Guide for application – plant protection products
If you want to import, sell or in some other way supply a plant protection product that is either a chemical product or contain microorganisms, the product need to be authorised by the Swedish Chemicals Agency. For such products you apply in accordance with the EU Plant Protection Products Regulation. This guide provides information about the different types of applications that you can apply for.
If you want to place a plant protection product on the Swedish market, the product must be authorised by the Swedish Chemicals Agency.
To obtain an authorisation for a plant protection product, you can apply for
- a new product authorisation through zone work sharing
- a new product authorisation through mutual recognition.
If you are the holder or represent a holder of a product authorisation you may need to apply for a renewal of a product authorisation. When the approval of the active substance has been renewed within the EU, you must apply for the renewal of your product authorisation in order to continue to have your product on the Swedish market. The application must be submitted within three months after the renewed approval of the active substance shall apply. To make your application as complete as possible it is important to start a dialogue with the evaluating authority already before the approval of the active substance has been renewed.
If you are the holder or represent a holder of a product authorisation and need to amend the product authorisation of your plant protection product, you must apply for an amendment. Changes to product approvals can generally be divided into two categories. Major changes that require a risk assessment are handled via the zonal procedure and administrative changes that are handled nationally.
Examples of amendments that require a zonal assessment:
- changing the composition of the product,
- addition of alternative co-formulants,
- extension or change of use.
Examples of amendments that are handled nationally:
- change of manufacturer of the product,
- addition of additional source of active substance (for which equivalence has already been evaluated),
- change of product name,
- change of classification,
- change of packaging (size and/or material),
- change of holder or permanent representative.
If you are the holder or represent a holder of an authorisation you may need to apply for an administrative prolongation of your product authorisation.
Product authorisations for plant protection products are limited in time and depend on the approvals of the active substances. It is the EU Commission that decides the periods of approval for active substances. If the EU Commission has decided to prolong the approval for the active substance you can apply for an administrative prolongation of your product authorisation. The application of an administrative prolongation can be submitted as soon as the EU Commission has taken their decision.
If you are the holder or represent a holder of a product authorisation and want to withdraw your product authorisation, you must inform the Swedish Chemicals Agency about that. Please, do so by sending an email to firstname.lastname@example.org to tell us which product you would like to withdraw. You must also tell the reasons why you want the product authorisation to be withdrawn.
If the product is already authorised, but not for the use in question, it is possible to apply for an extension of a product authorisation for minor use (UPMA).
If your product is authorised in another member state within the EU and it is identical to a product that is already authorised in Sweden, it is possible to apply for a parallel trade permit in Sweden.
If you want to claim data protection along with your application for product authorisation, you must submit a list specifying for which test and study reports that data protection is claimed. You can claim data protection for documentation required for applications for new authorisations, renewal of authorisations or amendment of a product authorisation regarding an additional crop.
When claiming data protection, you must provide the following information:
- The reasons that submitted test and study reports are necessary for the authorisation.
- Certificates that the test and study reports are compliant with the principles of good laboratory practise (GLP) and good experimental practise (GEP).
- A confirmation that a period of data protection never has been granted before.
In certain cases, the Swedish Chemicals Agency can make an exception from the requirement for authorisation of a plant protection product. You can apply for a permit for experimental use of plant protection products for research and development purposes.
In certain cases, the Swedish Chemicals Agency can grant a derogation from the requirement for authorisation of a plant protection product. You can apply for a derogation when there is an emergency situation.
If you want to apply for an approval of an active substance to be used in a plant protection product you can find information about the procedure at the website of the EU Commission.
There are a number of different fees for plant protection products. For example, if you apply to have a plant protection product assessed for authorisation, you must pay a fee for the assessment. You must also pay an annual fee based on the volume of your sales of the pesticide.
The assessment of your application is based on legislation and related guidance documents. The guidance documents are in many cases agreed on EU-level.
The basis for our assessment is the information given by the applicant on how the product shall be used and the documentation submitted. We cooperate with the Swedish Board of Agriculture and the Swedish Food Agency on issues relating to efficacy and residues as well as the risk for consumers.