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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

9.1.

Aquatic toxicity

F19.1.1.

Short-term toxicity testing on invertebrates (preferred species Daphnia )

The registrant may consider long-term toxicity testing instead of short-term.

9.1.1.

The study does not need to be conducted if:

  • there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes,

  • a long-term aquatic toxicity study on invertebrates is available, or

  • adequate information for environmental classification and labelling is available.

For nanoforms, the study may not be waived on the basis of high insolubility in water alone.

The long-term aquatic toxicity study on Daphnia (Annex IX, section 9.1.5.) shall be considered if the substance is poorly water soluble, or for nanoforms if they have low dissolution rate in the relevant test media.

9.1.2.

Growth inhibition study aquatic plants (algae preferred)

9.1.2.

The study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes.

For nanoforms, the study may not be waived on the basis of high insolubility in water alone.

9.2.

Degradation

9.2.1.

Biotic

9.2.1.1.

Ready biodegradability

9.2.1.1.

The study does not need to be conducted if the substance is inorganic.

Annotations

Textual amendments

F1

Substituted 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).

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 VII

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.