Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation that began on 18 December 2006. It was updated on 16 December 2008 by Regulation (EC) No 1272/2008. REACH focuses on how chemicals are produced and used, and how they may affect human health and the environment. The law contains 849 pages and took seven years to create. It is often called the most complex law in the European Union’s history and the most important in 20 years. REACH is the strictest rule to date for managing chemicals and will influence industries worldwide. The regulation started on 1 June 2007 and was implemented in steps over the next ten years. REACH also created the European Chemicals Agency, which oversees the technical, scientific, and administrative tasks related to the regulation.

Overview

When REACH is fully in place, all companies that make or bring chemical substances into the European Union in amounts of one tonne or more each year must register these substances with the European Chemicals Agency (ECHA), located in Helsinki, Finland. REACH applies to some chemicals found in objects (called "articles" in REACH terms), so any company that imports goods into Europe might be affected.

ECHA has set three main deadlines for registering chemicals. These deadlines depend on the amount of chemical produced or imported each year. Companies that handle 1,000 tonnes per year must register by 1 December 2010, those with 100 tonnes per year by 1 June 2013, and those with 1 tonne per year by 1 June 2018. Chemicals that are more dangerous or toxic also must meet the 2010 deadline.

By 1 December 2008, about 143,000 chemical substances sold in the European Union had signed up early. While this step was not required, it gives companies more time to complete full registration. Selling chemicals that have not been signed up or registered is illegal under REACH ("no data, no market").

REACH also focuses on chemicals of very high concern (SVHC) because they may harm human health or the environment. Starting 1 June 2011, ECHA must be informed if SVHCs are used in products in amounts over one tonne per year and present in more than 0.1% of the product’s mass. Some uses of SVHCs require approval from ECHA, and those requesting approval must provide plans to replace them with safer alternatives (called "substitution"). As of 21 January 2025, 247 SVHCs were listed for possible approval.

REACH applies to all chemicals produced or imported into the EU. ECHA manages the technical, scientific, and administrative tasks of the REACH system.

To help simplify the registration of 143,000 substances and reduce animal testing, groups called substance information exchange forums (SIEFs) are formed. These groups include companies and data holders working with the same chemical. They work together to share costs and create one registration file. However, this process creates challenges, as SIEFs often include hundreds of companies that previously had no connection and must now:

• find each other and communicate openly
• share data
• divide costs fairly
• make complex decisions together

to complete a detailed registration file within a short time.

The European Commission helps businesses affected by REACH by providing free software called IUCLID. This tool helps companies collect, manage, and submit data about chemical properties and effects. Submitting this data is required for registration. In some cases, a chemical safety assessment (CSA) is required, and a chemical safety report (CSR) must be included with the registration file. These tasks are completed using the online software REACH-IT.

The goal of REACH is to protect human health and the environment by identifying the natural properties of chemical substances. At the same time, REACH aims to support the EU chemicals industry’s ability to innovate and remain competitive.

Background

In 2001, the European Commission (EC) released a report titled "A Future Chemical Strategy." This report suggested a system for managing chemicals. Under this system, chemicals made in amounts greater than 1 tonne must be "registered," those made in amounts greater than 100 tonnes must be "evaluated," and certain harmful substances, such as those that cause cancer, change genes, or harm reproduction (called CMRs), must be "authorized" before they can be used.

In October 2003, the EC introduced a new plan to manage the production, import, and sale of chemicals in Europe. This plan became law after the European Parliament approved its final version, known as REACH. The law officially started on 1 June 2007.

Requirements

A key part of the REACH regulation is the requirement to share information about chemicals throughout the supply chain. This ensures that manufacturers, importers, and their customers know about the health and safety risks of the products they use. For many retailers, the need to provide information about substances in their products within 45 days of a consumer’s request is difficult. Having detailed information about substances in products allows retailers to work with manufacturers to replace or remove harmful substances. The list of harmful substances is constantly growing, so organizations must regularly check updates on the European Chemicals Agency’s website.

A requirement is to collect, gather, and submit data to the European Chemicals Agency (ECHA) about the dangerous properties of all substances (except Polymers and non-isolated intermediates) made or imported into the EU in amounts greater than 1 tonne per year. Certain highly concerning substances, such as those that cause cancer, genetic mutations, or harm to reproduction (CMRs), must be approved before they can be used.

Chemicals are registered in three stages based on the amount produced or imported each year:

• Substances made or imported in more than 1,000 tonnes per year, or those of the highest concern, must be registered within the first 3 years.
• Substances made or imported in 100–1,000 tonnes per year must be registered within the first 6 years.
• Substances made or imported in 1–100 tonnes per year must be registered within the first 11 years.

