GB30000.24-2013
Rules for classification and labelling of chemicals - Part 24: Reproductive toxicity
化学品分类和标签规范 第24部分：生殖毒性
GB 30000.24-2013 is a current mandatory Chinese national standard for Rules for classification and labelling of chemicals - Part 24: Reproductive 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
GB 30000.24-2013 applies to the classification and labelling of chemical substances and mixtures that exhibit reproductive toxicity in accordance with the UN GHS. This standard is mandatory for chemical manufacturers and importers in China. It specifically covers adverse effects on sexual function, fertility, and offspring development, as well as effects on lactation. It does not cover genetic mutations that are heritable to offspring, which are addressed in GB 30000.22-2013.
Technical requirements
This standard establishes the classification criteria for reproductive toxicants, dividing them into two primary hazard categories and an additional category for lactation effects. Category 1 is for known or presumed human reproductive toxicants, further subdivided into Category 1A (based on human evidence) and Category 1B (based on animal data). Category 2 is for suspected human reproductive toxicants where evidence is not sufficient for Category 1. The standard details the weight of evidence approach, requiring a comprehensive assessment of all available data from human epidemiological studies, animal tests, and in vitro studies. Manufacturers must evaluate both maternal toxicity and developmental effects to determine the final classification. For mixtures, the standard specifies concentration limits (thresholds) for classified components, triggering classification when a component exceeds the defined limits. It also introduces bridging principles to classify untested mixtures based on data from similar tested mixtures.
Testing methods
The standard references various testing methods to gather evidence for classification, including developmental toxicity studies, prenatal and postnatal toxicity studies, and one- or two-generation toxicity studies. It acknowledges the use of screening tests and data from repeated dose toxicity studies where specific reproductive organs are affected. The evaluation heavily relies on assessing maternal toxicity endpoints such as maternal mortality, mating and fertility indices, body weight changes, and clinical observations to distinguish between specific reproductive toxicity and secondary non-specific effects.
FAQs
What products are regulated under GB 30000.24-2013?
GB 30000.24-2013 regulates chemical substances and mixtures that may cause adverse effects on sexual function, fertility, or offspring development, as well as those affecting lactation. It applies to all such chemicals manufactured or imported into China.
Are there any updates from the previous version of GB 30000.24-2013?
Yes, this standard replaced GB 20598-2006. Key updates include the addition of concentration limits for the additional category of 'effects on or via lactation' in mixtures, and the alignment of technical content with the UN GHS Rev.4. The title was also updated to 'Rules for classification and labelling of chemicals'.
How does GB 30000.24-2013 handle mixtures without test data?
For untested mixtures, the standard provides bridging principles such as dilution, batch-to-batch consistency, and substantially similar mixtures. If these principles cannot be applied, classification is based on the concentration limits of the individual components within the mixture.
The summary above provides a high-level overview of GB 30000.24-2013. 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 of GB 30000.24-2013 today to access all detailed parameters, classification tables, and labelling requirements.
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 20598-2006