Questions and answers about biocides

Where can I find Q&As about biocides in English?

The European Chemicals Agency (ECHA) has a large number of questions and answers on their web site. You will find them here https://www.echa.europa.eu/support/qas-support/browse External link.

Do you have questions to the Swedish Chemicals Agency?

Products used as hand sanitizers are counted as biocidal products, product type 1. To know if you are allowed to sell or use a biocidal product you must know what active substances the product contains and what status these substances have in the EU Review Programme. If you do not know which active substances your product contains, ask your supplier.

You can find out the status of each substance by searching in the Database on Biocidal Active Substances provided by the European Chemicals Agency External link. External link.. You can also ask us at the Swedish Chemicals Agency, should you need any help finding out the status of your active substances.

In Sweden, the hand sanitizers and surface disinfectants containing active substances that are currently being reviewed within the EU Review Programme are exempted from the requirement of authorisation. This means that you are allowed to make such products available on the market without applying for an authorisation for the product.

For you to be able to sell or release your product on the market, normally you must make sure that your supplier of the substances or the products are listed on the so-called Article 95 List. This is valid for most disinfectants and suppliers of these and the active substances these products contain.

Apart from the specific regulations that apply for biocidal products, other rules are also valid for disinfectants. At this webpage, we have gathered the requirements in different legislations External link. that might concern your product in parallel with the biocidal products regulations. (In Swedish) For example, companies manufacturing disinfectants must make an activity report to the Swedish Products Register. You can create an account and report your business activity to the Products Register via this webpage External link..

Ethanol is one of the active substances currently being reviewed in the EU Review Programme for active substances in biocidal products. In Sweden, hand sanitizers and surface disinfectants containing active substances that are currently being reviewed within the EU Review Programme are exempted from the requirement of authorisation. This means that you are allowed to make such available on the market without applying for an authorisation for the product.

This is valid for e.g. disinfectants based on ethanol since ethanol still is being reviewed. It is also valid if the product also contain an active substance already authorised at EU-level.

For you to be able to sell or release your product on the market, normally you must make sure that your supplier of the substances or the products are listed on the so called Article 95 List. This is valid for most disinfectants and suppliers of these and the active substances these products contain.

Apart from the specific regulations that apply for biocidal products, other rules are also valid for disinfectants. At this webpage, we have gathered the requirements in different legislations External link. that might concern your product in parallel with the biocidal products regulations. (In Swedish) For example, companies manufacturing disinfectants must make an activity report to the Swedish Products Register. You can create an account and report your business activity to the Products Register via this webpage External link..

Propan-1-ol and propan-2-ol are active substances which are approved within the EU. Disinfectants containing active substances approved by the EU, normally need a product authorisation if they are going to be made available or used on the EU market. This according to the EU Biocidal Products Regulation.

For you to be able to sell or release your product on the market, normally you must make sure that your supplier of the substances or the products are listed on the so called Article 95 List. This is valid for most disinfectants and suppliers of these and the active substances these products contain.

Apart from the specific regulations that apply for biocidal products, other rules are also valid for disinfectants. At this webpage, we have gathered the requirements in different legislations External link. that might concern your product in parallel with the biocidal products regulations. (In Swedish) For example, companies manufacturing disinfectants must make an activity report to the Swedish Products Register. You can create an account and report your business activity to the Products Register via this webpage External link.

Hydrogen peroxide is an active substance approved in the EU. Disinfectants containing active substances approved by the EU, normally also need a product authorisation if they are going to be made available or used on the EU market. This according to the EU Biocidal Products Regulation.

For you to be able to sell or release your product on the market, normally you must make sure that your supplier of the substances or the products are listed on the so called Article 95 List. This is valid for most disinfectants and suppliers of these and the active substances these products contain.

Apart from the specific regulations that apply for biocidal products, other rules are also valid for disinfectants. At this webpage, we have gathered the requirements in different legislations External link. that might concern your product in parallel with the biocidal products regulations. (In Swedish) For example, companies manufacturing disinfectants must make an activity report to the Swedish Products Register. You can create an account and report your business activity to the Products Register via this webpage External link..

Active chlorine generated from sodium chloride by electrolysis and active chlorine released from hypochlorous acid are active substances which are approved within the EU in product type 1 from 1 July 2021. Disinfectants containing active substances approved by the EU, need a product authorisation if they are going to be made available or used on the EU market according to the EU Biocidal Products Regulation. The substances are being reviewed as existing active substances within the EU Review Programme for the biocidal product types 2–4, which means that an already existing exemption from the requirement of authorisation also is valid for these product types.

Active chlorine released from sodium hypochlorite is an active substance approved in the EU. Disinfectants containing active substances approved by the EU also need a product authorisation if they are going to be put or be used on the EU market. This according to the EU Biocidal Products Regulation.

For you to be able to sell or release your product on the market, normally you must make sure that your supplier of the substances or the products are listed on the so called Article 95 List. This is valid for most disinfectants and suppliers of these and the active substances these products contain

Apart from the specific regulations that apply for biocidal products, other rules are also valid for disinfectants. At this webpage, we have gathered the requirements in different legislations External link. that might concern your product in parallel with the biocidal products regulations. (In Swedish) For example, companies manufacturing disinfectants must make an activity report to the Swedish Products Register. You can create an account and report your business activity to the Products Register via this webpage External link.

To apply for using substances not approved within the EU, you will need to apply for a derogation regarding these substances. Read more about derogations and how to apply for these. External link.

Apart from the specific regulations that apply for biocidal products, other rules are also valid for disinfectants. For example, companies manufacturing disinfectants must make an activity report to the Swedish Products Register.

At this webpage, we have gathered the requirements in different legislations External link. that might concern your product in parallel with the biocidal products regulations. (In Swedish)

Most of the rules we at the Swedish Chemicals Agency are responsible for do not apply for exporting products. Our rules and regulations rather handle import and putting products on the Swedish market. However, we are responsible for the PIC Regulation, which does regulate export. The PIC Regulation concludes that exporting companies based in an EU member state, must report if they plan to export certain hazardous chemicals to a country outside the EU. Read more about the PIC Regulation. External link.

You must control what rules that apply for disinfectants in the country you want to export your product to. You can do this by contacting the chemicals agency in that specific country.

At the website of the European Chemicals Agency, you can find the contact details of the chemicals agencies in the other EU countries External link. External link..

Last published 26 November 2020