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Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (Text with EEA relevance)
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There are currently no known outstanding effects for the Regulation (EC) No 648/2004 of the European Parliament and of the Council, ANNEX IV.
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For those surfactants for which an environmental risk assessment is available in the context of [F1the REACH Regulation], and Technical Guidance Documents, this risk assessment shall be considered together with the complementary risk assessment run in the scope of this Regulation.
Textual Amendments
F1Words in Annex 4 substituted (31.12.2020) by The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(2); 2020 c. 1, Sch. 5 para. 1(1)
The complementary risk assessment run in the scope of this Regulation, in case it is likely that recalcitrant metabolites are produced, shall be considered in the context of assessments made on the basis of [F2the REACH Regulation]. This is to be assessed case by case and in particular on the basis of the results of the tests referred to in part 3.
Textual Amendments
F2Words in Annex 4 substituted (31.12.2020) by The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(3); 2020 c. 1, Sch. 5 para. 1(1)
The study shall cover the aquatic environmental compartment. Additional information relating to specific risk assessment concerns might be required by the [F3competent authority] on a case by case basis. Additional information might include other environmental compartments such as sewage sludge and soil. A tiered approach shall be adopted concerning the information required for the technical file referred to in Articles 5 and 9. The file shall contain at least the information described under points 1, 2 and 3 below.
Textual Amendments
F3Words in Annex 4 substituted (31.12.2020) by The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(4); 2020 c. 1, Sch. 5 para. 1(1)
However, to minimise testing, and especially to avoid unnecessary animal testing, the additional studies listed under point 4.2.2 should be requested only where such information is necessary and proportionate. [F4If the manufacturer disputes the competent authority's view concerning the extent of the additional information required, it may submit the case to the Secretary of State for a decision. The Secretary of State must:
— within 90 days of the manufacturer submitting the case, make a decision as to the extent of additional information required;
— take appropriate expert advice and take that advice into account when coming to a decision;
— after taking a decision, promptly communicate it to the manufacturer and the competent authority.]
Textual Amendments
F4Words in Annex 4 substituted (31.12.2020) by The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(5); 2020 c. 1, Sch. 5 para. 1(1)
F5...
Textual Amendments
F5Words in Annex 4 omitted (31.12.2020) by virtue of The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(6); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F6Words in Annex 4 point 1 heading omitted (31.12.2020) by virtue of The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(7); 2020 c. 1, Sch. 5 para. 1(1)
importance of the application (societal value),
use conditions (release scenario),
use volume,
availability and suitability of alternatives (performance and economic considerations),
assessment of relevant environmental information.
Toxicity information on test liquors shall be provided. F7...
Textual Amendments
F7Words in Annex 4 point 3 omitted (31.12.2020) by virtue of The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(8)(a); 2020 c. 1, Sch. 5 para. 1(1)
[F8If no data are available on residue identity then, depending on the potential risk and the importance and quantity of the surfactant used in detergents, the competent authority may require the manufacturer to provide it with the information referred to in point 4.2.1.
Textual Amendments
F8Words in Annex 4 point 3 inserted (31.12.2020) by The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(8)(b); 2020 c. 1, Sch. 5 para. 1(1)
If the competent authority requires the manufacturer to provide that information and the manufacturer takes the view that the provision of that information is unnecessary, it may submit the case to the Secretary of State for a decision. The Secretary of State must:
— within 90 days of the manufacturer submitting the case, make a decision as to whether or not the provision of the information is necessary;
— take appropriate expert advice and take that advice into account when coming to a decision;
— after taking a decision, promptly communicate it to the manufacturer.]
Any of the tests described in Annex III, may be run with pre adapted inoculum in order to provide evidence of the relevance of pre-adaptation for the surfactant.
At least one of the tests referred to below shall be included:
[F9method of EU Regulation 440/2008, Annex, Part C, C.12. (biodegradation – modified SCAS test). ]
[F10method of EU Regulation 440/2008, Annex, Part C, C.9. (biodegradation – Zahn-Wellens test).]
