1. What is bisphenol A?
Definition and history of its use
Bisphenol A (BPA) is a synthetic organic molecule belonging to the family of aromatic compounds. It was first discovered in 1891 by the Russian chemist Alexander Dianin, but its industrial use only really took off in the mid-20th century. Since then, BPA has become a key ingredient in the production of plastics and resins.
BPA is widely used in the manufacture of polycarbonate plastics, known for their transparency, lightness, and impact resistance. These materials are found in a variety of products, such as reusable water bottles, optical lenses, and CDs/DVDs. Furthermore, BPA plays a key role in the production of epoxy resins, which serve as a protective coating for food cans, beverage cans, and industrial applications.
YesWeLab performs specialized analyses to ensure that materials in contact with food (plastics, metals, papers, inks, varnishes) comply with European (EC 1935/2004) and American (FDA) standards through global and specific migration tests.
The industrial sectors concerned
In France, nearly sixty industrial sectors still use BPA or its derivatives today. These include the manufacture of cables, adhesives, sealants, brake fluids, medical devices, and printing inks used for receipts. Its versatility makes it an essential substance in many fields, but also a potential source of contamination for the population.
Chemical properties and characteristics
Bisphenol A is an aromatic compound composed of two phenol groups linked by a methylene bridge. This chemical structure gives BPA high thermal and chemical stability, properties sought after in the production of durable materials. However, these same characteristics also make it a persistent substance in the environment, difficult to biodegrade, and likely to accumulate in ecosystems.
With limited solubility in water but a strong affinity for fats, BPA can migrate into food and beverages when used in food containers. This migration is exacerbated by heat or pH fluctuations, posing a significant risk to human health.
Why has Bisphenol A become a cause for concern?
The scientific interest in BPA stems primarily from its endocrine-disrupting properties. This molecule can mimic natural hormones, such as estrogen, and thus disrupt the body's normal hormonal functions. The first studies on its effects date back to the 1990s, revealing a correlation between BPA exposure and reproductive, metabolic, and neurological disorders.
2. The effects of bisphenol A on human health and the environment
Bisphenol A is at the heart of numerous health and environmental concerns due to its chemical properties and widespread use. This endocrine disruptor has significant effects on human health, particularly in the most vulnerable populations, as well as on ecosystems.
The impacts on human health
Bisphenol A acts as an endocrine disruptor, meaning it interferes with the hormonal system by mimicking or blocking the action of natural hormones. These disruptions can cause various disorders, particularly affecting the reproductive, metabolic, and neurological systems.
In humans, prolonged exposure to BPA has been associated with decreased fertility, developmental disorders in fetuses and young children, and an increased risk of metabolic diseases such as type 2 diabetes. Studies have also highlighted a link between BPA and behavioral disorders, including attention deficit hyperactivity disorder in children.
Pregnant women and infants are particularly vulnerable. BPA can cross the placental barrier, exposing the fetus to concentrations that can affect its development. Furthermore, research has shown that in utero exposure can have long-term consequences, such as increased susceptibility to hormone-dependent cancers.
Environmental effects
Bisphenol A, due to its resistance to chemical and biological degradation, is a significant source of environmental pollution. This substance can accumulate in soils, surface waters, and sediments, where it persists for long periods.
In aquatic environments, BPA poses a direct threat to wildlife. It is known to disrupt the reproductive cycles of fish and amphibians, leading to population declines. In some organisms, such as aquatic invertebrates, it causes developmental and growth abnormalities.
Terrestrial ecosystems are not spared. Plastic waste containing BPA, when it degrades, releases this substance into the soil, compromising the quality of agricultural land and potentially affecting food chains.
Sources of exposure
Exposure to bisphenol A can occur through several routes:
- Food route : This represents the main source of exposure, with BPA migrating from food containers (cans, polycarbonate bottles) into food and beverages.
- Skin contact : The use of thermal paper, such as receipts, directly exposes the skin to BPA. This route of exposure is particularly concerning for professionals who regularly handle these materials.
- Inhalation : Although less frequent, this route of exposure can occur due to BPA emissions into the ambient air of industrial environments.
The urgent need to reduce exposure
Faced with these risks to human health and the environment, the need to reduce exposure to BPA has become a priority for health authorities. Gradual bans and recommendations for alternatives aim to protect the most vulnerable populations while limiting the environmental impact of this persistent substance.
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3. Regulations surrounding bisphenol A
Growing concerns about the health and environmental effects of bisphenol A have led to rapid regulatory changes at both national and European levels. These measures aim to protect vulnerable populations and regulate the use of this substance in industry.
The first regulatory actions in France
France was one of the first countries to take action to reduce its population's exposure to bisphenol A. In 2012, Law No. 2012-1442 was adopted to suspend the manufacture, import, export, and sale of food containers containing BPA. This ban came into effect on January 1, 2015, marking a significant step in managing the risks associated with this substance.
