Chemical similarity check service

Companies can ask ECHA to carry out a chemical similarity check on their active substance in cases where no final decision on the approval of the active substance has yet been adopted. This can be when the active substance is being assessed under the Biocidal Products Regulation (BPR) ("Regulation (EU) No 528/2012"), including where the active substance dossier was submitted under the Biocidal Products Directive 98/8/EC, or when companies have not yet submitted an application for approval of the active substance.

The chemical similarity check is an assessment similar to the technical equivalence assessment described in Article 54 of the BPR. However, it is performed solely on the substance identity and chemical composition of an active substance originating from one source with the aim of establishing its similarity regarding the chemical composition of the same substance originating from a different source.

The chemical similarity check differs from the technical equivalence assessment under Article 54 of the BPR because a decision on the approval of the active substance has not yet been adopted and, therefore, the official reference source of the active substance is not yet established.

The service is designed for the following situations:

a. Individual applications: The comparison of one alternative source of a biocidal active substance which has been submitted for assessment under the Biocidal Products Directive 98/8/EC or the Biocidal Products Regulation (EU) No 528/2012 but for which no final decision on the approval has yet been adopted, with the source(s) described in the dossier submitted for the assessment of this biocidal active substance.

b.  Joint applications: The comparison of two or more sources of the same active substance in view of a prospective joint application for active substance approval under the Biocidal Products Regulation (EU) No 528/2012.

The chemical similarity check service is an additional service provide by ECHA that was not foreseen under BPR, and is of a voluntary nature. The service is accompanied with a charge depending on the scope of the assessment to be carried out as defined in the ECHA Management Board Decision 31/2013.

To request a chemical similarity check, companies need to submit an application to ECHA through R4BP 3. 

 

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