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Active substances
Active substances under the scope of BPR

In accordance with Regulation (EU) No. 528/2012 (Biocide Regulation), biocidal products may only be sold or used in a commercial activity if they have previously been authorized.

Only biocidal products whose active substances are approved for the respective product type in which the biocidal product is to be used and are listed in the so-called Union list of approved biocidal active substances or in Annex I of the BPR are permitted.

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2-stage approval process

1. authorisation of active substances at european level

 

2. product authorisation (national or at union level)

"existing" and "new" active ingredients

summarized facts to know :

EXISTING active SUBSTANCES

Existng  active substances are those that were already placed on the market before May 14, 2000 and are listed in Annex I of Regulation (EC) No. 1451/20076.

 

If these active substances are still in the review process and have not been approved yet, biocidal products containing those active substances can still be placed on the market in accordance with national regulations.

 

In germany, biocidal products  have to be registered with the Federal Institute for Occupational Safety and Health (BAuA).

 

If an active substance is included in the Union list, the obligation of authorization of a biocidal product -contains this active substance-  according BPR  is then required.

 

 

new active SUBSTANCES

New active substances are those that were placed on the market in biocidal products after May 14, 2000 and are not listed in Annex I of Regulation (EC) No. 1451/2007.

 

If these active substances are still in the review process and have not yet been approved, biocidal products that contain such active substances cannot be placed on the market.

 

In germany, it is not possible to register those biocidal products with the Federal Institute for Occupational Safety and Health (BAuA).

If an active substance is included in the Union list, the obligation of authorization of a biocidal product -contains this active substance-  according BPR  is then required.

 

 

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Active substances and formulation development

Anyone who has ever work with the development of disinfectants and the selection of active substances will quickly realize that the number of those is limited and that the impression could quickly arise that such a development is easily done.

 

Companies are often  looking to the left or right, but do not  look at the total package that is before them to develop a new product that is competitive. Doing so it seams to be a  easy and cost-saving way by adopting the claims and product properties of "almost identical" existing products the market offers, and yet the surprise is usually great if this product  finally does not keep its promises in the laboratory or in practice! In  worst case  the product has already been launched, produced in stock,  is in the hands of customers  or on the tables, at the floors or in stables  and  the first complaints drops into their letterbox.

Then good advice is hard to find.

If you think about the demands placed on a formulation of an disinfectant  today as also on the risks associated with a "failure" of the products for both manufacturers and consumers then it quickly becomes clear:

 

Developing a formulation is certainly not rocket science and also does not deal with witchcraft but the selection of active ingredients and  the co-ingredients are key elements and tips the scale. 

 

With DESICONs know-how, our many years of experience and our huge network of experts

we will work with you to develop your individual formulation and realize your goals.

Have a look outside the box!

Consumer expectation / wishful thinking

about the performance of chemical disinfectants 

- a broad spectrum of efficacy

- quick, reliable and irreversible effect

- resistance to hot,cold temperatures and light

- without negative effect on organic dirt

- long-lasting effect

- no resistances

- compatible / harmless for humans, animals and the environment

- material compatible

- excellent stability and durability

- no dangerous goods

- not classified as dangerous according to CLP

- marketable for a long time,

and it should be economical.

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"It is a waste of time to do something mediocre" (Madonna)

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