DEAS 1198 :2024 
ICS 65.160  
© EAS 2024                                                                                                                             First Edition 2024 
 
DRAFT EAST AFRICAN STANDARD  
Nicotine pouches  — Specification  
EAST AFRICAN COMMUNITY  DEAS 1198: 2024     
 
© EAC 2024 – All rights reserved  
  
  DEAS 1198: 2024  
© EAC 2024 – All rights reserved  Introduction  
 
Tobacco -free oral nicotine pouches are a rapidly growing category of products in the world. It is therefore 
important to provide requirements governing thei r composition, safety and quality across the complete life 
cycle from manufacturer to consumer.  
The purpose of this standard is to define safety and quality requirements for producers of nicotine pouches. 
Meeting these requirements intend to reassure regul ators and the public that product safety and quality is 
maintained across products and batches and can be reliably demonstrated with documentary, and that 
appropriate information is provided and/or available to consumers.  DEAS 1198: 2024  
  Foreword  
Development of the East African Standards has been necessitated by the need for harmonizing requirements 
governing quality of products and services in the East African Community. It is envisaged that through 
harmonized standardization, trade barriers that are encountered when goo ds and services are exchanged 
within the Community will be removed.  
In order to achieve this objective, the Community established an East African Standards Committee mandated 
to develop and issue East African Standards.   
The Committee is composed of repre sentatives of the National Standards Bodies in Partner States, together 
with the representatives from the private sectors and consumer organizations. Draft East African Standards 
are circulated to stakeholders through the National Standards Bodies in the P artner States. The comments 
received are discussed and incorporated before finalization of standards, in accordance with the procedures 
of the Community.  
East African Standards are subject to review, to keep pace with technological advances. Users of the E ast 
African Standards are therefore expected to ensure that they always have the latest versions of the standards 
they are implementing .  
The committee responsible for this document is Technical Committee EASC/TC 013, Tobacco and tobacco 
products .  
Attenti on is drawn to the possibility that some of the elements of this document may be subject of patent 
rights. EAC shall not be held responsible for identifying any or all such patent rights.  
 
 
 
 
 
 DEAS 1198: 2024  
© EAC 2024 – All rights reserved  Nicotine pouches — Specification  
1 Scope  
This draft East African  Standard prescribes the requirements, methods of test and sampling for pre-portioned 
nicotine pouches  exclusively intended for oral use by placing them between the gum and buccal mucosa for a 
period, to facilitate uptake of the nicotine via the oral mucos a, followed by disposal of the pouch after use . 
Note: this includes products such as white pouched nicotine products that are used by placing them under the 
upper lip for a period, before disposal.  
This draft East African standard does not cover;  
i. pre-portioned, tobacco -free oral nicotine pouches in which the nicotine is not of natural origin;  
 
ii. smokeless tobacco products, such as moist snuff, tobacco oral pouches, snus, nasal snuff, chewing 
tobacco or any other tobacco -containing smokeless tobacco products;   
 
iii. Nicotine -Containing, Tobacco -Free Oral Products that are licensed medicinal nicotine products, such 
as nicotine replacement therapies (NRT);  
 
iv. products that are subject to an authorization requirement under Directive 2001/83/EC (Community 
code relating to medic inal products for human use)  or to the requirements set out in Directive 
93/42/EEC (Medical Device Directive) or  
v. inhaled -nicotine products, such as cigarettes, other combusted tobacco products, tobacco -heating 
products or e -cigarettes.  
 
vi. method for assessing the health risks or potential reduced health risks of tobacco -free oral nicotine 
pouches . 
2 Normative references  
The following referenced documents are indispensable for the application 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.  
Codex Stan 192  General standard for food additives  
 
ISO 15152 Tobacco and tobacco products -Determination of the content of tota l alkaloids as nicotine —
Continuous -flow analysis method  
 
ISO 15592 -1 Fine -cut tobacco and smoking articles made from it — Methods of sampling, conditioning and 
analysis — Part 1: Sampling  
 
ISO 18787 - Foodstuffs  — Determination of water activity  
 
CORESTA R ecommended Method No. 88 Determination of water activity of tobacco and tobacco products   
CORESTA Recommended Method No. 69 Determination of pH of tobacco and tobacco products  
 
 DEAS 1198: 2024  
  3 Terms and definitions  
For the purposes of this standard, the following terms  and def initions shall apply  
3.1 nicotine pouches  
Pre-portioned, product  that contain nicotine compound, typically flavorings and other ingredients, but which 
does not contain tobacco, exclusively intended for oral use and for uptake of the nicotine via t he oral mucosa.  
Note 1 to entry: The term pre -portioned means that product comes in portion form, namely forms such as in 
tablet form, sachets, pouches and other similar forms, specifically designed to facilitated the oral function or 
application of the nicotine pouches  in measured small unit quantities.  
 
