1.Without prejudice to Article 17 of Directive 1999/45/EC, manufacturers placing on the market the substances and/or [F1mixtures] covered by this Regulation shall hold at the disposal of the competent authorities of the Member States:
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:
a technical file on results of the tests mentioned in Annex II,
a technical file on results of the tests and information mentioned in Annex IV.
2.Whenever substances and/or [F1mixtures] covered by this Regulation are placed on the market, the manufacturer shall be responsible for the correct performance of the relevant tests mentioned above. He shall also have available documentation on the testing carried out to demonstrate compliance with this Regulation, and to show that he is allowed to benefit from the property rights concerning the test results, other than for those test results already in the public domain.
3.Manufacturers placing on the market the [F1mixtures] 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 a Member State to request that such a datasheet be made available to a specific public body to which the Member State has assigned the task of providing this information to medical personnel.
The information contained in the datasheet shall be kept confidential by the specific public body and by the medical personnel, and shall be used only for medical purposes.
Textual Amendments