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Germall Plus
At ORY®, we believe you should know what’s in your products and why. This page lists the published research behind what we say about Germall Plus (diazolidinyl urea, iodopropynyl butylcarbamate, and propylene glycol). Each section starts with our claim, then tells you how well the research supports it, then lists the sources so you can read them yourself.
Please note: Preservatives protect water-containing products from bacteria, yeast, and mold. They do not treat the skin or prevent infection on the skin. Every ORY® water-based formula should pass a preservative efficacy (challenge) test, such as USP <51> or ISO 11930, before sale.
Formaldehyde-releaser notice: Germall™ Plus contains diazolidinyl urea, which slowly releases small amounts of formaldehyde. People with formaldehyde allergy should avoid products that contain it. On ORY® labels, it appears by its ingredient names: Propylene Glycol, Diazolidinyl Urea, Iodopropynyl Butylcarbamate. Germall™ is a trademark of Ashland.
How to read this page Supported — backed by peer-reviewed research or official safety reviews. Supported, with caveats — the research points this way, but mostly from laboratory or animal studies, or at different strengths than ORY® uses. Limited evidence — little or no published research yet. We say so openly. |
1. General Description and Role
Claim: Germall™ Plus is a broad-spectrum preservative blend of diazolidinyl urea (antibacterial) and iodopropynyl butylcarbamate, or IPBC (antifungal), in propylene glycol. In ORY® products, it helps protect water-based formulas, including alkaline liquid soaps, from bacteria, yeast, and mold at low use levels. |
Verification: Supported, with caveats. The Cosmetic Ingredient Review (CIR) Expert Panel concluded diazolidinyl urea is safe at the minimum effective concentration, not to exceed 0.5%, and IPBC is safe at up to 0.1% but should not be used in products that are aerosolized. CIR has not reviewed this trade blend as a whole.
Citations:
- Elder, R. L. (Ed.). (1990). Final report on the safety assessment of diazolidinyl urea. Journal of the American College of Toxicology, 9(2), 229–245 (conclusion: safe at the minimum effective concentration, not to exceed 0.5%; not reopened in Andersen, F. A. (2008), International Journal of Toxicology, 27(Suppl 1), 77–142). https://doi.org/10.3109/10915819009078735
- What it shows: CIR safety assessment of diazolidinyl urea.
- Lanigan, R. S. (1998). Final report on the safety assessment of iodopropynyl butylcarbamate (IPBC). International Journal of Toxicology, 17(5 Suppl), 1–37 (safe at ≤0.1%; should not be used in products intended to be aerosolized; not reopened in Johnson, W., Jr. (2017), International Journal of Toxicology, 36(5 Suppl 2), 37S–38S). https://doi.org/10.1177/109158189801700503
- What it shows: CIR safety assessment of IPBC.
- Elder, R. L. (Ed.). (1990). Final report on the safety assessment of diazolidinyl urea. Journal of the American College of Toxicology, 9(2), 229–245 (conclusion: safe at the minimum effective concentration, not to exceed 0.5%; not reopened in Andersen, F. A. (2008), International Journal of Toxicology, 27(Suppl 1), 77–142). https://doi.org/10.3109/10915819009078735
2. Composition and Production
Claim: Liquid Germall™ Plus is roughly 60% propylene glycol, 39% diazolidinyl urea, and 1% IPBC. At 0.1–0.5% in a product, it supplies well under 0.5% diazolidinyl urea and about 0.005% IPBC or less. |
Verification: Supported. Composition is from supplier data. Diazolidinyl urea works partly by releasing small amounts of formaldehyde over time.
Citations:
- de Groot, A. C., Flyvholm, M. A., Lensen, G., Menné, T., & Coenraads, P. J. (2009). Formaldehyde-releasers: Relationship to formaldehyde contact allergy. Contact allergy to formaldehyde and inventory of formaldehyde-releasers. Contact Dermatitis, 61(2), 63–85. https://doi.org/10.1111/j.1600-0536.2009.01582.x
- What it shows: Inventory of formaldehyde-releasers.
