MINISTRY OF SOCIAL PROTECTION*

< GO "**977

.
DECREE NUMBER
and. _____FROM 2008

DECRETON~MER02 20&12008 DE'200B

By which Decree 3249 of 2006 is modified and other provisions are issued

THE PRESIDENT OF THE PUBLIC OF COLOMBIA

In exercise) of his constitutional and legal powers, especially those conferred

in numeral I 11 of article 189 of the Political Constitution, Law 09 of 1979 and the
article 245 of Law 100 of 1993,

DECREES:

ARTICLE 31.- Modify article 3 of Decree 3249 of 2006, which will remain as follows:

"ARTICLE 3.-REQUIREMENTS. The requirements for the manufacture and marketing of dietary
supplements are as follows:

1. That the product does not comply with the definitions established in current health
legislation3 for foods, medicines, phytotherapeutic products or pharmaceutical
preparations based on natural resources and alcoholic beverages.
2. The maximum permitted amount of vitamins, minerals and trace elements for these
products per daily consumption will be the maximum tolerable consumption levels (UL)
indicated in Annex 1, which forms an integral part of this decree.
3. They may not contain within ingredients, i, substances that represent risks to health,
such as: hormones, pesticide residues, i, antibiotics, >, veterinary medications, >, heavy
metals, among others.Likewise, narcotic substances may not be included, psychotropics
that generate dependence.
4. Ingredients established by the following reference entities3 will be accepted: Food and
Drugs Administration (FDA); ; Codex Alimentarius;>; European Food Safety Authority
(EFSA), Colombian Institute of Family Welfare (ICBF) and their respective updates.
5. Those ingredients, additives or substances for which there are quality and safety alerts
will not be accepted.
6. Plant mixtures may be made as long as each ingredient is approved 3 by the entities 3
referred to in numeral 4 of this article and has a proven nutritional value.
7. Those products3 that contain1 as unique active ingredients, those established in the
pharmacological standards as vitamin supplements, will not be accepted as dietary
supplements.

ARTICLE 2.- Modify article 7 of Decree 3249 of 2006, which will read like this:

"ARTICLE3 7.- CERTIFICATE3 OF THE .GOOD5 PRACTICES OF

MANUFACTURING-GMP. In order for plants where3 dietary supplements3 are manufactured to
obtain1 the Good Manufacturing Practices3-GMP Certificate, the following3 rules must be taken
into account:
DECRETON NUMBER 3863 DE2008 SHEET°2

Continuation of Decree 11 by which Decree 3249 of 2006 is modified and others are issued
provisions"

1.Dietary supplements manufactured in plants located in the national territory dedicated to

the exclusive manufacture of these products:

Plants located in the national territory dedicated exclusively to the manufacture of dietary
supplements must comply with the provisions indicated in Annex 2 of this decree (Good
Manufacturing Practices - GMP, in food plants or factories that manufacture, condition or
semi-process into dietary supplements).

For the purposes of the procedure for obtaining the Good Manufacturing Practices
Certificate, the provisions established in articles 1, 2, 5, 6, 7, 8 and 9 of Decree 549 of
2001 or a standard that modifies, adds or replaces it will apply.

While the Ministry of Social Protection issues the corresponding Good Manufacturing
Practices Inspection Guide, the interested party may be certified in accordance with the
provisions of Article 1 of Decree 549 of 2001 or a rule that modifies, adds or substitutes it,
except for the presentation of the completed self-assessment guide.

2. Dietary supplements manufactured in plants located in the national territory where

medicines or phytotherapeutic products are manufactured:

For plants located in the national territory that manufacture dietary supplements in plants
where medicines are manufactured, the Certificate of Good Manufacturing Practices for
medicines, issued by the National Institute for Drug and Food Surveillance, INVIMA, will
be accepted.

When these are dietary supplements manufactured in phytotherapeutic product

laboratories, the Certificate of Good Manufacturing Practices or the Certificate of
Production Capacity will be accepted, in accordance with the terms and conditions
established in article 6 of Decree 2266 of 2004 modified by article 3 of Decree 3553 of 2004
or standard that modifies it, additions or ituya.

