Application Guide – Biocidal Products

Content:

Are all the active substances in your biocidal product approved for the right product type within the EU? Apply for authorisation under the biocidal regulation!

Does your biocidal product contain active substances that are under evaluation in the EU review programme? Then you may need to apply for authorisation according to Swedish rules.

Are you unsure what rules apply to your biocidal product? Read more about the regulations for biocidal products.

Application according to BPR

This is an overview of the different application types that are available when you need to apply for authorisation according to the Biocidal Products Regulation. You can also find links to relevant guidance documents and other information related to the specific application type.

You can apply for a national authorisation if you intend to sell and market the product in Sweden. If an authorisation has not been required for the product until now it is important to submit your application for an authorisation on the day of the approval of the last active substance in the product. This way you can continue to market and sell the product during the evaluation of your application.

Apply for authorisation through R4BP at ECHA's websiteexternal link

Read more about how to apply for authorisation according to EU Biocidal products regulation at ECHA's websiteexternal link

Practical guide on how to apply for national authorisation at ECHA's websiteexternal link

You can apply for a mutual recognition in parallel if you want to sell and market your product in more than one country. A parallel process means applying for approval at the same time in the countries where you want to sell and market your product. One of the Member States is responsible for the evaluation of the application; the Reference Member State. When the Reference Member State has completed its evaluation and all Member States have agreed on the conditions of the approval, all countries authorise the product at the same time.

Apply for authorisation through R4BP at ECHA's website.external link

Read more about how to apply for authorisation according to EU Biocidal products regulation at ECHA's website.external link

Practical guide on how to apply for national authorisation at ECHA's website.external link

You can apply for a mutual recognition in sequence if you want to sell and market your product in more than one country. A process in sequence means applying for approval subsequent in the countries where you want to sell and market your product. One of the Member States is responsible for the evaluation of the application; the Reference Member State. When the Reference Member State has completed its evaluation and have authorised the product, the Concerned Member States mutually recognize the authorisation, with the same conditions that the Reference Member State have established.

Apply for authorisation through R4BP at ECHA's website.external link

Read more about how to apply for authorisation according to EU Biocidal products regulation at ECHA's website.external link

Practical guide on how to apply for national authorisation at ECHA's website.external link

A Union authorisation means that you get permission to sell and market your biocidal product within the EU area with only one application. You can apply for Union authorisation for a biocidal product with similar conditions of use across the EU. You cannot apply for Union authorisation if the product contains active substances meeting the exclusion criteria or belongs to product types 14, 15, 17, 20 or 21.

The possibility to apply for Union authorisation depends on which product type the product belongs to. You can apply for Union authorisation for products in product 1, 2, 3, 4, 5, 6, 13, 18 and 19 already. For products in product types 7, 8, 9, 10, 11, 12, 16 and 22 Union authorisations may be granted as of January 1 2020 earliest.

Apply for Union authorisation through R4BP at ECHA's website.external link

Read more about how to apply for Union authorisation according to EU Biocidal products regulation at ECHA's website.external link

Practical guide on how to apply for Union at ECHA's website.external link

It is possible to apply for authorisation for a biocidal product family under certain conditions. Biocidal products within a biocidal product family should have similar uses and the same active substances. Variations in the composition must not affect the level of risk negatively or significantly reduce the efficiency of the products. Applications may be submitted in accordance with a national authorisation, mutual recognition in sequence, mutual recognition in parallel or Union authorisation.

If you want to add new products to the family, this must be notified 30 days before new products are placed on the market. However, registration is not required if the product is covered by the family's authorisation or if the variation in composition concerns only pigments, perfumes and dyes within the permitted variations.

Apply for authorisation of a biocidal product family or notify new members to a family through R4BP at ECHA's website.external link

Read more about how to apply for Apply for authorisation of a biocidal product family at ECHA's website.external link

You can apply for renewal of the authorisation under the EU Biocidal Product Regulation when all the active substances in your product is approved within EU for the product type. In order to continue to market and sell the product while it is being evaluated, you will need to submit an application for authorisation no later than the day of approval of the last active substance in the product.

If the application has not been received in time, the product may be sold only 180 days after the approval of the last active substance. It is permitted to continue to use existing stocks up to 365 days after that date.

Apply for renewed authorisation through R4BP at ECHA's website.external link

Read more about how to apply for renewed authorisation at ECHA's website.external link

Practical guide on how to apply for renewed authorisation at ECHA's website.external link

For products that are authorised according to the EU Biocidal Products Regulation you can apply for a change in conditions using the Register for Biocidal Products (R4BP) at ECHA.

Apply for change of conditions through R4BP at ECHA's website.external link

Practical guide on how to apply for change of conditions at ECHA's website.external link

You may apply for approval according to a simplified procedure if all active substances in the product are listed in Annex I of the EU Biocidal Products Regulation and if the product fulfils all the conditions in Article 25 of the Regulation.

Apply for simplified authorisation through R4BP at ECHA's website.external link

Read more about how to apply for simplified authorisation at our website.

Read more about how to apply for simplified authorisation at ECHA's website.external link

Practical guide on how to apply for simplified authorisation at ECHA's website.external link

If an active substance is not yet in the EU Review Programme for active substances in biocidal products, it is considered to be a new active substance. Biocidal products that only contain new active substances may be placed on the EU market if the product has been granted a temporary authorisation.

Apply for temporary authorisation through R4BP at ECHA's website.external link

You can apply for an authorisation of a biocidal product that is the same as a product already approved under the EU Biocidal Products Regulation or for which an application for approval has been submitted. This means that approval may be granted based on the evaluation of the reference product.

