CA-Nov14-Doc.4.1.A

CA-Nov14-Doc.4.1.A

To whom it may concern Dear Madam/Sir, Resulting from the awareness about the impacts and the requirements to create an active substance dossier and for securing their business, four totally independent ozone equipment manufacturers have joined forces, which resulted in the foundation of the “Ozone Registration Group” (ORG). The members of the ORG are: Ozonia, Degrémont Technologies AG, hereinafter referred to as “Ozonia”, Xylem/Wedeco, Xylem Europe GmbH, hereinafter referred to as “Xylem”, ProMinent Dosiertechnik GmbH, hereinafter referred to as “ProMinent”, BWT Wassertechnik GmbH, hereinafter referred to as “BWT” The members of the ORG represent the largest fraction of the European and even global ozone markets. The global market share of all members altogether is approximately 75%. Ozone generation The technical predominant applied and dominating technologies are ozone generation from oxygen (always and only) contained in gas or in water. Two widely used methods to generate ozone from oxygen in gas are: (1) the dielectric barrier discharge (DBD)1 (mostly used), and (2) UV irradiation. Ozone can also be generated from oxygen in water using electrolysis. More information about the different ozone generation processes can be found in Annex to this letter. Ozone AS dossier of the ORG The ORG plans to submit the Ozone AS dossier in early 2015 and is also in the process of offering Letter of Access to all ozone equipment manufacturers and/or operators, in any case, before September 2015. The following PT-groups are covered in the AS dossier of the ORG: PTs 2, 4, 5 and 11. This pre- selection of PTs made by the ORG represents the majority and most relevant ozone applications, as summarized in table 1. 1 There are three terms to name the process of generation of ozone in a plasma: corona discharge, dielectric barrier discharge (DBD) and silent barrier discharge. All three terms are naming the same physical process. DBD is the most accurate term. 1 Table 1: Examples for applications of included PTs Application PT Size of use Swimming pool water 2 small … medium / private user Rinsing water for bottles in beverage industry 4 small … large Drinking water 5 small … large Circulation water of cooling towers 11 small … large Other PT groups covering marginal markets (such as PT 3, PT 12, etc.) could be of interest for third parties, but are not of interest for the ORG for various reasons. In addition, domestic applications of ozone for hygiene purposes will not be supported by the ORG, which considers the safety margin of some of these applications too limited. The ozone AS dossier of the ORG is currently in its final stage of preparation and will be submitted in early 2015. Furthermore the ORG is in the process of setting up a non-profit organization called EurO3zon (future website: www.EurO3zon.org) which will be licensed for issuing letters of access (LoA) to third parties. It is expected to be ready selling LoAs by the beginning of 2015. The price setting of LoA will be determined in a fair, transparent and non-discriminatory manner. Please also note that the ORG does not seek to make profit from the sales of LoA rather than recovering incurred costs in result of the dossier efforts. For the applicants the LoA will be a good and manageable investment with much lower risks. Buying an LoA as they can benefit of the efforts and in-depth knowledge of the ORG for a minimum period of 10 years. Additionally the ORG understands that any party with more extensive needs for covering specialized PT groups, being not in the scope of the ORG dossier, it is possible to submit a subsequent dossier that is extending the scope of the dossier written by the ORG. Product authorization The members of the ORG will submit product authorizations using the Union authorization procedure. To the knowledge of the ORG ozone generated by all technologies described in this letter could be covered via one (1) single product authorization dossier. The motivation for this choice is that independent from the chosen technology ozone is always generated from oxygen, contained in a feeding gas or water. If this position is not appreciated by the CA meeting than a differentiation could be made between ozone generated from (1) gas (using the dielectric barrier discharge method or UV irradiation) or from (2) water (using electrolysis). Authorization holder Most of the ozone generating devices that are operated in the market are of small to medium size. For those end-users a “single-point” authorization - e.g. by the manufacturer of the device – is desired in all cases. Consequently to the view of the ORG the majority of end-users of ozone generators (customers) can never be the authorization holder. This is practical unachievable and requires more resources and knowledge from the end-users than these can invest (irrelevant of the size of their operations). As outlined above and explained in more details