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||INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10
GUIDANCE NOTE ON FULFILLING THE REQUIREMENTS OF ANNEXES VI
specify the information that shall be submitted for registration
purposes according to Articles 10
. 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
and the duty of care.
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
. 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 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.
STEP 2 — CONSIDER INFORMATION NEEDS
The registrant shall identify what information is required for the registration
. First, the relevant Annex or Annexes to be followed shall be identified, according to tonnage. These Annexes set out the
standard information requirements, but shall be considered in conjunction with Annex XI
, which allows variation from the standard approach, where it can be justified. In particular, information on exposure, use
and risk management measures shall be considered at this stage in order to determine the information needs for the substance.
STEP 3 — IDENTIFY INFORMATION GAPS
The registrant shall then compare the information needs for the substance with the information already available 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.
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
), or a testing strategy shall be proposed (Annexes IX
), 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.
In some cases, the rules set out in Annexes VII
may require certain tests to be undertaken earlier than or in addition to the standard requirements.
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.
INFORMATION REFERRED TO IN ARTICLE 10
(a) (i) TO (v)
1. GENERAL REGISTRANT INFORMATION
1.1.1. Name, address, telephone number, fax number and e-mail address
1.1.2. Contact person
1.1.3. Location of the registrant's production and own use site(s), as appropriate
1.2. Joint submission of data
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
, 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
, as appropriate.
1.3 Third party appointed under Article 4
1.3.1. Name, address, telephone number, fax number and e-mail address
1.3.2. Contact person
For each substance, the information given in this section shall be sufficient to enable each substance to be identified. 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 other identifier of each substance
2.1.1. Name(s) in the IUPAC
nomenclature or other international chemical name(s)
2.1.2. Other names (usual name, trade name, abbreviation)
or ELINCs number (if available and appropriate)
2.1.4. CAS name and CAS number (if available)
2.1.5. Other identity code (if available)
2.2. Information related to molecular and structural formula of each substance
2.2.1. Molecular and structural formula (including SMILES notation, if available)
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
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 (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.
3. INFORMATION ON MANUFACTURE AND USE(S) OF THE SUBSTANCE(S)
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:
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)
3.5. Brief 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
Where applicable, an indication of the uses which the registrant advises against and why (i.e. non-statutory recommendations
). 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 Articles 4 and 6 of Directive 67/548/EEC.
In addition, for each entry, the reasons why no classification is given for an endpoint 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 Articles 23, 24 and 25 of Directive 67/548/EEC.
4.3. Specific concentration limits
, where applicable, resulting from the application of Article 4(4) of Directive 67/548/EEC and Articles 4 to 7 of Directive
5. GUIDANCE ON SAFE USE CONCERNING:
Where a Chemical Safety Report is not required, the following additional information is required:
5.8. Disposal considerations
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.
6.1. Main use category:
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:
(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:
6.2.1. Human exposure:
(a) oral; and/or
(b) dermal; and/or
6.2.2. Environmental exposure:
(a) water; and/or
(b) air; and/or
(c) solid waste; and/or
6.3. Pattern of exposure:
(a) accidental/infrequent; and/or
(b) occasional; and/or