Reference number  
DRS 396: 2018  
© RSB 2018  
 
 
 RWANDA 
STANDARD  DRS  
396 
 
First edition  
2018 -mm-dd 
 
Bacteria -based household cleaning 
products — Specification  
 
  DRS 396: 2018  
©RSB 2018  - All rights reserved                  ii 
 In order to match with technological development and to keep continuous progress in industries, 
standards are subject to periodic review. Users shall ascertain that they are in possession of the latest 
edition  
 
 
 
 
 
 
 
 
© RSB 2018  
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized 
in any form or by any means, electronic or mechanical, including photocopying and microfilm, without 
prior written permission from R SB. 
Requests for permission to reprodu ce this document should be addressed to : 
Rwanda Standards  Board  
P.O Box 7099 Kigali -Rwanda  
KK 15 Rd, 49  
Tel. +250 788303492  
Toll Free: 3250  
E-mail: info@rsb.gov.rw  
Website: www.rsb.gov.rw  
ePortal: www.portal.rsb.gov.rw  DRS 396: 2018  
iii                ©RSB 2018  - All rights reserved  
 Contents  Page 
Foreword  ................................ ................................ ................................ ................................ ...................  iv 
1 Scope  ................................ ................................ ................................ ................................ .............  1 
2 Normative references  ................................ ................................ ................................ ...................  1 
3 Term s and definitions  ................................ ................................ ................................ ..................  1 
4 Requirements  ................................ ................................ ................................ ................................  2 
4.1 General requirements  ................................ ................................ ................................ ..................  2 
4.2 Specific requirements  ................................ ................................ ................................ ..................  3 
5 Packaging and labelling ................................ ................................ ................................ ...............  4 
5.1 Packaging  ................................ ................................ ................................ ................................ ...... 4 
5.2 Labelling  ................................ ................................ ................................ ................................ ........  4 
6 Sampling  ................................ ................................ ................................ ................................ ....... 5 
Annex  A (normative )  Risk Group and Bio -safety Level Definitions  ................................ ....................  6 
A.1 European Economic Community (Directive 93/88/EEC, Oct. 1993)  ................................ ........  6 
A.2 NIH Guidelines on Recombinant DNA (April 2002)  ................................ ................................ ... 6 
A.3 Canadian Laboratory Bio -safety Guidelines (2nd ed. 1996)  ................................ ......................  6 
A.4 CDC/NIH Bio -safety in microbiological and Biomedical Laboratories (4th Edition, 1999)  .... 7 
Annex  B (normative)  Complementary components of formulation  ................................ ....................  8 
Annex  C (normative)  Required information for the quality control of household use of bacteria 
based products  ................................ ................................ ................................ ...........................  10 
C.1 General information  ................................ ................................ ................................ ...................  10 
C.2 Technical information  ................................ ................................ ................................ ................  10 
Annex  D (normative)  Test for solubility  ................................ ................................ ...............................  12 
D.1 Preparation of synthetic hard water  ................................ ................................ .........................  12 
D.2 Procedure  ................................ ................................ ................................ ................................ .... 12 
Annex  E (normative)  Test for rinsing properties  ................................ ................................ ................  13 
Annex  F (normative)  Determination of pH  ................................ ................................ ...........................  14 
F.1 General  ................................ ................................ ................................ ................................ ........  14 
