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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)
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There are currently no known outstanding effects for the Regulation (EC) No 1907/2006 of the European Parliament and of the Council,
ANNEX VII
.
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Editorial Information
X1Substituted 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).
Column 1 of this Annex establishes the standard information required for:
non-phase-in substances manufactured or imported in quantities of 1 to 10 tonnes;
phase-in substances manufactured or imported in quantities of 1 to 10 tonnes and meeting the criteria in Annex III in accordance with Article 12(1)(a) and (b); and
substances manufactured or imported in quantities of 10 tonnes or more.
Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. For substances not meeting the criteria in Annex III only the physicochemical requirements as set out in section 7 of this Annex are required.
Column 2 of this Annex lists specific rules according to which the required standard information may be omitted, replaced by other information, provided at a different stage or adapted in another way. If the conditions are met under which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration dossier.
[F1Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.]
Textual Amendments
F1 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).
In addition to these specific rules, a registrant may adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex XI with the exception of Section 3 on substance-tailored exposure waiving. In this case as well, he shall clearly state the reasons for any decision to adapt the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annex XI (2) .
Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.
When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.
COLUMN 1 STANDARD INFORMATION REQUIRED | COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 |
---|---|
7.1. State of the substance at 20 °C and 101,3 kPa | |
7.2. Melting/freezing point | 7.2. The study does not need to be conducted below a lower limit of - 20 °C. |
7.3. Boiling point | 7.3. The study does not need to be conducted:
|
7.4. Relative density | 7.4. The study does not need to be conducted if:
|
7.5. Vapour pressure | 7.5. The study does not need to be conducted if the melting point is above 300 °C.If the melting point is between 200 °C and 300 °C, a limit value based on measurement or a recognised calculation method is sufficient. |
7.6. Surface tension | 7.6. The study need only be conducted if:
If the water solubility is below 1 mg/l at 20 °C the test does not need to be conducted. |
[F27.7. Water solubilityFor nanoforms, in addition the testing of dissolution rate in water as well as in relevant biological and environmental media shall be considered. | 7.7. The study does not need to be conducted if:
If the substance appears ‘ insoluble ’ in water, a limit test up to the detection limit of the analytical method shall be performed. For nanoforms the potential confounding effect of dispersion shall be assessed when conducting the study.] |
[F27.8. Partition coefficient n-octanol/water | 7.8. The study does not need to be conducted if the substance is inorganic. If the test cannot be performed (e.g. the substance decomposes, has a high surface activity, reacts violently during the performance of the test or does not dissolve in water or in octanol, or it is not possible to obtain a sufficiently pure substance), a calculated value for log P as well as details of the calculation method shall be provided.For nanoforms the potential confounding effect of dispersion in octanol and water shall be assessed when conducting the study. For nanoforms, whether of inorganic or organic substances, for which the partition coefficient n-octanol/water is not applicable the study of dispersion stability shall be considered instead.] |
7.9. Flash-point | 7.9. The study does not need to be conducted if:
|
7.10. Flammability | 7.10. The study does not need to be conducted:
|
7.11. Explosive properties | 7.11. The study does not need to be conducted if:
Note : Neither a test for propagation of detonation nor a test for sensitivity to detonative shock is required if the exothermic decomposition energy of organic materials is less than 800 J/g. |
7.12. Self-ignition temperature | 7.12. The study does not need to be conducted:
|
7.13. Oxidising properties | 7.13. The study does not need to be conducted if:
The full test does not need to be conducted for solids if the preliminary test clearly indicates that the test substance has oxidising properties. Note that as there is no test method to determine the oxidising properties of gaseous mixtures, the evaluation of these properties must be realised by an estimation method based on the comparison of the oxidising potential of gases in a mixture with that of the oxidising potential of oxygen in air. |
