Kenya Standard                                  KS  2976 : 2023 
           
 
 
 
 
 Smokeless Tobacco product  
-Specification  
 
 
 
 
    
 
 
 
 
 
 
 
        
 
 
 
 
 
 
 
DRAFT   KENYA STANDARD                                                                           OCTOBER 2023   
2023 
 
 
  
 
 
 
 
 
 
© KEBS 202 3        First Edition  
  TECHNICA L COMMITEE REPRESENTATION  
 
The following organizations were represented on the Technical committee:  
 
Government chemist Department  
Pharmacy and poisons Board  
Kenya   Medical Research Institute  
NACADA  
Ministry of Health  
National Public Health Laboratories  
National Quality Control Laboratory  
 
Kenya Bureau of standards -Secretariat  
 
 
 
 
 
 
 
REVISION OF KENYA STANDARDS  
 
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Suggestions for improvements to published standards , addressed to the Managing Director, Kenya 
Bureau of Standards, are welcome.  
 
 
 
 
 
© Kenya Bu reau of standards, 202 3 
 
Copyright:  Users are reminded that by virtue of Section 6 of the Copyright Act, Cap. 130 of the Laws of Kenya, copyright sub sists in 
all Kenya Standards and except as provided under Section 7 of this Act, no Kenya Standard may be reproduced, stored in a 
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 Kenya      Standard                              KS 2976:2023 
        
          
 
 
 
 
 
 
 
 Smokeless Tobacco Product -Specification  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
KENYA BUREAU OF STANDARDS (KEBS)  
 
Head Office:  P.O. Box 54974, Nairobi -00200, Tel.: (+254 020) 605490, 602350, Fax: (+254 020) 604031  
E-Mail: info@kebs.org,  Web:http://www.kebs.org   
 
Coast Region     Lake Region          Rift Valley Region  
P.O. Box 99376, Mombasa -80100   P.O. Box 2949, Kisumu -40100        P.O. Box 2138, Nakuru -20100  
Tel.: (+254 041) 229563, 230939/40                Tel.: (+254 057) 23549, 22396        Tel.: (+254 051) 210553, 210555  
Fax: (+254 041) 229448    Fax: (+254 057) 21814  
 
 
 
  
  
 
Foreword  
 
This   Draft Kenya Standard     has been developed   by the Tobacco and  tobacco 
products  technical committee under the guidance of the standards projects  committee   in 
accordance   with the procedures of the Kenya Bureau of standards.  
 
Smokeless tobacco products(S LTPs) are non-combustible products that are consumed 
orally through the buccal mucosa route, chewing , or sniffing , or any other route of 
administration.  
 
. 
The products   may be   pouched in    a cellulose matrix inside  
 
During the  preparation of this   standard, reference was made   to the following documents  
PAS 8877:2022  
Tobacco -free oral nicot ine pouches  
– Composition, manufacture and  
testing – Specification (published by the British standards   Institution)  
 
 SIS/TS    72:2020    Nicotine containing tobacco free   oral pouches –Safety   and quality 
related requirements (published by the Swedi sh Standards  Institute)  
 
PS 5468:2020 - Pakistan standard specification for Nicotine containing tobacco free oral   
product.  
Globally Harmonized System of Classification and  
Labelling of Chemicals (GHS), United Nations, New York  
and Geneva.  
 COUNCIL OF  EUROPE. European Pharmacopoeia.  
Strasbourg, France: European Directorate for the  
Quality of Medicines and Healthcare. Nicotine  
Monograph  
 
UNITED STATES PHARMACOPEIA AND THE  
NATIONAL FORMULARY. USP 32 -NF 27. Rockville,  
Maryland: The United States Pha rmacopeial Convention  
Inc., pp. 3079 –3081, Nicotine Monograph.  
 
