An application for authorisation of a biocidal product must be accompanied by a risk assessment of health and the environment. When you apply for authorisation, you must present documentation that shows the safe and effective use of your product.
We evaluate each application individually
We evaluate each application that is submitted to us. The evaluation of a product is based on legislation and its associated guidance documents. Often, the guidance documents have been developed within the EU. The basis for our evaluation is the applicant's information on how the product is to be used and other submitted documentation. In some cases, other government agencies are also involved in the evaluation process, for example the National Food Agency.
Contact us well in advance of the application
It is important that you contact us well in advance if the Swedish Chemicals Agency is to evaluate the complete documentation in the application, preferably one year before you submit the application. This is important in order for us to be able to give you the support you need before applying, but also for us to be able to plan our work in a good way.
According to the Biocidal Products Regulation, you are obliged to consult with us prior to an application, if Sweden is to be the reference Member State, that is if the Swedish Chemicals Agency is the authority responsible for evaluating the complete documentation in your application.
We recommend that you book a meeting with relevant officers before submitting such an application, a so-called pre-submission meeting. During this meeting, we can discuss the process, the data requirements or other issues that are relevant to your application. Such a meeting is free of charge for applying companies.
Contact us via firstname.lastname@example.org
Processing of applications
When we have received your application it will be given a registration number. State this number if you contact us with questions about your application. We will also inform you about which application fee you are to pay for your application. When we have received your application and you have paid the application fee, we will file it under the type of application. The rule is that we process applications of the same type in the order in which we receive them. In certain cases, such as applications for a derogation in an emergency situation, we may need to prioritise those applications over others which have arrived earlier. When processing applications for renewed approval, we take account of how long a time the existing approval applies.
How the actual evaluation of your application is carried out depends on which type of application you have chosen to submit. For certain types of application, Sweden is the country which carries out the evaluation of the documentation. For other types of application, another member country has chief responsibility for evaluating the documentation. We can then provide our views on the evaluation of the evaluating country and make an assessment if it is also relevant to Swedish conditions. When we have evaluated your application we will take a decision on the case. If we authorise the product, the decision will specify the conditions that apply to the product and how the product may be used. If, when we have evaluated your application, we cannot see that safe and effective use of the product is possible, we cannot approve it. Your application will in that case be rejected.
We will keep in touch with you
It is quite common that we receive applications where a document or a piece of information is missing, or where documents have not been signed. In those cases you must complete your application and submit the documentation later. This will delay the processing of your case. We will contact you if there are ambiguities in your application.
In those cases where we find during the evaluation that your application needs to be rejected, we will inform you before taking that decision. This also applies if we find that the product needs to be authorised subject to stricter conditions than those you applied for. You will then have a certain amount of time to provide your views.
How long does it take to process your case?
The amount of time it takes for us to assess your application, and inform you of our decision, depends on a number of things. It depends partly on what type of application you have submitted, what type of product the application refers to, which documentation you are referring to, and how complete your application is. It is therefore not possible for us to give exact information in advance of how long it will take to process a particular application.
The EU legislation on biocidal products shows how long it may take to process applications. You will find these predetermined time limits in the Biocidal Products Regulation.