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 é uma norma nacional chinesa obrigatória vigente: Rules for classification and labelling of chemicals - Part 24: Reproductive toxicity. Setor: Eletrônicos. Foco: Rotulagem e classificação. Entrada em vigor: 1 de nov. de 2014.

A aplicabilidade depende do escopo do produto, da via de certificação, dos avisos da autoridade competente e das regras de transição. Solicite uma tradução ou verifique a fonte antes de usar este registro em uma decisão de conformidade.

Visão geral de conformidade

Esta visão geral está disponível por enquanto apenas em inglês.

Escopo e aplicabilidade

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.

Requisitos técnicos

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.

Métodos de ensaio

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.

Perguntas frequentes

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.

Indicações de aplicabilidade

Tipo: Básica
CCS: A80
Órgão competente: Ministry of Industry and Information Technology
Comitê técnico: Ministry of Industry and Information Technology

Relações

Substitui:GB 20598-2006