OVERVIEW OF THE REGITRATION PROCESS OF COSMETICS IN BRAZIL - Ananda Ferreira

OVERVIEW OF THE REGITRATION PROCESS OF
         COSMETICS IN BRAZIL
              Ananda Ferreira

Table Of Content
 Definition                                Importation of Cosmetics

 Institutions Involved in                  Labeling Requirements

  Registration Process                      Timelines

 Registration Process                      References
   Cosmetics With Sanitary Registration
     Requirement

 Notification Process
   Cosmetics Exempt From Sanitary
     Registration

DEFINITION

In Brazil, Cosmetics are part of a category of products involving Personal Care Products,
Cosmetics and Perfumes. Therefore, the information contained in this presentation relates to
these 3 types of products.

Personal Care Products, Cosmetics and Perfumes are preparations consisting of natural or
synthetic substances, for external use on various parts of the human body, skin, capillary
system, nails, lips, external genital organs, teeth and mucous membranes of the oral cavity, with
the sole or main purpose of cleaning them, perfuming them, altering their appearance,
correcting body odors and or protecting or maintaining them in good condition.

DEFINITION
CLASSIFICATION:

                  are personal care products, cosmetics and perfumes whose formulation
                  complies with the definition, and are characterized by having basic or
       Class 1:
                  elementary properties, whose proof is not initially necessary and do not
                  require detailed information regarding their mode of use and their
                  restrictions of use, due to the intrinsic characteristics of the product.(*)

                  are personal care products, cosmetics and perfumes whose formulation
       Class 2:   complies with the definition, and which have specific indications, whose
                  characteristics require proof of safety and/or efficacy, as well as
                  information and care, mode and restrictions of use. (*)

                                                         (*) List of Class 1 and Class 2 Products in RDC 07/2015

DEFINITION
Personal care products, cosmetics and perfumes must comply with the
                                                                                CLASS 1   CLASS 2
provisions:
Follow the list of permitted preservative action substances for personal care
                                                                                   √         √
products, cosmetics and perfumes (RDC 29/2012)
Follow the list of permitted coloring substances for personal care products,
                                                                                   √         √
cosmetics and perfumes (RDC 44/2012)
Follow the list of substances which personal care products, cosmetics and
perfumes shall not contain, except under the conditions and with the               √         √
restrictions established (RDC 03/2012)
Follow the tist of substances prohibited from use in personal care products,
                                                                                   √         √
cosmetics and perfumes (RDC 48/2006)
Not containing restrictive substances contained in RDC 03/2012                     √         -
Follow the list of permitted ultraviolet filters for personal care products,
                                                                                   -         √
cosmetics and perfumes (RDC 47/2006)

INSTITUTIONS INVOLVED IN THE REGISTRATION PROCESS

                                      ANVISA:
     Ministry of Health
                                      promote the protection of the health of the
                                      population through the sanitary control of the
                                      production and consumption of products and
                                      services subject to sanitary surveillance, including
                                      the    environments,    processes,     inputs   and
 Brazilian Health Surveillance
                                      technologies related to them.
           Agency
          (ANVISA)
                                      GHCOS:
                                      Coordinates, supervises, and controls the activities
                                      related to the registration, information, inspection,
                                      norms and standards establishments, compliance
        Hygiene, Perfume, Cosmetics
                                      with   regulations     concerning     the   sanitary
           and Sanitizing Products
                                      surveillance of personal care products, cosmetics,
           Management (GHCOS)
                                      perfumes and sanitizers.

REGISTRATION PROCESS

                    COSMETICS THAT REQUIRE SANITARY             COSMETICS EXEMPT FROM SANITARY
                            REGISTRATION                                 REGISTRATION
                    • Suntan lotion                            • The other personal care products,
                    • Sunscreen (adult and children)             cosmetics and perfumes are exempt
                    • Antiseptic hand gel                        from registration.
                    • Product to straighten and color the
    PRODUCTS
                      hair
                    • Insect repellents (adult and children)

                    The commercialization can only occur       They are subject to the procedure of
                    after the concession of the registration   Prior   Communication       to   Anvisa.
COMMERCIALIZATION   published in the Official Journal of the   Commercialization may occur after
                    Union (DOU).                               advertising on Anvisa's website.

REGISTRATION PROCESS
                                 General Information

 Sanitary regularizations for personal care products, cosmetics and perfumes are performed in
  electronic form, through the Anvisa website (Agency Petition System - Datavisa).

 In order to manufacture or import the products, the companies must have a Company
  Operating Authorization (AFE) at Anvisa for the activities and classes of products they wish to
  market (personal care product, cosmetic and/or perfume) and must have a License with the
  competent local Health Authority.

 Compliance with Good Manufacturing Practices will be verified at the producer and/or
  importer establishment through an inspection carried out by competent Health Authority.

COSMETICS THAT REQUIRE SANITARY REGISTRATION:
                            Step by Step
Step 1 - Company Health Regularization:
Company Operating Authorization (AFE), local health licenses, Good Manufacturing Practices.

