in force 2022-10-14 MODIFIED+3,245 −962§
Amended by Regulation (EU) 2022/477 32022R0477
applies from: unchanged
Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.
Section 1 drops the fax number from contact details, adds a new point 1.1.4 requiring information on an only representative appointed under Article 8(1), and rewrites the joint submission rules of point 1.2 to describe, by reference to Article 11(1) and Article 11(3), how lead and member registrants must indicate which composition, nanoform or set of similar nanoforms specific submitted information pertains to.
Section 2 replaces the prior identity and composition sub-points with new wording, including a revised EC number description, a new distinction between UVCB and other substances with detailed constituent and impurity naming and concentration rules in points 2.3.2 to 2.3.4, expanded qualitative and quantitative analytical data requirements in points 2.3.5 and 2.3.6, a reworded analytical methods description in 2.3.7, an added crystal structure element in point 2.2.1, and a new point 2.5 requiring any other available information relevant to identification of the substance.
Section 3 changes point 3.5 from a brief general description of identified uses to a general description of identified uses, while the fax number is likewise removed from point 1.3.1's contact details.
Cited: Annex VI, v2 · Annex VI, v1
text before / after
02006R1907-20220501 → 02006R1907-20221014
ANNEX VI
INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10
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 … 1,135 unchanged words … 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.
INFORMATION REFERRED TO IN ARTICLE 10(a) (i) TO (v)
1. GENERAL REGISTRANT INFORMATION
1.1. Registrant
1.1.1. Name, address, telephone number, fax number and e-mail 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 or and 19 foresee that provide for the possibility for the lead registrant to submit parts of the registration may be submitted by a lead registrant information on behalf of other member registrants.
In this case, 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 identify describe the other registrants specifying:
their name, address, telephone number, fax number 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 e-mail address,
parts subsection 2.4 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 Annex. Each member registrant shall identify the lead registrant submitting relying on his behalf specifying:
his name, address, telephone number, fax number and e-mail address,
parts of the registration which are information submitted by the lead registrant.
Mention registrant shall indicate which information thus submitted pertains to which composition, nanoform or set of similar nanoforms of the number(s) given 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 Annex registrant shall describe the composition(s), nanoform or Annexes VII set of similar nanoforms of the substance to X, as appropriate. 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, fax number and e-mail 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 or and any other identifier of each substance
2.1.1. Name(s) in the IUPAC nomenclature or nomenclature. If unavailable, other international chemical name(s)
2.1.2. Other names (usual name, trade name, abbreviation)
2.1.3. EINECS EC number, i.e. Einecs, Elincs or ELINCs 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 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, 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. Nature Names of impurities, including isomers constituents and by-products impurities
In the case of a substance of unknown or variable composition, complex reaction products or biological materials (UVCB):
names of constituents present at a concentration of ≥ 10 %;
names of known constituents present at a concentration of < 10 %;
for constituents that cannot be identified individually, description of groups of constituents based on chemical nature;
description of the origin or source and the manufacturing process
2.3.3. Percentage Typical concentration and concentration range (in percentage) of (significant) main constituents, groups of constituents that cannot be identified individually and impurities
as specified in point 2.3.2
2.3.4. Nature Names and order typical concentration and concentration range (in percentage) of magnitude (… ppm, … %) additives
2.3.5. All necessary qualitative analytical data specific for the identification of any additives (e.g. stabilising agents or inhibitors)
2.3.5. Spectral data (e.g. the substance, such as ultra-violet, infra-red, nuclear magnetic resonance resonance, mass spectrum or mass spectrum) diffraction data
2.3.6. High-pressure liquid chromatogram, gas chromatogram 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, for the identification of its impurities and additives. 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 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. 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, 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 mixtures made available to downstream users and quantities of the substance in articles made available to downstream users.
3.5. Brief general 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 (see Section 1 of the safety data sheet)
Where applicable, an indication … 366 unchanged words … inclusion into or onto matrix; and/or
(c) non-dispersive use; and/or
(d) dispersive use.
6.2. Significant route(s) of exposure:
6.2.1. Human exposure:
(a) oral; and/or
(b) dermal; and/or
(c) inhalatory.
6.2.2. Environmental exposure:
(a) water; and/or
(b) air; and/or
(c) solid waste; and/or
(d) soil.
6.3. Pattern of exposure:
(a) accidental/infrequent; and/or
(b) occasional; and/or
(c) continuous/frequent.