Article 5 Granting of derogation

The request by a manufacturer for derogation shall be made by sending an application to the competent authority F1... providing evidence relating to the criteria mentioned under Article 6(1). F2The competent authority can make the request for derogation dependent upon the payment F3... of a fee. Such fees, if any, shall be levied in a non-discriminatory way and shall not exceed the cost of processing the application.

Applications shall include a technical file supplying all the information and justifications necessary for evaluating the safety aspects related to the specific use of surfactants in detergents failing to comply with the biodegradability limits, as set out in Annex III.

In addition to the results of tests stipulated in Annex III, the technical file shall include information and results of tests, as stipulated in Annexes II and IV.

The tests laid down in Annex IV, point 4 shall be carried out on the basis of F4the tiered approach referred to in the Commission Recommendation of 23rd December 2005 on the tiered approach technical guidance document for the purpose of implementing Regulation (EC) No 648/2004 of the European Parliament and the Council. F5...

The competent authority F6..., receiving applications for derogation in accordance with paragraphs 1 and 2, shall examine the requests F7and evaluate their compliance with the conditions for derogation F8... within six months of receiving the complete application.

If the competent authority F9... deems it necessary for the evaluation of the risk which may be caused by a substance and/or a F10mixture, it shall, within three months of receiving the application, ask for further information, verification and/or confirmatory tests concerning these substances and/or mixtures or their transformation products, of which they have been notified or have received information under this Regulation. The time period for the evaluation of the dossier by the competent authority ... will start only after the dossier is completed with the additional information. If the requested information is not provided within 12 months, the application shall be considered incomplete and thus invalid. F11...

If further information on metabolites is sought, stepwise testing strategies should be employed to ensure maximum use of in-vitro and other non-animal test methods.

On the basis of, in particular, the evaluation carried out F12under paragraph 3, the competent authority may grant a derogation F13.... F14... F15The competent authority shall make its decision within 12 months of completing the evaluation carried out under paragraph 3.

Such derogations may allow, limit or severely restrict the placing on the market and the use of surfactants as ingredients in detergents, depending on the results of the complementary risk assessment, as defined in Annex IV. They may include a phase-out period for placing on the market and the use of surfactants as ingredients in detergents. The F16competent authority may review a derogation as soon as information comes to light which would justify a significant revision of the technical file that was included in the application for derogation. For this purpose, the manufacturer shall, upon request, supply to the competent authority a technical file that has been updated regarding the items mentioned in Annex IV, point 2. On the basis of this updated information, the competent authority may decide to prolong, modify or terminate the derogation. Paragraphs 1 to 4 and 6 of this Article and Article 6 shall apply mutatis mutandis.

The F17competent authority shall publish the list of surfactants that have obtained derogation, with the corresponding conditions or limitations of use, as provided in Annex V.