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Resolution
nº 23, of March 15, 2000(*)
(DOU 16/03/2000)
The Collegiate
Board of Directors of the Brazilian Sanitary Surveillance Agency
in the use of the attribution vested in it by article 11, numeral
IV, of the Regulation of ANVS approved by Decree 3.029, of April
16, 1999, c/c paragraph 1 of Article 95 of the Bylaws approved
by Resolution n. 1, of April 26, 1999, at a meeting held on March
1, 2000, adopts the following Resolution of the Collegiate Board
of Directors and I, Director-Chairman, determine its publication:
Article 1
- Approve the Technical Regulation on the Manual of Basic Procedures
for Registration and Exemption from Obligatory Registration of
Food Products in the Annex of this Resolution;
Article 2
- Failure to comply with this Resolution constitutes a sanitary
infraction, rendering offenders liable to the penalties provided
for in Law n. 6.437, of August 20, 1977 and other applicable provisions.
Article.3
- This Resolution shall enter into force on the date of its publication.
Article 4
- Administrative Order SVS/MS n.º 120, of February 18, 1999,
is hereby revoked.
Gonzalo
Vecina Neto
(published in the D.O.U. of March 16, 2000 - Section 1)
ANNEX
TECHNICAL
REGULATION ON THE MANUAL OF BASIC PROCEDURES FOR REGISTRATION
AND EXEMPTION FROM OBLIGATORY REGISTRATION OF FOOD PRODUCTS
1. SCOPE
1.1. Objective
To establish
basic procedures for the registration and exemption from obligatory
registration of food products.
1.2. Scope
of application
The present
Manual applies to all sectors involved with the procedural steps
of registration processes of national and imported foods, additives,
and technology and packing coadjuvants.
2. DEFINITIONS
For the purpose
of this Resolution, the following apply:
2.1. Registration:
the legal deed that, after fulfillment of the procedures described
in this Resolution, recognizes the compliance of a product with
the current law, formalized by means of publication in the D.O.U.;
2.2. Exemption
from obligatory registration: the deed, based on the current legislation,
which provides exemption from registration of products at the
Brazilian Sanitary Surveillance Agency, after fulfillment of the
procedures described in this Resolution;
2.3. Sanitary License or Operation Permit: is the privative deed
of the competent state health agency of the States, Federal District
and of the Municipalities, granting permission for the operation
of establishments that carry out activities pertinent to food;
2.5. Final
packing: product resulting from the last stage of the manufacture
process that implies in modification of its composition;
2.6. Recycled
Packing: packing produced by specific technological process to
obtain resins from recyclable materials;
2.7. Food
raw material: any substance in raw state that, in order to be
used as food, needs to undergo treatment and or transformation
of a physical, chemical or biological nature;
2.8. Food
"in natura": all foods of vegetal or animal origin,
ready for immediate consumption, requiring only the removal of
inedible parts and treatments indicated for its perfect hygienic
cleaning and conservation;
2.9. Food
Product: any food or food raw material or crude food, with or
without the addition of other allowed substances, obtained by
appropriate technological process;
2.10. Ingredient:
any substance, including food additives, used in the manufacture
or preparation of a food and that remains in the final product,
even if modified;
2.11. Food
Additive: any ingredient added intentionally to foods, not with
the purpose of providing nourishment, in order to modify physical,
chemical, biological or sensorial characteristics, during the
manufacture, processing, preparation, treatment, packing, preservation,
storage, transport or manipulation of a food. When added to the
food, the additive or its products may themselves be converted
into a component of such food. This definition does not include
nutritional contaminants or substances that are incorporated into
food to preserve or to improve its nutritional properties;
2.12. Manufacturing
Technology Coadjuvant: every substance, excluding the equipment
and utensils used in the preparation and/or conservation of a
product, which is not consumed by itself as a food ingredient
and that is used intentionally in the preparation of raw materials,
foods, or their ingredients, to obtain a technological purpose
during treatment or preparation. It must be eliminated from the
food or inactivated, and only the presence of traces of the substance
or its derivatives are allowed in the final product;
2.13. Monitoring
of product quality: collection, evaluation and laboratory analysis
of products, when appropriate, in order to verify their compliance
with the required sanitary standard and or the Identity and Quality
Standard (PIQ) or Technical Regulation of the product (RT);
2.14. Sanitary
inspection of the Industry: the inspection procedure carried out
by the sanitary authority in the manufacturing unit, to verify
compliance with current legislation;
2.15. Requirement:
a resource to be used by the Sanitary Surveillance System, directed
to companies, to request complementation of data for better evaluation
of the process under study and adaptation to the current legislation.
