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
  • The European Chemicals Agency (ECHA) and Member States evaluate registered substances to ensure compliance and address any concerns regarding human health or the environment.

• Authorisation
  • Certain high-risk substances, identified as Substances of Very High Concern (SVHCs), require Authorization for use. This stage aims to control risks and encourage the transition to safer alternatives.

• Restriction
  • REACH can impose restrictions on the manufacturing, marketing, or use of certain substances if they pose unacceptable risks.

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.

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.