Amoéba's biocide validation process

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Extensive validation process: from laboratory to field trials

Amoéba has applied an extensive validation process to prove the efficiency and the non hazards on human health and environment of its Green biocide/BIOMEBA. Conscious of the importance that such a revolutionary biocide could play in water treatment processes, we opted for 10 stages of tests, applied in the most rigorous conditions, and whenever possible exceeded the recommended testing limits usually applied to chemical biocides (in blue in the illustration here below).

In addition to laboratory tests, we performed real-life field tests for over 8 years cumulated, in agreement with French regulatory authorities and in collaboration with water treatment companies and end-users.

Marketing and regulation for the biocidal product BIOMEBA in Europe

Manufacturing, sale, distribution and use of biocidal products are regulated activities in the EU. Therefore, like for medicines, biocidal products must be granted a marketing authorization before being made available on the European market, to ensure a high level of protection for humans and the environment.

Active substance of BIOMEBA biological biocide, the non-pathogenic amoeba Willaertia magna C2c Maky, natural wild strain not genetically modified is currently under assessment at European level, evaluating competent authority being the French ANSES (French Agency for Food, Environmental and Occupational Health & Safety).

Provisional MA for BIOMEBA biological biocide in France is expected by the end of first semester 2016 upon ANSES validation. Once validated, the provisional MA is valid during a three-year period and commercialisation can be initiated.

Based on the French evaluation, a provisional MA will be submitted to the competent authority of the other target European Member States.

In parallel, the BPC (Biocidal Product Committee) at ECHA (European agency, competent in the field of biocides) will support ANSES recommendation for active substance approval at European level, that will be followed by ‘definite’ approval of the biocidal product BIOMEBA marketing by the European Member States. Opinion of ECHA is expected in 2017.

 

Safety data sheet - SDS - Amoéba biological biocide BIOMEBA