Prior to obtaining the health registration, the interested party in the manufacture of dietary
supplements in plants that produce medicines or phytotherapeutic products must process
an authorization to manufacture these products in said plants with the National Institute of
Medicines and Foods, INVIMA, for which they must attach the respective cleaning
validation supports. Said authorization must be processed independently of obtaining the
Bu Certificate. enasManufacturing Practices-GMP. In special cases, if INVIMA considers it
relevant , you will be able to verify compliance with the cleaning validation processes
presented in the plant.

The requirement for presentation of cleaning validation media does not apply when the
establishment that carries out the preparation of medicines and phytotherapeutic products,
carries out only the secondary packaging of dietary supplements or, in fact, has areas and
equipment exclusively used for said manufacturing.

The manufacture of dietary supplements in areas certified for the production of medicines
or phytotherapeutic products must be carried out by campaign and with periodic
determination of traces to prevent the risk of cross-contamination, which will be verifiable
through production records.

Dietary supplements that are manufactured in pharmaceutical or phytotherapeutic product

laboratories may only be manufactured in common areas.

The authorization for the manufacture of dietary supplements in laboratories that manufacture
medicines or phytotherapeutic products will be subject to the maintenance of the conditions under
which the Good Manufacturing Practices - GMP were granted, or when the hygienic, technical,
location and quality control conditions under which the production capacity was granted are
applied. Consequently, if, in the use of the powers of inspection, surveillance and control, the
competent health authority subsequently finds B that the Good Manufacturing Practices - GMP, or
the hygienic, technical, locative and quality control conditions - have been breached, it will
automatically proceed to the cancellation of the authorization granted for the manufacture. dietary
supplements, through administrative act.

3. Dietary supplements manufactured in plants located in the national territory where foods are
manufactured:
DECRETON NUMBER 3863 DE2008 SHEET°3

Continuation of Decree 11 by which Decree 3249 of 2006 is modified and others are issued
provisions"

Plants located in the national territory dedicated to the production of foods that manufacture dietary
supplements must obtain the Certificate of Good Manufacturing Practices for Dietary Supplements
issued by the National Institute for Food and Drug Surveillance, INVIMA, in accordance with the
provisions of Annex 2, which is an integral part of this document. • decree (Good Manufacturing
Practice, i, GMP, in food plants or factories that manufacture, i, condition, or semi-process dietary
supplements)) and the standard that modifies, i, adds, or substitutes it.

The areas intended for food manufacturing that are to be shared for the production of dietary
supplements must obtain prior certification of Good Manufacturing Practices - GMP for dietary
supplements, the respective authorizations in accordance with the regulations in force for foods.
Yo
For the purposes of the procedure or obtaining, i, cOl[1 content, competence, i, validity and
extensions of the Certificate D of Good Manufacturing Practices, the provisions established in articles
1, 2, 5, 6, 7, 8 and 9 of Decree 549 of 2001 or the standard that is added, modified or replaced, will
be taken into account.

While the Ministry of Social Protection1 issues the corresponding Inspection Guide, the interested
party may be certified B in accordance with the provisions established in Article 1 of Decree 549 of
2001 or the rule that stipulates it, B, and modifies it . eBosubstitute, except for the presentation of
the self-assessment guide and diligence . gives.
II
4.Dietary supplementsImported to the country: I

4.1. Imported dietary supplements are manufactured in plants dedicated exclusively to the
manufacture of these products.OS. For dietary supplements manufactured in plants dedicated
exclusively to the production of these products, regardless of their designation in the country of
origin and that in Colombia they meet the characteristics to be classified as dietary supplements, the
Certificate of Good Manufacturing Practice or
its equivalent document issued by the author will be accepted.
competent health authority of the country of origin. If I do not have said document, a visit by the
National Institute will be required. I of Surveillance of Medicines and Foods,>, INVIMA, who will
issue the corresponding certification.B. (

For the purposes of establishing whether document 3 is equivalent, it is required to present

supports stating that the aspects evaluated in the plant where the product is manufactured
correspond to those required in Technical Annex No. 2 of this decree, regardless of the
denomination the document has or in the country of manufacture.

