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.
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:
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.
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.
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.
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.
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:
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.
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.
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Book a DemoAny 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
requirements.
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