 
The assistance derived from the above sources is hereby acknowledged with thanks . 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.0 Scope  
 
This Ke nya Standard    specifies    requirements    for smokeless tobacco prod ucts 
intended for human consumption by chewing, sniffing . sucking    or any other route of 
administration.   ,    
 
 
 
2.0 Normative   references  
 
The following docum ents are referred to in the text in  
such a way that some or all of their content constitutes.   
provisions of this document. For dated references, only  
the edition cited applies. For undated references, the  
latest edition of the referenced document (inclu ding  
any amendments) applies.  
Tobacco control Act,2007  
Tobacco control regulations, 2014  
Food, drugs and chemical substances Act, CAP 254  
WHO _ -Framework Convention on   Tobacco Control(FCTC),2003  
Protocol to eliminate illic it trade of tobacco products  
 
 
COOPERATION CENTRE FOR SCIENTIFIC RESEARCH  
RELATIVE TO TOBACCO  (CORESTA). Recommended  
Method No. 62: Determination of Nicotine in Tobacco   
 and Tobacco Products by Gas Chromatographic  
Analysis.  
 
 COOPERATION CENTRE FOR SCIENTIFIC RESEARCH  
RELATIVE TO TOBACCO (CORESTA). Recommended  
Method No. 87: Determination of N icotine in Tobacco  Products by GC/MS.  
4) 
 
 
 
 
3.0.      Definitions  
 
For the purposes of this document, the following d efinitions and abbreviations Shall apply  
3.1. b atch 
quantity of finished goods or intermediates of  
consistent quality produced at one time as defined by the manufacturer.  
 
3.2. component  
functional element or part of an oral nicotine pouch.  
3.3. constitue nt 
 
An individual chemical  substance within an ingredient, material or product  
 
3.4. consumable  
Single potion of   smokeless  tobacco product intended for  human use  through  the 
mucosa including chewing,sucking and sneefing   
 
3.5. Flavouring  
An Ingredient    that imparts taste, flavour or aroma   to  Smokeless tobacco product . 
 
3.6 globally Harmonized System (GHS)  
Globally Harmonized System of Classification and La belling  of Chemicals that 
defines and classifies the hazards of chemical products and communicates  health 
and safety information on labels and safety data sheets and ingredient of a product.  
3.7.  importer  
Authorised person,  or any  legal enti ty that imports  smokeless tobacco product  
 
3.8. ingredient  
include tobacco, components (e.g. paper, filter), including materials used to manufacture 
those components, additives, processing aids, residual substances found in tobacco 
(following storage and processing), and substances that migrate from the packaging 
material into the product (contaminants are not part of the ingredients).  
 
 
  
  
 
3.8. Manufacture  
All op erations of receiving   of materials,  production,  processing,  using of materials,  
packaging,  repackaging,  labelling,  relabelling , quality control,  storage,  release,  and 
distribution of smokeless tobacco products.  
 
 
3.9. manufacturer  
Authorised person, or legal entity that manufactures or  
designs  a smokeless tobacco product.   
 
 
3.10. nicotine  
alkaloid chemical substance C10H14N2  
, CAS 54 -11-5 
3.11. nicotine compound  
substance in which n icotine is chemically or physically  
associat ed with other chemical species. This i ncludes (but is not limited to nicotine salts, 
where the nicotine compound is produced by  
reaction of nicotine with a protonating species such as  
an acid functionality, an d materials where nicotine is  
chemisorbed or physisorbed onto a substrate  
 
3.12. outside packaging  
packaging   containing  
a unit packet or an aggregation of unit packets, in  
which oral nicotine pouches are placed on  
the market.  
 
3.13.  packaging materi al 
material comprising the container holding, and in  
contact with, the oral nicotine pouches  
3.14. Pharmaceutical grade  
Substance that is approved for use in humans   or for which a chemical purity standard 
has been established as the highest standard and  exceeds 99% purity.  
 