3.2 ingredient  
Substance (individual chemically defined substance or consisting of a mixture of substances) added to make 
the nicotine pouches. Example cellulose, nicotine, flavouring  but exclude pouch mat erials . 
 
3.3 consumable  
Single portion of nicotine pouches that is placed in the mouth for oral use  
 
3.4 nicotine compound  
substance in which nicot ine is chemically or physically associated with other chemical species  
NOTE This includes ( 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, and materials where nicotine is  
chemisorbed or physisorbed onto a substrate.  
 
3.5 nicotine   
The chemical substan ce named 3 -[1-methyl -2-pyrrolidinyl] pyridine . 
3.6 unit packet  
the smallest individual packaging of the nicotine pouches  that is placed on the market for sale.  
 
3.7 flavouring  
chemical substanc e, extract or natural Ingredient that imparts smell and/or tast e or aroma  to nicotine pouches.  
 
3.8 outside packaging  
Packaging (excluding transparent wrappers) in which nicotine pouches are placed on the market and which 
included a unit packet or an aggregation of unit packets.  
 
3.9 batch  
quantity of finished goods or intermediates of consistent quality produce d at one time as defined by the 
manufacturer  
 
3.10 component  
functional element or part of a tobacco -free oral nicotine pouch  
 Note: Examples include ingredients  andpouch materials.  
 
3.11 constituent  
individu al chemical substance within an ingredient, material or product  
 
3.12 manufacturer  
person, company or le gal entity that manufactures or designs a tobacco -free oral nicotine pouch product  
 
3.13 packaging material  
material comprisin g the container holding, a nd in contact with, the tobacco -free oral nicotine pouches  
 
3.14 pouch material  
porous material that forms the outer surface of a consumable enclosing the integrated  composition of the 
product ingredients  
 
3.15 tobacco  
the tobacco plant, including its seed s and leaves  
 
 DEAS 1198: 2024  
© EAC 2024 – All rights reserved  3.16 tobacco product  
 
a product composed, in whole or in part, of tobacco, including  tobacco leaves and any extract of tobacco 
leaves intended for use by smoking,  inhalation, chewing, sniffing or sucking and includes cigarette papers, 
tubes and filters;  
 
3.17 toxicological risk assessment (TRA)  
process by which the t oxicological risks to consumers associated with the use of tobacco -free oral nicotine  
pouches are evaluat ed and subsequently reviewed by a trained toxicologist . 
 
3.18 Contact se nsitizers   
Substances  that can cause allergic reactions or skin irritation .  
 
4 REQUIREMENTS  
4.1 General requirements  
4.1.1  All ingredients used shall be  safe, good quality  (food or pharma grade quality) and supplied with a 
unique batch code . 
 
4.1.2  The ni cotine used shall meet the requirements of approp riate pharmaceutical standards  
 
4.1.3  Pouch materials shall meet the requirements for  material and products intended to come into contact  
with foodstuffs.  
 
4.1.4  The product and flavour name shall be factual , non -promotional and not appealing particularly to  
children.  
 
4.2 Ingredients  
Nicotine  and/or nicotine compounds  
 
4.3 Specific requirements  
Nicotine pouches  shall conform to the requirement specified in the Table 1 when tested in accordance with the 
metho ds specified therein;  
Table 1:  Specific requirement for nicotine pouches . 
S/N CHARACTESTICS  REQUIREMENT  METHOD OF TEST  
I Water activity, max   0.7 CORESTA 88 or ISO 18787  
II Nicotine content, mg/pouch , (on dry 
basis) max    20 ISO 15152  
III pH, max  9.1 CORESTA 69  
4.4 Harmful substances  
4.4.1 The materials shall not contain any substances injurious to health as covered in respective tobacco 
control regulation and Act. Any added substance shall be of a nature and purity, which are suitable for use as 
food a dditive, medicinal, or pharmaceutical products in proportions of proved harmlessness.  
4.4.2  Ingredients shall not be used in the manufacture of any nicotine pouches if they meet any of the 
following classification criteria of the GHS via oral route of expo sure;  
i. Carcinogenicity (category 1 or 2;  
ii. Germ cell mutagenicity (category 1, 1A, 1B or 2)  
iii. Toxic to reproduction (category 1, 1A, 1B, or effects on or via lactation)  
Note: information on categories above may be found in Annex A  
 
 
 DEAS 1198: 2024  
  4.4.3  Ingredients shall not  be used in the manufacture of any nicotine pouches if they have been identified as  
Classified as “Carcinogenic to humans” (Group 1), “probably carcinogenic to human” (Group 2a) or “Possibly 
carcinogenic to humans” (Group 2b) by the International Agency f or Research on Cancer (IARC);  
 
4.4.4  Certain toxicologically undesirable constituents can be found naturally present in the flavorings . Those 
listed in the Table 2 shall not be used as ingredients in their own right but can be  present as constituents of 
ingredients . 
 
