GB30000.18-2013
Rules for classification and labelling of chemicals - Part 18: Acute toxicity
化学品分类和标签规范 第18部分：急性毒性
GB 30000.18-2013 is a current mandatory Chinese national standard for Rules for classification and labelling of chemicals - Part 18: Acute toxicity. It appears in the Electronics compliance cluster with a labeling & classification focus and has an implementation date of Nov 1, 2014.
Applicability depends on product scope, certification route, competent authority notices and transition rules. Requst for the translation or verify source before using this record in a compliance decision.
Compliance overview
Scope and applicability
This standard applies to the classification and labelling of chemical substances and mixtures that exhibit acute toxicity hazards. It is specifically designed for chemical manufacturers and importers aligning with the United Nations Globally Harmonized System (GHS) in China. Compliance with this standard is mandatory for hazard communication elements specified in Chapters 4 and 6.
Technical requirements
GB 30000.18-2013 establishes the criteria for classifying chemicals into five acute toxicity categories based on the Acute Toxicity Estimate (ATE). The classification evaluates adverse effects occurring after oral, dermal, or inhalation exposure. Manufacturers must determine the appropriate hazard category for each exposure route to ensure accurate hazard communication. For mixtures, the standard provides a tiered approach to classification. It utilizes bridging principles—such as dilution, batch concentration, and substantially similar mixtures—to estimate toxicity without additional animal testing, referencing OECD Test Guidelines. When test data is unavailable, classification is determined using the additivity formula based on the known ATE values of the mixture's relevant components. Suppliers must calculate the overall mixture toxicity and apply the corresponding label elements for the most severe hazard category identified.
Testing methods
The standard references established toxicological testing to determine LD50 and LC50 values for substances. Key evaluation procedures include 4-hour inhalation studies for gases, vapors, and dusts/mists, with specific conversion factors applied for 1-hour test data. Animal testing should be avoided for Category 5 unless absolutely necessary for human health protection. Data derivation also relies on in vitro data, pH values, and expert judgment for corrosivity assessments.
FAQs
What products are regulated under GB 30000.18-2013?
It regulates chemical substances and mixtures that present acute toxicity hazards via oral, dermal, or inhalation routes. This applies to all chemical products entering the Chinese market requiring GHS classification.
Are there any updates from the previous version of GB 30000.18-2013?
Yes, it replaced GB 20592-2006. Key updates include modifying the scope to focus on "labels" rather than "warning labels," integrating precautionary statements into an informative annex, and adding label examples for acute toxicity.
How does GB 30000.18-2013 align with international standards?
The technical content is consistent with the UN GHS (Rev. 4). It utilizes the same 5-category system and ATE methodology, ensuring alignment with global hazard communication practices. International manufacturers can easily map their existing GHS classifications to this Chinese standard.
The summary above provides a high-level overview of GB 30000.18-2013. To ensure complete compliance for your products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation PDF of GB 30000.18-2013 today to access all detailed parameters, ATE conversion tables, and labeling requirements. Secure your market access now by getting the complete official translation.
Applicability hints
- Type
- Foundational
- CCS
- A80
- Competent department
- Ministry of Industry and Information Technology
- Technical committee
- Ministry of Industry and Information Technology
Relationships
Replaces:GB 20592-2006