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The final opinion on Methylparaben (CAS No. 99-76-3) was issued by the Scientific Committee on Consumer Safety (SCCS) on December 15, 2023.
SCCS Final Opinion on Methylparaben: The Background
On November 7, 2018, the Commission conducted a review of Regulation (EC) No 1223/2009, which governs cosmetic products, specifically focusing on substances exhibiting endocrine-disrupting (ED) properties. These substances are chemical substances that can alter the functioning of the endocrine system, and consequently produce adverse effects upon human health.
While the Cosmetics Regulation lacks explicit provisions on EDs, it establishes a regulatory framework to ensure a high level of protection for human health. Environmental concerns related to cosmetic product ingredients are addressed under Regulation (EC) No 1907/2006 (‘REACH Regulation’).
Methylparaben is among the substances identified, triggering a call for data as part of this comprehensive evaluation process.
What is methylparaben?
Methylparaben is a widely used chemical compound that functions primarily as a preservative in cosmetic and pharmaceutical products. It helps extend shelf life by preventing the growth of bacteria, mold and fungi, ensuring that creams, lotions, makeup and other formulations remain safe and stable for consumers.
This ingredient is part of the paraben family, a group of compounds frequently added to personal care products to maintain their integrity over time. Due to its effectiveness at very low concentrations, methylparaben is commonly found in moisturizers, shampoos, sunscreens and even certain topical medications.
What is the reason behind the issuance of the SCCS Final Opinion?
Methylparaben, also known by its chemical name ‘Methyl 4-hydroxybenzoate,’ is presently regulated as a preservative (Annex V, entry 12) with allowable concentrations up to 0.4% (as acid) when used on its own or up to 0.8% for mixtures of esters (Annex V, entry 12, column g).
Various safety assessments have been conducted on Methylparaben. During the data collection phase, stakeholders submitted scientific evidence affirming the ingredient’s safety as a preservative in cosmetic products. In response, the Commission has tasked the SCCS with conducting a safety assessment of Methylparaben, taking into consideration the provided information.
Is methylparaben safe?
After evaluating various aspects such as physicochemical properties, toxicokinetics, exposure, and toxicological and safety evaluations, the SCCS concluded:
The use of Methylparaben as a preservative in cosmetic products at concentrations of up to 0.4% (expressed as acid) is safe.
If you’re looking to ensure the safety of your products, we’re here to provide you with answers and specialized guidance. Contact us at info@cosmeservice.com. We’re here to help!
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