How EU’s REACH Regulation takes the fight to forever chemicals

The European Union’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation is widely regarded as one of the world’s most comprehensive and influential pieces of chemicals legislation.

Since entering into force in 2007, it has fundamentally changed how chemicals are regulated across Europe by placing responsibility on industry to demonstrate that substances can be used safely before they are placed on the market.

Nearly two decades later, the REACH Regulation continues to evolve in response to emerging scientific evidence and new environmental challenges. None has proved more significant than per- and polyfluoroalkyl substances (PFAS), a vast group of synthetic chemicals whose persistence in the environment has earned them the nickname “forever chemicals”.

Their widespread use across modern industry, coupled with growing concerns over their impact on human health and ecosystems, has placed PFAS at the centre of one of the most ambitious regulatory initiatives in EU history.

As the European Commission considers restrictions covering thousands of PFAS compounds, REACH has become the principal mechanism through which Europe hopes to reduce future contamination while encouraging the development of safer alternatives. The outcome is expected to shape chemicals policy far beyond the EU’s borders.

Understanding the REACH Regulation

REACH, formally known as Regulation (EC) No 1907/2006, was adopted by the European Parliament and Council in December 2006 before entering into force on 1 June 2007.

It replaced dozens of fragmented pieces of European chemicals legislation with a single, integrated framework designed to improve the protection of human health and the environment while maintaining the competitiveness of the chemicals industry.

The REACH Regulation applies to almost every chemical substance manufactured or imported into the European Economic Area (EEA), whether used in industrial processes or incorporated into everyday consumer products. Today, tens of thousands of substances are registered under REACH, making it one of the largest chemical regulatory systems in the world.

One of REACH’s defining principles is that industry, rather than regulators, is responsible for demonstrating the safety of chemicals. Manufacturers and importers must understand the hazards associated with the substances they produce, assess potential risks and implement appropriate measures to manage them safely throughout the supply chain.

This principle is often summarised by the phrase “no data, no market”. Companies that fail to provide the required safety information cannot legally manufacture or sell their substances within the EU, creating a strong incentive to generate robust scientific evidence before products reach the market.

The European Chemicals Agency (ECHA), headquartered in Helsinki, oversees the technical implementation of REACH by managing chemical registrations, coordinating scientific evaluations and supporting Member States in enforcement.

Why was REACH introduced?

Before REACH, thousands of chemicals already in commercial use had entered the European market with relatively little information available about their long-term effects on people or the environment. Existing legislation placed much of the burden on regulators to prove that substances posed unacceptable risks before restrictions could be introduced.

REACH fundamentally reversed this approach.

Instead of authorities having to demonstrate that chemicals are dangerous, companies became legally responsible for proving that their substances can be used safely. This represented one of the most significant reforms of chemicals legislation anywhere in the world.

REACH Regulation was introduced with several key objectives:

• Protect human health from hazardous chemical exposure.
• Safeguard the environment from pollution and long-term contamination.
• Improve scientific understanding of chemicals through comprehensive data collection.
• Encourage innovation by promoting safer alternatives to hazardous substances.
• Enhance the competitiveness of the European chemicals sector.
• Reduce animal testing by encouraging companies to share existing data and use alternative testing methods wherever possible.

These objectives remain at the heart of REACH today, although the scientific focus has increasingly shifted towards highly persistent substances such as PFAS.

How REACH works

REACH is built around four interconnected regulatory processes that together provide oversight throughout a chemical’s lifecycle.

Registration

Any company manufacturing or importing a chemical in quantities exceeding one tonne per year must submit detailed information to ECHA before placing it on the market.

Registration dossiers include information covering:

• Chemical identity
• Physical and chemical properties
• Toxicological and ecotoxicological studies
• Exposure scenarios
• Safe handling recommendations
• Risk management measures

The quantity and complexity of information required generally increases with production volume, reflecting the greater potential for exposure.

Evaluation

Once submitted, registration dossiers undergo scientific scrutiny by ECHA and national competent authorities.

Authorities assess both the quality of submitted information and whether further studies are required. They may also investigate chemicals suspected of presenting unacceptable risks, helping identify substances that warrant closer regulatory attention.

Authorisation

REACH identifies particularly hazardous chemicals as Substances of Very High Concern (SVHCs).

These include chemicals that are:

• Carcinogenic
• Mutagenic
• Toxic for reproduction
• Persistent, bioaccumulative and toxic (PBT)
• Very persistent and very bioaccumulative (vPvB)
• Endocrine disruptors or substances presenting an equivalent level of concern

Once placed on the Authorisation List (Annex XIV), these substances cannot generally continue to be used unless companies obtain specific authorisation demonstrating that risks are adequately controlled or that socioeconomic benefits outweigh the remaining risks and suitable alternatives are unavailable.

Restriction

Restrictions represent the broadest and often most powerful regulatory tool available under REACH.

Where authorities determine that a chemical presents unacceptable risks that require action across the market, restrictions can prohibit or limit its manufacture, sale or use throughout the European Union under Annex XVII.

It is this restriction mechanism that has become central to Europe’s strategy for addressing PFAS.

REACH milestones

The REACH Regulation has continued to evolve since its introduction as scientific understanding and regulatory priorities have developed.

Why PFAS has become REACH’s greatest challenge

Although REACH regulates thousands of chemicals, few have attracted as much scientific, political and public attention as PFAS.

