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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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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. |
[F17.7. 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.] |
[F17.8. 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. |
[F27.14 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.] ] |
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).
[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.]
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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