Cosmetic Regulation in the Andean Community
In the Andean Community (Bolivia, Colombia, Ecuador and Peru), cosmetic products are mainly regulated by Decision 833. All cosmetic products made available in these countries must undergo a Mandatory Sanitary Notification (NSO) and need to be manufactured according to Good Manufacturing Practices (GMP).
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

DECISION 833

The Andean Community (Comunidad Andina de Naciones – CAN) is composed by 4 South American countries: Bolivia, Colombia, Ecuador and Peru.

In 2018, CAN approved Decision 833, harmonizing the standards for cosmetic products originating from Andean countries and imported products from other countries. The main goal of this Decision is to establish requirements and harmonized procedures that cosmetic products must follow, in order to carry out its control and surveillance on the market and achieve a high level of health protection or human security, avoiding information that could mislead the consumer.

Decision 833, which has entered in to force on May 2020, regulates the production, storage, importation and commercialization of cosmetics, as well as its quality control and health surveillance.

According to this regulation, the definition of a cosmetic product is similar to the one set in the European Cosmetics Regulation ((EC) Nº 1223/2009): “every substance or formulation destined to be placed in contact with superficial parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity, with the exclusive or main view of cleaning them, perfuming them, changing or modifying their appearance, protecting them, keeping in good conditions or correct body odors“.

Moreover, Article 3 of Decision 833 is also harmonized with Article 3 of the European Cosmetics Regulation, stating that all cosmetic products that are introduced in the Andean Subregion should not harm human health when applied under normal and reasonably foreseeable conditions of use.

Cosmetic products intended to be placed in the Andean Community market need to comply with international lists on ingredients that can be added or not to products and their corresponding functions and restrictions of conditions of use. These lists are:

  • Lists and dispositions issued by the U.S. Food and Drug Administration (FDA).
  • The Personal Care Products Council Cosmetic Ingredient List.
  • Directives and Regulations of the European Union referring to cosmetic ingredients.
  • Ingredients lists of Cosmetics Europe – The Personal Care Association.

A Mandatory Sanitary Notification (NSO – Notificación Sanitaria Obligatoria) must be performed for all cosmetic products introduced in the CAN market. The owner of the NSO is the natural or legal person who notifies, modifies, renews or requests the recognition of the NSO to the Competent National Authority. This person must be located in the Member Country of notification or recognition and is responsible for the regulatory compliance of the cosmetic product.

Cosmetic products that are manufactured in the Member Countries or placed on the Community market, must be manufactured in accordance with Good Manufacturing Practices (GMP). Moreover, cosmetics must comply with microbiological content limits set out on the Andean Technical Regulation on Microbiological Technical Specifications of Cosmetic Products.

If you wish to get more information on this or other subject, feel free to contact us at info@criticalcatalyst.com.

References:

  1. Decisión 833. Armonización de Legislaciones en materia de Productos Cosméticos. Comunidad Andina.
  2. Resolution Nº 2120. Andean Technical Regulation on Microbiological Technical Specifications of Cosmetic products. 2019.

further
reading

drug_device_combination_1
medical devices

Regulatory Framework of Drug-Device Combination

The advances in technology continue to merge different types of products and the historical lines of separation between medical devices and medicinal products are getting thinner. Products combining medicinal products and medical devices are regulated either by Regulation (EU) 2017/745 (MDR) or by Directive 2001/83/EC.

Read More »
cosmetic products

SCCS Preliminary Opinion on Alpha-Arbutin and Beta-Arbutin

Alpha-arbutin and Beta-arbutin are used in cosmetic with antioxidant, bleaching and skin conditioning functions. Following concerns raised during discussion within the Working Group on Cosmetic Products and consequent call for data on these ingredients, the SCCS assessed the safety of Alpha-arbutin and Beta-arbutin in cosmetic products.

Read More »
cosmetic products

Request for SCCS Scientific Opinion on Citral

The European Commission requested the SCCS to assess whether the derived safe use levels for Citral by the application of the QRA2 based on the induction of skin sensitization is adequate to protect consumers. A period of 9 months was set for issuing the scientific opinion.

Read More »
cosmetic products

SCCS Scientific Advice on the Safety of Triclocarban and Triclosan

The European Commission Scientific Committee on Consumer Safety (SCCS) has published its preliminary version of the scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products. The deadline for comments was set at 27 May 2022.

Read More »
cosmetic products

Cosmetic Regulation in the Andean Community

In the Andean Community (Bolivia, Colombia, Ecuador and Peru), cosmetic products are mainly regulated by Decision 833. All cosmetic products made available in these countries must undergo a Mandatory Sanitary Notification (NSO) and need to be manufactured according to Good Manufacturing Practices (GMP).

Read More »
cosmetic products

Cosmetic Product Labelling in the European Union

The Regulation (EC) No 1223/2009 lays down the mandatory information that needs to be included in the packaging and container of a cosmetic products. In addition to this information, most cosmetic products include certain claims, which must be supported and properly substantiated.

Read More »
cosmetic products

Environmental Claims in the UK

Green claims are a trend among consumer goods and services. We often see claims like ‘clean beauty’, ‘environmental friendly’ and so many others. But how can companies ensure that these claims are not misleading? The UK’s Competition and Markets Authority (CMA) has published its Green Claims Code, in order to help companies comply with legal obligations when making environmental claims.

Read More »
cosmetic products

Parabens in Cosmetic Products

Parabens are widely used as preservatives in cosmetic and personal care products. Over the years, there have been some concerns related to the safety of parabens. The SCCS has published several opinions regarding the use of these ingredients in cosmetics, indicating the concentration levels they considered safe for human health. In the EU, some parabens can be safely used as preservatives, while others are prohibited in cosmetic products.

Read More »
cosmetic products

The Product Information File (PIF)

A Product Information File (PIF) is mandatory for all cosmetic products placed in the European Union market. It is a document that compiles the technical information of the cosmetic product and it must be kept for a period of 10 years by the Responsible Person.

Read More »