GB30000.21-2013
Rules for classification and labelling of chemicals - Part 21: Respiratory or skin sensitization
化学品分类和标签规范 第21部分：呼吸道或皮肤致敏
GB 30000.21-2013 is a current mandatory Chinese national standard for Rules for classification and labelling of chemicals - Part 21: Respiratory or skin sensitization. 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 30000.21-2013 applies to the classification and labelling of chemicals that exhibit respiratory or skin sensitization properties. This standard is mandatory for chemical manufacturers and importers in China. It aligns with the UN *Globally Harmonized System of Classification and Labelling of Chemicals (GHS)* (Rev. 4) and replaces the previous GB 20595-2006. It is applicable to substances and mixtures that may cause allergic reactions upon inhalation or skin contact.
Technical requirements
This standard specifies the classification criteria and labelling requirements for respiratory sensitizers and skin sensitizers. It divides these hazards into Category 1, with optional sub-categories Category 1A (strong sensitizers) and Category 1B (other sensitizers) based on evidence weight and severity. For respiratory sensitizers, classification relies on human evidence (e.g., asthma, rhinitis) and, where available, animal data. For skin sensitizers, criteria include positive results from animal tests (e.g., Local Lymph Node Assay, Guinea Pig Maximisation Test) and human diagnostic patch test data. The standard also details the bridging principles for classifying mixtures without whole-mixture test data, utilizing data from similar tested mixtures or component concentrations. Specific concentration limits are established for classifying mixtures containing sensitizing components. Labelling requirements mandate the use of specific pictograms, signal words (Danger for respiratory, Warning for skin), and hazard statements (e.g., H334, H317) as defined in the GHS framework.
Testing methods
The standard references various testing approaches to determine sensitization. For skin sensitization, it mentions the Local Lymph Node Assay (LLNA), Guinea Pig Maximisation Test (GPMT), and Buehler test. It also references human diagnostic methods like patch tests and bronchial provocation tests for respiratory sensitizers. The overview focuses on the evidence weight approach rather than detailing specific test protocols.
FAQs
What products are regulated under GB 30000.21-2013?
GB 30000.21-2013 regulates chemical substances and mixtures that may cause respiratory or skin sensitization. It applies to all such chemicals manufactured, imported, or used in China.
Are there any updates from the previous version of GB 30000.21-2013?
Yes, this standard replaced GB 20595-2006. Key updates include the addition of sub-categories 1A and 1B, modifications to classification criteria, and the integration of labelling elements in line with the UN *GHS* Rev. 4.
How does GB 30000.21-2013 differ from international standards?
GB 30000.21-2013 is technically consistent with the UN *Globally Harmonized System of Classification and Labelling of Chemicals (GHS)* (Rev. 4). It adopts the same classification principles and labelling elements as GHS.
The summary above provides a high-level overview of GB 30000.21-2013. 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 30000.21-2013 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 20595-2006