Decision 833 and its impact on NSO recognition of cosmetics in Peru
Jeanette Cornelio Bello
ABSTRACT
Cosmetic products in Peru are regulated by an Andean Regulation, which is called Decision. This article makes known in a very concise way the beginnings of the regulation of cosmetic products in the Andean Subregion in order to understand about the new decision, Decision 883, which has been in force since 2021. In this article, it is given to learn about 3 important changes identified in the current Decision and how they impact the application processes for recognition of a Mandatory Sanitary Notification in Peru.
KEY WORDS:
Mandatory Sanitary Notification, Mutual Recognition, Decision 516, Decision 833, generic name, cosmetic action, cosmetic product.
ABSTRACT
Cosmetic products in Peru are regulated by an Andean Regulation, which is called Decision. This article makes known in a very concise way the beginnings of the regulation of cosmetic products in the Andean Subregion in order to understand about the new decision, Decision 883, which has been in force since 2021. In this article, it is given to learn about 3 important changes identified in the current Decision and how they impact the application processes for recognition of a Mandatory Sanitary Notification in Peru.
KEY WORDS:
Mandatory Sanitary Notification, Mutual Recognition, Decision 516, Decision 833, generic name, cosmetic action, cosmetic product.
In order to understand the impact of the recent Decision 833, a regulation in force in all the countries of the Andean Community (Bolivia, Colombia, Ecuador and Peru), it is necessary to go back to the beginning of this century, which framework an important milestone in the regulation of cosmetic products.
Thanks to the effort and commitment of dedicated and countless meetings between the governmental and private entities of these countries, on March 8th, 2002, a model of advanced regulations in the Subregion was approved: Decision 516 “Harmonization of Legislation on Cosmetic Products”, which introduced two important concepts in the framework of the process of integration and harmonization of regulations among the member countries of the Subregion.
The first concept would be related to the establishment of a unique identification number of a cosmetic product acceptable and recognizable throughout the Andean Community, called Mandatory Health Notification (NSO). In this way, and according to what is established in this Decision, cosmetic products require for their marketing and circulation in the Andean Subregion of the Mandatory Health Notification, which is presented before the Competent National Authority of the first Member Country of marketing, attaching all the detailed information established in this Decision, and once the number or code of Mandatory Health Notification is granted, the other Member Countries will recognize the assigned number or code, that is, the adoption of the mutual and automatic recognition is established, which would be the second concept that gave rise to Decision 516.
The adoption of this decision laid the foundations in a positive way, creating a new dynamic and evolution both at the regulatory level, in the Andean integration processes, as well as at the level of trade in cosmetic products in the subregion.
This same basis is what has allowed, after almost 20 years, the governmental and private entities of the member countries to meet again, with the purpose of updating and adjusting the procedures to recognize and modify the Mandatory Health Notification, as well as the guidelines and directives that allow a more efficient control in the market with regard to the supervision of the Sanitary safety and quality of cosmetic products, as is literally indicated in the new decision that harmonizes the legislations in the field of cosmetic products: Decision 833, which entered into force on March 01st, 2021, repealing Decision 516 (with only articles 18, 19, 20, 22, 29 and its Annex 2 remaining in force, until the Andean technical regulations on labelling and GMP of cosmetic products enter into force).
Decision 833 maintains the essence and objective of its predecessor: to safeguard the protection of public or human health, through specific and transparent procedures; additionally considering and bearing in mind the advances and changes in economic and technological factors.
The changes and updates introduced in Decision 833 are not different from those established in Decision 516, and in spite of all the modifications made, this section will focus on 3 main changes, which are related to the impact of the process of recognition of a Mandatory Health Notification.
In the first place, it can be seen in Chapter I of the current Decision, which consists of only 2 articles, of which the second article includes 31 definitions, of which the following definition should be highlighted:
Generic denomination: Common name identifying a range of cosmetic products having the same function.
The need to highlight this new definition is because it is related to the second change identified in the Decision 833. In Chapter III, Article 9, where the requirements to request the issuance of the Mandatory Heath Notification are established, it is stated that, as part of the general information, the generic denomination that allows the identification of the product to be notified must be informed. Likewise, this article establishes that, as part of the technical information, the ingredients of the basic composition that exert their cosmetic action, even if they have no restrictions, must also be declared quantitatively.
The third change, which I consider to be the most important, is the inclusion of Chapter IV, which consists of a single article establishing the requirements for the purposes of Recognition of the Mandatory Health Notification before the Competent National Authorities of the other member countries, and which indicates that the holder of the Mandatory Health Notification must submit a certified copy or the electronic document containing the identification code of the Mandatory Health Notification, accompanied by a copy of the documents containing the information required in Article 9 submitted for obtaining the NSO of the first Member Country.
It is convenient to remember that the identification code of the Mandatory Health Notification is valid for 7 years; for this reason, in the Andean market there is an important percentage of products notified and recognized with the requirements of the repealed Decision 516.
In this regard, and as established in Article 2 of Decision 851, the identification codes of the Mandatory Health Notification issued before the entry into force of Decision 833 will remain in force until their respective expiration date; however, when the holders of a Mandatory Health Notification require modifications of information, renewals, and acknowledgments of their Mandatory Health Notification (NSO) code, they must comply with the provisions of the Decision in force.
That is to say, in the case that any company that has its products notified under the requirements of Decision 516, and would like to initiate a process of recognition of a Mandatory Health Notification in Peru, it must previously adapt before its Competent National Authority for the general and technical information of its products according to the new provisions established in the current Decision and which were detailed above. Subsequently, the application for recognition may be submitted to the Peruvian Competent National Authority (DIGEMID).
However, both processes imply evaluation times and perhaps additional times in case such requests have observations from the Competent Authorities of each CAN member country, therefore, the projections of commercializing a product under the new requirements may take longer than planned.
On the other hand, it is important that the NSO holders in Peru must take into account that the update and review of the new requirements are due to the fact that the standard under which their products were approved is no longer in force, and that a new application for recognition of an NSO is nowadays under the provisions of a new Decision.
The process of changes and adaptation may seem difficult, especially when it comes to regulations that may impact the timing of marketing projects, however, this process can be easier if you have the advice and guidance of experts in the field that facilitate the understanding of these changes, allow to establish the process of adaptation and thus achieve the approvals of these changes considering the plans of launches, marketing, among others. Likewise, it is of utmost importance to review the updates of the regulations governing cosmetic products and consult with an expert on the impact of such updates on the production, marketing, distribution and/or storage of such products; and thus be able to establish the necessary strategies to achieve the plans established for the marketing of a cosmetic product under the new provisions to be established in Peru.
REFERENCES:
- 1. Cosmetics Regulation in the Andean Community. Author: Andean Community. General Secretariat 2003
https://www.comunidadandina.org/biblioteca-andinoteca/regulacion-de-cosmeticos-en-la-comunidad-andina/
2. Decision 516
3. Decision 833