In parallel, the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) played a key role by publishing reports as early as 2011 on the health effects of BPA and recommending its substitution in materials in contact with food, particularly to protect infants, young children and pregnant women.
Measures at the European level
The European Union has also strengthened its regulatory framework over the years. Initially, Regulation (EU) No 10/2011 limited the specific migration of BPA into food contact materials. However, in light of new scientific data, the European Food Safety Authority (EFSA) reassessed the tolerable daily intake (TDI) in 2023, reducing it to 0.2 nanograms per kilogram of body weight per day, compared to 4 micrograms previously.
In December 2024, Regulation (EU) No 2024/3190 marked a turning point by completely banning the use of BPA in food contact materials. This ban also includes its salts and derivatives, with a few strictly regulated exceptions, such as large capacity containers (> 1000 liters) and certain filtration membranes, provided that the BPA remains undetectable (limit of 0.01 mg/kg).
Obligations for manufacturers
The regulation also imposes new requirements on manufacturers and distributors, including:
- Declaration of Conformity (DoC) : All materials intended for food contact must be accompanied by a declaration certifying the absence of BPA or, where applicable, compliance with regulatory thresholds.
- Transition period : Companies have 18 months to adapt their production processes. Exceptional exemptions, limited to three years, may be granted if documented evidence demonstrates the absence of viable alternatives.
Managing substitutes
While the ban on BPA is an important step, it raises the issue of substitutes. Authorities, particularly the European Commission, have expressed concerns about the use of alternative bisphenols, such as bisphenol S (BPS) or bisphenol B (BPB), which have similar endocrine-disrupting properties. Consequently, these compounds are also included in recent regulations to prevent the unfortunate phenomenon of substitution.
Towards global harmonization
While the European Union and France are at the forefront of regulation, other regions of the world are also beginning to limit the use of BPA. In the United States, for example, the Food and Drug Administration (FDA) has banned its use in baby bottles and sippy cups, although overall restrictions are less stringent than in Europe. This gradual harmonization is crucial to reducing global exposure to BPA and its negative impacts.
3. Analytical techniques for the determination of bisphenol A
Bisphenol A (BPA) analysis is essential for regulatory compliance and ensuring the safety of food contact materials. Specialized laboratories use advanced techniques to detect and quantify this substance, meeting the requirements of industry and regulatory authorities. This section explores the main analytical methods used for BPA determination, focusing on their principles, limitations, and applications.
Soxhlet extraction coupled with HPLC-MS: a reference method
Soxhlet extraction, combined with high-performance liquid chromatography coupled with mass spectrometry (HPLC-MS), is a widely used technique for quantifying bisphenol A.
Principle of the method
The method begins with the extraction of BPA from solid matrices or polymers using a specific organic solvent in a Soxhlet apparatus. This step releases the substance from the complex materials, ensuring complete and efficient extraction. The extract is then analyzed by HPLC-MS, a technique that separates and identifies chemical compounds based on their mass and chemical properties.
Limit of quantification (LOQ)
The sensitivity of this method is exceptional, with a limit of quantification of less than 0.01%. This precision is crucial to ensure compliance with the strictest regulations, particularly those imposed by the European Union.
Advantages and applications
This method is ideal for polymers, varnishes, and food coatings. It offers reliable and reproducible results, even for complex matrices. Certified laboratories favor this technique because of its robustness and its ability to detect low concentrations of BPA.
Sample collection and preparation equipment
The choice of sampling medium is crucial to ensuring the accuracy of results. Samples must be collected in specific, airtight, and inert containers to prevent any contamination or alteration of the analyzed compounds. Accredited laboratories define strict protocols to guarantee the traceability and quality of analyses.
Rigour in sample preparation
Before analysis, samples are packaged to prevent any BPA degradation. This includes using certified containers and adhering to specific storage conditions.
Quality standards and certifications
The laboratories performing these analyses are often ISO 17025 accredited, guaranteeing reliability and accuracy of results that comply with regulatory requirements.
4. Recent scientific studies on bisphenol A
Scientific research on bisphenol A has intensified in recent decades due to growing concerns about its effects on human health and the environment. These studies have deepened our understanding of this substance and helped shape current regulations.
The reassessment of risks by EFSA
In 2023, the European Food Safety Authority (EFSA) published a new risk assessment of bisphenol A, marking a turning point in the understanding of its health effects. Experts significantly reduced the tolerable daily intake (TDI) from 4 micrograms to 0.2 nanograms per kilogram of body weight per day . This revision is based on recent data showing that exposure to very low doses can impair the immune, reproductive, and nervous systems.
This drastic reduction in the TDI highlighted the need to re-examine population exposure levels and risk management measures. Canned products, identified as a major source of BPA migration into food, were a particular focus of these investigations.
