Introduction to EU REACH Regulation

The EU REACH Regulation, standing for Registration, Evaluation, Authorisation, and restriction of Chemicals, was enacted in June 2007 as a cornerstone policy by the European Union to protect human health and the environment from the adverse effects of chemicals. It's a comprehensive law applicable to all chemical substances, not only those used in industrial processes but also in our day-to-day lives. As a direct regulation within the European Economic Area (EEA), REACH has a broad scope, encompassing the EU Member States along with Iceland, Liechtenstein, and Norway, ensuring a unified approach to chemical safety across Europe.

How REACH Works

REACH operates on a fundamental principle of “One Substance, One Registration,” requiring companies to register the chemical substances they manufacture or import above one tonne per year. This process is crucial for gathering and assessing information on the properties and hazards of substances, facilitating better risk management. The regulation is structured around four key processes:


  • Registration
    • Manufacturers and importers must provide detailed information on the properties and uses of their chemical substances, allowing for the assessment of potential risks.
  • Evaluation
  • Restriction
    • REACH can impose restrictions on the manufacturing, marketing, or use of certain substances if they pose unacceptable risks.
How REACH Works
Products and Compliance

Products and Compliance

REACH has a significant impact on a wide range of products within the EU market, highlighting the importance of compliance for manufacturers, suppliers, and importers. The regulation mandates that responsible parties must identify and manage risks linked to the substances they deal with. Moreover, they are required to communicate safety information about chemicals up and down the supply chain, ensuring that all parties are informed about the characteristics of chemical substances they may encounter.

Understanding Articles Under REACH

An "article" under REACH is defined as an object which, during production, is given a special shape, surface, or design that determines its function to a greater degree than its chemical composition does. This definition encompasses a wide range of products, from simple items like paper sheets to complex goods like electronic devices. For articles containing SVHCs above a certain threshold, companies have specific notification and communication duties to fulfil.

Understanding Articles Under REACH
Obligations and Responsibilities

Obligations and Responsibilities

REACH places substantial responsibilities on companies operating within the EEA, emphasizing the need for proactive management of chemical risks. Key obligations include registering chemical substances, providing safety data sheets, and notifying ECHA of the presence of SVHCs in articles. These measures are critical for ensuring product safety and regulatory compliance.

Enforcement and Penalties

Compliance with REACH is enforced at the national level by designated authorities in each Member State. Non-compliance can result in significant penalties, including fines and restrictions on market access. The enforcement framework ensures that companies meet their REACH obligations, protecting public health and the environment. Please click here to know more about the enforcement of each country.

Enforcement and Penalties

Exemptions Under REACH

While REACH is a comprehensive regulation that covers a wide array of substances and products, there are specific exemptions in place that account for particular uses or contexts where the standard REACH compliance requirements may not be applicable.

Common Exemptions

Certain substances are exempt from REACH regulation due to their specific use contexts. These exemptions typically apply to substances used:

  • In Radioactive Materials: Substances which are radioactive and are covered by more specific national exemptions due to their use in controlled environments.
  • For Defense Purposes: Substances that are used in the interest of defense or national security are also often covered by specific national exemptions.

This acknowledges the unique requirements and controls already placed on such substances in these contexts.


Understanding Exemptions

It is important for manufacturers, importers, and suppliers to understand these exemptions and whether they apply to their products. A comprehensive understanding of these exemptions can help companies navigate the REACH regulations more effectively and ensure compliance where it is required.

For more detailed information on specific exemptions and how they may apply to your products, please click here.

The iLenSys Advantage

Contact us to explore how iLenSys can enhance your compliance strategy, ensuring your business not only meets but exceeds REACH regulatory requirements.

iLenSys provides expert services and solutions tailored to help businesses navigate the complexities of REACH compliance. From substance registration to supply chain communication and SVHC management, our comprehensive support simplifies compliance,ensuring your operations are both safe and sustainable.

Unveil the Potential of iCM

Unlock the full potential of environmental compliance with iCM—your end-to-end solution for navigating the complexities of regulations with ease and precision. iCM is not just software; it's the key to transforming compliance into competitive advantage.

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Frequently Asked Questions

Any company manufacturing, importing, or selling products within the European Economic Area (EEA) needs to comply with REACH. This includes not only EU-based companies but also those outside the EU if they export to the EEA.

REACH stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals. It's an EU regulation aimed at ensuring the safe production, use, and management of chemical substances to protect human health and the environment.

SVHCs are Substances of Very High Concern. These are chemicals that may have serious effects on human health or the environment. REACH requires companies to manage SVHCs carefully, including obligations to communicate their presence in products.

Companies are expected to know their supply chain and the composition of their products. If an SVHC is present in any product above 0.1% (w/w), companies must communicate this to customers and, in some cases, notify the European Chemicals Agency (ECHA).

Penalties vary by EU Member State but generally include fines and may involve withdrawal of non-compliant products from the market. In severe cases, criminal charges could apply, especially if non-compliance leads to significant harm to human health or the environment.

No, compliance with REACH is mandatory for accessing the EU market. Products not in compliance may be restricted from sale within the EEA, and companies may face legal and financial penalties.

iLenSys offers comprehensive support for navigating the complexities of REACH compliance, from conducting thorough product assessments and SVHC screenings to developing a compliant supply chain strategy. Our expertise ensures that your business not only meets but exceeds regulatory

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