Research and analysis

Investigation of the need for CSAs and CSRs for substances registered in the 1 to 10 tonnage band

Published 29 June 2023

Applies to England, Scotland and Wales

Executive summary and conclusions

Under Article 138(1) of UK REACH (Registration, Evaluation, Authorisation and restrictions of CHemicals), the Secretary of State must review whether to extend the requirement to complete Chemical Safety Assessments (CSAs) and Chemical Safety Reports (CSRs) to manufacturers and importers in the 1 to 10 tonne band. This review must be completed within 18 months of the UK leaving the EU.

Under Article 138(1) the review must take account of:

• the costs for manufacturers and importers of drawing up the chemical safety reports
• the distribution of costs between actors in the supply chain and the downstream user
• assessment of the benefits for human health and the environment

This review focussed only on carcinogenic, mutagenic or reproductive toxic (CMR) substances registered in the 1 to 10 tonne band.

The ‘costs analysis’ was based on the same approach as used by the European Commission in its equivalent review, which listed 7 costs for producing each section of the CSA. Information from the ‘Comply with UK REACH’ database was used to determine the numbers of CMR substances expected to be registered exclusively at 1 to 10 tonnes and at both 1 to 10 tonnes and above.

There was a total of 262 CMR substances in the 1 to 10 tonne band, of which 56 CMR substances were exclusively in that band.

The total costs of producing each component required for a CSA was an average of £17,185 per CSA per CMR registration for those substances exclusively in the 1 to 10 tonne band. For registrations at both 1 to 10 tonnes and above, the estimated average cost was lower, at around £13,500, because information can be drawn from CSAs and CSRs which are already available in the higher tonnage registrations.

We have calculated an overall cost for extending the CSA and CSR duty to all CMR registrations under 10 tonnes of approximately £3.7 million. This is based on the assumption that all grandfathered registrants and Downstream User Import Notifications (DUINs) will go on to provide full registration data and that the one substance, one registration principle of REACH continues to apply. These costs also only include new economic costs and not transfer costs.

All registrations in EU REACH that were held by companies in Great Britain at the time of exit were automatically transferred into UK REACH (grandfathering). A downstream user is someone who uses a chemical down the supply chain from the manufacturer or importer.

The ‘benefits review’ was based broadly on benefits identified in the Commission’s report. The benefits reported are purely narratives and do not include an assessment of the avoidance of adverse health impacts.

For this reason, it is not possible to provide a quantitative comparison of the quantitative costs of producing the CSA against qualitative savings for avoidance of health impacts.

The main benefit can be summarised as the potential improvements in risk management through the supply chain associated with CSAs and improved safety data sheets for those CMR substances which are exclusively in the 1 to 10 tonne range. The improved risk management should have benefits to protection of human health. There may also be improvements for environmental protection as the identification of a hazard in a CSA would also trigger environmental risk assessment.

The benefits of improved risk management might also extend to greater efficiency in regulation, and a reduction in duplication of effort due to the reporting of more consistent information.

The benefits of having the CSA information for the 1 to 10 tonne band might also extend to businesses. These could include:

• better risk management and welfare of workers leading to reduced health care costs and loss of productivity
• reputational benefits from demonstration of compliance with globally recognised chemicals regulation
• stimulation of innovation and substitution to avoid the additional CSA costs

However, there could also be some market impacts if additional costs lead to the withdrawal of substances which are used in manufacturing or other activities, including by downstream users.

Conclusions

It is possible to draw some conclusions from the quantitative economic analysis and qualitative benefits narratives.

We have indicated the potential costs of generating CSAs for registrations of CMRs which are either exclusively in the 1 to 10 tonne band or in both the 1 to 10 tonnes as well as higher bands. These result in an overall cost estimate of £3.7 million for all 262 CMR substances registered or notified on the UK REACH Service database. It is not possible to determine whether some registrants and notifiers will not eventually provide full registration information data, or the potential scale of this, but it would mean a reduction in the total costs.