3. REFERENCES
3.1. Decree
55.871, of March 26, 1965 - Modifies Decree n. 50.040, of January
24, 1961, referring to the rule regulating the employment of food
additives, altered by Decree n.681, of March 13, 1962.
3.2. Decree
- Law 986, of October 12, 1969 - Institutes basic rules on foods.
3.3. Decree
n. 63.526, of November 4, 1968 - Approves special technical rules
on the employment of food additives and sets forth other provisions.
3.4. Resolution
CNNPA n. 08, of June 24, 1975 - Sets forth provisions regarding
substances and materials that may be used in the production of
containers or utensils meant to be in contact with foods and others.
3.5. Administrative
Order n. 33 - SVS/MS, of 13/03/80, published in the D.O.U. 18/03/80
- Sets forth provisions on registration renewal.
3.6. Law n.
8.080, of September 19, 1990 - Sets forth provisions regarding
the Unified Health System (SUS).
3.7. Administrative
Order n. 9 - DINAL/MS of February 23, 1990 - Sets forth provisions
on products exempt from registration.
3.8. Administrative
Order n. 1.428, of November 26, 1993 - Approves the Technical
Regulation for Sanitary Inspection of Foods, the Guidelines for
Good Production Practices, the Technical Regulation for establishing
Identity and Quality Standards.
3.9. Administrative
Order n.326 - SVS/MS, July 30, 1997 - Sanitary and Hygiene Conditions
and Good Manufacturing Practices for Establishments that Produce/Industrialize
Food.
3.10. Administrative
Order n. 540 - SVS/MS, of October 27, 1997 - Approves the Technical
Regulation: Food additives - definitions, classification and use.
3.11. Administrative
Order n. 1.634, of October 29, 1997.
3.12. Administrative
Order n. 579 SVS/MS, of November 17, 1997- Exemption from issuance
of documents that imply in repetition of the food registration
deed.
3.13. Law
n. 9.782, of January 26, 1999 - Sets forth provisions about the
National Sanitary Surveillance System, creates the Brazilian Sanitary
Surveillance Agency and sets forth other provisions.
3.14. Resolution
n. 01, of April 26, 1999, Annex I - Bylaws of the Brazilian Sanitary
Surveillance Agency.
3.15. Resolution
n. 237, of July 2, 1999 - Institutes standard form for collecting
the sanitary inspection fee and Statement of classification of
type of company.
3.16. Resolution
n. 16, of April 30, 1999, published in the D.O.U. on 03/12/99
- Approves the Technical Regulation of Procedures for Registration
of Foods and or New Ingredients.
3.17. Resolution
n. 17, of April 30, 1999, published in the D.O.U. on 03/12/99
- Approves the Technical Regulation Establishing the Basic Guidelines
for Evaluation of Risk and Safety of Foods.
3.18. Resolution
n. 18, of April 30, 1999, published in the D.O.U. on 03/11/99
- Approves the Technical Regulation Establishing the Basic Guidelines
for Analysis and Proof of Functional and or Health Claims on Food
Labels.
3.19. Resolution
n. 19, of April 30, 1999, published in the D.O.U. on 10/12/99
- Approves the Technical Regulation of Procedures for Registration
of Foods with Functional and or Health Claims on their Labels.
3.20. Resolution
ANVS n. 104, of May 14, 1999, published in the D.O.U. on 17/05/99
- Approves the Technical Regulation on Aroma Additives/Aromas.
3.21. Provisional
Remedy n. 2.000-13, of February 11, 2000 published in the D.O.
U. on 12/02/00 - Alters provisions of Law 9.782, of January 26,
1999, which defines the National Sanitary Surveillance System,
creates the Brazilian Sanitary Surveillance Agency and sets forth
other provisions.
4. GENERAL
PRINCIPLES
4.1. All the
establishments that perform activities related to foods must be
inspected and licensed by the sanitary authority.
4.2. The products
listed in Annex I are exempt from register, whereas the products
listed in Annex II must be registered at the competent agency
of the Ministry of Health.
4.3. The products
included in one annex may be transferred to the other annex. This
may occur due to the quality report on the product, carried out
by means of quality monitoring or as a result of occurrence of
health loss attributed to food consumption.
4.4. All food
must be produced in compliance with the Identity and Quality Standard
(PIQ) or Technical Regulation (RT) and other established guidelines,
approved by the competent authority.
4.5. Failure
to comply with the criteria established in item 4.4, evidenced
by means of the monitoring of product quality, shall render the
companies liable to the penalties provided for in the current
legislation.