The effects on fetal and infant development
Epidemiological and experimental studies have shown that exposure to bisphenol A during pregnancy can have long-term effects on child development. BPA crosses the placental barrier, exposing the fetus to concentrations that can disrupt organ development, particularly of the brain and reproductive system.
Researchers have also identified links between early exposure to BPA and the development of metabolic disorders, such as childhood obesity. These findings underscore the importance of protecting pregnant women and infants from this substance, thus justifying the strengthened regulatory measures adopted in recent years.
The impact on the gut microbiota
Another significant development concerns the effects of bisphenol A on the gut microbiota. Recent research has revealed that chronic exposure to BPA can disrupt the balance of gut bacteria, leading to inflammation and an increased risk of metabolic and immune diseases. These findings open new perspectives on the mechanisms of action of BPA beyond its role as an endocrine disruptor.
Migration and environmental persistence
Studies on BPA migration in the environment have also contributed to a better understanding of its ecological impacts. BPA can contaminate soils and waterways, where it persists for extended periods. Particular attention is being paid to micropollutants resulting from the degradation of BPA-containing plastics, which can accumulate in aquatic and terrestrial wildlife.
Furthermore, studies have shown that storage conditions for plastic products, such as heat and pH variations, significantly influence BPA migration into food and beverages. This data reinforces the need to improve packaging design to minimize risks.
Towards new research approaches
Current research focuses on developing more sensitive detection methods to monitor exposure to BPA and its alternatives. Biomonitoring techniques, which measure BPA levels in bodily fluids (urine, blood), provide a more accurate picture of individual exposures and allow for better targeting of at-risk groups.
Furthermore, interdisciplinary studies combining toxicology, epidemiology, and molecular biology play a key role in the overall understanding of the effects of BPA. These approaches not only allow for the assessment of the hazards of this substance but also guide policymakers in developing appropriate policies.
5. Regulations related to bisphenol A dosage
Regulations concerning bisphenol A (BPA) have been significantly strengthened in recent years in response to health and environmental concerns related to this substance. These measures include strict detection limits, targeted bans, and specific laboratory testing requirements. This section examines the main regulations governing BPA testing and their implications for industry.
European regulatory framework
Prohibition of the use of BPA in materials that come into contact with food
Since January 1, 2015, France has banned the manufacture, import, export, and sale of any food packaging containing BPA. This initiative was extended to the European level with Regulation (EU) 2024/3190 , which entered into force in January 2025.
- This regulation completely bans BPA in plastics, resins, printing inks, silicones and other materials that come into contact with food.
- Detection thresholds are set at very strict levels, often below 0.01%, to guarantee that this substance does not migrate into food.
Traceability obligations and declaration of conformity (DoC)
Manufacturers and distributors must provide a declaration of conformity for all materials that may contain bisphenols, including:
- The guarantee that the products comply with regulatory thresholds.
- Complete documentation of the analyses carried out, including the methods used and the limits of quantification (LOQ). These declarations must accompany the materials throughout their distribution chain, ensuring full transparency for the authorities and consumers.
Roles of accredited laboratories in compliance
Analytical standards and certifications
BPA analyses must be carried out by accredited laboratories that comply with ISO 17025 . These laboratories guarantee:
- The use of validated methods, such as Soxhlet extraction coupled with HPLC-MS or HS-GC-MS screening .
- The accuracy of the results, with limits of quantification adapted to regulatory requirements (< 0.01% for BPA).
Materials monitoring and validation
Laboratories play a key role in validating materials used in the food, cosmetics, and pharmaceutical industries. Their expertise is essential for:
- Identify potential sources of BPA migration.
- To propose corrective solutions and safe alternatives in case of non-compliance.
Penalties and risks in case of non-compliance
Regulatory sanctions
Manufacturers who fail to comply with thresholds or conformity declaration requirements are subject to severe penalties:
- Immediate withdrawal of the products concerned from the market.
- Financial penalties and legal proceedings.
Risks to brand image
Non-compliance can also damage a company's reputation, particularly in a context where consumers are increasingly attentive to product safety and environmental impacts.
Implications for manufacturers
Current regulations mandate strict control of BPA levels in materials and finished products. This requires:
- Collaboration with certified laboratories to carry out accurate and documented analyses.
- The implementation of strategies to replace BPA with safer alternatives.
- Constant regulatory monitoring to anticipate legislative changes.
These requirements aim to protect consumer health while encouraging industries to adopt more responsible and innovative practices.
YesWeLab: Your partner for Bisphenol A analysis
YesWeLab offers specialized analyses for materials in contact with food.
Global and specific migration tests ensure that materials (plastics, metals, paper, inks, varnishes) do not transfer dangerous substances to food, thus guaranteeing compliance with European (EC Regulation No. 1935/2004) and American (FDA) standards.
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