ANNEX IISupplementary provisions
ANNEX II Minimum requirements regarding a technical file to be included in the application for a new textile fibre name (referred to in Article 6) A technical file to be attached to an application for the inclusion of a new textile fibre name in the list set out in Annex I, as provided for in Article 6, shall contain at least the following information: (1) Proposed name of the textile fibre: The name proposed shall be related to the chemical composition and shall provide information about the characteristics of the fibre, if appropriate. The name proposed shall be free of any intellectual property rights and shall not be linked to the manufacturer. (2) Proposed definition of the textile fibre: The characteristics mentioned in the definition of the new textile fibre, such as elasticity, shall be verifiable via testing methods to be provided with the technical file along with the experimental results of analyses. (3) Identification of the textile fibre: chemical formula, differences from existing textile fibres, together with, where relevant, detailed data such as melting point, density, refractive index, burning behaviour and FTIR spectrum. (4) Proposed agreed allowance to be used in the calculation of fibre composition. (5) Sufficiently developed identification and quantification methods, including experimental data: The applicant shall evaluate the possibility to use the methods listed in Annex VIII or the harmonised standards to be introduced in that Annex to analyse the most expected commercial mixtures of the new textile fibre with other textile fibres and shall propose at least one of those methods. For those methods or harmonised standards where the textile fibre can be considered as an insoluble component, the applicant shall evaluate the mass correction factors of the new textile fibre. All the experimental data shall be submitted with the application. If methods listed in this Regulation are not suitable, the applicant shall provide adequate reasoning and propose a new method. The application shall contain all the experimental data for the methods proposed. Data on the accuracy, robustness and repeatability of the methods shall be provided with the file. (6) Available scientific information concerning possible allergic reactions or other adverse effects of the new textile fibre on human health, including results of tests conducted to that effect in compliance with relevant Union legislation. (7) Additional information to support the application: production process, consumer relevance. The manufacturer or any person acting on the manufacturer’s behalf shall provide representative samples of the new pure textile fibre and the relevant textile fibre mixtures necessary to conduct the validation of the proposed identification and quantification methods. The Commission may request additional samples of relevant fibre mixtures from the manufacturer or the person acting on the manufacturer’s behalf.