Lead and cadmium in ion selective electrodes

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Closes 14 Dec 2022

Introduction

1. What is your name?
2. What is your email address?
3. What is your organisation?
4. Do you agree or disagree that the exemption for lead and cadmium used in ion selective electrodes including glass of pH electrodes to the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations should be renewed?

The exemption request

Entry 65 in Table 1, Schedule A2 of the 2020 Regulations is for lead and cadmium to be used in ion selective electrodes including glass of pH electrodes. The exemption for category 8 (medical devices) applications is due to expire by 21st July 2023; the applicant, COCIR (the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries, representing one main manufacturer of blood gas system producers) has requested a renewal until August 2026.

Granting the renewal of this exemption would lead to the continued introduction of 4.3g of cadmium and 9.9g of lead to the GB market annually. The applicant states that no suitable substitutes that have been verified to meet the technical performance required have been identified.

 

(Required)
5. Do agree or disagree with the proposed end date (i.e. August 2026) of the exemption renewal?
(Required)
6. Do you agree or disagree that the wording of the exemption should be changed noting that if the wording is changed, the scope of the exemption would be much narrower? Existing wording: lead and cadmium to be used in ion selective electrodes including glass of pH electrodes Proposed wording: lead and cadmium in thick film pastes, in ion selective electrodes used for blood gas systems.

Proposed change to wording of the exemption

The applicant proposed the following change in the wording of the exemption entry: lead    and cadmium in thick film pastes, in ion selective electrodes used for blood gas systems. This wording is more specific to the applicant’s exemption requirements but may narrow the potential applications for which the exemption can be used. Therefore, it is important to understand whether there are other exemption uses that may not be covered within the specific application that the applicant proposes to use.

 

(Required)
7. Do you know of alternative substances to lead and cadmium that can be used in the production of the ion selective electrodes used in these blood gas systems? For example, lead-free thick film pastes

Alternatives and substitute testing

According to the exemption applicant, testing is still ongoing for alternative RoHS compliant thick film pastes, with a focus on alternatives developed by the same manufacturer to minimise the changes to the technical characteristics of the paste, and thus reduce the timeframes for substitute development and approval. Alternative technologies which avoid the use of thick film pastes are possible but would require additional time to qualify alternatives due to more significant product design and production process changes. In addition to these changes, the many decades of experience and reliability of data gathered while using thick film pastes would also have to be overcome, resulting in considerably longer timeframes for substitute development and approval. 

This consultation aims to collect opinions on the current state of play regarding alternatives and substitutes, at a substance and a device level, and to further understand the alternatives and any limitations that the alternatives currently available might have for end users.

(Required)
8. Do you know of alternative devices (with comparable features and performance), which do not rely on RoHS-restricted substances. For example, blood gas systems which do not use replaceable cartridges using the lead-containing electrodes.
(Required)
9. Are you aware of any research initiatives (past, present or planned) which are looking into possible alternatives for some or all of the application range of lead and cadmium in thick film pastes, in ion selective electrodes used for blood gas systems.
(Required)
10. Can you estimate how many lead-containing cartridges, or other equipment covered by this exemption your organisation produces or purchases per year (if applicable)?
11. As part of the evaluation, environmental impacts will be assessed. Please estimate possible amounts of waste to be generated through a forced substitution should the exemption not be granted. For example, can you estimate the number of devices that would no longer be useable without replacements, and therefore would become waste (if applicable)?
12. As part of the evaluation, socio-economic impacts shall also be assessed. Please estimate possible impacts on employment in total, in GB and outside GB, should the exemption not be granted. Please tick to indicate the main sectors in which possible impacts are expected

Socio-economic impacts

This consultation is also looking to further understand how the granting or revocation of this exemption request may impact on business, from manufacturing through to end user applications, as well as wider society and social impacts (e.g., human health impacts). We welcome opinions and supporting evidence for any viewpoints associated with the socio-economic impacts of this exemption.

13. Please estimate additional costs associated with a forced substitution should the exemption not be granted, and how this is divided between various sectors:
14. Please summarise your view on the potential impacts on human health, if this exemption was not granted?
15. Please provide any further information and/or data that you think is of importance to substantiate your views.