Consultation outcome

Summary of responses

Updated 16 December 2022

Introduction

The authorisation process under UK REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where feasible alternatives exist.

The Health and Safety Executive (HSE) provided a recommendation to the Secretary of State on which SVHCs are a priority for inclusion in Annex 14 of UK REACH (the Authorisation List) in December 2021. HSE recommended that 2 substances are priorities to be added to the Authorisation List:

• Dicyclohexyl phthalate (DCHP)
• Disodium octaborate

This document sets out the responses to the call for evidence received in respect of DCHP only.

Read the summary of responses in relation to disodium octaborate.

DCHP is an endocrine disruptor of concern to human health and is toxic for reproduction (may damage the unborn child). Between 17 June and 12 August 2022, Defra, the Scottish Government and the Welsh Government held a call for evidence on DCHP to seek evidence on the use of the substance in Great Britain, availability of alternatives, impacts on the environment, public health and society as well as any general comments.

This evidence will help inform the Secretary of State’s decision on whether to add DCHP to the Authorisation List. That would mean that prior authorisation would be needed to use DCHP, or place it on the market, after the specified sunset date. If the Secretary of State decides to add DCHP to the Authorisation List, the decision will require consent from Scottish and Welsh Ministers.

Overview

We received 6 responses to the call for evidence on DCHP in total. Responses were from 2 businesses, one trade association, 2 non-governmental organisations (NGOs) and an individual. One of the businesses is a formulator of DCHP and the trade association represents businesses that use DCHP. We also received an email response from a business that we have considered alongside formal call for evidence responses.

To raise awareness of the call for evidence we held workshops with industry trade associations and NGOs where we discussed evidence gaps and asked for interested parties to respond. We also utilised UK REACH registration data to notify known users of DCHP by email that we were holding a call for evidence and how to respond.

Responses to the call for evidence will be used by Defra, Scottish Government and Welsh Government to inform the decision on whether DCHP should be added to the Authorisation List.

We are grateful to everyone who took the time to respond and share their views. This document highlights the main points raised but is not an exhaustive commentary on every response received.

Questions and responses

Uses

Respondents gave details on a range of uses of DCHP, including as a plasticiser, in adhesives and sealants, in tunnelling and mining and in car parts, which included parts used in braking systems, electrical charging systems, cooling and lighting systems and as an adhesive or locking fluid in vehicle production. One business stated that they were also a formulator of DCHP.

The primary function of DCHP identified by respondents was as a plasticiser. Respondents also stated that DCHP is used to make printer ink water resistant and as a phlegmatiser and dispersing agent for formulations of organic peroxides.

Respondents also stated that DCHP is used in articles. One respondent stated that in car parts, a representative article contains <1g of the substance (avg. ~1.9% w/w, range 0.1-6 % w/w in homogeneous material).

Government response

The majority of these responses are consistent with the uses that HSE identified in their recommendation. The HSE recommendation did not include information on the use of DCHP in car parts. We are grateful to the respondent for bringing this use to our attention and we will work with industry to fully understand how this use would be impacted if DCHP is added to the Authorisation List.

The use of DCHP when present in articles is exempt from the authorisation requirement. Therefore, the use of DCHP when present in articles would not be affected by adding DCHP to the Authorisation List.

Availability of alternatives

Two respondents named potential alternatives for DCHP in plasticisers. One respondent also stated that industry was best placed to assess the availability of alternatives and that this should be done on a case-by-case basis. One respondent highlighted the need to avoid substituting one hazardous substance for an equally or more hazardous substance, known as regrettable substitution.

Two respondents, who were businesses, have already substituted DCHP with phthalate-free alternatives. One of these respondents stated that it was hard to source phthalate-free packaging within Great Britain and that they need to source their alternative from the EU.

Government response

We aim to avoid the possibility of regrettable substitution. One of the reasons HSE recommended adding DCHP to the Authorisation List was to prevent DCHP from being used as a substitute for other phthalates already on the Authorisation List. We will take into account the need to avoid regrettable substitution in the decision making process.

While it may be hard to source alternatives to DCHP within Great Britain, there are alternatives to phthalates in general on the global market. One of the purposes of authorisation under UK REACH is to provide motivation for industry to substitute to safer alternatives where possible. Adding a substance to the Authorisation List may mean that alternatives to the substance become more readily available in Great Britain as industry is required to move to alternatives.

Market and supply chain

Respondents stated that DCHP is used in construction, plastics, toy manufacture, car part manufacture and semi-conductor industries.

We received a detailed response from a trade association stating that 859,575 cars were built (~80% for export) and 1,647,181 new cars were registered in the UK in 2021. A representative vehicle may contain between 1 and 100 articles each containing <1g DCHP. The respondent stated that automotive turnover in the UK in 2021 was £67.1 billion and the sector employs 797,300 people, with the highest concentration of automotive companies being in the West Midlands, East and South-East of England and East Midlands.

