WHAT ARE THE COSTS FOR REGISTRATION?

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The costs associated with the REACH registration process fall into three categories:

• Costs for the joint or "master file" portion of the case
• The costs of the specific part of the file or "member file
• The costs of the ECHA fee.

Registration file = Main file + Member file

Each registrant is individually required to submit to ECHA a registration dossier for each of his substances through the REACH-IT portal. This is the specific part of the registration dossier. The costs associated with this part are detailed in part 3 of this article.

Companies registering a substance are also required to submit certain information jointly. The joint submission filed by the lead registrant constitutes the joint part of the registration dossier. The costs associated with it are detailed in part 2 of this article.

What is the distribution of data between the main file and the member file?

The different information associated with the two parts of the dossier is divided as follows (table taken from the ECHA technical guide on registration).

Costs associated with the joint part of the registration package (main package)

Article 11 of the REACH Regulation defines the obligation for registrants to jointly submit part of the information related to the registration of the substance: " Registrants are required to jointly submit information on the intrinsic properties of the substance (studies and testing proposals, if any), its classification and labelling and may also, if they agree, jointly submit guidance on safe use and the chemical safety report (CSR )."

The objectives of this common part are to avoid duplication of studies on the same substance and to standardize the classification and labeling elements for the same substance. The sharing of data results in a considerable reduction of costs.

The exchange of information necessary for the development of this joint part is done within a SIEF.

What is a SIEF?

SIEF is an acronym for Substance Information Exchange Forum. A SIEF facilitates the sharing of data, but also of costs. Joining a SIEF allows to share studies, and thus avoid the multiplication of
‍tests on animals...
The objective of a SIEF is " to facilitate, for the purpose of registration, the exchange of information between potential registrants, and thus avoid duplication of studies and agree on classification and labeling when there is a difference in the classification and labeling of the substance between potential registrants."
‍Note: Not all members of a SIEF will necessarily go through to registration

The roles of registrants within a SIEF: Lead Registrant or Member Registrant

Within a SIEF, the joint party information is submitted by a Lead Registrant (LR) who acts on behalf of the other registrants who are the Member Declarants (MR). These Member Declarants must, in addition to purchasing a Letter of Access from the Lead Registrant, submit other information in their member file (or specific part).

To summarize:

• The Lead Registrant is responsible, on behalf of all other registrants, for the common part of the registration package ("master package" or "LR package")
• Other registrants (Member Registrants) purchase access rights to the common area via a letter of access and additionally submit a member file.

Costs associated with the main file for LRs (Primary filers)

Costs of acquiring physico-chemical, toxicological and eco-toxicological data

The first step in compiling the REACH Registration dossier as a Lead Registrant is to determine the information needed to fulfill the requirements of Annexes VII, VIII, IX and X of REACH (Data Gap).

A Data Gap consists of analyzing existing data, then searching the literature and/or available databases (possibly on similar substances), in order to conclude on the missing studies to be included in the registration dossier.

As an example, according to the study conducted by Manfred Fleischer in Business Chemistry, the average data acquisition costs for the different REACH annexes are as follows

Integration of data in IUCLID

For the Lead Registrant, the IUCLID registration dossier includes, in addition to its own information, the data submitted on behalf of all member registrants (classification, labeling, physicochemical, toxicological and eco-toxicological study summaries, etc.). ).

The constitution of the IUCLID file includes:

• The specific data of the declarant (site, tonnage, coordinates) - they are in the specific part of the file
• Generation of analytical data if not available - they are in the specific part of the file
• Chemical Safety Report (CSR) - submitted on behalf of all registrants
• Physico-chemical, toxicological and eco-toxicological data - submitted on behalf of all reporters

Costs associated with the development of the CSR if relevant

The CSR (Chemical Safety Report) is required for registrations of substances over 10 tons per year.

The CSR is a summary of Annexes VII and X of REACH and is provided by the Lead Registrant.

Costs associated with the main file for MRs (Member Filers)

In order to be able to submit a registration file as a Registrant Member, it is first necessary to obtain a Letter of Access.

Reporting Members must have a Letter of Access

The Letter of Access, also known as LoA, is a document that grants you the right to refer to the Master Registrant's registration file.
‍
The Letter of Access :

• grants permission to use and refer to one or more studies of an information holder,
• authorizes a Member Declarant to refer to the joint submission for a certain tonnage range.v

The Letter of Access will be useful in the event of an inspection by the competent authorities to prove compliance with the above conditions.

