Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance) (c. 1907)

[X1 ANNEX VI U.K. INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10

Editorial Information

X1 Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006).

INFORMATION REFERRED TO IN ARTICLE 10(a) (i) TO (v) U.K.

2. IDENTIFICATION OF THE SUBSTANCE U.K.

[F1 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.]

Textual Amendments

F1 Substituted by 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).

2.1. Name or other identifier of each substance U.K.

2.1.1. Name(s) in the IUPAC nomenclature or other international chemical name(s) U.K.

2.1.2. Other names (usual name, trade name, abbreviation) U.K.

2.1.3. EINECS or ELINCs number (if available and appropriate) U.K.

2.1.4. CAS name and CAS number (if available) U.K.

2.1.5. Other identity code (if available) U.K.

2.2. Information related to molecular and structural formula of each substance U.K.

2.2.1. Molecular and structural formula (including SMILES notation, if available) U.K.

2.2.2. Information on optical activity and typical ratio of (stereo) isomers (if applicable and appropriate) U.K.

2.2.3. Molecular weight or molecular weight range U.K.

[F1 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. U.K.

2.3.1. Degree of purity (%) U.K.

2.3.2. Nature of impurities, including isomers and by-products U.K.

2.3.3. Percentage of (significant) main impurities U.K.

2.3.4. Nature and order of magnitude (… ppm, … %) of any additives (e.g. stabilising agents or inhibitors) U.K.

2.3.5. Spectral data (e.g. ultra-violet, infra-red, nuclear magnetic resonance or mass spectrum) U.K.

2.3.6. High-pressure liquid chromatogram, gas chromatogram U.K.

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 U.K.

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. U.K.

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 U.K.

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 U.K.

2.4.3. Description of surface functionalisation or treatment and identification of each agent including IUPAC name and CAS or EC number U.K.

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 U.K.

2.4.5. Surface area (specific surface area by volume, specific surface area by mass or both) U.K.

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.] ] U.K.