What Is REACH Registration Evaluation Authorisation and Restriction of Chemicals and Why It Matters for Your Business

2025-04-24 16:34:30

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In today’s global marketplace, ensuring compliance with chemical regulations is more than a legal necessity – it is a critical part of doing business responsibly. One of the most comprehensive regulations in this field is REACH. Whether you’re a manufacturer, importer, or downstream user, understanding REACH is essential. In this article, we’ll break down what REACH is, why it matters, where it applies, and how to stay compliant.

 

Understanding REACH: What Is the REACH Regulation?

REACH stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals. It is the European Union’s main chemical regulation, introduced in 2007 to protect human health and the environment from the risks posed by chemicals.

The regulation requires companies to identify and manage the risks linked to the substances they manufacture and place on the EU market. If the risks cannot be managed, authorities can restrict the use of these substances.

 

Why REACH Matters: The Impact of REACH on Your Business

REACH directly affects businesses that manufacture, import, or use chemical substances in their products. Compliance is mandatory if you want to maintain access to EU markets.

Even companies outside the EU are affected if they export products to Europe. Non-compliance can result in severe penalties, supply chain disruptions, and reputational damage.

More than a regulation, REACH is a market expectation. Businesses that demonstrate compliance will gain trust and a competitive advantage.

 

Key Requirements Under REACH: Registration, Evaluation, and Authorization

REACH obligations revolve around four main processes:

• Registration: Companies must register substances that they manufacture or import in quantities of one tone or more per year.
• Evaluation: Authorities evaluate the information submitted to clarify risks and ensure compliance.
• Authorization: Certain Substances of Very High Concern (SVHCs) can be added to the Authorization List (Annex XIV). Once on the list, these substances cannot be used or placed on the market after a specified sunset date, unless an authorization is granted for a specific use.
• Restriction: Some substances are restricted or banned under Annex XVII due to unacceptable risks. Restrictions may apply to substances on their own, in mixtures, or in articles, and may limit specific uses or impose concentration thresholds.

These steps ensure that chemical safety is properly assessed throughout the supply chain.

 

Who Needs to Comply? Common Obligations Under EU REACH and Similar Regulations

Compliance isn’t just for chemical manufacturers. Under REACH and REACH-like regulations, several types of businesses may have responsibilities:

Manufacturers: Companies that manufacture chemical substances within the regulatory jurisdiction (e.g. EU, UK, Türkiye, South Korea, China).

Importers: Businesses that import chemical substances, mixtures, or articles into a country or region subject to REACH or a similar regulatory framework.

Downstream Users: Companies that use chemicals in industrial or professional activities, including formulators, end-users, and re-importers.

Retailers may also have obligations, especially if they directly import products or sell articles containing regulated substances.

 

Countries and Regions Enforcing REACH and REACH-Like Regulations

1. European Union (EU):

The European Union is the origin of REACH, which stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals. Enacted in 2007, EU REACH is one of the most comprehensive chemical regulations in the world, designed to protect human health and the environment from the risks posed by chemicals. Under REACH, companies that manufacture or import substances into the EU in quantities of 1 tonne or more per year must register them with the European Chemicals Agency (ECHA). The regulation promotes the safe use of chemicals through robust data collection, hazard assessment, and risk management. It also encourages the use of alternative methods to assess chemical hazards, such as non-animal testing, making it a progressive framework in the field of chemical safety.

2. United Kingdom (UK REACH) REACH Like Regulation:

Following Brexit, the United Kingdom implemented its independent regulatory framework known as UK REACH, which came into force on January 1, 2021. While UK REACH closely mirrors the EU system, it operates independently and requires companies to manage registrations through the UK's Health and Safety Executive (HSE). Businesses placing chemicals on the market in Great Britain (England, Scotland, and Wales) must comply with UK REACH, including data submission, substance registration, and risk assessments. Northern Ireland remains aligned with EU REACH under the Northern Ireland Protocol. UK REACH ensures continuity in chemical safety post-Brexit, but companies will now have to manage dual compliance when trading with both the EU and GB markets

3. Türkiye: KKDIK

Türkiye has implemented KKDIK  (Registration, Evaluation, Authorization, and Restriction of Chemicals), which closely mirrors the structure and requirements of the EU’s REACH. It aims to ensure the safe use of chemicals, protect human health and the environment, and align with international trade standards. Companies that manufacture or import chemicals into Türkiye in quantities over 1 ton per year must comply with the registration obligations, so it is essential for businesses to understand the scope and deadlines under KKDIK.

