Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilDangos y teitl llawn

[X1 7. INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE U.K.

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: for gases, or for solids which either melt above 300 °C or decompose before boiling. In such cases the boiling point under reduced pressure may be estimated or measured, or for substances which decompose before boiling (e.g. auto-oxidation, rearrangement, degradation, decomposition, etc.).
7.4. Relative density	7.4. The study does not need to be conducted if: the substance is only stable in solution in a particular solvent and the solution density is similar to that of the solvent. In such cases, an indication of whether the solution density is higher or lower than the solvent density is sufficient, or the substance is a gas. In this case, an estimation based on calculation shall be made from its molecular weight and the Ideal Gas Laws.
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: based on structure, surface activity is expected or can be predicted, or surface activity is a desired property of the material. If the water solubility is below 1 mg/l at 20 °C the test does not need to be conducted.
[F1 7.7. Water solubility For 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: the substance is hydrolytically unstable at pH 4, 7 and 9 (half-life less than 12 hours), or the substance is readily oxidisable in water. 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.]
[F1 7.8. 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: the substance is inorganic, or the substance only contains volatile organic components with flash-points above 100 °C for aqueous solutions, or the estimated flash-point is above 200 °C, or the flash-point can be accurately predicted by interpolation from existing characterised materials.
7.10. Flammability	7.10. The study does not need to be conducted: if the substance is a solid which possesses explosive or pyrophoric properties. These properties should always be considered before considering flammability, or for gases, if the concentration of the flammable gas in a mixture with inert gases is so low that, when mixed with air, the concentration is all time below the lower limit, or for substances which spontaneously ignite when in contact with air.
7.11. Explosive properties	7.11. The study does not need to be conducted if: there are no chemical groups associated with explosive properties present in the molecule, or the substance contains chemical groups associated with explosive properties which include oxygen and the calculated oxygen balance is less than -200, or the organic substance or a homogenous mixture of organic substances contains chemical groups associated with explosive properties, but the exothermic decomposition energy is less than 500 J/g and the onset of exothermic decomposition is below 500 °C, or for mixtures of inorganic oxidising substances (UN Division 5.1) with organic materials, the concentration of the inorganic oxidising substance is: less than 15 %, by mass, if assigned to UN Packaging Group I (high hazard) or II (medium hazard), less than 30 %, by mass, if assigned to UN Packaging Group III (low hazard). 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: if the substance is explosive or ignites spontaneously with air at room temperature, or for liquids non flammable in air, e.g. no flash point up to 200 °C, or for gases having no flammable range, or for solids, if the substance has a melting point ≤ 160 °C, or if preliminary results exclude self-heating of the substance up to 400 °C.
7.13. Oxidising properties	7.13. The study does not need to be conducted if: the substance is explosive, or the substance is highly flammable, or the substance is an organic peroxide, or the substance is incapable of reacting exothermically with combustible materials, for example on the basis of the chemical structure (e.g. organic substances not containing oxygen or halogen atoms and these elements are not chemically bonded to nitrogen or oxygen, or inorganic substances not containing oxygen or halogen atoms). 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.
[F2 7.14 bis. Dustiness For 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

X1 Substituted 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).

(1)

[X1 This 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

X1 Substituted 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).