Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilShow full title

COLUMN 1 STANDARD INFORMATION REQUIRED	COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1
[F1 9.1.3. Short-term toxicity testing on fish: the registrant may consider long-term toxicity testing instead of short-term.	9.1.3. The study does not need to be conducted if: there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance the substance is highly insoluble in water or the substance is unlikely to cross biological membranes, or a long-term aquatic toxicity study on fish is available. For nanoforms, the study may not be waived on the basis of high insolubility in water alone. Long-term aquatic toxicity testing as described in Annex IX shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further effects on aquatic organisms. The choice of the appropriate test(s) will depend on the results of the chemical safety assessment. The long-term aquatic toxicity study on fish (Annex IX, Section 9.1.6) shall be considered if the substance is poorly water soluble, or for nanoforms if they have low dissolution rate in the relevant test media.]
[F1 9.1.4. Activated sludge respiration inhibition testing	9.1.4. The study does not need to be conducted if: there is no emission to a sewage treatment plant, or there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the substance is highly insoluble in water, or the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant. For nanoforms, the study may not be waived on the basis of high insolubility in water alone. The study may be replaced by a nitrification inhibition test if available data show that the substance is likely to be an inhibitor of microbial growth or function, in particular nitrifying bacteria.]
[F1 9.2. Degradation	9.2. Further degradation testing shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance. For nanoforms that are not soluble, nor have high dissolution rate, such test(s) shall consider morphological transformation (e.g. irreversible changes in particle size, shape and surface properties, loss of coating), chemical transformation (e.g. oxidation, reduction) and other abiotic degradation (e.g. photolysis). The choice of the appropriate test(s) will depend on the results of the chemical safety assessment.]
[F1 9.2.2. Abiotic 9.2.2.1. Hydrolysis as a function of pH.	9.2.2.1. The study does not need to be conducted if: the substance is readily biodegradable, or the substance is highly insoluble in water. For nanoforms, the study may not be waived on the basis of high insolubility in water alone.]
9.3. Fate and behaviour in the environment
[F1 9.3.1. Adsorption/desorption screening	9.3.1. The study does not need to be conducted if: based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol-water partition coefficient), or the substance and its relevant degradation products decompose rapidly. For nanoforms, use of any physicochemical property (e.g. octanol-water partition coefficient) as a reason for waiving the study shall include adequate justification of its relevance to low potential for adsorption.] ]

(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).