Uitreksels Zwitserse regelgeving
Disinfectant spray approved by Swiss Authorities
SILVER BREEZE has been approved by the Swiss Federal Health Office (SFOPH.)and has been registered with the following numbers as a disinfectant spray for commerce:
(Swiss Federal Office of Public Health)
SFOPH T Nr. (Swiss legislation): 104893
Poisoning class (Swiss legislation): free
SFOPH E Nr. (Swiss regulation on disinfectant products): 1520
Extracts from the Swiss regulation:
According to the regulation on disinfectant and disinfection products, SILVER BREEZE is approved by the chemical department of SFOPH and has been added to the toxicological list. This product must fulfil the requirements of the toxicological norms, as well as the regulation on disinfectant and disinfection products, before being placed on the market.
Each product on the market needs a registration dossier that must be transmitted to the chemical department.
The biocides of chemical disinfectants reduce the numbers of microbes on surfaces, the structure or metabolism of the microbe is destroyed. For a product to be considered effective, a sufficient number of micro-organisms have to be eliminated.
It is the duty of the registered to prove the effectiveness of the product. The microbes are subdivided into bacteria, mycosis, myco-bacteria (pathogen of tuberculosis), viruses and spore-forming bacteria.
In order to define a product as “disinfectant” in Switzerland, it must be capable to act against bacteria and mycosis. The effectiveness is tested on a certain quantity of bacteria and mycosis, which can change according to the regulations in force. In addition to the standard requirements, further organisms, such as salmonellas, viruses, myco-bacteria, spores, etc have to be specifically listed on the label. The effectiveness of each single group has to be demonstrated separately.
SFOPH carry out an evaluation of the dossier, and decide the effectiveness of the disinfectant from the reports received from the experts. The text on the label and the instructions must be conform to the properties and the effectiveness.
Once the above requirements are fulfilled, the disinfectants receives approval and a SFOPH-E number.
Anaylses for the determination of the effectiveness (according to SFOPH requirements)
In order to prove the effectiveness of a product, the experts have established standard tests, wherein the general principles are listed.
For over 20 years, standard tests exist in various countries. In order to unify the methods of these tests, and the evaluation of the Control Authorities, the European Committee for the Standardization (CEN) has created a technical committee for disinfectant products, the CT216. We are in a transition phase, in which, to prove the effectiveness of a product, it must fulfil the “regional” tests, some of which are existing since a short or a long period (AFNOR,DGHM), as well as the European regulations.
The evaluations will be approved according to the general pre-established regulations, which are existing since a long time, except when these diverge excessively from the European regulations.
In order to establish the properties of the biocides, an experimental part consisting of three phases has been supplied. Each phase or stage supplies further information regarding the strong and weak points of the product.
Phase 1:
Phase 1 consists on a qualitative suspension test. An evaluation takes place to see if the product has a basic effect against specific organisms. The product is diluted with water in order to reach various concentrations. This is a qualitative test, as the result will show if the product, in the various tested concentrations, is effective or not. Further interfering substances are not added in this phase of the tested concentrations.
Phase 2:
Phase 2/Stage 1 consists on a quantitative suspension test. Not only the product is diluted in water, but interfering substances are added, which stimulate an organic load. Such a load is often encountered in practice, since we find dirty surfaces, instruments or hands to be disinfected. This phase is important, since certain substances react to proteins and in this way are hindered, and the product looses its effectiveness. It is a quantitative test, as the reduction of the number of specific organisms, calculated in log10-stages is transmitted.
Phase 3:
Phase 3/Stage 2 exposes a decisive stage, as the experimental conditions of the tests are confronted with the circumstances, which predominate during the application in practice. In other words, practical conditions are created with these tests. Contrary to the tests of the two above-mentioned stages, which are the same for all types of application, in this last phase, the tests differ according to the field of application of the disinfectant.
SILVER BREEZE, produced for the public, serves as a disinfectant for surfaces, and therefore has been tested in phase 3 being considered suitable in this application field.
These three test phases supply the necessary knowledge for the approval of the effectiveness of SILVER BREEZE, produced for the public, effective against various specific organisms, efficient on various concentrations of application and effective within established time limits. Since these tests are standardized, a reliable confrontation of the compositions of the various active substances is possible.
SILVER BREEZE has been classified by the Control Authorities as a very effective disinfectant, since the reduction of the number of micro-organisms treated with SILVER BREEZE has satisfied the severe legislative requirements, which is more than:
5 log 10 for bacteria
4 log 10 for mycosis
4 log 10 for viruses
Various micro-organisms used for the diverse phases of tests 1 – 3
- Enterovirus Polio1, Stamm SABIN, culture on cell VERO
- Adenovirus human Typus, culture on cell KB
- Orthopoxvirus Vaccinia, culture on cell VERO
- Aspergillus niger, ATCC 8739
- Candida albicans, ATCC 10231
- E. coli, ATCC 10536 and 25922, K12 NCTC 10535