Authorisation process for DEHP under REACH - Timeline

ECHA ECHA
COMMISSION ECHA
Added a new Developed draft
Included DEHP in Added a new ECHA
entry on the COMMISSION recommendation
Annex XIV entry on the
Candidate List Eight-week for amendment
(Authorisation) to Sunset date for the Candidate List for
for DEHP due to public of Authorisation
REACH due to use of DEHP. DEHP due to its
its endocrine consultation on List entries for
reprotoxic Exemptions endocrine
disrupting draft DEHP, to
properties. granted for medical disrupting
properties to the recommendation consider whether
Exemptions devices properties for
environment (5 June 2018 – 6 exemptions are
granted for medical (21 January 2015) human health August 2018) still justified
devices (December
(July 2017) (12 December
(February 2011) 2014)
2018)

COMMISSION
ECHA Member State Amends Annex XIV COMMISSION
(Authorisation) to COMMISSION
90-day public Committee Sunset date (after
ECHA REACH, reflecting Latest application
consultation on Adoption of which use of
draft Published its DEHP endocrine date for
opinion on DEHP will be
recommendation recommendation disrupting properties to authorisation, 18
ECHA’s draft human health and the months after entry
banned) 36
for Authorisation. months after entry
(12 December recommendation environment (regulatory into force
2018 – 12 March for Authorisation (10 July 2019) into force
procedure with (~Q1/Q2 2021)
2019) (26 June 2019) scrutiny). (~Q3/Q4 2022)
(~Q3/Q4 2020)

We are here

✓ Uses of DEHP that have been exempted so far (e.g. medical devices), may require authorisation due to DEHP’s endocrine disrupting effects on human health
and the environment, once the Commission amends Annex XIV (Authorisation).
✓ According to the minutes from the Member State Committee (MSC) which took place in June 2019, the request from public consultation to exempt the use of
DEHP in blood bags as well as the use of DEHP in EEE (electrical or electronic equipment) under RoHS were discussed. MSC was of the opinion that no
information was submitted which would form the basis for inclusion of a further specific exemption.
✓ Delays of the appointment of the new Commission may affect the timing of the authorisation process. The new College of Commissioners is expected to take
office on 1 December 2019.
Medical Device Regulation (MDR) - Timeline

Provisions shall apply

(including the justification
Commission presented Council of the EU European Parliament Publication of the MDR
Entry into force for the presence of CMR
its proposal for regulation adopted the MDR adopted the MDR on the Official Journal
and ED substances, such
as DEHP)
(25 May 2017)
(26 September 2012) (7 March 2017) (5 April 2017) (5 May 2017)
(26 May 2020)

We are here

✓ Medical Device Regulation (EU 2017/745) indicates that from 26 May 2020 medical devices containing Carcinogenic, Mutagenic and Reprotoxic (CMR) Category 1A and 1B and
endocrine disrupting (ED) substances – including DEHP - in quantity above 0.1% w/w will need specific justification
✓ Specific justification shall be based upon:
➢ An analysis and estimation of potential patient or user exposure to the substance
➢ An analysis of possible alternative substances, materials or designs
➢ Argumentation as to why possible substance and/or material substitutes or design changes are inappropriate in relation to maintaining the functionality, performance
and the benefit-risk ratios of the product
➢ Latest relevant scientific committee “Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which
are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine disrupting (ED) properties”