- Lanigan, R. S. (1998). Final report on the safety assessment of iodopropynyl butylcarbamate (IPBC). International Journal of Toxicology, 17(5 Suppl), 1–37 (safe at ≤0.1%; should not be used in products intended to be aerosolized; not reopened in Johnson, W., Jr. (2017), International Journal of Toxicology, 36(5 Suppl 2), 37S–38S). https://doi.org/10.1177/109158189801700503
- What it shows: Describes IPBC.
- de Groot, A. C., Flyvholm, M. A., Lensen, G., Menné, T., & Coenraads, P. J. (2009). Formaldehyde-releasers: Relationship to formaldehyde contact allergy. Contact allergy to formaldehyde and inventory of formaldehyde-releasers. Contact Dermatitis, 61(2), 63–85. https://doi.org/10.1111/j.1600-0536.2009.01582.x
3. Skin Type Suitability
Claim: At its use level, Germall™ Plus can be used for most skin types, but it is not recommended for people with formaldehyde allergy or very reactive skin. |
Verification: Supported, with caveats. Reviews show that formaldehyde-releasers can cause reactions in people already allergic to formaldehyde, and the risk depends on how much formaldehyde is released. ORY® offers formaldehyde-free alternatives.
Citations:
- de Groot, A. C., Flyvholm, M. A., Lensen, G., Menné, T., & Coenraads, P. J. (2009). Formaldehyde-releasers: Relationship to formaldehyde contact allergy. Contact allergy to formaldehyde and inventory of formaldehyde-releasers. Contact Dermatitis, 61(2), 63–85. https://doi.org/10.1111/j.1600-0536.2009.01582.x
- What it shows: Review of formaldehyde-releasers and allergy.
- de Groot, A., White, I. R., Flyvholm, M. A., Lensen, G., & Coenraads, P. J. (2010). Formaldehyde-releasers in cosmetics: Relationship to formaldehyde contact allergy. Part 2. Contact Dermatitis, 62(1), 18–31. https://doi.org/10.1111/j.1600-0536.2009.01631.x
- What it shows: Patch test and provocation data.
- de Groot, A. C., Flyvholm, M. A., Lensen, G., Menné, T., & Coenraads, P. J. (2009). Formaldehyde-releasers: Relationship to formaldehyde contact allergy. Contact allergy to formaldehyde and inventory of formaldehyde-releasers. Contact Dermatitis, 61(2), 63–85. https://doi.org/10.1111/j.1600-0536.2009.01582.x
4. Hair and Scalp Suitability
Claim: In haircare, Germall™ Plus protects water-based shampoos, conditioners, leave-ins, and scalp products from microbial growth. It has no direct effect on hair. |
Verification: Supported. This is a formulation role; ORY® haircare products are not intended to treat dandruff or scalp conditions.
Citations:
- Lundov, M. D., Moesby, L., Zachariae, C., & Johansen, J. D. (2009). Contamination versus preservation of cosmetics: A review on legislation, usage, infections, and contact allergy. Contact Dermatitis, 60(2), 70–78. https://doi.org/10.1111/j.1600-0536.2008.01501.x
- What it shows: Review of cosmetic preservation.
- Lundov, M. D., Moesby, L., Zachariae, C., & Johansen, J. D. (2009). Contamination versus preservation of cosmetics: A review on legislation, usage, infections, and contact allergy. Contact Dermatitis, 60(2), 70–78. https://doi.org/10.1111/j.1600-0536.2008.01501.x
5. Benefits
Claim: Germall™ Plus helps keep water-based products, including alkaline liquid soaps, free of harmful microbial growth at low use levels. |
Verification: Supported. Preservatives protect the product, not the skin.
Citations:
- Lundov, M. D., Moesby, L., Zachariae, C., & Johansen, J. D. (2009). Contamination versus preservation of cosmetics: A review on legislation, usage, infections, and contact allergy. Contact Dermatitis, 60(2), 70–78. https://doi.org/10.1111/j.1600-0536.2008.01501.x
- What it shows: Review of contamination and preservation.
