I. Introduction
Background of the EU's food contact material regulations
Food contact materials play a crucial role in our daily lives as they come into direct contact with the food we consume. To safeguard the health of consumers, the European Union has been implementing a series of strict regulations regarding these materials. These regulations aim to prevent the migration of harmful substances from the materials into the food, ensuring food safety.
On January 20, 2025, the EU Regulation (EU) 2024/3190 officially took effect. This regulation is a significant update in the control of bisphenol - related substances in food contact materials. It comprehensively replaces the original (EU) 2018/213 regulation and revises the (EU) 10/2011 food contact plastic regulation. The new regulation significantly expands the scope of control. Not only is the use of bisphenol A (BPA, CAS: 80 - 05 - 7) and its salts in food contact materials prohibited, but also bisphenol derivatives with carcinogenic, teratogenic, reproductive - toxic, or endocrine - disrupting properties (classified as category 1A/1B according to the CLP regulation or endocrine - disrupting category 1), such as BPS (CAS: 80 - 09 - 1), BPB (CAS: 77 - 40 - 7), and BPAF (CAS: 1478 - 61 - 1), are included in the control list. The regulation covers seven major types of materials, namely plastics, adhesives, rubbers, varnishes and coatings, printing inks, silica gels, and ion - exchange resins.
In terms of detection limits, the new regulation requires a leap - forward improvement. Compared with the limit of 0.05mg/kg (50ppb) in the old regulation, the new regulation tightens the detection limit of bisphenol A to 1μg/kg (1ppb), making the control 50 times more stringent. At the same time, the regulation clearly requires that even if non - BPA bisphenol substitute substances are used, no BPA residues should be detected in the products, which poses extremely high requirements for the sensitivity and accuracy of detection technologies.
II. Key Points of the EU (EU) 2024/3190 Regulation
2.1 Prohibited substances
The (EU) 2024/3190 regulation strictly prohibits the use of bisphenol A (BPA, CAS: 80 - 05 - 7) and its salts in food contact materials. This is due to BPA's potential risks to human health, such as its suspected endocrine - disrupting properties. In addition, bisphenol derivatives with carcinogenic, teratogenic, reproductive - toxic, or endocrine - disrupting properties (classified as category 1A/1B
according to the CLP regulation or endocrine - disrupting category 1) are also prohibited. Examples of these derivatives include BPS (CAS: 80 - 09 - 1), BPB (CAS: 77 - 40 - 7), and BPAF (CAS: 1478 - 61 - 1). These substances, like BPA, may pose threats to human health when they migrate from food contact materials into food, so the EU has taken measures to ban their use in the production of such materials.
2.2 Scope of application
The regulation covers seven major categories of food contact materials. Plastics, which are widely used in food packaging and containers, are one of the key areas of regulation. Adhesives, often used to bond different parts of food - contact products, must also comply with the new rules. Rubbers, such as those used in seals and gaskets in food - related equipment, are within the scope. Varnishes and coatings, which may come into direct contact with food in some cases, are subject to the regulation. Printing inks, especially those used on food packaging, need to meet the requirements to prevent the migration of harmful bisphenols into food. Silica gels, which can be found in some food - contact applications, and ion - exchange resins, often used in water treatment and food processing, also fall under the purview of this regulation. This wide - ranging scope ensures that all potential sources of bisphenol exposure from food contact materials are effectively controlled.
2.3 Stringent detection limits
One of the most significant changes brought by the new regulation is the tightened detection limit for bisphenol A. While the previous regulation set the limit at 0.05mg/kg (50ppb), the new (EU) 2024/3190 regulation reduces this limit to an extremely low 1μg/kg (1ppb). This 50 - fold increase in stringency means that even trace amounts of BPA in food contact materials are now highly regulated. Moreover, the regulation stipulates that even when non - BPA bisphenol substitute substances are used, no BPA residues should be detected in the products. Such strict requirements pose great challenges to the existing detection technologies, demanding higher sensitivity and accuracy to ensure compliance.
