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Phthalate ester
1、 Hazards of Phthalate Substances, i.e. Phthalates
According to the latest research in Germany, phthalates, a harmful chemical to health, are present in many cosmetics, toys, and food packaging. Research has shown that the decrease in global male sperm count over the past few decades may be related to the chemical phthalates widely used as softeners in light industry. This substance is widely present in cosmetics, children's toys, and food packaging. If its content exceeds the standard, it will cause great harm to human health.
Phthalates are a type of chemical that can soften. It is widely used in hundreds of products such as toys, food packaging materials, medical blood bags and hoses, vinyl flooring and wallpaper, detergents, lubricants, personal care products, such as nail polish, hair sprays, soap and shampoo.
Research has shown that phthalates play a role similar to estrogen in both human and animal bodies, disrupting the endocrine system and causing a decrease in semen and sperm count, low sperm motility, abnormal sperm morphology, and in severe cases, testicular cancer. They are the "culprits" causing male reproductive problems.
Among cosmetics, nail polish has the highest content of phthalates, which is also contained in many aromatic ingredients of cosmetics. This substance in cosmetics will enter the body through women's respiratory system and skin. If used too much, it will increase women's risk of breast cancer and harm the reproductive system of their future baby boys.
From the current situation, people attach the greatest importance to phthalates in children's products. The European Union officially made a decision in 1999 to strictly limit the content of phthalates in toys that come into contact with the mouth (such as baby pacifiers) and other children's products used by children under the age of 3 within EU member states. Experts have found that soft plastic toys and children's products containing phthalates may be imported by children. If left for a long time, it can cause the release of phthalates to exceed safe levels, which can harm children's liver and kidneys and also cause premature puberty.
2、 Directive on Limit of Phthalate Content in Toys
The EU Directive 2005/84/EC on restricting the content of phthalates in toys and child care products came into effect on January 16, 2007. All EU member states should translate this directive into national legislation by July 16, 2007, and ensure that their respective laws are implemented from January 16 next year. Romania and Bulgaria, which will join the European Union on January 1, 2008, are also required to comply with relevant laws. This directive will have a significant impact on importers.
According to the directive, child care products refer to any product that helps children sleep, relax, maintain hygiene, and breastfeed or suckle, including various shapes and types of pacifiers.
The annex to Directive 2005/84/EC, which has the greatest impact on manufacturers, clearly lists the following restrictions:
-The concentration of Class 3 phthalates (DEHP, DBP, and BBP) in plastics used for toys or child care products shall not exceed 0.1%.
-Toys and child care products with DEHP, DBP, and BBP concentrations exceeding 0.1% are not allowed to be sold in the EU market.
-Children are allowed to use imported toys and child care products, and the concentration of Class 3 phthalates (DINP, DIDP, and DNOP) in their plastics must not exceed 0.1%.
-Toys and child care products with DINP, DIDP, and DNOP concentrations exceeding 0.1% are not allowed to be sold in the EU market.
Obviously, the content restrictions on DEHP, DBP, and BBP will affect all toys and child care products, not just toys and child care products that can be imported for children, because the official risk assessment classifies these three substances as (Class II reproductive toxins). On the other hand, the instructions indicate that there is insufficient or controversial scientific evidence regarding DINP, DIDP, and DNOP. The EU therefore adopts the precautionary principle, which limits the role of DINP, DIDP, and DNOP based on potential risks rather than actual risks, but the restrictions are relatively lenient. 3、 Phthalate substances in various forms, namely phthalates (listed in no particular order):
-Di-2-ethylhexyl phthalate (DEHP) phthalate (2-ethylhexyl) ester
-Dibutyl phthalate (DBP)
-Benzylbenzyl phthalate (BBP) butyl benzyl phthalate
-Diisononyl phthalate (DINP) diisononyl phthalate
-Di-n-octyl phthalate (DNOP) di-n-octyl phthalate
-Diisodecyl phthalate (DIDP)
-Dimethyl phthalate (DMP) dimethyl phthalate
-Diethyl phthalate (DEP) diethyl phthalate
-Dipropyl phthalate (DPrP) dipropyl phthalate
-Diisobutyl phthalate (DIBP)
-Dipentyl phthalate (DPP)
-Dicyclohexyl phthalate (DCHP)
-Dihydroxy phthalate (DHP)
-Diisooctyl phthalate (DIOP)
-Dinonyl phthalate (DNP) dinitronate
Limit requirements for phthalates
Different countries and regions have different limit requirements for phthalates. The following are common limit requirements:
1. European Union
REACH regulation:
The content of 6 phthalates (DEHP, DBP, BBP, DINP, DIDP, DNOP) shall not exceed 0.1% (1000 ppm).
Toy Safety Directive 2009/48/EC:
Restrict phthalates in toys.
2. United States
CPSIA：
The content of six phthalates (DEHP, DBP, BBP, DINP, DIDP, DNOP) shall not exceed 0.1%.
California 65:
Restrict phthalates such as DEHP, DBP, BBP, etc.
3. China
GB 6675：
Restrict phthalates in toys.
GB/T 20388：
Method for detecting phthalates in textiles.
Scope of application for phthalate ester detection
Phthalate detection is applicable to the following products and materials:
Toys: such as plastic toys, plush toys.
Children's products: such as pacifiers and tableware.
Food contact materials: such as food packaging and tableware.
Cosmetics: such as nail polish and perfume.
Medical devices: such as infusion tubes and blood bags.
Textiles: such as coated fabrics.
Standards and methods for detecting phthalates
The detection of phthalates usually adopts the following standards and methods:
1. Testing standards
EU EN 14372:
Method for detecting phthalates in children's products.
ASTM D3421:
Method for detecting phthalates in plastics.
Chinese GB/T 20388:
Method for detecting phthalates in textiles.
2. Testing methods
Gas chromatography-mass spectrometry (GC-MS):
Separate phthalates by gas chromatography and detect their content by mass spectrometry.
High performance liquid chromatography (HPLC):
Separate phthalates by liquid chromatography and detect their content by UV detector.
The process of detecting phthalates
Sample preparation:
Prepare representative samples according to testing requirements.
Extraction of Phthalates:
Extract phthalates from the sample using solvents such as n-hexane.
Purification sample:
Purification of extraction solution by solid-phase extraction (SPE) and other methods.
Instrument analysis:
Use GC-MS or HPLC to detect the content of phthalates.
Result analysis:
Based on the test results, determine whether the sample meets the limit requirements.
How to reduce the content of phthalates
Material selection:
Choose raw materials that do not contain phthalates.
production process
Optimize production processes and reduce the use of phthalates.
Alternative substances:
Use environmentally friendly alternatives such as citrate esters and epoxidized soybean oil.
Quality Control:
Regularly conduct phthalate ester testing on products to ensure compliance with limit requirements.
summary
Phthalates are a class of harmful chemicals widely used in products such as plastics, coatings, cosmetics, etc. Due to its potential reproductive toxicity, carcinogenicity, and environmental hazards, phthalates are strictly restricted in consumer products in many countries and regions. Export products need to undergo phthalate ester testing according to the requirements of the target market to ensure compliance with relevant regulations and standards.
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