4.2. Imported dietary supplements manufactured in plants dedicated exclusively to the

manufacture of medications and/or phytotherapeutic products. For dietary supplements
manufactured in plants that produce medications, regardless of their name in the country of origin
and that in Colombia meet the characteristics to be classified as dietary supplements, the
Certificate of Good will be accepted. Manufacturing Practice for medications issued by the
competent health authority of the country of origin.

When these are dietary supplements manufactured in plants that produce phytotherapeutic
products, the Certificate of Good Manufacturing Practices or the Certificate of Production Capacity
will be accepted, in accordance with the deadlines and conditions established in article 6 of Decree
2266 of 2004 modified by article 3 of Decree 3553 of 2004 or the standard that modifies it. ify, add,
or substitute.

ARTICLE 33.- Modify article 12 of Decree 3249 of 2006, which will read as follows:

"ARTICLE 12. PROCEDURE FOR OBTAINING THE HEALTH REGISTRATION. For the
purposes of obtaining the health registration of the products object of this decree, the interested
party must complete the following procedure:

1. Submit the application to the National Institute of Food and Drug Surveillance - INVIMA, with the
legal and technical documentation established in this decree.

2. If the product that is the subject of the application contains ingredients not included in the
reference list cited in Annex 3 that is an integral part of this decree: "References for substances
permitted in dietary supplements", the application for health registration will be denied, unless
the Specialized Chamber of Natural Products of the Reviewing Commission of the National
Institute of Medicines Surveillance and Food, i, INVIMA, or whoever takes his place, in
accordance with the procedure for ingredients, additives and substances not included in the
DECRETON NUMBER 3863 DE2008 SHEET°4

Continuation of Decree 11 by which Decree 3249 of 2006 is modified and others are issued
provisions"

accepted references, I, have evaluated3 and accepted3 the new substance.

3. If the documentation is found to be incomplete, at the time of receipt, I, the proceeding will be in
accordance with what is established in articles 12 and 13 of the Contentious or Administrative
Code. 3.

4. With the information provided by the interested party, i, the National Institute of Surveillance of
Medicines and Foods, i, INVIMA, will process the results of the study of the documentation and
will deny or approve the health record, i, or communicate that it is necessary3 to provide
additional information. For this purpose, the Institute will have a period of fifteen (15) business
days.

5. If additional informationI or clarificationi of the documents presented is needed, >, the

interested party3 will be required to provide B the missing information or clarify the information
presented, i, for which the applicantB will have a period of three (2) months. The National
Institute of Medicines and Food Surveillance,>, INVIMA, will proceed by means of a reasoned
resolution1 to declare the rejection of the request and immediately afterwards, it will search for
the request and the return and delivery of the respective documentation will be carried
out at INVIMA. Likewise, there will be no refund for the respective payment.

6. Once the petitioner submits complete information, INVIMA will have fifteen (15)
business days to deny or approve the requested registration. INVIMA may visit the
production plant in order to verify the aspects it considers necessary and may take
samples for analysis and quality control.

In the event that the product contains any ingredient or additive whose presence cannot
be analyzed by the National Institute for Food and Drug Surveillance, INVIMA, the
manufacturer or importer will be required to provide a certificate of analysis of the
product issued by the health authority of the country of origin, a laboratory recognized
by it; likewise, the Institute may take samples for the respective analysis.

PARAGRAPH-.The issuance of the respective record will be made through an

administrative act issued by the National Institute for Food and Drug Surveillance,
INVIMA, which will contain: name of the product; composition; proclamation or accepted
declaration; owner; manufacturer; importer, when applicable, validity; registration
number, preceded by the nomenclature "SO", without prejudice to the fact that the
registrations issued under the nomenclature Product for Specific Use, PUE correspond
to this type of products.

