Adopted opinions and previous consultations on applications for authorisation

This page provides further information on the applications for authorisation or review reports, which have undergone consultation. The applications for authorisation are in the opinion development phase until the final opinions of the Committees for Risk Assessment and Socio-economic Analysis have been adopted and sent to the European Commission. Its decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.

On 1 February 2020, the United Kingdom (UK) withdrew from the EU. The transition period provided by the withdrawal agreement ended on 31 December 2020. As of 1 January 2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period. Therefore, authorisation applications and decisions in so far as these concern persons established in the UK (except Northern Ireland) are no longer considered valid.

ID	Application type	Name	EC Number	CAS Number	Applicant(s)	Use name	Status
0087-01	Initial	Bis(2-methoxyethyl) ether (Diglyme)	203-924-4	111-96-6	MAFLON S.P.A.	Use of bis(2-methoxyethyl) ether (diglyme) as a carrier solvent in the formulation and subsequent application of sodium naphthalide etchant for fluoropolymer surface modification whilst preserving article structural integrity.	Commission decided
0084-01	Initial	Bis(2-methoxyethyl) ether (Diglyme)	203-924-4	111-96-6	Roche Diagnostics GmbH	Use of diglyme as a process chemical in the manufacture of one specific type of Dynabeads® used in immunodiagnostic assays (in vitro diagnostic)	Commission decided
0085-01	Initial	Bis(2-methoxyethyl) ether (Diglyme)	203-924-4	111-96-6	Life Technologies AS	Use of diglyme as a process chemical in the manufacture of Dynabeads.	Commission decided
0086-01	Initial	Bis(2-methoxyethyl) ether (Diglyme)	203-924-4	111-96-6	Bracco Imaging s.p.a	Use of bis(2-methoxyethyl) ether (diglyme) as a processing aid in the purification of 5-amino-2,4,6-triiodoisophthalic acid dichloride (EC 417- 220-1; CAS 37441-29-5) by precipitation	Commission decided
0122-01	Review report	Bis(2-ethylhexyl) phthalate	204-211-0	117-81-7	VINYLOOP FERRARA S.p.A.	Formulation of recycled soft PVC containing DEHP in compounds and dry-blends	Withdrawn
0123-01	Review report	Bis(2-ethylhexyl) phthalate	204-211-0	117-81-7	Plastic Planet srl	Formulation of recycled soft PVC containing DEHP in compounds and dry-blends	Opinions adopted
0123-02	Review report	Bis(2-ethylhexyl) phthalate	204-211-0	117-81-7	Plastic Planet srl	Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce the following PVC articles: (1) articles used outside of the interior space in applications in the field of construction, civil engineering, garden features such as ponds and roofing, agriculture (including horticulture) and industrial workplaces without potential for mouthing or prolonged contact with human skin or any contact with mucous membranes; (2) articles used in interior space in industrial and agricultural workplaces; or (3) footwear used in professional, industrial and/or agricultural workplaces.	Opinions adopted
0122-02	Review report	Bis(2-ethylhexyl) phthalate	204-211-0	117-81-7	VINYLOOP FERRARA S.p.A.	Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce the following PVC articles: (1) articles used outside of the interior space in applications in the field of construction, civil engineering, garden features such as ponds and roofing, agriculture (including horticulture) and industrials workplaces without potential for mouthing or prolonged contact with human skin or any contact with mucous membranes; (2) articles used in interior space in industrial and agricultural workplaces; or (3) footwear used in professional, industrial and/or agricultural workplaces.	Withdrawn
0004-02	Initial	Bis(2-ethylhexyl) phthalate (DEHP)	204-211-0	117-81-7	DEZA a.s.	Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)]	Withdrawn
0003-02	Initial	Bis(2-ethylhexyl) phthalate (DEHP)	204-211-0	117-81-7	Grupa Azoty Zakłady Azotowe Kędzierzyn S.A.	Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)]	Withdrawn

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