Final Report of the Amended Safety Assessment of PVM/MA Copolymer and Its Related Salts and Esters as Used in Cosmetics
Abstract
Polyvinyl methyl ether/maleic acid (PVM/MA) copolymer, and its related salts and esters, are used in cosmetics, mainly as binders, film formers, and hair fixatives. Animal and human data relevant to the use of these ingredients in cosmetic products were reviewed by the CIR Expert Panel. The Panel concluded that these ingredients are safe for use in cosmetic products.
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At present, only one early-stage clinical study registered on ClinicalTrials.gov (NCT04893212) has been reported.
“At present, only one early-stage clinical study registered on ClinicalTrials.gov (NCT04893212) has been reported.”
From Polydopamine-Based Biomaterials in Oral Medicine: Applications, Mechanisms, and Translational Challenges (2026) · cites this paper as [107]
This trial is designed to assess the 6-month osseointegration performance of PDA-coated titanium screws in 20 patients with tooth loss, using an implant stability quotient greater than 70 as the primary endpoint, and is expected to conclude in 2025.
“This trial is designed to assess the 6-month osseointegration performance of PDA-coated titanium screws in 20 patients with tooth loss, using an implant stability quotient (ISQ) greater than 70 as the primary endpoint, and is expected to conclude in 2025.”
From Polydopamine-Based Biomaterials in Oral Medicine: Applications, Mechanisms, and Translational Challenges (2026) · cites this paper as [107]
These requirements remain among the most critical translational hurdles that must be addressed before widespread clinical adoption of PDA-based coatings can be realized.
“These requirements remain among the most critical translational hurdles that must be addressed before widespread clinical adoption can be realized.11,107”
From Polydopamine-Based Biomaterials in Oral Medicine: Applications, Mechanisms, and Translational Challenges (2026) · cites this paper as [107]
The US FDA classifies PDA as a 'novel coating' rather than a simple physical modification, thereby necessitating the submission of a comprehensive biological evaluation package in accordance with ISO 10993, as well as GLP-compliant large-animal safety studies and evidence from clinical randomized controlled trials.
“The US Food and Drug Administration (FDA) classifies PDA as a “novel coating” rather than a simple physical modification, thereby necessitating the submission of a comprehensive biological evaluation package in accordance with ISO 10993, as well as GLP-compliant large-animal safety studies and evidence from clinical randomized controlled trials (RCTs).”
From Polydopamine-Based Biomaterials in Oral Medicine: Applications, Mechanisms, and Translational Challenges (2026) · cites this paper as [107]
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References 14 · Cited by 25
- Authors
- Burnett, C. L., Bergfeld, W. F., Belsito, D. V., Hill, R. A., Klaassen, C. D., Liebler, D. C., Marks, J. G., Shank, R. C., Slaga, T. J., Snyder, P. W., & Andersen, F. A.
- Affiliations
- Cosmetic Ingredient Review Scientific Analyst/Writer
- Cosmetic Ingredient Review Expert Panel Member
- Director, Cosmetic Ingredient Review
- Corresponding author
- Andersen, F. Alan
- ORCID
- Venue
- International Journal of Toxicology
- Publisher
- SAGE Publications
- Published
- 2011-10
- Volume
- 30
- Issue
- 5_suppl
- Pages
- 128S-144S
- ISSN
- 1091-5818 (ISSN-L)
- 1092-874X
- OpenAlex
- W2166639645
- Cited by
- 25
- References
- 14
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 1 · 2023: 2 · 2022: 5 · 2021: 2 · 2019: 1 · 2017: 2 · 2016: 3 · 2014: 1 · 2013: 1
- FWCI
- 0.85
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- International Journal of Toxicology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Dermatology › Contact Dermatitis and Allergies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Carcinogens and Genotoxicity Assessment
- Physical Sciences › Chemistry › Analytical Chemistry › Dye analysis and toxicity
- Keywords
- cosmetic safety, cosmetic ingredients, binders, film formers
- MeSH terms
- Animals, Consumer Product Safety, Cosmetics, Humans, Maleates, Polyethylenes
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