REACH Regulation Explained: What Companies Need to Know

The REACH Regulation is one of the most important pieces of chemical legislation in Europe. Yet many companies are still unsure about which requirements apply to them and what obligations they must fulfill.

In this article, you will learn what REACH is, which businesses are affected, and how to efficiently ensure compliance with regulatory requirements.

What Does REACH Stand For?

REACH stands for:

Registration, Evaluation, Authorisation and Restriction of Chemicals

The Regulation (EC) No. 1907/2006 came into force in 2007 and governs the manufacture, import, use, and distribution of chemical substances within the European Union.

The main objectives of REACH are to:

• Protect human health
• Protect the environment
• Improve transparency throughout the supply chain
• Place responsibility for the safe use of chemicals on businesses

Unlike previous regulations, the burden of proof lies with companies rather than regulatory authorities.

Which Companies Are Affected by REACH?

Many organizations assume that REACH only applies to chemical manufacturers. In reality, the regulation affects a wide range of industries that manufacture, import, distribute, or use chemical substances and products within the EU.

Examples include:

• Chemical manufacturers
• Plastics producers
• Engineering companies
• Automotive suppliers
• Electronics manufacturers
• Importers and distributors
• Pharmaceutical and medical device companies
• Construction and building materials companies

Even businesses that do not manufacture chemicals may have obligations regarding the substances contained in their products.

The Four Core Elements of REACH

Registration of Substances

Manufacturers and importers must register chemical substances if they produce or import them in quantities exceeding one tonne per year.

Registration is submitted to the European Chemicals Agency (ECHA) and includes detailed information about:

• Substance properties
• Hazard assessments
• Exposure scenarios
• Safe use conditions

Evaluation

Authorities evaluate submitted information to determine whether additional data is required.

The purpose is to assess potential risks to human health and the environment.

Authorisation of Substances of Very High Concern (SVHCs)

Certain substances are classified as Substances of Very High Concern (SVHCs).

These may include substances that are:

• Carcinogenic
• Mutagenic
• Toxic for reproduction
• Persistent and environmentally hazardous

Such substances may be added to the Candidate List and can later become subject to authorization requirements.

Restrictions

The manufacture, use, or placing on the market of certain substances may be restricted or prohibited.

Companies must continuously monitor whether substances used in their products are affected by new restrictions.

What Are the Main Compliance Obligations?

The exact requirements depend on a company’s role within the supply chain.

Typical obligations include:

Obtaining Substance Information

Companies must know which substances are contained in their products and materials.

Managing Safety Data Sheets (SDS)

Safety Data Sheets must be maintained, updated, and made available to relevant departments.

Monitoring SVHCs

When a substance is added to the Candidate List, additional communication and reporting obligations may arise.

Documenting Supplier Information

Information received from suppliers must be traceable and properly documented.

Tracking Regulatory Changes

REACH requirements continue to evolve. New restrictions or Candidate List updates may directly impact products and business processes.

Common Challenges in Practice

For many companies, the biggest challenge is not understanding the legislation itself, but managing the large amount of compliance-related data.

Common issues include:

• Substance data is stored across multiple systems.
• Safety Data Sheets are managed manually.
• Supplier information is incomplete or inconsistent.
• Regulatory updates are identified too late.
• Compliance information is not centrally available.

Especially in organizations with large product portfolios, manual processes can quickly become time-consuming and error-prone.

Why Digitalization Is Essential for REACH Compliance

Modern businesses need a centralized view of all compliance-relevant information.

This includes:

• Substance data
• Safety Data Sheets
• SVHC status
• Restrictions
• Supplier information
• Product compliance status

By integrating ERP systems such as SAP with specialized chemical regulatory databases, companies can automate the collection, maintenance, and monitoring of compliance information.

This reduces administrative effort while minimizing the risk of non-compliance.

Conclusion

The REACH Regulation affects far more companies than many realize. Any business that manufactures, imports, processes, or distributes products containing chemical substances should understand and comply with its requirements.

Today, the primary challenge is often not interpreting the regulation itself, but efficiently managing the vast amount of related data.

Organizations that invest in automated processes and centralized compliance solutions can improve transparency, reduce risk, and meet regulatory requirements more efficiently.

As regulatory demands continue to grow, digital compliance management is becoming a key factor for long-term success.