The costs of the Letter of Access

If you want to register a substance as a Registrant Member, you have to pay the LoA to access the tests and studies collected by the Lead Registrant in the joint part of the registration dossier (or master dossier).

The cost of the LoA can vary greatly from one joint submission to another depending on the number of studies included in the file and the number of members who have joined the joint submission. It is important to note that you are only paying for the data required for your tonnage band, not all the data included in the lead submitter's file.

The cost of the LoA depends on the tonnage band.

EcoMundo can help you identify the LoA costs of the substances you intend to register.

Please note! There are different ways of calculating the LoA, it depends on whether the cost sharing is based on :

• The assumed number of filers
• The evolution of the number of declarants

In all cases, the method of calculation must comply with the rules set forth in Regulation 2016/9 issued in January 2016.

What are the costs of the main file if I am the only one to make the registration file?

If you are the only registrant for a given substance at the time you submit the dossier, you will have to bear all of these costs alone initially.

If later on a company wants to register the same substance as you, you will be able to share the costs. That is why it is important to track the costs you incur when you submit your application.

Costs associated with the specific part of the registration file (member file)

Analytical data

Some data will be specific to your company, such as for example data on the manufacture and use of the substance (see table on the distribution of data between the main dossier and the member dossier in part 1).

You will also need to provide analytical tests. One can count 1 500 to 4 000 euros of tests for a mono-constituent substance.

Note: The next REACH deadline is 31 May 2018. In order to be able to carry out the analytical tests necessary for the registration of your substances before this date, it is preferable to call upon the test laboratories as soon as possible. Indeed, there is already a bottleneck at this level.

Preparation of the CSR if not shared with the Lead Registrant

The Member Registrant must complete its own chapters of the Chemical Safety Report (CSR), as well as chapters 9 and 10 if the dossier includes Exposure Scenarios.

Costs related to the constitution of an IUCLID file

The specific part of the registration dossier in IUCLID format includes the information specific to the Registrant Member and its substance. It consists of :

• The identity of the substance
• The role of the company in the supply chain
• Contact information for the registrant
• The specific uses that the Notifier Member makes of the substance
• Production volumes and sites
• Analytical data
• The Safety Data Sheet
• etc.

For hazardous substances in the tonnage ranges above 10 tons per year, a CSR is mandatory.

It is possible that the Exposure Scenarios described in the Lead Registrant's CSR

• Are not included in the LoA
• And/or do not cover the Member Declarant's use of the substance

In this case, you will need to add a CSR covering your Exposure Scenarios in your IUCLID file.

Note: For UVCB substances, the collection of analytical data and the establishment of Exposure Scenarios is a more delicate and therefore more time consuming task.

For companies based outside of the EU: OR fees

The costs of the "Only Representative" (OR), a status created for companies based outside the European Union, must be added to the joint and specific parts of the file.

To learn more about the Only Representative, feel free to visit
‍our article
‍.

Costs associated with the ECHA fee

The last part of the REACH registration costs is the submission fee to ECHA.

General case

Article 74 of
‍Regulation N°1907/2006
defines the fees and charges. The costs of registration depend on the tonnage of your substance but also on the size of your company; However, paragraph 2 of this article states that "it is not necessary to pay a fee for the registration of a substance in a quantity between 1 and 10 tonnes when the registration dossier includes all the information referred to in Annex VII".

Note: The submission must be joint when the same substance is manufactured or placed on the European market by more than one company.

What is an SME?

An enterprise is an SME if it meets the conditions detailed in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises.

Article 2 of the May 6, 2013 Commission Recommendation Annexes states the main factors for determining whether your business is an SME:

• A medium-sized company employs less than 250 people and its annual turnover does not exceed 50 million euros or its balance sheet does not exceed 43 million euros
• A small business employs less than 50 people and its annual turnover or balance sheet does not exceed 10 million euros
• A microenterprise employs less than 50 people and its turnover or balance sheet does not exceed 2 million euros.

Note: Both conditions (size and turnover) are mandatory. To determine the status of an SME, information regarding the last two years before registering as such or before performing the act subject to the fee is required.

What discounts are granted to SMEs by ECHA?

Percentage reductions are granted by the European Commission according to the size of the structure as follows:

• 30% discount for medium-sized companies
• 60% discount for small businesses
• 90% discount for micro-businesses