EU Restricts Kojic Acid to 1% in Face and Hand Products; Canada's Cosmetic Ingredient Hotlist Is Still Silent

The finding

In the European Union, kojic acid is no longer an unlisted cosmetic active. After a Scientific Committee on Consumer Safety (SCCS) assessment that ended with a final opinion (SCCS/1637/21) that the ingredient is safe at up to 1% when used as a skin-lightening agent, Commission Regulation (EU) 2024/996 of 3 April 2024 wrote that limit into Annex III of Regulation (EC) No 1223/2009 and narrowed the permitted product types to face and hand products.[1][2]

In Canada, the Cosmetic Ingredient Hotlist still has no entry for kojic acid (CAS 501-30-4). A search of the published Hotlist page, the Changes page, and the 2025–2026 proposed Hotlist update package found no kojic acid listing.[3] The EU consultation-and-restriction path therefore does not, by itself, change what the Hotlist says about leave-on brightening formulas sold as cosmetics in Canada. What it does change is the comparative regulatory map: Europe now has an explicit concentration and product-type ceiling; Canada’s Hotlist remains silent.

What the SCCS actually said

Kojic acid (INCI: Kojic Acid; CAS 501-30-4; EC 207-922-4) is a fungal metabolite used for tyrosinase inhibition and melanogenesis suppression in skin-lightening leave-ons. It sat on the Commission’s priority list of substances with potential endocrine-disrupting properties. A 2019 call for data fed an SCCS mandate.[1][2]

The timeline matters because the preliminary and final texts diverged:

• Preliminary opinion adopted 26–27 October 2021. In that draft, the SCCS concluded that 1% was not safe for the intended cosmetic uses and, as an example for combined twice-daily face cream plus hand cream, indicated that the maximum should not exceed 0.04%.[1]
• Commenting period from 5 November 2021 to 14 January 2022. The Committee recorded that comments changed sections on absorption, safety evaluation, discussion, and the answer to question 2.[1]
• Final opinion adopted 15–16 March 2022; corrigendum by written procedure on 10 June 2022 (SCCS/1637/21).[1]

The final conclusion, after the corrigendum, is explicit: “Kojic acid is safe when used as a skin lightening agent in cosmetic products at concentrations of up to 1%.”[1] The Opinion also flags that adding kojic acid to peeling agents may raise absorption when the barrier is weakened, that non-cosmetic uses were out of scope, and that derivatives such as kojic acid dipalmitate, kojic acid isopalmitate, and chloro-kojic acid were not assessed because no data were submitted.[1]

Exposure numbers in the final safety evaluation are specific. Using a clinical percutaneous absorption study (Fukase 2005) of a 1% cream and Notes of Guidance product-use amounts, the SCCS derived systemic exposure doses (SED) of 0.0075 mg/kg bw/day for face plus neck, 0.0067 mg/kg bw/day for hands, and 0.0142 mg/kg bw/day for aggregate face, neck, and hands. With an adjusted NOAEL of 2 mg/kg bw/day (from a 28-day oral rat NOAEL of 6 mg/kg bw/day with an extra assessment factor of 3), margins of safety were 267 (face+neck), 199 (hands), and 141 (aggregate).[1] The Opinion notes that bleaching products applied beyond face, neck, and hands could push exposure higher.[1]

How the EU turned the Opinion into a leave-on rule

Regulation (EU) 2024/996 cites the SCCS conclusion that kojic acid is safe up to 1% as a skin-lightening agent, then states that there is still a potential risk when concentration exceeds certain levels. The Commission’s legislative choice was therefore restriction, not a ban: Kojic Acid is added to Annex III for “Face and hand products” at a maximum concentration of 1% in the ready-for-use preparation.[2]

Transition footnote *2 attached to that entry sets market dates: from 1 February 2025, non-compliant products shall not be placed on the Union market; from 1 November 2025, they shall not be made available on the Union market.[2]

For formulators of leave-on brightening products, the practical EU reading is narrow:

• Concentration ceiling: 1%.
• Product scope in Annex III: face and hand products (not a general “all leave-on body” licence).
• Function context in the recital: skin lightening / whitening / depigmenting use.
• Derivatives assessed by SCCS: none, unless separately evaluated later.[1][2]

That is the European status as of the published Regulation. It is not a Hotlist text, and it does not automatically apply in Canada.

