ANNEX RESOLUTION No.

282-2012
(COMIECO-LXII)

REGULATION TECHNICAL RTCA 65.05.52: 11 CENTRAL AMERICAN

PRODUCTS USED IN FEEDING ANIMAL Y ESTABLISHMENTS. REQUIREM

ENTS FROM REGISTRY SANITARY Y CONTROL.

CORRESPONDENCE: This Regulation has no correspondence with any standard

international.

ICS 65,120 RTCA 65.05.52: 11

Central American Technical Regulations, edited by:

Ministry of Economy, MINECO

Organism Salvadoran from Regulation Technique, OSARTEC Ministry f

rom Promotion, Industry Y Commerce, MIFIC
Ministry of Industry and Commerce, SIC
Ministry of Economy, Industry and Commerce, MEIC
 REPORT

The respective Technical Committees Technical Regulations through entities Technical Regulations of
the Central American countries are the bodies responsible for carrying out the study or the
adoption of technical regulations. They are made up of representatives from the Academic,
Consumer, Private Enterprise and Government sectors .

East document was approved as Central American Technical Regulation , RTCA 65.05.52:
11 products used in feeding animal Y establishments. Requirements of sanitary registry and control, by
the Subgroup of Agricultural Inputs and the Subgroup of Measures
of Normalization. The formalization of this technical regulation involves ratification by the
Council of Ministers for Economic Integration (COMIECO).

PARTICIPATING MEMBERS

For Guatemala
Ministry of Agriculture, Livestock and Food

For El Salvador
Ministry of Agriculture and Livestock

For Nicaragua
Ministry of Agriculture and Forestry

For Honduras
Secretariat of Agriculture and Livestock

For Costa Rica

Ministry of Agriculture and Livestock
1. OBJECT

Establish sanitary registration and control provisions for:

to. The products used in food animal.

b. The establishments that elaborate, commercialize, repack or store products used in food animal.

2. SCOPE OF APPLICATION

Apply to the products used in feeding animal, any be his origin, A)

Yes as to establishments that produce,
market, repack or store used products in feeding animal in the countries from the region Central
American

3. DEFINITIONS AND ABBREVIATIONS

3.1 Additive intentionally added ingredient not normally consumed directly as food, whether
or not nutritional value and affects the characteristics of feed or animal
products. Microorganisms, enzymes, acidity regulators, trace elements, vitamins and other
products, depending on the purpose of use and method include administration.

3.2 Marginal annotation or registration modification: change of record origina

l, endorsed by the Authority Competent.

3.3 Food for animals (I think): material simple or compound, already be processed,
semi -processed or raw, which is used directly in feed animals.

3.4 Food for consumption own: those foods for animals formulated by the producer
himself, to be consumed by his animals.

3.5 Food by request: any product used in animal feed which is made according to specificatio
ns applicant.

3.6 Food balanced: mixture from ingredients, additives or premixes what HE used to be
supplied directly to animals with the purpose to fill adequately nutritional
requirements, depending on the species and function to that destine
3.7 Food medicated : any food what contain medicines veterinarians, with the
aim of preventing or treating diseases, promoting growth or improving the
efficiency of feed conversion or others.

3.8 Analysis Guaranteed : study from quality to through of

the which he developer should show the guaranteed amounts of specific nutrients in the product.

3.9 Authority Competent: entity official responsible from the application of the present
Regulation, for its effective fulfillment by the sectors involved in the subject and activity that this
one understand

3.10 Certificate of analysis: document issued by a laboratory for

the control of Quality, which certifies the results obtained from the analysis of quality of a
lot specific.

3.11 Certificate from free sale: document official, issued by the Authority Competent heal
th record, which certifies that a product used in animal feed, is marketed freely in their territory.

3.12 Certificate from registry: document official issued by the Authority Competent healt
h record, which attests that it has complied with all registration requirements sanitary.

3.13 Marketer : individual (natural, individual) or legally constituted entity that is dedicated
to import, export, sell or distribute products used in animal feed .

3.14 Qualitative-quantitative composition : complete description of the

ingredients and content of each, in a product used in animal feed , issued by the processor.

3.15 Establishment: physical space where they are manufactured, marketed,

repackaged or stored, products used in food animal.

3.16 State Part: state what They are part of the Protocol to the Treaty general from Central
American Economic Integration (Protocol of Guatemala).

3.17 Standard analytical: preparations what they

contain a concentration known from a specific item or substance,
used as comparison standards in assays and test in laboratories from control from quality.
3.18 Packing, crating or packaging materials that are used to protect products used
in animal feed for storage and transport.