Government response

We are considering the impact that adding DCHP to the Authorisation List would have on the market as part of the decision-making process.

Competitiveness

Two respondents stated that there may be increased production costs due to moving to alternatives, however one of these stated that these costs would be ‘slight’. One respondent stated that there would be no change in costs to their business as they have already substituted to a phthalate-free alternative. One respondent stated that adding DCHP to the Authorisation List would give them more choice and flexibility in their business (which requires plastic packaging) because phthalate-free alternatives would become more readily available.

Government response

We recognise there are costs associated with the authorisation process. We will take these into account along with the need for SVHCs to be substituted where safer alternatives are technically and economically feasible when making a decision on whether DCHP should be added to the Authorisation List.

Other impacts of inclusion in the Authorisation List: innovation and business opportunities

Some respondents supported the inclusion of DCHP to the Authorisation List stating that society and the environment would be better off as a result. Respondents stated that adding DCHP to the Authorisation List would create a market for alternatives and bio-based plasticisers and that companies would not innovate to develop alternatives if they were not required to.

In addition, one of the respondents gave detailed information on uses taken from the European Chemicals Agency (ECHA) substance web page . They also stated that because UK REACH registration data is not yet fully populated, uses identified in EU registrations should be considered as possible uses in Great Britain. The response provided a report (Olsson et al , 2014) that quantified some costs to society from exposure to EDCs. The response also stated that DCHP was identified by ChemTrust as a key phthalate to take action on in a 2018 research project due to its presence in plastic packaging.

Government response

Adding DCHP to the Authorisation List would require companies to move to safer alternatives where these are technically and economically feasible. Adding substances to the Authorisation List often increases innovation because companies find investing in research and development into alternatives is less costly than applying for authorisation (ECHA, 2020).

DCHP is an EDC of concern to human health and it is toxic for reproduction. HSE took data from the European Chemicals Agency into account in its recommendation. This was based on an assumption that the industrial profile for Great Britain is not substantially different to the EU.

Sustainability and social impact

Responses stated that there are a number of alternatives to DCHP as a plasticiser and highlighted the need to avoid regrettable substitution.

One respondent was in support of banning DCHP due to its endocrine disrupting properties. The respondent also cited that exposure to EDCs has been associated with an increased risk of cardiovascular disease.

Government response

We aim to avoid the possibility of regrettable substitution. One of the reasons HSE recommended adding DCHP to the Authorisation List was prevent DCHP from being used as a substitute for other phthalates already on the Authorisation List.

Adding a substance to the Authorisation List would mean that a company could not use or place that substance on the market unless they were granted a use specific authorisation. Authorisation is time limited and can only be granted where the business demonstrates that the risks arising from the use are adequately controlled or that the socio-economic benefits outweigh the risks and there are no suitable alternatives.

Applications for authorisation

Only one respondent (a business) gave information on likely applications for authorisation. They stated that neither they nor their downstream users would apply for authorisation should DCHP be added to the Authorisation List.

Government response

This is useful information that will be considered as part of the decision making process. However, with only one response on this section it is not possible to form any firm conclusions.

Regulatory options

One respondent stated that regulatory action that meant that DCHP is no longer used is the best option. Another respondent stated that regulatory action in the EU is likely to have an impact in Great Britain due to the interconnectedness of supply chains in the EU and Great Britain. This response noted that the EU has consulted on whether to add DCHP to the EU REACH Authorisation List.

Government response

Adding DCHP to the Authorisation List would mean that it cannot be used unless a company has been granted a time limited and use specific authorisation.

We are aware that the EU has consulted on adding DCHP to the EU REACH Authorisation List. The final decision in the EU has not yet been made. If the EU adds DCHP to the EU Authorisation List it will likely impact supply chains in Great Britain because the EU is our closest trading partner. However, the decision on whether to add DCHP to the Authorisation List in Great Britain will be decided on the risks and benefits to Great Britain.

Other remarks

Two respondents used this section to say that they were in favour of adding DCHP to the Authorisation List.

One respondent stated that they were in support of DCHP being phased out, but they thought that there should not be a mechanism for companies to apply for authorisation to continue use. They stated that they did not believe that any use of DCHP would be justified.

Government response

We note that all 3 respondents were in favour of preventing the use of DCHP, which is consistent with adding DCHP to the Authorisation List. These responses will be taken into account in the decision making process.

Authorisation can only be granted where the business demonstrates that the risks arising from the use are adequately controlled or that the socio-economic benefits outweigh the risks and there are no suitable alternatives.

The next steps

The responses to the call for evidence will be used to inform the decision on whether DCHP should be added to the Authorisation List. We plan to publish a draft decision in due course. The call for evidence responses will be securely held by Defra for 2 years in line with retention policies.