CurrentMandatory

GB30000.26-2013

Rules for classification and labelling of chemicals - Part 26: Specific target organ toxicity - Repeat exposure

化学品分类和标签规范 第26部分:特异性靶器官毒性 反复接触

GB 30000.26-2013 is a current mandatory Chinese national standard for Rules for classification and labelling of chemicals - Part 26: Specific target organ toxicity - Repeat exposure. 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 chemicals that exhibit specific target organ toxicity from repeated exposure. It is designed for chemical manufacturers and importers needing to comply with the Chinese GHS regulations. Compliance with this standard is mandatory for relevant chemical products entering the Chinese market. It references the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Technical requirements

GB 30000.26-2013 establishes the criteria for classifying substances and mixtures that cause specific target organ toxicity upon repeated exposure. The standard divides substances into two main hazard categories based on the severity and nature of the observed effects. Manufacturers must classify their products into Category 1 or Category 2 using a weight-of-evidence approach. This includes evaluating data from human epidemiological studies and experimental animal research, as referenced in GB 13690. For mixtures, the standard provides specific rules when whole-mixture data is available or when applying bridging principles. If test data is lacking, classification is based on the concentration limits of its toxic components. Mixtures containing Category 1 or Category 2 components above specific thresholds must be classified accordingly. The standard also details the required label elements, including hazard pictograms, signal words, and precautionary statements. The label requirements mandate the use of specific signal words: Danger for Category 1 and Warning for Category 2. Appropriate hazard statements must be assigned to describe the nature of the hazard, such as causing damage to organs. Suppliers must ensure all label elements comply with the specifications in Chapter 7. Additional guidance on precautionary statements is provided in the informative annexes.

Testing methods

Evaluation relies on reliable evidence from human experience or appropriate experimental animal studies. Standard animal studies typically include 28-day, 90-day, or lifetime exposures, assessing parameters like hematology, clinical chemistry, and pathology. Toxicological assessments must consider the dose, concentration, and duration of exposure. The standard references guidance values for oral, dermal, and inhalation routes to assist in the weight-of-evidence evaluation, as outlined in GB 30000.25.

FAQs

What products are regulated under GB 30000.26-2013?

It regulates chemical substances and mixtures that may cause specific target organ toxicity through repeated exposure, requiring proper GHS classification and labelling.

Are there any updates from the previous version of this standard?

Yes, it replaces GB 20601-2006, updating the title, scope, and adding general provisions, decision logic appendices, and label examples to align with the 4th revised edition of the UN GHS.

How does GB 30000.26-2013 differ from other toxicity standards?

This standard specifically addresses repeated exposure toxicity, whereas GB 30000.25 covers specific target organ toxicity from a single exposure. Other toxic effects like acute toxicity or carcinogenicity are evaluated separately.

The summary above provides a high-level overview of GB 30000.26-2013. 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 30000.26-2013 today to access all detailed parameters, tables, and testing procedures.

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 20601-2006