Textual Amendments
F9Words in Annex 4 point 4.1.2 substituted (31.12.2020) by The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(9)(a); 2020 c. 1, Sch. 5 para. 1(1)
F10Words in Annex 4 point 4.1.2 substituted (31.12.2020) by The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(9)(b); 2020 c. 1, Sch. 5 para. 1(1)
Failure to pass the inherent biodegradability test would indicate potential for persistency which may be considered, in general terms, as sufficient to prohibit the placing on the market of such a surfactant except in cases where the criteria set out in Article 6 indicate that there is no justification for refusing a derogation.
The following tests referred below shall be included:
[F11method of EU Regulation 440/2008, Annex, Part C, C.10. (biodegradation – activated sludge simulation tests).]
Textual Amendments
F11Words in Annex 4 point 4.1.3 substituted (31.12.2020) by The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(10); 2020 c. 1, Sch. 5 para. 1(1)
Failure to pass the activated sludge simulation biodegradability test would indicate potential for the release of the metabolites by sewage treatment, which may be considered, in general terms, as evidence of need for a more complete risk assessment.
Toxicity information on test liquors is to be provided on:
identity of the metabolite (and analytical means by which it was obtained);
key physical chemical properties (water solubility, Octanol: Water partition coefficient (Log Po/w, etc.).
Fish: the test recommended is that in [F12EU Regulation 440/2008, Annex, Part C, C.1. (acute toxicity for fish)]
Textual Amendments
F12Words in Annex 4 point 4.2.2 substituted (31.12.2020) by The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(11)(a); 2020 c. 1, Sch. 5 para. 1(1)
Daphnia: the test recommended is that in [F13EU Regulation 440/2008, Annex, Part C, C.2. (daphnia SP. acute immobilisation test)]
Textual Amendments
F13Words in Annex 4 point 4.2.2 substituted (31.12.2020) by The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(11)(b); 2020 c. 1, Sch. 5 para. 1(1)
Algae: the test recommended is that in [F14EU Regulation 440/2008, Annex, Part C, C.3. (algal inhibition test)]
Textual Amendments
F14Words in Annex 4 point 4.2.2 substituted (31.12.2020) by The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(11)(c); 2020 c. 1, Sch. 5 para. 1(1)
Bacteria: the test recommended is that in [F15EU Regulation 440/2008, Annex, Part C, C.11. (biodegradation – activated sludge respiration inhibition)]
Textual Amendments
F15Words in Annex 4 point 4.2.2 substituted (31.12.2020) by The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(11)(d); 2020 c. 1, Sch. 5 para. 1(1)
Biotic: the test recommended is that in [F16EU Regulation 440/2008, Annex, Part C, C.5. (degradation – biochemical oxygen demand)]
Textual Amendments
F16Words in Annex 4 point 4.2.3 substituted (31.12.2020) by The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(12)(a); 2020 c. 1, Sch. 5 para. 1(1)
Abiotic: the test recommended is that in [F17EU Regulation 440/2008, Annex, Part C, C.7. (degradation – abiotic degradation: hydrolysis as a function of PH)]. The information to be provided will consider as well the potential of metabolites for bio-concentration and their partitioning to the sediment phase.
Textual Amendments
F17Words in Annex 4 point 4.2.3 substituted (31.12.2020) by The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(12)(b); 2020 c. 1, Sch. 5 para. 1(1)
Moreover, if some metabolites are suspected for endocrine disrupting activity, it is recommended to determine if these have potential to result in adverse affects as soon as validated testing schemes to assess such adverse effects are available.
F18...
Textual Amendments
F18Words in Annex 4 omitted (31.12.2020) by virtue of The Detergents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/672), regs. 1, 26(13); 2020 c. 1, Sch. 5 para. 1(1)
European Inventory of Existing Commercial Substances.
European List of Notified Chemical Substances.
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