5. PROCEDURES
5.1. PRODUCTS
EXEMPT FROM OBLIGATORY REGISTRATION
5.1.1. The
products of Annex I are exempt from obligatory registration at
the competent agency of the Ministry of Health.
5.1.2. Companies
must inform the beginning of manufacture of the product(s) to
the sanitary authority of the State, the Federal District or the
Municipality, according to the model in Annex X, and may thereafter
begin commercialization.
5,1,3. The
sanitary authority will have a period of 60 (sixty) days, from
the date of the company's communication, to undertake the sanitary
inspection of the manufacturing unit, in the terms of item 5.1.4.
5.1.4. The
accomplishment of the inspection within this period shall depend
on one or all of the following: nature of the product, risk associated
with the product, date of the last inspection and report on the
company.
5.1.5. In
the event of the company not being approved upon the inspection
mentioned in item 5.1.3, it shall notified to adopt the following
procedures, without loss to the application of other penalties
provided for in the legislation:
a. suspend
production;
b. recall the product(s) from the market, when the sanitary authority
deems it necessary on the basis of the pertinent legislation,
paying for the costs of disseminating the notification to the
population.
5.1.6. The
following products are exempt from obligatory registration and,
additionally, exempt from the need to inform the beginning of
manufacture to the sanitary authority of the State, the Federal
District or the Municipality:
5.1.6.1. food raw materials and foods "in natura";
5.1.6.2. the food additives (intentional) listed in the Brazilian
Pharmacopoeia, used in compliance with Good Manufacturing Practices
and those exempt by the competent agency of the Ministry of Health;
5.1.6.3. The food products prepared according to the Identity
and Quality Standard, used as food ingredients, intended for employment
in the preparation of industrialized food, in properly licensed
establishments, provided they are included in the Brazilian food
legislation;
5.1.6.4. Bakery, pasta, pastry, confectionery, candy, rotisserie
and ice cream products, when intended exclusively for direct sale
to the CONSUMER, carried out at the PRODUCER's own counter, even
when packed in containers or packing in order to facilitate their
commercialization.
5.2. PRODUCT
REGISTRATION
5.2.1. All
the products included in Annex II must be registered at the competent
agency of the Ministry of Health.
5.2.2. The registration must be requested by the interested company,
at the Sanitary Surveillance agency of the State, Federal District
or Municipality where one of the manufacturing units of the company
is located. The required documentation is listed in Annex III;
5.2.3. The registration application requires the presentation,
by the company, of the specific documents mentioned in Annex III,
of Application Forms FP1 and FP2, included in Annexes V and VI,
whose filling out instructions are presented in Annexes VII, VIII
and IX
5.2.4. The abovementioned forms must be docketed at the Sanitary
Surveillance agency of the State, Federal District, or Municipality.
5.2.5. For recycled packing, only the final packing is registered.
5.2.6. The fee for registration of the product or administrative
procedures is ruled by specific Resolution on Sanitary Surveillance
Inspection Fee.
5.2.7. Other procedures for product registration:
5.2.7.1. Single Registration
May be requested when a product is manufactured by different manufacturing
units of the same company, located in one or more States/Countries.
The single registration must be requested by only one of the manufacturing
units of the company, which becomes responsible for any modifications
made to the product.
The company must present to the sanitary surveillance agency the
Sanitary License or the Operation Permit of each one of the manufacturing
units and attach the other documents required in Annex III
The company may attach to the file the inspection reports on each
one of the manufacturing units.
The label must clearly identify the name of the manufacturer and
the address of the producing unit.
5.2.7.1.1. The single registration may also be requested in the
following situations:
5.2.7.1.1.1. Products with the same formula base, distinguished
by: fruit and/or flavor and/or aroma and/or covering and/or shape
and/or concentration of ingredients, provided the difference does
not modify the nature of the product. Products with the same formula
base, distinguished only by the COLORING as long as its IDA (Acceptable
Daily Ingestion) is not specified or not limited. When there is
a variation of colorings with numerical IDA, the registration
is dfferent for each product;
5.2.7.1.1.2 Products with the same formula base and different
brands.
5.2.7.1.2. Extension For Single Registration
The extension for the single registration in the cases provided
for in item 5.2.7.1.1.1 may be requested.
5.2.7.2. Product registration in the case of distributing company
The distributing company may use its trademark on the products
manufactured by another/other company(ies) by means of contract,
in which case it must, obligatorily, present a copy of the Sanitary
License or Operation Permit.
The registration of a product that uses the brand or the name
of a distributing company, must be requested by the manufacturer
indicating in the corresponding field of the application form
the trademark of the distributing company.