ARTICLE 4.- Modify article 21 of Decree 3249 of 2006, which will read as follows:

"ARTICLE 21. LABELING AND LABELING INFORMATION. The packaging of dietary

supplements must have a label or label that contains, at a minimum, the following
information:

1. Name and/or brand of the product: A name or brand must be used that does not
mislead or deceive the consumer. These products cannot be labeled and/or labeled
as foods, medicines, phytotherapeutic products, or as pharmaceutical preparations
based on natural products or alcoholic beverages.
2. Legends: They must include the following:

a) "THIS PRODUCT IS A DIETARY SUPPLEMENT, IT IS NOT A MEDICINE OR AND

DOES NOT SUPPLEMENT A BALANCED NUTRITION"; "
b) In the event that a product contains any of the substances prohibited in sport,
according to the current list of the World Anti-Doping Agency, it must include the
legend "THIS PRODUCT 3 CONTAINS SUBSTANCES PROHIBITED IN SPORT";
c) "Keep out of reach of children";
d) For national products, the legend must be: "Colombian Industry" or "Made in
Colombia"; "Elaborated in Colombia" or similar;
e) "Manufactured by or packaged by (...)";
f) On the label and/or label of dietary supplements that contain allergens or
substances that cause hypersensitivity, such as cereals containing wheat, oats,
rye, gluten, soybeans and their derivatives, crustaceans and their derivatives,
fish and their derivatives, the legend: "MAY CAUSE HYPERSENSITIVITY" must be
included;
g) Dietary supplements containing artrazine or FO Camarillo number five must
 DECRETON NUMBER 3863 DE2008 SHEET°5

Continuation of Decree 11 by which Decree 3249 of 2006 is modified and others are issued
provisions"

indicate that they contain this dye and include the legend: "MAY CAUSE
HYPERSENSITIVITY."

\1)')1।
DECREETONUMBER 3863 DE2008 SHEET°6

Continuation of Decree by which Decree 3249 of 2006 is modified and others are
11

issued
provisions"
h) Dietary supplements containing aspartame must include the legend: "THE
CONSUMPTION OF THIS PRODUCT IS NOT SUITABLE FOR PEOPLE WITH
PHENYLKETONURIA"; "
i) "DO NOT CONSUME DURING PREGNANCY AND LACTATION";
j) "Dietary supplement".

The legends referred to in letters a) and b) of this article must be displayed visibly, in
the Spanish language, in legible form, in the same size as the letter of the authorized
declaration, in capital letters and with a color that contrasts with the color of the
background of the label.

3. List of ingredients.
4. Nutritional Composition: Nutrients must be included with name and quantity per unit
of measurement and with percentage of the recommended daily value when
applicable and portion size and portions per container.
5. Name and address: The company name and address of the manufacturer must be
indicated. For imported products, in addition to the above, the company name and
address of the importer of the product must be specified.
6. Batch identification and expiration date.
7. Storage conditions.
8. Instructions for use: This is the recommended daily amount for the adult population
and recommendations for population groups when applicable.
9. Health Register.
10. Declarations, when applicable.
11. Warnings, when applicable. eleven

ARTICLE 5.- Modify article 22 of Decree 3249 of 2006, which will read as follows:

"ARTICLE 22.- LABELS, LABELS AND PACKAGING OF IMPORTED DIETARY

SUPPLEMENTS. The labels, labels and packaging of imported dietary supplements will
be accepted as they come from the country of origin, as long as they contain the following
information in Spanish: a) name and address of the importer; b) composition; c) storage
conditions; d) mode of use; e)ad vertencias , when applicable; d) the legends dealt with in
paragraphs a), c), e), i) and j) of numeral 2 of article 21 of this decree and those contained
in paragraphs b), f) g) and h) thereof, when applicable. This information may be printed on
the label or on an additional label.

In any case, they must comply with what is established in article 20 of this decree."

ARTICLE 6.- Modify article 24 of Decree 3249 of 2006, which will read as follows:

"ARTICLE 24.- ADVERTISING. Advertising of dietary supplements will be adjusted to the

benefits attributed to each of the characteristic ingredients of the composition and must be
previously approved by the National Institute for Food and Drug Surveillance, INVIMA, in
accordance with the regulations issued for this purpose by the Ministry of Social
Protection.