Narratives of possible benefits have been identified for improved risk management, human health protection, business benefits, regulatory management, and innovation. These are untested and qualitative and cannot be balanced against the costs of producing the CSA. They indicate that extending the duty to carry out CSA and CSRs could contribute to the achievement of the objectives of REACH for a high level of protection of human health and the environment.

The current review of UK REACH registration through the REACH Alternative Transitional Registration model may result in changes in information requirements. It would not be appropriate to draw conclusions independently of that wider development work and, therefore, we do not propose any amendments to requirements for CSAs in CMR registrations in the 1 to 10 tonnage band at this time.

In memory of Helen Pontier whose dedicated work contributed so much to the review and this report.

1. Introduction

Article 138 of UK REACH contains a series of powers and duties to carry out policy reviews of aspects of REACH.

Article 138(1) states:

The Secretary of State shall carry out a review to assess whether or not to extend the application of the obligation to perform a chemical safety assessment and to document it in a chemical safety report to substances not covered by this obligation because they are not subject to registration or subject to registration but manufactured or imported in quantities of less than 10 tonnes per year. When carrying out the review the Secretary of State shall take into account all relevant factors, including:

• the costs for manufacturers and importers of drawing up the chemical safety reports
• the distribution of costs between actors in the supply chain and the downstream user
• the benefits for human health and the environment
• the views of any appropriate authority

On the basis of this review, the Secretary of State may, if appropriate, formulate proposals to extend this obligation.

This review must be completed within 18 months of the end of the transition period.

1.1. Context

Defra is carrying out detailed development work on a possible Alternative Transitional Registration model for UK REACH. This is looking at alternative approaches to the hazard, use and exposure information in transitional registration dossiers, and as such is likely to have an impact on the obligations for registrations in the 1 to 10 tonne band.

1.2. Transitional registration information

Under UK REACH, transitional registration information is submitted to the Health and Safety Executive in 2 phases, an initial notification followed by full submission of the remainder of the information at a later date. Grandfathered registrants had to submit their initial notifications by April 2021 and downstream users by October 2021. The first deadline for full submission of the remainder of the data is October 2026. Therefore, this review has used information mainly supplied through the notification stages as of 29 April 2022.

2. Aims and objectives

The main aim of this review is to scope out issues and possible costs and benefits of extending requirements for CSAs and CSRs to substances registered in the 1 to 10 tonne band. We have used existing information to draft the report, including the costs and benefits analysis in sections 5 and 6 of this reports.

It considers the number of substances registered or notified in the 1 to 10 tonne band, in particular those which are CMR substances.

3. Method

The scope of this review was restricted to extending requirements for CSAs and CSRs only to CMR substances which are, or are expected to be, registered in the 1 to 10 tonne band. This was a prioritisation measure to respond to the risks CMR substances can present.

This review assessed available evidence in the context of the work on the Alternative Transitional Registration model.

The evidence gathering involved 3 steps:

1. Literature review.
2. Analysis of the UK database.
3. Costs and benefits analysis.

3.1. Literature review

The literature review was based on web searches to find information relating to CSAs and CSRs. It drew out relevant sections from a range of documents, including the report on the equivalent review by the European Commission.

3.2. The UK database analysis

The UK REACH Service database analysis included grandfathered registrations and downstream user import notifications. It identified substances that were exclusively in the 1 to 10 tonne band as well as substances that were in both the 1 to 10 tonne band and higher ones. CMR substances were separated out to use in the economic analysis.

3.3. Costs and benefits analysis

The economic analysis used costings per substance for developing a CSA and CSR as given in the Commission Report and multiplied this by the number of UK registered and notified substances to arrive at possible total costs.

The benefits analysis used in the Commission Report was used as a start to list potential benefits to the population of Great Britain, environment and industry. We did not adopt the method used in the Commission report analysis of the willingness to pay for avoiding adverse impacts on human health. This is because the data are not available to demonstrate the causality between extending the requirement for CSA and CSRs to the 1 to 10 tonne band and morbidities that might be avoided.