Apply for authorisation of same biocidal product through R4BP at ECHA's website.external link

Read more about how to apply for authorisation of same biocidal product.

Practical guide on how to apply for authorisation of same biocidal product at ECHA's website.external link

You may obtain a parallel trade permit in Sweden for a biocidal product authorised in another EU country if it is identical to a product already authorised in Sweden. The holder of a parallel trade permit may import and sell such a product on the Swedish market.

Apply for parallel trade permit through R4BP at ECHA's website.external link

Read more about parallel trade permit.

The Swedish Chemicals Agency may grant an exemption from the requirement for authorisation of biocidal products only in exceptional cases. There are two different types of derogations according to the Biocidal Products Regulation:

  • derogation to prevent danger
  • derogation for research and development.

Read more about when you need to apply for an exemption.

Applications of derogations to prevent danger shall be submitted to the Swedish Chemicals Agency.

Application form to apply for derogation for a biocidal product, MIP-0002-E (DOCX 49 kB)

Biocidal products and active substances may be used for research and development without approval on condition that they are used according to the regulations in Article 56 of the Biocidal Products Regulation and that they fulfil the prerequisites described above.

If this trial could mean release of emissions into the environment, such use must be reported in advance to the Swedish Chemicals Agency.

Notify the use through R4BP at ECHA's website.external link

Practical guide on research and development at ECHA's website.external link

You must pay a fee to have your application considered by Swedish Chemicals Agency. When an application is received by the Swedish Chemicals Agency we will send you a confirmation that we received the application, together with a notification of the fee and information on how to pay it. Pay the fee when you receive the confirmation letter or invoice.

Here is an overview of fees in connection with biocidal products.

Help with calculating your application fee.external link

You can recall a product if you wish to remove an authorised product from the market.

If you are a proxy holder or holder of an authorised permit and wish to recall a product, contact the Swedish Chemicals Agency.

Application according to Swedish rules

Here, you are given an overview of the different application types that are available, help with links to relevant guidance documents and application forms for the specific application type.

You can apply for national authorisation according to Swedish rules when the active substance in your product is still under evaluation in the EU review programme for that product type.

You need to submit four forms; the general application form MIP-0001-E, and the A, B and C forms for chemical or biological products. Biological products are those in which the active substance is a microorganism, including viruses and fungi.

MIP-0001-E Application for approval of biocidal products according to national rules in Sweden (DOC 156 kB)

A, B and C forms

Biological biocidal products

Chemical biocidal products

A-form Information on active substance (microorganism) (DOC 222 kB)

A-form Information on active substance (DOCX 51 kB)

B-form Information on the product (DOC 296 kB)

B-form Information on the product (DOC 229 kB)

C-form Risk assessment and summary of the characteristics of the product (DOC 111 kB)

C-form Risk assessment and summary of the characteristics of the product (DOC 101 kB)

Here you find guidance on applying for authorisation according to Swedish rules (in Swedish, PDF 2160 kB)

You can apply for renewed authorisation according to Swedish rules if your product is already authorised and the active substance in your product is still under evaluation in the EU review programme for the correct product type. We recommend that you apply for renewal of approval about two years before the existing authorisation expires so that we have time to consider the request.

You need to submit four forms; the general application form MIP-0001-E, and the A, B and C forms for chemical or biological products. Biological products are those in which the active substance is a microorganism, including viruses and fungi.

MIP-0001-E Application for approval of biocidal products according to national rules in Sweden (DOC 156 kB)

A, B and C forms

Biological biocidal products

Chemical biocidal products

A-form Information on active substance (microorganism) (DOC 222 kB)

A-form Information on active substance (DOCX 51 kB)

B-form Information on the product (DOC 296 kB)

B-form Information on the product (DOC 229 kB)

C-form Risk assessment and summary of the characteristics of the product (DOC 111 kB)

C-form Risk assessment and summary of the characteristics of the product (DOC 101 kB)

Here you find guidance on applying for authorisation according to Swedish rules (in Swedish, PDF 2160 kB)

You can apply for a change of conditions of an authorisation according to Swedish rules if you want to change the conditions for an existing product authorisation.

MIP-0010-E Application for change of conditions for a biocidal product (DOCX 45 kB)

Here you find guidance on applying for authorisation according to Swedish rules (in Swedish, PDF 2160 kB)

The Swedish Chemicals Agency may grant an exemption from the requirement for authorisation of biocidal products, a derogation, only in exceptional cases.

The Swedish rules apply when the product contains

  • only active substances under evaluation
  • a combination of active substances which are being evaluated and approved according to Biocidal Products Regulation.

Read more about how to apply for a derogation from a product authorisation

Here you find guidance on applying for authorisation according to Swedish rules (in Swedish, PDF 2160 kB)

You can notify an additional name for a product if your product is authorised in Sweden and you wish to sell it under another trade name.

You submit the notification to the Swedish Chemicals Agency.

MIP-0003-E Application for additional name of a biocidal product (DOCX 45 kB)

Here you find guidance on applying for authorisation according to Swedish rules (in Swedish, PDF 2160 kB)

You must pay a fee to have your application considered by Swedish Chemicals Agency. When an application is received by the Swedish Chemicals Agency we will send you a confirmation that we received the application, together with a notification of the fee and information on how you shall pay it. Pay the fee when you receive the confirmation letter or invoice.

Here is an overview of fees in connection with biocidal products.

Help with calculating your application fee.external link

You can recall a product if you wish to remove an authorised product from the market.

If you are a proxy holder or holder of an authorised permit and wish to recall a product, contact the Swedish Chemicals Agency.

Last published 14 September 2020