F.2 Apparatus  ................................ ................................ ................................ ................................ .... 14 
F.3 Reagents  ................................ ................................ ................................ ................................ ..... 14 
F.4 Procedure  ................................ ................................ ................................ ................................ .... 14 
 DRS 396: 2018  
©RSB 2018  - All rights reserved                  iv 
 Foreword  
Rwanda Standard s are prepared  by Technical Committees and approved by R wanda Standards Board (RSB) 
Board  of Directors in  accordance with the procedures of RSB, in compliance with Annex 3 of the WTO/TBT 
agreement on the preparation, adoption and application of standards.  
The main task of technical committees is to prepare national standards.  Final Draft Rwanda S tandards adopted 
by Technical committ ees are ratified  by me mbers of RSB Board of Director s for publication and gazettment as 
Rwanda Standards.  
DRS 396 was prepared by Technical C ommittee RSB/TC 042, Surface Active Agents . 
The assistance de rived from the above source is hereby acknowledged with thanks.  
Committee membership  
The following organizations were represented on the Technical Committee on Surface Active agents (RSB/TC 
042) in the preparatio n of this standard.  
University of Rwanda/College of Science and Technology (UR/CST)  
J&K 
MORIJA Cosmetics/Morija Supply Ltd  
Beauty Makers Association (BMA)  
KAN-HAN Ltd  
GAKO Organic Farming Training Center (GOFTC/Rwanda All Green Investment Ltd 
MINAGRI/RALIS  
Rwanda  Standards Board  (RSB) – Secretariat  DRS 396: 2018  
v                ©RSB 2018  - All rights reserved  
 Introduction  
Microorganisms (such as bacteria and fungi) are naturally occurring, ubiquitous (found everywhere), and 
necessary in order for our environment to function. The vast majority of thes e microorganisms are fundamentally 
harmless to humans, animals, and the environment. Clearly, there are several potentially harmful bacteria that 
do present a public health risk (e.g., Staphylococcus , E. coli, Salmonella and so forth), but it is easy to fo rget 
that most microorganisms are beneficial and necessary for our healthy existence and survival.  
Specialty chemicals and cleaning products comprised of microorganisms have been used successfully and 
safely for many years in a wide spectrum of industrial and household/consumer applications. These products 
work because the microorganisms can break down, degrade, and eventually consume a great variety of soil 
and other materials via the respective enzymes and metabolic pathways they utilize. At the same time , we know 
these microorganisms to be low risk because, traditionally, only non -pathogenic (i.e., non -disease causing) 
organisms are used in cleaning product applications.  
The microorganisms commonly used in cleaning products are all well -known, non -pathogenic and non -toxigenic 
microorganisms that meet the criteria for classification as WHO Risk Group 1, that is, safe for people and the 
environment . 
 DRS 396: 2018  
1                ©RSB 2018  - All rights reserved  
 Bacteria -based household cleaning products  — Specification  
1 Scope  
This Draft Rwanda Standard specifies requirements, sampling and test methods for bacteria -based household 
cleaning products.  
This Document covers products based on viable microorganisms for the treatment of septic systems, sanitary 
sewage pipelines for wastewater and for other sites with the aim of degrading organic matter and reducing 
odors.  
It does not cover the cleaning products to be used  in hospitals and other establishments related to health.  
2 Normative references  
The following documents are referred to in the text in such a way that some or all of  their content constitutes 
requirements of this document.  For dated references, only the edition  cited applies. For undated references, the 
latest edition of the referenced document (including any amendments) applies.  
RS EAS 814 , Determination of biodegradability of surfactants — Test method  
RS ISO 21149,  Cosmet ics — Microbiology — Enumeration and detection of aerobic mesophilic bacteria  
RS ISO 18416, Cosmetics — Microbiology — Detection of Candida albicans  
RS ISO 21150,  Cosmetics — Microbiology — Detection of Escherichia coli  
RS ISO 22717 , Cosmetics — Microbiolo gy — Detection of Pseudomonas aeruginosa  
RS ISO 22718,  Cosmetics — Microbiology — Detection of Staphylococcus aureus  
RS 278, Cosmetics — Methods of sampling  
3 Terms and definitions  
For the purposes of this standard, the follow ing terms and definitions apply . 
3.1 
bacteria -based products  
