Frequently asked questions regarding disinfectants and the coronavirus

Right now, there are many questions about disinfectants due to the outbreak of the coronavirus. Here, you will find the answers to the most common questions asked to us by companies.

If you are a private individual and have questions about how to use disinfectants, we have gathered information for you here. (In Swedish)

The Swedish Chemicals Agency has sent out information to the businesses that we know are temporarily manufacturing or importing disinfectants due to covid-19. If you have not been reached by the information letter, you can read the information here instead. (In Swedish)

Manufacturing or importing hand sanitizers. What rules apply?

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. 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. However, until 30 June, the Swedish Chemicals Agency accepts manufacturing and selling of disinfectants without the suppliers being on the Article 95 List.

Read more about the position of the Swedish Chemicals Agency in this matter. (In Swedish)

The Swedish Chemicals Agency has decided on temporary regulations that provide exemptions from the language requirements that labelling and safety data sheets should be in Swedish for certain disinfectants. The exemption applies to hand and surface disinfectants that are to be used professionally. The exception does not apply to products to be used by private individuals. Danish, English or Norwegian are now also accepted, instead of Swedish. However, information about the active substance, its concentration and the intended use of the product must still be provided in Swedish in some way. But the information does not need to be on the packaging, it can be provided on a separate information sheet or otherwise. The regulations will come into force on April 9 and apply until 30 December 2020. Read more about the temporary rules for disinfectants. (In Swedish)

Read more about labelling of biocidal products.

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 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.

Manufacturing or importing disinfectants with ethanol. What rules apply?

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. However, until 30 June, the Swedish Chemicals Agency accepts manufacturing and selling of disinfectants without the suppliers being on the Article 95 List. Read more about the position of the Swedish Chemicals Agency in this matter. (In Swedish)

The Swedish Chemicals Agency has decided on temporary regulations that provide exemptions from the language requirements that labelling and safety data sheets should be in Swedish for certain disinfectants. The exemption applies to hand and surface disinfectants that are to be used professionally. The exception does not apply to products to be used by private individuals. Danish, English or Norwegian are now also accepted, instead of Swedish. However, information about the active substance, its concentration and the intended use of the product must still be provided in Swedish in some way. But the information does not need to be on the packaging, it can be provided on a separate information sheet or otherwise. The regulations will come into force on April 9 and apply until 30 December 2020. Read more about the temporary rules for disinfectants. (In Swedish)

Read more about labelling of biocidal products.

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 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.

Manufacturing or importing disinfectants with propan-1-ol or propan-2-ol (IPA).

Propan-1-ol and propan-2-ol are active substances which are authorised within the EU. Disinfectants containing active substances approved by the EU, normally 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. The Swedish Chemicals Agency has now decided about an exemption from the requirement of product authorisation for products containing propan-1-ol and propan-2-ol as the active substance in the biocidal product types 1–4. This means that companies that want to manufacture or import products containing propan-1-ol and propan-2-ol are allowed to do so without first applying for an authorisation. Sales to the general public may only take place through pharmacies or grocery stores. This derogation is valid until 16 September 2020.

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 upon the so called Article 95 List. This is valid for most disinfectants and suppliers of these and the active substances these products contain. However, until 30 June, the Swedish Chemicals Agency accepts manufacturing and selling of disinfectants without the suppliers being on the Article 95 List.

Read more about the derogation and the position of the Swedish Chemicals Agency in this matter. (In Swedish)

The Swedish Chemicals Agency has decided on temporary regulations that provide exemptions from the language requirements that labelling and safety data sheets should be in Swedish for certain disinfectants. The exemption applies to hand and surface disinfectants that are to be used professionally. The exception does not apply to products to be used by private individuals. Danish, English or Norwegian are now also accepted, instead of Swedish. However, information about the active substance, its concentration and the intended use of the product must still be provided in Swedish in some way. But the information does not need to be on the packaging, it can be provided on a separate information sheet or otherwise. The regulations will come into force on April 9 and apply until 30 December 2020. Read more about the temporary rules for disinfectants. (In Swedish)

Read more about labelling of biocidal products.

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 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.

Manufacturing or importing disinfectants with hydrogen peroxide. What rules apply?

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 put or be used on the EU market. This according to the EU Biocidal Products Regulation. The Swedish Chemicals Agency has now decided about an exemption from the requirement of product authorisation for products containing hydrogen peroxide as the active substance in the biocidal product types 1–4. This means that companies that want to manufacture or import products containing hydrogen peroxide are allowed to do so without first applying for an authorisation. Sales to the general public may only take place through pharmacies or grocery stores. This derogation is valid until 19 September 2020. Read more about the derogation. (In Swedish)

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 upon the so called Article 95 List. This is valid for most disinfectants and suppliers of these and the active substances these products contain. However, until 30 June, the Swedish Chemicals Agency accepts manufacturing and selling of disinfectants without the suppliers being on the Article 95 List.

