Regulation of Law No. 27,642 on the Promotion of Healthy Eating was approved

On March 22nd, 2022, the regulation of Law No. 27,642 on the Promotion of Healthy Eating, known as Front-of-Package Labeling Law (the “Law”) was approved. The regulation to the Law can be found in Annex I of Decree No. 151/2022 (the “Regulation”), which became effective on March 23rd, 2022.

Among the main aspects of the Law that have been regulated are the obligation to incorporate the warning label and its characteristics (sections 4 and 5), the maximum values that will define the excess of critical nutrients, calories, sweeteners, and caffeine (section 6), the prohibition of incorporating certain elements in containers/labels (section 9), the prohibitions/restrictions that will apply to advertising, promotions and sponsorships (section 10) and those prohibitions that will apply to educational establishments of the initial, primary and secondary level (section 12), the faculties of the enforcement authority and other governmental agencies (sections 13 and 14), and the deadlines that must be met (sections 19 and 20).

 On April 4th, the National Agency of Medicines, Food and Medical Technology (ANMAT, after its acronym in Spanish), acting within the framework of the faculties granted by the Law, incorporated into its website a system to carry out certain procedures and procedures derived from the Law.

Who are the obligated subjects?

The Regulation clarifies that the scope of “obligated subjects” extends to public and private persons, for-profit or non-profit entities, and to physical and online points of sale (section 3).

Nevertheless, the Regulation maintains the list contained in the Law (human or legal persons that manufacture, produce, fractionate, package, order to package or manufacture, distribute, market, import, place their logo on or otherwise participate in the marketing chain of food and non-alcoholic beverages for human consumption throughout the country). 

What products must have warning labels and how must said labels be applied?

Those foods and non-alcoholic beverages packaged in the absence of the customer in whose final composition the amounts of added sugars, saturated fats, total fats, sodium and/or energy are equal to or greater than the limits defined in section 6 of the Regulation, must include (a) warning label(s). Furthermore, a precautionary legend will be mandatory in those foods that contain sweeteners and/or caffeine in the terms of section 4 of the Law (section 4).

The Regulation also provides that food and non-alcoholic beverages packages with more than one main side must bear the appropriate warning label and the precautionary legend on each of them.

The technical specifications that the warning labels and precautionary legends must abide by are found in Annex II of Decree No. 151/2022.

What are the maximum nutrient limits?

Section 6 of the Regulation determines the cut-off points for critical nutrients (added sugars, saturated fats, total fats and sodium), sweeteners, caffeine and calories in two-tier table.

It is made clear that the cut-off points will not be applied to foods for specific medical purposes, dietary supplements and formulas for infants and children up to thirty-six (36) months of age.

Moreover, it is indicated that in the case of foods that require preparation with the addition of other ingredients or reconstitution for their consumption, the established limits must be applied to the prepared/reconstituted food ready for consumption, in accordance with the preparation instructions established by the manufacturer indicated on the label.

New Online Tool for Questions and Proceedings

ANMAT incorporated into its website a virtual tool that allows certain queries and procedures related to the procedures established in the Law and the Regulations to be carried out.

The services that this virtual tool currently provides are the following:

•    Stamp calculator: it is publicly accessible. It is used to carry out the official calculation of the critical nutrient profile and presents the warning stamps and precautionary legends that food products covered by the Law must include.

•    Affidavits: allows companies to present the affidavits of critical nutrients.

•    Extension manager: allows companies to submit the request for extensions and exceptions.

•    Search engine: allows online consultation of declared public information on food and non-alcoholic beverages, consolidated from the sworn declarations of the obligated subjects.

You can access this tool through the following link:

https://sellos.anmat.gob.ar/Home

Prohibition of incorporating certain information and/or elements in the containers/labels

The Regulation introduced some clarifications regarding section 9 of the Law. It is provided that packaged foods and non-alcoholic beverages that contain warning labels must not include any of the following in their packages:

•    Complementary Nutritional Information.
•    Logos or phrases with the sponsorship or endorsement of scientific societies or civil associations.
•    Popular characters among children, animations, cartoons, celebrities, athletes or pets, interactive elements, gifts or promised gifts, prizes, collectables, accessories, stickers, visual-spatial games, digital downloads, or any other item, as well as the participation or promise to participate in contests, games, sports, musicals, theatrical or cultural events, together with the purchase of products with at least one critical nutrient in excess, that encourage, promote or foster their consumption, purchase or choice.

