Annex IV COMPLEMENTARY RISK ASSESSMENT FOR SURFACTANTS IN DETERGENTS

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.

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.

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.

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.

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