Bisphenol A (BPA) ban is the new barrier to your EU market entry

For businesses aiming to succeed in the European Union (EU) market, compliance with chemical safety standards is critical.

With the advent of Commission Regulation (EU) 2024/3190 concerning food contact materials (FCMs), non-compliance with Bisphenol A (BPA) rules instantly transforms into a hard commercial barrier that may halt your products at the border, derail market entry plans, and threaten inventory solvency.

This regulatory shift fundamentally redefines risk management within your supply chain.

The question is no longer if you need to comply, but how you will overcome this barrier swiftly and proactively.

The European Union’s implementation of  Commission Regulation (EU) 2024/3190, effectively enacting a near-total prohibition on Bisphenol A (BPA) in key food contact materials (FCMs), is a critical, non-negotiable hard barrier to EU market access.

For any business operator relying on BPA-based raw materials or finished goods for the EU market, failure to achieve rapid compliance carries tangible and immediate financial consequences.

Non-compliant products will face mandatory refusal, restriction, or suspension at the EU border and within the internal market. This mandates that BPA compliance is now a central pillar of your EU market entry strategy.

Bisphenol A (BPA) (4,4’-isopropylidenediphenol; CAS 80-05-7) is a crucial substance historically used in manufacturing various Food Contact Materials (FCMs).

Primarily, it functions as a monomer or starting substance in epoxy resins used for varnishes and coatings applied to metal food packaging (like cans, tins, and jar lids), as well as large storage tanks. It is also employed in certain plastic FCMs, particularly polycarbonate and polysulfone, and may be present in printing inks and adhesives forming part of finished articles.

BPA is a substance of high concern because it can migrate from the material into the food, leading to dietary exposure for consumers.

Following a major re-evaluation requested by the European Commission in 2016, the European Food Safety Authority (EFSA) published an updated opinion in 2023.

EFSA identified that BPA exposure poses a health concern for all population groups, with effects on the immune system being a primary concern. Adverse effects were also noted on the metabolic, reproductive, and developmental systems.

The most profound consequence for industry is the drastically lowered safe exposure level:

• Previous Temporary Tolerable Daily Intake (TDI) (2015): 4 micrograms per kilogram (µg/kg) bodyweight per day (4,000 ng/kg).
• New TDI (2023): 0.2 nanograms per kilogram (ng/kg) bodyweight per day.

This new safe level is 20,000 times lower than the previous one.

Before this new regulation, Bisphenol A use was managed primarily through limits, as set out in Commission Regulation (EU) 2018/213.

1. Specific Migration Limit (SML): BPA used in plastics and varnishes/coatings was subject to an SML of 0.05 mg of BPA per kg of food (mg/kg).

2. Specific prohibitions: Use was already prohibited in polycarbonate infant feeding bottles and drinking cups, as well as migration from varnishes/coatings intended for foods specifically for infants and young children.

Commission regulation (EU) 2024/3190, adopted on 19 December 2024, repeals Regulation (EU) 2018/213 and introduces a new regime based on minimization and prohibition.

Due to the drastically lowered TDI and the inability of existing analytical methods to reliably quantify migration at the resulting low levels, the use of Bisphenol A and its salts is now generally prohibited in the manufacture of various Food Contact Materials (FCMs).

This prohibition covers adhesives, rubbers, ion-exchange resins, plastics, printing inks, silicones, and varnishes and coatings.

The regulation also mandates that FCMs manufactured using other bisphenols or bisphenol derivatives shall not contain any residual BPA.

Only a very few highly specific applications are granted derogations, underscoring the severity of the ban:

1. Plastics (Polysulfone): BPA may be used in manufacturing polysulfone filtration membrane assemblies critical for food production (e.g., filtering pathogens/contaminants from dairy).

2. Varnishes and coatings (large capacity): Bisphenol A is permitted in liquid epoxy-based varnishes and coatings for tanks, vessels, and piping interconnecting containers with a capacity greater than 1,000 litres.

Critically, for both derogations, the restriction specifies that BPA migration into food shall not be detectable, and the final articles must be meticulously cleaned and flushed before their first contact with food.

This non-detectability standard sets a formidable technical compliance bar, regardless of the previous quantitative Specific Migration Limit (SML).

The detection limit for non-detectability is generally set at 0.01 mg of substance per kg of food or food simulant. For BPA and other bisphenols, a detection limit of 1 µg/kg (0.001 mg/kg) is usually applied.

The Regulation proactively addresses the substitution challenge by restricting other hazardous bisphenols and their derivatives.

Specifically those classified as mutagenic (1A/1B), carcinogenic (1A/1B), toxic to reproduction (1A/1B), or category 1 endocrine disruptors for human health.

Potential Bisphenol A alternatives, such as Bisphenol S (BPS) (FCM 154), already carry the harmonized classification of toxic to reproduction category 1B, necessitating an up-to-date safety assessment for their continued use.

1. Impossibility of demonstration: The established TDI is so low that reliably and consistently quantifying BPA migration at the level of a derived Specific Migration Limit (SML) is currently analytically impossible.
2. The only recourse is prohibition: Consequently, the EU decided that the only way to safeguard consumer health was a blanket prohibition on the use of BPA and its salts in the manufacture of Food Contact Materials (FCMs), including plastics, adhesives, rubbers, ion-exchange resins, printing inks, silicones, and crucially, varnishes and coatings (epoxy resins, widely used in metal packaging like cans and jar lids).
3. Proactive documentation: Every batch of material placed on the market must be accompanied by a Declaration of Compliance (DoC) affirming conformity with the relevant EU regulations, including an explicit indication as to whether BPA or other relevant bisphenols were used. If your documentation cannot definitively prove that your product complies with the new prohibition, its commercial viability in the EU ends immediately.