PFAS comprise a family of several thousand fluorinated chemicals that possess unique properties. Their exceptionally strong carbon-fluorine bonds make them resistant to heat, water, oils and chemicals, allowing them to perform in conditions where many conventional materials fail.

As a result, PFAS are used across a remarkable range of sectors, including:

For decades these properties made PFAS highly attractive to manufacturers. However, the same chemical stability that gives them their commercial value also makes them extraordinarily persistent in the environment.

Why are PFAS called forever chemicals?

Unlike many conventional chemicals, most PFAS break down extremely slowly.

Once released, they can remain in groundwater, rivers, soils and oceans for decades while travelling considerable distances from their original source. Many PFAS compounds have also been detected in wildlife, food chains and human blood across Europe and around the world.

Although research into many individual PFAS continues, studies have associated certain compounds with a range of adverse health outcomes, including:

Environmental remediation presents an equally significant challenge.

Removing PFAS from contaminated drinking water or soil often requires sophisticated treatment technologies that are both technically demanding and extremely expensive. Consequently, preventing future releases has become a central objective of European chemicals policy.

From individual restrictions to regulating PFAS as a class

Initially, REACH addressed PFAS one chemical at a time.

Restrictions have already been introduced for several well-known compounds and specific applications, including certain long-chain perfluorocarboxylic acids (PFCAs), PFHxA in selected consumer products and many uses of PFAS-containing firefighting foams.

However, regulators increasingly recognised that this substance-by-substance approach was insufficient.

With several thousand PFAS in commercial use, restricting one compound often resulted in manufacturers replacing it with another closely related chemical possessing similar environmental characteristics. This phenomenon, known as “regrettable substitution”, risked perpetuating the same environmental problems while remaining technically compliant with existing legislation.

The experience prompted a fundamental shift in regulatory thinking. Rather than continuing to regulate individual chemicals, European authorities began considering restrictions covering the PFAS family as a whole.

The proposed universal PFAS restriction

In January 2023, authorities from Germany, Denmark, the Netherlands, Norway, and Sweden submitted what has been described as the largest restriction proposal ever considered under REACH.

Rather than targeting individual chemicals, the proposal seeks to restrict the manufacture, placing on the market and use of thousands of PFAS across numerous industrial and consumer applications.

Since then, ECHA’s scientific committees, including the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC), have been evaluating evidence submitted by industry, researchers, governments and civil society. Their work includes examining sector-specific uses, the availability of alternatives and the potential socioeconomic consequences of a broad restriction.

Once ECHA completes its scientific opinions, the proposal will move to the European Commission and Member States for political consideration before any final restriction can be adopted.

If approved, the measure would represent one of the most significant chemical restrictions ever implemented anywhere in the world.

Balancing environmental protection with industrial innovation

While reducing PFAS emissions enjoys broad political support, developing practical regulation is far from straightforward.

Many PFAS remain difficult to replace in sectors where reliability and performance are critical. Industries including semiconductor manufacturing, aerospace, defence, renewable energy, hydrogen production and advanced medical technologies continue to depend on certain PFAS because suitable alternatives either do not yet exist or require further development.

Recognising these challenges, the proposed restriction includes the possibility of time-limited derogations for uses considered essential to society while alternatives are developed and commercialised.

This reflects one of REACH’s central objectives: protecting health and the environment without unnecessarily undermining Europe’s industrial competitiveness or technological innovation.

Recent developments

Alongside the proposed universal restriction, the EU has continued strengthening its broader approach to PFAS management through complementary legislation.

Updated drinking water rules require Member States to monitor PFAS more consistently, while revisions to European water quality legislation expand monitoring of additional PFAS compounds in surface and groundwater. At the same time, targeted REACH restrictions continue to limit PFAS in areas such as consumer products and firefighting foams.

Beyond PFAS, the European Commission continues reviewing REACH itself to ensure the Regulation remains fit for purpose in the face of emerging scientific evidence, increasing sustainability ambitions and the objectives of the European Green Deal and the Chemicals Strategy for Sustainability.

These ongoing developments illustrate that REACH is not a static piece of legislation but a living regulatory framework that evolves alongside advances in science and technology.

REACH’s global influence

Although REACH applies within the European Union and European Economic Area, its influence extends far beyond Europe’s borders.

Manufacturers around the world frequently adapt products to meet REACH requirements because access to the European market depends on compliance. As a result, companies operating in North America, Asia and elsewhere often redesign products, reformulate chemicals and improve safety documentation to align with European standards.

The Regulation has also inspired similar approaches to chemicals management in other jurisdictions, reinforcing Europe’s position as a global leader in chemical safety and environmental protection.

The next chapter for REACH

Nearly 20 years after entering into force, REACH remains the cornerstone of European chemicals regulation. Its introduction transformed chemical governance by placing responsibility on industry to demonstrate safety before substances reach the market, establishing principles that continue to influence regulators around the world.

Today, PFAS represent the Regulation’s defining challenge. Their persistence, widespread use and environmental impacts have exposed the limitations of regulating hazardous substances individually and accelerated a broader shift towards managing entire groups of chemicals with shared characteristics.

The proposed universal PFAS restriction is therefore more than a response to a single family of chemicals. It reflects a broader evolution in regulatory thinking, one that prioritises prevention over remediation and seeks to balance environmental protection with technological progress.

Whatever form the final legislation ultimately takes, REACH’s approach to PFAS is likely to shape the future of chemicals policy, sustainable manufacturing and industrial innovation for many years to come.