Document 190503

Associação dos Distribuidores e Importadores de Perfumes, Cosméticos e Similares
Rua Tabapuã, 649 – Cj 74 – São Paulo – SP - CEP 04533-012 - Brasil
Tel/Fax: (+55) 11-3168-4518
[email protected]
By Sergio H.Nascimento
Regulatory Affairs Coordinator of ADIPEC
(Revised by ASSEVISA & ATVS)
1. Brazilian Regulatory Legislation
According to the Brazilian Law # 6.360 promulgated in 23 September 1976, perfumes, cosmetics,
toilletries and similar products must be registered at the Brazilian Sanitary Vigilance Agency
(ANVISA) a federal organization that belongs to the Ministry of Health and that regulates the
manufacturing, importation and sales of cosmetics, perfumes, toiletries, medicine drugs, home care
products, medical devices, foods, etc. This particular Law and their updated Directives has
established the criteria for product composition (allowed and restricted ingredients), labeling
instructions, product registration dossiers, etc.
It is important to notice that since 2000, the Law # 6.360 has been regulated through Directives
issued by ANVISA establishing rules and procedures very similar to the Cosmetic and Toiletries
Directives of the EEC. Such Directives has been discussed and approved in The Mercosul (Latin
America Common Market) and adopted in Brazil.
As per the Directive # 343/05 issued in December 13th, 2005 cosmetics and toiletries were
classified by their in use risk degree and the definition of perfumes, cosmetics and toiletries were
changed to: preparations whose ingredients (natural or synthetic) to be used externally in various
parts of the human body such as skin, hair, nails, lips, genitals, teeth, membranes of the oral cavity,
with the only objective to clean the, odorize them, change their appearance, or correct body odors,
or protect and/or keep the body in good conditions.
2. Products Risk Degree 1 (or category 1)
Product classified as risk degree 1 (or Category 1) are products whose chemical formulations match
the definition of cosmetics, perfumes and toiletries listed above (Directive # 343) and whose
properties and characteristics does not required detailed data regarding their in use instructions and
use restrictions due to product simple characteristics and composition. Examples: Simple shampoos
and conditioners, shaving foams and lotions, make up products, mild creams, products with non
anti-aging or non anti-dandruff claims, body lotions and creams without vitamins and UV filters in
their chemical formula, etc. Products classified as Category 1 are not registered in ANVISA. They
are notified through a dossier containing simple and basic product data and labeling text which is
submitted on line without any tax. In general, after the Notification dossier submission, product can
be imported and distributed immediately in the market. However, if for any reason ANVISA finds
some contradictory data in the Notification dossier, the distributor are asked to clarify the previous
data submitted and the notification can, eventually be rejected.
ANVISA uses to monitor the Notification process submitted electronically through internet and, in
case of any error is found the Notification process can be rejected There is not any previous process
analysis, but a detailed an electronic monitoring of the process by the Cosmetic Department of
It is important to notice that products classified as Risk Degree 1 cannot present solar filters
chemicals in its composition unless in a very small quantity for formulation protection.
The importing company must monitor the directives issued by the Brazilian Cosmetics Technical
Chamber - CATEC (available in the ANVISA web site) regarding the inclusion of some ingredients
that change the Risk Degree classification of the products (Examples, Vitamin C, Vitamin A,
camphor, methyl salicilate, etc.).
3. Products Risk Degree 2 (or category 2)
Products classified as higher risk degree (or Category 2) are products whose chemical formulation
complies with the definition adopted in the ANVISA Directive # 343/2005 but have specific and
particular indications (Example: products with “anti” claims, creams with sunscreen filters, creams
to be used in the eyes area, hair coloring products, hair straightener products, baby products, etc. )
whose characteristics demands detailed data (in use test reports) regarding their safety and/or
efficacy (claims proof) as well as, more detailed data regarding their in use instructions and use
restrictions. Products classified as Category 2 must be registered in ANVISA and registration
timing is about 60 – 90 days after submission of the registration dossier, if the importing company
is not asked to submit any additional data. Along with the submission of the product registration
dossier, the importing company must pay a registration tax which value depends on its economical
size. In order to import and distribute products that need to be registered, the importing company
must wait until the registration number is published at the Brazilian Official Gazette. This is not a
requirement for products of Risk Degree 1.
4. Positive and Restrictive Ingredients Listing
According to the Brazilian regulations for perfumes, cosmetics and toiletries there are Positive and
Restrictive ingredients listings (chemicals which cannot be used in the product formulation, except
in the conditions and restrictions established in the current sanitary regulations), listing of UV filters
allowed to be included in the formulation without cause any side effect to the consumer skin, and
Negative listings (chemicals prohibited to be used in perfumes, cosmetics and toiletries according to
the current legislation. Those listings are available in the ANVISA web site.
5. Notification / Registration Valid Date
According to the Brazilian Regulatory Legislation for perfumes, cosmetics and toiletries
Notification and Registration processes are valid for 5 (five years) and after this period of time,
must be renewed 6 months before their expiration date through a similar process since product
formulation has not been changed. For products Risk Degree 1, the Notification renewal process
will be done without any fee payment. For products Risk Degree 2 it is demanded a new registration
process with the payment of a new registration fee. In case of a notification and registration process
is not renewed after 5 years, they are automatically canceled by ANVISA system.
6. Product Dossier
According to the Directive # 343/2005 article 13, the local manufacturer and/or the local importer
must have all the product data proving the quality, safety and efficacy of the product manufactured
and/or imported. As well as the labeling text and claims must be supported by technical literature or
by the test reports done with the product (in the country of origin or locally). All that documents
constitute the “Product Dossier”, a collection of product technical documents which must be
presented during the ANVISA annual inspection in order to renew the working license of the
importing company. This inspection is performed yearly or can be done at any time and is
performed by the local health authorities who check all the product documents including the test
reports, which eventually were not submitted to the ANVISA during the notification / registration
In general, the documents to be submitted to ANVISA during the Notification and/or Registration
process are copies of the documents of the “Product Dossier”.
