Pareceres adotados e consultas anteriores sobre pedidos de autorização

Pareceres adotados e consultas anteriores sobre pedidos de autorização

Pareceres adotados e consultas anteriores sobre pedidos de autorização

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2021, an application for an authorisation submitted by a person established in the UK (except Northern Ireland) is no longer valid in the EU, unless that application has been transferred to a legal entity established in the EU or Northern Ireland before the end of the transition period.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. 

 

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Substance Details

Name
Bis(2-ethylhexyl) phthalate
EC Number
204-211-0
CAS Number
117-81-7
Entry Nr in Annex XIV
4
Use name
Formulation of recycled soft PVC containing DEHP in compounds and dry-blends
Broad information on use applied for (conditions of use and function)
DEHP has no independent function at the formulation stage. DEHP is not added by the authorisation holder, a waste recycling company, but is already present in the post-consumer flexible PVC waste (and possibly also in post-industrial waste) received. The authorisation holder processes the waste into flexible PVC recyclate.

The presence of DEHP in the flexible PVC recyclate may be of benefit to the users of the recyclate, as DEHP contributes, together with other plasticisers, to the flexibility of the recyclate placed on the market by the authorisation holder. The DEHP-concentration in the recyclate is below 5% w/w.

In the formulation process, soft PVC recyclate containing DEHP is added to a mixing unit, together with other material and/or additives, and mechanically mixed under ambient temperature. The resulting dry-blend can be transferred to an extruder where it is heated to a liquid state and mechanically agitated to homogenise the material and produce pellets.

Annual tonnage used: 50 - 500
Review period requested: 7 years

Initial application available here: 0008-01
Use applied for number in application for authorisation
1
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): 12
Environmental release category (ERC): 3
Process category (PROC): 3, 8b, 14, 15
Product category (PC): 32
Article category related to subsequent service life (AC): 13
Technical Function: plasticiser
Summary table of RMMs and OCs (non confidential)
Chemical Safety Report (original and updated, if available) (non confidential)


Analysis of Alternatives (non confidential report)
Substitution Plan (non confidential summary)
Socio-Economic Analysis (non confidential report)
Joint Analysis of Alternatives and Socio-Economic Analysis (non confidential report)
Explanatory note
Additional information
ID
0122-01
Applicant(s)
VINYLOOP
FERRARA
S.p.A.
Application type
Review report
Status
Withdrawn
Other consultations on the same/ similar use
0123-01
Comments submitted to date
Link
Response to comments by applicant
Responses to RAC and SEAC requests by Applicant(s) (non confidential)
Compiled RAC and SEAC opinions
Minority positions
Adopted commission decision (OJ summary)
Authorisation decision