Industry must also prepare risk assessments and provide safety measures to downstream users who handle the substance.

Evaluation allows authorities to ask registrants, and in rare cases downstream users, for more information. There are two types of evaluation:

• Dossier evaluation checks whether testing proposals avoid unnecessary animal testing and ensure registration dossiers meet requirements. According to the European Chemicals Agency’s 2018 report, 74% (211 out of 286) of cases reviewed had missing important safety information.
• Substance evaluation happens when there is reason to believe a substance may harm human health or the environment, such as because it is similar in structure to another harmful substance. All registration dossiers for a substance are reviewed together with other available information.

Substance evaluation is part of the Community Rolling Action Plan (CoRAP). A 2018 review found that 352 substances were prioritized for evaluation, with 94 completed. For nearly half of these, officials concluded that current use was unsafe for health or the environment. Risk management plans have been started for 12 substances since REACH began. For 74% of substances (34 out of 46), concerns were found, but no regulatory action has been taken. Officials also noted that 64% of substances under evaluation (126 out of 196) lacked enough data to prove their safety.

REACH allows substances of very high concern to continue being used only if they are approved. This approval process ensures that risks from using these substances are either controlled or justified by economic reasons, after considering safer alternatives.

The Regulation also allows restrictions on the use of certain substances across the EU if it is shown to be necessary. Member States or the EU Commission may propose such restrictions.

By March 2019, 185 authorizations had been granted, and no eligible request was ever rejected. Some groups have criticized these approvals, saying safer alternatives exist and that this delays replacing harmful substances. In March 2019, the European Court of Justice canceled an authorization, criticizing the European Chemicals Agency for failing to identify safer alternatives.

Manufacturers and importers must create risk-reduction plans for all known uses of a chemical, including uses by downstream users. Downstream users, such as plastic pipe producers, should share details about how they use chemicals with their suppliers. If downstream users refuse to share this information, they must have their own corporate social responsibility (CSR) plans.

History

REACH is the result of a major change in EU chemical rules. It passed the first step in the European Parliament on November 17, 2005, and the Council of Ministers agreed on a shared plan on December 13, 2005. The European Parliament approved REACH on December 13, 2006, and the Council of Ministers officially accepted it on December 18, 2006. Balancing costs and benefits has always been important, with the cost to follow the rules estimated at about €5 billion over 11 years, and the potential savings in healthcare costs from improved health. However, different studies have shown widely varying estimates for these costs. REACH became active on January 20, 2009, and was fully completed by 2015.

A separate rule called the CLP Regulation (for "Classification, Labelling, Packaging") applies the United Nations Globally Harmonized System of Classifying and Labeling Chemicals (GHS). This rule will gradually replace older rules about dangerous substances and dangerous preparations.

The REACH regulation was updated in April 2018 to include specific requirements for information about nanomaterials.

In the European Green Deal of 2020, a plan was made to update REACH to ban between 7,000 and 12,000 harmful substances in all consumer products, except when they are truly necessary. This goal was a priority for the European Commission, but it may be changed significantly due to efforts by the EU chemical industry and the European People's Party.

Rationale

The law was created for two main reasons: to protect people's health and to protect the environment. Using substances that might be harmful (such as phthalates or brominated flame retardants) is considered not good, and the REACH regulation will require some of these substances to be stopped from being used. Even though using these chemicals in products that are not eaten by humans (like electronic devices) might seem safe, chemicals can still enter the human body and the environment in different ways. For example, chemicals can be released into the air during use, where they can be breathed in or swallowed. Even if these chemicals do not directly harm people, they can pollute the air or water and enter the food chain through plants, fish, or other animals. According to the European Commission, safety information is not available for 99 percent of the thousands of chemicals that were on the market before 1981. In 1981, there were 100,106 chemicals used in the EU, as reported in the last survey. Of these, only 3,000 have been tested, and more than 800 are known to cause cancer, genetic changes, or harm to reproduction. These chemicals are listed in Annex 1 of the Dangerous Substances Directive (now Annex VI of the CLP Regulation).

Some people argue that using certain toxic chemicals is acceptable because "at very low levels they are not a concern to health." However, many of these substances can build up in the human body over time, reaching harmful levels. They may also react with other chemicals, creating new substances that have new risks.