- Lundov, M. D., Moesby, L., Zachariae, C., & Johansen, J. D. (2009). Contamination versus preservation of cosmetics: A review on legislation, usage, infections, and contact allergy. Contact Dermatitis, 60(2), 70–78. https://doi.org/10.1111/j.1600-0536.2008.01501.x
6. Use Across ORY® Product Lines
Claim: Germall™ Plus is used in water-based ORY® Skincare, Haircare, and liquid soaps, and in some Cosmetics — never lip products or sprays. |
Verification: Supported, with caveats. IPBC is not used in lip or oral products, aerosols, or body lotions for children under 3. In the EU, IPBC is limited to 0.02% in rinse-off and 0.01% in leave-on products. From January 1, 2027, Washington State prohibits cosmetics that contain diazolidinyl urea and other formaldehyde-releasers.
| Product line | Typical level | How ORY® uses it |
| Skincare | 0.1–0.5% | Lotions, creams, gels, and cleansers (not lip products or baby body lotions). |
| Haircare | 0.1–0.5% | Shampoos, conditioners, and leave-ins (not sprays). |
| Handmade Soap line | 0.1–0.5% | Liquid and cream soaps (not cold-process bars). |
| Cosmetics | 0.1–0.5% | Foundations, mascaras, and cream products (not lip products or sprays). |
Citations:
- Lanigan, R. S. (1998). Final report on the safety assessment of iodopropynyl butylcarbamate (IPBC). International Journal of Toxicology, 17(5 Suppl), 1–37 (safe at ≤0.1%; should not be used in products intended to be aerosolized; not reopened in Johnson, W., Jr. (2017), International Journal of Toxicology, 36(5 Suppl 2), 37S–38S). https://doi.org/10.1177/109158189801700503
- What it shows: CIR aerosol restriction.
- European Union. Regulation (EC) No 1223/2009 on cosmetic products, Annex V (allowed preservatives), including entry 56 (iodopropynyl butylcarbamate) and entry 3 (salicylic acid), with use limits and conditions. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20240424
- What it shows: EU preservative limits.
- Washington State Department of Ecology. Chapter 173-339 WAC — Toxic-Free Cosmetics (implementing RCW 70A.560): 25 formaldehyde-releasing preservatives, including diazolidinyl urea, prohibited in cosmetics from January 1, 2027. https://ecology.wa.gov/regulations-permits/laws-rules-rulemaking/closed-rulemaking/wac-173-339
- What it shows: Washington formaldehyde-releaser rule.
- U.S. Food and Drug Administration. 21 CFR 701.20 — Definition of “soap” (only true soap, made mainly of alkali salts of fatty acids and sold only as soap, is exempt from cosmetic rules). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-G/part-701/subpart-B/section-701.20
- What it shows: FDA definition of soap; other bars are cosmetics.
- Lanigan, R. S. (1998). Final report on the safety assessment of iodopropynyl butylcarbamate (IPBC). International Journal of Toxicology, 17(5 Suppl), 1–37 (safe at ≤0.1%; should not be used in products intended to be aerosolized; not reopened in Johnson, W., Jr. (2017), International Journal of Toxicology, 36(5 Suppl 2), 37S–38S). https://doi.org/10.1177/109158189801700503
7. Pros
Claim: A robust, low-dose preservative with CIR conclusions for each active, useful in alkaline liquid soap. |
Verification: Supported. Each active has a CIR conclusion with stated limits.
Citations:
- Elder, R. L. (Ed.). (1990). Final report on the safety assessment of diazolidinyl urea. Journal of the American College of Toxicology, 9(2), 229–245 (conclusion: safe at the minimum effective concentration, not to exceed 0.5%; not reopened in Andersen, F. A. (2008), International Journal of Toxicology, 27(Suppl 1), 77–142). https://doi.org/10.3109/10915819009078735
- What it shows: Safety conclusion.
- Lanigan, R. S. (1998). Final report on the safety assessment of iodopropynyl butylcarbamate (IPBC). International Journal of Toxicology, 17(5 Suppl), 1–37 (safe at ≤0.1%; should not be used in products intended to be aerosolized; not reopened in Johnson, W., Jr. (2017), International Journal of Toxicology, 36(5 Suppl 2), 37S–38S). https://doi.org/10.1177/109158189801700503
- What it shows: Safety conclusion.
