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Dr Reach: How much to budget for REACH registration in 2010?

Budgeting for 2010? There are several different types of cost associated with REACH registration which companies need to consider.

As part of registration activities, terms like ‘Dossier Preparation’ can be used in different ways. For instance, this may or may not include chemical safety assessments (CSAs), while CSAs may or may not include exposure assessments.

So, companies should carefully check what activities and data are being paid for as part of any registration. Costs can be divided according to three main categories:

I Dossier Compilation

Each registrant must submit its own IUCLID5 file for a substance, even if part of a joint registration. Compared to registration fees and data costs, the costs of dossier compilation and submission as part of a joint registration may only constitute a fraction – less than 10% – of total registration costs. There are exceptions for intermediates, low-tonnage substances or where separate chemical safety reports are necessary.

II Fees

A fee is payable to the European Chemicals Agency (ECHA) by the registrant for every substance it registers. Reference should be made to the Fees Regulation (340/2008).

For substances manufactured or imported above 1,000 tonnes per year the current base fee for a large company submitting a joint registration is €23,250. The fee may therefore be greater than dossier compilation.

For intermediates under Articles 17 or 18 of the REACH Regulation, the base fee for a large company submitting a joint registration is €1,200. Additional fees are payable for ‘opt-outs’, confidentiality claims and any updates to registration.

III Data Costs

As part of a registration dossier, each company must submit its own Annex VI data. This includes relevant analytical data (NMR, mass-spec, IR, UV).

Costs for toxicological, ecotoxicological and environmental studies can be shared by registrants. Each registrant must be an owner or have access to relevant/necessary studies. Some studies may be freely publicly available to the extent that there is no cost associated for registration, other than data interpretation and input to IUCLID5.

Testing costs alone can range from a few thousand Euros to several million Euros. For instance, if a carcinogenicity study is required for registration, this may alone cost half a million Euros. This level of testing is however not usually necessary and in any case, requires testing proposals to be submitted to ECHA before any test is performed. Where companies own these studies already, they will certainly be seeking ‘pay-back’, as enabled by REACH!

If testing proposals are required to be submitted to ECHA, this will mean that much lower costs will need to be attributed to 2010 budgets but substantial additional costs may be payable later on if, and when, the tests are carried out.

Intermediates under Article 18 only require information available to the registrant to be submitted and/or Annex VII data. This presents a significant reduction in costs. However, the REACH Regulation mandates documentation of ‘strictly controlled conditions’ for industrial processing. Intermediates usually do not require chemical safety reports (CSR).

Companies have the option of submitting shared chemical safety reports, as appropriate and where necessary. These may include exposure data. Typical costs range from a few tens of thousands of Euros to 50,000 Euros. Costs will primarily depend on the hazard of the substance and the number of ‘uses’ covered by the registration. Exposure assessments can however become more significant and costly, especially if in situ (workplace/environment) measurements are necessary.

In addition, most ‘substance information exchange fora’ (SIEFs) and/or consortia will require the sharing of administrative and legal costs for registration, particularly for joint registrations. These costs can often range between a few tens of thousands Euros to several hundred thousand Euros. This wide range in potential costs is a result of SIEF and consortium size – varying from a few to several hundred companies.

Below I give two scenarios to illustrate cost-sharing possibilities with equal sharing of data:

• Scenario 1
• Substance with 10 registrants; data & admin cost of €250,000
• = €25,000 per substance per company

• Scenario 2
• Substance with 5 registrants, data & admin cost of €500,000
• = €100,000 per substance per company

Summary

Costs for registration therefore depend on:

• use of the substance eg intermediate
• number of registrants
• actual testing required by ECHA
• available data
• exposure data needs
• timelines for data requirements

For a ‘typical’ substance manufactured or imported above 1,000 tpy, registration costs have been estimated at around €325,000, which takes into account use of existing available data, some read-across data and other factors. For an intermediate manufactured or imported above 1,000 tpy, this would be reduced to around €14,000.

But costs can escalate to 10 times or more higher than these average figures depending, for instance, on the extent to which registrants need to reimburse data-owners for the right to refer to their data.

After 2010, however, companies may be entitled to some reimbursement as further companies share registaration costs in 2013 or 2018.