57Thmeeting of Representatives of Members States Competent Authorities for the Implementation

CA-May14-Doc.8.2

57thmeeting of representatives of Members States Competent Authorities for the implementation of Regulation 528/2012 concerning the making availableon the market and use of biocidal products

Request from Ireland for a Commission decision in accordance with Article 3(3) concerning the products AquaClean SA and AquaClean ACF-32

The Commission received from Ireland, pursuant to Article 3(3) of Regulation (EU) 528/2012 regarding the making available on the market and use of biocidal products (BPR), a request to decide whether the productsAquaClean SA and AquaClean ACF-32 containingbacterial cultures used and specifically designed for the breakdown of organic sludge's are biocidal products or not.

Further to a first discussion of the case at the 56th CA meeting, the Commission services collected further information on the two products.

The information provided in this note has been collected at the following address: from BluePlanet Europe.

The general description of the product AquaClean indicates that[1]:

The photosynthetic bacteria in AquaClean, which are similar metabolically to algae, compete with algae for the essential macronutrients, nitrogen and phosphorous. By effectively competing with the algae, the photosynthetic bacteria leave little nutrients for the algae to grow on. While they provide the same benefits as the algae in terms of oxygenation, they have none of the detrimental side effects, cosmetic or otherwise.

In addition, from the product labels of the two products[2],[3], as provided on the internet, it appears that AquaClean ACF is claimed to:

• Inhibits growth of filamentous algae
• Reduces eggs and larvae of water breeding insects
• Help to control flies and mosquitoes

These claims indicate that the product has a biocidal function and is supposed to be used against unwanted organisms.

Concerning AquaClean ACF/SA no claim is made referring to a biocidal function. However, the mode of action of the product is claimed to be based on competitive exclusion of algae having detrimental side effects.

Pursuant to the Söll case, a product used against algae in so far as it contains an active substance (bacterial cultures), which provokes a biological action (the bacteria grow on nitrogen and phosphorous nutrients) which forms an integral part of a causal chain (by competing for the essential macronutrients, the photosynthetic bacteria leave little nutrients for the algae to grow on), the objective of which is to produce an inhibiting effect in relation to harmful organisms (algae), shall be considered a biocidal product.

Based on this, the preliminary conclusions of the Commission services are the following:

• AquaClean ACF/SA should be regarded as a biocidal product if it is confirmed that the mode of action of the product is based on competitive exclusion of algae having detrimental side effects;

• AquaClean ACF-32 should be considered a biocidal product as the nature of some the claims indicates that the product has a biocidal function.

The Commission services would welcome the views of the Member states on these preliminary conclusions.

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Annex I

Information collected from BluePlanet website[4]

Products

AquaCleanTM is a proprietary combination of various species of live bacteria used for the treatment of industrial, agricultural and residential, organically contaminated wastewater.

The micro-organisms in AquaCleanTM are non-toxic and non-pathogenic live bacteria suspended in a liquid medium that is non-offensive to humans, animals, plants and all types of aqua-culture.

The bacteria in AquaCleanTM remain in an adult state after manufacture which gives AquaCleanTM its ability to quickly adapt to different environments. The combination of these diverse components in AquaCleanTM provides the flexibility to treat highly complex organic components in different systems utilizing aerobic and anaerobic applications.

[…]

AquaClean and Microbe-Lift Industrial Product Lines are formulated to meet the needs of Industrial, Agricultural, Commercial and Domestic wastewater management. Our core products are formulas of naturally occurring bacteria, with proven ability to degrade difficult to treat compounds in a broad spectrum of conditions requiring aerobic, anaerobic, facultative, as well as chemo and photo-synthetic bacteria activities. For certain problematic conditions, we have formulated products enhanced with enzymes and selected blends of bacteria tailored to effectively address the specific needs.

[…]

Application and Treatment will vary with the composition of the wastewater, retention time allowed for bio- augmentation, and therefore each Project must address any potential limiting factors caused by micro-nutriments, toxicity, temperature, salinity or pH levels.

[…]

In contrast, AquaClean reduces and limits algae growth by two mechanisms: competitive exclusion and the production of a natural inhibitor, which is not harmful to other aquatic plants or animals.

The photosynthetic bacteria in AquaClean, which are similar metabolically to algae, compete with algae for the essential macronutrients, nitrogen and phosphorous. By effectively competing with the algae, the photosynthetic bacteria leave little nutrients for the algae to grow on. While they provide the same benefits as the algae in terms of oxygenation, they have none of the detrimental side effects, cosmetic or otherwise.

Annex II

Product labels as available from BluePlanet website

AquaClean - ACF-32

AquaClean- ACF-SA

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[1]See Advantages of AquaClean over Copper Sulfate (CuSO4).

[2] See and reproduced in Annex II.

[3]See and reproduced in Annex II.

[4] See