(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 that Directive. That restriction does not apply to certain exempted applications listed in Annex IV to that Directive.

(2)

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

(3)

By Commission Delegated Directive (EU) 2015/863 (2), bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) were added to the list of restricted substances referred to in Annex II to Directive 2011/65/EU.

(4)

Delegated Directive (EU) 2015/863 provides that the restriction of DEHP, BBP, DBP and DIBP is not to apply to spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of medical devices, including in vitro medical devices, placed on the market before 22 July 2021.

(5)

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, BBP, DBP and DIBP in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices (‘the requested exemption’).

(6)

The evaluation of the exemption application concluded that the total negative environmental and health impacts of substituting refurbished parts containing DEHP, BBP, DBP and DIBP with new substance-free refurbished parts are likely to outweigh the total environmental and health benefits. The evaluation included stakeholder consultations required by Article 5(6) of the Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website.

(7)

In order to ensure a high level of protection for the environment, health and consumer safety, reuse should take place in auditable closed-loop business-to-business return systems and reuse of spare parts should be notified to the customer.

(8)

The requested exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3) and thus does not weaken the environmental and health protection afforded by it.

(9)

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

(10)

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.

(11)

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

(12)

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,