REACH-forordningen om kjemikalier: godkjenning av bis(2-ethylhexyl)-phthalate (DEHP)
Kommisjonens gjennomføringsbeslutning av 9. august 2014 om godkjenning av bruk av bis(2-ethylhexyl)-phthalate (DEHP) i henhold til europaparlaments- og rådsforordning (EF) nr. 1907/2006
Commission Implementing Decision of 9 August 2014 granting an authorisation for a use of bis(2-ethylhexyl) phthalate (DEHP) under Regulation (EC) No 1907/2006 of the European Parliament and of the Council
Dansk departementsnotat offentliggjort 09.01.2015
Nærmere omtale
BAKGRUNN (fra kommisjonsbeslutningen, engelsk utgave)
(1) Bis(2-ethylhexyl) phthalate (DEHP) (hereinafter referred to as “DEHP”) is 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 Rolls-Royce plc on 20 May 2013 in accordance with Article 62 of Regulation (EC) No 1907/2006, for the use of DEHP in the processing of a stop-off formulation containing that substance during the diffusion bonding and manufacture of aero engine fan blades.
(3) On 3 January 2014 the European Chemicals 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 opinion, the risks to human health from the use of DEHP applied for are adequately controlled in accordance with the provisions in 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 that use provided that the risk management measures and operational conditions described in the application, in particular in the chemical safety report, are applied.
(6) In its opinion, the SEAC recommended the review period referred to in Article 60(9)(e) of Regulation (EC) No 1907/2006 to be set at seven years. This period was recommended taking into account the adequate control of the risks for workers arising from the use of the substance, the lack of suitable alternatives at present and the on-going research programme by the applicant in search of technically feasible alternatives with a time-frame of five to ten years. The time necessary to implement alternatives in the context of the particular high standards of safety and testing requirements in the aerospace industry was also taken into consideration. The recommended period would allow the progress made by the applicant to be assessed in the context of a review.
(7) In their opinions, the RAC and the SEAC did not recommend any additional conditions or additional monitoring arrangements to those described in the application.
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.
(1) Bis(2-ethylhexyl) phthalate (DEHP) (hereinafter referred to as “DEHP”) is 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 Rolls-Royce plc on 20 May 2013 in accordance with Article 62 of Regulation (EC) No 1907/2006, for the use of DEHP in the processing of a stop-off formulation containing that substance during the diffusion bonding and manufacture of aero engine fan blades.
(3) On 3 January 2014 the European Chemicals 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 opinion, the risks to human health from the use of DEHP applied for are adequately controlled in accordance with the provisions in 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 that use provided that the risk management measures and operational conditions described in the application, in particular in the chemical safety report, are applied.
(6) In its opinion, the SEAC recommended the review period referred to in Article 60(9)(e) of Regulation (EC) No 1907/2006 to be set at seven years. This period was recommended taking into account the adequate control of the risks for workers arising from the use of the substance, the lack of suitable alternatives at present and the on-going research programme by the applicant in search of technically feasible alternatives with a time-frame of five to ten years. The time necessary to implement alternatives in the context of the particular high standards of safety and testing requirements in the aerospace industry was also taken into consideration. The recommended period would allow the progress made by the applicant to be assessed in the context of a review.
(7) In their opinions, the RAC and the SEAC did not recommend any additional conditions or additional monitoring arrangements to those described in the application.
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.