WHAT ARE BIOCIDAL PRODUCTS?
Biocidal products are all products containing active substances that in any way kill, repel or attract living organisms. However, the decision on whether a product is a biocidal product does not depend solely on the composition but notably on how the product is advertised. Sales strategy must be followed by a strategy for obtaining the permit.
Therefore, we can, free of charge, prepare a strategy and budget for obtaining the permit, which will facilitate your decision on how to move forward with the process.
Strategy preparation
First, we will determine which is the best process for you, for obtaining the permit (notification or authorisation), and then together with you, prepare a strategy to obtain the permit.
Preparing the budget
In accordance with the set strategy, we can, free of charge, prepare a budget for obtaining the permit, which will facilitate your decision on how to move forward with the process.
Obtaining permit
We will oversee the process until the permit is obtained (notification or authorisation of the biocidal product), which allows you to market the biocidal product.
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Tel: +386 59016985
email: info@bisafe.si
What kind of permit do I need?
Each biocidal product requires a permit before it is supplied to the customer.
The gradual introduction of all provisions of Regulation 528/2012 on biocidal products enables obtaining the permit according to different procedures. The procedures is generally divided into: notification and authorisation.
Notification – Preliminary national procedure
The preliminary procedure is suitable for all biocidal products containing one or more non-authorised active substances. Because notification is regulated under national regulations and rules, the procedures between countries vary significantly.
We can arrange notifications in all EU and Balkan countries on your behalf.
During the notification procedure, we perform the following activities:
We will remain a reliable consultant, providing advice and guiding you in obtaining the required documentation.
Authorisation
Authorisation is used for biocidal products containing only approved active substances.
The procedure for obtaining a national permit (authorisation) for biocidal products is complex, because many studies must be collected, processed and interpreted to assess safety before submitting the application. The process of obtaining, preparing and interpreting studies requires expertise in many diverse areas, including analytics, toxicology, risk assessment and others, so the time needed for authorisation and related costs can only be predicted after a thorough analysis.
In order to facilitate your decision on continuing the process, we can prepare, free of charge, a strategy and budget, specifying all costs incurred during authorisation.
GET IN TOUCH
Tel. +386 59016985
e-mail: info@bisafe.si
Strategy preparation
Authorisation can be carried out according to different authorisation procedures in very different ways, so the first and most important step is to prepare a strategy. It is our duty to listen to your wishes and expectations and to offer the best possible solution. In the first step, we identify the studies required, review the existing documentation and present the different possibilities as well as their strengths and weaknesses.
Since we do not like to be just enforcers of regulations, we can join forces to consider the option to change the recipe. A minor change to the recipe for the existing products often allows for a broader use of the product and reduces authorisation costs.
Statements on labelling are very important and often are a neglected element. Minor changes to the statements on labelling can enable you to remain in the market or to sell in new market segments.
If your range of products covers several similar products, it is reasonable to group them into a family, which significantly reduces registration costs. At the same time, it should be noted that grouping into families has certain limitations that we will help you overcome.
Last but not least, the procedure itself should be selected. If you sell to major EU countries, it is reasonable to obtain a Union authorisation. If you want to enter country by country, a national authorisation might be more appropriate for you, followed by the mutual recognition procedure? Together we will select the procedure most suitable for you in terms of time and costs.
Because authorisation of a biocidal product is very costly, it is reasonable to share the expenses with other companies. Also in this segment, procedures within the authorisation offer many options to be considered. Do not ignore your competitors as you may become partners in the authorisation procedure.
Preparing the budget
The procedure for obtaining, preparing and interpreting studies requires expertise in many diverse areas, including analytics, toxicology, risk assessment and others, so the cost needed for the national authorisation should be determined for each biocidal product separately.
Within the biocidal product authorisation, you must obtain the letter of access (LoA), for each active substance in the product, from their respective supplier. The price is determined by the supplier of the active substance.
Some suppliers simply give their LoA to their customers for free, others want you to commit to buying the active substance from them, and still others set a one-time price.
The fee that needs to be paid to the competent authority in each Member State or to ECHA for a biocidal product authorisation depends on the size of the company applying for the authorisation and the selected form of authorisation. The fee also depends on the country in which you apply for authorisation.
In the authorisation procedure, results from physico-chemical, toxicological and ecotoxicological studies must be submitted, allowing for the classification of the biocidal product and its risk assessment.
The number of studies that need to be carried out depends mostly on the form and composition of the biocidal product. Efficiency studies must also be conducted to prove that the product is efficient under specified conditions.
In the authorisation procedure, it must be demonstrated that the biocidal product is safe for use, which requires preparation of exposure scenarios and risk assessment for human health and environment. Therefore, the price depends on the number of active substances and uses.
In the authorisation procedure, it must be demonstrated that the biocidal product is safe for use, which requires preparation of exposure scenarios and risk assessment for human health and environment. Therefore, the price depends on the number of active substances and uses.
As part of the authorisation procedure, several documents must be prepared, including an IUCLID 6 dossier, product safety report (PAR) and a summary of product characteristics (SPC). All documents should be submitted to the competent authority via the R4BP web tool.
We are aware that authorisation might be very costly, so we can prepare for you, free of charge, a budget for authorisation and specify the costs you will incur with authorisation. This enables you to make an informed decision on continuing with the process.
Authorisation
At the last stage, during which the necessary documentation is prepared, we will prepare summaries of the studies required in agreement with external providers, risk assessment and assessment report for the biocidal product. Subsequently, we will prepare an IUCLID dossier and the summary of product characteristics, and submit the application to the competent authority. After submitting the application, we will communicate with the competent authorities on your behalf. In this way you will have a consultant standing by your side even after submitting the dossier.
During the stage when the documentation necessary for authorisation of the biocidal product is being prepared, we perform the following activities for you:
GET IN TOUCH
Tel. +386 59016985
email: info@bisafe.si