Canada: Hotlist silence is the current fact

Health Canada’s Cosmetic Ingredient Hotlist is the public list of substances that, when present in a cosmetic, may contravene the Food and Drugs Act or the Cosmetic Regulations, or may push a product out of the cosmetic category.[3] Periodic updates are published; a consultation on proposed Hotlist updates opened 19 November 2025 and closed 17 February 2026.[3]

As of 17 September 2026 (ET), kojic acid does not appear as a prohibited or restricted Hotlist entry on the live Hotlist page, does not appear in the Changes narrative as a kojic-specific amendment, and is not among the substances named in the published proposed-updates consultation document.[3] Separately, hydroquinone and retinol (among other actives) do carry Hotlist conditions; kojic acid is not grouped with them in those pages.[3]

So the Canada versus EU difference is structural:

• EU: binding Annex III limit (1%, face and hand) after SCCS review of endocrine-disrupting concerns.[2]
• Canada cosmetics Hotlist: no kojic acid row; no published concentration cap under that instrument.[3]

Nothing in the public Hotlist materials reviewed for this article shows Health Canada adopting the SCCS 1% face-and-hand rule. Any future Hotlist proposal would be a new event, not an implied consequence of Regulation 2024/996.

Evidence at leave-on concentrations near 1%

Regulatory safety opinions are not efficacy trials. For leave-on brightening claims at about 1%, the human clinical literature is thinner than the toxicology dossier, and grades should stay conservative.

Deo and colleagues (2013) ran a single-centre, single-blind, randomized parallel-group trial in 80 adults with melasma (four arms of 20). Nightly kojic acid 1% cream alone produced a mean 58.72% improvement in Melasma Area and Severity Index (MASI) over 12 weeks. The combination of 1% kojic acid plus 2% hydroquinone showed the highest mean improvement (71.87%). Adding 0.1% betamethasone valerate did not improve on the kojic–hydroquinone pairing in that study. Adverse events were limited in number: burning in one patient on 1% kojic acid alone and in two patients on kojic plus hydroquinone; one acneiform eruption in the triple arm. The authors noted the need for larger studies.[4]

That trial supports a careful statement: Limited to Moderate evidence that 1% leave-on kojic acid can reduce melasma severity on MASI over 12 weeks in a small Indian tertiary-care cohort, with mild irritation reported in a minority of participants.[4] It does not establish population-level cosmetic “brightening” performance for all leave-on formats, skin types, or combination vehicles.

On safety for cosmetic use near 1%, the Cosmetic Ingredient Review (CIR) Expert Panel’s 2010 final report concluded kojic acid was safe in cosmetics up to 1%, after reviewing sensitization and skin-lightening endpoints and noting that depigmentation in animal models appeared at higher concentrations than the 1% use level.[5] The later SCCS Opinion revisited endocrine-related and exposure questions with updated absorption assumptions and still landed at 1% for skin-lightening use, while excluding derivatives without data.[1][5]

May irritate at higher concentrations or in sensitive users; allergic contact dermatitis is reported in the literature base cited by both CIR and clinical authors, even if incidence in Deo’s arms was low.[4][5] The SCCS further cautions against pairing with peeling regimes that compromise the barrier.[1]

Related brightening actives on the Index include kojic AcidKojic AcidEmergingKojic Acid · Tyrosinase inhibitor / chelatorSkin-brightening fungal metabolite under active CIR re-review; historically CIR-safe up to 1%.Open in the Index →, niacinamideNiacinamideStrongNiacinamide · Vitamin B3 amideWater-soluble B3 with strong evidence for barrier, tone and sebum; among the most studied topical actives.Open in the Index →, tranexamic acidTranexamic acidModerateTranexamic Acid · Synthetic lysine analogueAntifibrinolytic drug repurposed for melasma; topical trials are small but consistent.Open in the Index →, azelaic acidAzelaic acidStrongAzelaic Acid · Dicarboxylic acidPrescription-grade evidence for rosacea and acne at 15–20 %; cosmetic versions run lower.Open in the Index → and ascorbic acidAscorbic acidStrongAscorbic Acid · Vitamin C (L-ascorbic acid)The active form of vitamin C; well-evidenced for photoageing at 10–20 % and low pH, but unstable.Open in the Index →.

What the record does and does not show

• The SCCS final Opinion and corrigendum are safety assessments for topical cosmetic use up to 1% as a skin-lightening agent, with stated exclusions (derivatives, non-cosmetic uses, peeling combinations).[1]
• Regulation (EU) 2024/996 is the binding EU concentration and product-type restriction with dated placement and availability cut-offs.[2]
• Canada’s Cosmetic Ingredient Hotlist, on the public pages checked, does not list kojic acid; proposed Hotlist updates in the closed 2025–2026 consultation package likewise do not name it.[3]
• Efficacy evidence cited here for 1% leave-on use rests primarily on one small randomized single-blind melasma trial plus a CIR safety review; that is not Strong evidence for broad cosmetic brightening claims.[4][5]

For Canadian leave-on brightening formulas, the accurate regulatory sentence is therefore comparative rather than predictive: Europe has capped kojic acid at 1% in face and hand products; Canada’s Cosmetic Ingredient Hotlist has not spoken. Any claim that Health Canada “followed,” “mirrored,” or “rejected” the SCCS path would require a Hotlist action that is not in the public record reviewed for this article.