CHAPTER-2: Granting of authorisations
ARTICLE 60: Granting of authorisations
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|ARTICLE 60:||Granting of authorisations|
1. The Commission shall be responsible for taking decisions on applications for authorisations in accordance with this Title.
2. Without prejudice to paragraph 3, an authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with Section 6.4 of Annex I and as documented in the applicant's chemical safety report, taking into account the opinion of the Committee for Risk Assessment referred to in Article 64(4)(a). When granting the authorisation, and in any conditions imposed therein, the Commission shall take into account all discharges, emissions and losses, including risks arising from diffuse or dispersive uses, known at the time of the decision.
The Commission shall not consider the risks to human health arising from the use of a substance in a medical device regulated by Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (48), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (49) or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (50).
3. Paragraph 2 shall not apply to:
(a) substances meeting the criteria in Article 57(a), (b), (c) or (f) for which it is not possible to determine a threshold in accordance with Section 6.4 of Annex I;
(c) substances identified under Article 57(f) having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties.
4. If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis referred to in Article 64(4)(a) and (b):
(a) the risk posed by the uses of the substance, including the appropriateness and effectiveness of the risk management measures proposed;
(b) the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise as demonstrated by the applicant or other interested parties;
(c) the analysis of the alternatives submitted by the applicant under Article 62(4)(e) or any substitution plan submitted by the applicant under Article 62(4)(f), and any third party contributions submitted under Article 64(2);
(d) available information on the risks to human health or the environment of any alternative substances or technologies.
5. When assessing whether suitable alternative substances or technologies are available, all relevant aspects shall be taken into account by the Commission, including:
(a) whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking into account the appropriateness and effectiveness of risk management measures;
(b) the technical and economic feasibility of alternatives for the applicant.
6. A use shall not be authorised if this would constitute a relaxation of a restriction set out in Annex XVII.
7. An authorisation shall be granted only if the application is made in conformity with the requirements of Article 62.
8. Authorisations shall be subject to a time-limited review without prejudice to any decision on a future review period and shall normally be subject to conditions, including monitoring. The duration of the time-limited review for any authorisation shall be determined on a case-by-case basis taking into account all relevant information including the elements listed in paragraph 4(a) to (d), as appropriate.
9. The authorisation shall specify:
(a) the person(s) to whom the authorisation is granted;
(b) the identity of the substance(s);
(c) the use(s) for which the authorisation is granted;
(d) any conditions under which the authorisation is granted;
(e) the time-limited review period;
(f) any monitoring arrangement.
10. Notwithstanding any conditions of an authorisation, the holder shall ensure that the exposure is reduced to as low a level as is technically and practically possible.