The wording on the label must identify the distributor and the
manufacturer.
5.2.7.3. Registration of outsourced production (new registration)
Used when the food company has an authorized manufacturing unit
for food production and wishes to outsource products that it produces
or does not produce. The registration application must be made
by one of the companies that present the conditions for producing
food. The necessary requirements for outsourcing, in addition
to the documents in Annex III, are:
a) the Sanitary Surveillance of the State, Federal District or
Municipality must be informed of this agreement by means of presentation
of the outsourcing contract or equivalent document;
b) the wording on the label must identify the manufacturer and
the owner of the trade mark;
c) the companies must present a copy of the Sanitary License or
Operation Permit.
5.2.7.4. Registration of Products not included in Annex II
5.2.7.4.1. Product without Identity and Quality Standard (PIQ)
or without Technical Regulation (RT):
The interested company must present a proposal of PIQ or RT, attaching
international reference, in the following order of priority: Codex
Alimentarius, European Community (EC) and Code of Federal Regulations
(CFR) - FDA-USA; as well as legislation on the subject in other
countries or meet the requirements of the guidelines of evaluation
of risk and safety established in specific technical regulation;
5.2.7.4.2. Recycled Packing
The company must present a proposal for technical regulation,
containing the following information:
· international reference, in the following order of priority:
Codex Alimentarius, European Community (EC) and Code of Federal
Regulations (CFR) - FDA-USA or meet the requirements of the guidelines
for evaluation of risk and safety established in specific technical
regulation;
· studies on the toxicity of the packing material;
· methodology for determination of migration (total and
specific) to the food;
· list of foods for which it will be used and technological
justification;
· analytical methodology for the identification and verification
of the degree of purity of the packing material.
5.2.7.5. Registration of Imported Food Products
For the purpose of registration and exemption from the obligatory
registration of imported products, the same steps and procedures
must be observed as those for foods produced nationally, provided
for in this Regulation.
For the purpose of registration, the products imported in the
original packing and ready for sale to the consumer shall be registered
in compliance with the specific legislation.
6. RESPONSIBILITIES
6.1. Of the
company:
6.1.1. to be licensed by the sanitary authority of the State,
Federal District or Municipality, which shall issue the Sanitary
License or Operation Permit;
6.1.2. to establish and implement Good Manufacturing Practices
in compliance with legislation and present the Manual of Good
Manufacturing Practices to the sanitary authorities, upon inspection
and or as requested;
6.1.3. the importers and distributing companies of food products
must implement and make use of a Manual of Good Manufacturing/Storage
Practices, as well as for the other stages of the productive process
under their responsibility;
6.1.4. to adopt, in the productive chain, a methodology that ensures
the control of critical points that can cause risks to the health
of consumers;
6.1.5. to officially inform the sanitary authority, within 30
(thirty) days, from the beginning of the commercialization, the
places where their products, registered and exempt from registration,
are being commercialized, and to request to the Sanitary Surveillance
agency of the State, Federal District or Municipality that it
collect samples of the products, with a view to Control Analysis;
6.1.6. the producing and importing companies of food products
must update the formulas of the products exempt from registration,
making them available to the sanitary authority upon request;
6.1.7. to inform to the sanitary authority, within a maximum period
of 10 (ten) days, the date of beginning of manufacture of the
products exempt from registration. The commercialization of the
products may be initiated thereafter.
6.2. It belongs to the Sanitary Surveillance agency of the State,
Federal District or Municipality:
6.2.1. to inspect the manufacturing units to verify compliance
with the Good Manufacturing Practices.
6.2.2. to analyze the procedure of registration application of
the product, observing the Technical Regulations, Resolutions,
Administrative Orders and other legal instruments related to the
product, including those related to labeling;
6.2.3. to issue a conclusive opinion in the specific box of the
Application Form (FP2) and when:
a. approved,
to mention the regulation(s) on which the analysis was based,
to date and sign it, identifying the technician in charge;
b. rejected, to mention the reason(s) on which the rejection was
based (also mentioning the legislations), to date and sign it,
with identification of the technician who carried out the analysis.
6.2.4. to
inform to the Brazilian Sanitary Surveillance Agency, by means
of monthly management reports, the list of companies who requested
inspection, indicating the categories, products, brands and types
of packing, as well as the ones that were inspected, indicating
the conclusive opinion.
6.3. It belongs to the Brazilian Sanitary Surveillance Agency:
6.3.1. to grant or to reject, with due justifications, the registration
applications previously analyzed;
6.3.2. to cancel the registration of a product upon request, for
irregularity or publication error. In the latter case, the registration
is republished, without charge, by means of presentation of the
documents included in Annex III.
