INFORMATION REFERRED TO IN ARTICLE 10(a) (i) TO (v)
INFORMATION REFERRED TO IN ARTICLE 10(a) (i) TO (v)
1.1. Registrant
1.1.1. Name, address, telephone number and email address
1.1.2. Contact person
1.1.3. Location of the registrant's production and own use site(s), as appropriate
1.1.4. Where an only representative has been appointed in accordance with Article 8(1), the following information regarding the natural or legal person established outside the Union who appointed the only representative: name, address, telephone number, email address, contact person, location of the production site(s) or formulation site(s), as appropriate, company website, as appropriate and national company identification number(s), as appropriate.
1.2. Joint submission of data
Articles 11 and 19 provide for the possibility for the lead registrant to submit parts of the registration information on behalf of other member registrants.
When, in accordance with Article 11(1), the lead registrant submits information referred to in Article 10, point (a)(iv), (vi), (vii) and (ix), the lead registrant shall describe the composition(s), nanoform or set of similar nanoforms to which this information relates in accordance with points 2.3.1 to 2.3.4 and subsection 2.4 of this Annex. Each member registrant relying on information submitted by the lead registrant shall indicate which information thus submitted pertains to which composition, nanoform or set of similar nanoforms of the substance that the registrant identifies in accordance with Article 10, point (a)(ii), and Article 11(1).
When, in accordance with Article 11(3), a registrant submits information referred to in Article 10, point (a)(iv), (vi), (vii) or (ix), separately, this registrant shall describe the composition(s), nanoform or set of similar nanoforms of the substance to which this information relates in accordance with points 2.3.1 to 2.3.4 and subsection 2.4 of this Annex.
1.3 Third party appointed under Article 4
1.3.1. Name, address, telephone number and email address
1.3.2. Contact person
2. IDENTIFICATION OF THE SUBSTANCE
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.
2.1. Name and any other identifier of each substance
2.1.1. Name(s) in the IUPAC nomenclature. If unavailable, other international chemical name(s)
2.1.2. Other names (usual name, trade name, abbreviation)
2.1.3. EC number, i.e. Einecs, Elincs or NLP number, or the number assigned by the Agency (if available and appropriate)
2.1.4. CAS name and CAS number (if available)
2.1.5. Other identity code, such as customs number (if available)
2.2. Information related to molecular and structural formula or crystal structure of each substance
2.2.1. Molecular formula and structural formula (including SMILES notation and other representation if available) and description of crystal structure(s)
2.2.2. Information on optical activity and typical ratio of (stereo) isomers (if applicable and appropriate)
2.2.3. Molecular weight or molecular weight range
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 (%), if applicable
2.3.2. Names of constituents and impurities
In the case of a substance of unknown or variable composition, complex reaction products or biological materials (UVCB):
2.3.3. Typical concentration and concentration range (in percentage) of constituents, groups of constituents that cannot be identified individually and impurities as specified in point 2.3.2
2.3.4. Names and typical concentration and concentration range (in percentage) of additives
2.3.5. All necessary qualitative analytical data specific for the identification of the substance, such as ultra-violet, infra-red, nuclear magnetic resonance, mass spectrum or diffraction data
2.3.6. All necessary quantitative analytical data specific for the identification of the substance, such as chromatographic, titrimetric, elemental analysis or diffraction data
2.3.7. Description of the analytical methods or the appropriate bibliographical references that are necessary for the identification of the substance (including the identification and quantification of its constituents and, where appropriate, its impurities and additives). The description shall consist of the experimental protocols followed and the relevant interpretation of the results reported under points 2.3.1 to 2.3.6. 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 subsection (2.4). The description shall consist of the experimental protocols followed and the relevant interpretation of the results reported under points 2.4.2 to 2.4.5. This information shall be sufficient to allow the methods to be reproduced.
2.5. Any other available information relevant for the identification of the substance
3. 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.
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:
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.
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)
3.4. Form (substance, ►M3 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 ►M3 mixtures ◄ made available to downstream users and quantities of the substance in articles made available to downstream users.
3.5. General description of the identified use(s)
3.6. Information on waste quantities and composition of waste resulting from manufacture of the substance, the use in articles and identified uses
3.7. Uses advised against ►M7 (see Section 1 of the safety data sheet) ◄
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.
4. CLASSIFICATION AND LABELLING
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,
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,
4.3 Specific concentration limits, where applicable, resulting from the application of Article 10 of Regulation (EC) No 1272/2008.
5. GUIDANCE ON SAFE USE CONCERNING:
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)
5.2. Fire-fighting measures (Safety Data Sheet heading 5)
5.3. Accidental release measures (Safety Data Sheet heading 6)
5.4. Handling and storage (Safety Data Sheet heading 7)
5.5. Transport information (Safety Data Sheet heading 14)
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)
5.7. Stability and reactivity (Safety Data Sheet heading 10)
5.8. Disposal considerations
5.8.1. Disposal considerations (Safety Data Sheet heading 13)
5.8.2. Information on recycling and methods of disposal for industry
5.8.3. Information on recycling and methods of disposal for the public.
6. INFORMATION ON EXPOSURE FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES PER YEAR PER MANUFATCURER 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.
6.1. Main use category:
6.1.1.
industrial use; and/or
professional use; and/or
consumer use.
6.1.2. Specification for industrial and professional use:
used in closed system; and/or
use resulting in inclusion into or onto matrix; and/or
non-dispersive use; and/or
dispersive use.
6.2. Significant route(s) of exposure:
6.2.1. Human exposure:
oral; and/or
dermal; and/or
inhalatory.
6.2.2. Environmental exposure:
water; and/or
air; and/or
solid waste; and/or
soil.
6.3. Pattern of exposure:
accidental/infrequent; and/or
occasional; and/or
continuous/frequent.