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Phthalate Testing

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01

Overview

Phthalates are a class of chemicals widely used as plasticizers, primarily in plastic products such as PVC (polyvinyl chloride) to increase flexibility and elasticity. Since phthalates have been proven to have endocrine disrupting effects that can affect the reproductive system and child development, major global markets impose strict restrictions on phthalates in toys and childcare articles. The US CPSIA, EU REACH Regulation Annex XVII Entries 51 and 52, and China GB 6675 have all set limit requirements for phthalates. The types and number of restricted phthalates continue to increase with regulatory updates.
02

Applicable Product Scope

Applicable Product and Service Categories

Phthalate testing applies to the following products: toys and children's products (especially toys containing PVC plastic parts, teethers, pacifiers, inflatable pools, children's books, etc.), food contact materials (plastic packaging, sealing rings, bottle cap liners, etc.), consumer products (plastic shoes, artificial leather gloves, shower curtains, wire and cable sheathing, cosmetic containers, etc.), medical devices (blood bags, infusion tubing, etc., some of which have separate regulations), and textiles (products with PVC coatings or prints). For toys and children's products, phthalate restrictions are a global mandatory requirement.
03

Restricted Substances and Limit Requirements

Technical Standards and Compliance Indicators

The restriction requirements for phthalates are divided into the following categories based on different regulations:
I. Section 108 of the U.S. CPSIA (Consumer Product Safety Improvement Act)
CategorySubstance NameCAS No.Limit value
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Permanently banned (3 types)DEHP (Di(2-ethylhexyl) phthalate)117-81-70.1% (1000 ppm)
DBP (Dibutyl phthalate)84-74-20.1% (1000 ppm)
BBP (Butyl benzyl phthalate)85-68-70.1% (1000 ppm)
Transitional Ban - Mouthable (5 types)DINP (Diisononyl phthalate)28553-12-00.1% (1000 ppm)
DIDP (Diisodecyl phthalate)26761-40-00.1% (1000 ppm)
DnOP (Di-n-octyl phthalate)117-84-00.1% (1000 ppm)
DIBP (Diisobutyl phthalate)84-69-50.1% (1000 ppm)
DPENP (Dipentyl phthalate)131-18-00.1% (1000 ppm)
ClauseScope of ControlLimit value
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Article 51DEHP, DBP, BBP0.1% each (all toys and child care articles)
Article 52DINP, DIDP, DNOP0.1% each (toys and childcare articles that can be placed in the mouth)
II. Annex XVII of the EU REACH Regulation
The above limits apply to accessible plastic parts in toys and child care articles for children under 12 years of age that can be placed in the mouth by children.
III. EU RoHS 2.0 Amendment (2015/863) Incorporates four phthalates (DEHP, BBP, DBP, DIBP) into the restricted substances list for electrical and electronic equipment, with the limit value of each being1000 ppm(0.1 %).
4. China GB 6675.1-2014 The limits for DEHP, DBP, BBP in toys are0.1 %(mouthable parts), the limit for DINP, DIDP, DNOP is0.1 %(mouthable parts).
04

Test Methods and Standards

Core Testing Items and Specifications

The phthalates test method is based on the following standards:
Typical Testing ProcedureThe plastic sample is crushed or sliced, then dissolved in tetrahydrofuran. After adding an internal standard, it is purified through a silica gel column, concentrated, and analyzed using GC-MS. The limit of detection is generally100 ppm(0.01 %).
EN 14372 (Cutlery and feeding utensils for children)Determination of 6 phthalates by GC-MS.
CPSC-CH-C1001-09.3 (U.S. Consumer Product Safety Commission Standard)After dissolution or crushing, the sample is extracted with tetrahydrofuran (THF) and then qualitatively and quantitatively analyzed by GC-MS. This method is the official method for CPSIA compliance testing.
GB/T 22048 (Chinese Standard)Determination of phthalates in toys and children's products, using GC-MS method.
ISO 8124-3 (Safety of toys)Covers migration testing of certain phthalates.
The quantification of each phthalate is expressed as a weight percentage in homogeneous materials.
05

Certification Process

Complete steps from application to certification

Phthalates Compliance Testing Process
Step 1Confirm the product's target market (US CPSIA, EU REACH, China GB 6675, etc.).
Step 2Disassemble the product to the homogeneous material level and identify all components containing plastic/rubber.
Step 3Sample each homogeneous material containing plastic/rubber.
Step 4Submit samples to an ISO 17025-accredited laboratory for phthalate testing.
Step 5Determine compliance against the limits of applicable regulations.
Step 6Issue a test report and reference the test results in CE/CPSC compliance documents.
06

Required Documents and Notes

List of Required Documents and Materials for Application

To apply for phthalate testing, the following information must be provided: product name and model.
Product disassembly photos and component list (indicating material type and color)
Samples to be tested (at least 5 to 10 grams per homogeneous material)
Explanation of applicable regulations. Note: The restriction on phthalates is a homogeneous material level restriction, and different plastic components in the product must be tested separately. PVC is the most common plastic containing phthalate plasticizers and should be given special attention. Some new plasticizers (such as DINCH
DEHT, etc.) are not restricted by phthalate regulations and can be used as alternatives. Phthalate testing is a destructive test, and samples are non-recoverable. Product suppliers should provide raw material compliance declarations (SDS or ingredient declarations) to control phthalate content from the source. Different regulations govern different types and numbers of phthalates; it is recommended to simultaneously meet the most stringent market requirements. The scope of phthalate control under CPSIA is limited to children's toys and child care articles for children under 12 years of age, but some US states (such as California Prop 65) also impose phthalate restriction requirements on adult consumer products.
07

Advantages of Anmai Testing Phthalates Testing Services

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Dongguan Anmai Testing Technology Co., Ltd. Address: Room 1005, Baisihui, No. 286 Changqing South Road, Chang'an Town, Dongguan City | Email: anmai@dganmai.com | Business Hours: Monday to Saturday 9:00-18:00 | Guangdong ICP Filing No. 20058375