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Tacettin İKİZ



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What is REACH Compliance?

Started by Tacettin İKİZ, January 05, 2025, 12:09:30 AM

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Tacettin İKİZ

What is REACH Compliance?

REACH stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals. It is a regulation adopted by the European Union (EU) to improve the protection of human health and the environment from the risks posed by chemicals, while also enhancing the competitiveness of the EU chemicals industry. REACH places the responsibility on businesses to identify and manage the risks associated with the substances they manufacture and market in the EU.

Definition and Purpose of REACH Compliance 
REACH compliance means that a company meets the requirements of the REACH regulation. This involves registering substances with the European Chemicals Agency (ECHA), ensuring that substances used are safe, and communicating information about chemicals throughout the supply chain.

The primary goals of REACH are to:
  • Ensure a high level of protection for human health and the environment 
  • Promote alternative methods for assessing the hazards of substances 
  • Ensure the free circulation of substances on the internal market 
  • Enhance the competitiveness and innovation of the EU chemicals industry 

Key Components of REACH 
REACH involves four main processes:

  • Registration – Companies manufacturing or importing more than 1 tonne of a chemical substance per year must register it with ECHA. The registration dossier includes information on the substance's properties, uses, and safe handling. 
  • Evaluation – ECHA and EU member states evaluate the information provided in registration dossiers to assess risks and ensure compliance with REACH requirements. 
  • Authorisation – Substances of Very High Concern (SVHC) require authorisation before they can be used. The goal is to progressively replace SVHCs with safer alternatives. 
  • Restriction – Certain hazardous substances may be restricted or banned if they pose an unacceptable risk to health or the environment. 
Substances of Very High Concern (SVHC) 
SVHCs are substances that may have serious effects on human health or the environment. These include:

  • Carcinogenic, mutagenic, or toxic for reproduction (CMR) substances 
  • Persistent, bioaccumulative, and toxic (PBT) substances 
  • Very persistent and very bioaccumulative (vPvB) substances 
  • Substances with equivalent concern (e.g., endocrine disruptors) 

The list of SVHCs is maintained by ECHA and updated regularly. Companies using or supplying SVHCs must provide adequate information to ensure safe use and, in some cases, obtain authorisation to continue using them.

Applicability of REACH 
REACH applies to almost all chemical substances, whether they are used in industrial processes or in everyday products such as cleaning products, paints, clothing, furniture, and electrical appliances. It affects a wide range of companies, including:

  • Manufacturers of chemical substances 
  • Importers of chemical substances and mixtures 
  • Downstream users who handle chemicals in their business operations 
  • Distributors who store and sell chemical substances 

Exemptions to REACH 
Certain substances and uses are exempt from some or all REACH requirements. Examples include:

  • Radioactive substances 
  • Substances used in medicinal products 
  • Substances under customs supervision 
  • Non-isolated intermediates 

Obligations of Companies under REACH 
Companies must take specific actions to comply with REACH, including:

  • Identifying the substances they manufacture, import, or use 
  • Determining whether they need to register these substances 
  • Communicating safety information down the supply chain through Safety Data Sheets (SDS) 
  • Substituting hazardous substances with safer alternatives whenever possible 

Consequences of Non-Compliance 
Failure to comply with REACH regulations can result in significant penalties, including:

  • Fines imposed by regulatory authorities 
  • Bans on selling non-compliant products within the EU 
  • Legal action and damage to the company's reputation 
  • Loss of access to the EU market 

Global Impact of REACH 
Although REACH is an EU regulation, its impact is felt globally. Companies outside the EU that export chemical substances or products to the EU must also comply with REACH. This has led to the adoption of similar regulations in other countries, such as:

  • TSCA (Toxic Substances Control Act) – United States 
  • CEPA (Canadian Environmental Protection Act) – Canada 
  • K-REACH – South Korea 
  • China REACH – China 
Conclusion 
REACH compliance is essential for companies that manufacture, import, or use chemical substances within the EU. By adhering to REACH regulations, companies can ensure the safety of their products, protect human health and the environment, and maintain access to the EU market. It is a critical part of responsible chemical management in a global economy.
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