- Elder, R. L. (Ed.). (1990). Final report on the safety assessment of diazolidinyl urea. Journal of the American College of Toxicology, 9(2), 229–245 (conclusion: safe at the minimum effective concentration, not to exceed 0.5%; not reopened in Andersen, F. A. (2008), International Journal of Toxicology, 27(Suppl 1), 77–142). https://doi.org/10.3109/10915819009078735
8. Cons
Claim: Germall™ Plus is a formaldehyde-releaser with use restrictions and a coming state ban. |
Verification: Supported. We list these limits so you have the full picture:
- Formaldehyde-releaser. Can cause reactions in formaldehyde-allergic people.
- IPBC restrictions. Not for lip, oral, aerosol, or young children’s body products.
- Washington State. Formaldehyde-releasers prohibited in cosmetics from January 1, 2027.
- Propylene glycol. Occasional allergen.
- Not natural-certified. Excluded from most natural standards.
Citations:
- de Groot, A. C., Flyvholm, M. A., Lensen, G., Menné, T., & Coenraads, P. J. (2009). Formaldehyde-releasers: Relationship to formaldehyde contact allergy. Contact allergy to formaldehyde and inventory of formaldehyde-releasers. Contact Dermatitis, 61(2), 63–85. https://doi.org/10.1111/j.1600-0536.2009.01582.x
- What it shows: Allergy.
- Washington State Department of Ecology. Chapter 173-339 WAC — Toxic-Free Cosmetics (implementing RCW 70A.560): 25 formaldehyde-releasing preservatives, including diazolidinyl urea, prohibited in cosmetics from January 1, 2027. https://ecology.wa.gov/regulations-permits/laws-rules-rulemaking/closed-rulemaking/wac-173-339
- What it shows: Washington rule.
- Jacob, S. E., Scheman, A., & McGowan, M. A. (2018). Propylene glycol. Dermatitis, 29(1), 3–5. https://doi.org/10.1097/DER.0000000000000315
- What it shows: Propylene glycol allergy.
- de Groot, A. C., Flyvholm, M. A., Lensen, G., Menné, T., & Coenraads, P. J. (2009). Formaldehyde-releasers: Relationship to formaldehyde contact allergy. Contact allergy to formaldehyde and inventory of formaldehyde-releasers. Contact Dermatitis, 61(2), 63–85. https://doi.org/10.1111/j.1600-0536.2009.01582.x
9. Safety Notes
Claim: Patch test before use; for external use only. |
Verification: Supported. Follow these precautions:
- Patch test any new product on a small area for 24–48 hours before full use.
- Do not use if you are allergic to formaldehyde, formaldehyde-releasers, iodine-containing preservatives, or propylene glycol.
- Not for lip products, sprays, or body lotions for children under 3.
- Water-based products are only as safe as their preservation. Keep lids closed, do not add water to the product, and discard it if it changes color, smell, or texture.
- Stop use if redness, burning, itching, or rash occurs, and talk to a healthcare provider.
- For external use only. Avoid the eyes unless the product is made for the eye area.
- If you are pregnant, nursing, have a medical condition, or are buying for a child, ask a healthcare provider before use.
Citations:
- Elder, R. L. (Ed.). (1990). Final report on the safety assessment of diazolidinyl urea. Journal of the American College of Toxicology, 9(2), 229–245 (conclusion: safe at the minimum effective concentration, not to exceed 0.5%; not reopened in Andersen, F. A. (2008), International Journal of Toxicology, 27(Suppl 1), 77–142). https://doi.org/10.3109/10915819009078735
- What it shows: Safety conclusion.
- Lanigan, R. S. (1998). Final report on the safety assessment of iodopropynyl butylcarbamate (IPBC). International Journal of Toxicology, 17(5 Suppl), 1–37 (safe at ≤0.1%; should not be used in products intended to be aerosolized; not reopened in Johnson, W., Jr. (2017), International Journal of Toxicology, 36(5 Suppl 2), 37S–38S). https://doi.org/10.1177/109158189801700503
- What it shows: Restrictions.
- de Groot, A., White, I. R., Flyvholm, M. A., Lensen, G., & Coenraads, P. J. (2010). Formaldehyde-releasers in cosmetics: Relationship to formaldehyde contact allergy. Part 2. Contact Dermatitis, 62(1), 18–31. https://doi.org/10.1111/j.1600-0536.2009.01631.x
- What it shows: Formaldehyde allergy.
