El Salvador has recently updated its implementation of Central American Technical Regulation (RTCA) No. 71.01.35:06: Productos Cosméticos. Registro sanitario y autorización de productos Cosméticos (“Cosmetic Products. Sanitary Registration and Authorization of Cosmetic Products”; RTCA No. 71).
For those unfamiliar with some of the chemical and consumer product regulatory terms used in Central and South America, a “sanitary registration” is generally defined as the National registration (authorization) required for any product applied to or entering the body—whether a device, instrument, or pharmaceutical. Each of such products must be subjected to a variety of microbiological and physiochemical tests, whose data will be used, in part, to determine the product(s) fitness for registration. More specifically, “[i]t is a guarantee that accredits the company and certifies that its products are safe for consumption and use, with high standards of marketing, import, export and distribution.”[1] The precise definition(s) of “cosmetic products” may vary depending on the intended use, country, market(s) and other aspects, but they can generally be understood to mirror the Comunidad Andina (“Andean Community”) Decisión 833, Armonización de Legislaciones en materia de Productos Cosméticos (“Harmonization of Legislation in Matter of Cosmetic Products”) which explains such 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.”
The manifest purpose of RTCA No. 71 is to “establish the conditions and requirements under which the registration or registration of cosmetic products for marketing [sic].” Section 4 of RTCA No. 71 presents the Definitions used under the Regulation. Of specific note here is Section 4.9, which mandates “The cosmetic product that, due to its components, is attributed properties therapeutic [sic], it must be registered as a medicine”. Thus Section 4.9 is highly proscriptive. Additionally, in Section 4.15, we see the definition of “Holder of the sanitary register”, which is consistent with the way in which many Central and South American countries manage these types of registrations – where the person making the registration is the “owner of the registry”. That is, the person who first presents the registration application to the competent authority is considered to be the legal owner of the registration once granted. For this reason, m4 Global Consulting LLC recommends that companies wishing to make sanitary registrations in the region carefully consider the potential pitfalls of having a distributor, a customer, or other non-legally affiliated person make these or any other regulatory notifications.
Section 5.1 is of particular interest, as it establishes the following:
“For the health registration or registration of cosmetic products, the States Parties will adopt the updated lists of:
5.1.1 Annex II (List of prohibited substances in cosmetic products);
5.1.2 Annex III (List of substances that cosmetic products may not contain except with the established restrictions);
5.1.3 Annex IV (List of colorants admitted in cosmetic products);
5.1.4 Annex V (List of preservatives admitted in cosmetic products); and
5.1.5 Annex VI (List of ultraviolet filters allowed in cosmetic products) of the Regulation (EC) No 1223/2009 of the European Parliament and of the Council and its updates.”
Section 5.1 also decrees “Compilations published by PCPC, the Personal Care Product [Council] will also be recognized. Council of the USA the European database – Cosing, with preeminence the list less restrictive [sic]”. Cosing is the European Commission database for information on cosmetic substances and ingredients contained in the: Cosmetics Regulation (EC) No 1223/2009 of the European Parliament and of the Council, Cosmetics Directive 76/768/EEC (cosmetics directive), as amended, Glossary of common ingredient names for the purpose of labelling cosmetic products placed on the market (as established by Decision (EU) 2019/701 of 5 April 2019), and the Opinions on cosmetic ingredients of the Scientific Committee for Consumer Safety (list of SCCS opinions)].
Section 6 details the specific “Requirements for the Registration or Sanitary Registration of Cosmetic Products”. It expressly notes “All documents must be presented in Castilian/Spanish language. Official documents written in a different language must be submitted with their respective translation(s)”. Interestingly, and perhaps concerningly from Intellectual Property or business confidentiality points of view, Section 6.8 requires the “[p]resentation of a copy of the contract by third parties or the manufacturer’s document that clarifies the relationship between them” (when applicable). It is unclear if there is a means to either exempt firms from providing such and/or if such information may be kept confidential.
Section 7 speaks to the specific “Content of the Product Registration Application [for] Cosmetics”. In an apparent nod (intentional or otherwise) to some of the aspects of the United States’ Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), NOTE 1 of the section asserts “Several manufacturers may be included in the registration application, as long as the product is of the same owner, keep[s] the same formula, specifications and labeling by all its manufacturers. Likewise, [y]ou must provide the data and documents for each manufacture”.
Section 8 addresses “Subsequent Modifications to the Registration or Registration Sanitary [sic] of a Cosmetic product”. Specifically, “When changes are made to the cosmetic product, the interested party must request their approval to the authority attaching the requirements for the processing of the modifications that are listed below.” As with Section 6, Castilian/Spanish language is required, with translations as necessary. Among the modifications directly addressed by this section are a change of manufacturer, a change of ownership, a formulation change, a change of either the manufacturing company name or the owner’s name, a product name change, the additional of an alternate manufacturing facility, a change in packaging/presentation, adding or removing shade(s), variants or fragrance(s), change/addition/removal of a distributor, and a change of legal representative.
Per Section 9, registrations are valid for five years from the date of issuance. Section 10 directs that renewal requests must be made in advance of the expiration period, although it is unclear from the text if a granted renewal request will be for an additional five-year term or for some other period. Finally, Section 12 lists the “Causes for Cancellation of the Sanitary Registration or Registration of a Cosmetic Product” (although it is unclear from the text if this list is exhaustive), and Section 13 provides the requirements for monitoring and verification (of products so regulated herein).
[1] Sanitary Registrations. Lara IP. Retrieved from https://laraip.com/en/sanitary-registrations/#:~:text=Technically%2C%20sanitary%20registrations%20are%20an,as%20well%20as%20medicinal%20products.&text=In%20addition%20to%20the%20above,that%20is%20a%20quality%20product.
Michael S. Wenk, President/Director of m4 Global Consulting LLC, has written and spoken extensively on chemical regulation in the South America and the Middle East, most recently publishing the handbook “Chemical Regulation in the Middle East” under the Wiley and Sons imprint in 2018. Mr. Wenk is a globally-recognized authority on the topics, and m4 Global Consulting LLC has the experience, resources and expertise to assist companies in complying with the myriad of regulations in these regions.
Mr. Wenk can be reached at +(678) 836 6419, or by e-mail at michael@m4globalconsultingllc.com.
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