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The document explains the legislative framework, including core GLP directives on inspections, verification and harmonisation, and then maps GLP requirements across product-specific chemical areas. It links specific regulations such as REACH and CLP to GLP compliance expectations, identifies relevant receiving authorities, and summarizes obligations like GLP-aligned testing for safety evaluations.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/eu-legislation-with-good-laboratory-practice-glp-provisions-march-2024/444072/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/eu-legislation-with-good-laboratory-practice-glp-provisions-march-2024/444072.png","ImageObject",300,407,{"name":92,"@type":93},"dabgoudw","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-04","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":14},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What does the document define as Good Laboratory Practice (GLP)?","Question",{"text":112,"@type":113},"GLP is defined as a quality system covering organisational processes and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"Which EU directives form the core GLP legislative framework described here?",{"text":117,"@type":113},"The document highlights Directive 2004/9/EC on inspection and verification of GLP and Directive 2004/10/EC on harmonisation of laws for applying GLP principles to tests on chemical substances.",{"name":119,"@type":110,"acceptedAnswer":120},"How do REACH requirements relate to GLP compliance?",{"text":121,"@type":113},"Under REACH, ecotoxicological and toxicological tests and analyses must be carried out in compliance with GLP principles provided for in Directive 2004/10/EC (or other internationally recognised equivalent standards).","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},444072,1791099430,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":14,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":52,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144},3985747860484,"https://ap-avatar.wpscdn.com/davatar_276721f389ce27ea32af1340a28f341c","EUROPEAN COMMISSION  \nDIRECTORATE-GENERAL FOR INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP AND SMES  \nEcosystems I: Chemicals, Food, Retail  \nF.2 – Bioeconomy, Chemicals & Cosmetics  \nVersion: March 2024  \nEU LEGISLATION WITH GOOD LABORATORY PRACTICE (GLP) PROVISIONS  \nThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents. Only European Union legislation printed in the paper edition of the Official journal of the European Union is deemed authentic.  \n1. Introduction ................................................................................................................. 1  \n2. EU legislative framework............................................................................................ 2  \n3. Chemicals .................................................................................................................... 2  \n4. Biocides & pesticides .................................................................................................. 3  \n5. Food & feedstuff ......................................................................................................... 4  \n6. Medicinal products ...................................................................................................... 8  \n7. Cosmetics .................................................................................................................... 9  \n8. Detergents .................................................................................................................... 9  \n1. INTRODUCTION  \nGood laboratory practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. Its purpose is to ensure the quality and integrity of the safety data submitted to regulatory authorities ('GLP receiving authorities') .  \nThe principles of GLP are applied to the non-clinical safety testing of test items contained in a range of products. The application of GLP is required by a variety of different product-specific legislation. This document lists all the EU legislation containing GLP provisions.  \n2. EU LEGISLATIVE FRAMEWORK  \n2.1. Directive 2004/9/EC  \nDirective 2004/9/EC on the inspection and verification of good laboratory practice lays down the obligation for EU countries to designate the authorities responsible for GLP inspections in their territory. It also comprises reporting and internal market (mutual acceptance of data) requirements. The Directive in its Annex I contain the OECD Revised Guides for Compliance Monitoring Procedures for GLP, as well as the OECD Guidance for the Conduct of Test Facility Inspections and Study Audits, that should be followed during laboratory inspections and study audits.  \n2.2. Directive 2004/10/EC  \nDirective 2004/10/EC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances is the second core EUGLP Directive. It contains the principles of GLP in its Annex I.  \nArticle 1(1) of the Directive requires that \"Member States shall take all measures necessary to ensure that laboratories carrying out tests on chemical products, in accordance with Directive 67/548/EEC, comply with the principles of good laboratory practice (GLP) \" . Directive 67/548/EEC is the Dangerous Substances Directive, which is repealed by the CLP Regulation (listed below) from 1 June 2015.  \nArticle 1(2) specifies that this requirement \"shall apply also where other Community provisions provide for the application of the principles of GLP in respect of tests on chemical products to evaluate their safety for man and/or the environment.\" These other provisions are listed in this document.  \n3. CHEMICALS  \n3.1. Regulation (EC) No 1907/2006 (REACH)  \n","cbCaitZ5nnmMF1Y0","https://ap.wps.com/l/cbCaitZ5nnmMF1Y0","pdf",316957,"English","# Introduction\n# EU legislative framework\n## Directive 2004/9/EC\n## Directive 2004/10/EC\n# Chemicals\n## Regulation (EC) No 1907/2006 (REACH)\n## Regulation (EC) No 1272/2008 (CLP)\n# Biocides & pesticides\n# Food & feedstuff\n# Medicinal products\n# Cosmetics\n# Detergents","[{\"question\":\"What does the document define as Good Laboratory Practice (GLP)?\",\"answer\":\"GLP is defined as a quality system covering organisational processes and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.\"},{\"question\":\"Which EU directives form the core GLP legislative framework described here?\",\"answer\":\"The document highlights Directive 2004/9/EC on inspection and verification of GLP and Directive 2004/10/EC on harmonisation of laws for applying GLP principles to tests on chemical substances.\"},{\"question\":\"How do REACH requirements relate to GLP compliance?\",\"answer\":\"Under REACH, ecotoxicological and toxicological tests and analyses must be carried out in compliance with GLP principles provided for in Directive 2004/10/EC (or other internationally recognised equivalent standards).\"}]","EU Legislation with Good Laboratory Practice (GLP) Provisions - March 2024 | PDF",1790706768,25]