2.4 Transitional arrangements
For disposable food contact products, there is a certain grace period. Products that comply with the original regulations can continue to be placed on the market until July 20, 2026. After the end of this transitional period, there is an additional 12 - month period during which the remaining inventory can be sold until it is exhausted. This allows manufacturers some time to adjust their production lines and switch to compliant materials.
For reusable food contact products, they can be first placed on the market until July 20, 2026. Professional food production equipment has a longer grace period and can be placed on the market until January 20, 2028. However, after January 20, 2029, the sale of non - compliant reusable food contact products will be completely prohibited. These transitional arrangements are designed to balance the need for strict regulation with the practicalities of the industry, giving businesses time to adapt to the new requirements without causing excessive disruption to the market.
III. Impact on the Food Contact Material Industry
3.1 Challenges for enterprises
The implementation of the EU (EU) 2024/3190 regulation has brought about several significant challenges for enterprises in the food contact material industry.
In terms of raw material selection, companies now face the arduous task of finding suitable substitutes for bisphenol - containing substances. BPA has been widely used in the production of plastics, coatings, and adhesives due to its favorable properties such as high strength and heat resistance. However, with the ban, enterprises must search for alternative materials that not only meet the performance requirements but also comply with the new regulations. For example, finding non - bisphenol - based resins for plastic production can be difficult as these substitutes may have different processing characteristics, costs, and availability. Some alternative materials might be more expensive, which could increase production costs significantly. Additionally, the performance of these substitutes may not be as well - established in the market, leading to concerns about product quality and reliability.
When it comes to production process improvement, enterprises need to re - evaluate and adjust their manufacturing processes. The production lines that were previously optimized for materials containing bisphenols may no longer be suitable. For instance, if a company was using BPA - containing epoxy resins in its coating process, the new substitute resins may require different curing conditions, temperatures, or catalysts. Modifying the production process to accommodate these changes can be time - consuming and costly. It may also require additional investment in new equipment or the retraining of employees. Moreover, during the process of improving the production process, there may be disruptions to the production schedule, potentially leading to decreased productivity in the short term.
Product testing has also become a major challenge. The extremely low detection limit of 1μg/kg (1ppb) for bisphenol A in the new regulation demands highly sensitive and accurate testing methods. Many enterprises may not have the in - house testing capabilities to meet such stringent requirements. Outsourcing testing to third - party laboratories can be an option, but it also comes with its own set of challenges. Ensuring the reliability and accuracy of the testing results from external laboratories is crucial. In addition, the cost of frequent and high - precision testing can add a significant burden to the enterprise's budget. And with the requirement that even when using non - BPA bisphenol substitute substances, no BPA residues should be detected, the complexity and cost of testing have further increased.
3.2 Market access risks
Non - compliance with the EU (EU) 2024/3190 regulation poses significant market access risks for enterprises. The EU is a large and lucrative market for food contact material products. However, if a company's products do not meet the new regulatory requirements, they will be prohibited from entering the EU market. This means that all the efforts put into product development, production, and marketing for the EU market will be in vain.
Products that are found to contain prohibited bisphenol - related substances during customs inspections or market surveillance will be detained, seized, or even recalled. Such actions not only result in direct financial losses, including the cost of the products, transportation, and storage, but also damage the company's reputation. A negative reputation in the market can lead to a loss of customer trust, which may have long - term consequences for the company's business, both in the EU and other markets.
Moreover, the EU's regulatory requirements often set a precedent for other regions and countries. Non - compliance with the EU regulations may also lead to difficulties in entering other international markets as other countries may follow the EU's lead in tightening their own regulations on food contact materials. This can further limit the company's market opportunities and growth potential, making it essential for enterprises to ensure full compliance with the EU (EU) 2024/3190 regulation to safeguard their market access and business sustainability.
IV. Zhejiang RTS Test's Technical Breakthroughs
4.1 Ultra - trace substance capture technology
Zhejiang RTS Test has adopted an improved solid - phase extraction (SPE) process. By optimizing the composition of the extraction column packing and the ratio of the elution solvent, the company has achieved highly efficient enrichment of bisphenol A residues as low as the nanogram level (ng) in samples. This technology effectively addresses the issues of insufficient capture efficiency and unstable recovery rates of trace target substances in traditional solid - phase extraction techniques. With this optimized method, the recovery rate remains stable within the range of 85% - 110%, fully meeting the requirements of trace analysis techniques. For example, in a sample with a very low concentration of bisphenol A, the improved SPE process can accurately and efficiently extract the target substance, ensuring that even the slightest amount of BPA can be detected and analyzed.
4.2 High - precision qualitative and quantitative system
The company makes use of ultra - high - performance liquid chromatography - tandem mass spectrometry (UPLC - MS/MS) technology and adopts the multiple reaction monitoring (MRM) mode. By selecting characteristic parent ions and daughter ions for double verification, it can effectively eliminate matrix interference and avoid false - positive and false - negative results. The relative standard deviation (RSD) of the detection results is ≤5%, which meets the precision requirements of trace detection. When analyzing a complex sample matrix, the UPLC - MS/MS system can precisely identify the characteristic ions of bisphenol A, and through the MRM mode, accurately measure the content of BPA in the sample, providing highly reliable qualitative and quantitative results.
4.3 Full matrix adaptation ability
In response to the different matrix characteristics of various food contact materials such as plastics, coatings, adhesives, and rubbers, RTS has established exclusive pretreatment schemes for each. For high - molecular polymer materials, microwave - assisted extraction (MAE) technology is employed to accelerate the release of target substances. For example, when dealing with plastic - based food contact materials, MAE can quickly break down the polymer structure and release the bisphenol A trapped inside. For oil - based simulated food contact scenarios, the sample purification process is optimized to ensure stable detection under different matrix conditions. For instance, in the detection of food contact materials in contact with oily foods, the optimized purification process can effectively remove oil - related impurities, enabling accurate detection of bisphenol A residues.
V. Zhejiang RTS Test's Bisphenol A Testing Services
5.1 Full - category testing coverage
Zhejiang RTS Test offers specialized testing services for the seven major categories of food contact materials regulated by the EU.
For disposable food contact products, it includes plastic tableware, which is widely used in fast - food restaurants and take - out services; food packaging films/bags that are essential for protecting food during transportation and storage; and the inner coatings of paper - based food packaging, which prevent food from being contaminated by the paper material.
In the category of reusable food contact products, plastic water cups and lunch boxes are commonly used in daily life, and stainless - steel container inner coatings are important to prevent the metal from reacting with food.
For indirect food contact materials, metal can inner coatings protect the food from the metal and prevent corrosion; food packaging printing inks, which are often in contact with food - packaging surfaces, need to meet strict standards to avoid the migration of harmful substances; and silicone gaskets used for sealing, which are widely used in food - related containers, are also tested.
The company also provides testing for production - use consumables such as resins, additives, and ion - exchange resins used in the production of food contact materials. These materials are the building blocks of food contact products, and their safety is crucial to ensure the overall compliance of the final products.
5.2 Multi - scenario compliance testing services
Raw material screening testing is carried out to detect bisphenol A residues in the resins, auxiliaries, and other raw materials used in the production of food contact materials. By conducting this test at the source, enterprises can avoid potential compliance risks. For example, if a resin used in plastic production contains bisphenol A residues, it can lead to the non - compliance of the final plastic product. Early detection and elimination of such risks can save significant costs associated with product recalls and re - production.
Finished product compliance verification is performed in accordance with the requirements of the EU (EU) 10/2011 regulation. Different food - contact scenarios are simulated, such as acidic (4% acetic acid), alcoholic (10%, 20%, 50% ethanol), and oily (olive oil, isooctane) environments. These simulations are designed to closely mimic the actual conditions in which food contact materials are used. By testing the migration amount of bisphenol A under these different scenarios, the company can provide accurate and reliable test reports, ensuring that the finished products meet the regulatory requirements.
Alternative substance compliance testing is provided for enterprises that use alternative materials such as PET and HDPE to replace bisphenol A - containing materials. This service not only tests the compliance of the alternative materials but also verifies the absence of BPA residues. As more and more enterprises are looking for alternatives to bisphenol A, ensuring the compliance of these new materials is essential to meet the EU regulations.
5.3 Efficient compliance guarantee services
The company has optimized the testing cycle. Through the standardization of testing processes and the rational allocation of equipment resources, the testing cycle for bisphenol A has been shortened to 3 - 5 working days. This is of great significance for enterprises with urgent shipping needs, as it allows them to quickly obtain test results and meet the time - sensitive requirements of the market.
In terms of compliance report support, Zhejiang RTS Test issues Chinese and English test reports that meet the requirements of EU CE certification. These reports contain comprehensive information such as testing methods, instrument models, matrix information, and test results. The detailed content of the reports can be directly used as supporting materials for enterprises to submit compliance statements to EU regulatory agencies, providing strong evidence of product compliance.
The company also offers value - added regulatory services. This includes the interpretation of the EU (EU) 2024/3190 regulation, helping enterprises understand the complex regulatory requirements. It also involves the planning of compliance paths, providing customized solutions for different enterprises based on their specific product lines and production processes. Additionally, the company assists with the declaration of the bisphenol substance list, guiding enterprises through the necessary procedures to ensure full compliance with the regulations.
VI. How Zhejiang RTS Test Helps Enterprises Seize the Compliance Window Period
RTS stepped in. First, it conducted a comprehensive raw material screening test for the enterprise. By carefully analyzing the resins and additives used in the production of food packaging materials, it was found that although the main raw materials did not contain BPA, some trace additives had very low - level BPA residues.
Based on this result, RTS provided the enterprise with a series of solutions. It helped the enterprise select alternative additives that met the EU regulations. For the finished products, it carried out compliance verification tests under various simulated food - contact scenarios. According to the EU (EU) 10/2011 regulation, it simulated acidic, alcoholic, and oily food - contact environments and accurately detected the migration amount of bisphenol A.
Finally, with the help of RTS, the enterprise successfully adjusted its production process and product formulation. The products passed the EU compliance review smoothly and entered the EU market on time, seizing the market opportunity in the compliance window period.
VII. Conclusion
7.1 Summary of the EU regulation and Zhejiang RTS Test's role
In summary, the EU's (EU) 2024/3190 regulation represents a significant step forward in safeguarding consumer health in relation to food contact materials. By expanding the scope of prohibited bisphenol - related substances and tightening the detection limits, the EU has set a higher standard for food safety. This regulation has brought about various challenges for enterprises in the food contact material industry, from raw material substitution and production process adjustment to the need for highly sensitive product testing.
Zhejiang RTS Test has emerged as a reliable partner for these enterprises. Its technical breakthroughs in ultra - trace substance capture, high - precision qualitative and quantitative analysis, and full matrix adaptation have enabled it to meet the stringent requirements of the new regulation. The company's comprehensive testing services, covering full - category materials, multi - scenario compliance testing, and efficient compliance guarantee, have provided enterprises with the necessary support to navigate the complex regulatory landscape. Through case studies, it has been demonstrated that RTS can effectively help enterprises identify and address compliance issues, enabling them to seize the compliance window period and access the EU market successfully.
7.2 Outlook for the future of the food contact material industry
Looking ahead, as regulatory requirements around the world continue to tighten in the name of consumer safety, the food contact material industry will face increasing pressure to innovate and ensure compliance. Enterprises will need to continuously invest in research and development to find more sustainable and compliant materials and production processes. The role of professional testing institutions like RTS will become even more crucial. These institutions will not only provide testing services but also offer valuable insights into regulatory trends and compliance strategies.
Moreover, the industry may witness a shift towards more standardized and harmonized global regulations. As different regions strive to protect consumer health, there may be more convergence in the requirements for food contact materials. This could simplify the compliance process for multinational enterprises but also pose challenges as they need to keep up with the evolving global standards. Overall, the future of the food contact material industry lies in its ability to adapt to regulatory changes, innovate in materials and production, and collaborate with professional testing and compliance service providers to ensure the safety and quality of food contact products.