Phthalate Testing

1. Introduction to Phthalates

Phthalates are a class of esters derived from phthalic acid. They are primarily used in polyvinyl chloride (PVC) materials to transform rigid plastics into flexible ones, serving as plasticizers. They are widely applied in hundreds of products, including toys, food packaging materials, medical blood bags and tubing, vinyl flooring and wallpaper, detergents, lubricants, and personal care products (such as nail polish, hair spray, soap, and shampoo).

2. Exposure Pathways

Food may become contaminated with phthalates during processing, heating, packaging, or serving. For example, plastic wrap used for microwaving food, plastic containers, plastic chopsticks, gloves for eating hand-torn chicken, plastic water bottles, and beverage containers may all contain phthalates.

Phthalates in cosmetics can enter the body through the respiratory system and skin. Excessive use may increase the risk of breast cancer in women and harm the reproductive systems of their future male infants.

Soft plastic toys and children's products containing phthalates may be mouthed by children. If left in the mouth for a prolonged period, the leaching of phthalates may exceed safe levels, endangering children's liver and kidney functions and potentially causing precocious puberty.

Indoor furnishings or household items; handbags, wallets, clothing, shoes, and hats; medical plastic gloves or blood transfusion bags; electronic products such as mobile phones, headphones, and mice; plastic necklaces, rings, bracelets, earrings, and other accessories; ballpoint pens, pencil cases, and other stationery may also contain phthalates.

3. Hazards

Studies indicate that phthalates act similarly to estrogen in humans and animals, disrupting endocrine functions. They can reduce semen volume and sperm count, impair sperm motility, cause abnormal sperm morphology, and in severe cases, lead to testicular cancer. They are considered a major contributor to male reproductive issues.

In cosmetics, nail polish contains the highest levels of phthalates, and many fragrances in cosmetics also contain this substance. When absorbed through the respiratory system or skin, excessive use of such products can increase the risk of breast cancer in women and harm the reproductive systems of their future male infants.

4. Regulatory Restrictions

2005/84/EC, REACH Annex XVII Articles 51, 52, SVHC;

2015/863/EU;

GB 24613 Limit of Harmful Substances in Coatings for Toys;

GB 31701 Safety Technical Specification for Infant and Children Textile Products;

GB/T 18885 Technical Requirements for Ecological Textiles;

OEKO-TEX Standard 100 Ecological Label for Textiles by the International Association for Research and Testing in the Field of Textile Ecology;

SIA (HR4040);

California Proposition 65;

SOR/2010-298

ST2012

5. Testing Methods

Testing methods for phthalates are well-established, with standards published both domestically and internationally. Typically, organic solvent extraction is followed by analysis using Gas Chromatography-Mass Spectrometry (GC-MS).

Key testing standards include:

GB 24613 Limit of Harmful Substances in Coatings for Toys, Appendix C;

GB/T 20388 Textiles—Determination of Phthalates;

GB/T 21911 Determination of Phthalates in Food;

GB/T 21928 Determination of Phthalates in Plastic Food Packaging Materials;

GB/T 22048 Toys and Children's Products—Determination of Phthalates in Polyvinyl Chloride Plastics;

GB/T 24168 Determination of Phthalates in Textile Dyeing and Finishing Auxiliaries;

GB/T 28599 Determination of Phthalates in Cosmetics;

GB/T 29608 Rubber Products—Determination of Phthalates;

GB/T 29786 Determination of Phthalates in Electrical and Electronic Products;

GB/T 30646 Determination of Phthalate Content in Coatings;

EN 14372 Child Use and Care Articles—Cutlery and Feeding Tools—Safety Requirements and Tests 6.3.2;

EN 15777 Textiles—Test Method for Phthalates;

ISO/TS 16181 Footwear—Critical Substances Potentially Present in Footwear and Footwear Components—Determination of Phthalates in Footwear Materials;

SC-CH-C1001-09.3 Standard Operating Procedure for Determination of Phthalates;

ASTM D3421-75 Practice for Extraction and Determination of Plasticizer Mixtures from Vinyl Chloride Plastics;

ASTM D 7083-2004 (2010) Practice for Determination of Monomeric Plasticizers in Poly(Vinyl Chloride) (PVC) by Gas Chromatography;

ST 2012 1ST 1.9 Japan Toy Safety Standard 1.9

HealthCanada Method C-34 Determination of Phthalates in Polyvinyl Chloride Consumer Products