Read more about the position of the Swedish Chemicals Agency in this matter. (In Swedish)

The Swedish Chemicals Agency has decided on temporary regulations that provide exemptions from the language requirements that labelling and safety data sheets should be in Swedish for certain disinfectants. The exemption applies to hand and surface disinfectants that are to be used professionally. The exception does not apply to products to be used by private individuals. Danish, English or Norwegian are now also accepted, instead of Swedish. However, information about the active substance, its concentration and the intended use of the product must still be provided in Swedish in some way. But the information does not need to be on the packaging, it can be provided on a separate information sheet or otherwise. The regulations will come into force on April 9 and apply until 30 December 2020. Read more about the temporary rules for disinfectants. (In Swedish)

Read more about labelling of biocidal products.

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 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.

Manufacturing or importing disinfectants with active chlorine. What rules apply?

Active chlorine generated from sodium chloride by electrolysis and active chlorine released from hypochlorous acid are regarded as new active substances in biocidal product type 1 according to the EU Biocidal Products Regulation. For products with new active substances, an exemption for putting the product on the market as well as using the product is required, if they are not already authorised by the Regulation.

The substances are being reviewed as already 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. The Swedish Chemicals Agency has now decided about an exemption from the requirement of product authorisation for products containing active chlorine generated from sodium chloride by electrolysis and active chlorine released from hypochlorous acid as the active substance in the biocidal product types 1. This means that companies that want to manufacture or import products containing these substances are allowed to do so without first applying for an authorisation. Sales to the general public may only be ready to use products and take place through pharmacies or grocery stores. This derogation is valid until 16 September 2020. Read more about the derogation. (In Swedish)

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. The Swedish Chemicals Agency has now decided about an exemption from the requirement of product authorisation for products containing active chlorine released from sodium hypochlorite as the active substance in the biocidal product types 1–4. This means that companies that want to manufacture or import products containing this substance are allowed to do so without first applying for an authorisation or a derogation. Sales to the general public may only take place through pharmacies or grocery stores. This derogation is valid until 19 September 2020.

Read more about the derogation. (In Swedish)

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. However, until 30 June, the Swedish Chemicals Agency accepts manufacturing and selling of disinfectants without the suppliers being on the Article 95 List.

Read more about the position of the Swedish Chemicals Agency in this matter. (In Swedish)

The Swedish Chemicals Agency has decided on temporary regulations that provide exemptions from the language requirements that labelling and safety data sheets should be in Swedish for certain disinfectants. The exemption applies to hand and surface disinfectants that are to be used professionally. The exception does not apply to products to be used by private individuals. Danish, English or Norwegian are now also accepted, instead of Swedish. However, information about the active substance, its concentration and the intended use of the product must still be provided in Swedish in some way. But the information does not need to be on the packaging, it can be provided on a separate information sheet or otherwise. The regulations will come into force on April 9 and apply until 30 December 2020. Read more about the temporary rules for disinfectants. (In Swedish)

Read more about labelling of biocidal products.

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 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.

Manufacturing or importing disinfectants with active substances not approved within the EU.

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.

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 that might concern your product in parallel with the biocidal products regulations. (In Swedish)

I am exporting hand sanitizers. What do I have to keep in mind?

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.

You have to 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.

Read more at other authorities' websites

The European Chemicals Agency ECHA has information related to Covid-19 on their website. Read news and other information relevant for companies that make disinfectants at ECHA.

The European Centre for Disease Prevention and Control ECDC has published information on which disinfectants are recommended in various situations. Read ECDC's recommendations here.

Keep in mind that your business may be subject to laws and regulations that other authorities are responsible for

In the Swedish alcohol legislation, there are requirements on how technical alcohol and alcoholic compounds must be denatured. The Public Health Agency has temporarily changed these rules. Read more at the Public Health Agency's website. (In Swedish)

Ethanol-based hand spirit is subject to the rules of the Alcohol Tax Act. Read more about alcohol tax on the Swedish Tax Agency's website. (In Swedish)

Disinfectants are often flammable and there are rules for such products. Read more about transportation of dangerous goods at the Swedish Civil Contingencies Agency. 

Read more about the rules and permits when handling flammable liquid hand sanitizers etc. at the Swedish Civil Contingencies Agency. (In Swedish)

The Swedish Work Environment Authority has rules on the labelling of packages and containers of hazardous chemicals used or stored in workplaces. These rules apply, for example, if you repackage disinfectants into smaller packages within your own business. Read more on the Swedish Work Environment Authority's website.

The Swedish Environmental Protection Agency har rules on the obligation to get a permit or notify the manufacture of disinfectants. Read more on the Swedish Environmental Protection Agency's website. (In Swedish)