Preservatives in non-cosmetic products: Increasing human exposure requires action for protection of health. 2022

Carola Lidén, and Niklas Andersson, and Ian R White
Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.

The widespread use of skin sensitizing preservatives is well-known. Contact allergy to preservatives is often caused by their presence in cosmetic products. Preservative use in non-cosmetic products is less well-known. We have reviewed European Union (EU) legislations on classification and labelling, biocides and cosmetics, concerning conditions for use of the most used sensitizing preservatives (including formaldehyde-releasing substances, isothiazolinones and parabens). We have analysed temporal trends in their use in non-cosmetic products (tonnes, number of products, concentrations), based on annual reports to the Swedish Products Register 1995-2018; and we discuss implications for stakeholders. Major changes over time are that the use of most of the preservatives has increased by tonnes and/or by number of products, and that several use concentrations have declined following harmonized classification as a skin sensitizer with low concentration limits for this classification. We conclude that the massive increase in use of preservatives is alarming, and that urgent action is needed for protection of health. Their use in non-cosmetic products is broad, increasing and often undisclosed. In the EU, legislations concerning chemicals can provide relevant restrictions to reduce their use and associated health risks, monitored by efficient surveillance. Prevention would be benefited by better coordination between legislations.

UI MeSH Term Description Entries
D010226 Parabens Methyl, propyl, butyl, and ethyl esters of p-hydroxybenzoic acid. They have been approved by the FDA as antimicrobial agents for foods and pharmaceuticals. (From Hawley's Condensed Chemical Dictionary, 11th ed, p872) 4-Hydroxybenzoic Acids,Paraben,para-Hydroxybenzoic Acids,4 Hydroxybenzoic Acids,para Hydroxybenzoic Acids
D011310 Preservatives, Pharmaceutical Substances added to pharmaceutical preparations to protect them from chemical change or microbial action. They include ANTI-BACTERIAL AGENTS and antioxidants. Pharmaceutic Aids (Preservatives),Pharmaceutic Preservative,Pharmaceutic Preservatives,Pharmaceutical Preservative,Pharmaceutical Preservatives,Preservative, Pharmaceutic,Preservative, Pharmaceutical,Preservatives, Pharmaceutic
D003358 Cosmetics Substances intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Included in this definition are skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product. (U.S. Food & Drug Administration Center for Food Safety & Applied Nutrition Office of Cosmetics Fact Sheet (web page) Feb 1995) Personal Care Products,Care Product, Personal,Care Products, Personal,Personal Care Product,Product, Personal Care,Products, Personal Care
D004202 Disinfectants Substances used on inanimate objects that destroy harmful microorganisms or inhibit their activity. Disinfectants are classed as complete, destroying SPORES as well as vegetative forms of microorganisms, or incomplete, destroying only vegetative forms of the organisms. They are distinguished from ANTISEPTICS, which are local anti-infective agents used on humans and other animals. (From Hawley's Condensed Chemical Dictionary, 11th ed) Biocide,Disinfectant,Biocides
D005557 Formaldehyde A highly reactive aldehyde gas formed by oxidation or incomplete combustion of hydrocarbons. In solution, it has a wide range of uses: in the manufacture of resins and textiles, as a disinfectant, and as a laboratory fixative or preservative. Formaldehyde solution (formalin) is considered a hazardous compound, and its vapor toxic. (From Reynolds, Martindale The Extra Pharmacopoeia, 30th ed, p717) Formalin,Formol,Methanal,Oxomethane
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D017449 Dermatitis, Allergic Contact A contact dermatitis due to allergic sensitization to various substances. These substances subsequently produce inflammatory reactions in the skin of those who have acquired hypersensitivity to them as a result of prior exposure. Allergic Contact Dermatitis,Dermatitis, Allergic Eczematous,Dermatitis, Contact, Allergic,Allergic Contact Dermatitides,Allergic Eczematous Dermatitides,Allergic Eczematous Dermatitis,Contact Dermatitides, Allergic,Contact Dermatitis, Allergic,Dermatitides, Allergic Contact,Dermatitides, Allergic Eczematous,Eczematous Dermatitides, Allergic,Eczematous Dermatitis, Allergic

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