Cosmetic’s

Regulation
in Brazil
COS 611 Ethical and Regulatory
Arrangements about Cosmetic
Products

Cristina Pinos

1
Introduction
• In Brazil, the Ministry of Health
controls the manufacture and
importation of all cosmetic,
perfumery and personal hygiene
products and is regulated through
ANVISA- Agência Nacional de
Vigilância Sanitária

• To refer to cosmetic, perfumery or

personal hygiene products, the term
cosmetic products is use
2
 Introduction
• Some of the applicable regulations, for cosmetic
products, are:
• RDC 7/2015: General regulation

• RDC 15/2015: Regularization of infant products

• RDC 481/1999: Microbiological parameters

• Ordinance PRT 344/1998: Regulation on substances and

drugs subject to special control

• RDC 44/2012: Colorants permitted

• RDC 528/2021: Preservatives permitted

3
Resolution RDC 07/2015
General Regulation

4
Annex I:
Definition

Resolution RDC 07/2015

5
• ANVISA defines cosmetic
products as:
“preparations made from natural or
synthetic substances, for external use
in various parts of the human body,
skin, hair, nails, lips, external genitals,
teeth and mucous membranes of
the oral cavity, with the sole or
principal purpose of cleaning,
perfuming, altering and correcting
bodily odors and/or protecting or
keeping them in good condition”
6
Annex II:
Classification of
toiletries, cosmetics,
and perfumes

Resolution RDC 07/2015

7
• On the other hand, ANVISA
classifies cosmetic products in 2
categories:
✓ 1st grade products

✓ 2nd grade products

8
1st Grade Products
• A product lays in this category if:
✓ It does not necessarily need an initial testing
✓ It does not require detailed information on its
application nor in its restrictions

• This products do NOT require registration with

ANVISA, but notification through a simple
dossier containing basic information about
the product (composition, physical-chemical
data, microbiological data, etc.)

9
 1st Grade Products
• Some of the products in this category
are:
✓ Eau de Cologne, Perfumed Water,
Perfume and Aromatic Extract

✓ Cuticle softener (non-caustic)

✓ Facial/body foundation (without

photoprotective purpose)

✓ Conditioner / Cream rinse / Hair rinse

(except those with anti-fall, anti-dandruff
action and/or other specific benefits that
justify prior verification)

✓ Among others 10
2nd Grade Products
• A product lays in this category when:
✓ Its characteristics require proof of safety
and/or efficacy
✓ It has specific indications
✓ It has information and care, mode and
restrictions of use

• Its registration and approval by ANVISA

is mandatory, prior to the entry of the
product in the market.

11
 2nd Grade Products
• Some of the products in this
category are:
✓ Hydrogen peroxide from 10 to 40
volumes (including creams except
products for medical use)

✓ Antiperspirant deodorant

✓ Cosmetic products for kids

✓ Antidandruff shampoo and conditioner

✓ Tanning lotions

✓ Among others
12
Annex V: Labeling
Requirements for
Toiletries, Cosmetics,
and Perfumes

Resolution RDC 07/2015

13
a) Objective

• Determine the essential information

that must appear on the labels of
Cosmetic products regarding their
use, as well as all the necessary
information regarding the product

14
b) Definitions

1. Primary packaging: wrap/recipient with 5. Name: distinguishing one's product from

is in direct contact with the product. another
2. Secondary packaging: contains the 6. Brand: name that distinguish a product
primary packaging(s). from a manufacturer from another
3. Label: printed identification glued to 7. Origin: place of production
containers, packages, or wraps. 8. Batch: Quantity of a product in a
4. Brochure instructions: additional manufacturing cycle, properly
information which accompanies the identified, whose main characteristic is
product the homogeneity

15
 b) Definitions
9. Shelf life: length of time for which the identification number and the number for
product remains usable or saleable, without the product marketing authorization
losing its properties 14. Ingredients/composition: description of the
10. Registry holder: entity who holds the components with its generic name, using
registration of cosmetic products the INCI

11. Manufacturer: company in charge of 15. Warnings and use restrictions: mandatory
manufacturing the product information set out at in the lists of

12. Importer: legal entity responsible for the substances when there exist and to

introduction to the country the foreign inform the presence of them at the label

product and those fixed at the Annex V of this

resolution
13. Product registration number: company
16
 Brochure
Brand instructions

Secondary
package

Primary
package
Name
Warning &
Restrictions
Label

Ingredients

Manufacturer

Origin
Shelf life 17
c) General Labeling Requirements

18
Resolution RDC 15/2015
Regularization of infant products

19
• This resolution establishes the
technical requirements related to
the formulation, safety,
innocuousness and labeling for the
registration of children's cosmetic
products

• ANVIA considers children between 0

and 12 years of age

20
Annex I: Categories &
Groups of Children’s
products

Resolution RDC 15/2015

21
• There are 3 categories
• Hygiene Products: hair conditioner
w/o rinse, toothpaste w/o fluoride,
deodorant, among others
• Cosmetic products: nail polish,
blush, lipstick, sunscreen, among
others
• Perfumes: eau de cologne and
perfume
• To refer to any of these products
the term “infant product” is used

