Some supplement ingredients carry a dose ceiling in the EU that seems arbitrary until you understand where it comes from. It isn't usually because the ingredient is dangerous at higher doses — it's because of a specific regulatory framework called Novel Food, and the ceiling is the direct output of a safety evaluation with a number attached to it. Two ingredients relevant to marine and longevity-focused supplementation — astaxanthin and nicotinamide riboside (NR) — are useful real examples of how this actually works.
What makes a food “novel” in the first place
Under Regulation (EU) 2015/2283, a “novel food” is any food or food ingredient that was not used for human consumption to a significant degree within the EU before 15 May 1997 — the date the original Novel Food Regulation came into force.1 The cutoff is historical, not safety-based: an ingredient can be perfectly safe and still be classified as “novel” simply because it lacks a documented pre-1997 consumption history in the EU. Once something is classified as novel, it cannot be legally sold in EU food or supplements until it goes through a formal safety evaluation and receives explicit authorization — with the exact conditions of that authorization (maximum dose, permitted population, required labelling) fixed by the evaluation itself.1
Astaxanthin: how the 8 mg/day ceiling was actually set
Astaxanthin-rich oleoresin from the microalga Haematococcus pluvialishas a long history in EU supplements, but a fragmented regulatory one. Its first authorization was granted in Sweden in 1995 — before the 1997 cutoff — at a maximum intake of 8 mg astaxanthin per day, and later notifications from other companies claimed “substantial equivalence” to that original approval.23
The ceiling itself comes directly from EFSA's own risk math: the Acceptable Daily Intake (ADI) for astaxanthin was set at 0.2 mg per kg of body weight per day.4 When the European Commission asked EFSA in 2018 to formally evaluate whether the existing 8 mg/day supplement ceiling was still consistent with that ADI, EFSA's 2020 opinion concluded that 8 mg/day from supplements is safe for adults even accounting for high-estimate background dietary intake — but that adolescents aged 14 to under 18 could reach the ADI in that combined exposure scenario, and children under 14 would exceed it.45
That finding is exactly why Commission Implementing Regulation (EU) 2021/1377 restricted astaxanthin supplements containing up to 8 mg/day to adults and adolescents 14 years and older — not the general population.35 A further amendment in 2023 (Regulation (EU) 2023/1581) extended use to children aged 3 to under 10 and adolescents 10 to under 14, but only at reduced maximum levels appropriate to those age groups' lower body-weight-adjusted ADI — not at the full 8 mg/day.26
The takeaway: the 8 mg ceiling isn't a round marketing number. It's the output of an ADI (mg/kg body weight) applied to an adult reference body weight, with age-specific ceilings below that for younger populations, all traceable to a specific EFSA opinion and a specific Commission regulation.
Nicotinamide riboside (NR): a newer authorization, with its own population limit
Nicotinamide riboside chloride was authorized as a Novel Food in 2019, following an EFSA safety opinion evaluating its use as a food-supplement source of niacin.78 The authorization permits use in food supplements for the general adult population at a maximum of 300 mg/day, based on EFSA's assessment that the production process, composition, and stability of the novel form raised no safety concerns, and that animal and human data showed no genotoxicity concerns at that intake level.8
One condition matters as much as the dose ceiling itself: NR is not permitted in supplements intended for pregnant or breastfeeding women without further specific assessment.9 A supplement using NR that doesn't observe this population restriction — regardless of dose — would fall outside its actual authorization.
A subsequent 2021 EFSA opinion evaluated extending NR's use into meal-replacement products and nutritional drink mixes at higher levels, and reached a more cautious conclusion: the panel found the safety of that broader use had not been established, citing an insufficiently wide margin between estimated infant exposure and the benchmark dose used in the safety modelling.10 That's a useful illustration of how Novel Food authorizations are use-case specific — an ingredient authorized for one product category and population at one dose isn't automatically cleared for a different format or a wider population without its own separate evaluation.
Why this framework matters for formulation decisions
Two practical lessons follow directly from how these two ingredients were actually authorized:
- A Novel Food authorization is not a single yes/no answer— it's a specific combination of ingredient form, maximum dose, and permitted population (and sometimes product category). Changing any one of those variables without checking the current Union list entry can put a formulation outside its authorization even if the ingredient itself is “approved.”
- Ceilings can move.Astaxanthin's conditions of use were amended twice in three years (2021, 2023) as new age-group data came in. Treating a Novel Food ceiling as permanently fixed, rather than checking the current entry in the EU's Union list of authorised novel foods before formulating, is a preventable compliance gap.