Table 2: Toxicologically undesirable constituents that can be naturally present in flavourings  
Substance name  CAS number (s)  
agaric acid  666-99-9 
aloin  1415 -73-2 
capsaicin  404-86-4 
hypericine  548-04-9 
beta-asarone  5273 -86-9 
1-allyl-4-meth oxybenzene, also known as estragole  140-67-0 
hydrocyanic acid  3017 -23-0 
menthofuran  494-90-6 
4-allyl-1,2-dimethoxy -benzene , also known as methyleugenol  93-15-2 
pulegone  89-82-7;15932 -80-6 
quassin  76-78-8 
1-allyl-3,4-methylenedioxybenzene,also known a s safrole  94-59-7 
teucrin A  12798 -51-5 
thujone (alpha and beta)  546-80-5; 76231 -76-0 
1,2-benzopyrone, also known as coumarin  91-64-5 
 
4.5 Toxicological risk assessment  
4.5.1  The manufacturer shall conduct a toxicological risk assessment (TRA) on all co nsumable components, 
their quantities present, and all packaging materials that are in contact with the consumables, in order to 
establish their suitability for use in the finished product.  
4.5.2  To determine the toxicologically supportable level of materi al use, the TRA shall evaluate the potential 
hazards associated with the materials, including where applicable, those of any undesirable constituents. The 
TRA shall evaluate likely exposure to the consumer considering both duration and site of product use,  based 
on reasonable and foreseeable use of the product.  
4.5.3  The toxicological risk assessments shall be conducted either by a trained toxicologist, or under the 
supervision of a trained toxicologist, using established procedures. The completed risk asse ssment shall be 
reviewed by a trained toxicologist and documented by the manufacturer for each commercial product.  
 
 
 DEAS 1198: 2024  
© EAC 2024 – All rights reserved  4.5.4  An updated toxicological risk assessment shall be conducted if the existing TRA is rendered obsolete by 
either:  
i. changes to the prod uct; or  
ii. the availability of new ingredient hazard information/data.  
5. Food additives  
5.1 All flavorings whether natural or artificial and food additives used shall be restricted to substance allowed 
and or assessed by expert bodies as Generally Recogniz ed as Safe (GRAS) in food  and shall comply to 
Codex Stan 192.  
 
5.2 Some substances or products that are capable of causing food allergies or  intolerances in a limited sub -
group of the population. If any Ingredients or processing aids are  used in the manufa cture or preparation of 
the nicotine pouches , that contain,  or are derived from the allergenic substances or products listed in Table 3, 
and are still present  in the finished product, even if in an altered form, the allergenic substance or product 
shall be  clearly stated on the outer packaging in which the Consum ables are sold to Consumers, as well as 
the product label and product information.  
 
Table 3: Food Allergens  
 
Allergenic substance or product  Exceptions  
Gluten, obtained from cereals, particularly  wheat 
(such as spelt and khorasan wheat),  rye, barley, oats 
or their hybridised strains,  and products thereof   Wheat based glucose syrups including 
dextrose, and products thereof;  
 
 Wheat based maltodextrins, and products 
thereof;  
 
 Glucose syrups based on ba rley; 
 
 Cereals used for making alcoholic distillates 
including ethyl alcohol of agricultural origin  
Crustaceans and products thereof   
Eggs and products thereof   
Fish and products thereof  Fish gelatin  
Peanuts and products thereof   
Soybeans and products  thereof   Fully refined soybean oil and fat, and 
products thereof  
 
 Natural mixed tocopherols, natural D -alpha 
tocopherol, natural D -alpha tocopherol 
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  
Milk and products thereof (including  
lactose)   Whey used for making alcoholic distillates 
including ethyl alcohol of agricultural origi n 
 
 Lactitol  
Nuts, namely: almonds ( Amygdalus communis L .), 
hazelnuts ( Corylus avellana ), walnuts ( Juglans regia ), 
cashews  (Anacardium occidentale ), pecan nuts 
(Carya illinoinensis (Wangenh.) K. Koch ), Brazil nuts 
(Bertholletia excelsa ), pistachio nuts ( Pistacia vera ), 
macadamia or Queensland nuts ( Macadamia  Nuts used for making alcoholic distillates including 
ethyl alcohol of agricultural origin  DEAS 1198: 2024  
  ternifolia ), and products thereof  
Celery and products thereof   
Mustard and products thereof   
Sesame seeds and  products thereof   
Lupin and products thereof   
Molluscs and products thereof   
 
