{"id":1739959,"date":"2025-09-01T19:02:44","date_gmt":"2025-09-01T13:32:44","guid":{"rendered":"https:\/\/pharmint.net\/?post_type=encyclopedia&p=1739959"},"modified":"2025-09-01T19:02:44","modified_gmt":"2025-09-01T13:32:44","slug":"reach-compliance","status":"publish","type":"encyclopedia","link":"https:\/\/pharmint.net\/es\/glossary\/reach-compliance\/","title":{"rendered":"REACH Compliance"},"content":{"rendered":"

What Is REACH Compliance?<\/strong><\/h2>\n

REACH<\/strong> stands for Registration, Evaluation, Authorization, and Restriction of Chemicals<\/strong>—a comprehensive EU chemicals regulation (EC No 1907\/2006) that came into force on 1 June 2007. It governs how chemical substances are manufactured, imported, and used in the EU, and seeks to protect human health and the environment.<\/p>\n

Who Must Comply with REACH in Pharma?<\/strong><\/h2>\n

REACH applies to companies in the pharmaceutical sector that manufacture, import, or handle chemical substances or mixtures in quantities exceeding 1 tonne per year<\/strong>. This includes APIs<\/a>, excipients<\/a>, solvents, and other intermediates used in medicine production. Both manufacturers and importers must register these substances with the European Chemicals Agency (ECHA).<\/p>\n

What are the Core Pillars of REACH?<\/strong><\/h2>\n

REACH is built on four regulatory pillars:<\/p>\n

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  1. Registration<\/strong>: Required for substances produced or imported in volumes above 1 tonne per year.<\/li>\n
  2. Evaluation<\/strong>: ECHA reviews dossiers for compliance; substances may face further regulatory scrutiny.<\/li>\n
  3. Authorization<\/strong>: Substances of Very High Concern (SVHCs) require special approval for continued use.<\/li>\n
  4. Restriction<\/strong>: Use of certain hazardous chemicals may be banned or limited via REACH Annex XVIII.<\/li>\n<\/ol>\n

    The burden of proof<\/strong> lies with industry—to assess risk, demonstrate safety, and ensure responsible use.<\/p>\n

    How Should Companies Maintain Ongoing REACH Compliance?<\/strong><\/h2>\n