(1)

Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to the Directive. That restriction does not apply to certain exempted applications listed in Annex IV to the Directive.

(2)

The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in its Annex I.

(3)

Pursuant to Commission Delegated Directive (EU) 2015/863 (2), bis(2-ethylhexyl) phthalate (DEHP) is a restricted substance listed in Annex II to Directive 2011/65/EU and its use is to be prohibited, from 22 July 2021, in medical devices, including in vitro medical devices above a maximum concentration value of 0,1% tolerated by weight in homogeneous materials.

(4)

On 17 July 2018, the Commission received an application made in accordance with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex IV to that Directive, for the use of DEHP in ion selective electrodes for analysing human body fluids and/or in dialysate fluids (‘the requested exemption’).

(5)

DEHP is used as a membrane solvent of ion selective electrodes applied in point of care analysers which help to measure the concentration of ionic substances in human body fluids and/or in dialysate fluids.

(6)

A technical and scientific assessment study was carried out to evaluate the exemption application (3). The evaluation of the application concluded that alternatives to DEHP are currently not sufficiently reliable and that the substitution of DEHP in specific applications would result in negative environmental and health impacts that outweigh its benefits. The evaluation included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website.

(7)

The requested exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4) and thus does not weaken the environmental and health protection afforded by it.

(8)

It is therefore appropriate to grant the requested exemption by including the applications covered by it in Annex IV to Directive 2011/65/EU.

(9)

To provide efficient technical equipment for health services and to allow time for the development of suitable alternatives, the requested exemption should be granted for a duration of 7 years starting from the date of application of this Directive in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation.

(10)

Directive 2011/65/EU should therefore be amended accordingly.

(11)

In the interest of legal certainty and in order to protect the legitimate expectations of operators supplying the medical devices concerned that the requested exemption applies by the date of entry into force of the prohibition for the use of the restricted substance in question, and in the absence of any legitimate interest in creating a disruption to the supply of those medical devices as a result of the entry into force of that prohibition, this Directive should enter into force as a matter of urgency and should apply with retroactive effect from 21 July 2021,