CPSC-CH-C1001-09.4 Standard Operating Procedure for the Determination of Phthalates

Primary Objective: 

To align with the final rule of 16 CFR 1307, which took effect in April 2018, and upgrade the testing methods to cover 8 types of phthalates, expanding the testing scope to all contactable components of toys (including non-entry components), ensuring that products comply with federal U.S. phthalate restriction requirements, and supporting compliance certifications. 

Standard Definitions: 

Samples/Components: Continue with the definitions of 09.3, adding “Exemptions for Non-Contact Components” (components that are sealed and do not come into contact or are not exposed under normal or abusive conditions do not need to be tested); Quality Control Samples (QCS): External sources of certified reference materials (such as NIST SRMs) used to verify instrument performance; Alternative Methods: Recognize Health Canada C34, EN 14372, ASTM D7823, and other standards as alternative methods for compliance testing (these must cover all 8 target substances). 

Testing and Certification Requirements: 

Test Substances: Remove DNOP, DIDP from 09.3 and add DIBP, DPENP, DHEXP, DCHP (total 8 substances); 

Test Methods: Maintain the GC-MS core process, optimize chromatographic conditions (DB-5MS column, programmed temperature adjustments), selectable precipitant solvents include acetonitrile or hexane, and adjust the internal standard concentration to 30 μg/mL; 

Quality Control: Calibration check for solution recovery must be 100 ± 15%, and LRB (not to exceed method detection limit) and CRM (recovery rate within ±15% of reference value) must be tested simultaneously for every 20 samples or batch; 

Certification Requirements: Support third-party testing and certification, accept test reports from suppliers that meet 16 CFR 1109 requirements, applicable to all toys for children aged 12 and under, and care products for children aged 3 and under.