[X1 [F13. INFORMATION RELEVANT FOR THE SCREENING AND ASSESSMENT OF P, vP, B, vB and T PROPERTIES U.K.
3.1. Screening Information U.K.
The following information shall be considered for screening for P, vP, B, vB and T properties in the cases referred to in the second paragraph of Section 2.1 and may be considered for screening for P, vP, B, vB and T properties in the context of Section 2.2.
3.1.1. Indication of P and vP properties U.K.
Results from tests on ready biodegradation in accordance with Section 9.2.1.1 of Annex VII;
Results from other screening tests (e.g. enhanced ready test, tests on inherent biodegradability);
Results obtained from biodegradation (Q)SAR models in accordance with Section 1.3 of Annex XI;
Other information provided that its suitability and reliability can be reasonably demonstrated.
3.1.2. Indication of B and vB properties U.K.
Octanol-water partitioning coefficient experimentally determined in accordance with Section 7.8 of Annex VII or estimated by (Q)SAR models in accordance with Section 1.3 of Annex XI;
Other information provided that its suitability and reliability can be reasonably demonstrated.
3.1.3. Indication of T properties U.K.
Short-term aquatic toxicity in accordance with Section 9.1 of Annex VII and Section 9.1.3 of Annex VIII;
Other information provided that its suitability and reliability can be reasonably demonstrated.
3.2. Assessment Information U.K.
The following information shall be considered for the assessment of P, vP, B, vB and T properties, using a weight-of-evidence approach.
3.2.1. Assessment of P or vP properties U.K.
Results from simulation testing on degradation in surface water;
Results from simulation testing on degradation in soil;
Results from simulation testing on degradation in sediment;
Other information, such as information from field studies or monitoring studies, provided that its suitability and reliability can be reasonably demonstrated.
3.2.2. Assessment of B or vB properties U.K.
Results from a bioconcentration or bioaccumulation study in aquatic species;
Other information on the bioaccumulation potential provided that its suitability and reliability can be reasonably demonstrated, such as:
Results from a bioaccumulation study in terrestrial species;
Data from scientific analysis of human body fluids or tissues, such as blood, milk, or fat;
Detection of elevated levels in biota, in particular in endangered species or in vulnerable populations, compared to levels in their surrounding environment;
Results from a chronic toxicity study on animals;
Assessment of the toxicokinetic behaviour of the substance;
Information on the ability of the substance to biomagnify in the food chain, where possible expressed by biomagnification factors or trophic magnification factors.
3.2.3. Assessment of T properties U.K.
Results from long-term toxicity testing on invertebrates as set out in Section 9.1.5 of Annex IX;
Results from long-term toxicity testing on fish as set out in Section 9.1.6 of Annex IX;
Results from growth inhibition study on aquatic plants as set out in in Section 9.1.2 of Annex VII;
The substance meeting the criteria for classification as carcinogenic in Category 1A or 1B (assigned hazard phrases: H350 or H350i), germ cell mutagenic in Category 1A or 1B (assigned hazard phrase: H340), toxic for reproduction in Category 1A, 1B and/or 2 (assigned hazard phrases: H360, H360F, H360D, H360FD, H360Fd, H360fD, H361, H361f, H361d or H361fd), specific target organ toxic after repeated dose in Category 1 or 2 (assigned hazard phrase: H372 or H373), according to Regulation EC No 1272/2008;
Results from long-term or reproductive toxicity testing with birds as set out in Section 9.6.1 of Annex X;
Other information provided that its suitability and reliability can be reasonably demonstrated.] ]
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).
Textual Amendments