3.19 Destination species: animal species for which the product is formulated to be used
in the feeding.

3.20 Labeled: information what HE adhere, print or engrave in he packing, container or

packing from a product used in feeding animal.

3.21 Developer : person physical (natural, individual) or legal legally constituted that is
dedicated to the elaboration or formulation of products used in animal feed or that intervene in some
of its processes. In this area they areincluded processors for third parties or maquiladoras

3.22 Importer means a natural person (natural, individual) or legal entity as owner,
representative or distributor, import products used in animal feed.

3.23 False information: information presented in order to support a record that does
not correspond to the true intent and is passed by authentic

3.24 Inaccurate information: information presented in order to support

a log and unintentionally, is not precise.

3.25 Ingredient: component or part from any combination or mixture what It constitutes
a food, whether or not it has nutritional value, including food additives . They can be
substances from origin vegetable, animal, water or otherssubstances organic or inorganic

3.26 Feedstock: substance, whatever its origin, active or inactive, which is used
for making products used in animal feed, whether remains unaltered, as if suffers modification.

3.27 First name commercial: first

name with what he developer identify, register Y promotes the product used in food animal.

3.28 Premix: mixture of two or more ingredients, used to be

incorporated into balanced food or supplements.

3.29 Traceability or traceability: ability for follow he movement from a raw

material or food, to through from the Steps specific from production, process Y distribution.
3.30 Registrant: person physical (natural, individual) or legal, legally authorized for the owne
r or headline of the registry sanitary from a product used in feeding animal to register it before the
Authority Competent.

3.31 Repacker natural person (natural, individual) or legal legally constituted that is dedicated
to repackaging or fractioning a product used in animal feed .

3.32 Responsable technical or Regent : professional in sciences related to the nutritio

n animal, which in accordance with the provisions of the domestic law of each State Party is
authorized to fulfill the responsibilities of thetechnical, scientific and
professional management of various establishments.

3.33 Approval: procedure whereby an establishment or

a product used in animal feed, is registered and authorized by the competent authority.

3.34 Legal representative: physical (natural, individual) or legal person representing the
owner or owner's health record and responds to the Authority Competent.

3.35 SI: International System of Units

3.36 Supplement: mixture from two or plus ingredients, what HE supplies directly to animals
as a source of one or more nutrients and are daily supplement other foods.

3.37 Headline or owner of

the registry sanitary: person physical (natural, individual) or legal entity that has
in its favor the sanitary registration of a product.

3.38 Vehicle or excipient: material that is added to a formulation to facilitate

its preparation, enable its stability, modify its organoleptic properties or determine the physical-
chemical properties of the product and its bioavailability;without modifying its properties nutritional

Four. REGISTRY SANITARY FROM ESTABLISHMENTS Y HIS RENE

WAL

The establishments where they are elaborated, commercialized, repackaged or stored, products used
in animal feed, must be registered and authorized by the Competent Authority and are classified in:
to) Developers
b) Repackers
c) Marketers (importers and exporters).
d) Expenses or distributors.
and) Bodegas de storage.
They will be exempted from registration and storage holds outlets
(distributors) belonging to processors and repackers.

4.1 Requirements general:

to) Tell with the authorization from functioning correspondent low the normative current official in
each State Part.
b) Tell with a representative legal, in he country of the registry sanitary.
c) Tell with a responsable technical or regent in he country of registration sanitary.
d) Harmonized application of sanitary registration or renewal duly filled
and relevant supporting documents, signed and stamped by the owner or legal representative and
by the ruler or technical support.
and) In the case of representatives of foreign processors, provide legal documentation that back
up the authorization for the representation in he country what HE aims to to register.
F) Documents legal what back
up the constitution from the company in case from the legal person or identity of applicant in
case of natural person (natural, individual).

4.2 The developers. In addition to the general requirements must:

to) Processors in Central America, presenting the Manual of Good Manufacturing Practices (GMP);
outside the Central American region , present an official
certification, stating that compliance with Good Manufacturing Practices.

b) Have the services of a quality control laboratory, either own or third parties.
c) Declare your warehouses and outlets (distributors).

4.3 The repackers. In addition to the general requirements must:

to) The repackers in Central America, presenting the Manual BPM

as apply outside from the region Central American present a certification official to
do record he fulfillment in the what apply the Good Practices from Manufacture.
b) The product repackaged (divided or repackaged), must not undergo alteration in its
composition original.
c) Do not should be marketed with a end different for he what originally It was Elaborated.
d) Tell with authorization by written from the developer for repack
and) Keep adequate records to ensure traceability from the beginning of the process of repackaging.
F) Declare your warehouses and outlets (distributors).

