The National Agency for Regulation, Control and Sanitary Surveillance (“ARCSA”) has incorporated new categories and activities into its sanitary operating permit system. This update falls within the general regulatory framework governing operating permits and the resolutions issued by ARCSA during 2026.

Below, we outline the applicable regulations and the new activities that require an operating permit:

1. Applicable Regulations. Resolution No. ARCSA-DE-2023-001-AKRG, published in Official Gazette No. 238 on January 26, 2023, issued the “Substitute Technical Sanitary Regulation for Granting Operating Permits to Establishments Subject to Sanitary Control and Surveillance, Except for Health Service Establishments,” which constitutes the general framework for obtaining a sanitary operating permit.

2. New Categories and Activities. Through Resolution No. ARCSA-ARCSA-2026-0007-R, published in the Second Supplement to Official Gazette No. 245 on March 17, 2026, ARCSA ordered the implementation in its electronic system of new categories, activities, requirements, and fees applicable to operating permits. Subsequently, through Resolution No. ARCSA-ARCSA-2026-0009-R, published in Official Gazette No. 272 on April 24, 2026, the deadline for such implementation was extended until June 18, 2026.

3. New Activities Subject to an Operating Permit. Pursuant to the extension provided for under
   Resolution No. ARCSA-ARCSA-2026-0009-R, in August 2026 ARCSA published the new classification
   of establishments and activities, pursuant to which the following activities have been determined to be
   subject to obtaining the corresponding operating permit:

Pharmaceutical Sector and Medical Devices: (i) Pharmaceutical laboratories for biological products, (ii) Pharmaceutical laboratories for radiopharmaceuticals, (iii) Distributors of active pharmaceutical ingredients, (iv)Representative offices and distributors of medical devices, including baby bottle nipples and feeding bottles, and (v) Logistics and/or storage of medical devices.

Cosmetics, Hygiene Products, and Pesticides: (i) Conditioning of cosmetic products, household hygiene products, absorbent personal hygiene products, or combined products, and (ii) Companies engaged in the commercialization of pesticides for household, industrial, or public health use.

Food: (i) Processing facilities for edible ice and frozen products, excluding dairy-based products, (ii) processing facilities for salt, spices, seasonings, creams, broths, sauces, and dressings, (iii) processing facilities for foods intended for special dietary purposes, (iv) processing facilities for snacks, and (v) processing facilities for food products and dietary supplements containing non-psychoactive cannabis or hemp, or derivatives thereof.

Collective Food Services and Tobacco: (i) Catering services, (ii) Manufacturers of tobacco products, (iii) Distributors of tobacco products, including electronic devices that release nicotine, and (iv) Retailers of tobacco products, including electronic devices that release nicotine.

Cosmetology and Beauty: (i) Establishments providing combined cosmetology and aesthetic services, (ii) Spas, (iii) Beauty salons, and (iv) Hair salons and/or barbershops.

Tourism and Accommodation: (i) Bars registered with MINTUR, (ii) Hotels, (iii) Hostels, (iv) Inns, tourist haciendas, and lodges, (v) Resorts, (vi) Shelters, (vii) Tourist camps, (viii) Guest houses, and (ix) Other accommodation and lodging services not previously listed.

Care and Recreation: (i) Child development centers, (ii) Children’s homes, shelters, and children’s villages, (iii) Shelters for adults and older adults, and (iv) Swimming pools, thermal baths, steam baths, Turkish baths, saunas, whirlpools, and showers.

For further information, please contact:

• María Rosa Fabara Vera: mrfabara@bustamantefabara.com
• Andrés Becdach Fierro: abecdach@bustamantefabara.com
• Tomás Bonilla Sevilla: tbonilla@bustamantefabara.com