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Editor-in-chief: Maurizio Roncaccia

Editors: Paul Trouth and Päivi Jokiniemi

Article related to: Biocides

Ensure technical equivalence before applying for an EU or national authorisation for a biocidal product

Biocides

Does your biocidal product contain an active substance which comes from an alternative source that differs from the reference source of the approved active substance? An alternative source means that the manufacturing process, the manufacturing location or the manufacturer of the active substance is different.

If this is the case, you need to ask ECHA to assess whether your active substance is technically equivalent to the one already approved before you can submit an application for biocidal product authorisation.

Below are the steps that you need to take to get the technical equivalence of your active substance assessed.

Step 1: Collect information for your dossier

A. Information requirements

When you start to compile your dossier, keep in mind that the information requirements differ if you choose to apply for Tier I or Tier II technical equivalence assessment.

Tier I assessment focuses on the substance identity and the impurity profile. In addition to these requirements, for Tier II toxicological and ecotoxicological data are also evaluated. Paragraph 3.3 in the Guidance on applications for technical equivalence lists the information requirements of the technical equivalence application and guides you to further reading.

B. Application type determines the fee

The fee for your application will be based on the type of your application and varies therefore from €5 000 to €40 000. Annex III of the BPR Fee Regulation gives a detailed explanation of the different fees related to technical equivalence assessment.

Step 2: Create a IUCLID 5 dossier

A. Include all information in the IUCLID 5 dataset

Now that you know what information needs to be submitted to ECHA, prepare your IUCLID 5 dossier. Check section 2.5 of the Biocides Submission Manual 3b: Active substances Part B, Technical equivalence to find detailed instructions on how to include all required information in your IUCLID 5 dataset.

Before finalising the dossier creation, remember that if your application is for Tier II assessment, you also need to attach a self-assessment of technical equivalence in section 13 of your IUCLID 5 dossier. The template for the self-assessment is available in Annex I of the Guidance on applications for technical equivalence.

To be able to submit your application to ECHA, create a "BPR active substance application" dossier in IUCLID 5 and export it to your computer.

Remember that each dossier can only refer to one alternative source. If you need to get several alternative sources assessed, for example if you obtain your active substance from more than one different source with a different manufacturing process, you need to submit separate applications for each alternative source of the active substance.

If the reference active substance is not yet approved as part of the review programme, the chemical similarity of the active substances must be confirmed.

ECHA is currently developing a process for this and you can soon read more about it on ECHA's website.

B. Further reading on dossier creation

If you need more instructions on how to create and build a IUCLID 5 dossier, read the following support documents:

BPR dossier creation/IUCLID Quick Guide, available on the IUCLID website.
Biocides Submission Manual 1: Using IUCLID for biocide applications, available on ECHA's website.

Step 3: Submit and follow-up your application using R4BP 3

A. Prepare the supporting document

The supporting document includes information about the reference active substance, its product-type and the type of assessment that you request from ECHA (Tier I or Tier II).

Download the template Application for assessment of technical equivalence from ECHA's website and fill in all required information.

B. Use R4BP 3 to submit your application

Remember to upload your IUCLID 5 file and the supporting document to your application. The submission wizard in R4BP 3 will guide you through the submission.

If you are not familiar with R4BP 3 yet, have a look at the Biocides Submission Manual 2: Using R4BP 3 for biocide applications first to get useful information of the basic functions of the software.

If you have used R4BP 3 before, you will find advice on how to submit a dossier for technical equivalence assessment in the Biocides Submission Manual 3b: Active substances Part B, Technical equivalence.

C. Remember to follow up your application in R4BP 3

All important information related to your application will be communicated to you through R4BP 3. Therefore, it is essential to keep checking your account after you have submitted your application.

To complete your application you need to pay the invoice that you receive through R4BP 3. More information related to invoicing and R4PB 3 can be found in the Biocides Submission Manual 5: Invoicing in R4BP 3.

If ECHA needs additional information from you when assessing your application, this request will be sent to you through R4BP 3.

Once the assessment of the application is completed, you will have an opportunity to comment on the outcome of the assessment. The assessment will be completed within 90 days from the payment of the application fee and the final decision will be sent to you using R4BP 3.

Useful links:

Did you know?

The obligation to assess the technical equivalence of your active substance before applying for a product authorisation is based on the Commission Delegated Regulation (EU) No 837/2013 that is amending Annex III of the Biocidal Products Regulation.

It states that the biocidal product may be authorised even if one or more of the active substances contained therein has been manufactured in a different location or according to a different process, including from different starting materials, as long as it can be ensured that those active substances do not have significantly more hazardous properties than the one that has been evaluated for the purpose of approval.

The technical equivalence assessment can only be made for already approved substances. If your alternative source for an active substance is still under review, you will soon have the possibility to apply for the new chemical similarity service, which ECHA plans to launch in early 2014.

biocides