Authorisation of biocidal products
Biocidal products sold and used in Finland require authorisation by Tukes. During the transitional period of the Biocidal Products Regulation some products are excluded from the authorisation procedures.
The following biocidal products must be authorised by Tukes:
- A product marketed and used in Finland with an active substance that is about to be approved within the EU
- A product included in the EU’s review programme but whose active substance is not yet approved might need an approval according to the Chemicals Act prior to making it available to the market. These products are
- insecticides and insect repellents,
- wood preservatives containing diamine or polymeric betaine,
- slimicides used in the paper industry, and
- antifouling products containing zinc pyrithione.
The status of active substance reviews can be checked from the European Chemicals Agency’s (ECHA) website by using the search field for biocidal active substances.
Applicable authorisations for biocidal products
National authorisation grants companies permission to sell a biocidal product in the EU country from which the authorisation is sought. The application and related material is submitted via the R4BP 3 application.
If the authorisation is sought in Finland, Tukes reviews the product in accordance with the Biocidal Products Regulation within about 1,5 years from approval of the application. Tukes grants authorisations only for Finland.
If the active substance is a candidate for substitution, Tukes completes a comparative assessment and checks the availability of another authorised biocidal product or a non-chemical method that presents a significantly lower overall risk to human and animal health and the environment.
Tukes will ban or place use restrictions on a product for which national authorisation is sought if there is another sufficiently effective and already authorised product that does not cause other significant economic or practical disadvantages and that does not promote resistance in the organism in question.
Union authorisation for products in certain product type categories is an EU-wide authorisation that the EU grants for products with similar conditions of use across the EU. Application is preceded by an advance application aimed at assessing the similarity of conditions of use within the EU.
Union authorisation is not granted
- for product types 14, 15, 17, 20 and 21, or
- if the product contains active substances, such as substances in CMR categories 1A and 1B, which meet the exclusion criteria.
Mutual recognition in parallel
Mutual recognition in parallel is an authorisation with which a company can market its products also in another EU country in addition to the country from which national authorisation was applied for. A company can apply for mutual recognition in parallel at the same time as applying for national authorisation.
The application is submitted via the R4BP 3 application.
Mutual recognition enables the processing of authorisations simultaneously in different member states. Once the countries have reached an agreement on the approval criteria, the products can be authorised at the same time in all of the countries where the authorisation has been applied.
Mutual recognition in sequence
Mutual recognition in sequence is possible if a company already has a national authorisation in one member state but wishes to market its products also in other EU countries. The company can apply for mutual recognition of the national authorisation in sequence in those EU countries where the product has not yet been authorised.
The application is submitted via the R4BP 3 application. Tukes processes the application for mutual recognition in sequence within about six months from the submission date of the application.
Authorisation of the same product
Authorisation of the same product can be applied for under the following conditions:
- if an identical product has already been mutually recognised in Finland.
- if the product is identical with another product that belongs to the same product family or has already been granted a separate product authorisation or Union authorisation.
The authorisation can be applied for via the R4BP 3 application, and the applicant can be either a company that has received mutual recognition or another company. Authorisation requires a Letter of Access granting access to the product data used in previous reviews (EU 414/2013 and Amendment 1802/2016).
Simplified authorisation procedure
Authorisation in accordance with the simplified authorisation procedure can be applied for for products that contain active substances listed in Annex I of the Biocidal Products Regulation and that meet the criteria set out in Article 25 of the Biocidal Products Regulation.
If the criteria are not met, for example regarding the use of personal protective equipment, regular national authorisation of the product must be applied for. Authorisation according to the simplified authorisation procedure is applied for from one EU country. When the product has been approved, the company can submit a notification of commencing marketing activities via the R4BP application. Once the notification has been submitted, the company can market its product in other EU countries.
Amendments of authorisations
Amendments of authorisations for approved products in accordance with the Biocidal Products Regulation are divided into three types:
- Administrative change means an amendment of an existing authorisation of a purely administrative nature involving no change to the properties or efficacy of the biocidal product or biocidal product family.
- Minor change means an amendment of an existing authorisation that is not of a purely administrative nature and requires only a limited re-assessment of the properties or efficacy of the biocidal product or biocidal product family.
- Major change means an amendment involving any changes other than an administrative change or minor change.
A separate implementation Regulation concerning the amendments of authorisations has been published, and various changes are classified in detail in Annex I ((EU) No 354/2013). If the amendment in question is not found in Annex I, the company must apply for amendment classification from the European Chemicals Agency (ECHA) with R4BP 3 application.
Authorisation under the Chemicals Act is granted for products whose active substance has not yet been approved in the EU. Product authorisations can be amended based on separate applications.
Can more than one product be included in the same application?
- Similar products may be authorised as a product family under certain conditions.
- A biocidal product family refers to a group of biocidal products
- that are used in the same way
- whose active substances have the same specifications
- whose consistency differs in a specified manner, however the differences in consistency must not increase the risk or impair the efficacy of the products.
- Certain differences in consistency may be allowed in products belonging to the same biocidal product family:
- the concentration of the active substance may be lower
- the concentration of substances other than the active substance may vary
- substances other than the active substance may be substituted with other substances that pose a risk of up to the same severity.
- A biocidal product family is divided into subgroups, and the classification, hazard and precautionary statements for each product within the subgroup are the same. An exception is the biocidal product family of a concentrate for professional use and ready-for-use products obtained through dilution of that concentrate.
- A company can include new products in an approved product family via a notification, and the consistency of these products can vary within the limits of the products in the approved product family.
- A company can include new products in an approved product family also without a notification if the products differ from the approved products only in pigment, scent or colouring.
Who can apply for authorisations?
- The manufacturer or marketer of the product can apply for authorisation. Also a consultant can apply for authorisation for another company. The authorisation holder must be from the European Union, Norway or Switzerland.
How do you apply for authorisation?
- Authorisations in accordance with the Biocidal Products Regulation are applied for via the ECHA’s Register for Biocidal Products R4BP 3. The company must have an ECHA account in order to use the register. If the application is submitted by a consultant on behalf of the company, the consultant must also have necessary login details and access to the company’s information.
- Both the applications and granted authorisations are managed via the R4BP 3 application. Any communication with the authority relating to the application process also takes place via this register.
- Authorisations under the Chemicals Act are applied for directly from Tukes. The application should be sent as an e-mail attachment to [email protected]
What attachments are needed when applying for biocidal product authorisation?
Information requirements for a national authorisation are listed in Annex II and III to the Biocidal Products Regulation. The required material needs to be compiled as a single file using the IUCLID software, and the IUCLID file then attached to the application sent via R4BP. (Biocidal Products Regulation (EU) No 528/2012, Annex II and III)
Required attachments when applying for mutual recognition:
- summary of product characteristics (SPC) in Finnish
- label in Finnish and Swedish
- safety data sheets in Finnish and Swedish
- Letter of Access to active substance and product material
- when applying for mutual recognition in sequence, the application must also include the product review report (if not already in the R4BP 3 register) and the authorisation decision of the national authorisation translated into English (if in another language in R4BP 3).
Information requirements for applications under the Chemicals Act are listed in Ministry of the Environment Decree 419/2014.