(Utkast) Kommisjonens gjennomføringsbeslutning om godkjenning av bruk av bis(2-ethylhexyl) phthalate (DEHP) og dibutyl phthalate (DBP) i henhold til europaparlaments- og rådsforordning (EF) nr. 1907/2006
(Draft) Commission Decision granting an authorisation for uses of Bis(2-ethylhexyl) phthalate (DEHP) and dibutyl phthalate (DBP) under Regulation (EC) No 1907/2006 of the European Parliament and of the Council
Utkast til kommisjonsbeslutning godkjent av komite (representanter for medlemslandene) 13.01.2015
BAKGRUNN (fra kommisjonsbeslutningen, engelsk utgave)
(1) Bis(2-ethylhexyl) phthalate (hereinafter referred to as “DEHP”) and dibutyl phthalate (hereinafter referred to as “DBP”) are listed in Annex XIV to Regulation (EC) No 1907/2006 and therefore subject to the authorisation requirement referred to in Article 56(1) of that Regulation.
(2) An application for authorisation was submitted by Roxel (UK Rocket Motors) Ltd on 12 August 2013 in accordance with Article 62 of Regulation (EC) No 1907/2006, for the industrial use of DEHP in the manufacture of solid propellants and motor charges for rockets and tactical missiles, for the industrial use of DBP in the manufacture of solid propellants and motor charges for rockets and tactical missiles, as well as for the industrial use of DBP within a specialty paint in the manufacture of motors for rockets and tactical missiles.
(3) On 25 June 2014 the European Chemicals Agency (hereinafter referred to as “Agency”) sent to the Commission the opinions of the Committee for Risk Assessment (“RAC”) and the Committee for Socio-economic Analysis (“SEAC”) pursuant to the third subparagraph of Article 64(5) of Regulation (EC) No 1907/2006.
(4) According to the RAC opinions, the risks to human health from the use of DEHP and two uses of DBP applied for are adequately controlled in accordance with the provision of Article 60(2) of Regulation (EC) No 1907/2006, provided that the risk management measures and operational conditions as described in the application are adhered to.
(5) It is therefore appropriate to authorise the three uses provided that the risk management measures and operational conditions described in the application, in particular in their respective chemical safety reports, are fully applied.
(6) In its opinions, the SEAC recommended the review period referred to in Article 60(9)(e) of Regulation (EC) No 1907/2006 to be set at four years for all of the three uses applied for. The length of the review period takes into account the adequate control of the risks for workers arising from the two uses of DBP and one use of DEHP, the lack of suitable alternatives in terms of their technical feasibility for the applicant at present and the possible socio-economic implications in the short term for the applicant and its supply chain in the event of no authorisation. The conclusion on the suitability of alternatives for the applicant is made on the basis that any potential substitutes to DEHP and DBP in the three uses applied for would need to meet requalification requirements for defence industry products. The proposed review period is considered sufficient to cover the necessary time, as specified in the applicant's replacement programme, that the applicant needs in order to meet the requalification requirements prior to placing DEHP/DBP-free propellants and motor charges for rockets and tactical missiles on the market and being able to use a DBP-free specialty paint. The applicant did not demonstrate the need for a longer review period for any of the uses applied for.
(7) It is therefore appropriate to set the review period referred to in Article 60(9)(e) of Regulation (EC) No 1907/2006 at four years for each of the three uses.
(8) A full application of the risk management measures and operational conditions described in the application, in particular in the respective chemical safety reports, to ensure adequate control of risks for all the three uses applied for is a necessary condition for the authorisation. In their opinions, the RAC and SEAC did not recommend any additional conditions or additional monitoring arrangements for any of the three uses. However, in order to facilitate the enforcement of the decision, it is appropriate to include a monitoring arrangement requiring the holder of the authorisation to submit, upon request, to the competent authority of the Member State where the use takes place a succinct summary of the risk management measures and operational conditions of the relevant parts of the above mentioned chemical safety report in an official language of that Member State.
(9) 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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