Argentina Cosmetics Regulations




In Argentina cosmetics products are defined as- “Any mixture or substance which is intended to apply superficially in contact with parts of human body (capital and hair system, epidermis, lips, nails, external genital organs, teeth, and oral mucous membranes) for the sole purpose of cleaning, modifying appearance, perfuming, odor removing and to keep or protect them in good condition".


Argentina Market Overview:
  • Argentina Beauty and Personal Care Products Market is expected to register CAGR of 7.21% during the forecast period 2020-2025.

  • Baby care products market in Argentina is estimated to attain the market size of US 41,776.559 million in 2026.

  • Revenue in personal care segment is projected to reach US$515M in 2021 and 6% of total market revenue will be generated through online sales by 2023.

Classification

They are further categorized according to requirements for the confirmation of safety, restrictions for use and mode, efficacy of products as written in provision No. 345/06 (ANMAT) and Resolution No. 07/05.


Grade I

They are the products used for personal hygiene, perfuming, and cosmetic purpose whose formulation meets the condition of GMC Res. No. 110/94 and are characterized by having basic properties or elemental properties. Initially the verification is not necessary and do not require detailed information as to their restrictions to use or mode, due to the intrinsic character of the product mentioned in indicative list given in Annex II.

Grade I products includes face and body creams without sun protection, make-up removers, makeup products without sun protecting ingredients, hair products without any claims like anti-hair loss, anti-dandruff or any other specific claims, gels and oils, lip, eyes and eyebrow liners, deodorants (except antiperspirant action) and perfumes, teeth products (except fluoride, anti-plague, anti-caries effect and claims like that), colognes, depilatory and epilators products, color cosmetics, nail products, bath products, shaving products except with antiseptic actions, soaps and mechanical exfoliator, talc/powders etc.


Grade II

Products use for personal hygiene, cosmetics and perfumes whose formulation falls within the definition of GMC Res. No. 110/94 have specific indications and their characteristics require verification on the product safety, efficacy, care, information, modes and restriction for use as mentioned in Annex III.

This classification was based on the probability of occurrence of undesirable effects due to improper use of product, purpose for use, its formulation, parts of the body to which it is intended and care to be perceive in is use.

Grade ii cosmetics include children products, sun related products, hair products with specific claims, bleaching products, tooth products with specific claims, face products for acne, wrinkles and fine lines, hygiene and cleaning products, antiseptic soaps, insect repellents, intimate use products, etc.


Regulatory Parties In Argentina

  • Ministry Of Health

  • ANMAT

In Argentina, ANMAT- National Administration of Drugs, Food and Medical Technology handle the regulation of cosmetics through Resolution MS and AS No. 155 of 1998.

ANMAT update the standards related to cosmetic products for Personal Hygiene, perfuming and the activities intrinsic to them. – BO 04/02/98

  • MERCOSUR

ANMAT is harmonized with the European Union or southern Common Market (el Mercado Comun del sur, MERCOSUR is a trade association of five countries: Brazil, Argentina, Uruguay, Paraguay and Venezuela in which Argentina is a part of MERCOSUR.


Product Registration Process

Admission Of Grade I Products Registration In Electronic File:


Manufacturers or importers of cosmetics authorized by ANMAT can make the admission of cosmetic products online. IT department of ANMAT grants User name and personal access Key by which the company can enter the cosmetics system. For establishment of that company has to fill two forms namely-

  1. Application for registration of initiation of electronic file system for cosmetic products.

  2. Registration request of the activities in the electronic file system for cosmetic products.

These forms are submitted at the entrance desk of Health Products Surveillance Directorate for addressing the inspection service of cosmetic products. After successful inspection, ANMAT computer coordination will deliver the password and username.


Admission Of Grade II Products:

  1. Form submission for admission – R-155.

  2. Product and their technical requirement list.

  3. Modification request form (brand, name, origin, formula, establishment, label).

  4. Alternative establishment request form.

  5. Change of producer establishment request form.

  6. Formula change request form.

  7. Sign and label change request form.


Import Of Cosmetic Products In Argentina

The import of cosmetics in Argentina can be costly and quiet difficult. There are agencies which give favor for importation of cosmetics from Argentina. One of the leading countries in the beauty and cosmetics production in Latin America is Argentina.

Documents required for import cosmetics are -

  • Product import authorization request form.

  • Payment receipt for corresponding fee.

  • Copy of certificate of registration showing qualification of cosmetics import establishment.

  • Copy of enabling provision of the formation having the data of recent technical director.

  • Copy of the designation of technical director other than the one designated in the enabling provision.

  • Copy of the demonstration made to the health authority of the cosmetics product involved along with the details of data of product, owner of product, and importing establishment are recorded.

  • Affirmation required by ANMAT disposition 162/01.

  • Copy of letter of representation.

  • Document of transport.

Certificate Of Free Sale (CLV)

Grade I

  1. Application – The request is made through PLATFORMA DE TRAMITITES A DISTANCIA (TAD). For this the applicant company must be registered in the electronic file of ANMAT.

  2. Obtaining certificate – after the application has been evaluated, the CLV may be issued or rejected. In both situations notification will be given via TAD. Also the company must enter its “notifications” that is the certificate should no longer be withdrawn personally.

Grade II

  1. Application – The request is made through PLATFORMA DE TRAMITES A DISTANCIA (TAD) which is approved by decree no. 1063/2016 and should be regulated by Resolution no. 12/2016 of SECRETARIA DE MODERNIZACION ADMINISTRATIVA of the Ministerio de Modernización de la Nación and Resolution no. 73- E / 2017 of the Ministerio de Modernización de la Nación.

  2. Obtaining certificate – For obtaining the certificate issued electronically through TAD, notification is sent by mail to the company. The responsible person will enter the platform and search the Notifications tab and download the certificate and cited with that which are the part of the electronic file.

  3. Correction of the procedure – If there are any errors in the application, or the authority need some more information, Health Authority will carry out a correction process.

Labelling Of Cosmetic Products

Labeling should be in Spanish language and should be in accordance with Resolution GMC No. 36/04. The requirements in labeling are given below:

  • Identity of the product in the language of the state where the product is going to be sold.

  • Statement providing net quantity in metric units of measurement.

  • Any warnings or cautions.

  • Name and address of the manufacturer or distributer.

  • Directs given for the use of product.

  • Ingredient list ( using INCI ).

  • Expiration or use by before date.

Animal Testing

In Argentina a bill is proposed for promising the end of animal testing for cosmetics. The bill was introduced by Rio Negro province Senator and Magdalena Odrada. If this bill made into law will prohibit the sale of new animal tested cosmetics and the animal testing for cosmetic ingredients.

Cruelty free cosmetics may be the further trend for the sale of cosmetics in Argentina.