3.4. Assumptions and limitations

3.4.1. Assumption: existing registration requirements are implemented, and transfer costs are set at zero

Where a substance has previously been registered at a higher tonnage, it is assumed that hazard assessments will have been completed and utilised as part of the existing CSA and will be available to registrants at 1 to 10 tonnes. The cost paid by the 1 to 10 tonnes registrants to the higher tonnage registrants for data access is, therefore, taken as a ‘transfer payment’ and not an ‘economic cost’. A zero-cost is assumed for completing the physicochemical, human health and environmental hazard assessments for these lower tonnage registrants. The existing transitional registration process may be subject to change through the development of the alternative transitional registration model. In that case the information regarding hazard assessments may not be available to, or needed by, registrants to the same extent. This would mean that zero-cost transfers would not occur to the same extent as assumed.

3.4.2. Assumption: transitional notifications on the database will be followed up by full registrations

The UK REACH Service database was used to gather information on the numbers of CMR registrations that were either exclusively in the 1 to 10 tonne band or in both the 1 to 10 tonne band and a higher band. The economic assessment is an estimate based on the assumption that all grandfathered and downstream user import notifications will go on to submit full registration data. However, for various business reasons a company may choose to cease manufacture or import and as a result will not have to complete a registration. This would affect the economic assessment and the total costs would be lower than our estimate.

By contrast, downstream users with limited experience of registration duties may face greater resource issues in accessing or generating the information required, in which case their individual costs may be higher than our estimates.

3.4.3. Other assumptions

• The principle of one substance one registration should involves a high degree of collaboration between registrants, so they can share data and costs.

• Costs of generating registration data per substance under UK REACH will be the same as those indicated in the Commission’s report under EU REACH.

3.4.4. Restriction to CMR substances

The review was limited to established CMR substances so did not address the potential costs and benefits of extending the requirement for CSA and CSRs to all substances.

4. Results overview

The results are split into 3 parts:

1. Literature review results (Section 4.1).
2. Analysis of the Comply with UK REACH and discussion of the costs analysis (Section 5).
3. Benefits narratives (Section 6).

4.1. Literature review

The main focus was on the equivalent report by the European Commission and the review of evidence on the benefits and costs of REACH by Umweldbundesamt (UBA, the German Environment Agency).

5. Economic analysis

The economic analysis assesses the possible costs if the obligation to perform a CSA is extended to substances produced at 1 to 10 tonnes a year that meet the criteria for classification in the hazard classes for carcinogenicity, cell mutagenicity or toxicity to reproduction, category 1A or 1B (CMR substances). The analysis was conducted using information from the UK REACH Service database as of 29 April 2022.

5.1. Analysis for extending CSA and CSR requirement to substances registered at 1 to 10 tonnes

The analysis in this section uses a unit cost for producing a CSA which was built up from a set of individual cost factors. The number of CMR substances registered or notified on the UK REACH Service database either exclusively at 1 to 10 tonnes or at both 1 to 10 tonnes and a higher tonnage band were then identified. The sum of these figures was used to derive a total cost, as shown in Section 5.2, Table 2.

5.1.1. Number of substances

Information from the DUINs and grandfathered registrations in the UK REACH Service database revealed a total of 262 CMR Category 1A or 1B substances registered or notified at 1 to 10 tonnes. Table 1 provides a breakdown of these substances in terms of carcinogenicity, mutagenicity or reproductive toxicity.

Table 1. Numbers of CMR substances identified in the UK REACH Service database at 1 to 10 tonnes only and at 1 to 10 tonnes and above

	1 to 10 tonnes only	1 to 10 tonnes and above	Total
Number classified as Carcinogenic Category 1A or 1B	39	165	204
Number classified as Mutagenic Category 1A or 1B	19	90	109
Number classified as Reprotoxic Category 1A or 1B	20	63	83
Total number of CMRs 1A or 1B	56	206	262

Note: substances can carry more than one hazard, for example a carcinogenic substance may also be mutagenic.

