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Impacts of REACH – Authorisation (Final Report)

This study deals with the impacts of REACH authorisation. It builds on available information and is an attempt at generating quantitative estimates of the overall impacts of REACH au-thorisation. It involves a review of the existing literature and surveys with industry, NGOs,


the EC, ECHA and MSCA’s. The results of the study have fed into the second review of REACH by the European Commission in 2017.

ECHA has identified 103 registrants who have ceased manufacturing or importing a SVHC, 69 of which occurred to substances on the Candidate List (the remainder to Annex XIV sub-stances).

The main impacts observed by the respondents to the survey were:

reduction in the number of suppliers of SVHCs;

reduced availability of the SVHC for their use;

an increase in the price of the SVHC, and

conditions being imposed on safe handling and use of an SVHC.

Limitations in the data (PRODCOM, Eurostat) do not enable to assess if REACH has led to a reduction in EU sales of SVHCs with suitable alternative substances or technologies. Reasons why PRODCOM data may not be suitable for the task:

substitution takes time before changes become visible

alternatives being tested may continue to prove unsuitable

increased demand and sales of SVHC after the sunset date for those substances that ob-tained a review period

Partial evidence that relocation outside EEA is likely to be rare, possibly also due to the fact that all applications to date have been successful.

Most respondents said REACH Authorisation had not had a significant net impact on sales revenue (to date).

Partial evidence that REACH Authorisation pushed companies to invest more in R&D.

The present study found that the Authorisation process leads to substitution where it is technically feasible, even if the cost of applying for Authorisation could have been cheaper.

This report sets out several drivers for these substitutions, with numerous case study exam-ples. In such instances, it is nevertheless difficult to determine what motives prompted com-panies to substitute, whether the Authorisation process, other aspects of REACH and so on.

Survey results indicate that: those companies who switched to an alternative due to REACH Authorisation, indicated either a net loss in sales or no net change.

The survey results indicate that the levels of exposure reductions and emissions reductions of SVHCs achieved by both applicants and those that substituted (i.e. did not need to apply for authorisation) seemed to be relatively small (see Section 7.3). This is not necessarily sur-prising since companies should have been reducing their exposure over many years/dec-ades. While qualitatively it can be shown that REACH authorisation is having a positive ef-fect, due to lack of detailed data, it is currently not possible to quantify these benefits.

Despite being 10 years into the REACH process, this study suggests it is still too early to be able to quantify the benefits of REACH authorisation. To quantify the benefits, historical data on the number of workers exposed and changes in exposure level over time would be re-quired. Some of these data does exist at Member State (MS) level as some Member States


have confidential databases (for their MS) containing historical values for worker exposure which the study team were unable to obtain. In the future, should applicants reapply for au-thorisation (i.e. review report) the monitoring data which is set as a requirement in some of the authorisation decisions could provide some additional data to assist in assessing the scale of reductions being achieved over time.

Table 29: Summary of REACH benefits in the Study on the costs and benefits of authorisation

Driver/Pathway Indicators Gaps in impacts considered

Listing of SVHC on candidate list (“an-nouncement effects”)

Decisions to phase out sub-stances or to not-support uses because of listing on candidate list (predictive character of the candidate list)

Market data: limitations of data (i.e.

PRODCOM, Eurostat) make it hard to as-sess if there has been a reduction in sales of SVHCs and increase in sales of alterna-tive substances. Uncertainties over the im-pact on sales and revenues

Authorisation pro-cess:

Adequate control route (threshold sub-stances)

SEA route

No. of applications: adequate control route applications versus SEA route applications; number of approvals; number of exemp-tions in Annex XIV

No. of substances replaced with alternatives

No. of relocations outside EEA Reduction in exposure, emissions and waste.

Improvement in RMMs Market data on sales and reve-nues of SVHCs and alternatives (trend in SVHC substances as compared to others, suppliers of alternatives)

Increase in R&D spending Substitution of SVCH could result in reduced production costs (less need for control measures) and overall improved production effi-ciency (labour productivity, en-ergy consumption)

Improved communication net-works of micro-sized companies

There is only a qualitative assessment of the possible different impacts on SMEs as opposed to big firms

Only qualitative assessment about im-provement in RMMs

No access to national databases on worker exposure to carcinogens makes it harder to estimate historical trends in exposure levels and draws conclusion on actual re-duction of worker exposure

Uncertainty whether the main driver for reducing emission and exposure is REACH Authorisation or national legislations (na-tional OELs)

No quantitative estimate of the changes in R&D spending

Uncertainty over the overall effects of re-location (limited cases of rere-location were identified, companies unwilling to provide information)

Little data (limited sample) about the ef-fects on employment

Not enough information (limited sample) about effects on quality, price and availa-bility of products

No quantification of benefits from better information

Only one instance of SVHC that undertook authorisation process for environmental hazards. No information on direct impacts on the environment. In some cases where controls on human health have been opti-mised, benefits for the environment are supposed to have ensued as well.


Driver/Pathway Indicators Gaps in impacts considered

Reduction of risks for the environment re-main thus largely untested, not quantified.

Generation of infor-mation

Better information available for authorities: they know more about remaining uses of SVHCs and their production sites, more data to support control of expo-sure and emissions