The Regulation clarifies that (i) by the term “civil associations or scientific societies” it must be understood as those entities or organizations of people dedicated to any of the branches of medicine, nutrition and/or sports; (ii) by the term "children's characters" it must be understood those aimed at children and adolescents, where human actors or human actresses participate, as well as cartoons, licensed characters or caricatures, of any origin and in any animation technique ; and (iii) the term celebrities "refers to actors as well as musicians and social media influencers."

On the other hand, it should be noted that, while the Law indicates that the prohibitions are applicable to "packages", the Regulation establishes that those prohibitions refer to the "labeling" of food and non-alcoholic beverages. Both terms have clearly different meanings under Argentine legislation.

Restrictions and prohibitions on advertising, sponsorships, promotions

The Regulation establishes that all advertising, promotion and/or sponsorship addressed to the public and divulged through traditional and digital mass media of packaged non-alcoholic foods and beverages that contain a warning label will be under the supervision and control of ANMAT. The ANMAT  must issue the explanatory or complementary regulations for the implementation of these rules in accordance with the  medium in which the advertising is carried out (section 10). To the present date, ANMAT has not yet issued any explanatory or complementary regulations.

Prohibitions in educational establishments

Article 12 of the Regulation sets forth that no food nor any non-alcoholic beverages may be offered, commercialized, advertised, promoted, or sponsored in educational establishments of the initial, primary, and secondary level of the National Educational System if containing any warning seal..

Enforcement Authority

The Regulation designates the Ministry of Health as the Law enforcement authority at the national level and clarifies that it may act in coordination with: (i) ANMAT; (ii) the Ministry of Foreign Affairs, International Trade and Worship; (iii) the Ministry of Productive Development, (iv) the National Communications Entity (ENACOM), (v) the Ministry of Education, (vi) the Ministry of Social Development, and (vii) the National Contracting Office (section 13).

On the other hand, the Regulation sets forth that to obtain the approval of the labels of the products covered by Section 4 of the Law, the obligated subjects must report to the National Food Institute (dependent on ANMAT), through a sworn statement, the information on the content of critical nutrients and calories, as well as the presence of sweeteners and/or caffeine. In this sense, the Regulation states that ANMAT will establish the complementary regulations for the purposes of compliance with the aforementioned affidavit (section 14).

Sanctions regime

The Regulation clarifies that the application of the sanctions set forth in Decree No. 274/2019 will be independent of the claims that could be made by any person under Law No. 24,240 on Consumer Protection. Moreover, the creation of a National Registry of Infractions of the Law is foreseen (section 15).

Deadlines

The Regulation establishes a schedule of two (2) stages for the fulfillment of obligations arising from the Law, in relation to the due dates (“cut-off points”) set forth in section 6 of the Regulation (section 19):

i.    First stage

The first stage comprises the first nine (9) months as of the entry into force of the Law. This period is extended to fifteen (15) months for Small and Medium Enterprises (“PyMES”, as per its acronym in Spanish). This first stage may be extended by ANMAT only once and for justifiable reasons for 180 calendar days, counted as of the expiration of the previous terms.

ii.    Second stage

The Second Stage has as a limit for its implementation a term of eighteen (18) months as of the date of entry into force of the Law, which extends up to twenty-four (24) months for PyMES.

There are sections of the Law and the Regulation whose scope and interpretation are not yet clear or may be contradictory. Thus, it is very likely that the Ministry of Health, in its capacity of enforcement authority, even  if acting jointly together with other regulatory bodies provided for in the Regulation (such as ANMAT), will need to issue complementary regulations to provide more clarity about its proper implementation and scope.