Biocidal product dossier

It depends on where you sell. Union authorisation is one authorisation valid across the EU for products with similar conditions of use everywhere, and product types 2 and 4 are both eligible. You apply to ECHA with written agreement from the authority that will evaluate it. National authorisation starts in one country, and mutual recognition, in sequence or in parallel, extends it to others. The simplified procedure isn’t open to hydrogen peroxide products, because the substance isn’t listed in Annex I.

Foresight maps your data to each Annex III requirement for a chemical product and marks what’s complete, what can be waived with a justification and what still needs testing. Then it drafts each section in IUCLID’s format, with the summary of product characteristics. Annex III also requires a documented pre-submission consultation with the evaluating authority, so Foresight prepares the papers for it.

From the Biocidal Products Regulation and its Annex III, the active substance’s approval, ECHA’s guidance, such as its efficacy guidance for disinfectants, and your own study reports. Every requirement and every gap links to its source, so your team can check the wording directly.

The person you name. They agree the route and the gap list before drafting starts, and check every section against its data at the end. Nothing goes into R4BP 3 until they approve it. These checks reduce the risk of error without removing it.

Foresight rechecks the sections it affects, such as those that rest on the active substance’s approval. In September 2026, for example, the Commission postponed the expiry of hydrogen peroxide’s approval for product types 2 and 4 to 31 July 2029. The dossier your expert approved stays as it is until they accept the change.

The price follows the dossier’s size: your product’s claims, the gaps in the data you hold and the route. You see it with the scope, before any drafting starts. Fees to ECHA and the evaluating authority are separate.