3.15. pouch material  
porous material that forms the outer surface of  
a consumable   enclosing the integrated  
composition of the product ingredients  
 
3.16.  supplier  
person,  or legal entity that provides to  
a manufacturer   any material, component or  
packaging material that a manufacturer requires   
 to design, manufacture, test, control and market  
a oral nicotine pouch  
 
3.18.  oral nicotine pouch  
pre-portioned consumer product that does not contain  
tobacco but contains ni cotine or nicotine compounds,  
and other materials; intended for oral use to facilitate  
uptake of nicotine via the oral mucosa  
 
3.19 toxicological risk assessment (TRA)  
process by which the toxicological risks to consumers  
associated with the use of ora l nicotine  
pouches are evaluated and subsequently reviewed by  
a trained toxicologist  
 
3.20. unit packet  
smallest individual package of oral  
nicotine pouches placed on the market for sale  
3.21. water activity  
dimensionless ratio between the vapour press ure of  
water in the consumable to the vapour pressure of  
distilled water under identical conditions  
 
 
4.0. Requirements  
 
4.1 General   requirements  
 
4.1.1.  Smokeless tobacco products   shall not contain ingredients, materials or 
constituents from animal origin  
 
4.1.2. Alcohol shall not be present as an ingredient. If any alcohol/ethanol is used in the 
manufacturing of    smokeless tobacco products   this should be removed from the final 
product and potential residual levels shall be less than 0.5  
 
4.1.3. Ingredients shall not be used in the manufacture of  
 Smokeless tobacco products   if they are classified  
as either carcinogenic (category 1 or 2), germ  
cell mutagen (category 1, 1A, 1B or 2), or toxic to  
reproduction (category 1, 1A or 1B, or effects on or via  
lactation), by the oral route of exposure.  
 
 
 
4.1.4. Nicotine used in oral nicotine pouches  
shall conform to pharmaceutical grade purity   
 specifications. Nicotine shall be of natural origin,  
 (purified from tobacco ).  
 
 
4.1.5. all consumable ingredients in  smokeless tobacco products  shall be restricted to 
either those allowed for use in foods and/or assessed by expert bodies as generally 
recognized as safe (GRAS) in foods, or those allowed by regulatory authorities for use in 
oral medicinal products. All con sumable ingredients shall meet o r exceed food -grade 
quality or pharma -grade purity, respectively . 
 
 
 
 
 
4.1.6. The producer shall ensur e that  the use of ingredients in a final consumable  is or has 
been subjected to a toxicological risk assessment  demonstrating safety   under reasonable 
and foreseeable   use. The toxicological risk assessment or a summary thereof shall be 
documented by the  producer for each commercial product.  
 
4.2.  Specific   requirements   
Nicotine containing   oral pouches shall conform to the   requirements set in table   1   
below  
 
Table 1.  Requirements   for nicotine   containing oral pouches  
 
s/no Parameter  /Requirement/ Limit Test method  
i    
i) a Nicotine  content  per pouch 
, mg, max.  20  CORESTA 
Recommended 
Method No. 62 
[N4]; or  
b) CORESTA 
Recommended 
Method No. 87 
[N5]. 
ii) pH, max,  9.1 CORESTA 
Recommended 
Method No. 69 
[N6]. 
iii) Water   activity, max,  0.7 CORESTA 
Recommended 
Metho d No. 88 
[N7]. 
 
 
  
 a If nicotine compounds are used in the product, the total  
nicotine content of the consumable from all sources shall  
not exceed 20 mg of nicotine per consumable, as sold.  
 
 
 
5.0. Pa ckaging, Product   Information   and labelling  
 
 
The Tobacco control act  defines a tobacco product as ‘  a product composed in 
whole or in part, of tobacco, including  tobacco leaves and any extract of to bacco 
leaves intended for use by smoking, inhalation, chewing, sniffing or sucking and 
includes papers, tubes and filters’’.  
Nicotine   containing pouches there fore   fall u nder this category and thus 
subject  to   packaging and labelling requirements   specified by the tobacco 
control  regulations  
 
5.1. Packaging  
 
5.1.1  Any wrapping material (including unit packet  
materials) coming into contact with the consumable  
shall meet requirements for materials and products  
intended to come into contact with foods tuffs. 
 
