(Utkast) Kommisjonens gjennomføringsbeslutning om godkjenning av bruk av bis(2-metoksyetyl)eter (diglym) i henhold til europaparlaments- og rådsforordning (EF) nr. 1907/2006 (Bracco Imaging s.p.a)
(Draft) Commission Implementing Decision granting an authorisation for a use of Bis(2-methoxyethyl)ether (diglyme) under Regulation (EC) No 1907/2006 of the European Parliament and of the Council (Bracco Imaging s.p.a)
Utkast til kommisjonsbeslutning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 20.2.2018
BAKGRUNN (fra kommisjonsbeslutningen, engelsk utgave)
(1) Bis(2-methoxyethyl)ether (diglyme) is listed in Annex XIV to Regulation (EC) No 1907/2006 and is therefore subject to the authorisation requirement referred to in Article 56(1)(a) of that Regulation.
(2) On 9 February 2016, Bracco Imaging s.p.a ('the applicant') submitted, in accordance with Article 62 of Regulation (EC) No 1907/2006, an application for authorisation for the use of diglyme as a processing aid in the purification of 5-amino-2,4,6-triiodoisophthalic acid dichloride by precipitation.
(3) On 6 April 2017, the Commission received the opinions of the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC) of the European Chemicals Agency on the application pursuant to the second subparagraph of Article 64(5) of Regulation (EC) No 1907/2006.
(4) In its opinion, RAC confirmed that it is possible to determine a derived no-effect level (DNEL) for the reprotoxic properties of diglyme in accordance with Section 6.4 of Annex I to Regulation (EC) No 1907/2006 and therefore that diglyme is a threshold substance.
(5) In its opinion, RAC also concluded that the risk to human health from the use of diglyme applied for is adequately controlled in accordance with Article 60(2) of Regulation (EC) No 1907/2006. Therefore, it is appropriate to grant an authorisation for the use of diglyme applied for, provided that the risk management measures and operational conditions described in the application and, in particular, in the chemical safety report , are fully applied.
(6) In its opinion, SEAC recommended the review period referred to in Article 60(9)(e) of Regulation (EC) No 1907/2006 to be set at twelve years. The Commission takes into account the relevant elements from RAC's and SEAC's assessments, and in particular RAC’s conclusion that the risk to human health arising from the use of the substance is demonstrated to be adequately controlled, SEAC's conclusion that, although the assessment of the benefits of the continued use of the substance is based on potential losses by the applicant, some of which might be distributional in nature from a societal point of view, the socio-economic benefits of continued use of the substance are high, the lack of suitable alternatives before the sunset date, and the timeline needed for the transition to the most plausible alternative process identified, as well as the time needed for the approvals of the medicinal product by the corresponding regulatory authorities. The Commission concurs with the SEAC recommendation.
(7) Therefore, as regards the use of diglyme applied for, the review period referred to in Article 60(9)(e) of Regulation (EC) No 1907/2006 should be set at twelve years as from the sunset date set out in Annex XIV to Regulation (EC) No 1907/2006.
(8) In their opinions, RAC and SEAC considered that additional conditions and monitoring arrangements for the use as described in the application were not necessary.
(9) The language used for description of the risk management measures and operational conditions included in the application for authorisation is different from the official language of the Member State where the use applied for takes place. Therefore, in order to facilitate the enforcement of the authorisation, it is appropriate to include a monitoring arrangement requiring the authorisation holder to submit, upon request, a succinct summary of those risk management measures and operational conditions in an official language of that Member State.
(10) This Decision does not affect the obligation of the authorisation holder to ensure that the use does not adversely affect human health or the environment pursuant to Article 1(3) of Regulation (EC) No 1907/2006. Furthermore, it does not affect either the obligation of the authorisation holder to ensure that the exposure to the substance is reduced to as low a level as is technically and practically possible pursuant to Article 60(10) of Regulation (EC) No 1907/2006 or the obligation of the employer to eliminate or reduce to a minimum the risks to the health and safety of workers at work involving hazardous chemical agents pursuant to Article 5(2) of Council Directive 98/24 . In addition, this Decision is without prejudice to the application of the Union Directives in the area of health and safety at work, in particular Council Directive 89/391/EEC , Council Directive 98/24, Council Directive 92/85/EEC and Council Directive 94/33/EC .
(11) This Decision is without prejudice to any obligation to comply with emission limit values set in accordance with Directive 2010/75/EU of the European Parliament and of the Council and Directive 2008/50/EC of the European Parliament and of the Council , as well as with emission limit values set to achieve compliance with the environmental quality standards established both in Directive 2008/105/EC of the European Parliament and of the Council and by Member States in accordance with Directive 2000/60/EC of the European Parliament and of the Council . Compliance with the provisions of this Decision should not necessarily result in compliance with emission limit values or environmental quality standards under other Union legislation, which may include separate or more onerous requirements.
(12) The measures provided for in this Decision are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,
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