Step 2 - Identification of the petition at Anvisa:
Identification of the subject code and verification of the necessary documentation through the Anvisa
website.

Step 3 - Petition at Anvisa:
The petition process starts at Anvisa's website, and at the end, the Health Surveillance Inspection Fee
(TFVS) will be generated. After the fee paid, attach mandatory documentation and register the
petition through the Anvisa website.

Step 4 - Analysis of the petition by Anvisa

Step 5 - Result of the petition:
Approval or rejection published in the DOU.

COSMETICS THAT REQUIRE SANITARY REGISTRATION:
                Documents Required for Registration
                                                                                       NATIONAL    IMPORTED
                                                                                       COSMETICS   COSMETICS
Purpose of the product                                                                    √            √
Quali-quantitative formula, with all its quantities and components specified by your
names INCI (Nomenclature International of Ingredients Cosmetics, according to             √           √
the abbreviation in English)
Function of the formula ingredients                                                       √           √
Bibliography and/or reference of ingredients (when the substance does not
appear in the INCI nomenclature, identification, safety and efficacy data should          √           √
be included)
Organoleptic and physico-chemical technical specifications of the finished
                                                                                          √           √
product
Microbiological specifications of the finished product                                    √           √
Stability data                                                                            √           √
Safety data of use (proof of safety)                                                      √           √
Evidence of benefits attributed to the product (proof of effectiveness)                   √           √

COSMETICS THAT REQUIRE SANITARY REGISTRATION:
                Documents Required for Registration

                                                                                        NATIONAL    IMPORTED
                                                                                        COSMETICS   COSMETICS
Proof of chemical stability of the ingredient in the finished product in products
containing retinoids and/or ascorbic acid and derivatives, and products                     √          √
containing urea, when the final pH is above 7,0.
Stability study considering pH for straightening products, in case the straightening
                                                                                            √          √
active is not foreseen in specific regulation
Final Art of Labelling with all legible sayings (for imported products: or tag on the
                                                                                            √          √
label in Portuguese with all legible sayings)
Statement of Responsibility completed and signed by the Legal Representative
                                                                                            √          √
and Technical Responsible
General company information                                                                 √          √
Original packaging or copy (primary, secondary packaging and leaflet)                       -          √
Translation of the original label, except saying in English or Spanish                      -          √
Original formula of the imported product                                                    -          √

NOTIFICATION PROCESS
                Cosmetics Exempt from Sanitary Registration

Personal care products, cosmetics and perfumes exempt from sanitary registration must be
notified to Anvisa. Prior Communication is the administrative procedure to be applied to inform
Anvisa of the intention to commercialize these types of products through electronic registration
of the product made in the Cosmetic Automation System (SGAS).

Step by Step:

Step 1:
Registration of the company in the SGAS.

Step 2:
Registration of the product to be communicated in the SGAS.

Step 3:
Health Surveillance Inspection Fee (TFVS) will be generated and must be paid.

NOTIFICATION PROCESS
               Cosmetics Exempt from Sanitary Registration
Step 4:
 The protocol process is done online, with no physical delivery of documentation required. The
  online protocol is automatically generated in the SGAS, after confirmation of payment of the TFVS.
 The documents generated at the end of the electronic procedure must be printed, signed by the
  Technical Responsible and the Legal Representative.
 These documents must be filed at the company, and be available for sanitary surveillance actions.

Step 5:
Follow-up of the request for Prior Communication through the SGAS.

Step 6:
Commercialization may occur after advertising on Anvisa's website.
After the company petitions the product in SGAS and pays TFVS, the status "Exempt from Registration"
will be presented and the company will already be authorized to market the product.

IMPORTANTION OF COSMETICS

 Only an importer established in Brazil can regularize an imported product.

 The importer must have the Company Operating Authorization (AFE) with the activity of importing
  the category of personal care products, cosmetics and perfumes.

 The import of cosmetics, personal care products and perfumes will be subject to the registration of
  Import Licensing in Foreign Trade Integrated System (SISCOMEX), submitting to the supervision by
  the health authority before its customs release.

 The import of goods and products subject to non-automatic licensing in SISCOMEX must have the
  prior and express consent of ANVISA by granting the import licensing before shipping the product
  to Brazil.

 Import Licensing: request electronically in SISCOMEX, by the importer or his legal
 representative,   for   non-automatic     licensing   procedures   to   verify   compliance   with
 requirements for imports of goods and products under sanitary surveillance.

IMPORTANTION OF COSMETICS
Documentation required:

 Petition Form
 Proof of payment of the Health Surveillance Fee (TFVS)
 Import Licensing
 Access authorization for physical inspection, when applicable
 Commercial Invoice
 Bill of Lading
 Information about the product and the importing legal entity, such as product and company
   regularization and Import Licensing number
 Declaration of the lots or departures, identified alphanumerically, when applicable
 Declaration of the holder of the registration authorizing the import by a third party
 Instrument of representation of the legal entity that holds the regularization of the product with Anvisa in
   favor of the legal representative
 Document of registration referring to the proof of mooring of the product in the storage environment and
   its respective location, issued by the legal representative of the legal entity that manages the customs
   area where the product is stored.

