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Celiac Disease. Law 26.588. Modification.

Original Language Title: Enfermedad Celíaca. Ley 26.588. Modificación.

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Law 27196

Celiac Disease. Law 26,588. Amendment. Sanctioned: October 07, 2015 Enacted in Fact: November 12, 2015

The Senate and Chamber of Deputies of the Argentine Nation, meeting in Congress, etc., are sanctioned by law:

ARTICLE 1-Incorporate as Article 4 (a) of Law 26,588, of celiac disease, the following:

' Article 4 ° bis: The institutions and establishments listed below must offer at least one food option or a gluten-free menu (without TACC) that meets the manufacturing conditions and nutritional requirements by portion, certifying the implementing authority: (a) Places intended for persons in situations of deprivation of liberty; (b) Health facilities with admission to the public, private and social security sectors; (c) places of residence and/or temporary coexistence; or (d) the canteens and kiosks of educational institutions; e) air, land and water transport undertakings offering food service on board; (f) restaurants and bars; (g) kiosks and dealers (i) the fast food premises; (i) the food of the terminals and the transport operators; (h) Those determined by the implementing authority in coordination with the jurisdictions in accordance with the availability of those already laid down in this Article. '

ARTICLE 2-Substitute Articles 1 °, 3 °, 4 °, 5 °, 6 °, 7 °, 8 °, 9 °, 11, 12, and points (a), (b), (c), (f) of Article 13, and incorporating point (g) to Article 13 of Law 26,588, which shall be drawn up as follows:

' Article 1 °: State of national interest the medical action, clinical and epidemiological research, professional training in early detection, diagnosis and treatment of celiac disease, its dissemination and access to food and Gluten-free medicines.

Article 3: The application authority is to determine the quantity of wheat gluten, oats, barley or rye gluten (TACC) containing by unit of measure the foodstuffs and the medicinal products to be classified as gluten-free or with gluten content. To the extent that detection techniques are permitted by the implementing authority, the gradual decrease in toxicity shall be established.

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Article 4 °: Foodstuffs and medicinal products which are marketed in the country, and which comply with the provisions of Article 3 of this Law, in order to be considered as gluten-free, must be printed on their packaging or packaging and in their labels and leaflets, respectively, in a clearly visible manner, the 'gluten free' legend and the symbol established by the implementing authority. All medicinal products or medicinal products included in the Register of Medicinal Products which cannot dispense with gluten as an integral part of their formula must be based on their presence and be quantified by "unit of dose". (a) a pharmaceutical form conforming to the provisions of Article 3 of this Law. Medicines that use gluten-containing ingredients should clearly include the legend: 'This medicine contains gluten'.

Article 5: The Ministry of Health must keep a record of the food products and the medicinal products that are marketed in the country and which comply with the provisions of Article 3 of this Law, which will be updated bimonthly and publish once a year by the means determined by the implementing authority. '

Article 6: The implementing authority should promote compliance with the conditions of good manufacturing practice for the production and control of food products and medicinal products that are marketed in the country and which comply with the requirements of this Regulation. with the provisions of Article 3 of this Law, coordinating actions with the laboratories of bromoology and medicinal products. '

Article 7 °: Producers and importers of foodstuffs and of medicinal products intended for coeliacs must certify for their marketing in the country the condition of "gluten free", as provided for in Article 3 of this Law.

Article 8 °: Producers, importers or any other natural or legal person who places foodstuffs and medicinal products on the market, as provided for in Article 3, must disseminate, advertise or promote them by accompanying the advertising or spreading the legend "gluten free" or "This medicine contains gluten" as appropriate. If the form of broadcast, advertising or promotion allows it, the legend must be informed visually and soundly.

Article 9 °: The social works framed in laws 23,660 and 23,661, the social work of the Judicial Branch of the Nation, the Directorate of Social Aid for the National Congress Staff, the pre-paid medical entities and the entities that provide care to the staff of the universities, as well as all those agents who provide medical care services to their members regardless of the legal status they possess, must provide care coverage to people with celiac, who includes the detection, diagnosis, monitoring and treatment of the same, including flours, premixtures or other industrial foods which require certification as a gluten-free condition, the coverage of which shall be determined by the implementing authority, in accordance with nutritional requirements and by updating its amount periodically according to the official consumer price index of the National Institute of Statistics and Census (INEC).

Article 11: The Ministry of Health, in coordination with the Ministry of Science, Technology and Innovation

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Productive and the universities of the National University System, must promote research on celiac, in order to improve the methods for early detection, diagnosis and treatment of the disease. The Ministry of Health, in coordination with the Ministry of Education, should develop dissemination programs in the educational fields, in order to promote awareness of celiac and the competent national public bodies. promote incentive measures for access to gluten-free food and medicines. Likewise, the Ministry of Health of the Nation will have to promote and implement training activities of celiac patients and their family group in the self-production and preparation of food suitable for their consumption.

Article 12: The Executive Branch must adapt the provisions of the Argentine Food Code and the ANMAT Register of Medicinal Specialties to the provisions of this law within the period of ninety (90) days of its official publication.

Article 13: The following conduct shall be considered to be an infringement of this law: (a) the impression of 'gluten free' legends or 'This medicinal product contains gluten' in packaging or packaging of foodstuffs and medicinal products which do not comply with the provisions of Article 3 of this Law; good manufacturing practices to be established for the production and control of foodstuffs and medicinal products which are marketed in the country and which comply with the provisions of Article 3 (c) any form of dissemination, advertising or promotion such as "gluten free", food products and medicines that do not comply with the provisions of Article 3 (f) The lack of supply of food options or gluten-free menus in accordance with the provisions of Article 4 (a); (g) the actions or omissions to any of the obligations laid down, committed in infringement of this law and its regulations which are not mentioned in the preceding points. '

ARTICLE 3 °-Commune to the National Executive Branch.



BELOVED BOUDOU. -JULIAN A. DOMINGUEZ. -Juan H. Estrada. -Lucas Chedrese.

Date of publication: 18/11/2015

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