4.4 Validity. The health establishment registration will be valid for five years
and for renewal must meet the requirements of sanitary registration set out in paragraph 4,
as appropriate. Any request for renewal must be made threemonths before your expiration.

4.5 Cancellation of the registry sanitary. He registry sanitary of

the establishment may be canceled for breach of the current legislation of each State part.

5. SANITARY REGISTRATION,
RENEWAL AND CONTROLS FOR OTHER PRODUCTS USED IN FEEDI
NG ANIMAL

Everybody the products used in feeding animal what HE make, import, export, repack or market,
must be registered and authorized by the Competent Authority.

5.1 Requirements registry.

To register or renovate products used in animal feed , those interested should comply with
the following:

to) Harmonized application for sanitary registration ( Normative Annex A) duly filled,
signed Y sealed by he owner or representative legal Y by he regent or technical responsible

b) Power of attorney of the processor or owner granted in favor of the registrant authorizing him
to carry out these activities before the Competent Authority

c) Certificate of free sale ( Normative Annex B) original, issued by the Competent Authority of the
country of origin. If the product used in animal feed is not sold in the country and is
made exclusively for export, the competent authorityshall issue a certificate
indicating the causes or reasons for such condition, always Y when do
not be reasons what affect the Health public, animal and environment.
 d) Guaranteed analysis , in original signed and stamped by the technician responsible for the
processor or of the laboratory from analysis, voiced in units of YES.

and) List of ingredients, which comprises the raw materials used, in the formulation with generic
or common names , including additives, drugs and vehicles, in original signed Y sealed by he resp
onsable technical of the developer.

F) Qualitative-quantitative composition Full, issued by the technical manager of

the processor, including the name of product.

g) Method of analysis physical, chemical and biological, as appropriate, internationally

recognized or validated by the processor, for the control of the quality.

h) Methodology from analysis physical, chemical Y biological, according correspond, when HE try
methods validated by the maker.

i) Process of elaboration of product, including flow chart (with temperature, time, pressure
and others), original signed and sealed by the technician responsible for the
establishment developer.

j) Certificate of analysis of a commercial lot of the product to be registered, issued by the

processor or by he laboratory from control of quality, in original signed and sealed by the technici
an responsible for same.

k) Label project to be approved by the Competent Authority

l) Statement of life by the manufacturer, in which specified storage conditions under which the
product is stable for a given period from weather, voiced in days, weeks, months or years.

m) Standard Analytical for medicated feeds, as required by the competent authority.

n) When the product used in animal feed is manufactured by a different company to the headline of
the registry, should present document legal or contract between the parties (contract of maquila).

ñ) A sample do not higher to 10 Kg from accordance with the analysis to perform, sealed by the product
manufacturer to register, accompanied by an original
packaging, with which it is intended market, when required the Authority Competent.

or) He voucher from payment by he service from registry sanitary, when correspond

5.2 Registration Renewal sanitary:

5.2.1 It may be renewed whenever the sanitary registration has not been canceled or
prohibited his use in anyone from the state Part. The request from renewal must be submitted to
the Competent Authority three months before theexpiration date of the sanitary
registration. Once overcome the health registration if the
registrant keep interest his commercialization, must proceed to process a registry sanitary new.

5.2.2 To renew the registration, you must present:

to) Harmonized application form for renewal (Annex Regulatory A2) full
and relevant supporting documents, signed and stamped by the owner or legal representative and
by the ruler or technical support.

b) Sworn statement from the processor or technical representative before a notary, stating
that the conditions under which the original registration was granted have not undergone
any legal, technical or scientific modification , otherwise all the documents Y tests what back
up the same, in original, with their formalities legal and corresponding consulates. If it issued in a
language other than Spanish must present the official translation correspondent.

c) Free sale certificate (Annex Regulatory B) If the product used in animal feed is not sold in the
country of origin, the competent authority shall issue a certificate indicating the causes of
this condition, as long as no be reasons what affect thehealth public, animal Y ambient.

d) Draft from label for be approved by the Authority Competent.

and) He voucher from payment by he service from registry sanitary, from agreement to the legislati
on of each State Part.

6 GENERAL ASPECTS OF REGISTRY.

6.1 Legalization of official documents . All documents issued by the Competent Authority of
the country of origin of the product, as well as special powers that support the registration
or renewal of the registration of products used in foodanimal, they must comply with their legal
and consular procedures . When they are written in a language other than the official one, they must
be accompanied by their corresponding official
translation to Spanish. All other informationsubmitted to support registration in language different to
the official, must from accompany from a translation free to the Spanish.

