26.—(1) Annex 4 is amended as follows.
(2) In the first paragraph, for “Directive 93/67/EEC, or Regulation (EEC) No 793/93 and Regulation (EC) No 1488/94”, substitute “ the REACH Regulation ”.
(3) In the second paragraph, for “Directive 93/67/EEC, or Regulation (EEC) No 793/93”, substitute “ the REACH Regulation ”.
(4) In the third paragraph, for “Committee referred to in Article 12(2)”, substitute “ competent authority ”.
(5) In the fourth paragraph, for the second sentence, substitute—
“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.”.
(6) Omit the fifth paragraph.
(7) In point 1, in the heading, omit “(in accordance with the provisions laid down by Annex VII.A of Directive 67/548/EEC)”.
(8) In point 3—
(a)omit the second and third sentences;
(b)at the end, insert the following paragraphs—
“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.
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.”.
(9) In point 4.1.2—
(a)for the first indent, substitute— “ — method of EU Regulation 440/2008, Annex, Part C, C.12. (biodegradation – modified SCAS test). ”;
(b)for the second indent, substitute— “ — method of EU Regulation 440/2008, Annex, Part C, C.9. (biodegradation – Zahn-Wellens test). ”.
(10) In point 4.1.3, for the indent, substitute— “ — method of EU Regulation 440/2008, Annex, Part C, C.10. (biodegradation – activated sludge simulation tests). ”.
(11) In point 4.2.2—
(a)in the paragraph beginning with “Fish:”, for “Annex V.C.1 of Directive 67/548/EEC”, substitute “ EU Regulation 440/2008, Annex, Part C, C.1. (acute toxicity for fish) ”;
(b)in the paragraph beginning with “Daphnia:”, for “Annex V.C.2 of Directive 67/548/EEC”, substitute “ EU Regulation 440/2008, Annex, Part C, C.2. (daphnia SP. acute immobilisation test) ”;
(c)in the paragraph beginning with “Algae:”, for “Annex V.C.3 of Directive 67/548/EEC”, substitute “ EU Regulation 440/2008, Annex, Part C, C.3. (algal inhibition test) ”;
(d)in the paragraph beginning with “Bacteria:”, for “Annex V.C.11 of Directive 67/548/EEC”, substitute “ EU Regulation 440/2008, Annex, Part C, C.11. (biodegradation – activated sludge respiration inhibition) ”.
(12) In point 4.2.3—
(a)in the first paragraph, for “Annex V.C.5 of Directive 67/548/EEC”, substitute “ EU Regulation 440/2008, Annex, Part C, C.5. (degradation – biochemical oxygen demand) ”;
(b)in the second paragraph, for “Annex V.C.7 of Directive 67/548/EEC”, substitute “ EU Regulation 440/2008, Annex, Part C, C.7. (degradation – abiotic degradation: hydrolysis as a function of PH) ”.
(13) Omit the final, unnumbered paragraph that begins “NB”.
Commencement Information
I1Reg. 26 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1