Author: Expert Team (R&D and Legal Departments), Bio Light
Dosage is one of the most complex topics for dietary supplement manufacturers. How much vitamin D can be added to a capsule? Is melatonin allowed? What about herbal extracts without clear limits?
With the adoption of Law No. 4122-IX and upcoming amendments to Order No. 1114, Ukraine is shifting to a European dosage control model based on EFSA scientific data.
What’s Changing
The current regulation provides general limits but no specific maximums. The new law allows the Ministry of Health to define exact permitted doses.
4-Level Hierarchy
- Level 1 — EFSA Upper Limit (UL)
- Level 2 — EFSA Safe Level
- Level 3 — National limits
- Level 4 — Other substances
Each level applies only if the previous one is absent.
What is EFSA
EFSA is the European Food Safety Authority — an independent EU body that sets safe intake levels.
Why It Matters
- directly referenced in Ukrainian law
- based on elemental content
- regularly updated
Allowed Substances
- vitamins (13 types)
- minerals (17 types)
- plants (600+)
- amino acids (29)
- microorganisms
- physiologically active substances
Prohibited Substances
- aloe-emodin, danthron, emodin
- ephedra
- yohimbe
- prescription drug substances
Novel Food
Ingredients not authorized in the EU cannot be used.
Practical Tips
- follow EFSA limits
- calculate elemental content
- verify plant status
- pay attention to critical substances
Turnkey Supplement Manufacturing — Bio Light
Formulation development requires regulatory expertise.
Bio Light provides:
✓ formula audit
✓ dosage recalculation
✓ ingredient verification
✓ label development
✓ full-cycle manufacturing
Contact us: biolight.com.ua
This material is for informational purposes only and does not constitute legal advice.
