Consultation outcome

Summary of responses and government response

Updated 11 January 2022

The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (‘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 EEE waste. Phthalates have long been a matter of concern because if they are released into the environment during waste treatment operations there is the potential for secondary poisoning and, through inhalation, effects on the respiratory tracts of those who come into contact with them. Therefore, it is crucial that there are restrictions on their use.

The restriction of phthalates in medical devices and monitoring and control instrumentation has already been granted in the EU, meaning businesses and producers have already adapted and are developing alternatives. A domestic restriction would prevent GB from becoming a ‘dumping ground’ for phthalate-containing medical devices and monitoring and control instruments.

Our consultation on amendments to the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations sought views, therefore, on restricting the use of phthalates in medical devices and monitoring and control instruments.

Responses to the consultation

The public consultation was open for four weeks; from 14 September until 12 October 2021. There were eight responses to it. Six of these were from or representing industry but two respondents did not provide any identifying information. Seven respondents responded to the consultation via Citizen Space and one sent their response via email. We are grateful to all respondents for taking the time to respond.

All of the respondents agreed that the use of phthalates in medical devices and monitoring and control instruments should be restricted.

The following provides background and more detailed analysis of the responses to the consultation.

Background

Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment is a piece of European legislation that limits the amounts of ten hazardous substances that can be used in the manufacture of electrical and electronic equipment. The UK played a key role in developing the original European legislation, and The Restriction of the Use of Certain Hazardous Substances in Electronic and Electronic Equipment 2012 (‘The RoHS Regulations’) transposed the Directive into UK law.

Powers conferred on the European Commission under the RoHS Directive to amend the list of restricted substances and associated concentration limits in that Directive and to consider applications from business for exemptions from the restrictions for specific products have been repatriated to the Secretary of State by Regulations made using powers from the European Union (Withdrawal) Act 2018 (EU Exit Regulations). These repatriated powers enable the Secretary of State to amend the list of restricted substances and maximum permitted concentration thresholds for each of those substances inserted into the RoHS Regulations by EU Exit Regulations, as they apply in GB. The RoHS Regulations, as they apply in relation to NI, continue to be automatically updated to take account of amendments to the list of restricted substances, concentration limits and exemptions in the Directive.

The European Union adopted legislation (Commission Delegated Directive (2015/863)) in 2015, which amended the RoHS Directive to add the following four phthalates to the list of restricted substances and maximum concentration values in Annex II to that Directive (the maximum concentration values are in brackets):

• Bis(2-ethylhexyl) phthalate (DEHP) (0.1%),
• Butyl benzyl phthalate (BBP) (0.1%),
• Dibutyl phthalate (DBP) (0.1%) and
• Diisobutyl phthalate (DIBP) (0.1%)

Defra commissioned an independent report from Anthesis which was published alongside the consultation and recommended that the restriction should apply in GB. The restriction already applies in Northern Ireland.

Analysis of responses by question

Do you agree with the proposal to add four phthalates, Bis(2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP) and Diisobutyl phthalate (DIBP) to the restricted substances applied to medical and monitoring and control instruments at a maximum concentration level of 0.1%

All eight respondents agreed with the proposal.

None of the respondents provided further comments or evidence.

Do you agree with the findings of the independent technical evaluation in support of this proposal?

Defra commissioned an independent review from technical consultants. The findings of that review were published alongside the consultation.

The review includes:

• references and scientific evidence in support of the adoption of the proposed restrictions
• information on the use of substances in equipment
• information on detrimental effects and exposure, in particular during waste management operations
• information on possible substitutes and other alternatives, on their availability and reliability
• justification for the proposed provision being the most appropriate measure
• information on socio-economic impacts

The review concludes that restricting phthalates in medical devices would bring extra protection for waste operators and reduce emissions to the environment. The industry has been developing alternatives to phthalates for several years and requests for exemptions for their use should be seen as bridging requests until alternatives have been validated. The review also concludes that the annual net cost to business would be less than £5 million.

All eight respondents responded to this question and agreed with the findings of the technical report. There was one response to the part of the question that asked for any comments or information on the technical report which stated

The detrimental effects caused by the four listed restrictive substances (consultation Annex II) are well documented. We have recognised this in our products.

Do you agree with our assessments of business impacts?

Our evidence suggests that restricting the use of phthalates in medical devices would have little impact on business. This is explored in more detail in our technical evaluation mentioned above. But in summary, there would be very few costs to businesses because they are already compliant with EU requirements and are not expecting any deviation from those requirements in GB following departure from the EU. It is also worth mentioning here that industry has expressed concern that GB could become a dumping ground for medical devices containing phthalates with the potential to pollute the supply chain.

All respondents to the consultation responded to this question. Seven respondents did agree with the assessment of business impacts and one responding that they did not know.

One respondent answered the part of the question that asked for evidence and comments on the impacts on business with the following comment:

As the European Union has also agreed these changes, we anticipate more limited business impacts. However, in principle, it is important for the government to at least consider the differences between UK and EU regulations in technical equipment and the impact this can have on businesses. This is particularly the case while negotiations over the Northern Ireland protocol continue.

The majority of businesses have already moved away from the use of phthalates, but it is positive that the government wishes to enforce higher, safer standards.

Next steps

The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (‘The RoHS Regulations’) will be amended to extend the restriction on the use of four phthalates (Bis(2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP) and Diisobutyl phthalate (DIBP) in medical devices and monitoring and control instruments.

This will come into force on 1 July 2022.