in Annex there are devices in the market that can be operated with all kinds of feed gas containing oxygen (air, enriched oxygen 2 from air, and pure oxygen). So the authorization holder should be independent from the feed gas which is used, consequently the manufacturer of the device is better suited to fulfill this role. Otherwise, this will have an economic impact on the sector we can hardly oversee, and will again only harm the industry involved, especially to the numerous end-users. Additionally, to have the end- user as the authorization holder would create a non-handable workload to the Competent Authorities, responsible to issue such authorization. Moreover we have to keep in mind that ozone generating equipment is mostly operated to oxidize undesired organic and inorganic substances during purification of water streams, while disinfection is not the majority application in the oxidation market. The disinfection capability is in most applications only an indirect side-effect for which the majority of the end-users are even not interested in. Yours sincerely, Mr. Bernhard Paolini, Degrémont Technologies AG, Chairman Dr. Matthias Rothe, ProMinent Dosiertechnik GmbH Dr. Matthias Hoffmann, BWT Wassertechnik GmbH Dr. Jörg Mielcke and Dr. Tim Pühmeier, Xylem Water Solutions Representatives of the Ozone Registration Group 10th November 2014 3 Annex Ozone generation Ozone generated from oxygen in gas Ozone can be generated from oxygen using ambient air (Oxygen ~21%) or technical oxygen (Oxygen >93%) by the dielectric barrier discharge method (Figure 1) . “Ozone gas” is always a mixture of the feedgas source plus the ozone generated from its contained oxygen. This is classified and measured using so called ozone concentration and ozone capacity. The ozone concentration is that in the gas phase and not to be mismatched with a concentration in solution where the ozone is applied. Cooling CoolingAbla uWaterf Kühlwasser water dischargeKühlwasse r FI PI FI TI Luft oder Feedgas oOzonezonhalt igcones G-as Sauerstoff Air or O taining gas 2 Ref.: TECHNICAL RULE Ozone Electrodes for ozone generation Ozonerzeugungselemente DVGW W 625:1999-03 by dielectric barrier discharge Figure 1: Ozone generation from oxygen using ambient air (Oxygen ~21%) or technical oxygen (Oxygen >93%) More details on one of the generation processes, namely the dielectric barrier discharge method that is converting oxygen containing gas to “ozone product gas”, are presented in the next figure. Here is dry oxygen containing gas passing through the discharge gap (Figure 2) inside an ozone generator. While passing through the discharge gap a part of the oxygen is transformed to ozone. Since not all of the electric energy supplied to the process cannot be utilized in the ozone forming reaction it has to be removed by forced cooling. Sufficient cooling of the ozone generator is important as heat itself will lead to ozone destruction (to oxygen). The ozone containing gas (short: ozone gas or ozone) leaving the ozone generator is then supplied to the point of use depending on the feed gas type and ozone concentration desired. 4 Annex Ref.: TECHNICAL RULE DVGW W 625:1999-03 1 Power Source 2 High Voltage Connection 3 Discharge Gap 4 Dielectric Material 5 Ground Electrode Figure 2: Ozone generation from oxygen by dielectric barrier discharge using ambient air (Oxygen ~21%) or technical oxygen (Oxygen >93%) Figure 3 gives a complete process overview for (cooling) water treatment with ozone generated from oxygen contained in different feeding gases. Dosing of N2 or Air (opt.) Figure 3: Ozone generated from oxygen in gas – complete process overview Figure 4 represents a scheme with more details on the ozone injection process in water treatment. 5 Annex Ref.: TECHNICAL RULE DVGW W 625:1999-03 Figure 4: Ozone generated from oxygen in gas – complete process overview Figure 5 gives a view on ozone bubbling through to-be-treated water after injection. Figure 5: Ozone injection - where ozone meets the water to be treated (Ref.: Ozonia) Figure 6 gives a view on medium-sized devices in which ozone is generated from oxygen contained in feeding gas, including more details on the ozone generating module contained therein. 6 Annex Figure 6: Ozone generated from oxygen contained in feeding gas – view on medium-sized installation and the ozone generating device contained therein (Ref.: BWT) Figure 7 gives more examples of small and medium-sized ozone generating devices in which ozone is generated from oxygen contained in feeding gas. Figure 7: Examples of typical ozone generators with small and medium-sized ozone production capacity and in which ozone is generated from oxygen contained in feeding gas (Ref.: ProMinent and Xylem/Wedeco) Figure 8 gives a view on large-sized ozone-generating devices in which ozone is generated from oxygen contained in feeding gas, including the required power supply unit.

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