G/TBT/N/GTM/101  
13 October  2021 
(21-7726) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : GUATEMALA  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible : Ministerio de Salud Pública y Asistencia Social  (Ministry of Public 
Health and Social Welfare)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding t he notification shall be indicated if different from above:  
Departamento de Regulación y Control de Alimentos de la Dirección General de 
Regulación, Vigilancia y Control de la Salud del Ministerio de Salud Pública y Asistencia 
Social  (Food Regulation and C ontrol Department of the Directorate -General of Health 
Regulation, Surveillance and Control at the Ministry of Public Health and Social Welfare)  
Edificio DGRVCS Av . Bolívar 28 -07, zona 8 5to . Nivel 
Tel.: 22312913  
www.mspas.gob.gt  
tnormativodrca@mspas.gob.gt  
secretariadrca@mspas.gob.gt  
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : The 
notified Standard shall apply to food supplements intended for adults and children over 
three years of age, produced domestically or imported into Guatemala by any natural or 
legal person . Food additive : Any substance not normally consumed as a food by itself and 
not normally use d as a typical ingredient of the food, whether or not it has nutritive value, 
the intentional addition of which to food for a technological (including organoleptic) 
purpose in the manufacture, processing, preparation, treatment, packing, packaging, 
transpo rt or holding of such food results, or may be reasonably expected to result, 
(directly or indirectly) in it or its by -products becoming a component of or otherwise 
affecting the characteristics of such foods . This definition does not include contaminants 
or substances added to food for maintaining or improving nutritional qualities . Food 
supplement : Any food the purpose of which is to supplement the diet and deliver nutrients 
that are lacking from the daily diet . These products are a concentrated source of nutrients 
and/or other substances with a nutritional effect, alone or in combination, including 
compounds such as vitamins, minerals, proteins, amino acids or other nutrients and their 
by-products . They can be marketed in different forms such as, inter ali a, pills, capsules, 
tablets, powder, liquids or syrups, as set doses, to be taken  exclusively by mouth and not 
as conventional foods . The consumption of these products must not pose a risk to health.  
5. Title, number of pages and language(s) of the notifi ed document : NORMA 
TÉCNICA PARA LA EVALUACIÓN CON FINES DE REGISTRO Y SU POSTERIOR VIGILANCIA 
EN MERCADO DE SUPLEMENTOS Y COMPLEMENTOS ALIMENTICIOS PARA LA POBLACIÓN 
A PARTIR DE LOS 3  AÑOS DE EDAD, EN EL DEPARTAMENTO DE REGULACIÓN Y CONTROL 
DE ALIMENTOS  (Technical Standard for the evaluation for the purposes of registration G/TBT/N/GTM/101  
- 2 - 
  with the Food Regulation and Control Department and subsequent market surveillance by 
this Department of food supplements intended for adults and children over three years of 
age) (11 pa ges, in Spanish)  
6. Description of content : Given that Guatemala has no specific regulations governing the 
evaluation mechanism for the purposes of the sanitary registration of food supplements 
with the Food Regulation and Control Department of the Direct orate-General of Health 
Regulation, Surveillance and Control at the Ministry of Public Health and Social Welfare, 
and that it is the responsibility of the Directorate -General of Health Regulation, 
Surveillance and Control to issue technical regulations on processed food and beverages, 
the purpose of the "Technical Standard for the evaluation for the purposes of registration 
with the Food Regulation and Control Department and subsequent market surveillance by 
this Department of food supplements intended for adults and children over three years of 
age" is to establish the requirements and parameters for registering such products with 
the Food Regulation and Control Department.  
7. Objective and rationale, including the nature of urgent problems where 
applicabl e: The purpose of the notified Standard is to establish the conditions and 
requirements for the sanitary reference registration and subsequent market surveillance 
of food supplements . It does not apply to products defined as medicines ; homoeopathic, 
herbal or botanical products, etc. ; or to products intended for children under three years 
of age.  
8. Relevant documents : - 
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : To be determined  
10. Final date for comments : 60 days from notification  
11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Departamento de Regulación y Control de Alimentos de la Dirección General de 
Regulación, Vigilancia y Control de la Salud del Ministerio de Salud Pública y Asistencia 
Social  
Edificio DGRVCS Av . Bolívar 28 -07, zona 8 5to . Nivel 
Tel.: 22312913  
www.mspas.gob.gt  
tnormativodrca@mspas.gob.gt  
secretariadrca@mspas.gob.gt  
 
https://www.mspas.gob.gt/servicios/control -de-alimentos/normativas -en-
construccion/send/430 -normativas -en-construccion/9964 -norma -suplementos -002-
2021v2.html