6.2 Validity of certificates counter and analysis. The validity of these

documents, be from a period do not higher to a year to the date from his issue. In he case If this
document does not declare the origin, the interested
party mayadditionally present the certificate from origin issued by the Authority Competent.

6.3 The Competent Authority may request with additional technical-scientific

justification additional information for the registration, if extra controls are required , the cost of
the same will be covered by the registrant.

6.4 The state Part will be able apply for certifications official of
the country from origin, with the proper justification technical-scientific.

6.5 The States Parties they will record foods made

exclusively for export, always Y when he establishment developer count with registry Y control of
the Competent Authority of the country of origin; In
addition, the products must haveofficial sanitary controls respective.

6.6 Establishments to which this Regulation must keep adequate records to

facilitate traceability and traceability of raw materials and
food for animals, according proceed, what permit he retirement of the product of the market timely
andeffective, in the event of a risk
to animal or human health way. The traceability or traceability should be possible a He
passed toward ahead Y a step back in the process chain productive.

6.7 Each State Party shall regulate the category of food for own consumption (consumption) in a
ccordance with their national law, they can not be marketed.

6.8 He food to order of the client this subject to registry Y do

not can contain additives or medicines not approved by the Authority Competent.

6.9 The foods medicated They are subjects from registry. The ingredients assets, the Dosage,
species of destination and indications for the use of medicines or additives used in the
preparation of animal feed must comply with the approvalof the Competent Authority .

6.10 The Competent Authority, when checking the falsity of the information of the consigned
data or the disturbance from the documents presented, will
deny or cancel he sanitary registry according to the case.

6.11 Each State Part will regulate the donations from products, according his legislation.

6.12 The registration of raw materials and additives for the production of products
will be done according to the provisions of the Annex D.

6.13 The references for the use of additives, veterinary drugs and their
combinations in products, will be from accordance with the ready in he Annexed F.
7 EXEMPTION FROM REGISTRY SANITARY

The products will be exempt from registration in the following situations:

to) For research purposes in the country.

b) The samples with Finnish from registry, when correspond
c) Samples for feeding animal with Finnish from analysis from laboratory.
d) In cases from eventuality or emergency sanitary, HE will proceed according the settled down for
each State Part.
and) Those who accompany the animals are destined for exhibitions,
contests, circuses, exhibitions or other events
F) The what HE find in phase experimental, in his country from origin.
g) Those listed in the Annex AND.

After assessment of the relevant applications, the competent authority may authorize the importation
requested, provided they do not constitute unacceptable
risk to public health, animal or environment. This authority will determine the amount to
be imported and the requirements to be met.

8 NUMBER Y CERTIFICATE FROM REGISTRY SANITARY

In the event that the competent authority approves health registration shall register the product
as appropriate, assigning a number to which the product is identified.

Once registered, the competent authority shall issue the certificate of sanitary
registration corresponding official

9. REGISTRATION PERIOD SANITARY

Sanitary registration granted shall be valid for five years from its inscription, being
able be renovated by periods same to request of
the interested. Without embargo, when it infringe the stipulated in East regulation or HE demonstrate
what theterms original of sanitary registration have been modified, we will proceed to demand
the necessary corrections or the cancellation of the registration sanitary.

10 PROHIBITION TO THE IMPORT

He State Part do not will authorize requests from import with Finnish commercial from products that
do not have the sanitary registration duly approved and in force,
except those contemplated in he numeral 7 (Exemptions of the registrysanitary).
eleven. ASSIGNMENT

Any transfer of ownership of the sanitary registry must be notified and the corresponding procedures
must be performed before the Competent Authority.

12 ANNOTATION MARGINAL OR MODIFICATION OF

THE REGISTRY SANITARY

He registry sanitary a product may be modified to petition of

the registrant or from Your representative in the country. To do this, you must submit
a request in writing, stating the reason for the proposed change, along with the documentation
required by the Competent Authority.

The following cases will be considered:

to) Change from reason Social of the developer, conserving he country from origin of the product.
b) Change from headline of
the registry sanitary without Modify he origin (Assignment from registry).
c) Change of name of the representative of record sanitary.
d) Change or extension of indication of use.
and) Change or extension of species destination.
F) Change of commercial name of the product.
g) Change or extension of presentation.
h) Change of vehicles.
i) Change in the precautions, warnings or contraindications.
j) Change of label, without to vary his information.
k) Material change packing.
l) Change of address of establishment of importer.

Marginal annotations or modifications must be resolved

(approved or denied) and notified to the interested party in writing by the Competent
Authority. They do not imply a new sanitary registry , as long as
they are valid. Should not beapproved, must state the reasons for the denial.

