Health

#TECP2609881AFrance sets fees for biocidal substance approvals and product authorisations

🇫🇷France··Other·Medium Impact·View source ↗

AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.

🇬🇧 English

France sets the euro fees companies must pay when they seek approval for biocidal active substances or market authorisation for biocidal products under EU biocides rules. The fees vary by application type, product type, user category, and whether the active substance is a micro-organism. Businesses placing disinfectants, pest-control products, preservatives, or other biocides on the French or EU market should budget for these charges before filing applications or renewals.

AI-generated summary. May contain errors. Refer to official sources for legal decisions.

Key Changes

  • Sets fees for evaluating applications to approve biocidal active substances, starting at €250,000 for one product type and lower amounts for micro-organisms.
  • Sets renewal fees for active substance approvals, including additional charges for extra product types.
  • Sets fees for provisional and first market authorisation applications for biocidal products, with extra charges for additional user categories, product types, or substances considered for substitution.

Obligations

What this law requires

high

Pay a €250,000 fee for evaluation of an application to approve a biocidal active substance for one biocidal product type under Article 9 of Regulation (EU) No 528/2012.

applicants seeking approval of a biocidal active substance
licensing
high

Pay an additional €150,000 for each additional biocidal product type included in an application to approve a biocidal active substance, unless the active substance is a micro-organism.

applicants seeking approval of a biocidal active substance for multiple product types
licensing
high

Pay a €180,000 fee for evaluation of an application to approve a biocidal active substance that is a micro-organism for one biocidal product type.

applicants seeking approval of a micro-organism biocidal active substance
licensing
high

Pay an additional €90,000 for each additional biocidal product type included in an application to approve a biocidal active substance that is a micro-organism.

applicants seeking approval of a micro-organism biocidal active substance for multiple product types
licensing
high

Pay a €250,000 fee for evaluation of an application to renew approval of a biocidal active substance for one biocidal product type under Article 14 of Regulation (EU) No 528/2012.

applicants seeking renewal of approval of a biocidal active substance
licensing

Affected Parties

Biocidal product manufacturers and applicantsChemical and life-sciences regulatory teams+2 more…

Tags

biocides,market authorisation,regulatory fees…