Understanding Who Must Comply With EU REACH Regulation

EU REACH applies to many businesses that make, import, or use chemicals in the EU—not just chemical manufacturers. Whether the regulation applies to you depends on what you do, what you place on the market, and how much you handle each year.

This blog explains who is covered by REACH, what activities trigger compliance, and how REACH applies to substances, mixtures, and articles, using clear examples and practical explanations.

Who Do REACH Regulations Apply To?

REACH applies broadly to companies that manufacture, import, or use chemicals within the European Union (EU) and the European Economic Area (EEA), which includes Norway, Iceland, and Liechtenstein.

In general, REACH obligations apply when a company manufactures or imports chemical substances in quantities of 1 tonne or more per year per legal entity.

Under REACH, the responsibility for compliance lies with industry, not regulators. Companies must identify hazards, assess risks, and demonstrate that substances are used safely.

What Activities Trigger REACH Obligations?

You may be subject to REACH if you are involved in any of the following activities:

• Manufacturing chemical substances in the EU/EEA

• Importing chemical substances into the EU/EEA

• Formulating mixtures (e.g., paints, detergents, coatings)

• Producing or importing articles containing substances

• Recovering chemical substances from waste

• Using substances in industrial or professional processes

REACH applies regardless of whether chemicals are sold directly, used internally, or embedded in finished products.

Who Is Covered by REACH?

Manufacturers

Companies that manufacture chemical substances within the EU/EEA must register those substances if the quantity reaches 1 tonne or more per year.

Importers

Companies that import substances, mixtures, or articles from outside the EU/EEA are responsible for REACH compliance—not the non-EU supplier.

Downstream Users

Companies that use chemicals in their operations, such as formulators, industrial users, or professional users, are considered downstream users.
They must ensure their uses are covered under REACH registrations and comply with risk management measures.

Distributors

Distributors store and place chemicals on the market. While they usually do not register substances, they have important obligations related to supply-chain communication.

Non-EU Companies (via Only Representatives)

Non-EU manufacturers cannot register directly under REACH. Instead, they may appoint an Only Representative (OR) based in the EU to fulfill registration and compliance obligations on their behalf.

Does REACH Apply to Articles?

Yes — REACH also applies to articles, such as:

• Clothing and textiles

• Furniture

• Electronics

• Automotive components

• Toys and consumer goods

However, obligations for articles are more specific and depend on certain conditions.

When Is Registration Required for Substances in Articles?

A company producing or importing articles must register a substance contained in an article only if both of the following conditions are met:

1. The substance is intended to be released during normal or reasonably foreseeable use, and

2. The total quantity of that substance exceeds 1 tonne per year

Example:

• Ink released from a pen

• Fragrance released from scented products

If a substance is not intended to be released, registration is generally not required, but other obligations may still apply.

REACH Obligations for Articles Without Intended Release

Even when registration is not required, REACH may still apply if:

• The article contains a Substance of Very High Concern (SVHC) above 0.1% (w/w)

• The article is placed on the EU market

In such cases, companies must fulfill communication and notification obligations, including:

• Providing information to customers (Article 33)

• Submitting SCIP notifications for SVHC-containing articles

Does REACH Apply to Recovered Substances?

Yes.
If you recover a chemical substance from waste and place it on the market in quantities of 1 tonne or more per year, REACH obligations may apply unless specific exemptions are met.

Are There Any Exemptions Under REACH?

Some substances are partially or fully exempt from REACH, including:

• Radioactive substances

• Waste

• Substances used in food or feeding stuffs

• Certain naturally occurring substances

However, exemptions are narrow and must be assessed carefully, as incorrect assumptions can lead to non-compliance.

Who Is Responsible for REACH Registration?

Responsibility depends on the supply chain structure:

• EU manufacturers register substances they produce

• EU importers register substances they import

• Non-EU manufacturers rely on EU importers or appoint an Only Representative

• For articles, responsibility lies with the article producer or importer

There is no shared responsibility by default—each legal entity must understand and meet its own obligations.

Why Understanding Applicability Is Critical

Many REACH compliance issues arise not from technical data gaps, but from misunderstanding whether REACH applies at all.

Correctly identifying:

• Your role (manufacturer, importer, downstream user)

• Your product type (substance, mixture, article)

• Your annual tonnage

is the foundation for all further compliance actions.

Final Thoughts

REACH applies to a wide range of businesses across multiple sectors—not just chemical manufacturers. If your company manufactures, imports, or uses chemicals or articles in the EU market, REACH obligations are likely relevant to you.

Understanding whether and how REACH applies to your company is the first and most important step toward compliance. Once applicability is clear, businesses can move confidently toward registration, risk assessment, and supply-chain communication.