Do not They are considered annotations marginal or modifications Y by the so much HE will
require of a registry sanitary for each a from the following variations:
 i. Products with different trade names for a product under the same registration sanitary.
ii. Country of origin.
iii. Change in the list of ingredients including active ingredients , in medicated products.
iv. Change in the analysis guaranteed.
v. Change of developer.

13 CANCELLATION OF THE REGISTRY SANITARY

registration health of any product will be canceled by the Competent Authority, prior
to their maturity, when:

to) The I requested by written he owner of registry sanitary.

b) The use and handling of the product represents an inadmissible risk verified
for public health, animal or ambient.

c) Any irregularity, fraud or falsehood in the composition of the

product or in the information provided for the registration is detected sanitary.

14 REQUIREMENTS OF LABELED

The draft label, will be presented in Spanish or another, at his request.

14.1 Compulsory label.

Any product used in animal feed that is manufactured, handled, stored, repackaged, distributed or
used in the territory of the Central American region, must contain the respective label that complies
with the provisions of this regulation.
It must have a letter size readable by the naked eye and have clearly printed the following
information in internationally accepted nomenclature, expressing the units according to the SI.

14.2 Content general from the label or packing:

i. Registration number sanitary.
ii. Name of the product.
iii. Shape physical of the product (flour, pelletized, extruded, dust Y others).
iv. Kind from product, species and category animal from destination.
v. Net weight of product.
 saw. Analysis guaranteed.
vii. List of ingredients including vehicles.
viii. Indications of use.
ix. Precautions, warnings, restrictions or limitations of use, which must be indicated in bold.
x. Conditions of storage.
xi. Name, address, telephone and the country of the processor. In case of manufacturing to third
parties (maquila) it must be specified: prepared by ...... for ... ..; in case o
frepackaging must
be specified: prepared by ...... .. ... repackagedby……..
xii. Name, address and telephone number importer.
xiii. Number from lot, date from manufacturing Y date from expiration, (day month Year).

When the labeling from the country of origin is not in the Spanish language or does not contain the
information required in these regulations, the product may be marketed with a complementary label
(sticker or adhesive) which must be approved by the Competent Authority and adhered without
hiding from the original label the lot number, expiration date and the processor.

14.3 Shape from express the information of the content from the label:

to) On he first name of

the product, the species animal Y the function of the same:

i. He first
name commercial should be appropriate according he product Y HE prohibits he name
of a food or raw material misleading or deception as to the nature, quality, properties,
origin and use.
ii. The characteristics of the food must be in accordance with the declared use ,
the species, category and stage of life of the animal to which it is destine
iii. He first name from a food for animals do not HE should derive from a or plus raw
materials or a combination of the names of these, omitting other raw materials that make
up the food for animals.
iv. When a food contain sources from nitrogen do not protein, do not HE may use
the finished "protein" or "Proteinized" in he first name commercial from saying food.
v. He finished "vitamin", "Vitaminado" or any other what the suggest HE can use in
the commercial name of a product when it has been formulated as
a premix or supplement vitamin
saw. The term "mineral" or "mineralized" may be used in the name of a product, provided in the
case of mineral salts containing trace minerals.
vii. The term "dehydrated" must precede the name of the product, which has
undergone drying process artificial.
 viii. The term "iodinated" shall refer to an ingredient containing not less than
0.007% iodine, uniformly distributed.

b) About the analysis guaranteed:

i. Maximum percentage of humidity.

ii. Minimum percentage of protein raw
iii. Maximum percentage of crude protein equivalent to non- protein nitrogen , when it is added
to food.
iv. Minimum percentage of ether extract or raw fat .
v. Maximum percentage of fiber raw
saw. Minimum energy content calculated
vii. Percentage minimum and maximum of calcium (AC).
viii. Minimum percentage of phosphorus (P)
ix. Percentage minimum Y maximum from Salt (NaCl), when East I presented in the formula.
x. First
name Y concentration minimum from vitamins: TO, D3 Y AND in UI by kg from product an
d the the rest vitamins in milligrams by kg from product.
xi. Name and minimum concentration of minerals: microminerals (traces) in mg per kg
of product; macrominerals in %.
xii. The guarantee for vitamins or minerals is not required when the animal feed does
not represent in any way supplement or vitamin premix and / or minerals
xiii. Warranty for protein raw, protein raw equivalent, Energy, abstract ethereal and fiber do
not HE requires when he food for animals do not contains these nutrients or they are in very
high concentrations low.

xiv. The values from Energy must Express oneself in kilocalories by kilogram from food (kcal /
kg) according to the criteria established:

