🇺🇸 FDA
GRAS · food ingredient (21 CFR 184.1553 sodium caseinate · 184.1554 calcium caseinate) · DSHEA dietary supplement
Casein (Micellar · Calcium Caseinate · Sodium Caseinate · Hydrolysate)
Also known as: Micellar casein · Calcium caseinate · Sodium caseinate · Casein hydrolysate
Mechanism of action
- Slow-digesting protein produces a prolonged plateau of moderate hyperaminoacidemia (Boirie 1997 PMID 9405716 dual-tracer)
- Sustained mTORC1 activation across the overnight window (Res 2012 PMID 22330017 presleep RCT)
- Reduced overnight muscle protein breakdown via continuous amino acid flux
Molecular + tissue targets
- Skeletal muscle protein synthesis (overnight window)
- Net whole-body protein balance
- Pre-sleep nitrogen flux
Dosage range
20-40 g pre-sleep (Res 2012 PMID 22330017 RCT n=16 young males · 40 g casein vs placebo · effectively digested overnight + stimulated MPS); daily protein 1.2-1.6 g/kg/day total covers casein cohort
Safety notes
Lactose may be present in non-purified concentrates; milk allergy is a contraindication; sodium-rich vs calcium-rich salt forms vary substantially — monitor sodium intake in hypertension when using sodium caseinate
Cross-market regulatory status
🇪🇺 EFSA
Authorized protein claims (Reg 432/2012) for muscle mass + bone maintenance available when food source provides ≥ 12% energy from protein
🇧🇷 ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 Anexo V alegação funcional verbatim: "As proteínas auxiliam na formação dos músculos e ossos." (Anexo III ≥ 8,4 g/dia adultos ≥ 19 anos · Anexo VII proteína de referência AAE/g)
Authorized claims · verbatim (4)
Direct quotes from each jurisdiction's framework · never paraphrased · with framework reference and conditions of use.
🇪🇺 EFSA · 3 claims
Reg 432/2012
Protein contributes to a growth in muscle mass.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of protein" — ≥ 12% of energy value provided by protein; "high protein" — ≥ 20% of energy value provided by protein
Authorized 2012
Reg 432/2012
Protein contributes to the maintenance of muscle mass.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of protein" — ≥ 12% of energy value provided by protein; "high protein" — ≥ 20% of energy value provided by protein
Authorized 2012
Reg 432/2012
Protein contributes to the maintenance of normal bones.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of protein" — ≥ 12% of energy value provided by protein; "high protein" — ≥ 20% of energy value provided by protein
Authorized 2012
🇧🇷 ANVISA · 1 claim
IN 28/2018 Anexo V alegação funcional
As proteínas auxiliam na formação dos músculos e ossos.
Conditions: IN 28/2018 Anexo V: alegação restrita aos suplementos cuja: a) quantidade de proteína atenda aos valores mínimos do Anexo III (≥ 8,4 g/dia adultos ≥ 19 anos); b) quantidade de aminoácidos essenciais por grama de proteína atenda aos valores mínimos para a proteína de referência (Anexo VII)
Authorized 2018
Common use cases
- overnight muscle recovery
- pre-sleep supplementation
- sarcopenia prevention
- satiety / appetite management
Cross-reference
Health goals: athletic performance longevity stack menopause support weight management
Lifestyles: athletic performance senior 60 plus
Full dossier: /ingredients/casein/
Machine-readable JSON: /api/nc/casein.json