LABELING REQUIREMENTS
Mandatory labelling:

Item                                                                                          Packaging    (*)

Name of the product and group/type to which it belongs if it is not implicit in the name      Primary and Secondary
Brand                                                                                         Primary and Secondary
Product registration number                                                                   Secondary
Lot                                                                                           Primary
Expiry date                                                                                   Secondary
Content                                                                                       Secondary
Country of origin                                                                             Secondary
Manufacturer/Importer/Holder                                                                  Secondary
Address Manufacturer/Importer/Holder                                                          Secondary
Mode of Use (if applicable)                                                                   Primary and Secondary
Warnings and Restrictions of Use (if applicable)                                              Primary and Secondary
Specific Labelling                                                                            Primary and Secondary
Ingredients/Composition                                                                       Secondary

              (*) When there is no secondary packaging all the required information must appear on the primary packaging.

LABELING REQUIREMENTS
 The labelling shall not contain any therapeutic indications, names or indications which are
  misleading or confusing as to the origin, composition, purpose or safety of the product.

 The labeling must contain the Company Operating Authorization (AFE) number and the process
  number of the product, generated in the Anvisa system, which will correspond to the registration
  number.

 The expiration date expressed in "month and year" dispenses the recording of the date of
  manufacture. In the case of the terms "validity 2 years or 24 months", the date of manufacture must
  appear on the label.

 The instructions for use can be found in an attached leaflet. In this case it must be indicated on the
  primary packaging: - "See attached leaflet".

 When the packaging is small and does not allow the inclusion of warnings and restrictions of use,
  these may appear on an attached leaflet. It must be indicated on the primary packaging: - "See
  attached leaflet".

LABELING REQUIREMENTS
 The specific words highlighted below must be added to the primary and secondary packaging:

AEROSOLS:
"Avoid inhalation of this product".

NEUTRALIZERS, PRODUCTS FOR CURLING AND STRAIGHTENING HAIRS:
"This preparation should only be used for its intended purpose, being DANGEROUS for any other use".

HAIR LIGHTENING AGENTS AND HAIR DYES:
Labels of hair dyes and lightening agents that contain substances capable of producing acute or
chronic intoxications must contain the following warnings:
"CAUTION. Contains substances that may cause skin irritation to certain people. Before use, do the touch
proof".

SIMULATORY SUNTAN LOTION:
The labels of products designed to simulate tanning of the skin should contain the warning:
"Warning: does not protect against solar action".

LABELING REQUIREMENTS
For each of the products below, there are specific words required on the labelling, as set out in
Annex VI of RDC 07/2015:

 Aerosols
 Neutralizers, Products For Curling And Straightening The Hairs
 Hair Lightening Agents And Hair Dyes
 Hair Dyes With Lead Acetate
 Depilatory Products
 Teeth And Mouthwashes With Fluoride
 Antiperspirant Products
 Hair Tonics

TIMELINES
                                               TIMELINE
                                                                           ADDITIONAL CONSIDERATIONS
                                           (CALENDER DAYS)
 Analysis of petitions for Personal Care
 Products, Cosmetics and Perfumes by             90 days                                   N/A
                  Anvisa

                                                                  Counted from the day of its publication in the Official
Registration of Personal Care Products,
                                                10 years          Journal of the Union (DOU), and may be revalidated
  Cosmetics and Perfumes Validity
                                                                  successively by equal period.
                                           180 days before the
   Revalidation of the Registration of
                                           validity date of the                            N/A
               Products
                                               registration

         Prior Communication                     5 years           May be revalidated for equal and successive periods.
                                           180 days before the
Revalidation of the Prior Communication    validity date of the                            N/A
                                             communication

       Import Licensing Issuance                 7 days                                    N/A

        Import Licensing Validity               120 days                                   N/A

REFERENCES
ANVISA Website. Resolution RDC 7/2015. Link:
http://portal.anvisa.gov.br/documents/10181/2867685/%283%29RDC_07_2015_COMP.pdf/b6bca3b2-454d-4b05-8749-
2a264b096bc8

ANVISA Website. Resolution RDC 237/2018. Link:
http://portal.anvisa.gov.br/documents/10181/4881763/RDC_237_2018_.pdf/50b54103-1b51-41c5-8c92-af50f4444038

ANVISA Website. Resolution RDC 81/2008. Link:
http://portal.anvisa.gov.br/documents/33880/2568070/rdc0081_05_11_2008.pdf/a02a1a3f-eaf1-4264-b1c0-084eb426fc37

ANVISA Website. Electronic Prior Communication (SGAS). Link:
http://portal.anvisa.gov.br/registros-e-autorizacoes/cosmeticos/produtos/comunicacao-previa-eletronica-sgas

ANVISA Website. Cosmetics Registration. Link:
http://portal.anvisa.gov.br/registros-e-autorizacoes/cosmeticos/produtos/registro

ANVISA Website. General information about Cosmetics. Link:
https://bit.ly/2Aok8rj

THANK YOU
For additional information
please Contact Us at:

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