Different ways for authorisation of biocidal products
There are several options for those wishing to apply for authorisation of a biocidal product. As a principal rule, all biocidal products must be authorised before they can be sold or used in Sweden. Keep in mind that the active substance or substances in the product must be under evaluation or authorised before you can apply for authorisation for a product.
Applying for authorisation of a biocidal product can be time consuming and costly, and in addition, specific skills are required. It may therefore be good to know that there are a number of options when it comes to authorisations. Below we have listed different options as well as things to consider regarding the respective options.
Alternative or additional name
You may sell a biocidal product that has already been authorised in Sweden with your own trade name. You can do so if the company that is the holder of the authorisation for this product allows it. To do so, submit a notification of an additional name for the existing authorisation if it was granted under national rules. If the product is authorised under the EU Biocidal Products Regulation (Regulation (EU) No 528/2012) this is referred to as an alternative name.
You do not need to pay a fee for application for authorisation or an annual fee. For products authorised under national rules, there is no fee for adding additional names.
However, you must obtain a certificate from the company that holds the authorisation stating that you are entitled to sell their product under a different name. You cannot make any changes to the product authorisation, which means you cannot change its composition or use. You will not get an individual registration number for your product; your product will have the same registration number as the company that holds the authorisation.
Your own authorisation
You can apply for your own authorisation of the product. If you have your own authorisation you can make any changes to your product. There are several different types of applications for authorisation.
A national authorisation is a product authorisation for the Swedish market. The application fee is high and it is time consuming to apply for authorisation. You must have the skills required for an application procedure. You can only sell your product in Sweden if you don’t apply for mutual recognition in other EU countries.
If the active substance is under evaluation in the EU review programme, the authorisation requirement in the national rules (the Swedish Pesticides Regulation) applies to certain product types. If the active substance has been authorised at EU level, the authorisation requirement according to the EU Biocidal Products Regulation applies to all product types.
If the product is already authorised in another EU country, you can apply for mutual recognition to get the product authorised in Sweden.
For authorisations granted under the EU Biocidal Products Regulation, you may apply for mutual recognition in other Member States according to a parallel procedure, or in sequence. This makes it possible to sell the product in several countries within the EU.
Authorisation of same biocidal product
If you have a product that is the same as a product that is already authorised under the EU Biocidal Products Regulation, or for which an application for authorisation has been submitted, you can seek approval for the same biocidal product. Your authorisation is based on the product evaluation of the reference product.
The fee for the same biocidal product is significantly lower than for an individual authorisation. You can make any changes to your product.
The reference product must be authorised in accordance with the rules of the EU Biocidal Products Regulation in order for you to be able to apply for authorisation of the same biocidal product. It is not possible if the product is authorised under the national rules.
In case of renewal of the product authorisation, your product will not be automatically included in the renewed authorisation of the reference product, and you must apply for a renewed authorisation of your product. You must have an agreement with the company that holds the reference product to show that your product is the same, the agreement must give you access to the product data.
Simplified product authorisation
To be able to apply for a simplified product authorisation the active substances in the product must be included in Annex I to the EU Biocidal Products Regulation. There are also several conditions for the product that must be met, for example, it must not contain any substance that may cause concern or contain nanomaterials.
The fee is significantly lower than the fee for an individual authorisation. You can make any changes you want to your product.
A Union authorisation means that you are authorised to sell and market your biocidal product throughout the EU with only one application. By one single application you can make your product available on all the EU countries' markets, as the authorisation is valid throughout the Union.
The application fee for a Union authorisation is higher than for an individual product authorisation. It is not possible to apply for Union authorisation for all product types, nor for all active substances.
Product authorisation for a biocidal product family
You can apply for authorisation of the biocidal product family under the EU Biocidal Products Regulation as a national authorisation, mutual recognition, simplified procedure or as a Union authorisation. In other words, you can apply for all types of authorisations for a family.
A family product authorisation applies to all the products in the family. The authorisation makes it possible to offer several products on the market. You can file a notification to add new products to your family. Family authorisation can be a good option if you have several products with only minor variations. Products within the family that differ only in relation to pigments, perfumes or dyes need not be notified before they are made available on the market.
The application fee is higher than for an individual product authorisation. The products in the family must not have big variations. If you include your product in another company's family authorisation, your product will have the same authorisation period as that family.
Parallel trade permit
The fee for a parallel trade permit is significantly lower than the fee for an authorisation.
Collaborate with other companies
Producing all the data needed to get a product authorisation is a costly procedure. If your company chooses to share another company's product authorisation, keep in mind that you may have to pay that company to access their data. Your company must enter into an agreement with the company that holds the authorisation. This is an agreement strictly between your companies, and the authorities will not be involved in the agreement. Subsequently, you or the other company will need to submit a permit to the authority, which shows that you have access to the other company's data and may use the documentation in connection with your application.
Tests on vertebrate animals must not be repeated
Please note that tests on vertebrates must not be repeated. Before starting such trials, you must submit a request for information as to whether such trials or studies have already been submitted to the Chemicals Agency or a competent authority in connection with a previous application. In relation to other trials, you may also submit a request as to whether trials or studies have been submitted with a previous application. If trials or studies have been submitted in the past, the authorities must provide the names and contact details of the reporting agent and the data owner. In relation to tests on vertebrate animals, there is a special procedure governing compensation for data sharing if the parties cannot agree.
Derogations from the rules
In special cases, the Swedish Chemicals Agency may grant a derogation from the requirement for authorisation for biocidal products. Derogations from the authorisation requirement under national law may be granted where there are special reasons. The reasons are examined following an application for a derogation to the Swedish Chemicals Agency.
Derogations from the authorisation requirement under the EU Biocides Products Regulation may be granted where necessary due to a danger to public health, animal health or the environment which cannot be avoided by other means. Derogations also apply where necessary for the protection of cultural heritage. These derogations also require an application to the Swedish Chemicals Agency.
Derogations from the authorisation requirement also apply if the use relates to an experiment or trial for research and development.