EU to assess two Annex IV exemption requests

13 Dec 2021

Oeko-Institut has been appointed by the European Commission to assist in reviewing requests for exemptions of Restricted Substances under the Directive 2011/65/EU, commonly known as RoHS 2. The purpose of this consultation is to collect contributions from stakeholders. Oeko is responsible for collecting and evaluating information provided by Stakeholders, whereas institutions of the European Union are solely responsible for making decisions.

The Oeko-Institut has begun assessment of the two exemption requests for the new RoHS project – pack 25.

Below are the exemptions requests raised with the EU for the RoHS Directive:

  • Mercury in pressure transducers (Mercury in melt pressure transducers for capillary rheometers at temperatures over 300°C)
  • DEHP in a PVC base material (Bis (ethylhexyl) phthalate (DEHP) as a plasticizer in polyvinyl chloride (PVC), is used to produce amperometric, potentiometric and conductometric electrochemical sensors, which are used in medical devices for the analysis of whole blood (i.e. in-vitro diagnostic medical devices).

This study will provide information on exemption requests for two new exemptions that will be listed in Annex IV of Directive 2011/65/EU. It is important to note that this list of exemptions is specific to monitoring and control instruments for medical devices.

The consultation period started on 30 November 2021 and will last for a period of 10 weeks, finishing on 8 February 2022.

When submitting stakeholder contributions, it should clearly state if the exemption requests are justified or if there is no explanation. Your contribution must be supported by relevant technical and scientific evidence presented as part of the submission.

The confidential information submitted during the consultation will be posted on the CIRCABC (Communication and Information Resource Centre for Administrations, Businesses and Citizens) website. Stakeholders will be given the opportunity to exchange further information after the consultation. Following the consultation period, the exchange of information or need for technical discussion will be identified.

Consultations will be conducted with the following groups:

  • EEE industry
  • EEE industry federations
  • Consultancies
  • Research institutions & universities
  • NGOs
  • Public administrations

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