Regulatory context

The Andean Community (Comunidad Andina, CAN) is a trade consortium comprised of four South American countries: Colombia, Peru, Ecuador and Bolivia. It was formed in 1969 with the Cartagena Agreement.

The CAN cosmetics regulation is based on Decision 516 “Armonización de Legislaciones en materia de Productos Cosméticos”, and was replaced by Decision 833 as of November 2019 (but delayed until March 1, 2021 due to COVID).

The new regulation is similar to the previous one, but introduces some changes to cosmetic product categories, for example, and provides additional detail on some of the definitions and concepts.

For CAN countries, a cosmetic product is defined as “any substance or formulation intended to come into contact with the superficial parts of the human body (epidermis, hair and capillary system, nails, lips and external genitalia) or with the teeth and oral mucous membranes, for the sole or main purpose of to clean, to perfume them, to modify or improve their appearance, to protect them, to maintain them in good condition or to correct body odor.”

“Substances or formulas intended for the prevention, treatment or diagnosis of diseases, or products intended to be ingested, inhaled, injected or implanted in the human body” do not fall under the scope of cosmetics.

It’s also important to note that cosmetic products cannot claim any therapeutics effects.

Here is the list of cosmetic product categories in the Andean Community:

• Cosmetics for children
• Cosmetics for the eye area
• Cosmetics for the skin
• Cosmetics for the lips
• Cosmetics for the toilet and bodily hygiene (including wet wipes and antibacterial gels with less than 70% alcohol)
• Deodorants and antiperspirants
• Cosmetics for the hair
• Cosmetics for the nails
• Perfumed products
• Products for oral and dental hygiene
• Products for shaving and after shaving
• Products for tanning, sun protection and self-tanning
• Depilatories
• Products for lightening the skin
• Insect repellents applied to the skin
• Others as determined by the authorities

All cosmetic products must be notified to the CAN Authorities before being placed on the market. This mandatory notification (Notificación Sanitaria Obligatoria, NSO) must be be carried out by the Responsible Person established within the territory in the first country of sale and is valid for seven years.

The following information must be included in the Notification:

1- General information

• Name of the legal representative or agent along with documents related to this representation
• Name and address of the manufacturer(s) and of the holder of the NSO
• If applicable, name and address of the packager and conditioner
• Product name and, if necessary, name of the cosmetic group and product brand name
• Commercial presentation
• Cosmetic form (galenic form)
• Name oftechnical manager
• Proof of payment of tax established by the member country

2- Technical information

Product description with qualitative formula. A quantitative declaration is required for restricted substances and actives. If the product contains nanomaterials, national authorities should be informed of the chemical identity and size of these materials.

• List of ingredients in INCI
• Organoleptic and physico-chemical specifications of the end product
• Microbiological specifications
• Studies confirming the advantages, claims and cosmetic effects of the end product
• Label
• Instructions for product use, if applicable
• Primary and secondary (if applicable) packaging materials
• Description of the batch number codification system

Restrictions on ingredients are specified in the Decision. The authorities of the Andean Community refer to the following International Lists:

• List of ingredients from the Food and Drug Administration
• List of ingredients from The Personal Care Products Council
• List of ingredients from Cosmetics Europe
• Directives and Regulations on cosmetic ingredients from the European Union

The Community also took some measures around specific ingredients:

– Resolution 1905 « Por la que se prohíbe el uso de los parabenos de cadena larga como ingredientes para productos cosméticos en la Comunidad Andina » bans long-chain parabens.

– Resolution 1953 “Restricción y prohibición del uso de ingredientes utilizados en jabones cosméticos para el aseo e higiene corporal que tengan acción antibacterial o antimicrobiana“ bans some antimicrobial ingredients in soaps. It also restricts triclosan and triclocarban in other cosmetic products.

Microbiological limits applicable in the Community are specified in Resolution 2120 “Reglamento Técnico Andino sobre Especificaciones Técnicas Microbiológicas de Productos Cosméticos”, which will also be applicable on March 1, 2021.

Regarding labels, Decision 833 refers to the Andean Technical Regulation. However, as of today, this Regulation still does not exist, and Decision 516 is still applicable.

The following information must be included on the label, according to Decision 516:

• Name of the manufacturer or the person responsible for selling the product
• The product’s country of origin
• Nominal quantity in terms of weight or volume
• Precautions for use
• Lot number
• NSO number with the country of emission
• Ingredients list in INCI preceded by the word “Ingredients”

In Peru, the “Reglamento para el registro, control y vigilancia sanitaria de productos farmaceuticos y afines” refers to the Andean Community Decision regarding cosmetics.

In Ecuador, “Resolución 15 284-A” ratifies “Reglamento Técnico Ecuatoriano RTE INEN 093 (1R) Productos Cosméticos”, which is based on Decision 516.

How does it work?

BIORIUS can conduct a formula review and verification of required information on cosmetic product labels.

1. Formula Review: A toxicological and regulatory assessment of the ingredients and impurities as well as the establishment of the INCI list and warnings.Upon conclusion of the analysis, a formula review report is issued, which highlights the following elements:
   • Ingredients
   • Percentages of each ingredient
   • Restrictions (from Decision 833 and Resolutions 1905 and 1953)
   • Margins of Safety
   • INCI list
   • Warnings
   • Expert comments, including strategic recommendations
2. Verification of Required Information on Cosmetic Product Labels: Based on Decision 516.

Through these essential steps, BIORIUS assists with the preparation of the cosmetic registration file which is required for a product launch.