6.3.3. to keep the States updated with the Register of companies,
registered products and products exempt from registration, as
well as of the inspected companies.
7. GENERAL
PROVISIONS
7.1. Validity
of the registration
The registration of the products is valid for 05 (five) years,
throughout the national territory. The revalidation of the registration
must be requested within up to 60 (sixty) days before the date
of its expiry.
7.2. Formulation of requirement:
7.2.1. the period established for fulfilling the requirement is
of 30 (thirty) days from notification of the interested party;
7.2.2. the formulation of requirement must be made in a clear
and precise way, indicating all the pertinent legislation;
7.2.3. failure to comply with the requirement within the established
period of time shall result in rejection of the application, publication
in the D.O.U. and filing of the process;
7.2.4. the requirement for complementation of the obligatory documents
listed in Annex III is not possible, and the process, in this
case, is rejected and published in the D.O.U..
7.3. The publication of the registration of the products of Annex
II, in the D.O.U., is enough to prove granting of the registration
by the competent agency of the Ministry of Health, dispensing
from later issuance of any documents that imply in repetition
of the deed, such as certificates, statements and others.
7.4. The documents required for the other administrative procedures,
such as modifications, cancellation and renewal, that the company
holding the product wishes to carry out, are included in Annex
III
7.4.1. When the modifications occur due to updating of specific
legislation, there will be no charge for the company, nor need
to docket this modification at the Sanitary Surveillance agency
of the State, Federal District or Municipality, provided they
are made within the period of adjustment established by the new
Technical Regulation Technician. The responsibility for this adjustment
belongs exclusively to the company.
7.5 The information on the course of processes is obtained at
the agency where the process was docketed, at the docket of the
Brazilian Sanitary Surveillance Agency or at the General Management
of Foods, by means of official documentation (letter, official
correspondence, fax or others), or consultation on the Internet
at the electronic address of the Agency.
7.6. The company must inform to the Sanitary Surveillance agency
of the State, Federal District or Municipality any change of address
of the manufacturing unit, change of corporate name, incorporation
of companies and closing of the activity of the company. The Sanitary
Surveillance agency of the State, Federal District or Municipality
must forward the documentation to the Agency for making the alterations.
7.7. In the situations where the State has already implanted the
decentralization of its actions, the regional and municipal units
may docket the documents referring to food registration and issue
the Sanitary License.
8. TRANSIENT
PROVISIONS
8.1. Companies
that hold the registration number of products that, in compliance
with this Resolution, are exempt, may, optionally, use it on the
labeling of their respective products, until the end of the packing
supply or until the date of expiry of the registration.
8.2. The registration applications and other administrative procedures
for the products that are exempt from registration, in progress
on the date that this Regulation enters into force, shall automatically
be cancelled by the competent sanitary authority.
9. LIST OF
THE ANNEXES AND TABLES
9.1. ANNEXES
I - PRODUCTS EXEMPT FROM OBLIGATORY REGISTRATION
II - PRODUCTS WITH OBLIGATORY REGISTRATION
III - LIST OF DOCUMENTS REQUIRED ACCORDING TO THE ADMINISTRATIVE
PROCEDURE
IV - FORM FOR REGISTER OF COMPANIES (FCE)
> > FCE Form (pdf)
> > FCE Form (WORD)
V - APPLICATION FORM 1 (FP1)
> > FP1 Form (pdf)
> > FP1 Form overleaf (pdf)
> > FP1 Form (WORD)
> > FP1 Form overleaf (WORD)
VI - APPLICATION FORM 2 (FP2)
> > FP2 Form (pdf)
> > FP2 Form overleaf (pdf)
> > FP2 Form (WORD)
> > FP2 Form overleaf (WORD)
VII - GENERAL INSTRUCTIONS FOR FILLING OUT FP1 and FP2
VIII - INSTRUCTIONS FOR FILLING OUT FP1
IX - INSTRUCTIONS FOR FILLING OUT FP2
X - FORM FOR INFORMING THE BEGINNING OF MANUFACTURE OF PRODUCTS
EXEMPT FROM REGISTRATION
> > Form
> > Form overleaf
See also: Prodir program with electronic form
XI - INSTRUCTIONS FOR FILLING OUT THE FORM FOR INFORMING THE BEGINNING
OF MANUFACTURE OF PRODUCTS EXEMPT FROM REGISTRATION (FRONT/OVERLEAF/ANNEX)
9.2. TABLES
01 - ADMINISTRATIVE PROCEDURES
02 - MEASUREMENT UNITS
03 - STANDARDIZED ABBREVIATIONS
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