22
Annex II: Specific
Requirements for
Children’s Products

Resolution RDC 15/2015

23
• This annex establishes:
• The product

• What ages can use it

• Security Assessment

• What are the warnings the label

must have

• Other limitations and

requirements

24
25
Resolution RDC 481/1999
Microbiological parameters

26
Annex: Microbiological Control
Parameters of Cosmetic Products
Application Area
Limits of Acceptability
& Age Group
a) Count of total aerobic mesophilic microorganisms, not
• Infant products more than 102 UFC/g o ml. (Max. Limit: 5 x102 UFC/g o ml
• Products for b) Absence of Pseudomonas Aeruginosa in 1g or 1ml
eye area c) Absence of Staphylococcus aureus in 1g o 1ml
Type I
• Products that d) Absence of total and focal coliforms in 1g o 1ml
are in contact e) Absence of sulfite-reducing Clostridium in 1g (exclusively
with mucous for talcum powder)

f) Total count of aerobic mesophilic microorganisms, not

Other cosmetic
more than 103 UFC/g p ml. (Max. Limit: 5𝑥102 UFC/g o ml)
products
g) Absence of Pseudomonas aeruginosa in 1g or 1ml
Type II susceptible to
h) Absence of Staphylococcus aureus in 1g or 1ml
microbiological
i) Absence of sulfite-reducing Clostridia in 1g (exclusively in
contamination
talcum powder) 27
Ordinance PRT 344/1998
Technical Regulation on substances and drugs
subject to special control

28
Definitions
a) Drug: Substance or raw material that
has medicinal or health properties

b) Narcotic: Substance that can cause

physical or mental dependence

c) Medication: Pharmaceutical
product, technically obtained or
manufactured, for prophylactic,
curative, palliative or diagnostic
purposes

29
Annex I

PRT 344/1998

30
• This section is divided in lists, being
some of them the following:
• A1- Narcotics (subject to “A”
prescription notification)
• A2 - Medications permitted for use
only in special concentrations
• A3 - Psychotropic substances
(Subject to “A” prescription
notification)
• B1- Psychotropic substances
(Subject to “B” prescription
notification)
• B2 - Anorectic Psychotropic
substances (Subject to “B2”
prescription notification)
31
• C1- Other substances subject to
special control

• C2 - Retinoic substances (subject to

special prescription notification)

• C3 - Immunosuppressant substances

• C5 - Anabolic substances

• D1- Precursor substances of drugs

and/or psychotropics

• D2 - Chemical inputs for the

manufacturing and synthesis of
drugs and/or psychotropics

32
Resolution RDC 44/2012
Colorants permitted

33
• Colorants must be used according to the
specific field of application:
1. Coloring substances allowed for all types of
products.
2. Coloring substances allowed for all types of
products except those that are applied to the eye
area.
3. Coloring substances allowed exclusively in
products without contact with mucous membranes
under normal or predictable conditions of use.
4. Coloring substances permitted exclusively in
products that have a short shelf life in contact with
skin and hair

34
Clarifications
1. Colorants must fulfill with the identity and
purity specifications established by the
international reference organizations

2. The maximum allowable metallic impurities for

artificial organic dyes are:

o Barium chloride(BaCl2): 500 ppm

o Arsenic (As2O3): 3 ppm

o Lead (Pb): 20 ppm

o Other heavy metals: 100 ppm. 35

Clarifications
3. Lacquers and salts of coloring
substances (in the list) will be allowed,
as long as they do not use substances
from the list of prohibited substances.

4. Insoluble barium, strontium, and

zirconium lakes, salts, and pigments of
these coloring substances will be
permitted, when their insolubility is
demonstrated by an appropriate test.

36
 Clarifications
5. Trace amounts of prohibited ingredients
may be permitted, as long as their
presence is technically impossible to avoid
under good manufacturing practice and
as long as the finished product is safe.

6. Coloring substances intended exclusively

for dyeing hair are not included in this list.

37
Resolution RDC 528/2021
Preservatives permitted

38
Definition
• Preservative: substance that is
added as an ingredient to cosmetic
products in order to inhibit the growth
of microorganisms during their
manufacture and storage or to
protect the products from
inadvertent contamination during
use

39
• Annex I contains the
list of permitted
preservatives for
cosmetic products,
with their maximum
authorized
concentration, INCI,
limitations,
conditions of use
and warnings

40
References
Agência Nacional de Vigilância Sanitária - ANVISA.
(1998). Ordinance PRT 344/1998.
(1999). Resolution RDC 481/1999.
(2012). Resolution RDC 44/2012.
(2015). Resolution RDC 15/2015.
(2015). Resolution RDC 7/2015.
(2021). Resolution RDC 528/2021.
Ministério da Saúde. (2020, October 26). Conceitos e definições. Retrieved
from Governo do Brasil: https://www.gov.br/anvisa/pt-
br/acessoainformacao/perguntasfrequentes/cosmeticos/conceito
s-e-definicoes