What is REACH?

What is REACH?

The Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) (EC 1907/2006) is an environmental regulation that restricts chemical substances that are manufactured, imported, sold or used within EU countries in order to safeguard human health and the environment. 

When Did REACH Go Into Effect?

Adopted by the European Union, REACH entered into force on June 1, 2007. The legislation took seven years to pass and is considered one of the EU’s most complex pieces of legislation. It is also a landmark regulation worldwide in its efforts to curb public exposure to chemicals with known negative side effects. 

Why Was REACH Created?

REACH was implemented to protect human health and the environment from chemical substances known to have detrimental effects on people, animals, and ecosystems. 

Negative impacts to humans include:

• High blood pressure
• Kidney damage
• Cardiovascular disease
• Reproductive issues
• Cancer

Negative impacts to the environment include:

• Toxicity to aquatic life
• Loss of biodiversity
• Decreased growth in plants and animals
• Negative health effects in vertebrates

How Does REACH Work?

The European Chemicals Agency (ECHA)—the agency responsible for overseeing the EU’s chemicals legislation—evaluates chemical substances for their potential impact on human health and the environment. This includes examining how the risks of a substance can be managed.

Following its review, ECHA will typically take one of two actions:

1. Impose restrictions on the substance by adding it to the Substances of Very High Concern (SVHC) List, also known as the ECHA Candidate List.
2. Choose not to impose any restrictions on the substance.

If ECHA decides to add a substance to the Candidate List, it becomes officially recognized as an SVHC. Following this designation, suppliers who choose to continue using the chemical are legally required to fulfill several obligations, including providing detailed safety information, responding to consumer requests within 45 days, and notifying the ECHA if the SVHC exceeds certain thresholds in their product formulations. 

Annex XVII (Restricted Substances List)

The Annex XVII, also known as the Restricted Substances List, lists substances that are restricted for use in certain applications or products due to their hazardous properties. Chemical substances added to the Restricted Substances List could be either completely banned or limited to specific uses (in certain concentrations). 

Candidate List for Substances of Very High Concern (SVHC List)

Unlike the Restricted Substances List, chemicals added to the SVHC list are not banned or limited in quantity. Instead, they trigger a strict reporting requirement. Companies with an SVHC present above 0.1% w/w in articles must notify ECHA as well as provide safe use information for customers. 

Which Substances Are Covered in REACH?

This depends on the list:

• The Restricted Substance List contains 74 unique substances/entries. 
• The SVHC List contains 247 chemicals that can harm people or the environment.

The Restricted Substances List is updated on an as-needed basis, while the SVHC List is typically updated twice a year in January and June. However, sometimes additional updates will occur throughout the year as needed. In November 2024, ECHA released a rare third update to the SVHC list, adding Triphenyl Phosphate (TPhP).

The full lists can be found on the ECHA website. Information featured includes the substance name, the Chemical Abstract Service Registry number (CAS No.), entry number, conditions, and any relevant appendices. 

Examples of Restricted REACH Substances

An example of a substance on these lists is Lead (Pb) – CAS No. 7439-92-1. 

Widely used for centuries due to its unique physical, chemical, and economic properties, lead has long been popular for industrial manufacturing purposes. Lead can be used in PCB solders, cables, and coatings. It can also be found in some electronic component finishes. But lead is also a neurotoxin proven to have a variety of negative health effects, including:

• Kidney damage
• Cardiovascular problems
• Reproductive issues
• Nerve damage

Lead contamination can also have negative consequences on the environment, including stunting plant and animal development as well as impacting the neurological system in invertebrates. 

Lead is entry number 63 on the SVHC list.

Who Does REACH Apply To?

Broadly, REACH applies to manufacturers and importers who either produce goods in or import goods to the European Union. While some other entities may also have compliance obligations under REACH, manufacturers and importers are the primary bearers of responsibility for compliance.

Depending on what a company is importing or manufacturing, different rules apply. 

1. If a company manufactures or imports ANY chemical substance in quantities of >1 metric ton (1,000 kg) per year, they must register the substance with ECHA under REACH.
2. If the company produces or imports articles containing a substance listed on the SVHC List in concentrations above 0.1% w/w AND the total amount of the SVHC in those articles exceeds 1 metric ton (1,000 kg) per year, they must notify the ECHA.
3. If an article contains a chemical substance on the SVHC List that’s higher than 0.1% w/w, the company must submit a SCIP notification to ECHA, regardless of the total tonnage. 

REACH assigns the registration obligation on manufacturer and importer. Registrations are submitted to the European Chemicals Agency (ECHA) through their website.  

The registration dossier must contain information including: 

• Hazard information
• Assessment of the risks the substances may pose
• How to control these risks
• Properties and uses

These evaluations must be done prior to manufacturing or importing goods in the EU. 

Substances manufactured, sold, or imported in volumes exceeding 10 tons per year must also have a chemical safety assessment and be recorded in the chemical safety report as part of the dossier. The assessment will look at hazard assessment (classification, PBT conclusions and dose characterization) as well as exposure assessment (scenarios and exposure limits).

It’s important to note that there is a duty to ensure registration information stays up to date with any new or relevant information. This record-keeping is a critical part of remaining in compliance with REACH.

Is REACH Mandatory?

Yes, REACH reporting is mandatory for all manufacturers and importers who fall within scope of the REACH requirements. 

What Are the Penalties for REACH Noncompliance?

Penalties for noncompliance vary across the 27 EU countries, but generally include:

• Financial penalties
• Administrative fines
• Loss of market access

In cases where violators have committed a criminal offense, sentences for failing to comply with REACH range from several months to up to eight years in prison. 

How Is REACH Enforced?

