Marine Bio-Active Mouthrinse

These describe what an ingredient is, not whether it is a problem. The stance marks above are the ratings; these are not.

• common irritantmelaleuca alternifolia leaf oil

  • melaleuca alternifolia leaf oil: An essential oil whose oxidation products carry its sensitising potential; the EU assesses it as a moderate skin sensitiser. SCCS Scientific Opinion on Tea Tree Oil (CAS/EC 68647-73-4 / 285-377-1), SCCS/1681/25, adopted 30 October 2025, which concludes it is a moderate skin sensitiser. It does not set maximum levels of its own: it assesses the concentrations the applicant defended, and finds no concern at 2,0% in shampoo, 1,0% in shower gel, 1,0% in face wash and 0,1% in face cream, for oil conforming to ISO 4730:2017, in adults, in non-sprayable formats. It draws on the earlier SCCP opinions SCCP/1155/08 and SCCP/0843/04 and incorporates their data by reference; it says nothing about their status.

• fragrance materialmentha piperita oil, menthol, limonene, citrus limon peel oil, citral, linalool

  • mentha piperita oil: A cooling essential oil the EU names on its own account as a fragrance substance to be declared on the label. EU Regulation (EC) 1223/2009, Annex III entry 361, inserted by Commission Regulation (EU) 2023/1545: a fragrance substance whose presence must be indicated in the list of ingredients above 0,001% in leave-on and 0,01% in rinse-off products. It is declarable in its OWN right, not by way of any component it carries. The name to look for on a label is "Mentha Piperita Oil". The duty applies now. Transition footnote (40) lets stock that does not comply, lawfully placed on the Union market before the 31 July 2026 cut-off, be made available until 31 July 2028.
  • menthol: The cooling component of mint oils, named by the EU as a fragrance substance to be declared on the label. EU Regulation (EC) 1223/2009, Annex III entry 338, inserted by Commission Regulation (EU) 2023/1545: a fragrance substance whose presence must be indicated in the list of ingredients above 0,001% in leave-on and 0,01% in rinse-off products. It is declarable in its OWN right, not by way of any component it carries. The name to look for on a label is "Menthol". The duty applies now. Transition footnote (40) lets stock that does not comply, lawfully placed on the Union market before the 31 July 2026 cut-off, be made available until 31 July 2028.
  • limonene: A citrus-smelling fragrance component named separately on the label; the one name covers three related isomers. EU Regulation (EC) 1223/2009, Annex III entry 88: a fragrance substance whose presence must be indicated in the list of ingredients above 0,001% in leave-on and 0,01% in rinse-off products, because of established contact-allergy risk. That entry carries transition footnote (37): stock that does not comply, lawfully placed on the Union market before the 31 July 2026 cut-off, may still be made available until 31 July 2028. It is marked on the racemic dl-limonene/Dipentene line and the (S)-(l-limonene) line, but NOT the (R)-p-mentha-1,8-diene (d-limonene) line, CAS 5989-27-5, whose duty was already running as entry 88 before Commission Regulation (EU) 2023/1545 and so needed no transition. All three isomers are declared under the single glossary name "Limonene", so that name on a label does not identify which of them is present.
  • citrus limon peel oil: A citrus peel oil the EU names on its own account as a fragrance substance to be declared on the label. EU Regulation (EC) 1223/2009, Annex III entry 353, inserted by Commission Regulation (EU) 2023/1545: a fragrance substance whose presence must be indicated in the list of ingredients above 0,001% in leave-on and 0,01% in rinse-off products. It is declarable in its OWN right, not by way of any component it carries. The name to look for on a label is "Citrus Limon Peel Oil". The duty applies now. Transition footnote (40) lets stock that does not comply, lawfully placed on the Union market before the 31 July 2026 cut-off, be made available until 31 July 2028.
  • citral: A lemon-scented fragrance component named separately on the label; the one name covers three related substances. EU Regulation (EC) 1223/2009, Annex III entry 70: a fragrance substance whose presence must be indicated in the list of ingredients above 0,001% in leave-on and 0,01% in rinse-off products, because of established contact-allergy risk. As replaced by Commission Regulation (EU) 2026/909 of 27 April 2026, the entry is a GROUPED one covering citral, geranial and neral, declared collectively as "Citral", with per-product-type caps from 0,032% in deodorant to 1,2% in rinse-off and leave-on hair products. Its three substances carry two different sell-through dates: products not complying may not be placed on the Union market from 1 January 2027 in every case, and may not be made available from 1 July 2028 for citral, footnote (**), or from 1 August 2028 for geranial and neral, footnote (***). In the consolidated text those two footnotes are renumbered (46) and (47); both are worded "these substances", where the footnotes that attach to a single named substance say "that substance".
  • linalool: A floral fragrance component named separately on the label. EU Regulation (EC) 1223/2009, Annex III entry 84: a fragrance substance whose presence must be indicated in the list of ingredients above 0,001% in leave-on and 0,01% in rinse-off products, because of established contact-allergy risk.

• humectantglycerin

  • glycerin: A humectant, and one of the two ingredients a comparison of moisturiser components found made a significant difference to skin hydration. FDA OTC skin protectant monograph, 21 CFR 347.10(h), lists glycerin as a skin protectant at 20 to 45%. On the humectant half: Jeong CB, Han JY, Cho JC, Suh KD, Nam GW, "Analysis of electrical property changes of skin by oil-in-water emulsion components", Int J Cosmet Sci 2013;35(4):402-410, DOI 10.1111/ics.12059, PMID 23621673, found that "glycerine and urea showed significant skin hydration effects compared with other humectants".