Out of these 262 CMR substances, 56 substances appear exclusively in the 1 to 10 tonne band. Extending the CSA and CSR requirement to substances in the 1 to 10 tonne band would mean a CSA would have to be completed for these substances for the first time and exposure and risk characterisation undertaken for downstream uses connected with registrant’s market. There is potentially a transfer cost between registrant and downstream user. Whether the result is a cost or a benefit in a particular case would depend on factors such as whether the supplier’s CSA or CSR assists the downstream user to carry out the risk assessment which is already required of them under the COSHH (Control of Substances Hazardous to Health) Regulations.

5.1.2. The costs of producing the CSA and CSR

A significant proportion of costs may come from the exposure assessment and risk characterisation (approximately £9,800 per substance) and from the PBT and vPvB assessment (for substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative). The estimate for PBTs is £640 for screening and approximately £25,000 for the PBT assessment where the screening indicates that it is needed. It is assumed that the full PBT assessment is only needed in a small proportion of substances.

Other costs include £790 to produce the extended Safety Data Sheets and £5,135 for communicating with downstream users on all uses of substances. This is undertaken especially in the exposure assessments and risk characterisation and costs can be higher in isolated cases.

The total estimated average costs are:

• £17,185 per CSA per CMR registered exclusively in the 1 to 10 tonne band. This cost includes the screening costs but does not include the assessment component of costs for PBT and vPvB. Consequently, there may be companies for which the cost of producing the CSA will be much higher.

• £13,500 per CSA per CMR for substances registered in both the 1 to 10 tonne band and a higher band. This lower sum is because some of the data (for example, hazard assessment and classification) is already available in the higher tonnage registrations. It does not need to be reproduced and can be used in lower tonnage registrations, but it is not possible to provide a data transfer cost.

5.2. Total cost of producing CSA and CSR for all registered substances

Having established costs of generating CSAs per CMR substance for registrations which are exclusively in the 1 to 10 tonne band and for those which are in both the 1 to 10 tonne band and a higher band, the next step was to multiply by the number of registrations in each category. Table 2 shows the results, assuming one CSA per CMR substance registration.

Table 2. Total costs of CSAs for all CMR registrations

	1 to 10 tonnes only	1 to 10 tonnes and above	Total
Number of substances	56	206	262
Total cost of CSA for registrants (excludes further PBT assessment costs)	£962,360 (average cost of CSA x number of substances £17,185 x 56)	£2,784,090 (average cost of CSA x number of substances £13,515 x 20)	£3,746,450

We estimate a total cost of approximately £3.7 million to registrants for extending the CSA and CSR obligation to 1 to 10 tonnes substances.

We assumed that registrants bear this full direct cost burden in registering CMR Category 1A or 1B substances at the lower tonnage range. It was assumed in the Commission Report that a proportion of this burden is passed down to downstream users in the form of higher prices. These prices are considered transfer costs and will not be counted in the overall total cost of the CSA.

6. Benefits analysis

6.1. General method

This section draws on the conclusions of the European Commission and German Environment Agency reports. It provides narratives but they have not been subjected to detailed analysis to validate them or consider their applicability to the UK.

We have not attempted to monetise human health or environmental benefits and it is not possible to balance the total CSA and CSR costs against the narratives of these benefits. As noted previously we have not replicated the Commission’s use of a willingness to pay assessment. It also cannot isolate benefits of extending CSA and CSR from benefits derived from other legislation in place to protect human health, such as Control of Substances Hazardous to Health (COSHH) Regulations, which are about controlling exposure and risk in the workplace.

6.2. Potential benefits of CSA and CSR requirements

Potential benefits of extending requirements for CSA and CSR to CMR substances registered in the 1 to 10 tonne band can be summarised, although in practice these may be limited if they only result from the substances for which there is currently no CSA and CSR because they fall only in the 1 to 10 tonne band:

• Consistent and adequate risk management measures, for manufacturers, downstream users and producers and users of articles.

• Human health protection, as a result of improved risk management measures, there could be anticipated direct benefits for human welfare, as well as cost benefits such as savings in health care costs or avoidance of losses in productivity.

