TITLE-VII: AUTHORISATION
CHAPTER-2: Granting of authorisations
ARTICLE 64: Procedure for authorisation decisions
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| ARTICLE 64: | Procedure for authorisation decisions |
1. The Agency shall acknowledge the date of receipt of the application. The Agency's Committees for Risk Assessment and Socio-economic Analysis shall give their draft opinions within ten months of the date of receipt of the application.
2. The Agency shall make available on its web-site broad information on uses, taking into account Articles 118 and 119 on access to information, for which applications have been received and for reviews of authorisations, with a deadline by
which information on alternative substances or technologies may be submitted by interested third parties.
3. In preparing its opinion, each Committee referred to in paragraph 1 shall first check that the application includes all
the information specified in Article 62 that is relevant to its remit. If necessary, the Committees shall, in consultation with each other, make a joint request
to the applicant for additional information to bring the application into conformity with the requirements of Article 62. The Committee for Socio-economic Analysis may, if it deems it necessary, require the applicant or request third parties to submit, within a specified time
period, additional information on possible alternative substances or technologies. Each Committee shall also take into account any information submitted by third parties.
4. The draft opinions shall include the following elements:
(a) Committee for Risk Assessment: an assessment of the risk to human health and/or the environment arising from the use(s)
of the substance, including the appropriateness and effectiveness of the risk management measures as described in the application
and, if relevant, an assessment of the risks arising from possible alternatives;
(b) Committee for Socio-economic Analysis: an assessment of the socio-economic factors and the availability, suitability and technical feasibility of alternatives associated with the use(s) of the substance
as described in the application, when an application is made in accordance with Article 62 and of any third party contributions submitted under paragraph 2 of this Article.
5. The Agency shall send these draft opinions to the applicant by the end of the deadline set out in paragraph 1. Within one month of receipt
of the draft opinion, the applicant may provide written notice that he wishes to comment. The draft opinion shall be deemed
to have been received seven days after the Agency has sent it.
If the applicant does not wish to comment, the Agency shall send these opinions to the Commission, the Member States and the applicant, within 15 days of the end of the period within which the applicant may comment or within 15 days of receipt
of notice from the applicant that he does not intend to comment.
If the applicant wishes to comment, he shall send his written argumentation to the Agency within two months of the receipt of the draft opinion. The Committees shall consider the comments and adopt their final opinions
within two months of receipt of the written argumentation, taking this argumentation into account where appropriate. Within
a further 15 days the Agency shall send the opinions, with the written argumentation attached, to the Commission, the Member States and the applicant.
6. The Agency shall determine in accordance with Articles 118 and 119 which parts of its opinions and parts of any attachments thereto should be made publicly available on its website.
7. In cases covered by Article 63(1), the Agency shall treat the applications together, provided the deadlines for the first application can be met.
8. The Commission shall prepare a draft authorisation decision within three months of receipt of the opinions from the Agency. A final decision granting or refusing the authorisation shall be taken in accordance with the procedure referred to in Article 133(3).
9. Summaries of the Commission decisions, including the authorisation number and the reasons for the decision, in particular where suitable alternatives exist, shall be published in the Official
Journal of the European Union and shall be made publicly available in a database established and kept up to date by the Agency.
10. In cases covered by Article 63(2), the deadline set out in paragraph 1 of this Article shall be shortened to five months.
- Referred by:
- ARTICLE 56: General provisions
- ARTICLE 60: Granting of authorisations
- ARTICLE 61: Review of authorisations
- ARTICLE 65: Obligation of holders of authorisations
- ARTICLE 118: Access to information