| Journal of Food Bioactives, ISSN 2637-8752 print, 2637-8779 online |
| Journal website www.isnff-jfb.com |
Review
Volume 12, December 2020, pages 87-96
The gap between scientific evidence and food regulation: analyzing the updated Brazilian normative on the use of bioactives in food supplements
Tables
| Bioactive compound | 0–6 months | 7–11 months | 1–3 years | 4–8 years | 9–18 years | >19 years | Pregnant women | Breastfeeding women | Claims | Observations |
|---|---|---|---|---|---|---|---|---|---|---|
| NA: Not authorized. The approved dosages correspond to the amount that must be present in the full product. Source: Adapted from Anvisa (2020c). | ||||||||||
| Hyaluronic acid (mg) | NA | NA | NA | NA | NA | 157.7 | NA | NA | – | – |
| Boron (mg) | NA | NA | NA | NA | NA | 8.866 | NA | NA | – | – |
| Undenatured Type II Collagen (mg) | NA | NA | NA | NA | NA | Min 1.2 | NA | NA | Undenatured Type II collagen helps maintain joint function | The claim is restricted to food supplements in which the minimum total collagen amount is 10 mg, and the amount of undenatured type II collagen is in accord with the minimum values established by the Appendix III of the present Normative |
| Hydroxymethylbutyrate (g) | NA | NA | NA | NA | NA | 2.99 | NA | NA | – | – |
| Methylsulfonylmethane (mg) | NA | NA | NA | NA | NA | 900 | NA | NA | – | – |
| Palmitoylethanolamide (mg) | NA | NA | NA | NA | NA | 150–600 | NA | NA | – | – |
| Silicon (mg) | NA | NA | NA | NA | NA | 2.96 | NA | NA | – | – |
| Probiotic | 0–6 months | 7–11 months | 1–3 years | 4–8 years | 9–18 years | > 19 years | Pregnant women | Breastfeeding women | Claims |
|---|---|---|---|---|---|---|---|---|---|
| NA: Not authorized. The approved dosages correspond to the amount that must be present in the full product. Source: Adapted from Anvisa (2020c). | |||||||||
| Bifidobcterium animalis subsp. lactis HN019 (ATCC SD5674) | NA | NA | NA | NA | NA | Min 2 × 109 | NA | NA | Bifidobcterium animalis subsp. lactis HN019 (ATCC SD5674) may contribute to the health of the gastrointestinal tract |
| Bifidobcterium animalis subsp. lactis BB12 (DSM 15954) | Min 1 × 109 | Min 1 × 109 | Min 1 × 109 | Min 1 × 109 | Min 1 × 109 | Min 1 × 109 | Min 1 × 109 | NA | Bifidobcterium animalis subsp. lactis BB12 (DSM 15954) may contribute to the health of the gastrointestinal tract |
| Bifidobcterium lactis NCC 2818 | Min 1 × 109 | Min 1 × 109 | Min 1 × 109 | NA | NA | NA | NA | NA | Bifidobcterium lactis NCC 2818 may contribute to the health of the gastrointestinal tract |
| Lactobacillus acidophilus NCFM (ATCC SD5221) | NA | NA | NA | NA | NA | Min 1 × 109 | NA | NA | Lactobacillus acidophilus NCFM (ATCC SD5221) may contribute to the health of the gastrointestinal tract |
| Lactobacillus gasseri BNR17 (KCTC 10902BP) | NA | NA | NA | NA | NA | Min 1 × 1010 | NA | NA | Lactobacillus gasseri BNR17 (KCTC 10902BP) may contribute to the health of the gastrointestinal tract |
| Lactobacillus rhamnosus GG (DSM 33156) | Min 1 × 1010 | Min 1 × 1010 | Min 1 × 1010 | Min 1 × 1010 | Min 1 × 1010 | Min 1 × 1010 | NA | NA | Lactobacillus rhamnosus GG (DSM 33156) may contribute to the health of the gastrointestinal tract |
| Lactobacillus rhamnosus GG (ATCC 53103) | Min 1 × 1010 | Min 1 × 1010 | Min 1 × 1010 | Min 1 × 1010 | Min 1 × 1010 | Min 1 × 1010 | Min 1 × 1010 | Min 1 × 1010 | Lactobacillus rhamnosus GG (ATCC 53103) may contribute to the health of the gastrointestinal tract |
| Lactobacillus rhamnosus HN001 (ATCC SD5675) | Min 6 × 109 | Min 6 × 109 | Min 6 × 109 | NA | NA | NA | Min 6 × 109 | Min 6 × 109 | Lactobacillus rhamnosus HN001 (ATCC SD5675) may reduce the risk of eczema (atopic dermatitis) in infancy, when administered to pregnant and breastfeeding women, from the 35th week of pregnancy to the 6th month of breastfeeding, and to their offspring, high-risk breastfed, from birth until 2 years of age |
| Limosilactobacillus reuteri DSM 17938 | Min 1 × 108 | NA | NA | NA | NA | Min 1 × 108 | NA | NA | Limosilactobacillus reuteri DSM 17938 may contribute to the health of the gastrointestinal tract in adults. Limosilactobacillus reuteri DSM 17938 may contribute to reduce intestinal discomfort in breastfed infants younger than 6 months |
| Association of Lactobacillus rhamnosus R0011 (CNCM I-1720) and Lactobacillus helveticus R0052 (CNCM I-1722) | NA | NA | NA | 4 × 109, where 3.8 × 109 is L. rhamnosus and 2 × 108 is L. helveticus | 4 × 109, where 3.8 × 109 is L. rhamnosus and 2 × 108 is L. helveticus | 8 × 109, where 7.6 × 109 is L. rhamnosus and 4 × 108 is L. helveticus | NA | NA | The association of Lactobacillus rhamnosus R0011 (CNCM I-1720) and Lactobacillus helveticus R0052 (CNCM I-1722) may contribute to the health of the gastrointestinal tract |
| Association of Lactobacillus helveticus R0052 (CNCM I-1722) and Bifidobacterium longum R0175 (CNCM I-3470) | NA | NA | NA | NA | NA | 3 × 109, where 2.7 × 109 is L. rhamnosus and 3 × 108 is B. longum | NA | NA | The association of Lactobacillus helveticus R0052 (CNCM I-1722) and Bifidobacterium longum R0175 (CNCM I-3470) may help reduce anxiety in healthy individuals. The association of Lactobacillus helveticus R0052 (CNCM I-1722) and Bifidobacterium longum R0175 (CNCM I-3470) help reduce gastrointestinal complications, such as abdominal pain and nausea due to mild to moderated stress in healthy individuals |
| Association of Bifidobacterium lactis BI-07 (ATCC SD5220), Lactobacillus acidophilus NCFM (ATCC SD5221), Bifidobacterium lactis BI-04 (ATCC SD5219), and Lactobacillus paracasei Lpc-37 (ATCC SD5275) | NA | NA | NA | NA | NA | 1.7 × 1010, with 4.25 × 109 UFC for each strain | NA | NA | The association of Bifidobacterium lactis BI-07 (ATCC SD5220), Lactobacillus acidophilus NCFM (ATCC SD5221), Bifidobacterium lactis BI-04 (ATCC SD5219), and Lactobacillus paracasei Lpc-37 (ATCC SD5275) may contribute to the health of the gastrointestinal tract |