Lead and cadmium in ion selective electrodes

Overview

The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (the RoHS Regulations) restricts the use of 10 hazardous substances in electrical and electronic equipment (EEE) with a view to contributing to the protection of human health and the environment, including the sound recovery and disposal of waste.

Industry can apply for exemptions to allow the supply of products using one or more of the restricted substances above the threshold limits set down in the RoHS Regulations where specified criteria are met. Applications for exemptions are made to the Secretary of State under regulation 6 of the Hazardous Substances and Packaging (Legislative Functions and Amendment) (EU Exit) Regulations 2020 (the 2020 Regulations). Any exemption that is granted can be used across industry, not just the business that applied for the exemption. Exemptions are granted where it is determined that the necessary criteria have been met following a detailed evaluation conducted in accordance with regulation 5 of the 2020 Regulations.

Following the UK’s withdrawal from the EU, the function of granting, renewing and revoking exemptions were, in relation to Great Britain, transferred to the Secretary of State by the 2020 Regulations using powers in section 8 of the European Union (Withdrawal) Act 2018 (the Withdrawal Act).

Part of the evaluation process is a 6-week consultation to collect contributions from stakeholders.

A request for renewal for an exemption was submitted for lead and cadmium to be used in ion selective electrodes including glass of pH electrodes. These ion selective electrodes are used in many diagnostic and analytical applications, such as within blood gas analysers. Many of the devices these electrodes are used to help in the diagnosis of several medical conditions, including respiratory conditions, diabetes, and infections. The lead and cadmium specified in the exemption request is for use in the thick film pastes in the ion selective electrodes that are required for the sensors to function.

The requested duration of the exemption is until August 2026 and according to the application it would be expected to lead to the introduction of 4.3g of cadmium and 9.9g of lead to the UK market annually. The applicant states that no suitable substitutes have been verified to meet the technical performance required.

The exemption covers in vitro applications under category 8 (medical devices) of Electrical and electronic equipment (EEE), as covered in the 2012 RoHS regulations. The applicant proposed the following change in the wording of the current exemption entry: Lead and cadmium in thick film pastes, in ion selective electrodes used for blood gas systems. The original wording is lead and cadmium used in ion selective electrodes including glass of pH electrodes.

The purpose of this consultation is to seek views on the request for the renewal of an exemption to the substance restrictions in the RoHS Regulations, to collect additional data and information and to inform stakeholders about the application.