Journal of Food Bioactives, ISSN 2637-8752 print, 2637-8779 online
Journal website www.isnff-jfb.com

Perspective

Volume 7, September 2019, pages 7-17

A perspective on phenolic compounds, their potential health benefits, and international regulations: The revised Brazilian normative on food supplements

Figure

Figure 1.
Figure 1. Chemical structures of phenolic compounds mentioned in the Brazilian Normative Instruction N° 28. (a) chlorogenic acid, (b) rutin, (c) procyanidin B2, and (d) α-tocopherol.

Tables

Table 1. List of phenolic compounds for food supplements authorized by Anvisa’s Normative Instruction (NI N° 28) from July 26th, 2018
 
Phenolic compound0-6 months7-11 months1-3 years old4-8 years old9-18 years old+19 years oldBreastfeeding womenPregnant womenObservations
Source: Adapted from Agência Nacional de Vigilância Sanitária (2019c).
Chlorogenic acidNot allowedNot allowedNot allowedNot allowedNot allowedMin: Not establishedNot allowedNot allowed–
Max: 0.12 mg
RutinNot allowedNot allowedNot allowedNot allowedNot allowedMin: Not establishedNot allowedNot allowed–
Max: 0.6 mg
ProanthocyanidinsNot allowedNot allowedNot allowedNot allowedNot allowedMin: Not establishedNot allowedNot allowed–
Max: 7.5 mg
Vitamin ENot allowedNot allowedMin: 0.9 mgMin: 1.05 mgMin: 2.25 mgMin: 2.25 mgMin: 2.85 mgMin: 2.25 mgAs α-tocopherol. α-Tocopherol includes RRR-α-tocopherol, the only α-tocopherol form that naturally occurs in food., and the 2R-stereoisomers of α-tocopherol (RRR-, RSR-, RRS-, and RSS-α-tocopherol) that occur in fortified foods and supplements. Considering the commercially available synthetic form (rac-α-tocoferyl) with an activity of 0.67 x RRR-α-tocopherol, considering 1 IU of vitamin E as 1 mg of acetate of rac-α-tocoferyl.
Max: 200 mgMax: 300 mgMax: 600 mgMax: 1,000 mgMax: 800 mgMax: 800 mg

 

Table 2. List of source ingredients of bioactive compounds for food supplements authorized by Anvisa’s Normative Instruction (NI N° 28) from July 26th, 2018
 