5.1.2. The seal of the unit packet shall be tamper -evident such  
that a user can visually determine whether the product  
has been opened since manufacture.  
 
  
 
 
 
 
5.2. Product information and labelling  
 
5.2.1. Unit packets and outside packaging th at are visible  
to consumers shall meet the criteria specified in the tobacco control Act and 
regulations.   
5.2.2. Product info rmation stipulated in this standard   shall be  
permanently and irremovably placed on the pack, such  
that it remains intact when  opened, and be durable  
over the anticipated in -use lifetime of the product.  
 
5.3. Warning information  
 
5.3.1 Nicotine warning   
 Unit packets and outside packaging shall display the  
following warning in a clear and visible manner:  
“This product contains ni cotine which is a highly  
addictive substance.”  
5.3.2 Child safety  
Outside consumer packaging and unit packets  
shall carry information that the product is for adult  
consumption only, e.g. by using a symbol(s) or the  
following statements:  
a) keep out of  reach of children; and/or  
b) sale to persons under age 18 is prohibited  
 
5.3.3 Warning information labelling requirements  
The information specified in 5.3.1 and 5 .3.2 shall:  
a) be indelibly labelled on both unit packets and  
outside packaging;  
b) be posi tioned in a prominent and clearly visible  
location on one panel of the packaging;  
c) appear in conspicuous and legible type that  
contrasts with all other printed material on the  
package through effective use of typography, layout  
or colour; and  
d) not be obscured by any external wrapping.  
 
5.4 Product content information  
5.4.1. Consumable composition  
The product labelling   shall include a list  
comprising nicotine and ingredients contained in the  
Smokeless tobacco products .   
5.4.2 Allergens  
If any ingredients or processing aids that contain or  
are derived from the allergenic products or substances  
listed in Table 2  (other than those listed as exceptions)  
are us ed in the manufacture or preparation of the smokeless tobacco products  
 and are still present  
in the finished product, the presence of the allergenic  
product or substance shall be declared as part of the  
product labelling  
 
 
 
 
 
 
 
  
 NOTE : Table 2 identifies substances or products that are  
capable of causing allergies or intolerances and can.  
constitute a danger to health to those concerned  
 
Table 2  – Substances or products capable of causing food allergies or 
intolerance  
 
SL/NO  Allergenic prod uct 
substance or product  Exceptions  
i) Gluten, obtained from 
cereals, particularly wheat  
(such as spelt and khorasan 
wheat), rye, barley, oats or  
their hybridized strains and 
products thereof  Wheat -based glucose syrups, 
including dextrose, and  
products  thereof  
Wheat -based maltodextrins and 
products thereof  
Glucose syrups based on barley  
Cereals used for making 
alcoholic distillates, including  
ethyl alcohol of agricultural 
origin  
ii) Crustaceans and products 
thereof  - 
iii) Eggs   and products 
therefo re - 
iv) Fish and products thereof  Fish gelatin  
v) Peanuts   and products 
thereof  - 
vi) Soybeans and products 
thereof  Fully refined soybean oil and fat 
and products thereof  
Natural mixed tocopherols, 
natural D -alpha  
tocopherol, natural D -alpha 
tocophero l acetate and  
natural D -alpha tocopherol 
succinate from soybean  
sources  
Vegetable oils, derived 
phytosterols and phytosterol  
esters from soybean sources  
Plant stanol ester produced from 
vegetable oil sterols  
from soybean sources  
vii) Milk and product s 
thereof(including lactose)  Whey used for making alcoholic 
distillates, including  
ethyl alcohol of agricultural 
origin   
 Lactitol  
viii) Nuts, namely: almonds 
(Amygdalus  communis  
L.), hazelnuts ( Corylus 
avellana),  walnuts ( Juglans  
regia), cashews ( Anaca rdium  
occidentale ), pecan  
nuts ( Carya illinoinensis  
(Wangenh.) K. Koch), Brazil  
nuts (Bertholletia pistachio 
nuts (Pistacia   
vera), macadamia or 
Queensland nuts 
(Macadamia  
ternifoliia ), and products 
thereof  Nuts used for making alcoholic 
distillates inc luding  
ethyl alcohol of agricultural 
origin  
 