- For ruminants, pigs, horses, any pet or laboratory, the values will be expressed in
terms of digestible energy. For dairy
cows , the declaration of net energy is also admitted , expressed
in mega calories per kilogram (Mcal / kg).
- For all types of birds, the values will be declared in terms of energy metabolizable.
- Pet and aquatic species energy declaration is accepted also in
terms of energy metabolizable.
- The energy value of the animal feed will be estimated by
calculation, using for it boards from composition based in criteria international or equation
s of regression.
 - To calculate the energy content of the raw materials of a food and
whose values from Energy digestible do
not appear in the boards from composition of food, the corresponding value
will be used to pigs.

xv. The values for all mineral elements expressed in the guaranteed analysis,
they must be those of the pure element; they can never express themselves
in function of compounds with the exception of salt expressed as sodium chloride(NaCl).
xvi. When the calcium and salt content is expressed , on the label, it should be made of the
following shape: when he minimum is 5 % or less, he maximum no should from exceed
the minimum by plus from a unity percentage. When heminimum is higher to the 5 %,
the maximum does not can be higher what on 20 % of the minimum.
xvii. The values of vitamins expressed in the guaranteed analysis should be
indicated in terms from the vitamin pure, never can consigned
to function from compounds except: pyridoxine hydrochloride, choline chloride, thiamine hyd
rochloride, d-pantothenic acid or calcium pantothenate and menadione sodium bisulfite acid.
xviii. All drugs used in animal feed, should be expressed in milligrams per kilogram of food,
grams per ton of food or in percentage Y in terms of the ingredient active.
xix. The form of expression of any other nutrient or additive will be regulated by
the Authority Competent.

c) On the list of ingredients:

The list of ingredients, must list the raw materials that are in the formulation with generic or
common names, including additives, drugs and vehicles.

In the list of ingredients, raw materials declared, should not use brand names or marks. Only generic
or common names are accepted according to the international nomenclature.

i. He first name from each ingredient should write yourself in letters of the same size Y kind.
ii. Do
not must Appear references to the quality from a ingredient in the declaration from the formul
a
iii. Raw materials do not require a declaration of ingredients.

14.4 Content from label for cases specials:

In addition to compliance with the general content, the following must be complied with:

to) For foods what contain flour from origin ruminant:

When food for monogastric animals meal containing ruminant
origin, the label must indicate bold legend "FORBIDDEN IN USE THE FEEDING FR
OM BOVINE Y OTHERS RUMINANTS ".

b) For foods what contain medicines:

i. The word " MEDICATED " should Appear in bold immediately below of the name of
the product. This indication must be legible and the size of the letter must not be
less from the half of the type used in the name of theproduct.
ii. Name of the active ingredient of the medicine.
iii. Quantity of the ingredient active I presented in the formula.
iv. Purpose from use specific of the medication included in the formula.
v. The medication (s) used in the formulation must be declared in the list of ingredients.
saw. If a more detailed orientation is necessary , the back face can be used of
the label, Indicating "See part later from the label".
vii. The active ingredient, the amount, The indications for use,
precautions, including withdrawal period, warnings and limitations of use will
be approved according to the regulations national and references adopted by
the CompetentAuthority .

c) Foods what contain sources from nitrogen do not Protein:

i. Indications clear what guarantee he use Y driving suitable of the product.

ii. The feed guaranteed analysis containing nonprotein nitrogen must
contain the following information:

- Minimum crude protein , expressed in %.

- Protein crude equivalent to maximum non- protein added nitrogen , expressed in %.
- For he calculation from protein raw or equivalent to split from nitrogen, HE will use
the factor of 6.25.

Of the raw materials, sources of non-protein nitrogen, such as urea, ammonium phosphate,
ammonium nitrate or any ammoniated product, must be expressed in the guarantee as follows:

- Minimum nitrogen %.
- Protein raw equivalent to nitrogen do not protein, minimum... %.
- When animal feed containing any source of nitrogen does
not protein in his formulation, in the label HE should indicate in bold the
 caption: "CAUTION: Wear
AS INDICATED, SUMINÍSTRESE E X C L U S A M E IV N T E T
O R U M I N T E S A ".

fifteen. CONTROL OF ADVERTISING OF PRODUCTS USED

IN FOOD ANIMAL.

15.1 Of the advertising:

advertising of products used in animal

feed should not contain ambiguities, omissions or exaggerations what induce to error to
the user, in particular, in what what respects to the security on he use, driving, nature Y composition of
the product.Do not may contain information different from the what cover he registry of the product.

Advertising or advertising of those products that are not registered is prohibited.

15.2 Prohibition on the use of images:

The use of images that harm human dignity is prohibited.