Authorized ComponentCASSpecificationsFunctionAuthorized claims and requirements to make themRequirements for Complementary Labelling and otherOther information
Source: Agência Nacional de Vigilância Sanitária (2019c).
Tomato hydro soluble concentrate (Lycopersicon esculentum)For this component, the approved specifications belong to the following manufacturers: C.A.S. S.p.A – Verona – Italy; Hans Zipperle AG/S.p.A – Merano – Italy; Indena S.A.S. – Tours – FranceSource of chlorogenic acidNo claimsThe warning “This product should not be consumed by pregnant and breastfeeding women and children” must be written on the label.–
Tomato hydro soluble concentrate (Lycopersicon esculentum)For this component, the approved specifications belong to the following manufacturers: C.A.S. S.p.A – Verona – Italy; Hans Zipperle AG/S.p.A – Merano – Italy; Indena S.A.S. – Tours – FranceSource of rutinNo claimsThe warning “This product should not be consumed by pregnant and breastfeeding women and children” must be written on the label.–
Powdered cranberry (Vaccinium macrocarpon)For this component, the approved specifications belong to the following manufacturer: Naturex – DBS LLC – Sagamore – Massachusetts – USASource of proanthocyanidinsNo claimsThe warning “This product should not be consumed by pregnant and breastfeeding women and children” must be written on the label.–
Propolis extractNormative Instruction N° 3, DE from January 19th, 2001Source of phenolic compoundsNo claimsThe warning “This product should not be consumed by pregnant and breastfeeding women and children” must be written on the label.–
Powdered guarana (Paulinia cupana)These components must follow the specifications evaluated and approved by ANVISA.Source of caffeine1) Claim: Caffeine enables an elevated state of alert and improves the concentration. Requirements: this claim is exclusive for the dietary supplements in which the caffeine content meets the minimum amount established by IN 28/2018–Appendix III.
2) Claim: Caffeine improves endurance and performance during endurance physical activities.
Requirements: this claim is exclusive to the dietary supplements in which the caffeine content is 200 mg, consumed 1 h prior to the physical activity.		The warning “This product should not be consumed by pregnant and breastfeeding women and children” must be written on the label.–
Dextroalphatocopherol acetate/D-alpha-tocopherol acetate58-95-7FCC 6
FCC 10
ADOPTED: February 10th, 2016
PUBLISHED: March 2nd, 2016
doi: 10.2903/j.efsa.2016.4412		Source of Vitamin E1) Claim: Vitamin E is an antioxidant that helps protect against the damages caused by free radicals. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III
2) Claim: Source of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III.
3) Claim: Rich in/High content of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content corresponds to the double of the minimum amount established in IN 28/2018–Appendix III, since it does not surpass the maximum amount established in the Appendix IV.		No additional requirements.–
DL-alpha-tocopherol acetate/rac-alpha-tocopherol acetate/DL-alpha-tocopheryl acetate7695-91-2ADOPTED: February 10th, 2016
PUBLISHED: March 2nd, 2016
doi: 10.2903/j.efsa.2016.4412
European pharmacopoeia 9.0		Source of Vitamin E1) Claim: Vitamin E is an antioxidant that helps protect against the damages caused by free radicals. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III
2) Claim: Source of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III.
3) Claim: Rich in/High content of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content corresponds to the double of the minimum amount established in IN 28/2018–Appendix III, since it does not surpass the maximum amount established in the Appendix IV.		No additional requirements.–
Dextro-alpha-tocopherol/D-alpha-tocopherol59-02-9European pharmacopoeia 9.0
FCC 6
Prepared at the 55th JECFA (2000) and published in FNP 52 Add 8 (2000), superseding tentative specifications prepared at the 30th JECFA (1986) and published in FNP 37 (1986) and in FNP 52 (1992). A group ADI of 0.15-2 mg/kg bw for dl-alpha-tocopherol and d-alpha-tocopherol, concentrate, singly or in combination, was established at the 30th JECFA (1986).		Source of Vitamin E1) Claim: Vitamin E is an antioxidant that helps protect against the damages caused by free radicals. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III
2) Claim: Source of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III.
3) Claim: Rich in/High content of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content corresponds to the double of the minimum amount established in IN 28/2018–Appendix III, since it does not surpass the maximum amount established in the Appendix IV.		No additional requirements.–
DL-alpha-tocopherol10191-41-0Prepared at the 30th JECFA (1986), published in FNP 37 (1986) and in FNP 52 (1992). Metals and arsenic specifications revised at the 61st JECFA (2003). A group ADI of 0.15-2 mg/kg bw for dl-alpha-tocopherol and d-alpha-tocopherol, concentrate, singly or in combination, was established at the 30th JECFA (1986).
European pharmacopoeia 9.0
FCC 10		Source of Vitamin E1) Claim: Vitamin E is an antioxidant that helps protect against the damages caused by free radicals. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III
2) Claim: Source of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III.
3) Claim: Rich in/High content of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content corresponds to the double of the minimum amount established in IN 28/2018–Appendix III, since it does not surpass the maximum amount established in the Appendix IV.		No additional requirements.–
Mixture of tocopherolsFCC10
Prepared at the 30th JECFA (1986), published in FNP 37 (1986) and in FNP 52 (1992). Metals and arsenic specifications revised at the 61st JECFA (2003). A group ADI of 0.15-2 mg/kg bw for dl-alpha-tocopherol and d-alpha-tocopherol, concentrate, singly or in combination, was established at the 30th JECFA (1986).		Source of Vitamin E1) Claim: Vitamin E is an antioxidant that helps protect against the damages caused by free radicals. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III
2) Claim: Source of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III.
3) Claim: Rich in/High content of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content corresponds to the double of the minimum amount established in IN 28/2018–Appendix III, since it does not surpass the maximum amount established in the Appendix IV.		No additional requirements.–
Acidic succinate of D-alpha-tocopheryl893081European pharmacopoeia 9.0
FCC 10		Source of Vitamin E1) Claim: Vitamin E is an antioxidant that helps protect against the damages caused by free radicals. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III
2) Claim: Source of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III.
3) Claim: Rich in/High content of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content corresponds to the double of the minimum amount established in IN 28/2018–Appendix III, since it does not surpass the maximum amount established in the Appendix IV.		No additional requirements.–
Acidic succinate of DL-alpha-tocopheryl17407-37-3European pharmacopoeia 9.0Source of Vitamin E1) Claim: Vitamin E is an antioxidant that helps protect against the damages caused by free radicals. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III
2) Claim: Source of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III.
3) Claim: Rich in/High content of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content corresponds to the double of the minimum amount established in IN 28/2018–Appendix III, since it does not surpass the maximum amount established in the Appendix IV.		No additional requirements.–
Acidic succinate of D-alpha-tocopheryl-polyethylene glycol-1000USP NF 34Source of Vitamin E1) Claim: Vitamin E is an antioxidant that helps protect against the damages caused by free radicals. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III
2) Claim: Source of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content meets the minimum amount established in IN 28/2018–Appendix III.
3) Claim: Rich in/High content of vitamin E. Requirements: this claim is exclusive to the dietary supplements in which the vitamin E content corresponds to the double of the minimum amount established in IN 28/2018–Appendix III, since it does not surpass the maximum amount established in the Appendix IV.		No additional requirements.–

 

Table 3. α-Tocopherol content of common and specialty oils
 
OilConcentration (mg/100 g of oil)
Source: Adapted from Shahidi and de Camargo (2016) and de Camargo et al. (2019). nd, non-detected.
Almondsnd–34.9
Barley14.2–20.1
Brazil nutsnd–2.2
Camelina2.81–3.80
Cashewnd–7.84
Coconut0.20–1.82
Corn18.0–25.7
Cottonseed30.5–57.3
Grape11.8–18.8
Hazelnut15.7–42.1
Linseed0.54–1.20
Macadamia0.08–0.11
Olive11.0–17.0
Palm6.05–42.0
Peanut8.86–30.4
Pecannd–1.82
Pine2.2–16.6
Pistachiosnd–32.8
Rapeseed18.9–24.0
Rice bran0.73–15.9
Safflower36.7–47.7
Sesame0.24–36.0
Soybean9.53–12.0
Sunflower32.7–59.0
Walnutnd–3.80
Wheat germ151–192