Harmonisation of Laws Relating to the Application of GLP
The EU Directive requiring Member States to apply the OECD Principles of GLP when conducting nonclinical safety tests on chemical products, and to verify compliance. Together with Directive 2004/9/EC (inspection and verification) it embeds GLP and Mutual Acceptance of Data into EU law.
What this does not cover
stated in the document's own scope- Covers non-clinical (laboratory) safety studies on chemicals; clinical studies in humans are governed by Good Clinical Practice and the Clinical Trials Regulation.
- Establishes the obligation to apply GLP, with inspection and verification of compliance set out in the companion Directive 2004/9/EC.
- Gives force to the OECD GLP Principles but does not itself prescribe the scientific test methods, which come from the applicable testing guidelines.
- Addresses laboratory-study quality, not the manufacturing GMP that applies once a product is made, which sits in the EU GMP Guide.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Directive 2004/10/EC requires EU Member States to apply the OECD Principles of Good Laboratory Practice when carrying out non-clinical safety studies on chemical products, and to take the measures needed to ensure those principles are followed. It is the instrument that embeds GLP into EU law for the testing that supports the safety assessment of chemicals, medicines, agrochemicals, cosmetics and similar products. Rather than restating GLP in its own words, the directive gives legal force to the OECD Principles annexed to it, so the operative technical text is the OECD standard and the directive is the vehicle that makes it binding.
Scope & applicability
Nonclinical safety testing of chemical products (including medicinal, cosmetic, and industrial substances) within the EU. Complemented by 2004/9/EC on GLP inspection.
Legal basis & how it acquires force
This is a Directive, so it obliges Member States to transpose its requirements into national law rather than applying directly. It works as a pair with Directive 2004/9/EC, which governs the inspection and verification of GLP compliance and requires each Member State to designate national GLP monitoring authorities. Together they codified GLP and the OECD system of Mutual Acceptance of Data into EU law, replacing earlier directives on the same subject. The operative principles are the OECD GLP Principles reproduced in the directive’s annex.
Document structure
| Part | Covers |
|---|---|
| Obligation to apply GLP | The requirement that Member States apply the OECD GLP Principles to non-clinical safety testing |
| Scope of covered studies | The chemical-product safety studies to which the GLP obligation attaches |
| Annexed OECD Principles | The OECD Principles of GLP given legal effect — organisation, study conduct, records and archives |
| Relationship to verification | The link to Directive 2004/9/EC on inspection and verification of compliance |
| Transposition and reporting | Member-State transposition obligations and communication to the Commission |
Key requirements
- Apply OECD GLP principles to in-scope nonclinical safety studies
- Undergo national GLP inspection and study audit under Directive 2004/9/EC
- Declare GLP compliance status in study reports
Implementation tips
- Reference the OECD Principles as the technical content; use the Directive for the legal/inspection basis
Revision notes
Codified the earlier Directive 87/18/EEC; remains the EU legal basis for GLP alongside 2004/9/EC.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
The directive gives legal force to the OECD Principles of GLP, which is what enables Mutual Acceptance of Data: a study conducted to GLP and verified by one OECD member’s monitoring authority is accepted by the others, avoiding duplicate testing. It is the EU analogue of the US GLP regulation 21 CFR Part 58, and both trace to the same OECD standard, so their expectations are closely equivalent.
Directive 2004/10/EC: frequently asked questions
Quick answers to common questions about Directive 2004/10/EC.
What does Directive 2004/10/EC require?
It requires EU Member States to apply the OECD Principles of Good Laboratory Practice when conducting non-clinical safety studies on chemical products, and to ensure those principles are observed. The operative technical text is the OECD Principles annexed to the directive.
How does 2004/10/EC relate to Directive 2004/9/EC?
They are a pair. 2004/10/EC establishes the obligation to apply GLP; 2004/9/EC governs the inspection and verification of compliance and the designation of national GLP monitoring authorities. Together they embed GLP and Mutual Acceptance of Data into EU law.
Is this the same as US GLP under 21 CFR Part 58?
It is the EU counterpart. Both give legal effect to the OECD GLP Principles, so their expectations are closely equivalent, and Mutual Acceptance of Data means a compliant study is broadly recognised across OECD members.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.