PARAGRAPH.-In the labels and labels of containers and packaging and in the advertising
of dietary supplements, information that confuses,
ARTICLE 37.- DAILY REFERENCE VALUES3 AND MAXIMUM INTAKE LEVEL OF
VITAMINS,3, MINERALS AND TRACE ELEMENTS FOR DIETARY SUPPLEMENTS. For the
daily reference values and maximum intake level of vitamins, minerals and trace elements for
dietary supplements, the values contemplated in Annex 1, which forms an integral part of this
decree, are adopted.

ARTICLE 38.-GOOD MANUFACTURING PRACTICES IN FOOD PLANTS OR FACTORIES

THAT MANUFACTURE, I, CONDITION, OR SEMI PRODUCE DIETARY SUPPLEMENTS.
Modify in Annex 2 of Decree 3249 of 2006 or the rule that modifies, adds or replaces it, the
definitions of the Glossary, "Packaging Material" and "Production" and the numbers 1.2 and 2.4
which will remain 1 as indicated in Annex 2, which forms an integral part of this decree.

ARTICLE 39.- REFERENCES FOR SUBSTANCES ALLOWED IN DIETARY SUPPLEMENTS.

The references for substances allowed in dietary supplements are adopted in Annex 3 , which is
an integral part of this decree.
DECREETONUMBER DE2008 SHEET°7

Continuation of the decree) "By which Decree 3249 of 2006 is modified and other
provisions"
Substances not included in the references established in Annex 3 , which is an integral part of
this decree, will be considered new ingredients of dietary supplements.

ARTICLE 310.- OF THE PROCEDURE 0 FOR INGREDIENTS, 3, ADDITIVES AND

SUBSTANCES NOT INCLUDED IN THE ACCEPTED REFERENCES. When the ingredients,
additives and substances do not meet the references cited in Annex 3, which is an integral part
of this decree, they must be evaluated by the Specialized Chamber of Natural Products of the
Reviewing Commission of the National Institute of Medicines and Food Surveillance, INVIMA, or
whoever does so, who will prepare a list of the new accepted ingredients for dietary
supplements in Colombia, which must be updated3 and published3 on the Institute's website.

For the evaluation3 of a new ingredient, additive or substance, I, the interested party3 must
support their request, attaching the following information:

1.Name and address3 of the applicant.

2. Name of the new ingredient(s) of the dietary supplement. If it is a new plant or botanical, the
scientific name 3 and the part of the plant used must be included.
3. Content3 of the new ingredient3 in the product.
4. Mode of use of the product.
1 Bibliographic support, toxicity or presentation of the toxicity studies carried out on the
product, if applicable.
6 .Reference to scientific publications3 and scientific studies available with their respective
copies and translated3 into Spanish.
7 .Payment of the fee for the evaluation rights.

PARAGRAPH 3 FIRST.- Products containing3 vitamins, i, minerals5 or trace elements, which

have been granted3 sanitary registration3 as a medicine, must1 retain such condition, I,
complying3 with the provisions3 of the current regulations for medicines and in this case, they
do not need3 to be reclassified as dietary supplements.

SECOND PARAGRAPH.- The National Food and Drug Surveillance Institute, INVIMA, will
establish the guidelines for reclassification in a period of no less than six (6) months, from the entry
into force of this decree.

PARAGRAPH THREE.- Once the deadline established in paragraph 3 above has expired, the
establishments will have six (6) more months to exhaust the stock of products that meet the
conditions to be classified as dietary supplements that are on the market and that have been
granted health registration of foods, othotherapeutic medications. If after the deadline, there are
products on the market, INVIMA will order confiscation3 in accordance with the provisions3 of
Decree 3249 of 2006 or the rule that modifies, adds or replaces it, and will initiate the
corresponding sanctioning process.

ARTICLE 3 11.-HEALTH REGISTRATION PROTECTION. When it is the same dietary supplement,

it may be covered under the same health registry, with a maximum of three brands.

PARAGRAPH-. The health and safety measures that apply to one of the brands will be extended to
all brands covered under the same health registry.