products based on viable microorganisms that have the property of degrading organic matter and reducing 
odors from septic systems, sanitary sewage pipes and other similar systems.   
©RSB 2018  - All rights reserved                  2 
 3.2 
viable microorganism  
live and cultivable mi croorganism in culture media and under specific environmental conditions.  
3.3 
strain  
genetic variant or subtype of a micro -organism.  
3.4 
spore  
rounded resistant form adopted by a bacterial cell in adverse conditions.  
3.5 
wastewater  
water from personal hygiene and hygiene of utensils and surfaces in domestic, commercial and industrial 
kitchens.  
4 Requirements  
4.1 General requirements  
4.1.1  Selected strains of microorganisms in household cleaning products shall offer beneficial characteristics 
that include:  
a)  non-pathogenic to humans and animals  
b)  rapid degradation, consumption, and digestion of organic wastes  
c) generation of safe, innocuous digestion by -products that do not produce malodors  
d)  grow and reproduce quickly and readily in the environments in which these products are used.  
e)  the incorporation of bacteria into cleaning products is commonly done with bacteria in spore form.  
NOTE  Spores are a metabolically inactive state in the life of the cell. Spores are highly resilient due to their resistance 
to unfavorable environmental conditions (high heat, acidic/alkaline pH, low water content, little or no nutrients) and harsh 
antimicrobial chemicals (toxic chemical agents, radiation, and desiccatio n).  DRS 396: 2018  
3                ©RSB 2018  - All rights reserved  
 f) the vegetative cell then begins to degrade and break down complex material, including organic material 
comprised of proteins, carbohydrates, fats, oils, greases, sugars, cellulose, starch, and so forth, via the 
cells enzymatic activity. Enzymatic degr adation of these complex organic substrates results in smaller, 
simpler compounds and molecules which can be utilized by bacteria for metabolization and food source 
purposes. There are no free enzymes resulting from the microorganism spore in the final pro duct.  
4.1.2  The micro -organisms for bacterial -based products for use in the home shall be classified as WHO Risk 
Group 1  or equivalent bio -safety designation  (Annex A) . For strains that do not appear on any international bio -
safety  designation lists, alternative means may be acceptable; consultation with the Authority  shall be required . 
4.1.3 Genetically modified micro -organisms shall not be accepted in formulations;  
4.1.4 The supplier of the microorganisms shall present the certifi cate or declaration that ensures the non -
pathogenicity of the above product;  
4.1.5 Complementary formulation components;  
4.1.5.1 Only the ingredients listed in annex B shall be allowed;  
4.1.5.2 The use of flavorings, coloring agents and other substances wh ich may confuse the product with food, 
cosmetics or medicines shall not be allowed;  
4.1.6 The permitted forms of presentation of the products based on bacteria shall be: liquid, solid, paste and 
gel. 
4.1.7 For the record, the data and tests mentioned in an nex C shall be presented.  
4.2 Specific requirements  
The product shall comply with the requirements given in Table 1, whe n tested in accordance with the methods 
described therein.  
Table 1 – Specific requirements  
S/N Parameters  Requirements  Test methods  
(i)  Solubility in water  Completely soluble  Annex C 
(ii)  Rinsing properties  To pass the test  Annex D 
(iii)  pH 5.5 – 6.5 Annex E 
(iv)  Biodegradability test  To pass the test  RS EAS 814  
(v)  Total Aerobic Mesophilic 
Microorganisms (Bacteria plus 
yeast and mould), CFU/g, max.  1 × 102 RS ISO 21149  
(vi)  Escherchia coli in 1g or 1ml  absent  RS ISO 21150  
(vii)  Candida albicans in 1g or 1ml  absent  RS ISO 18416  
(viii)  Pseudomonas aeruginosa in 1g or 
1ml absent  RS ISO 22717  
(ix)  Staphylococcus  aureus in 1g or 
1ml absent  RS ISO 22718   
©RSB 2018  - All rights reserved                  4 
 5 Packaging and labelling  
5.1 Packaging  
The packages shall be resistant and compatible with the product, minimizing the direct contact of the operator 
with the product.  
5.2 Labelling  
5.2.1  The following information shall appear in legible and indelible marking on each container o r on a label 
securely attached to each container : 
a) name of the product  as “Bacteria -based household cleaner” ; 
b) the manufacturer's name , trade name or trademark  and full ad dress; 
c) net content;  
d) list of ingredients: Mention the microorganisms by the scientific name, and the other components of 
toxicological interest by the technical name ; 
e) batch number;  
f) manufacture  and expiry dates;  
g) instruction for use; and 
h) country of origin  
 