4. South Korea: K-REACH

South Korea’s K-REACH (Act on the Registration and Evaluation of Chemicals) REACh like Regulation was enacted to strengthen chemical safety management and protect public health. Similar to the EU’s REACH framework, K-REACH requires manufacturers and importers to register chemicals manufactured or imported in volumes exceeding 1 ton per year. K-REACH also emphasizes risk assessment, hazard classification, and chemical data sharing. Companies operating in South Korea must ensure compliance to avoid regulatory penalties and maintain market access.

5. Ukraine: UA-REACH

Ukraine’s REACH-like regulation, the Technical Regulation on the Safety of Chemical Products (UA-REACH), entered into force on 26 January 2025. Aligned with the EU REACH framework, UA-REACH introduces mandatory registration, classification, and risk assessment requirements for chemical substances manufactured, imported, or sold in Ukraine in quantities of 1 ton or more per year.

A pre-registration period is currently open (26 January 2025 to 26 January 2026), during which companies can notify substances ahead of full registration. Registration deadlines are staggered based on tonnage and hazard classification. They begin with certain hazardous and high-volume substances in January and October 2026 and extend through 2030 for lower-volume substances.

UA-REACH is enforced by the Ministry of Environmental Protection and Natural Resources and submissions are made via the DIIA Portal. Non-Ukrainian companies must appoint a local authorized representative to ensure compliance.

 

Consequences of Non-Compliance: Penalties and Business Risks

Non-compliance with REACH has serious consequences:

• Financial Penalties: Significant fines depending on the severity of the violation.
• Loss of Market Access: Non-compliant products can be banned from the EU market.
• Reputational Damage: Consumers and business partners are increasingly demanding compliance and sustainability.

Investing in compliance today will protect your business in the future.

 

Steps to Achieve REACH Compliance: A Practical Guide for Businesses

Achieving compliance doesn’t have to be overwhelming. Here’s a practical roadmap:

1. Identify Substances: List all substances used, manufactured, or imported.
2. Check Registration Status: Determine whether substances are already registered.
3. Compile Data: Collect safety and use data for required registrations.
4. Submit Dossiers: Submit dossier to regulatory authorities.
5. Maintain Compliance: Keep current records and monitor regulatory changes.

Partnering with regulatory experts can streamline the process and reduce risks.

 

The Future of REACH: Upcoming Changes and Global Trends in Chemical Regulations

REACH continues to evolve. The EU is increasing its focus on sustainability, green chemistry, and tighter restrictions on harmful substances.

Globally, we’re seeing a trend toward REACH-like regulations in various countries, forcing businesses to adopt comprehensive chemical management practices worldwide.

Staying informed and proactive is key to future-proofing your business.

 

How GPC Gateway Can Help You Stay REACH Compliant

Navigating REACH regulations can be complex but GPC Gateway makes it easy. With our advanced compliance platform, we offer:

• Substance Inventory Management: Stay on top of your chemical inventory and identify registration requirements.
• Compliance Status Tracking: Monitor the status of your substances and suppliers in real time.
• Automated Documentation: Easily create and manage safety data sheets and compliance dossiers.
• Expert Regulatory Support: Our team of specialists provides tailored advice and handles regulatory submissions to authorities on your behalf.
• Global Regulatory Coverage: In addition to EU REACH, we support compliance with UK REACH, KKDIK, K-REACH, UA-REACH and other international regulations.

With GPC Gateway, you gain peace of mind, knowing your compliance needs are covered - so you can focus on growing your business.

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