ARTICLE 312.- Modify article 52 of Decree 3249 of 2006 modified by article 1 of decree 4857 of
2007, which will remain as follows:

"Article 52. TRANSITIONAL. Productss that meet the conditions to be classified as dietary
supplements and that have been granted3 sanitary registration3 as foods, medicines or
phytotherapeutics without seriousness, must1 comply with the regulations in force, within forty-eight
(48) months following5 the date of entry into force of this decree. Failure to comply with this
deadline will result in the application of the measures. health, the maintenance of the health
record3 and the initiation of the sanctioning process in accordance with the provisions of Decree
3249 of 2006 or the rule that modifies it. add or substitute".

ARTICLE3 13.-VALIDITY. This decree is effective from the date of its publication, i, modifies, as
pertinent, Decree 3249 of 2006 and its Technical Annex 3 I No. 2 and repeals Technical Annex 3
No. 1 of Decree 3249 of 2006, Decree 4857 of 2007 and the regulations that are contrary.
DECREETONUMBER DE2008 SHEET°8

Continuation of the decree) "By which Decree 3249 of 2006 is modified and other
provisions"

2O&T200G
PUBLISH AND FULFILL
2 Uul LUUC
E /) I
Given in Bogotá, , DC

$ U/ — - /•

DIEGO~A~JIOLACIO BETAN URT

Minister of Protection3 cial
 DECRETON NUMBER 3863 J DE2008 SHEET N° 9

Continuation of the decree "By which Decree 3249 of 2006 is modified and others are issued
provisions"

APPENDIX
1.

ARIES AND MAXIMUM LEVELS OF CONSUMPTION ,

REFERENCE VALUES OF TOLERABLE , MINERALS3YOLlGOELEMENTS*s FOR
VITAMINS, SUPPLEMENT DIETARY ENTHENTS 1
Daily Reference Values
(DVR) Maximum Levels
Consumption3
Unit of Tolerable
(UL) and
Nutrientea
extent
Children over 4 years old and
Adults
Adults
VitaminaA mcg/IU 1500/5000 3000/100001
B-carotene3 Mg NE 77.
VitaminaD mcg/IU 10/400 50/2000
VitaminaE mQ/ IU 20/30 1000/1500
VitaminaK Mcg 80 1000~
Vitamin C/Ascorbic
Mg 60 1000
acid3
Mg 1,5 100!
Vitamin B 1/ Thiamine
Vitamin B 2/ Riboflavina
Mg 1,7 40
Niacin/Nicotinic acid3
Mg 20 35
Vitamin B6/ Pyridoxine
Mg 2 100
Acidofolic//
mcg 400 1000
Folacin/Folate

Vitamin B 12/a Mcg 6 2000th

Cobalamin
Biotin MCQs 300 900
pantothenic acid 0 Mg 10 200
Boron mg NE 6 :

Calcium Mg 1000 1500!

Copper Mg 2 10
Chrome Mcg 120 1000
Fluorine Mg 3 10
Match Mg 1000 25()L
Iron Mg 18 45
Magnesium Mg 400 350 L - Yo

Manganese3 Mg 2 11
Molybdenum Mcg 75 2000
Nickel 1 Mg NE 0.72 :

Potassium Mg 3500 370th

Selenium Mcg 70 400
Silicon Mg NE 700
Sodium Mg 1500 2300
Vanadium Mg NE 0.05 :

Iodine MCQs 150 1100

Zinc Mg 15 40
Warnings to include on Dietary Supplement Labels5:•

~ Pregnant women, I, do not consume dietary supplements containing Vitamin A, except with a
doctor's prescription. Maximum intake level for
DECRETON NUMBER- 3863 DE2008 SHEET°10