- 
ix) Celery and products thereof  - 
x) Mustard and products 
thereof  - 
xi) Sesame seeds and products 
thereof  - 
xii Lupin and products thereof  - 
xiii) Molluscs and products 
thereof  - 
 
 
 
 
 
 
 
 
 
 
 
 
5.4.4 Conta ct sensitizers  
5.4.4.1  
Any ingredients or processing aids that meet the  
classification criteria for contact sensitization and are  
present in the finished consumable at the following  
levels shall be declared on the packaging as:  
a) Category 1 contact se nsitizer: above 0.1%  
(weight/weight); or  
b) Category 1B contact sensitizer: above 0.1%   
 (weight/weight); or  
c) Category 1A contact sensitizer: above 0.01%  
(weight/weight).  
5.4.4.2  
The identity of the contact sensitizer shall be indelibly  
printed adjacen t to the ingredient list on the product  
labelling using the trivial name, if available, or  
otherwise the chemical name, as ‘‘Contains [name of  
the sensitizing substance]’’.  
 
5.5 Product labelling  
 
The labelling informa tion specified in this standard    shall: 
a) be indelibly labelled on the unit packet; and  
b) be printed on the outside packaging, where the  
product labelling location on the unit packet is  
obscured by outside packaging  
5.6 Other information  
 
5.6.1 Manufacturer information  
The product labelling shall contain manufacturer,  
importer and/or distributor contact details  not limited to physical address   for 
consumer questions, feedback and adverse event reporting. The  
manufacturer information shall meet the labelling  
requirements set out in this standard  
5.6.2 General product information  
All unit packaging shall provide a  
i) batch number,  
ii)manufacturing date and/or a Best Before or  
iii)Expiry   date 
iv)Country of origin and country of sale. . 
v) storage conditions  
vi)instructions for use  
vii)Disposal instructions   
a full list of ingredients;  
b) the quantity of each ingredient; and  
c) ingredient identification numbers.  
 
This informati on shall be indelibly labelled on the  unit packet  
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
ANNEX(NORMATIVE)  
 
Non-exhaustive list of toxicologically undesirable constituents  
SL/NO  SUBSTANCE NAME  CAS Number(s)i  
i) 1,2-benzopyrone (coumarin)  91-64-5 
ii) 1-allyl-3,4-
methylenedioxybenze ne (safrole)  94-59-7 
iii) 1-allyl-4-methoxybenzene 
(estragole)  140-67-0 
iv) 4-allyl-1,2-dimethoxy -benzene 
(methyl eugenol)  93-15-2 
v) 4-(Methylnitrosamino) -1-(3-
pyridyl) -1-butanone  64091 -91-4 
vi agaric acid  666-99-9 
vii Aloin  1415 -73-2 
viii) beta-asarone 5273 -86-9 
ix) Capsaicin  404-86-4 
x) Hydrocyanic acid  3017 -23-0 
xii) Hypericine  548-04-9 
xiii) Menthofuran  494-90-6 
xiv) N’-nitrosonornicotine (NNN)  16543 -55-8 
xv) Pulegone  89-82-7, 15932 -80-6 
xvi) Quassin  76-78-8 
xvii teucrin A  12798 -51-5 
xviii) alpha -thujone  546-80-5 
xix) beta-thujone  471-15-8