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Article related to: biocides
Authorisation of biocidal products now more flexible
With a recent change in legislation, there are now more options for you to get an authorisation for your biocidal product when the same product has already been authorised. We asked Dr Marko Susnik from the European Association of Craft, Small and Medium-Sized Enterprises (UEAPME) how the changes help small businesses.
The Same Biocidal Products Regulation provides an easier, faster and cheaper way to get an authorisation for your product when an identical product has already been authorised (or is waiting to be). Starting from an already existing authorisation application for an identical product authorisation can be thousands of euros cheaper than, for example, a separate national authorisation – and you will get the decision faster. It is also less time-consuming for you, as you don’t have to fill in a IUCLID file but simply apply through the biocides submission tool, R4BP 3.
The regulation was amended in October 2016 to offer more options to benefit smaller companies in particular. You can apply for authorisations with a reduced scope:
- For a national authorisation for your product when the identical product has a Union authorisation (or is waiting for one).
- For an authorisation for a single product or a smaller product family when there is an already authorised product family (or it is waiting to be authorised). You can use this option when the original product family has a Union, national or simplified authorisation.
For example, if there is already an application to get a product family authorised at Union-level and you are entitled to use it as starting point, you can apply for a separate authorisation for just one of the products (or a smaller family of products) in one Member State. Before this change to the legislation, you would have had to apply for exactly the same options as the original application: the whole product family for Union authorisation.
|Marko Susnik. |
Image: Marko Susnik.
Apply for what you need
Dr Marko Susnik, Advisor for UEAPME, says that applying for national authorisation based on an existing Union authorisation is a real benefit for smaller companies, particularly in smaller countries. “Companies in Austria, where I live, are very active in exporting biocidal products to the central European countries. For them, it’s too costly to apply for authorisation for the whole EU market, which they don’t need.” Now, they can go for the less expensive, national authorisation route for their identical product.
“Without these changes in the Same Biocidal Products Regulation, it could have been a show-stopper for small companies in the long run,” Dr Susnik says. This is why, together with the European Chemical Industry Council (Cefic) and the Association for Soaps, Detergents and Maintenance Products (A.I.S.E.), UEAPME lobbied to change the legislation. “We were able to make the process more flexible for small companies - without any negative impact on the level of protection for EU citizens’ health and the environment. It is early for these to be problems yet, but it is better to fix the rules now when the issue is not yet acute for companies,” Dr Susnik explains.
Practice will make perfect
The first Union authorisations are expected to be granted in 2017. According to Dr Susnik, the process needs to speed up so that companies can gain experience. “We do not want to see the market dominated by a couple of big players only because the fees and the processes are too heavy for the smaller ones.” He says that even though Union authorisation is not widely used yet, it could become much more attractive for small companies once the process is seen to be working and the necessary support is available.
He finds similarities with the REACH authorisation process in its early stages. “In the beginning, we saw predominantly large companies applying for authorisation. But if you look now for example at the recent chromates authorisation case under REACH, it was dominated by small companies,” he concludes.
What are “identical” products?
The precondition for authorisation of same biocidal products is that the products are identical. This means they should have the same composition of the active substances and other co-formulants used. The products should only have administrative differences, such as the name of the product or the company holding the authorisation.
What is a product family?
A group of biocidal products can be authorised as a family so that all the products are covered by just one authorisation. The products within the family should have similar uses (product type); the same active substances; a similar composition (within specified variations); and similar levels of risk and efficacy.
What is a sub-family of products?
A product family can consist of one or more sub-families. The products that belong to the same sub-family should have similar compositions; the same hazard and precautionary statements; a common set of risk management measures (though there can be product-specific instructions); and a common set of first aid instructions, disposal, storage and shelf life.
When you apply for authorisation for a product family, you must create a summary of the product characteristics using the SPC Editor tool, on three levels: family, sub-family and product level. This way, the common elements for your products only need to be reported once at the highest relevant level (family or sub-family).
- Same biocidal products authorisation
- Practical guide on same biocidal products
- Webinar on same biocidal products
- More flexibility for authorisation of biocidal products (News item 12 October 2016)
- New features in biocides IT tools (News item 27 October 2016)
- Biocides legislation
Text by Veera Saari
Top image: Fotolia
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Committee for Socio-Economic
1-4 and 8-11 June (tentative);
7-11 and 14-18 September (tentative)
Committee for Risk Assessment:
1-5 and 8-12 June;
7-11 and 14-18 September (tentative)
Member State Committee:
Biocidal Products Committee:
Management Board meeting: