A Closer Look at Phthalates in Food Contact Materials: Testing and Safety
In an era where food safety is paramount, manufacturers of food and food contact items must address the pressing issue of phthalates. These chemical compounds, commonly found in plastics and other everyday products, have raised concerns about their migration into food, posing potential health risks. Regulations restricting the use of phthalates in food contact items are increasing, and manufacturers must comply.
In this article, we’ll explore phthalate testing and its implications for the production of food contact items, illuminating its significance in ensuring regulatory compliance, upholding food safety standards, and ensuring consumer well-being.
What Are Phthalates and Why Are They Regulated in Food Contact Materials?
Phthalates are a group of chemical compounds primarily known for their role as plasticizers. These versatile compounds enhance the flexibility, durability, and transparency of plastics, making them indispensable in the production of various everyday items. In the context of food contact items, phthalates are commonly used to soften and mold plastics, making them suitable for applications such as food packaging, containers, and utensils. Their ability to improve the pliability of plastics has led to their widespread incorporation into food contact materials like cling wrap, beverage bottles, and even conveyor belts used in food processing.
However, phthalates’ propensity for migration from these materials into food has raised concerns about their potential impact on human health. Consequently, rigorous testing is essential to ensure that phthalate levels remain within safe limits in food contact items, minimizing any potential risks to consumers.
Regulations Governing Phthalates in Food Contact Materials
Regulations, both in the EU and the U.S., play a pivotal role in safeguarding consumer health by setting strict limits on the presence of phthalates in materials that come into contact with food. Manufacturers and suppliers in these regions are required to adhere to these regulations to ensure food safety and compliance with legal standards.
European Union
In the European Union, the use of phthalates in food contact material plastics, specifically the plastic layer that directly interfaces with food, is tightly regulated under EU Regulation 10/2011. This comprehensive regulation is instrumental in safeguarding the integrity of food products by imposing specific migration limits for several phthalate chemicals, ensuring that they remain within safe levels. These regulations are designed to address the potential health risks associated with phthalates migrating from food contact materials into consumable products. The Regulation was amended in July 2023 and went into effect on August 1, 2023.
Here are the key phthalates covered by EU Regulation 10/2011, along with their respective usage restrictions and specific migration limits:
1. Di-ethylhexyl phthalate (DEHP):
Only to be used as: Plasticizer in repeated use materials and articles contacting non-fatty foods. May also be used as technical support agent in concentrations up to 0.1% (w/w) in the final product.
Specific Migration Limit: 0.6 mg per kg
2. Benzyl butylphthalate (BBP):
Only to be used as: Plasticizer in repeated use materials and articles; (b) plasticizer in single-use materials and articles contacting non-fatty foods except for infant formula and follow-on formula; (c) technical support agent in concentrations up to 0.1 % (w/w) in the final product.
Specific Migration Limit: 6.0 mg per kg
3. Dibutylphthalate (DBP):
Only to be used as: Plasticizer in repeated use materials and articles contacting non-fatty foods; or as technical support agent in polyolefins in concentrations up to 0.05 % (w/w) in the final product.
Specific Migration Limit: 0.12 mg per kg
4. Diisononyl phthalate (DINP):
Only to be used as: Plasticizer in repeated use materials and articles; (b) plasticizer in single-use materials and articles contacting non-fatty foods except for infant formula and follow-on formula; (c) technical support agent in concentrations up to 0.1 % (w/w) in the final product.
Not to be used in combination with FCM substances 157, 159, 283, or 1085.
Specific Migration Limit: 1.8 mg/kg (sum of DINP and Diisodecyl phthalate [DIDP]).
5. Diallyl phthalate (DAP):
Use: Monomer.
Specific Migration Limit: Not-detectable (ND), meaning no migration is permitted.
Read more: Will Your Plastic Food Contact Products Make It in the EU?
United States
In addition to European regulations, the United States Food and Drug Administration (FDA) has its own regulation governing phthalates in food contact materials. Under FDA 21 CFR parts 175 through 178, the FDA has revoked authorizations for the use of twenty-three phthalates for food contact use. This rule (Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers) was issued in May 2022.
See a full list of these twenty-three phthalates in our Regulatory Update.
Phthalate Lab Testing
Phthalates lab testing of food contact items serves as the linchpin for ensuring compliance and safety. By subjecting these materials to rigorous testing, we can precisely measure phthalate levels, guaranteeing that they fall within the permissible limits mandated by regulatory authorities. This meticulous scrutiny not only upholds legal compliance but, more importantly, safeguards the well-being of consumers. Through advanced testing methodologies and expert analysis, QIMA provides the assurance that food contact items are free from harmful and noncompliant phthalate contamination, reinforcing trust in product safety and integrity throughout the supply chain.
Phthalate content is one of the most common reasons for products to fail laboratory testing. Thus, it is important to work with your suppliers to ensure that the manufacturing process is phthalates-free, or below set limits. At QIMA, we offer more than just testing; we provide oversight and facilitate communication with suppliers. Our expertise in supply chain management enables us to help you not only meet regulatory standards but also implement preventive measures to reduce phthalate content during manufacturing. This collaborative approach enhances product safety and quality, making QIMA your trusted partner in achieving compliance.
Contact us today and we’ll be happy to help you make sure your food packaging items are compliant.
Read More
Food Packaging and Food Contact Items Testing - Learn about QIMA’s food packaging and food contact materials testing services.
Understanding EU Food Contact Regulations - Read this whitepaper to learn how EU food contact material regulations impact your business.
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