REGISTRATION OF COSMETICS IN BRAZIL · ¾ RDC 19/2013: Technical requirements for granting...

REGISTRATION OF COSMETICS

IN BRAZIL

22Registration of Cosmetics in Brazil | www.globalregulatorypartners.com

Global Regulatory Partners, Inc

The Brazilian cosmetic industry represents more than 2% of the country’s GDP. The Brazilian Cosmetic market is projected to exceed Japan and become the second one in the world within the next 2 years. According to the Brazilian Association of the Cosmetic, Toiletry and Fragrance Industry, the consumption of cosmetics in Brazil, is driven by the new beauty trends, that are influenced heavily by the social media.

OVERVIEW OF COSMETIC MARKET IN BRAZIL:

BRAZIL’S COSMETIC REGULATORY AUTHORITIES:

ANVISA:

Promotes 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 cosmetic products.

GHCOS:

Coordinates, supervises, and controls the activities related to the registration, information, inspection, norms and standards establishments, compliance with regulations concerning the sanitary surveillance of personal care products, cosmetics, perfumes and sanitizers.

Figure 1: Brazil’s cosmetic regulatory authorities

Ministry of Health

Brazilian Health Surveillance Agency(ANVISA)

Hygiene, Perfume, Cosmetics and Sanitizing Products Management (GHCOS)



DEFINITIONS AND CLASSIFICATION:

In Brazil, Personal Care Products, Cosmetics and Perfumes, are defined as; “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.”

In Brazil, Personal Care Products, Cosmetics and Perfumes are classified into Class I and Class II as shown in Table 1 here below. The major cosmetic regulation in Brazil are provided in Table 2.

CLASSIFICATION DESCRIPTION EXAMPLES

Class I

¾ Products with basic or elementary properties

¾ They do not require detailed information on their labeling regarding their mode of use and their restrictions of use

¾ skin moisturizers (without sunscreen; except those for stretch marks),

¾ face cleansing creams, ¾ lotions, ¾ gels and oils (except those

for acne skin), ¾ perfumes, lipsticks (without

sunscreen), ¾ fingernail polishes, ¾ eye and facial makeup

preparations(without sunscreen),

¾ eyelash mascara ¾ cleansing shampoos and

hair conditioners.

Class II

¾ Product’s have specific indications that require proof of safety and/or efficacy, as well as more information on their labeling on their mode of use and restrictions of use.

¾ children’s products; ¾ sunscreen lotions and

creams ¾ products for straightening ¾ curling and/or dyeing hair ¾ products for wrinkles ¾ antiseptic soap ¾ insect repellent products

Table 1: Class I and Class II



OVERVIEW OF REGISTRATION PROCESS OF COSMETICS IN BRAZILThe registration of cosmetics in Brazil depends on their classification. In general cosmetics Class I are exempt from registration and require notification to Anvisa only (Figure 2). However, cosmetics from Class II require registration with Anvisa (Figure 3).

Notification Process of Class I Cosmetics

The notification process is known as ‘Prior Communication’. It is an administrative procedure that consists of informing Anvisa about the intention of commercializing these types of products. Prior communication is performed through Anvisa’s electrical platform known as the Cosmetic Automation System (SGAS). Once the notification process is completed, the company can commercialize its products after the notification is published on Anvisa’s website.

Notification Fees:Notification Fees depend on the size of the company and fee ranges between R$ 175.72 and R$ 3,414.32 brazilian reais.

Notification Timeline:It takes 2 moths to Anvisa to publish the notification on its website.

Registration Process of Class II Cosmetics

The registration process starts by submitting a petition through Anvisa electrical platform. After receiving the petition, Anvisa starts the review of the registration dossier submitted by the company and also performs an inspection to the manufacturing site to ensure its compliance with Good Manufacturing Practices. After finishing the review and the inspection, Anvisa publishes its decision in the Official Journal (Diario Oficial da União - DOU), after which product’s commercialization can starts.

Registration Timelines:The timelines for Anvisa registration of Class II cosmetics are about 90 days.

Registration Fees:Anvisa registration fee for Class II cosmetics depends on the size the company submitting the application. The range of the fees is between R$ 244.05 and R$ 4.881,00 brazilian reais.

Validity of the Sanitary License:The sanitary license for Class II cosmetics is five years from the date of publication in the Official Journal (DOU).



Figure 2: Notification Process of Class I Products

Figure 3: Sanitary Registration Process of Class II Products

STEP 1: Appoint Local Representative

STEP 1: Appoint Local Representative

STEP 5: Pay Health surveillence inspection Fee ( TFVS)

STEP 3: Receive AFE from Anvisa

STEP 7: Petition will be analyzed by Anvisa ( 90 days)

STEP 2: Apply for a Company Operating Authorization (AFE)

from Anvisa

STEP 6: Attach the mandatory documents and complete

petition thorugh Anvisa website

STEP 4: Apply and Receive a Subject code from Anvisa

STEP 8: Approval or rejection will be published in the DOU.

STEP 4: Pay Health Survillenve Inspection Fee (TFVS)

STEP 2: Register company in SGAS

STEP 5: Documents geneterated by SGAS must be signed by local

representative and stored at company (2 months)

STEP 3: Communicate to SGAS the intention to commerilaize via

electronic registration

STEP 6: Commercialization may happen once Anvisa publishes status

on website.



