REGULATORY REQUIREMENTS
PRODUCTION OF BIOCIDES
The construction and operation of a plant in which biocides or their active substances are ground, mixed, packaged or decanted are subject to approval pursuant to Section 4 BImSchG (Federal Immission Control Act), insofar as more than 5 tonnes a day are handled.
The State Trade Supervisory Office in Hannover granted Dr. Küke GmbH a permit (based on its application) to build and operate a chlorine dioxide production plant with a daily capacity of 165 tonnes (No. 4.2 of Annex 1 of the 4th Ordinance for the implementation of BImSchG – 4th BImSchV) at the Bissendorf site.
PLACING BIOCIDAL PRODUCTS ON THE MARKET
DK-DOX® in-situ biocides under REGULATION (EU) No. 528/2012 concerning the placing on the market and use of biocidal products
This regulation has been in force since 1 September 2013 and replaces Directive 98/8/EC, which was valid up until that point. From 1 September 2013, biocidal products may only be made available or used on the market if they have been authorised beforehand.
The Regulation provides for exceptions to this rule for BPs solely containing existing active substances that are still under evaluation (Article 89 of Regulation 528/2012 and Section 28 of the Chemicals Act).
These existing active substances are named in REGULATION (EU) No. 1062/2014 of 4 August 2014.
DK-DOX® products produce the existing biocidal active substance chlorine dioxide. This is listed in Regulation 1062/2014 for product types 2,3,4,5,11 and 12 as an existing active substance under number 491.
Thus, DK-DOX® products may be made available and used on the market until approval/non-approval of the existing active substance has been established. Until then, the placing on the market of biocidal products is subject to national legislation.
At the “59th meeting of representatives of Member States Competent Authorities for the implementation of Regulation 528/2012 concerning the making available on the market and use of biocidal products” (59th CA Meeting) it was established that from 1 September 2015 in-situ biocidal chlorine dioxide can only be made available on the market if the supplier of the precursors is on the Article 95 list.
The supplier of the precursors referred to in Article 95 is also the representative of the active substance dossier. Moreover, the entire in-situ system (precursor – active substance) is part of the active substance dossier.
The existing active substance chlorine dioxide, which is still listed under No. 491 of REGULATION (EU) No. 1062/2014, is now considered an in-situ generation system. As at the 59th CA Meeting, chlorine dioxide has now been defined and distinguished as follows:
- Chlorine dioxide generated from sodium chlorite by electrolysis
- Chlorine dioxide generated from sodium chlorite by acidification
- Chlorine dioxide generated from sodium chlorite by oxidation
These in-situ systems are currently being evaluated.
DK-DOX® comes under the generation system “Chlorine dioxide generated from sodium chlorite by oxidation”. The active ingredient dossier covers not only the precursor sodium chlorite but also the oxidising agents as precursors.
Dr. Küke GmbH ensures that the starting material for the production of DK-DOX products, sodium chlorite, as defined in the 59th CA Meeting, is only purchased in the supply chain from the dossier representative for the generation system. This is listed in the Article 95 list.
APPLICATION OF BIOCIDAL PRODUCTS
In most cases, the application of biocidal products is subject to standards and regulations. Thanks to its many years of focusing on the active substance chlorine dioxide, the company has the professional skills to actively deal with standardisation work. In doing so, we are helping to develop the generally accepted state of the art.
DIN
Participation in the Standards Committee 119-07-13-01 Working Group “EN for in-situ production and dosing of biocides for water treatment”
Subsequent appointment of German experts by the Standards Committee, including Dr. Fritz Küke, for cooperation in CEN/TC 164/WG 16 “Systems for in-situ production and dosing of biocides for water treatment”
DVGW
(German Association for Gas and Water)
Project group W-PK-1-3-15 “W 263 Hygiene in the Water Supply System”
FIGAWA
Sectors:
– Water infrastructure
– Water treatment
– Water metering & sensoring
– Drinking water installation
VCI
1. Working group “Biocides”
Ö-Norm
M 5879-3 requirements for chlorination systems for water treatment
– Part 3 Chlorine dioxide systems