7.14. Granulometry | 7.14. The study does not need to be conducted if the substance is marketed or used in a non solid or granular form. |
[F17.14 bis. DustinessFor nanoforms | 7.14 bis. The study does not need to be conducted if exposure to granular form of the substance during its life-cycle can be excluded.] |
COLUMN 1 STANDARD INFORMATION REQUIRED | COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 |
---|---|
[F38.1. Skin corrosion/irritation | 8.1. The study/ies do(es) not need to be conducted if:
If results from one of the two studies under point 8.1.1 or 8.1.2 already allow a conclusive decision on the classification of a substance or on the absence of skin irritation potential, the second study need not be conducted. |
8.1.1. Skin corrosion, in vitro | |
8.1.2. Skin irritation, in vitro | |
8.2. Serious eye damage/eye irritation | 8.2. The study/ies do(es) not need to be conducted if:
|
8.2.1. Serious eye damage/eye irritation, in vitro | 8.2.1. If results from a first in vitro study do not allow a conclusive decision on the classification of a substance or on the absence of eye irritation potential, (an)other in vitro study/ies) for this endpoint shall be considered.] |
[X28.3. Skin sensitisationInformation allowing:
| The study(ies) under point 8.3.1 and 8.3.2 do not need to be conducted if:
|
8.3.1. Skin sensitisation, in vitro/in chemicoInformation from in vitro/in chemico test method(s) recognised according to Article 13(3), addressing each of the following key events of skin sensitisation: (a) molecular interaction with skin proteins; (b) inflammatory response in keratinocytes; (c) activation of dendritic cells. | The(se) test(s) do not need to be conducted if:
If information from test method(s) addressing one or two of the key events in column 1 already allows classification and risk assessment according to point 8.3, studies addressing the other key event(s) need not be conducted. |
8.3.2. Skin sensitisation, in vivo | An in vivo study shall be conducted only if in vitro/in chemico test methods described under point 8.3.1 are not applicable, or the results obtained from those studies are not adequate for classification and risk assessment according to point 8.3. The murine local lymph node assay (LLNA) is the first-choice method for in vivo testing. Only in exceptional circumstances should another test be used. Justification for the use of another in vivo test shall be provided. In vivo skin sensitisation studies that were carried out or initiated before 10 May 2017 , and that meet the requirements set out in Article 13(3), first subparagraph, and Article 13(4) shall be considered appropriate to address this standard information requirement.] |
8.4. Mutagenicity | 8.4. Further mutagenicity studies shall be considered in case of a positive result. |
[F28.4.1. In vitro gene mutation study in bacteria | 8.4.1. The study does not need to be conducted for nanoforms where it is not appropriate. In this case other studies involving one or more in vitro mutagenicity study(ies) in mammalian cells (Annex VIII, sections 8.4.2. and 8.4.3 or other internationally recognised in vitro methods) shall be provided.] |
8.5. Acute toxicity | 8.5. The study/ies do(es) not generally need to be conducted if:
|
[F28.5.1. By oral route | 8.5.1. The study need not be conducted ifa study on acute toxicity by the inhalation route (8.5.2) is available. For nanoforms, a study by the oral route shall be replaced by a study by the inhalation route (8.5.2), unless exposure of humans via inhalation is unlikely, taking into account the possibility of exposure to aerosols, particles or droplets of an inhalable size.] |
COLUMN 1 STANDARD INFORMATION REQUIRED | COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 |
---|---|
9.1. Aquatic toxicity | |
[F29.1.1. Short-term toxicity testing on invertebrates (preferred species Daphnia )The registrant may consider long-term toxicity testing instead of short-term. | 9.1.1. The study does not need to be conducted if:
For nanoforms, the study may not be waived on the basis of high insolubility in water alone. The long-term aquatic toxicity study on Daphnia (Annex IX, section 9.1.5.) shall be considered if the substance is poorly water soluble, or for nanoforms if they have low dissolution rate in the relevant test media.] |
[F29.1.2. Growth inhibition study aquatic plants (algae preferred) | 9.1.2. The study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes.For nanoforms, the study may not be waived on the basis of high insolubility in water alone.] |
9.2. Degradation | |
9.2.1. Biotic | |
9.2.1.1. Ready biodegradability | 9.2.1.1. The study does not need to be conducted if the substance is inorganic. |
Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided.]
[X1This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.]
[X1Note: conditions for not requiring a specific test that are set out in [regulations under] Article 13(3) that are not repeated in column 2, also apply.]
Editorial Information
X1Substituted 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).
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