OFFICIAL BULLETIN REPUBLIC OF ARGENTINA – NATIONAL ADMINISTRATION OF PHARMACEUTICALS, FOOD AND MEDICAL DEVICES

OFFICIAL BULLETIN REPUBLIC OF ARGENTINA – NATIONAL ADMINISTRATION OF PHARMACEUTICALS, FOOD AND MEDICAL DEVICES

Provision 3015/2022

DI-2022-3015-APN-ANMAT#MS

City of Buenos Aires, 04/19/2022

SEEN EX-2022-27740039- -APN-DPVYCJ#ANMAT and

IN VIEW OF:

That these actions were taken as a result of a complaint received by the National Food Institute’s (INAL) Department of Food and Nutritional Surveillance of Food relating to the marketing of the product: Artisan Muesli – No Added Sugar – No Preservatives Energizing! with Nutrinola brand Andean Maca, cont. net 1 kg, Santa Fe – Argentina, which does not comply with current regulations.

For this reason, the Food and Nutritional Surveillance Department of Food issued Federal Consultation No. 7693 through the Federal Information System for Food Control Management (SIFeGA) to the Santa Fe Food Safety Agency (ASSAl) to report the product has been registered.

That in this sense, the ASSAI reported that there are no records of the product with these dates in their database.

In this context, it is highlighted that Maca is not provided for in the Argentine Food Code (CAA), so its use as an ingredient is not allowed.

That according to the provisions of Articles 1, 2 and 8 of the Argentine Food Code (CAA), all food, condiments, beverages or their raw materials and food additives that are prepared, divided, preserved, transported, sold or exposed must meet the requirements of the above code fulfill.

That there are also records in which ANMAT Regulation No. 5323/2016, published in the Official Gazette of May 19, 2016, prohibited the marketing throughout the national territory of products in which maca of any kind is found among its ingredients brand.

On the other hand, that the ASSAl reported as part of the investigation that they were marketing other varieties of Nutrinola muesli on online sales platforms with the inscription: Artisanal muesli – without preservatives – 100% vegan, invented name: Cocada; Handmade muesli – no added sugar – no preservatives, fancy name: Traditional; Tropical Granola – 100% vegan and granola base – suitable for vegans – no preservatives.

The ASSAI drew attention to this through Federal Consultation No. 7693 that there are no records of products with this brand, this name and this trade name in its database.

As a result, the Department of Food and Nutritional Control of Food has reported Federal Incident #3066 in the Food Control Information System (SIVA) module of SIFeGA and forwarded these actions to ANMAT’s Directorate of Institutional Relations for their knowledge and assessment of the to measures taken in relation to the promotion and sale of products on online sales platforms.

That the product Artisan Granola – no added sugar – no preservatives Energizing! Andean Maca branded Nutrinola violates Article 3 of Law 18284, Article 3 of Annex II of Decree 2126/71 and Articles 6 bis, 8, 13 and 155 of the CAA, due to the lack of health records on the product and establishment , contain a Ingredient not allowed in food resulting in mislabeled product and consequently illegal.

That the rest of the Nutrinola brand granola varieties violate Article 3 of Law 18284, Article 3 of Annex II of Decree 2126/71 and Articles 6 bis, 13 and 155 of the CAA, due to the lack of health records for products and establishments in mislabeled products and therefore illegal.

Since these are products that cannot be reliably and unequivocally identified as being manufactured, processed and/or fractionated in a specific establishment, they may not be manufactured in any part of the country, nor marketed or sold in the territory of the Republic, which is prohibited by Article 9 of the Law 18284 is regulated.

This is in view of the circumstances and to protect the health of citizens against the consumption of illegal products, since they are foodstuffs that are not registered, which is why their traceability cannot be guaranteed, their production conditions, their quality with an appropriate level of control In accordance with the conditions established by current regulations and their safety, the Food Responsibility Department of INAL recommends prohibiting the processing, fractionation and marketing of the above foods throughout the national territory.

That, in relation to the proposed action, this national administration is competent by virtue of the powers conferred by Article 8, subsection – of Decree No. 1490/92.

That the proposed procedure falls within the supervisory and control functions corresponding to the National Administration of Drugs, Foodstuffs and Medical Devices (ANMAT).

That the INAL and the ANMAT Summaries Coordination Directorate have taken the intervention of their jurisdiction.

That it acts in the exercise of the powers conferred by Decree No. 1490/92 and Decree No. 32 of January 8, 2020.

Therefore,

THE NATIONAL ADMINISTRATOR OF THE NATIONAL ADMINISTRATION OF DRUGS, FOOD AND MEDICAL DEVICES

HAS:

ARTICLE 1.- The manufacture, fractionation and marketing of Nutrinola branded products throughout the national territory and on online sales platforms is prohibited: Artisan Muesli – No Added Sugar – No Preservatives Energizing! with Andean Maca from Nutrinola, artisan muesli – without preservatives – 100% vegan, invented name: Cocada; Handmade muesli – no added sugar – no preservatives, fancy name: Traditional; Tropical Granola – 100% Vegan and Granola Based – Suitable for Vegans – No Preservatives Santa Fe – Argentina due to lack of sanitary product and facility registrations resulting in mislabeled products and consequently illegal.

Attached is an image of the labels of the products listed in the APPENDIX, which, registered under IF-2022-29600777-APN-DLEIAER#ANMAT, forms an integral part of this provision.

ARTICLE 2.- Communicate, publish, transmit to the NATIONAL DIRECTORATE OF THE OFFICIAL REGISTER and archive.

manuel limeres

NOTE: The annexes that make up this provision are published in the web edition of BORA -www.boletinoficial.gob.ar-.

and. 21.04.2022 No. 25816/22 from 04/21/2022