Continuation of Decree 11 by which Decree 3249 of 2006 is modified and others are issued.
provisions"

people with a diet high in retinol, with calcium metabolism problems or bone diseases.
2. People with high alcohol intake, in contact with these or smokers, do not. They should
consume dietary supplements that contain Beta Carotene.
3. For dietary supplements with Vitamin K. Anticoagulated patients cannot consume dietary
supplements with Vitamin K. .
4. Although there are no known adverse effects from excessive intake of thiamine, it does not
mean that these are not present, therefore intake should be extremely careful.
5. The absorption of Vitamin B12 is limited, therefore ingesting high amounts does not represent
any benefit.
6. Consumption3 greater than 1600 mg of calcium can cause kidney stones, hypercalcemia,
alkali-alkali syndrome, and kidney failure.
7. The IU of phosphorus and magnesium apply only to consumption from dietary supplements.
8. Intake of potassium dietary supplements of 3700 mg/day can produce erosion at the
gastrointestinal level. Children, the elderly and patients with conditions such as: pre-existing
hyperkalemia , kidney disease, acidosis, insulin deficiency or digital poisoning. They should
take dietary supplements with potassium without a doctor's prescription.
 . . 3869
DECRETON NUMBER 3863 DE2008 SHEET°11

Continuation of the decree) 11 by which Decree 3249 of 2006 is modified and others are issued
.provisions"

APPENDIX 2

Modify ANNEX 2 of Decree 3249 of 2006 (Good Manufacturing Practices, 1, GMP, in food plants or
factories that manufacture, condition or semi-manufacture dietary supplements) regarding the
definitions: "Packaging Material" and "Production", contained in the Glossary and numbers 1.2 and
2.4., whichwillremain1 So:
.

"Ideal packaging material: Any material, including printed material, used in the packaging of a dietary
supplement, excluding any outer packaging used for transportation or shipping. Packaging materials
are considered primary when they are intended to be in direct contact with the product, and secondary
when they are not."

"Production: All operations involved in the preparation of a product called a dietary supplement, from
receipt of materials, through processing, packaging, to the finished product." ” :

"1.2. There must be a Head of Production1 and Head of Quality Control, whose profession must be
that of Pharmaceutical Chemist, Chemist, Food Chemist, Engineer3, Chemist, Food Engineer3 Their
other related profession. Within the production1 and quality control operations, these professionals
must have autonomy in their decisions regarding the other production managers and/or quality control
analysts that you have the establishment. 3. These new positions must be included in the company's
organizational chart..

Establishments dedicated exclusively to the manufacture of dietary supplements must have a Head of
Production1 and Head of Quality Control, who must be Pharmaceutical Chemists. The Head of
Production1 must be independent of the Head of Quality Control.

If the establishment does not have a Pharmacist or Chemist in one of these positions, any of them may
be filled by a qualified professional as long as he or she demonstrates scientific education and practical
experience in the following sciences: a) Analytical and organic chemistry a) Biochemistry a)
Microbiology a d) Pharmaceutical sciences and technology ae) Pharmacology a and toxicology a)
Physiologyag)ControlIdequality ofpharmaceuticalproductssis and /ofoodsyh)quality0assurance; ; all of
this in order to allow him to exercise independent professional judgment, based on the application of
scientific principles and his experience, in making decisions and resolving practical problems that arise
in the manufacture and quality control of dietary supplements. Likewise in this case and in the food
plants where dietary supplements are manufactured, the establishment must ensure that the
authorization of the batches to be commercialized on the market is carried out by a Pharmaceutical
Chemist who must have sufficient autonomy to authorize or reject said commercialization.

"2.4. Establishments that manufacture dietary supplements in the area of medicines or

phytotherapeutics must have a Head of Production and a Head of Quality Control, who must be
Pharmaceutical Chemists.

Establishments that manufacture exclusively dietary supplements may have professionals other than
pharmaceutical chemists under the terms and conditions established in section I1.2 of this annex.
 DE'CRETON NUMBER 3863 DE2008 SHEET°12

Continuation of Decree 11 by which Decree 3249 of 2006 is modified and others are issued
provisions"

ANNEX3

REFERENCES S PERMITTED PARASUBSTANCES s DIETARY SUPPLEMENTS .