Because ECHA has no legal enforcement responsibilities, enforcing the regulation and penalizing violators is left up to individual EU member nations and their governments. ECHA does, however, require states to develop and implement an accountability framework that includes specific legal consequences for noncompliance. 

As ECHA explains, EU member states “must ensure that there is an official system of controls and also lay down legislation specifying penalties for non-compliance with the provisions of REACH.”

How Often Is REACH Updated?

ECHA updates REACH twice every year, typically in January and June. In some cases, however, the agency may add additional substances on a more ad-hoc basis. In 2024, for example, ECHA added five new substances in January, one in June, and then a seventh substance, Triphenyl phosphate (TPhP), in November. 

Latest Updates to REACH Regulations

In 2024, ECHA added five new substances in January, one in June, and another in November. These are the seven substances added to REACH’s Substances of Very High Concern List in 2024:

• 2,4,6-tri-tert-butylphenol 
• 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol
• 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one
• Bumetrizole
• Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol 
• bis(α,α-dimethylbenzyl) peroxide.
• Triphenyl phosphate (TPhP)
  

In addition, in January 2025 ECHA added another five substances to its SVHC List. These include:

• 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid 
• O,O,O-triphenyl phosphorothioate 
• Octamethyltrisiloxane 
• Perfluamine 
• Reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives 

How to Comply With REACH Regulations

Because of the number of countries it’s enforced in, and the potentially significant consequences for violators, complying with REACH should be a top priority for any compliance program. While there’s no single, infallible playbook for effectively adhering to REACH and its SVHC List, companies that consistently take several critical measures put themselves in a strong position to maintain REACH compliance.

• Manufacturers and their compliance teams should be aware of the complete formulations for their products, and have access to accompanying full material declarations (FMDs).
• In instances where one or several of its products does contain a substance of very high concern, businesses need to consistently carry out all their legal obligations, including providing detailed safety information; responding to consumer requests within 45 days; and notifying the ECHA if the SVHC exceeds certain thresholds in their product formulations. 
• Stay up to date on every REACH update, and carry out the accompanying due diligence to determine whether any of the newly restricted substances impact your products. 

How Can Z2Data Help Companies Manage Their REACH Compliance?

The Z2Data supply chain risk management (SCRM) platform can analyze product bills of materials (BOMs) and quickly and accurately identify noncompliant parts across all the most critical environmental regulations, including REACH, RoHS, China RoHS, SCIP, California Proposition 65, and many more. In addition, Z2Data provides compliance risk scores for over one billion components, a holistic assessment that considers compliance across the most important global directives. 

Finally, the tool is also capable of carrying out supplier campaigning, surveying your manufacturers to procure all the requisite information necessary to achieving 100% compliance across your entire product portfolio. 

What Is a REACH Certificate and How Can I Get One?

The idea of a “REACH certification” is something of a misconception. ECHA does not issue any certificates or certifications of compliance (CoC) with REACH. Instead, any certifications that exist have been drafted and issued by the manufacturer themselves, to function as a statement attesting to regulatory adherence. 

In some cases, organizations will use a test report from a third-party firm as the foundation for a certification. These forms of documentation demonstrate that the company isn’t just asking supply chain partners to take them at their word, and have actually carried out the due diligence necessary to verify REACH compliance. 

Finally, it’s important to note that ECHA doesn’t require a third-party certification for REACH compliance, and companies that pursue compliance verification via professional testing are not legally obligated to do so. 

REACH vs. RoHS: What’s the Difference?

Entirely distinct laws, the only similarities between REACH and RoHS are that they’re both major environmental regulations administered by the EU and enforced in the bloc’s 27 member nations. REACH is a multifaceted directive that imposes registration requirements on in-scope businesses; maintains and expands a list of hazardous substances through the SVHC List; and restricts the use of certain chemicals through its Authorisation List. 

RoHS, on the other hand, is primarily comprised of a list of 10 substances that the EU restricts in the use of electrical and electronic equipment (EEE). While a wide range of industries manufacture products that are considered within the scope of EEE, the regulation only restricts the use of 10 substances above narrowly defined thresholds: 

• Lead (1000 ppm, or parts per million)
• Cadmium (100 ppm)
• Mercury (1000 ppm)
• Hexavalent chromium (1000 ppm)
• Polybrominated biphenyls (PBB) (1000 ppm)
• Polybrominated diphenyl ethers (PBDE) (1000 ppm)
• Bis(2-ethylhexyl) phthalate (DEHP) (1000 ppm)
• Benzyl butyl phthalate (BBP) (1000 ppm)
• Dibutyl phthalate (DBP) (1000 ppm)
• Diisobutyl phthalate (DIBP) (1000 ppm)

REACH in Other Countries

While the most influential REACH regulation covering the largest market is EU REACH, other versions of the regulation are administered and enforced in several other countries. The two most important non-EU iterations of REACH are in the UK and China. 

The United Kingdom’s REACH regulation entered into force on January 1, 2021, and covers England, Scotland, and Wales. (The EU’s version continues to be enforced in Northern Ireland.) While UK REACH shares a lot of similarities with its EU counterpart, it is maintained and enforced by the UK government, and is subject to expansions and revisions independent of the EU law. 

China’s version of the EU law, which is officially known as MEE Order No. 12, was also implemented on January 1, 2021. The environmental regulation is administered and enforced by China’s Ministry of Ecology and Environment (MEE). While China REACH shares much of the same framework as the EU version, it’s more focused on requiring businesses to submit official notifications for new substances that are not listed in the nation’s Inventory of Existing Chemical Substances in China (IECSC), China’s central repository for all substances manufactured, processed, sold, imported, or exported within the country. 

There are three main types of notifications entities may be required to submit to the MEE, depending on the volume of the new substance being manufactured, sold, or otherwise used in China. Businesses should review the official notification rules published and maintained by China’s MEE for specific guidelines.