Regulation (EC) No 648/2004 of the European Parliament and of the CouncilShow full title

ANNEX IV U.K. COMPLEMENTARY RISK ASSESSMENT FOR SURFACTANTS IN DETERGENTS

For those surfactants for which an environmental risk assessment is available in the context of [F1 the 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

F1 Words 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 [F2 the 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

F2 Words 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 [F3 competent 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

F3 Words 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. [F4 If 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

F4 Words 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

F5 Words 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)

1. Identity of the surfactant F6 .... U.K.

1.1. Name U.K.

1.1.1. Names in the IUPAC nomenclature U.K.

1.1.2. Other names U.K.

1.1.3. CAS number and CAS name (if available) U.K.

1.1.4. Einecs(1) or Elincs(2) numbers (if available) U.K.

1.2. Molecular and structural formula U.K.

1.3. Composition of the surfactant U.K.

Textual Amendments

F6 Words 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)

2. Information on the surfactant U.K.

2.1. Quantities of the surfactant used in detergents U.K.

2.2. The information on use patterns given in this section shall be sufficient to allow an approximate but realistic estimate of function and environmental exposure to the surfactant as associated with its use in detergents. It shall include the following: U.K.

• 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.

3. Information on the potential recalcitrant metabolites U.K.

Toxicity information on test liquors shall be provided. F7 ...

Textual Amendments

F7 Words 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)

[F8 If 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

F8 Words 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.]

4. Additional studies U.K.

4.1. Biodegradability tests U.K.

4.1.1. Pre-adapted inoculum U.K.

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.

4.1.2. Inherent Biodegradability Tests U.K.

At least one of the tests referred to below shall be included:

• [F9 method of EU Regulation 440/2008, Annex, Part C, C.12. (biodegradation – modified SCAS test). ]

• [F10 method of EU Regulation 440/2008, Annex, Part C, C.9. (biodegradation – Zahn-Wellens test).]

Textual Amendments

F9 Words 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)

F10 Words 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.

4.1.3. Activated Sludge Simulation Biodegradability Tests U.K.

The following tests referred below shall be included:

• [F11 method of EU Regulation 440/2008, Annex, Part C, C.10. (biodegradation – activated sludge simulation tests).]

Textual Amendments

F11 Words 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.

4.2. Toxicity testing of biodegradation test liquors U.K.

Toxicity information on test liquors is to be provided on:

4.2.1. Chemical and physical information, such as: U.K.

• 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.).

4.2.2. Effects on organisms. Tests to be conducted in compliance with the principles of good laboratory practice. U.K.

Fish: the test recommended is that in [F12 EU Regulation 440/2008, Annex, Part C, C.1. (acute toxicity for fish)]

Textual Amendments

F12 Words 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 [F13 EU Regulation 440/2008, Annex, Part C, C.2. (daphnia SP. acute immobilisation test)]

Textual Amendments

F13 Words 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 [F14 EU Regulation 440/2008, Annex, Part C, C.3. (algal inhibition test)]

Textual Amendments

F14 Words 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 [F15 EU Regulation 440/2008, Annex, Part C, C.11. (biodegradation – activated sludge respiration inhibition)]

Textual Amendments

F15 Words 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)

4.2.3. Degradation U.K.

Biotic: the test recommended is that in [F16 EU Regulation 440/2008, Annex, Part C, C.5. (degradation – biochemical oxygen demand)]

Textual Amendments

F16 Words 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 [F17 EU 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

F17 Words 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

F18 Words 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)

(1)

European Inventory of Existing Commercial Substances.

(2)

European List of Notified Chemical Substances.