5.3 Contact sensitizers  
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 sensitizer: 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).  
6. Sampling  
The method of representing samples of the material and the criteria for conformity shall be done as prescribed 
in ISO 15592 -1  
7. Packaging, marking and labelling.  
7.1 Packaging.  
7.1.1. The retail unit packet shall be packed using a suitable ti ght sealed packaging material to avoid 
contamination  
7.1.2. Although the consumables are not ingested and are not a food, 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 foodstuffs.  
7.1.3  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.  
7.2 Marking and labelling  
7.2.1  Each reta il unit packet shall be  legibly and  indelibly marked on both unit packets and  outside packaging, 
not be obscured by any external wrapping  with the following  information  
a) Name of the product shall be nicotine pouch   
b) Name and address of the manufacturer  
c) Bran d name or trade name if any  
d) Net weight (in grams)  
e) Batch number  or code  
f)  Manufacturing and expiry date  DEAS 1198: 2024  
© EAC 2024 – All rights reserved  g) List comprising nicotine and ingredients contained in the  tobacco -free oral nicotine pouches in 
descending order of weight.  NOTE All ingredients with the  main purpose of  flavouring may be 
grouped together under the word ‘‘flavourings’’.  
h)  Maximum blend nicotine content {in%).  
i) Allergen declarations  
j) The identity of the contact sensitizer shall be indelibly printed adjacent to the ingredient list on the 
produc t labelling using the trivial name, if available, or otherwise the chemical name, as ‘‘Contains 
[name of the sensitizing substance].  
k) Unit packets and outside packaging shall display the  following warning in a clear and visible manner:  
“This product contain s nicotine which is a highly  addictive substance.”  The print shall be legible and 
size 17 points wordings of the warning  and shall comply as same as health warning as recommended 
in the respective partner states Tobacco Regulation and Act.  
       l) Hazard  category 4 Exclamation mark  
7.2.2  Outside cons umer 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  
c) Prohibited for children, pregnant and lactant women  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 DEAS 1198: 2024  
  Annex A  
(informative)  
Examples of Authoritative sources of information on the toxicological properties of compounds to be taken into 
account during  TRAs for nicotine pouches  
The following documents might include relevant information for TRAs.  
A.1 Carcinogenicity classifications:  
A.1.1  UN GHS:  
Either  category 1 or 2 via the oral route of exposure;  
A.1.2  IARC  either:  
– “Carcinogenic to humans” (Grou p 1); 
– “Probably carcinogenic to humans” (Group 2a); or  
– “Possibly carcinogenic to humans” (Group 2b);  
A.1.3  NTP as either:  
– “Known”; or  
– “Reasonably Anticipated To Be” human carcinogens;  
A.1.1.4 USEPA IRIS  as: 
 – “Human carcinogen” (A);  
– “Probable  carcinogen, limited human evidence” (B1);  
– “Probable carcinogen, sufficient evidence in animals” (B2);  
– “Possible human carcinogen CH - carcinogenic to humans” (C); or  
– “Likely to be carcinogenic” (LH).  
A.2 UN GHS  germ -cell mutagen via the oral rou te of exposure classifications:  
 • Category 1;  
• Category 1A; •  
Category 1B; or  
• Category 2.  
A.3 UN GHS  classifications as to toxic to reproduction via the oral route of exposure:  
• Category 1;  
• 1A;  
• 1B; or  
• effects on or via lactation.  DEAS 1198: 2024  
© EAC 2024 – All rights reserved  ABBREVI ATIONS  
CAS number - Chemical Abstracts Service Registry Number  
GRAS  - FDA term for a substance “Generally  Recognized by qualified experts As Safe  for use in food under 
the conditions of  its intended use”  
IARC  - International Agency for Research on Cancer  
TRA - Toxicological risk assessment  
GHS - Globally Harmonized System  
NTP – United States National Toxicology Program  
USEPA IRIS  – United State s Environmental Protection Agency Integrated Risk Information System  
USP - United States Pharmacopeia  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 DEAS 1198: 2024  
  Bibliography  
[1] PAS 8877:2022Tobacco -free oral nicotine pouches – Composition, manufacture and testing – Specification  
[2] PS: 5468 -2020 NICOTINE -CONTAINING TOBACCO FREE ORAL PRODUCT 3 -(1- methyl, 2 - Pyrrodinyl) 
Pyrindine  
[3] SIS/TS 72:2020 Nicotin e, tobacco free oral products – safety and quality related requirements.  
[4] COOPERATION CENTRE FOR SCIENTIFIC RESEARCH  RELATIVE TO TOBACCO (CORESTA). 
Recommended  Method No. 69: Determination of pH of Tobacco and  Tobacco Products