PFAS in Cosmetics: Current Regulations and Legal Framework

The Impact of PFAS Regulations on the Cosmetics Industry

PFAS (Forever Chemicals) in Cosmetics: Current Regulations and Legal Framework

Per- and polyfluoroalkyl substances (PFAS) are a broad group of synthetic chemicals also known as “forever chemicals” due to the exceptional durability provided by their carbon-fluorine bonds. Thanks to their resistance to water, oil, and stains, as well as their heat stability and surface-active properties, these substances—which can also be used in cosmetic products—have become one of the most intensively addressed issues by regulatory agencies in recent years.

So, what do current regulations say about the use of PFAS in cosmetics? How is the legal framework taking shape in the EU and Turkey? In this article, we examine PFAS regulations—which closely concern the cosmetics industry—from a chronological and comparative perspective.

Why Are PFAS in Cosmetics Being Regulated?

PFAS substances are known for their ability to persist in the environment and living organisms without breaking down for long periods. This persistence can lead to accumulation over time. Scientific studies have highlighted the effects of certain PFAS compounds on:

• liver and kidney function,
• potential immunosuppressive effects on the immune system,
• possible effects on hormonal balance,
• concerns related to developmental and reproductive health

have been raised. Although dermal exposure through cosmetic products is relatively low compared to other routes of exposure, assessing total exposure is important when considering daily and long-term use.

PFAS Regulations in the European Union

The European Union has adopted one of the most comprehensive regulatory approaches worldwide regarding PFAS. The key regulations pertaining to cosmetic products can be grouped under four main headings:

1. Cosmetics Regulation (EC) No. 1223/2009

This regulation, which establishes the basic framework for the safety, labeling, and placing on the market of cosmetic products in the EU, regulates the substances that may be used in cosmetic products through the lists in Annex II (prohibited substances), Annex III (restricted substances), and Annexes IV–VI (colorants, preservatives, and UV filters). Certain compounds from the PFAS family are listed as prohibited or restricted substances under these annexes.

In accordance with the Regulation’s fundamental principle, a cosmetic product must be safe and documented by the responsible person through a Product Safety Report in order to be placed on the market. For products containing PFAS, this assessment must be conducted within the framework of the relevant restrictions.

2. Restrictions Under REACH

REACH (EC) No. 1907/2006, the EU Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals, contains significant restrictions on PFAS substances. The key regulations under REACH Annex XVII are as follows:

• PFOA and its derivatives: Perfluorooctanoic acid (PFOA) and its salts may not be used above certain limits.
• C9–C14 PFCAs: Restrictions on the use of perfluorocarboxylic acids (C9–C14) and their derivatives have entered into force.
• PFHxS and derivatives: Perfluorohexane sulfonic acid and related compounds are also subject to restrictions.

REACH restrictions cover a wide range of products, including cosmetics. Cosmetics manufacturers must regularly verify that the raw materials they use comply with the REACH restrictions list.

3. The Stockholm Convention and the POPs Regulation

Compounds such as PFOS (perfluorooctane sulfonic acid) and PFOA, which are classified as Persistent Organic Pollutants (POPs), have been banned or strictly restricted worldwide under the international Stockholm Convention. The EU’s POPs Regulation (EU) 2019/1021 regulates the production, use, and placing on the market of these substances.

4. Universal PFAS Restriction

A proposal prepared under the leadership of Germany, the Netherlands, Denmark, Sweden, and Norway, which aims to comprehensively restrict the entire PFAS group, was submitted to the European Chemicals Agency (ECHA) in 2023. This proposal;

• aims to broadly restrict the production, use, and placing on the market of PFAS,
• affect numerous sectors, including the cosmetics industry,
• define sector-specific transition periods where deemed necessary,

Legal Situation in Turkey

In Turkey, cosmetic products are regulated under the Cosmetic Products Regulation. This regulation was drafted largely in accordance with the EU Cosmetics Regulation No. 1223/2009 and is enforced by the Turkish Medicines and Medical Devices Agency (TİTCK).

Under the regulation:

• Lists of prohibited and restricted substances are updated in line with EU legislation.
• PFAS compounds banned or restricted in the EU are also incorporated into Turkish legislation as part of the harmonization process.
• Product safety assessments and technical dossier requirements are applied in parallel with the EU.

For this reason, PFAS restrictions have become critical for Turkish cosmetics manufacturers supplying products to the EU market, both in terms of export compliance and domestic market compliance. The process of incorporating changes in EU legislation into national legislation is a topic that manufacturers must monitor regularly.

Impacts of PFAS Regulations on the Cosmetics Sector

Formulation Changes

Products containing PFAS compounds subject to restrictions may require reformulation. This process necessitates the evaluation of alternative ingredients in terms of performance, stability, and safety.

Supply Chain Management

It is becoming increasingly important for cosmetics manufacturers to request declarations and documentation regarding PFAS content from their raw material suppliers to ensure supply chain transparency.

Technical Dossier and Product Safety Report

Compliance with PFAS restrictions has become an integral part of the Product Safety Report. It is crucial for manufacturers to keep these documents up to date for audits and market surveillance.

Labeling and Consumer Information

Consumer information regarding products that contain or do not contain PFAS is becoming increasingly important in line with the principle of transparency. In some countries, voluntary labeling practices for PFAS-free products are also developing.

Compliance Roadmap for Cosmetics Manufacturers

1. Create a raw material inventory: Request written information from suppliers regarding the PFAS content of all raw materials used.
2. Screen your product portfolio: Determine which products may contain PFAS using a risk-based approach.
3. Monitor regulations regularly: Track updates to the annexes of the EU Cosmetics Regulation, REACH restrictions, and the global PFAS ban process.
4. Develop an analysis plan: Plan targeted PFAS analyses for suspect raw materials and products.
5. Develop alternative formulations: Conduct R&D on PFAS-free alternative ingredients.
6. Keep the technical dossier up to date: Document analysis reports, supplier declarations, and compliance assessments.

You can contact Nanolab’s team of experts to determine the appropriate scope of PFAS analysis for your product’s composition and target market.

Note: This article is for general informational purposes. For current regulatory references and compliance assessments, it is recommended to consult the original texts of relevant EU, ECHA, TİTCK, and national regulatory sources.