GB30000.22-2013
Rules for classification and labelling of chemicals - Part 22: Germ cell mutagenicity
化学品分类和标签规范 第22部分：生殖细胞致突变性
GB 30000.22-2013 is a current mandatory Chinese national standard for Rules for classification and labelling of chemicals - Part 22: Germ cell mutagenicity. 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 possessing germ cell mutagenicity according to the UN *Globally Harmonized System of Classification and Labelling of Chemicals* (GHS). It is applicable to chemical substances and mixtures that may cause heritable mutations in human germ cells. This standard is mandatory for chemical manufacturers and importers in China. It replaces the previous standard GB 20596-2006.
Technical requirements
The standard establishes two hazard categories for germ cell mutagenicity to accommodate the available weight of evidence. Category 1 includes substances known to or presumed to cause heritable mutations in human germ cells, further divided into Category 1A (based on positive evidence from human epidemiological studies) and Category 1B (based on positive results from mammalian in vivo heritable germ cell mutagenicity tests or somatic cell mutagenicity tests with supporting evidence). Category 2 covers substances that cause concern due to possible heritable mutations, based on positive evidence from mamm somatic cell tests or in vitro tests. For mixtures, classification is based on the test data of its components using specific threshold/concentration limits. If the mixture itself has not been tested, the bridging principles can be applied using data from similar tested mixtures. When a mixture contains a Category 1 mutagen at a concentration of ≥0.1% or a Category 2 mutagen at ≥1.0%, it must be classified accordingly. The standard also specifies the labelling requirements, including hazard pictograms, signal words (Danger for Category 1 and Warning for Category 2), hazard statements, and precautionary statements. The label must include product identifiers and supplier identification.
Testing methods
The standard references various in vivo and in vitro testing methods to determine germ cell mutagenicity. These include in vivo heritable germ cell mutagenicity tests (e.g., rodent dominant lethal mutation test, mouse heritable translocation test), in vivo somatic cell mutagenicity tests (e.g., mammalian bone marrow chromosome aberration test, mammalian erythrocyte micronucleus test), and in vitro mutagenicity tests (e.g., bacterial reverse mutation test, in vitro mammalian cell gene mutation test). The referenced test standards are based on equivalent OECD guidelines.
FAQs
What products are regulated under GB 30000.22-2013?
GB 30000.22-2013 regulates chemical substances and mixtures that possess germ cell mutagenicity, meaning they can cause heritable mutations in human reproductive cells. It applies to all such chemicals manufactured, imported, or sold in the Chinese market.
Are there any updates from the previous version of GB 30000.22-2013?
Yes, GB 30000.22-2013 replaces GB 20596-2006. Key changes include modifying the standard's name, updating normative references to use equivalent national standards instead of direct OECD guidelines, and adjusting the classification criteria and labelling elements to align with the fourth revised edition of the UN GHS.
How does GB 30000.22-2013 align with international standards?
The technical content of GB 30000.22-2013 is consistent with the UN *Globally Harmonized System of Classification and Labelling of Chemicals* (GHS) (fourth revised edition). It uses the same hazard categories, classification criteria, and labelling elements as the international GHS framework.
The summary above provides a high-level overview of GB 30000.22-2013. To ensure complete compliance for your chemical 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 30000.22-2013 today to access all detailed parameters, classification 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 20596-2006