Disinfectants, insect repellents and antibacterial products

• Regulation (EU) No 528/2012 — Biocidal Products

Who has to appoint one

Anyone placing a biocidal product on the EU market, including hand sanitisers, surface disinfectants, insect repellents and treated articles making a biocidal claim.

Thresholds and exemptions

None. A single antibacterial claim brings the product into this Regulation.

What must appear on the label

Authorisation number, active substance and concentration, hazard and precautionary statements under CLP, use instructions, first aid, and the authorisation holder's EU details.

Marketplace fields

Marketplaces suppress biocidal listings without a national authorisation number.

Documentation you must hold

Product authorisation in each member state or a Union authorisation, active substance sourced from an Article 95 listed supplier, efficacy data and safety data sheet.

Standards and testing

Efficacy testing under the relevant EN standards, plus toxicological and environmental data for the active substance.

Language requirements

The full label in the official language of each member state where the product is sold.

When it applies

Authorisation before the first sale. Timescales run to years, not weeks.

How long records are kept

10 years.

What happens if you do not comply

Immediate withdrawal, seizure, and fines. Unauthorised disinfectant claims were among the most sanctioned areas after 2020.

Who enforces it

National competent authorities for biocides and ECHA.

Where the boundary lies

This is the trap for cleaning and pet products: 'cleans' is a detergent claim, 'kills 99.9% of bacteria' is a biocidal claim and changes the entire regime. A treated article, such as a chopping board sold as antibacterial, is also caught.

Questions we are asked

Can a responsible person cover a disinfectant?

No. Biocides need a product authorisation held by an established entity, which is a different and much longer process.