CODEXALlMENTARIUS/S

OFFICIAL STANDARDSDELCODEXALlMENTARIUSs
http://www.codexalimentarius.net/web/standardlist.do?lanQ=es nq=es

FOOD ADDITIVES CODE

http://www.codexalimentarius.net/Qsfaonline/additives/index.html :.html
FDA
EAFUS:AFOODADDITIVEDATABASE, GRAS Listing http://www.cfsan.fda.Qov/-dms/eafus.htm htm I

FOODADDITIVESTATUSLlST
http://www.cfsan.fda.Qov/-dms/opa-appa.html#ftnC tftnC

BOTANICALL GRAS
http://www.ars-arin.aov/duke/svllabus/aras.htm iras.htm

TITLE21--FOODANODRUGS

PART172--FOODADDITIVESS PERMITTEDDFORDIRECTADDITIONNTOFOODFOR
HUMANCONSUMPTIONN
SubpartD--SpecialilDietaryandNutritionalil Additives
http://www .accessdata.fda.Qov/scripts/cdrh/cfdocs/cfCFR/CFRSearch. rch. cfm?CFRPart=172&s
howFR=1j &subpartNode=21 11 :3.0.1.1.3.44

PART182--SUBSTANCESS GENERALLYY RECOGNIZEDDASSAFE

http://www.cfsan.fda.Qov/-lrd/fcf182.html tml

PART184-- DIRECTFOODSUBSTANCES S AFFIRMED 2 ASGENERALLY AND RECOGNIZED D

ASSAFE
http://www.accessdata.fda.Qov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.rch.cfm?CFRPart=184&s
howFR=1 1

PARTIALLlSTOFENZYMEPREPARATIONSTHATATAREUSEDINFOODS
http://www.cfsan.fda.Qov/-dms/opa-enzV.html tml

FDASEAFOOD) LlST .
http://www.cfsan.fda.Qov/-frf/seaintro.html iitml

In addition to the GRAS lists, cited above, the following references can be consulted:
http://www.cfsan.fda.Qov/-rdb/opa-Qras.html itml
http://www.cfsan.fda.Qov/-dms/opascoQd.html tml

which contain GRAS notifications received since 1998, with their respective response from the FDA, in
addition to being at the end of the previously cited GRAS listings. EUROPEAN COMMISSION

Directives on foods for particular nutritional uses, "dietetic foods" or " dietary foods", which include lists
of nutritional substances that can be added to this type of supplements.
Commissionn Directivej 2001/15/EC :C
Commission Directive3 2004/5/EC C .
 DECRETON NUMBER 3863 DE2008 SHEET°13

Continuation of Decree 11 by which Decree 3249 of 2006 is modified and others are issued
provisions"

Commission Directive 2004/6/ECC

Commission Directive3 2006/34/EC C
http://ec.europa.eu/food/food/labellinanutrition/nutritional/index 'index en.htm

You can also consult a summary in Spanish, in which there are links to consult the directives
mentioned above.
http://europa.eu/scadplus/lea/es/lvbIl21100.htm ■htm

Directive 2002/46/EC E of the European Parliament and of the Council, of June 10, 2002, relating to the
approximation of the laws of the Member States relating to food supplements, which includes
substances that can be used in the manufacture of food supplements.
http://europa.eu/scadplus/lea/es/lvb/121102.htm htm

COLOMBIAN LEGISLATION A

Unprocessed foods included in the Colombian food composition table of the Colombian Institute of
Family Welfare (ICBF).
http://www.icbf.aov.co/espanol/planes/plan jlan nalde Alimentacion/alosarioicbf.xlsxIs

List of medicinal plants approved for therapeutic purposes included in Section I 23.1 and the list of
natural resources approved for therapeutic purposes included in Section I23.2 of the Manual I of
Pharmacological Standards 2006 or its updates. , in concentrations that do not exceed therapeutic
levels.

Pharmacological standardsIS 2006

23.Natural resources5 acceptedsparaffintherapeuticss
23.1 List of approved medicinal plants with therapeutic purposes
23.20 Other approved natural resources s confines therapeutics Yo

http://www.invima.aov.co/l o/l nvimallconsuu Itas/docs normative pharmacoloaicas/normasfarmacolo

olo
aicas%202006.pdfdf : YO