Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Published pursuant to Article 64(9) of Regulation (EC) No 1907/2006)
Date: 2026-02-11
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: chemical compound, chemical product, health control, health risk, market approval, marketing standard, medical device, medicinal product, packaging








C_202600736EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2026/736


11.2.2026






Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)


(Published pursuant to Article 64(9) of Regulation (EC) No 1907/2006
                (1)
)


(Text with EEA relevance)
(C/2026/736)


Decision granting an authorisation













Reference of the decision (2)



Date of decision


Substance name


Holder of the authorisation


Authorisation number


Authorised use


Date of expiry of review period


Reasons for the decision




C(2026) 595


4 February 2026


bis(2-ethylhexyl) phthalate (DEHP) (EC No 204-211-0; CAS No117-81-7)


Baxter S.A., Boulevard René Branquart 80, 7860 Lessines, Belgium


REACH/26/2/0


Formulation of bis(2-ethylhexyl) phthalate (DEHP) mixtures for application in immediate packaging of medicines and medical device


14 December 2031


In accordance with Article 60(4) of Regulation (EC) No 1907/2006, the socio-economic benefits outweigh the risk to human health and the environment from the use of the substance and there are no suitable alternative substances or technologies.




Vantive Manufacturing Limited, Moneen Road, Mayo, F23 XR63 Castlebar, Ireland


REACH/26/2/1


 




Baxter (Malta) Trading Co Ltd, A47 Marsa Industrial estate, MRS3000 Marsa, Malta


REACH/26/2/2


 




Gambro Dasco SpA., Via Modenese 66, 41036 Medolla, Emilia-Romagna Italy


REACH/26/2/3


 




Baxter S.A., Boulevard René Branquart 80, 7860 Lessines, Belgium


REACH/26/2/4


Use of bis(2-ethylhexyl) phthalate (DEHP)-containing plastics for immediate packaging of medicinal products


 




Vantive Manufacturing Limited, Moneen Road, Mayo, F23 XR63 Castlebar, Ireland


REACH/26/2/5


 




Baxter (Malta) Trading Co Ltd, A47 Marsa Industrial estate, MRS3000 Marsa, Malta


REACH/26/2/6


 




Gambro Dasco SpA., Via Modenese 66, 41036 Medolla, Emilia-Romagna Italy


REACH/26/2/7


 




Baxter S.A., Boulevard René Branquart 80, 7860 Lessines, Belgium


REACH/26/2/8


Use of bis(2-ethylhexyl) phthalate (DEHP)-based mixtures as a lubricating/sealing agent for the insertion of port closures into empty bags and assembly/connection of parts, that are used in immediate packaging of medicines


14 December 2028




Vantive Manufacturing Limited, Moneen Road, Mayo, F23 XR63 Castlebar, Ireland


REACH/26/2/9


 




Baxter (Malta) Trading Co Ltd, A47 Marsa Industrial estate, MRS3000 Marsa, Malta


REACH/26/2/10


 




Gambro Dasco SpA., Via Modenese 66, 41036 Medolla, Emilia-Romagna Italy


REACH/26/2/11


 






(1)  
            OJ L 396, 30.12.2006, p. 1.

(2)  The decision is available on the European Commission website at: Authorisation (europa.eu)



ELI: http://data.europa.eu/eli/C/2026/736/oj
ISSN 1977-091X (electronic edition)