GB30000.20-2013
Rules for classification and labelling of chemicals - Part 20: Serious eye damage/eye irritation
化学品分类和标签规范 第20部分：严重眼损伤/眼刺激
GB 30000.20-2013 is a current mandatory Chinese national standard for Rules for classification and labelling of chemicals - Part 20: Serious eye damage/eye irritation. 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 pose serious eye damage or eye irritation hazards. It is designed for chemical manufacturers and distributors aligning with the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). This standard is mandatory for chemical products entering the Chinese market that exhibit these specific hazard classes. It does not apply to pharmaceuticals, cosmetics, or food additives in their finished consumer state, which are subject to separate regulations.
Technical requirements
The standard establishes the criteria for classifying substances and mixtures into Category 1 (irreversible effects/serious eye damage) and Category 2 (reversible effects/eye irritation, further divided into 2A and 2B). For Category 1, the standard specifies conditions where effects on the cornea, iris, or conjiva are not fully reversible within a 21-day observation period. Manufacturers must evaluate both existing human/animal data and physicochemical properties like extreme pH values. For mixtures, the standard outlines a tiered approach utilizing bridging principles when test data for the mixture as a whole is not available. If the mixture contains components classified for skin or eye hazards at or above specific concentration limits, the mixture must be classified accordingly. When concentration limits are met, the mixture inherits the hazard category of its most severe relevant component. The standard also details the use of additivity formulas for calculating combined hazards from multiple irritating or corrosive components. Labeling requirements mandate the use of specific hazard pictograms, signal words, and hazard statements. For Category 1, the signal word "Danger" and the statement "Causes serious eye damage" are required. For Category 2, the signal word "Warning" is used. Suppliers must ensure that product identifiers and supplier identification are clearly displayed on the label.
Testing methods
The standard emphasizes a weight-of-evidence approach and a tiered testing strategy to minimize unnecessary animal testing. Key evaluation methods include: - Review of existing human and animal experience data. - Evaluation of Structure-Activity Relationships (SAR). - Assessment of extreme pH values (≤2 or ≥11.5) and buffering capacity. - Use of validated in vitro alternative tests for serious eye damage and eye irritation. - In vivo testing (e.g., rabbit Draize eye test) only as a last resort, following specific sequential steps.
FAQs
What products are regulated under GB 30000.20-2013?
It regulates chemical substances and mixtures that may cause serious eye damage or eye irritation, requiring them to be classified and labelled according to the GHS-aligned criteria.
Are there any updates from the previous version of this standard?
Yes, it replaces GB 20594-2006. The title was updated, and the standard aligns its technical content with the fourth revised edition of the UN GHS, including modifications to classification criteria and label elements.
How does GB 30000.20-2013 handle mixtures without overall test data?
It utilizes bridging principles (such as dilution, product batches, and interpolation) and additivity formulas based on the concentration limits of its hazardous components to classify the mixture without additional testing.
The summary above provides a high-level overview of GB 30000.20-2013. 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 30000.20-2013 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 20594-2006