Article 9 Information to be provided by manufacturers

F1Without prejudice to Article 45 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures^f1, manufacturers placing on the market the substances and/or mixtures covered by this Regulation shall hold at the disposal of the competent F2authority:

• information on one or more results of the tests mentioned in Annex III;

• for those surfactants failing to pass tests mentioned in Annex III, and for which a request for derogation was made as referred to in Article 5:

  1. (i)

     a technical file on results of the tests mentioned in Annex II,

  2. (ii)

     a technical file on results of the tests and information mentioned in Annex IV.

Whenever substances and/or mixtures covered by this Regulation are placed on the market, the manufacturer shall be responsible for the correct performance of the relevant tests mentioned above. F3The manufacturer shall also have available documentation on the testing carried out to demonstrate compliance with this Regulation, and to show that F4the manufacturer is allowed to benefit from the property rights concerning the test results, other than for those test results already in the public domain.

Manufacturers placing on the market the mixtures covered by this Regulation shall, upon request, make available without delay and free of charge, to any medical personnel, an ingredient datasheet as stipulated in Annex VII C.

This is without prejudice to the right of F5the relevant Ministers to request that such a datasheet be made available to F6the National Poisons Information Service (‘NPIS’) or such other body to which the relevant Ministers assign the task of providing this information to medical personnel F7within their respective territories.

F8For the purposes of this Article, ‘the relevant Ministers’ means:

• in England, the Secretary of State;

• in Wales, the Welsh Ministers;

• in Scotland, the Scottish Ministers;

The information contained in the datasheet shall be kept confidential by the F9the NPIS or other body assigned under the second subparagraph and by the medical personnel, and shall be used only for medical purposes.