such a manner that it is clear which information in the joint submission pertains to which nanoform of the substance.
Where technically and scientifically justified, the methodologies set out in Annex XI.1.5 shall be used within a registration dossier when two or more forms of a substance are “grouped” for the purposes of one, more or possibly all the information requirements.
The requirements specific to nanoforms apply without prejudice to requirements applicable to other forms of a substance.
Definition of a nanoform and a set of similar nanoforms:
On the basis of the Commission Recommendation of 18 October 2011 on the definition of nanomaterial, a nanoform is a form of a natural or manufactured substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm, including also by derogation fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm.
For this purpose, “particle” means a minute piece of matter with defined physical boundaries; “agglomerate” means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components and “aggregate” means a particle comprising of strongly bound or fused particles.
A nanoform shall be characterised in accordance with section 2.4 below. A substance may have one or more different nanoforms, based on differences in the parameters in points 2.4.2 to 2.4.5.
A “set of similar nanoforms” is a group of nanoforms characterised in accordance with section 2.4 where the clearly defined boundaries in the parameters in the points 2.4.2 to 2.4.5 of the individual nanoforms within the set still allow to conclude that the hazard assessment, exposure assessment and risk assessment of these nanoforms can be performed jointly. A justification shall be provided to demonstrate that a variation within these boundaries does not affect the hazard assessment, exposure assessment and risk assessment of the similar nanoforms in the set. A nanoform can only belong to one set of similar nanoforms
The term “nanoform”, when it is referred to in the other Annexes, shall refer to a nanoform or a set of similar nanoforms, when one has been defined, as defined in this Annex.’;
(b) Step 1 is replaced by the following:
‘STEP 1 — GATHER AND SHARE EXISTING INFORMATION
The registrant should gather all existing available test data on the substance to be registered, this would include a literature search for relevant information on the substance.
Wherever practicable, registrations should be submitted jointly, in accordance with Articles 11 or 19. This will enable test data to be shared, thereby avoiding unnecessary testing and reducing costs. The registrant should also collect all other available and relevant information on the substance including on all nanoforms of the substance that are covered by the registration, regardless whether testing for a given endpoint is required or not at the specific tonnage level. This should include information from alternative sources (e.g. from (Q)SARs, read-across from other substances, in vivo and in vitro testing, epidemiological data) which may assist in identifying the presence or absence of hazardous properties of the substance and which can in certain cases replace the results of animal tests.
In addition, information on exposure, use and risk management measures in accordance with article 10 and this Annex should be collected. Considering all this information together, the registrant will be able to determine the need to generate further information.’;
(c) Step 3 is replaced by the following:
‘STEP 3 — IDENTIFY INFORMATION GAPS
The registrant shall then compare the information needs for the substance with the information already available and the extent to which currently available information can be applied to all nanoforms covered by the registration and identify where there are gaps.
It is important at this stage to ensure that the available data is relevant and has sufficient quality to fulfil the requirements.’;
(d) Step 4 is replaced by the following:
‘STEP 4 — GENERATE NEW DATA/PROPOSE TESTING STRATEGY
In some cases it will not be necessary to generate new data. However, where there is an information gap that needs to be filled, new data shall be generated (Annexes VII and VIII), or a testing strategy shall be proposed (Annexes IX and X), depending on the tonnage. New tests on vertebrates shall only be conducted or proposed as a last resort when all other data sources have been exhausted.
The above approach shall also apply if there is a gap of available information for one or more nanoforms of the substance included in the jointly submitted registration dossier.
In some cases, the rules set out in Annexes VII to XI may require certain tests to be undertaken earlier than or in addition to the standard requirements.
NOTES
Note 1: If it is not technically possible, or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated, in accordance with the relevant provisions.
Note 2: The registrant may wish to declare that certain information submitted in the registration dossier is commercially sensitive and its disclosure might harm him commercially. If this is the case, he shall list the items and provide a justification.’;
(e) The introductory text in Section 2 Identification of the substance is replaced by the following:
‘For each substance, the information given in this section shall be sufficient to enable each substance to be identified and the different nanoforms to be characterised. If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of the items below, the reasons shall be clearly stated.’;
(f) Subsection 2.3. is replaced by the following:
‘2.3.
Composition of each substance. Where a registration covers one or more nanoforms, these nanoforms shall be characterised pursuant to section 2.4 of this Annex.
2.3.1.
Degree of purity (%)
2.3.2.
Nature of impurities, including isomers and by-products
2.3.3.
Percentage of (significant) main impurities
2.3.4.
Nature and order of magnitude (… ppm, … %) of any additives (e.g. stabilising agents or inhibitors)
2.3.5.
Spectral data (e.g. ultra-violet, infra-red, nuclear magnetic resonance or mass spectrum)
2.3.6.
High-pressure liquid chromatogram, gas chromatogram
2.3.7.
Description of the analytical methods or the appropriate bibliographical references for the identification of the substance and, where appropriate, for the identification of impurities and additives. This information shall be sufficient to allow the methods to be reproduced.
2.4.
Characterisation of nanoforms of a substance: For each of the characterisation parameters, the information provided may be applicable to either an individual nanoform or a set of similar nanoforms provided that the boundaries of the set are clearly specified.
The information in points 2.4.2 – 2.4.5 shall be clearly assigned to the different nanoforms or sets of similar nanoforms identified in point 2.4.1.
2.4.1.
Names or other identifiers of the nanoforms or sets of similar nanoforms of the substance
2.4.2.
Number based particle size distribution with indication of the number fraction of constituent particles in the size range within 1 nm – 100 nm.
2.4.3.
Description of surface functionalisation or treatment and identification of each agent including IUPAC name and CAS or EC number.
2.4.4.
Shape, aspect ratio and other morphological characterisation: crystallinity, information on assembly structure including e.g. shell like structures or hollow structures, if appropriate
2.4.5.
Surface area (specific surface area by volume, specific surface area by mass or both)
2.4.6.
Description of the analytical methods or the appropriate bibliographical references for the information elements in this sub-section. This information shall be sufficient to allow the methods to be reproduced.’;
(g) In section 3, the following introductory text is added after the title ‘INFORMATION ON MANUFACTURE AND USE(S) OF THE SUBSTANCE(S)’:
‘Where a substance being registered is manufactured or imported in one or several nanoforms, the information on manufacture and use under 3.1-3.7 shall include separate information on the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4.’;
(h) In section 5, the introductory text is replaced by the following:
‘This information shall be consistent with that in the Safety Data Sheet where such a Safety Data Sheet is required according to Article 31.
Where a substance being registered is also manufactured or imported in one or several nanoforms, the information pursuant to this Section shall address the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4 where relevant.’;
(i) In section 6, the following introductory text is added after the title ‘INFORMATION ON EXPOSURE FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES PER YEAR PER MANUFACTURER OR IMPORTER’:
‘Where a substance being registered is manufactured or imported in one or several nanoforms, the information pursuant to this Section shall address the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4 separately.’

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Source: https://www.legislation.gov.uk/eur/2018/1881/annex/division/3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2018-1881/annex/division-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.