5.2.2  In addition to 5.2.1, the following additional information shall appear on the label:  
 
i. a declaration that the product contains microorganisms;  
ii. information on disposal of the product and the packaging ; 
iii. the statements : “WATCH OUT! DANGEROUS IF SWALLOWED, CONTAINS LIVE 
MICROORGANISMS”, "BEFORE USE READ THE LABEL INSTRUCTIONS” ; 
iv. do not ap ply on food, cooking utensils, aquariums and food handling surfaces ; 
v. do not reuse empty containers ; 
vi. keep the product in its original container ; DRS 396: 2018  
5                ©RSB 2018  - All rights reserved  
 vii. wear gloves to apply the product ; 
viii. in case of direct contact with the product, wash the part with soap and water ; 
ix. in case of contact with eyes, rinse with plenty of running water and consult the nearest Health 
Service, taking the container or the product label ; 
x. keep the product out of reach of children and pets (in bold and capitalized) ; and  
xi. in case of aspiration or inhalation, move person to ventilated place (when appropriate).  
 
5.2.3  When applicable, the following information shall be added:  
 
A. on the procedures to be adopted in case of accidental spillage of the product ; and  
B. on incompatibilities and restrictions of use of the product, when applicable.  
6 Sampling  
Sampling shall be done in accordance with RS 278.   
©RSB 2018  - All rights reserved                  6 
 Annex  A 
(normative)  
 
Risk Group and Bio -safety Level Definitions  
A.1 European Economic Community (Directive 93/88/EEC, Oct. 1993)  
Group 1, biological agent means one that is unlikely to cause human disease;  
Group 2, biological agent means one that can cause human disease and might be a hazard to workers; it is 
unlikely to spread to the community; there is usually effective prophylaxis or treatment available;  
Group 3, biolog ical agent means one that can cause severe human disease and present a serious hazard to 
workers; it may present a risk of spreading to the community, but there is usually effective prophylaxis or 
treatment available;  
Group 4, biological agent means one th at causes severe human disease and is a serious hazard to workers; it 
may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment 
available.  
A.2 NIH Guidelines on Recombinant DNA (April 2002)  
Risk Group 1 (RG1) , agents are not associated with disease in healthy adult humans.  
Risk Group 2 (RG2), agents are associated with human disease which is rarely serious and for which preventive 
or therapeutic interventions are often available.  
Risk Group 3 (RG3), agents are  associated with serious or lethal human disease for which preventive or 
therapeutic interventions may be available.  
Risk Group 4 (RG4), agents are likely to cause serious or lethal human disease for which preventive or 
therapeutic interventions are not us ually available.  
A.3 Canadian Laboratory Bio -safety Guidelines (2nd ed. 1996)  
Risk Group 1 (low individual and community risk) , this group includes those microorganisms, bacteria, fungi, 
viruses and parasites, which are unlikely to cause disease in healthy wor kers or animals.  
Risk Group 2 (moderate individual risk, limited community risk) , a pathogen that can cause human or animal 
disease but under normal circumstances, is unlikely to be a serious hazard to healthy laboratory workers, the 
community, livestock, or the environment. Laboratory exposures rarely cause infection leading to serious 
disease; effective treatment and preventive measures are available and the risk of spread is limited.  DRS 396: 2018  
7                ©RSB 2018  - All rights reserved  
 Risk Group 3 (high individual risk, low community risk) , a pathogen tha t usually causes serious human or animal 
disease, or which can result in serious economic consequences but does not ordinarily spread by casual contact 
from one individual to another, or that can be treated by antimicrobial or anti -parasitic agents.  
Risk G roup 4 (high individual risk, high community risk) , a pathogen that usually produces very serious human 
animal disease, often untreatable, and may be readily transmitted from one individual to another, or from animal 
to human or vice -versa directly or indi rectly, or casual contact.  
A.4 CDC/NIH Bio -safety in microbiological and Biomedical Laboratories (4th Edition, 
1999)  
BIOSAFETY LEVEL 1 is suitable for work involving well -characterized agents not known to cause disease in 
healthy adult humans, and of minimal potential hazard to laboratory personnel and the environment.  
BIOSAFETY LEVEL 2 is similar to Level 1 and is suitable for work involving agents of moderate potential hazard 
to personnel and the environment.  
BIOSAFETY LEVEL 3 is applicable to clinical, diag nostic, teaching, research, or production facilities in which 
work is done with indigenous or exotic agents which may cause serious or potentially lethal disease as a result 
of exposure by the inhalation route.  
BIOSAFETY LEVEL 4 is required for work with d angerous and exotic agents which pose a high individual risk 
of aerosol -transmitted laboratory infections and life -threatening disease.   
©RSB 2018  - All rights reserved                  8 
 Annex  B 
(normative)  
 