16 CONFIDENTIALITY Y SECURITY FROM THE INFORMATION

The personnel of the entities responsible for sanitary registration , must comply with the
indicated by the instruments legal from each State Part respect to the confidentiality and security in the
handling of the information object of procedure, having to keep
secret Administrative Documentation so required in the performance of their duties.

The technical information contributed for he registry sanitary, considered confidential, may be used by
the Competent Authority for the purpose of preservation of public health ,
animal Y he ambient, according the what point out the laws Yrules local respective.

17 METHODS ANALYTICS, METHODOLOGIES Y SPECIFICATIONS

QUALITY

As a reference, the Competent Authority will apply the analytical

methods and methodologies, safety, control and quality specifications in
products used in animal feed contemplated in:

to) Association Official from Chemicals Analytics (AOAC).

b) Other recognized internationally.
c) Own, validated by the developer.
18 SURVEILLANCE AND CHECK

It corresponds surveillance and verification of this Regulation to the Competent Authority of the Central
American countries .

The States Parties shall exchange information regarding prohibitions, restrictions and approvals on
products used in animal feed.

The member countries will establish the measures and activities of control and control over
the establishments, products, manufacturing, import, storage, export, repackaging, distribution,
handling and use of products used in animal feed .

19 BIBLIOGRAPHY

to) Association American from Control Official from Foods For Animals (AAFCO).
b) Codex Alimentarius.
c) Feed Additive Compendium, The Miller Publishing Co. USA.
d) Current legislation of each State Party in respect of products used in food animal.
and) World Organization from Animal Health (OIE).
F) Organization of the United
Nations the Agriculture and Food (FAO), Guidelines in matter from products used in feedin
g animal.

twenty. REFERENCES

As reference the competent authorities may apply the specifications of safety control and quality
products used in animal feed referred to in:

to) Association American from Control Official from Foods For Animals (AAFCO).
b) Association Official from Analytical Chemicals (AOAC).
c) USDA Food Safety and Inspection Service (FSIS) .
d) Organization of Nations United for the Agriculture and Food (FAO) Guidelines in matter from pro
ducts used in feeding animal.
and) Codex Alimentarius.
F) Federal Code of Regulations (CFR) of the United States of America.
g) World Organization from Animal Health (OIE).
h) Feed Additive Compendium, The Miller Publishing Co. USA.
i) Directives of the European Economic Community.
j) List national from veterinary medicines approved for use in foods.
 ANNEX A (N
ORMATIVE)

A.1 FORM FROM REQUEST FROM REGIS

TRY FROM USED PRODUCTS IN THE FEEDING ANIMA
L.

1. FIRST NAME OF THE PRODUCT: First name commercial of the product to register.

1.1 Number from registry assigned (use official exclusive) ____________________

2. ESTABLISHMENT DATA APPLICANT

2.1 Name or company name :

2.2 Home:

2.3 Form of communication: Telephone, fax or e-mail.

2.4 Number of the registry official sanitary issued by the Competent Authority :

2.5 Names and surnames of the technical manager:

2.6 Profession:

2.7 ID professional:

2.8 Representative legal:

2.9 ID:

3. DATA OF THE ESTABLISHMENT ELABORADOR

3.1 Name or company name :

 3.2 Home:

3.3 Official health registration number :

3.4 Names and surnames of the technical manager:

3.5 Profession:

3.6 ID professional:

3.7 Country, State, City of origin of the product:

Four. Property Details IMPORTADOR

4.1 Name or company name :

4.2 Home:

4.3 Official health registration number :

4.4 Names and surnames of the technical manager:

4.5 Profession:

4.6 ID professional:

4.7 Country State, City of origin of the product:

5. DATA OF THE REPLACEMENT ESTABLISHMENT (when applicable)

5.1 Name or company name :

5.2 Home:
 5.3 Official health registration number :

5.4 Names and surnames of the technical manager:

5.5 Profession:

5.6 Professional identification:

5.7 Country, State, City of origin of the product:

6 OBSERVATIONS:

7 DATA FROM PRODUCT:

7.1 characteristics physical of the product (flour, pellets, granules, liquid, others).

7.2 Presentations:

7.3 Material of Packaging:

7.4 Indications of use (Species, ages, stages of development and purpose of use).

7.5 Life of the product:

The registration requirements established in this regulation are attached to this application.

All the information that is attached to this request is an integral part of it.