According to the new Brazilian regulations (RDC 211/2005) issued on July 14th, 2005 all the
documents listed below will are mandatory for product registration and warehouse inspection.
1) Product
composition Sheet
(Must be stamped
at the Brazilian
Embassy or
Consulate of the
country of origin)
2) Function of each Yes
ingredient of the
composition sheet
3) Ingredients
bibliography or
references (Only
when required)
Yes (For products
1. Ingredients must be listed
category 1 and 2)
according to INCI
2. Botanical ingredients must be
listed according to the INCI
nomenclature or in the Binomial
Linné System (in general
required for botanical extracts
from Asia countries).
3. Dyes must be declared
according to the Color Index
4. All ingredients listed in
centesimal composition (%)
Yes (For products
1. Each ingredient must be
category 1 and 2)
identified according to its
function (Examples: dye,
surfactant, humidifier,
emollient, solvent, etc.)
Yes (For products
category 1 and 2)
1.In general, for all ingredients.
For proprietary ingredients and
non conventional botanical
extracts not listed in the INCI
listing. In this case, ANVISA
will demand an international
bibliography or a technical
reference published in Chemical
Encyclopedias or any other
reputable technical publication.
2. In cases of new cosmetic
ingredients an in use safety test
report can be demanded by the
health authorities.
3. In some cases an ingredient
monograph can be demanded by
the ANVISA authorities, when
the particular chemical does not
figure in the INCI
4) Raw material
Yes (for products
technical specs
category 1 and 2)
(organoleptics and
physical chemistry)
5) Raw material
6) Physical
Chemical and
Specs of the
finished product
Yes (for products
category 1 and 2)
Yes (for products
category 1 and 2)
Yes (for products
category 1 and 2)
1. For each raw material used in
the formulation, a summary of
its main physical chemical
properties is now being
demanded (Example: pH,
density, molecular weight,
viscosity, odor, color, etc.). No
need to submit Material Safety
Data Sheet (MSDS)!
2. No need to declare the
commercial names of the
manufacturers of raw materials,
when listed in the INCI
3. Regarding of raw materials of
animal origin susceptible to
transmit BSE the cosmetic
product manufacturer must
submit to the ANVISA a
document certifying that
particular raw material is
allowed to be used in their
country of origin. These
documents must be stamped at
the Brazilian consulate or
embassy, in the country of
1. When applicable
1. A summary of the main
physical chemical
specifications (pH, density,
molecular weight, viscosity,
odor, color, etc) and
organoleptics (odor,
appearance, etc) of the finished
7) Finished
Yes (for products
category 1 and 2)
Yes (for products
category 1 and 2)
8) Manufacturing
Yes (for products
category 1 and 2)
9) Packaging specs
Yes (for products
category 1 and 2)
Yes (for products
category 1 and 2)
10) Product
stability test results
Yes (for products
category 1 and 2)
Yes (for products
category 1 and 2)
11) Lot Code
Yes (for products
category 1 and 2)
Yes (for products
category 1 and 2)
13) Product claims
Proof Test Results
(Efficacy product
test report)
Yes (for products
category 2)
Yes (only for
category 2
products, to proof
their specific
labeling claims,
such as antiwrinkle, antidandruff, antiaging, etc.)
14) Product in use
safety test data
Yes (for products
category 1 and 2)
Yes (only for
products category
12) Label artwork
(Original and in
Yes (for products
category 1 and 2)
product must be submitted to
the health authorities
1. When applicable, a summary
of the microbiological test
results of the finished product,
must be submitted to the
Health authorities
1. A simple description of the
manufacturing process. Only a
general description of the
main steps of the production
process (simple flow sheet
diagram or production block
diagram). No need to include
process conditions such as
temperature, pressure, etc.
1. General description of the
primary and secondary
packaging including sizing,
shape and materials.
1. A summary of the laboratory
product stability test results as
well as a summary of the
stability test protocol, assuring
the product shelf life.
1. General description of how to
read the product lot code
1. Photocopy of the product
labeling artwork with product
data and safety warnings
according to the Brazilian
cosmetics regulations.
1. Test report proofing the
veracity of the product benefits
claims, as stated in product
2. In general, it is demanded for
products with some specific
benefits claims, such as: antiseptic claims, anti-cellulite
claim, skin firming claim, antiwrinkle claim, products with
Vitamin C and DMAE, any
product to be used around the
eyes area, etc.
1. A summary of the safety in use
test (in vivo test). A test report
showing that the product it is
safe to be used in human
2. The safety test can be done by
15) Product finality Yes (for products
category 1 and 2)
16) Free Sale
Yes (for products
Certificate (FSC)
category 1 and 2)
(Must be stamped
PS: the original
at the Brazilian
FSC must be filed
with product
Embassy or
Consulate of the
country of origin)
17) Working
License (issued by
Yes (for products
category 1 and 2)
Yes (for products
category 1 and 2)
Yes (for products
category 1 and 2)
PS: For product
Notification and/or
Registration to
submit only a
photocopy of the
original FSC.
the manufacturer company,
since it is performed according
to the test protocols accepted
3. For lower risk of use products,
health authorities will accept
simple tests, such as skin
cumulative irritation patch
1. Description of product finality.
1. The FSC must be issued by the
Ministry of Health or by a
local cosmetic trade
association since it be certified
by the health authorities of the
country of origin.
2. Product name stated in the
FSC must be the same used in
the notification/registration
1. Must be renewed annually
according to the Brazilian
sanitary legislation