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Division 9 ECOTOXICOLOGICAL INFORMATIONX1

United Kingdom

Original text. Later amendments are not shown.

COLUMN 1 STANDARD INFORMATION REQUIRED COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

9.2.

Degradation

9.2.

Further biotic degradation testing shall be proposed if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance and its degradation products. The choice of the appropriate test(s) depends on the results of the chemical safety assessment and may include simulation testing in appropriate media (e.g. water, sediment or soil).

9.2.1.

Biotic

9.3. Fate and behaviour in the environment

9.3.4.

Further information on the environmental fate and behaviour of the substance and/or degradation products

9.3.4.

Further testing shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if the chemical safety assessment according to Annex I indicates the need to investigate further the fate and behaviour of the substance. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.

9.4.

Effects on terrestrial organisms

9.4.

Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment according to Annex I indicates the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms. The choice of the appropriate test(s) depends on the outcome of the chemical safety assessment.

These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.

9.4.4.

Long-term toxicity testing on invertebrates, unless already provided as part of Annex IX requirements.

9.4.6.

Long-term toxicity testing on plants, unless already provided as part of Annex IX requirements.

9.5.1.

Long-term toxicity to sediment organisms

9.5.1.

Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment indicates the need to investigate further the effects of the substance and/or relevant degradation products on sediment organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.

9.6.1.

Long-term or reproductive toxicity to birds

9.6.1.

Any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level.

Annotations

Editorial notes

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).

Notes on the whole EU Regulation

Textual amendments

F1

Substituted by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).

Notes on Annex X

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).

Footnotes

f1

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.

f2

Note: 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.