MAJOR COSMETIC LEGISLATION IN BRAZIL:

According to Law Nº 6.360/76, only companies authorized by the Ministry of Health and licensed by the Anvisa can extract, produce, manufacture, process, synthesize, purify fraction, pack, repack, import, export, store or ship cosmetics in Brazil. Table 3 below outlies all relevant Brazilian legislation for Cosmetic Registration, Cosmetic Labeling , and Cosmetic ingredients.

TOPIC REGULATIONS

Registration

¾ RDC 07/2015: Technical requirements for the regularization of personal care products, cosmetics and perfumes.

¾ RDC 15/2015: Technical requirements for the regularization of children’s personal care products, cosmetics and perfumes.

¾ RDC 19/2013: Technical requirements for granting registration of insect repellent cosmetic products.

¾ RDC 237/2018: Changes some topics of the RDC 07/2015 and RDC 15/2015.

Labeling

¾ RDC 07/2015: Chapter II / Annex V / Annex VI. ¾ RDC 250/2018: Requirements for the presentation of the Art of

Labelling Project in the process of regularization of personal care products, cosmetics and perfumes, and for the coexistence of more than one art of labeling or labeling for the same product.

Ingredients

¾ Updated F List of PRT 344/1998 : substances outlawed in Brazil ¾ RDC 83/2016 : List of substances that cannot be used in

toiletries, cosmetics and perfumes ¾ RDC 3/2012 : List of substances that toiletries, cosmetics and

perfumes should not contain Except under the conditions and restrictions laid down

¾ RDC 29/2012: List of permitted preservative-acting substances for toiletries, cosmetics and perfumes

¾ RDC 44/2012: List of permitted coloring substances for toiletries, cosmetics and perfumes

¾ RDC 69/2016: List of allowed ultraviolet filters for toiletries, cosmetics and perfumes

Table 3: Regulations



COMPANY OPERATING AUTHORIZATION (AFE)

In order to manufacture or import Class II Cosmetics in Brazil, local companies must have a Company Operating Authorization (AFE) for such products and a License from Anvisa.

The Certificate of Authorization of Operation (Certificate of AFE) is a document issued by Anvisa proving that the company is authorized to perform the activities described in the certificate. It contains data such as the company’s authorization number and address. Without having the Company Operating Authorization at ANVISA, the company cannot obtain the next approval, which is the Regulation of national and imported products

AFE is required from companies that perform activities of:

• Production / Manufacturing• Distribution• Storage• Export• Import



Company Rating Annual billing

Group I - Large CompanyGreater than R $ 50,000,000.00 (fifty million reais), according to Provisional Measure No. 2,190-34/2001.

Group II - Large Company

Equal or less than R $ 50,000,000.00 (fifty million reais) and greater than R $ 20,000,000.00 (twenty million reais), in accordance with Provisional Measure No. 2,190-34/2001.

Group III - Medium-sized company

Equal or less than R $ 20,000,000.00 (twenty million reais) and greater than R $ 6,000,000.00 (six million reais), in accordance with Provisional Measure No. 2,190-34/2001.

Group IV - Medium-sized company

Equal to or less than R $ 6,000,000.00 (six million reais), in accordance with Provisional Measure No. 2,190-34/2001.

Small Business (EPP)

Equal or less than R $ 4,800,000.00 (four million and eight hundred thousand reais) and greater than R $ 360,000.00 (three hundred and sixty thousand reais), in accordance with Complementary Law 139/2011.

Micro enterpriseEqual or less than R $ 360,000.00 (three hundred and sixty thousand reais), according to Complementary Law No. 139/2011.

Table 2: Company Rating depending on Corresponding Annual billing.

What is the size of the company?

Company size is the economic capacity of the company, determined according to its gross annual sales. The definition of company size does not allow changes at the time of registration of the company, being automatically registered by Anvisa as “Group I - Large”. If the company does not belong to the “Group I - Grande”, it is important to prove the size with Anvisa so that you can enjoy some discounts in the payment of the Sanitary Surveillance Inspection Fee (TFVS). In this sense, the company that has a different classification of “Group I - Large” must request the size change with Anvisa. See Table 2 below summarizes the Company Rating that is defined by its corresponding Annual Billing.

ABOUT GLOBAL REGULATORY PARTNERS, INC

Address: 400 Fifth Avenue, Suite #115, Waltham, MA 02451

Email: [email protected]

Website: www.globalregulatorypartners.com

Telephone: 781.672.4200

Corporate Office

Brazil

Rafael Marino Street, NETO 600Karaiba GardenUBERLANDIA – 38411-186Minas Gerais (MG)Telephone: (+55) 34-3235-1971

Japan

Ark Mori Building, Suite 50, 12/F1-12-32 Akasaka Minato-KTokyo, 107-6012Telephone : (+81)-3-4360-9287

China

21st Centry Tower, Suite 6030, 6/F210 Centry Avenue, Pudong DistrictShanghai, 200120Telephone: (+86) 021-517-27278

Mexico

Lake Alberto 442 – 5th floorTower A – Office 509Col. Anahuac 1st SectionDelegation Miguel Hidalgo, C.P. 11320Telephone: (+52) 55 7312 4169

For additional information, please contact us at [email protected]


Global Regulatory Partners Inc, (GRP) provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. As a qualified and licensed legal representative with offices in USA, China, Japan, Brazil, Mexico and Argentina, the company can represent life science companies in those countries and help them register their products in compliance with local regulations and in record time.

Argentina

Bouchard 4684to. GC1106ABFBuenos AiresTelephone: (54 11) 52523386

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