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).


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


  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.


medical devices

Safety Reporting in Clinical Investigations: a Gap Analysis of Guidance Documents 

Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.

Read More »
medical devices

Roles and Responsibilities of an Authorised Representative under EU MDR and IVDR 

If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.

Read More »
medical devices

Understanding the ISO Standards Lifecycle

ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements. But how exactly is a Standard developed, reviewed and withdraw?

Read More »
medical devices

Amendments to the Transitional Provisions of the European Union MDR and IVDR

The proposed amendments aim to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The ammendments proposal aims to extend the current transition period (Article 120 of the MDR), and it also deletes the ‘sell-off’ deadlines of both MDR and IVDR. The extension is staggered depending on the risk class of the device – until December 2027 for high-risk devices and December 2028 for medium and lower-risk devices.

Read More »
medical devices

EU MDR – Proposal for Extension of Transition Period

The transition to MDR has been slower than anticipated by the European Commission. Insufficient capacity of notified bodies and the low level of preparedness of manufacturers led to a proposal for extension of current MDR transition period with deadlines depending on the risk class of the devices.

Read More »
medical devices

MDCG 2022-18 – EU MDR Article 97

EU MDR Article 97 may be a temporary solution to avoid disruption of supply of Medical Devices on the EU Market. The MDCG 2022-18 presents a uniform approach for application of MDR Article 97 on non-compliant legacy devices under the conditions set by the competent authorities, while limiting the impact on the supply of safe and effective devices.

Read More »
cosmetic products

EU to set Labelling Requirements for 56 additional Fragrance Allergens in Cosmetic Products

World Trade Organization (WTO) has been notified by the European Commission of a draft amendment to Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in Cosmetic Products. The proposed date of adoption of the new regulation is expected to be in the first half of 2023 and the propose date of entry in force 20 days from the publication in the Official Journal of the European Union.

Read More »
cosmetic products

New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Read More »