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The authorisation of in-situ generated biocides (BPR528-2012) | Aquaox
Source: http://www.ctgb.nl/en/biocidal-products/types-of-applications-for-biocidal-products/which-procedure-should-i-follow-/devices-that-generate-a-biocidal-product-in-situ

In-situ generation of a biocidal product/active substance
An active substance is a substance that acts on or against harmful organisms.
A biocidal product consists of at least one active substance and possibly additional substances or auxiliary substances.
With in-situ generation, the biocide (the active ingredient) is both generated and used on site.
As soon as a biocidal product is placed on the market, it is no longer an in-situ generated biocide – for example where a biocide is generated with an apparatus, but is then packaged and marketed as such.

Mandatory authorisation
The legislation on biocidal products concerns the authorisation of biocidal substances and mixtures. For such substances and mixtures, authorisation is mandatory.

In principal, in-situ generated biocides also require authorisation from the Ctgb before they can be used in the Netherlands.
There are 2 exceptions. As long as these exceptions apply, no authorisations are required for those biocidal products. These exceptions are described in Appendix 9 of the Regulation on plant protection products and biocides (Rgb) as it was in force on 31 August 2013. That version of the Rgb remains in force until the regulation of the substances concerned is taken over by European legislation.
The exceptions are:

Ozone that is generated on site using equipment intended for this purpose does not fall within the scope of this law.

 Chlorine compounds that are generated on site from sodium chloride with equipment intended for this purpose do not fall within the scope of this law.

Therefore, all biocides that are generated on site require a national authorisation to be used in the Netherlands, with the exception of on-site generated ozone and chlorine compounds generated from sodium chloride that are not intended for disinfection of pipes for drinking water for humans and animals.

These exceptions are going to expire in the Netherlands. For ozone and for chlorine compounds generated from sodium chloride, a substance dossier must be submitted for the relevant uses in one of the European Member States no later than 1 September 2016 for the purpose of European approval of that substance.
If such a dossier is not submitted by 1 September 2016, then the exception will expire and all products and uses of that substance in the EU, therefore including the Netherlands, must be removed from the market no later than 1 September 2017.
If the dossier has been submitted, then the exception will remain in force until a European decision is taken on the substance.

What aspects are given an authorisation with in-situ generated biocides?
In-situ generated biocides are made on site from one or more precursors or from generally available substances (such as sea water or air).
If there are one or more precursors, then the regulations for authorisation of biocidal products apply to the precursors.

With in-situ generation of biocides, three situations are possible:

  1. A precursor is used that is placed on the market specifically for that purpose.
  2. A precursor is used that is not placed on the market specifically for that purpose.
  3. No precursor is used
  1. If a substance or mixture is placed on the market with the claim of serving as a precursor for the in-situ generation of a biocide, then that product must be authorised by the Ctgb.For example: copper and silver electrodes that are placed on the market to be used specifically for the disinfection of drinking water; (see authorisation 13292N).
    In the future, an authorisation will be required for using sodium chloride for disinfection of swimming water. The authorisation will apply to the sodium chloride. The applicant can choose to request an authorisation for sodium chloride that is intended to be used specifically in apparatus manufactured by firm X. In this way, a specific link is established between that sodium chloride and the specific apparatus manufactured by firm X.
    The applicant can also choose to request an authorisation for sodium chloride that can be used in apparatus manufactured by multiple firms for the generation of chlorine compounds. In that case, however, the application must demonstrate that all of these types of apparatus can generate the desired biocide on site from that sodium chloride.
  2. If an apparatus will be used for the in-situ generation of a biocide with the aid of a precursor, but the precursor does not have an authorisation from the Ctgb, then this is an illegal situation. In principle, all precursors require an authorisation from the Ctgb for use in apparatus intended for generating a biocide. Or the reverse: such apparatus can only be used in combination with a precursor that has been authorised. However, there is one important exception to this rule: for chlorine compounds that are generated on site from sodium chloride, no authorisation is required unless the intended use is for disinfection of pipes for drinking water for humans or animals. Note that this exception is in force until 1 September 2017.This exception means that plain table salt (sodium chloride), which can be purchased at the supermarket and therefore does not have an authorisation, can be used in apparatus for the generation of chlorine compounds for disinfection purposes other than the disinfection of pipes for drinking water for humans and animals.
  3. If no precursor is used, but only a generally available substance such as seawater or air, then no authorisation can be required for that generally available substance. For example: after 1 September 2017, this will be the case with ozone that is generated from air. Consequently, an authorisation will be issued for the in-situ generated substance (ozone) that is generated with specific apparatus manufactured by firm Y. In this way, a link is made between the in-situ generated biocide and the specific apparatus with which this generation must take place. Obviously, firm Y (which manufactures the apparatus) will request this authorisation. Firm Y will therefore submit an application for authorisation of ozone generated with their specific apparatus. The application must also include data about the ozone as it is generated with the corresponding apparatus. Here as well, the applicant can choose to request an authorisation for ozone that is generated on site with various brands of apparatus. The application must also demonstrate that all types of apparatus named in the application are capable of generating the desired ozone.

What about the equipment?
Under the Biocidal Products Regulation, authorisation of apparatus is not strictly necessary. However, if no precursor is marketed (case 3 above), then the generated substance in combination with the apparatus is authorised; in practice the manufacturer of the apparatus will request an authorisation for this apparatus.
There is also a difference in the period until 1 September 2017 and the period thereafter.

The following schematic clarifies the various situations

Until 1 September 2017
Apparatus to which a precursor is added Precursor is sodium chloride PT5 uses Apparatus may be used with sodium chloride only if this has been authorised by the Ctgb
Other uses besides PT5 Apparatus can be used with all types of sodium chloride
Precursor other than sodium chloride Apparatus may be used only with a precursor that has been authorised by the Ctgb
Apparatus to whichno precursor is added In-situ generation of ozone Apparatus may be used without authorisation
In-situ generation of biocides other than ozone Use of this apparatus requires authorisation from the Ctgb

 


From 1 September 2017
Apparatus to which a precursor is added Precursor is sodium chloride PT5 uses For sodium chloride an EU dossier has been submitted for PT5 Apparatus may be used only with sodium chloride that has been authorised by the Ctgb
For sodium chloride no EU dossier has been submitted for PT5 Apparatus may no longer be used
Other uses besides PT5 For sodium chloride, an EU dossier has been submitted for the corresponding PT Apparatus may be used with all types of sodium chloride until the EU decision about sodium chloride for the corresponding PT must be implemented. After this, the apparatus may be used only with sodium chloride that has been authorised by the Ctgb
For sodium chloride, an EU dossier has notbeen submitted for the corresponding PT Apparatus may no longer be used
Precursor other than sodium chloride For the corresponding precursor/PT combination, an EU dossier has been submitted Apparatus may be used only with a precursor that has been authorised by the Ctgb
For the corresponding precursor/PT combination no EU dossier has been submitted Apparatus may no longer be used
Apparatus to which no precursor is added In-situ generation of ozone For ozone, an EU dossier has been submitted for the corresponding PT Apparatus may be used until the EU decision about ozone and the corresponding PT must be implemented. After this, the apparatus may be used only with an authorisation from the Ctgb
For ozone, an EU dossier hasnot been submitted for the corresponding PT Apparatus may no longer be used
In-situ generation of biocides other than ozone For the corresponding biocide/PT combination, an EU dossier has been submitted Use of this apparatus requires authorisation from the Ctgb
For the corresponding biocide/PT combination no EU dossier has been submitted Apparatus may no longer be used