Complementary components of formulation  
Lactic acid  
Linear ethoxylated alcohol  
Amylase  
Beta Gluconase  
Sodium bicarbonate  
Sodium carbonate  
Cellulase  
Sodium, Potassium, Magnesium, Calcium, Ammonium and Ferrous Chlorides  
Dipropylene glycol monoethyl ether  
Hexylic, octyl and decyl ethers  
Disodium phosphate  
Phosphate mono and dibasic potassium  
Monosodium phosphate  
Tricalcium phosphate  
Glucose  
Hemicellulose  
Protein hydrolyzate  
Hydroxyethyl cellulose  
Lipase  DRS 396: 2018  
9                ©RSB 2018  - All rights reserved  
 Sodium molybdate  
Monoethanolamine  
Sorbitan mono oleate  
Pectinase  
Protease  
Magnesium sulphate  
Anionic and non -ionic surfactants  
   
©RSB 2018  - All rights reserved                  10 
 Annex  C 
(normative)  
 
Required information for the quality control of household use of bacteria 
based products  
C.1 General information  
1) Name of the applicant company;  
2) Full address of the applicant company;  
3) Copy of the authorization / authorization of the operation of the company issued by the Competent 
Health Authority;  
4) Name and signature of the legal representative before the Competent Sanitary Authority;  
5) Data and signature of the technical manager;  
6) Label text.  
7) In the case of imported products in addition to the items mentioned a bove include:  
a) Copy of the certificate of free sale issued by the Competent Sanitary Authority of the country of 
origin duly legalized;  
b) Copy of the certificate of registration issued by the Competent Sanitary Authority of the country of 
origin, duly legaliz ed, in the corresponding cases;  
c) Original label and corresponding translation, if applicable;  
d) Copy of the document containing the quali -quantitative formula issued by the manufacturer in the 
country of origin.  
C.2 Technical information  
1) Product description  
2) Name or brand of the product;  
3) Qualitative quantitative composition of the product, specifying microorganisms by their scientific name 
and microbial strains, their origin, number of viable microorganisms expressed in colony forming units 
per milliliter or per gram (cfu / ml) or (cfu / g) and other components expressed by their technical names 
or common names, where applicable, and in units of the metric system;  
4) Physical and chemical data of the product (color, state, miscibility, pH, specific gravity, viscosity , water 
solubility and other data when necessary);  
5) Description of the primary and secondary packaging, if any;  
6) Description of the lot or consignment identification system;  
7) Form of presentation;  
8) Microbiological test data indicating:  
a) The scoring of viable mi croorganisms for each microbial strain in cfu / ml or cfu / g;  
b) Absence of pathogenic microorganisms of the genera Salmonella, Shigella and Escherichia coli;  
c) Absence of Pseudomonas aeruginosa;  
d) Absence of microorganisms Saprophytes mainly Stenotrophomonas ma ltophilia with resistance 
outside the patterns defined in the literature through the presentation of data "in vitro" susceptibility 
to the recommended antimicrobial susceptibility;  
e) Biochemical identification data of the microorganisms used;  
f) Total count of viable microorganisms in cfu / ml or cfu / g.  
9) Stability test data including the total counts of viable microorganisms of the prepared product and at the 
end of the intended period of validity.  
10) Term of validity.  
11) Information on incompatibilities, where appropriate.  DRS 396: 2018  
11                ©RSB 2018  - All rights reserved  
 12) Efficacy data using methods recognized by the scientific community.  
13) Methods of deactivation and disposal of the product and its packaging taking care to avoid risks to 
human health and the environment.  
14) Data on the conservation of the product.   
©RSB 2018  - All rights reserved                  12 
 Annex  D 
(normative)  
 
