Annex II — REQUIREMENTS FOR DETERGENTS CONTAINING MICRO-ORGANISMS, REFERRED TO IN ARTICLE 5

1. All micro-organisms intentionally added in detergents shall: (a) belong to or be deposited in a collection of an International Depository Authority (IDA); (b) be identified and characterised using whole genome sequence analysis in accordance with the methodology to be established by the Commission in accordance with Article 30(6); (c) be identified with the following taxonomic information, taking into consideration the latest published information in the International Codes of Nomenclature: genus, species and strain name or code. 2. The following pathogenic micro-organisms shall not be present in any of the microbial formulations intentionally added in the finished product, in accordance with European or international standards or test methods: (a) Escherichia coli; (b) Streptococcus spp (Enterococcus spp); (c) Staphylococcus aureus; (d) Bacillus cereus; (e) Salmonella spp; (f) Pseudomonas aeruginosa; (g) Candida albicans. 3. Intentionally added micro-organisms shall not be genetically modified micro-organisms. 4. Intentionally added micro-organisms shall be, with the exception of intrinsic resistance, susceptible to each of the major antibiotic classes, namely aminoglycoside, macrolide, beta-lactam, tetracycline and fluoroquinolones, in accordance with the European Committee on Antimicrobial Susceptibility Testing disk diffusion method or equivalent. 5. When placed on the market, detergents containing micro-organisms shall have a standard plate count equal to or greater than 1x105 colony-forming units (CFUs) per millilitre or gram of product in accordance with European or international standards or test methods. 6. The minimum shelf life of a detergent containing micro-organisms shall not be shorter than 18 months and the detergent shall have a standard plate count equal to or greater than 1x104 CFUs per millilitre or gram of product at the end of shelf life in accordance with European or international standards or test methods. 7. Detergents containing micro-organisms shall be placed on the market only if safe use for human health and the environment is demonstrated based on a risk assessment performed in accordance with the methodology to be established by the Commission in accordance with Article 30(6). 8. The manufacturer shall substantiate all claims regarding the actions or performance of the micro-organisms intentionally added in the product with appropriate tests. 9. It is prohibited to claim or suggest on the label or by any other communication that the detergent has an antimicrobial or disinfecting effect, unless the detergent complies with Regulation (EU) No 528/2012. 10. The tests referred to in points 1, 2, 4, 5, 6 and 8 shall be conducted by laboratories meeting at least one of the following conditions: (a) they comply with the principles of good laboratory practice provided for in Directive 2004/10/EC or with international standards recognised as being equivalent; (b) they are accredited in accordance with the standard for laboratories referred to in Regulation (EC) No 765/2008.