- Elder, R. L. (Ed.). (1990). Final report on the safety assessment of diazolidinyl urea. Journal of the American College of Toxicology, 9(2), 229–245 (conclusion: safe at the minimum effective concentration, not to exceed 0.5%; not reopened in Andersen, F. A. (2008), International Journal of Toxicology, 27(Suppl 1), 77–142). https://doi.org/10.3109/10915819009078735
10. Product-line notes
- ORY® Skincare: For external use only. Not for deep or puncture wounds, animal bites, or serious burns.
- ORY® Haircare: Designed for the look and feel of hair and scalp comfort. Not intended to treat dandruff or scalp conditions, or to promote hair growth or prevent hair loss.
- ORY® Handmade Soap line: Cold-process bars contain very little free water and do not need this preservative. It is used only in liquid soaps, cream soaps, and water-containing syndet products; syndet and cream products are cosmetics under FDA rules, not soap, and list all of their ingredients.
- ORY® Cosmetics: Do not share applicators, and replace any product that changes color, smell, or texture.
11. References
Peer-reviewed research
- de Groot, A. C., Flyvholm, M. A., Lensen, G., Menné, T., & Coenraads, P. J. (2009). Formaldehyde-releasers: Relationship to formaldehyde contact allergy. Contact allergy to formaldehyde and inventory of formaldehyde-releasers. Contact Dermatitis, 61(2), 63–85. https://doi.org/10.1111/j.1600-0536.2009.01582.x
- de Groot, A., White, I. R., Flyvholm, M. A., Lensen, G., & Coenraads, P. J. (2010). Formaldehyde-releasers in cosmetics: Relationship to formaldehyde contact allergy. Part 2. Contact Dermatitis, 62(1), 18–31. https://doi.org/10.1111/j.1600-0536.2009.01631.x
- Elder, R. L. (Ed.). (1990). Final report on the safety assessment of diazolidinyl urea. Journal of the American College of Toxicology, 9(2), 229–245 (conclusion: safe at the minimum effective concentration, not to exceed 0.5%; not reopened in Andersen, F. A. (2008), International Journal of Toxicology, 27(Suppl 1), 77–142). https://doi.org/10.3109/10915819009078735
- Jacob, S. E., Scheman, A., & McGowan, M. A. (2018). Propylene glycol. Dermatitis, 29(1), 3–5. https://doi.org/10.1097/DER.0000000000000315
- Lanigan, R. S. (1998). Final report on the safety assessment of iodopropynyl butylcarbamate (IPBC). International Journal of Toxicology, 17(5 Suppl), 1–37 (safe at ≤0.1%; should not be used in products intended to be aerosolized; not reopened in Johnson, W., Jr. (2017), International Journal of Toxicology, 36(5 Suppl 2), 37S–38S). https://doi.org/10.1177/109158189801700503
- Lundov, M. D., Moesby, L., Zachariae, C., & Johansen, J. D. (2009). Contamination versus preservation of cosmetics: A review on legislation, usage, infections, and contact allergy. Contact Dermatitis, 60(2), 70–78. https://doi.org/10.1111/j.1600-0536.2008.01501.x
Government and regulatory sources
- Washington State Department of Ecology. Chapter 173-339 WAC — Toxic-Free Cosmetics (implementing RCW 70A.560): 25 formaldehyde-releasing preservatives, including diazolidinyl urea, prohibited in cosmetics from January 1, 2027. https://ecology.wa.gov/regulations-permits/laws-rules-rulemaking/closed-rulemaking/wac-173-339
- European Union. Regulation (EC) No 1223/2009 on cosmetic products, Annex V (allowed preservatives), including entry 56 (iodopropynyl butylcarbamate) and entry 3 (salicylic acid), with use limits and conditions. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20240424
- U.S. Food and Drug Administration. 21 CFR 701.20 — Definition of “soap” (only true soap, made mainly of alkali salts of fatty acids and sold only as soap, is exempt from cosmetic rules). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-G/part-701/subpart-B/section-701.20