Community authorisation
Article 11
1. The Community authorisation of a substance or substances shall take place in the form of the adoption of a specific measure. The Commission shall, where appropriate, prepare a draft of a specific measure, as referred to in Article 5, to authorise the substance or substances evaluated by the Authority and specify or change the conditions of its or their use. 2. The draft specific measure shall take into account the opinion of the Authority, relevant provisions of Community law and other legitimate factors relevant to the matter under consideration. Where the draft specific measure is not in accordance with the opinion of the Authority, the Commission shall provide without delay an explanation for the reasons for the differences. If the Commission does not intend to prepare a draft specific measure after a favourable opinion by the Authority, it shall inform the applicant without delay and provide the applicant with an explanation. 3. Community authorisation in the form of a specific measure, as referred to in paragraph 1, shall be adopted in accordance with the procedure referred to in Article 23(2). 4. After the authorisation of a substance in accordance with this Regulation, any business operator using the authorised substance or materials or articles containing the authorised substance shall comply with any condition or restriction attached to such authorisation. 5. The applicant or any business operator using the authorised substance or materials or articles containing the authorised substance shall immediately inform the Commission of any new scientific or technical information, which might affect the safety assessment of the authorised substance in relation to human health. If necessary, the Authority shall then review the assessment. 6. The granting of an authorisation shall not affect the general civil and criminal liability of any business operator in respect of the authorised substance, the material or article containing the authorised substance, and the food that is in contact with such material or article.