Omega-3 (EPA/DHA/ALA)

Qualified Health Claim docket 2003Q-0401

Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.

Conditions: Qualified Health Claim · mandatory "Supportive but not conclusive research shows that" prefix required by FDA enforcement discretion letter · maximum EPA+DHA from supplements: not exceed 2 g/day per FDA recommendation

Authorized 2004

Qualified Health Claim docket 2014Q-0337

Supportive but not conclusive research shows that consuming EPA and DHA combined may reduce blood pressure in the general population and reduce the risk of hypertension.

Conditions: Qualified Health Claim · mandatory "Supportive but not conclusive research shows that" prefix required by FDA enforcement discretion letter · maximum EPA+DHA from supplements: not exceed 2 g/day per FDA recommendation

Authorized 2019

Reg 432/2012 + 440/2011

DHA contributes to maintenance of normal brain function (≥ 250 mg/day).

Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used where food provides ≥ 250 mg DHA/day in daily portion(s); "source of omega-3 fatty acids" Annex condition: ≥ 40 mg EPA+DHA per 100 g and 100 kcal

Authorized 2012

Reg 432/2012

DHA contributes to maintenance of normal vision (≥ 250 mg/day).

Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used where food provides ≥ 250 mg DHA/day in daily portion(s); "source of omega-3 fatty acids" Annex condition: ≥ 40 mg EPA+DHA per 100 g and 100 kcal

Authorized 2012

Reg 432/2012

EPA and DHA contribute to the normal function of the heart (≥ 250 mg/day).

Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used where food provides ≥ 250 mg EPA+DHA/day in daily portion(s); "source of omega-3 fatty acids" Annex condition: ≥ 40 mg EPA+DHA per 100 g and 100 kcal

Authorized 2012

Reg 440/2011

Maternal DHA intake contributes to normal brain development of the foetus and breastfed infants (200 mg/day during pregnancy + lactation).

Conditions: Reg 1924/2006 art 10(2) + Reg 440/2011: claim may only be used where food provides a daily intake of 200 mg DHA in addition to the recommended daily intake of omega-3 fatty acids for adults (i.e., 250 mg DHA + EPA per day); target population: pregnant and lactating women

Authorized 2011

IN 28/2018 Anexo V alegação funcional

Fonte de ômega 3.

Conditions: IN 28/2018 Anexo V: alegação restrita aos suplementos cuja quantidade de EPA e DHA atenda aos valores mínimos do Anexo III (≥ 37,5 mg EPA+DHA/dia para adultos ≥ 19 anos · no mínimo 30 mg devem ser de DHA · gestantes/lactantes ≥ 45 mg/dia)

Authorized 2018

IN 28/2018 Anexo V alegação funcional

Os ácidos graxos ômega 3 EPA e DHA auxiliam na redução dos triglicerídeos.

Conditions: IN 28/2018 Anexo V: alegação restrita aos suplementos que forneçam no mínimo 1.500 mg de EPA e DHA somados na recomendação diária de consumo. Restrição: não é permitida a alegação caso o suplemento alimentar possua associação de ingredientes fontes de fitoesterois com ingredientes fontes de ácidos graxos ômega 3

Authorized 2018