• Environmental protection could improve through consideration of environmental exposure, its likely effects, and appropriate risk management for identified uses.

• Regulatory efficiencies through a single CSR and more consistent set of risk management measures, rather than an assortment of proposed measures generated by manufacturers and downstream users. It might contribute to prioritisation of authorisation or restriction activity.

• Business benefits that may accrue to businesses in Great Britain through producing the CSRs which may give them strengths in the marketplace, abroad and domestically, such as improving their reputation and standing with associated trade value.

• Knowledge and information about substances and our understanding of their uses and the markets will increase if the CSR requirement is extended to the 1 to 10 tonne band.

6.2.1. Environmental impacts

Even if the CSA and CSR were only extended to CMR substances it is to be expected that that there would still be some environmental benefits. This is because a PBT and vPvB screening is a requirement of all CSAs and it must be followed by a full assessment when indicated. A CMR hazard must also lead to risk assessment, including for the environment. These must then be reported in the CSR. These requirements will increase understanding of which substances could also be damaging to the environment. The Commission report findings concluded that the screening process would result in only 2.7% of registered CMR substances being also identified as a potential PBT or vPvB, with 20% of these being confirmed following the assessment stage. We have assumed the same outcomes for UK REACH.

Considerations for extending CSA requirements to registrations in the 1 to 10 tonne band will need to consider the costs of PBT and vPvB assessments. Our economic assessment provided some estimates of the costs of generating those parts of the CSA involving the PBT and vPvB assessment. Most of the costs of PBT and vPvB screening and assessment are connected with the follow-on assessments which are only required in a small minority of cases.

6.2.2. Possible disadvantages

The cost may have an impact on whether to continue to supply substances where rates of return are marginal with a consequential economic impact and market access to substances needed by downstream users. This would be considered in an impact assessment were any changes to REACH to be proposed.

6.3. Perceived benefits of extending the requirement to other substances

262 substances on the ‘Comply with UK REACH’ database at 1 to 10 tonnes are identified as CMR Category 1A or 1B. If the review were to examine substances meeting other hazard criteria, we would expect that more low tonnage substances would be brought within scope resulting in higher costs for industry to meet the CSA information requirements.

The ‘Comply with UK REACH’ database can be used to investigate the costs and benefits of extending requirements for CSA and CSR beyond CMRs and make allowance for those substances also registered above 10 tonnes where such information exists. This would need an additional review. If this is considered appropriate it may be advisable to use a prioritisation approach to assessment rather than to extend the CSA and CSR requirements to all substances.

7. Definitions

Actor in the supply chain: All manufacturers, importers, or downstream users in a supply chain of a substance.

Agency: The Health and Safety Executive as the authority established to carry out the obligations arising from the UK REACH Regulation.

CMR substance: Substances that are carcinogenic, mutagenic, or toxic to reproduction. A category of chemical substances, which alone, in mixtures or in articles can cause harmful effects to humans.

CSA: Chemical Safety Assessment. This is carried out for all registered substances manufactured or imported at 10 tonnes per year and above. It includes hazard assessments for physicochemical properties, human health and the environment, and exposure assessment and risk characterisation.

CSR: Chemical Safety Report. A CSR documents the chemical safety assessment.

Downstream user: Any natural or legal person established within Great Britain, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of their industrial or professional activities.

Downstream User Import Notification (DUIN): Transitional provision in UK REACH for Great Britain-based downstream users and distributors under EU REACH indicating their continued import of substances into Great Britain from the EU.

Grandfathering: Transitional provision in UK REACH that automatically transferred Great Britain-based EU REACH registrations into UK REACH.

Import: The physical introduction into Great Britain.

Importer: Any natural or legal person established within Great Britain who is responsible for the import.

Manufacture: The production or extraction of a substance in the natural state.

Registrant: The manufacturer or the importer of a substance or the producer or importer of an article with a duty to register a substance.

Safety Data Sheet (SDS): The Safety Data Sheet provides a mechanism for transmitting appropriate safety information on classified substances and mixtures, including information from the relevant Chemical Safety Report, down the supply chain.