In non-EU countries

Many countries not in the European Union have started using REACH rules or are working to create a system that follows global chemical safety standards, known as the Globally Harmonized System (GHS). Countries in the Balkans, such as Croatia and Serbia, are adopting the EU REACH system with support from the EU IPA program. Switzerland updated its chemical laws in February 2009 to include some REACH requirements. Turkey introduced a new chemical management rule in 2013 to prepare for REACH adoption. China is improving its system to better control chemicals in line with GHS standards.

In the UK, the government created a plan called "UK REACH," which some industry groups called "very expensive and unnecessary" because it would repeat EU safety data. The rules were first planned to start in October 2021 but were delayed to October 2023 and then to October 2025. After feedback from businesses, the UK government said it would look for a new way to handle UK REACH registrations that would avoid repeating EU data. In March 2021, over 20 UK organizations, including CHEM Trust and Breast Cancer UK, said they opposed plans to simplify UK REACH, calling it a "major weakening" of the rules after Brexit.

Controversy

More than ten years after the REACH regulation began, progress has been slow. In Europe today, about 100,000 chemicals are used. However, a report for the European Commission says only a small number of these chemicals have been carefully checked for their effects on health and the environment. Even fewer are controlled by rules.

REACH has faced challenges, including the cost for industries and the difficulty of following the new law. It also raises concerns about animal testing. Testing on animals with backbones is allowed, but only once for each new chemical if no other methods are available. If a company pays for these tests, it must sell the results for a "reasonable" price, though this term is not clearly explained. Some worry that buying necessary information could be very expensive for companies trying to register chemicals.

On June 8, 2006, countries outside the European Union, including the United States, India, and Brazil, criticized the REACH proposal. They said the law could harm international trade.

In 2006, the cosmetics company Lush opposed the legislation, believing it would increase animal testing. Lush asked its customers to send postcards to European lawmakers to show their disagreement. Over 80,000 customers sent postcards. In December 2006, Lush protested outside the European Parliament in Strasbourg by placing horse manure near the building.

A 2009 article in Nature by Thomas Hartung and Constanza Rovida estimated that 54 million animals with backbones would be used under REACH, with costs reaching €9.5 billion. This was compared to the European chemical industry’s annual income of €507 billion. Hartung once led the European Centre for the Validation of Alternative Methods (ECVAM). In a statement, ECHA, the European Chemicals Agency, said Hartung and Rovida’s assumptions were incorrect. ECHA’s different calculations reduced the number of animals by six times.

As plans for a 2025 update to REACH are being made, researchers and policy groups have pointed out conflicts between protecting the environment and keeping European chemical industries competitive. A 2025 study of German opinions showed disagreements between those who want to reduce chemical pollution and those who focus on keeping the chemical industry strong. These differences may limit how much the law can be changed.

Only representative services

Only representatives are EU-based organizations that must follow REACH (Article 8) and should use clear and fair work methods. The Only Representative is responsible for meeting the requirements of importers under REACH for substances entering the EU from non-EU manufacturers.

Non-EU consultancies can provide "only representative" services, but REACH states that a substance cannot be registered if the "only representative" is not based in the EU, unless the work is handed over to an EU-based registrant.

SIEFs will create new challenges. A report in the business news service Chemical Watch explained that some "pre-registrants" may be consultants seeking work opportunities, while others may attempt to charge very high fees for the data they provide.

Example of chemical inventories in various countries/regions

• REACH: A European Union rule about chemicals
• AICS: Australia's list of known chemical substances
• DSL: Canada's list of substances found in the country
• NDSL: Canada's list of substances not found in the country
• KECL: Korea's list of existing chemical substances
• ENCS: Japan's list of existing and new chemical substances
• PICCS: The Philippines' list of chemicals and chemical substances
• TSCA: A U.S. law that controls toxic substances
• Giftliste 1: A former Swiss list of toxic substances that was no longer used after 2005

Authorisation List

The European Chemicals Agency (ECHA) has created the REACH Authorisation List to limit how Substances of Very High Concern (SVHCs) are used. This list is an official recommendation from ECHA to the European Commission. The list is updated and expanded regularly. Right now, the Candidate List for Authorisation includes 247 SVHCs (see the ECHA list at https://echa.europa.eu/candidate-list-table), and some of these substances are already on the Authorization List.

To sell or use these substances, companies in the European Union (EU), such as manufacturers, importers, and retailers, must apply for authorization through ECHA. The applicant must submit a chemical safety report that explains the risks the substance may cause. They must also provide an analysis of possible alternative substances or technologies, including current and future research and development processes.