How to Register a Biocide to Sell It in Spain

A biocide can only be sold in Spain with prior authorisation. You start from an active substance approved for that product type, the future holder, established in the EU, files the application through R4BP3 with the Ministry of Health (or with ECHA for a Union authorisation), and the product is entered in the Official Register of Biocides.

While the active substance is still under EU review, the product is marketed under the earlier national rules, Royal Decree 3349/1983 or notification under Royal Decree 1054/2002, until the final decision.

How Do You Know If a Product Is a Biocide?

Regulation (EU) 528/2012 defines a biocidal product as a substance or mixture that contains or generates an active substance to destroy, deter or render harmless a harmful organism by any means other than mere physical or mechanical action. An insecticide, a surface disinfectant or a repellent all qualify.

In practice, the line is drawn by what the label promises. An air freshener that only adds fragrance is not a biocide; if the label says it kills bacteria or viruses, the same spray becomes one and needs authorisation.

Biocidal products shall not be made available on the market or used unless authorised in accordance with this Regulation.

How Many Types of Biocides Are There?

Annex V of the Regulation sorts biocides into four main groups and 22 product types, written as PT followed by their number. An active substance is approved for a specific type, so the PT decides which formulas you can use.

The product type also decides who is involved. Under the Ministry of Health's division of responsibilities, once the active substance is approved the competent authority for every type is its Directorate General for Public Health; AEMPS and Agriculture take part in assessing efficacy for some, such as human hygiene or livestock insecticides. During the transitional period, the national division of responsibilities applies.

The Steps to Authorisation

An application follows the same order for any new biocide:

1. Confirm the active substance is approved for your product type and obtain the letter of access to its dossier.
2. Prepare the technical dossier in IUCLID 6, with the summary of the biocidal product's characteristics.
3. File the application in R4BP3. Companies based in Spain attach their entry in the ROESB, the regional register of biocide establishments and services, which lists companies, not products.
4. Pay the fee the authority notifies: you have 30 calendar days to pay it.
5. Once granted, the product is entered in the Official Register of Biocides with its authorisation number.

A brand has a shorter route: the same biocidal product. Implementing Regulation (EU) 414/2013 allows a product identical to one already authorised to be authorised under another name and another holder; it gets its own number and, in every other respect, the authorisation matches the reference product.

Who Is the Holder When the Biocide Carries Your Brand?

The authorisation holder is the person established in the Union who is responsible for placing the biocide on the market and is named as such in the authorisation. It can be your company or the manufacturer that makes it for you, and it is best agreed in writing at the start of the project, because it decides who may sell the product and who answers to the authority.

Ilerspray has a crawling insect insecticide registered in Spain and Portugal, and an insect repellent, a flying insect insecticide and a household insecticide pending authorisation. With a minimum production volume, we file the authorisation for your brand and fill the product.

💡 Tip from our technical team: decide the label claims before formulating. A "kills 99% of bacteria" added at the end turns an air freshener into a biocide and changes the whole schedule.

If you are launching an insecticide or a disinfectant under your brand, our aerosol contract manufacturing page lists formats, propellants and the form to send us your brief.