Introduction
Scope
Applicability
Comment
On 5 July 2022, a Mexican standard (NOM) setting out good manufacturing practices (GMPs) for cosmetic products(1) was published in the Federal Official Gazette. The NOM aims to:
- establish the necessary health controls that are applicable to legal entities and premises operating in the cosmetics industry regarding the manufacturing of cosmetic products and related processes;
- guarantee that such products do not represent risks to consumers' health;
- implement preventive systems; and
- control and verify cosmetic products' quality to assure their safety.
The GMPs have been established as guidelines that are applicable to the manufacturing of cosmetic products, and the NOM has been issued to establish the basic requirements that must be followed during the production process, including with regard to:
- production conditions;
- personnel;
- storage; and
- packaging.
The NOM also establishes requirements to guarantee the quality and safety of cosmetic products and their use, consumption and effectiveness through the implementation of the GMPs. The GMPs are considered as the basis for the health authorities to ensure that:
- manufacturing and other processes take place under safe conditions;
- quality improvements are made; and
- risks to consumers' health are eliminated or reduced.
Among the concepts included in the NOM are:
- terms and definitions;
- symbols;
- personnel health and safety requirements;
- training;
- requirements relating to physical facilities;
- services;
- cleaning and maintenance;
- equipment;
- accessories and utensils;
- raw materials and packaging materials;
- production controls;
- storage;
- transport;
- quality control;
- complaints;
- product returns and recalls; and
- documentation requirements.
The NOM is applicable not only to the manufacturing of cosmetic products and related processes carried out within Mexican territory, but also to products imported into Mexican territory. In general, it applies to all processes up to the products' delivery to the final consumer.
The content and general scope of the NOM present important challenges for manufacturing companies and especially for importers of this type of product. It imposes obligations on importers to be informed of the manufacturing processes relating to the products and to be able to trace such processes, even where they correspond to foreign manufacturers. Further, several obligations are established that go beyond those specifically set forth by the General Health Law and its various regulations relating to this type of product.
The NOM will enter into force on 2 September 2022. However, the obligations relating to the documentary controls established therein will enter into force 180 calendar days following the NOM's publication – that is, on 31 December 2022. The obligation to comply with the requirements relating to the technical requirements of the facilities will enter into force 240 days after the NOM is published – that is, on 1 March 2023.
Adapting the production and marketing systems of cosmetic products to the provisions included in the NOM represents a serious challenge for the industry. Its implementation will undoubtedly lead to possible verifications and actions by the health authorities, both at federal and state level.
For further information on this topic please contact José Alberto Campos Vargas at Sanchez-DeVanny Eseverri SC by telephone (+52 55 5029 8500) or email ([email protected]). The Sanchez-DeVanny Eseverri SC website can be accessed at www.sanchezdevanny.com.
Endnotes