Parabens in cosmetics: what the rules say

Parabens are a common label term. This guide sticks to what regulators publish.

What parabens are

The FDA calls parabens a family of related chemicals that are commonly used as preservatives in cosmetic products. A preservative slows the growth of bacteria and mold in a product.

On a label they end in -paraben: METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN and others. Poliage’s Parabens flag matches 25 CosIng names, which include sodium and potassium salts such as SODIUM METHYLPARABEN.

What the FDA says

The FDA’s page says it does not have information showing that parabens, as they are used in cosmetics, have an effect on human health. It says it will continue to evaluate new data.

The FDA also says it has no special rules that apply only to preservatives in cosmetics. Cosmetic ingredients other than color additives do not need FDA approval before they go on the market.

What the EU rules say

The EU lists preservatives that are allowed in cosmetics in Annex V of Regulation (EC) No 1223/2009. Annex II lists substances that are prohibited.

Commission Regulation (EU) No 358/2014 of 9 April 2014 added five parabens to Annex II:

• isopropylparaben
• isobutylparaben
• phenylparaben
• benzylparaben
• pentylparaben

The same regulation changed Annex V so the 4-hydroxybenzoic acid entry no longer covers those five. The limits for the others are 0.4% (as acid) for a single ester and 0.8% (as acid) for a mixture of esters.

Commission Regulation (EU) No 1004/2014 of 18 September 2014 then set a lower limit for two of them. Butylparaben and propylparaben and their salts may not exceed 0.14% (as acid) as the sum of the individual amounts. In a mixture, the total can be up to 0.8%, but butyl and propyl together still stay within 0.14%.

These are the figures in the 2014 texts. The EU changes its annexes from time to time, so check the current text for a specific ingredient.

What the EU committee said

The European Commission’s independent scientific committee on cosmetic ingredients (SCCS) gave an opinion on propylparaben, SCCS/1623/20, adopted on 30 to 31 March 2021. It concluded that propylparaben can be used as a preservative in cosmetics up to 0.14%, after weighing the concerns about possible endocrine effects. The opinion repeats the 0.8% limit for mixtures and the 0.14% limit for butyl and propyl combined.

Using the flag

A Poliage product page says “Contains” followed by the paraben name and its function, which is preservative. The flag marks it when it is on your own avoid list. It is not a judgment.

Rules differ by region. A product sold in the U.S. is not bound by EU limits, and the FDA does not set one for parabens. The Poliage flag shows what is listed. It does not show the amount.

If a product irritates your skin, talk to a doctor or pharmacist. The patch testing guide explains how to try a product on a small area first.

What this guide does not do

It does not call parabens good or bad. It does not say whether a paraben-free product suits you. Labels can be misread, and a maker can change a formula without changing the barcode, so the label on the pack comes first.

Where this comes from

The FDA statements come from its page on parabens in cosmetics. The EU bans and limits come from Commission Regulations 358/2014 and 1004/2014, which amend Regulation (EC) No 1223/2009, and from the scientific committee’s 2021 opinion on propylparaben. The grouping comes from Poliage’s flag rules, which match CosIng names.