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2.
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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 the 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 Control 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
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3.
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Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ],
other:
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4.
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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 used 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, transport 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 alia, 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.
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5.
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Title, number of pages and
language(s) of the notified 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 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
pages, in Spanish)
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6.
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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 Directorate-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.
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7.
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Objective and rationale, including the nature of urgent problems
where applicable: 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.
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11.
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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
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