We declare that the information presented is true and any alteration or false information invalidates
this request, without prejudice to the criminal liability that implies.
--------------------------------------- ----------- ----------------------------
Firm Y seal Signature and seal
Responsable Technical Owner or Representative Legal

Place and Date

A.2 FORM OF APPLICATION FOR RENEWAL OF REGISTRATION HEALT

H FOR PRODUCTS USED IN FOOD ANIMAL

First
name from the company Applicant: _____________________________________________ Number fr
om registry sanitary from Company: ________________________________________ Name of
the owner or representative Legal: ____________________________________
Renewal (No from registry sanitary): _________________________________________ Address: ____
____________________________________________________________ Telephone Y fax:_________
_____________ Mail electronic: ______________________ Name commercial of
the Product: ______________________________________________ Manufacturer: ______________
__________________________________________________ Country of
Origin: ____________________________________________________________ City: ____________
______________________________________________________ State: ________________________
___________________________________________ Place Y date: _____________________________
________________________________

Is attached to this application, the requirements for renewal of records established in this regulation.

All the information that is attached to this request is an integral part of it.

We declare that the information presented is true and any alteration or false information invalidates
this request, without prejudice to the criminal liability that implies.

--------------------------------------- ----------- ----------------------------

Firm Y seal Signature and seal
 Responsable Technical Owner or Representative Legal

Place and date _______________________

ANNEX B (N
ORMATIVE)
CERTIFICATE OF FREE SALE
It must be issued by the Authority competent country of origin, recorded in original,
with the procedure corresponding consular and contain the following information:

Is certified by the present that the products used in animal feed down detailed, in accordance with (law
of the country of origin) is manufactured (n) and markets (n) in (country) by (name of company),
established (complete address), with sanitary registration No. (Number of the registry sanitary of
the establishment) elaborated by-for (in case of maquila).

1) First name commercial.

2) Health registration number .
3) Validity of document.
4) (Country, City / Date).
5) Signature and seal of the Competent Authority .

Applies to member states of the Central American region and beyond .

(INFORMATIVE)

CLASSIFICATION FROM USED PRODUCTS IN ANIMAL FEEDING

The classification of products is the following: CL

ASS:
1) Foods.

2) Balanced foods

3) Medicated balanced foods .

4) Premixes (protein, protein-energy, energy, vitamin, mineral and vitamin-mineral, among others).

5) Medicated premixes (protein, protein-energy, energy, vitamin, mineral and vitamin-

mineral, among others).

6) Supplements (protein, protein-energy, energy, vitamin, mineral and vitamin-mineral,

among others).

7) Medicated supplements (protein, protein-energy, energy, vitamins, minerals and vitamin-

minerals, among others).

8) Additives

9) Raw materials

(NORMATIVE)

REGISTRATION OF RAW MATERIALS AND ADDITIVES FOR

THE PREPARATION FROM USED PRODUCTS IN ANIMAL FE
EDING .

The following criteria are established for the registration of raw materials and additives used in
animal feed:

1) They will
be subject from registry everybody the additives, according the established definition by Codex A
limentarius, (microorganisms, yeasts, enzymes, regulators from acid, vitamins and
other products, in function of the purpose of its use and method of administration).
2) Do not will be subjects from registry amino
acids, vitamins Y minerals what contain a only chemical compound (an ingredient), except
those that present maximum limits of use. It will be subject
to registration, the combination of more than one ingredient of inorganic substances .

3) The raw materials from origin animal or vegetable, what contain a alone ingredient, will not be
subject to registration. They will be subject to registration in the case will dispense directly to
the public, packed and indications of use.

4) Any combination of raw materials of the previous subsection (3) is subject to registration.

The exemption of the registry, do not it implies the elimination from the controls official toilets , nor
the obligation of the industry to comply with current legislation, including
labeling, neither the obligation from carry records what permit thetraceability (traceability).

Establishments or importers of raw materials and additives must have an establishment register and
notify the Competent Authority of their activities.

LIST OF PRODUCTS NOT SUBJECT OF REGISTRATION

The products included in the following list will not be registered:

1) Bones of carnaza for pets.

2) Bone of cuttlefish.

3) Gravel.
The present list may be updated when deemed necessary.

The exemption of the registry, do not it implies the elimination from the controls official toilets , nor
the obligation of the industry to comply with current
legislation, including labeling, neither the obligation from carry the recordscorresponding.

The establishments processors or importers of the abovementioned products should have to

register property and notify to the Authority competent on their activities.
 REFERENCES USED FOR ADDITIVES, VETERINARY
DRUGS Y YOUR COMBINATIONS, IN FOODS FOR ANIMALS.

The following updated references are established:

1) Feed Additive Compendium, The Miller Publishing Co. USA.

2) Association American from Control Official from Foods for animals (AAFCO).
3) Guideline of the European Economic Community.
4) List National from each State Party.

-Fin Technical Regulation-