Test for solubility  
D.1 Preparation of synthetic hard water  
Weigh to the nearest 0.001 g, about 0.264 g of CaCl 2.2H 2O and 0.295 g of MgSO 4. 2H 2O. Transfer quantitatively 
to a 1 -L volumetric flask; dissolve in a small portion of distilled water an d make up to the mark with distilled 
water.  
The resulting solution will have a concentration of 8.1 millimole per litre calcium hardness.  
D.2 Procedure  
Using a pipette, transfer 5.0 mL of the detergent into a test tube and add sufficient synthetic hard water p repared 
in A.1 to give a volume of 50 mL. Stir vigorously for 5 min, and observe for solubility.  DRS 396: 2018  
13                ©RSB 2018  - All rights reserved  
 Annex  E 
(normative)  
 
Test for rinsing properties  
Dissolve 2.0 mL of the product as completely as possible in 98 mL of synthetic hard water (see A.1) at ambient 
temperature, in a clean 250 -mL Erlenmeyer flask. Stopper the flask and stir vigorously for 1 min. Pour out the 
solution. Rinse the flask by the same procedure, using three 75 mL portions of synthetic hard water alone. Invert 
the flask, allow to dry and exa mine for any residue not rinsed from the interior. The flask shall contain no more 
residues after being dried than a similar allowed drying after rinsing with synthetic hard water alone.   
©RSB 2018  - All rights reserved                  14 
 Annex  F 
(normative)  
 
Determination of pH  
F.1 General  
pH determination should be made in an acid free atmosphere.  
F.2 Apparatus  
F.2.1 Any standard pH meter , equipped with a low sodium error glass electrode. The instrument shall be 
calibrated and standardized with standard buffer solutions (see E.3.2) before use.  
F.2.2 Volumetric flask , 1000 mL capacity  
F.2.3 Beakers , 1000 mL  
F.3 Reagents  
F.3.1 Distilled water shall be boiled thoroughly or purged with carbon dioxide -free air to remove carbon dioxide 
and shall be protected with soda lime or soda asbestos while cooling and in storage. The pH of  this water shall 
be protected with soda lime or soda asbestos while cooling and in storage. The pH of this water shall be between 
6.2 and 7.2 at 27 °C. The residue on evaporation when heated at 105 °C for one hour shall not exceed 0.5 mL 
per litre.  
F.3.2 Standard buffer solutions with the pH range of 9 to 11 at 27 ºC for calibrating the pH meter.  
F.4 Procedure  
Weigh to the nearest milligram approximately 10 g of the material and transfer to a 1 -L volumetric flask. Partially 
fill the flask with distilled water and agitate until the sample is completely dissolved. Adjust the temperature of 
the solution and the distilled water to 27 °C ± 2 °C and fill to the calibration mark with distilled water, stopper the 
flask mix thoroughly and allow the solution to stand at a temperature of 27 °C ± 2 °C for two hours prior to 
measuring the pH. Measure the pH of the solution at 27 °C ± 2 °C using a glass electrode.  
 DRS 396: 2018  
15                ©RSB 2018  - All rights reserved  
 Bibliography  
[1] Mercosur Technical Regulation for products of domestic use based on bacteria . Argentine, 2015.  
[2] United States - National Institute of Health (US NIH), Guidelines for research involving recombinant or 
synthetic nucleic acid molecules , April 2016.  
[3] GS-37, Green Seal Standard for cleaning products for industrial and institutional use, Edition 7.2, July 
2015.  
 
 DRS 396: 2018  
ICS 71.100.40  
 
 
©RSB 2018  - All right s reserved