ANVISA amends food regulations

As a result of Decree No. 10,139 of 2019, ANVISA published on July 06, 2022  18 Food-Related Resolutions of the Collegiate Board, which will enter into force on September 01, 2022, with the purpose of reviewing rules and consolidating regulations.   

In general, the rules provide for health requirements for food production, labeling of packages and food composition.   

Below is a list of the main rules divided into subjects:   

Subject – Health requirements for the production of food substances: the revisions of these rules aim to establish appropriate safety parameters for the production of the following foods.  

1. RDC 711/2022: starches, biscuits, whole cereals, processed cereals, brans, flours, wholemeal flours, pastas and breads. Resulted from the revision of RDC 236/2005; 
2. RDC 713/2022: edible ices and edible ice preparations. Resulted from the revision of RDC 266/2005; 
3. RDC 714/2022: enrichment and restoration of foods. Resulted from the revision of Ordinance SVS/MS 31/1998;  
4. RDC 715/2022: hyposodic salt, weight-control foods, foods for nutrient-restricted diets and foods for diets with controlled sugar intake. Resulted from the revision and consolidation of Ordinances SVS/MS 54/1995; SVS/MS 29/1998; SVS/MS 30/1998; RCD 135/2017 and RCD 155/2017; 
5. RDC 716/2022: coffee, barley, teas, Yerba mate, spices, seasonings and sauces. The RDC provides for IN 159/2022, which establishes the lists of parts of vegetable species authorized for brewing teas and for use as spices. Resulted from the revision and consolidation of RDC 267/2005; RDC 276/2005; RDC 277/2005, RDC 219/2006 and arts. 2 and 3 and Annexes I and II of RDC 450/2020; 
6. RDC 717/2022: bottled water and ice for human consumption. Resulted from the revision and consolidation of RDC 274/2005 and RDC 316/2019;
7. RDC 719/2022: mixtures for preparation of food and ready-to-eat foods. Resulted from the revision of RDC 273/2005; 
8. RDC 720/2022: nutritionally modified or enhanced foods. Resulted from the revision of RDC 3/2013; 
9. RDC 723/2022: sugar, inverted sugar syrup, powdered sugar, table-top sweetener, candy, bonbons, cocoa powder, soluble cocoa, chocolate, white chocolate, chewing gum, cocoa butter, cocoa mass, molasses and rapadura sugar. Resulted from the revision and consolidation of Resolution CNNPA 3/1976 and of RDC 264/2005; RDC 265/2005; RDC 271/2005 and RDC 450/2020; 
10. RDC 726/2022: edible mushrooms, fruit products and vegetable products. Resulted from the revision and consolidation of RDC 17/1999; RDC 91/2000; RDC 268/2005; RDC 272/2005 and RDC 85/2016.  

Subject – Food and nutrition labeling: the revision of these rules introduces new parameters for label information, aimed at improving consumer comprehension and providing more transparent information.  

1. RDC 712/2022: labeling of foods containing cereals and pseudocereals for the classification and identification of such products as wholemeal products, and for highlighting the presence of whole ingredients. Resulted from the revision of RDC 493/2021; 
2. RDC 727/2022: labeling of packaged foods. Result of the revision and consolidation of the RDC 259/2002; RDC 123/2004; RDC 340/2002; RDC 35/2009; RDC 26/2015; RDC 136/2017; RDC 459/2020 and IN 67/2020; 
3. RDC 729/2022: nutrition facts labeling of packaged foods. This rule will enter into force on October 09, 2022. 

Subject – food composition: the new provisions aim to establish standards that prevent the production of unsafe foods, in order to protect the health of the consumer.  

1. RDC 722/2022: maximum permitted levels of contaminants in food. Resulted from the revision of RDC 487/2021, IN 160/2022, IN 88/2021, IN 115/2021 and IN 152/2022; 
2. RDC 724/2022: microbiological standards of food and their application. Resulted from the revision of RDC 331/2019, IN 161/2022, IN 60/2019, IN 79/2020 and IN 110/2021; 
3. DRC 725/2022: flavoring additives. Resulted from the revision and consolidation of RDC 2/2007 and IN 15/2017; 
4. RDC 728/2022: enzymes and enzyme preparations for use as technology adjuncts in the production of foods for human consumption; 
5. DRC 730/2022: assessment of the risk of veterinary medicinal products to human health, of the maximum limits for veterinary medicinal product residues in animal source foods, and of the analysis methods for conformity assessment purposes. Resulted from the revision of RDC 328/2019, IN 162/2022, IN 51/2019, IN 89/2021 and IN 117/2022.  

Companies of the food sector will have a 2-month deadline to adapt their production and operation in accordance with the new regulatory provisions.   

Demarest’s Life Sciences team is monitoring the updates of the industry and is available to provide any further clarification that may be necessary.