Paraben

Safety Information

United States (U.S.)

CIR

The safety of various parabens has been reviewed by the Cosmetic Ingredient Review (CIR) Expert Panel in 1984, 1986, 1995 and 2008 and found to be safe for use. In 2019, the Expert Panel again reviewed parabens, to include several previously unreviewed paraben salts and 4-hydroxybenzoic acid. The Expert Panel thoroughly reviewed all available scientific data and concluded the following 20 Paraben ingredients are safe in cosmetics in their present use and concentration:

*Not reported to be in current use. Were ingredients in this group not in current use to be used in the future, the expectation is that it would be used in product categories and at concentrations comparable to others in this group.

However, the Expert Panel concluded data was insufficient to determine the safety of benzylparaben (which was not reported currently in use.)

FDA

The FDA considers methylparaben and propylparaben to be Generally Recognized As Safe (GRAS) as antimicrobial agents in food [21CFR184.1490</a>; 21CFR184.1670 ].

Butylparaben, ethylparaben, and propylparaben are approved for use in food for humans as synthetic flavoring substances and adjuvants. [21CFR172.515] Ethylparaben may be used as an indirect food additive as a component of adhesives and coatings. [21CFR175.105]

In pharmaceutical drugs, methylparaben, ethylparaben, propylparaben, and butylparaben have been approved as inactive ingredients (excipients).

An FDA ingredient webpage titled, “Parabens in Cosmetics” concludes: “At this time, we do not have information showing that parabens as they are used in cosmetics have an effect on human health.”

European Union (EU)

According to the general provisions of the Cosmetics Regulation of the European Union, the following paraben ingredients are allowed to be used as cosmetic preservatives at concentrations up to 0.4 percent (as acid) for single esters or 0.8 percent (as acid) for mixtures of esters (Annex V, entry 12): 4-hydroxybenzoic acid, methylparaben, potassium ethylparaben, potassium paraben, sodium methylparaben, sodium ethylparaben, ethylparaben, sodium paraben, potassium methylparaben, and alcium paraben. Propylparaben and butylparaben have maximum concentration limits of 0.19 percent (single esters and their salts).

Isobutylparaben and its salts, isopropylparaben and its salts, phenylparaben, benzylparaben, and pentylparaben are prohibited from use in cosmetics products in the EU (Annex II).

Resources

U.S. Cosmetic Ingredient Review (CIR)

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U.S. Food and Drug Administration Voluntary Cosmetic Registration Program (VCRP)

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U.S. Food and Drug Administration Generally Recognized As Safe (GRAS)

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EU Cosmetics Inventory

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Paraben

What Is It?

Parabens are a family of related ingredients commonly used as preservatives in cosmetics and personal care products. They help prevent the growth of harmful bacteria and mold, protecting both products and consumers. Parabens are highly effective and widely used preservatives that enhance the shelf life and safety of products including all types of cosmetics, as well as foods and drugs, and protect the families who trust and enjoy them. The most commonly used parabens in cosmetics are methylparaben, ethylparaben, propylparaben, and butylparaben.

Why Is It Used?

The Cosmetic Ingredient Dictionary and Handbook (Dictionary) reports the function of 21 paraben ingredients as preservatives.

According to 2019 U.S. Food and Drug Administration (FDA) Voluntary Cosmetic Registration Program (VCRP) data, Methylparaben was used in 11,739 formulations (9,347 of which are leave-on formulations). Propylparaben had the next highest number of reported uses at 9,034 (7,520 of which are leave-on formulations).

The following parabens had no reported use according to the VCRP and PCPC data: benzylparaben, potassium paraben, calcium paraben, potassium propylparaben, potassium butylparaben, sodium isopropylparaben, potassium ethylparaben, potassium methylparaben and 4-hydroxybenzoic acid.

Scientific Facts

Paraben preservatives all share para-hydroxybenzoic acid, or PHBA, as a common chemical structure. PHBA occurs naturally in many fruits and vegetables. The parabens used in cosmetics are identical to those found in nature, and are quickly eliminated by the body.Any product that contains water is susceptible to being spoiled by the growth of fungi or bacteria, which could cause problems such as discoloration, malodor, or breakdown of the product. Under certain conditions, an inadequately preserved product can become contaminated, allowing harmful levels of microorganisms to grow. Parabens are highly effective preservatives that protect products against such changes, thus enhancing the shelf life and safety of products, and have been used safely for decades.