Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilShow full title

[X1 INFORMATION REFERRED TO IN ARTICLE 10(a) (i) TO (v) U.K.

1. GENERAL REGISTRANT INFORMATION U.K.

1.1. Registrant U.K.

1.1.1. Name, address, telephone number, fax number and e-mail address U.K.

1.1.2. Contact person U.K.

1.1.3. Location of the registrant's production and own use site(s), as appropriate U.K.

1.2. Joint submission of data U.K.

Articles 11 or 19 foresee that parts of the registration may be submitted by a lead registrant on behalf of other registrants.

In this case, the lead registrant shall identify the other registrants specifying:

• their name, address, telephone number, fax number and e-mail address,

• parts of the present registration which apply to other registrants.

Mention the number(s) given in this Annex or Annexes VII to X, as appropriate.

Any other registrant shall identify the lead registrant submitting on his behalf specifying:

• his name, address, telephone number, fax number and e-mail address,

• parts of the registration which are submitted by the lead registrant.

Mention the number(s) given in this Annex or Annexes VII to X, as appropriate.

1.3 Third party appointed under Article 4 U.K.

1.3.1. Name, address, telephone number, fax number and e-mail address U.K.

1.3.2. Contact person 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.

3. INFORMATION ON MANUFACTURE AND USE(S) OF THE SUBSTANCE(S) U.K.

[F2 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.]

Textual Amendments

F2 Inserted 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).

3.1. Overall manufacture, quantities used for production of an article that is subject to registration, and/or imports in tonnes per registrant per year in: U.K.

the calendar year of the registration (estimated quantity)

3.2. In the case of a manufacturer or producer of articles: brief description of the technological process used in manufacture or production of articles. U.K.

Precise details of the process, particularly those of a commercially sensitive nature, are not required.

3.3. An indication of the tonnage used for his own use(s) U.K.

3.4. Form (substance, [F3 mixture] or article) and/or physical state under which the substance is made available to downstream users. Concentration or concentration range of the substance in [F3 mixtures] made available to downstream users and quantities of the substance in articles made available to downstream users. U.K.

Textual Amendments

F3 Substituted by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).

3.5. Brief general description of the identified use(s) U.K.

3.6. Information on waste quantities and composition of waste resulting from manufacture of the substance, the use in articles and identified uses U.K.

3.7. Uses advised against [F4 (see Section 1 of the safety data sheet)] U.K.

Where applicable, an indication of the uses which the registrant advises against and why (i.e. non-statutory recommendations by supplier). This need not be an exhaustive list.

Textual Amendments

F4 Substituted by Commission Regulation (EU) No 453/2010 of 20 May 2010 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance).

4. CLASSIFICATION AND LABELLING U.K.

[F3 4.1 The hazard classification of the substance(s), resulting from the application of Title I and II of Regulation (EC) No 1272/2008 for all hazard classes and categories in that Regulation, U.K.

In addition, for each entry, the reasons why no classification is given for a hazard class or differentiation of a hazard class should be provided (i.e. if data are lacking, inconclusive, or conclusive but not sufficient for classification),

4.2 The resulting hazard label for the substance(s), resulting from the application of Title III of Regulation (EC) No 1272/2008, U.K.

[F3 4.3 Specific concentration limits, where applicable, resulting from the application of Article 10 of Regulation (EC) No 1272/2008.] ] U.K.

5. GUIDANCE ON SAFE USE CONCERNING: U.K.

[F1 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.]

5.1. First-aid measures (Safety Data Sheet heading 4) U.K.

5.2. Fire-fighting measures (Safety Data Sheet heading 5) U.K.

5.3. Accidental release measures (Safety Data Sheet heading 6) U.K.

5.4. Handling and storage (Safety Data Sheet heading 7) U.K.

5.5. Transport information (Safety Data Sheet heading 14) U.K.

Where a Chemical Safety Report is not required, the following additional information is required:

5.6. Exposure controls/personal protection (Safety Data Sheet heading 8) U.K.

5.7. Stability and reactivity (Safety Data Sheet heading 10) U.K.

5.8. Disposal considerations U.K.

5.8.1. Disposal considerations (Safety Data Sheet heading 13) U.K.

5.8.2. Information on recycling and methods of disposal for industry U.K.

5.8.3. Information on recycling and methods of disposal for the public. U.K.

6. INFORMATION ON EXPOSURE FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES PER YEAR PER MANUFATCURER OR IMPORTER U.K.

[F2 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.]

6.1. Main use category: U.K.

6.1.1.

(a)

industrial use; and/or

(b)

professional use; and/or

(c)

consumer use.

6.1.2. Specification for industrial and professional use: U.K.

(a)

used in closed system; and/or

(b)

use resulting in inclusion into or onto matrix; and/or

(c)

non-dispersive use; and/or

(d)

dispersive use.

6.2. Significant route(s) of exposure: U.K.

6.2.1. Human exposure: U.K.

(a)

oral; and/or

(b)

dermal; and/or

(c)

inhalatory.

6.2.2. Environmental exposure: U.K.

(a)

water; and/or

(b)

air; and/or

(c)

solid waste; and/or

(d)

soil.

6.3. Pattern of exposure: U.K.

(a)

accidental/infrequent; and/or

(b)

occasional; and/or

(c)

continuous/frequent.]

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).