This move from a Specific Migration Limit (SML) to an outright ban fundamentally changes the compliance landscape.

Regulation (EU) 2024/3190 repeals the previous Regulation (EU) 2018/213 and introduces a new, stricter regime. It operates on strict transitional deadlines, designed to force rapid adaptation across the entire supply chain.

That translates directly into severe commercial risks for manufacturers, importers, and distributors.

The core of the new rules is a prohibition on the use of Bisphenol A and its salts in the manufacture of several material groups, including plastics, varnishes and coatings, adhesives, and printing inks.

Given the complex process of identifying and integrating alternatives to BPA, particularly in chemical areas like varnishes and coatings, these deadlines present a high risk of stranded inventory and massive reformulation costs.

While there are limited, highly specific derogations for polysulfone filtration membranes and large storage tanks over 1,000 litres, these require that migration is non-detectable.

Furthermore, the declaration of compliance for your materials must now explicitly state whether Bisphenol A or other relevant bisphenols have been used in their manufacture.

The transition periods are your critical path to market, but they are finite. Key deadlines for placing articles on the market for the first time are:

Single use FCMs:

Single use FCMs manufactured using Bisphenol A and complying with the rules as applicable before the date of entry into force of regulation EU 2024/3190 not complying with it may be placed on the market until 20 July 2026.

With the exemption of the following categories which may be placed on the market until 20 January 2028: Single-use final food contact articles intended for the preservation of fruits or vegetables, fishery products and food contact articles on which a varnish or coating manufactured using BPA has only been applied to the exterior metal surface.

They may be filled with food and sealed during the 12 months following the expiry of the applicable transitional period. 

The resulting packaged food may be placed on the market until exhaustion of stocks.

Repeat-use FCMs:

Repeat-use final food contact articles manufactured using Bisphenol A and complying with the rules as applicable before the date of entry into force of EU 2024/3190 not complying with it may be placed on the market until 20 July 2026.

With the exemption of the following categories which may be placed on the market until 20 January 2028: Repeat-use final food contact articles used as professional food production equipment.

They may remain on the market until 20 January 2029 at the latest.

The direct impact on market entry plans is immediate. Products relying on Bisphenol A, even if compliant under the old Regulation (EU) 2018/213, must exit the market or be reformulated quickly to meet the new deadlines.

Any product manufactured using legacy BPA materials beyond these dates, or failing the stringent new tests for compliance, will be stopped at the border or seized within the EU.

The ban presents a substantial challenge, especially in the varnishes and coatings sector, where business operators have relied on BPA-based epoxy resins for decades across hundreds of formulations.

Reformulation is pricey and time-consuming, requiring extensive:

1. Chemical safety assessment: Ensuring alternatives meet the “non-hazardous” criteria and do not pose similar risks.

2. Functionality and performance testing: Validating new alternatives against critical parameters like mechanical strength, chemical stability, preventing microbiological spoilage, and, crucially, achieving adequate shelf life. Accelerated methods often do not exist for long-term shelf life testing, compounding the time challenge.

3. Specific challenges: Applications involving acidic foods (certain preserved fruits, vegetables, and fishery products) demand even stricter validation due to the aggressive environment they create inside packaging.

Overcoming this barrier requires a proactive and strategic approach. Relying on your existing supply chain data is no longer sufficient. A robust compliance strategy should include:

• Deep supply chain mapping: You must identify and verify the chemistry of all raw materials, as BPA can be present as a non-intentionally added substance (NIAS) from other bisphenols. By tracing every substance used in adhesives, rubbers, ion-exchange resins, plastics, printing inks, silicones, and varnishes/coatings you’ll identify the exposure points.

• Proactive reformulation: Partner with suppliers to find and validate compliant alternatives, being cautious not to simply switch to other restricted bisphenols like Bisphenol S (BPS), classified as toxic to reproduction category 1B. Be aware specially to the classification as hazardous substances of the alternatives.

• Documentation overhaul: Ensure your technical documentation and declaration of compliance are meticulously updated to reflect the new Regulation (EU) 2024/3190 and detailing any bisphenols or derivatives used in manufacturing and can withstand scrutiny from authorities.

Attempting this complex process without specialised expertise carries significant risk. A single oversight in your supply chain can lead to your products being denied entry.

The regulatory environment now treats BPA contamination as a critical flaw that renders a product illegal for import or placing on the market.

To ensure continuous market access beyond the rapidly approaching deadlines, businesses must transform their material sourcing and validation processes from reactive testing to proactive regulatory strategy.

By addressing this challenge head-on, you not only secure your place in the valuable EU market but also future-proof your business against the next wave of regulatory changes, as the EU is already turning its attention to other hazardous bisphenols.

The new BPA rules are a definitive market access barrier, but they are not insurmountable. With the right partner, you can navigate this transition efficiently, protect your revenue, and build a more resilient supply chain.

BPA compliance is the new critical success factor. Delaying action risks catastrophic commercial consequences, from seized imports and unusable stock to market exclusion.

Ensure your entry strategy is robust and your inventory is safe.

Let our compliance specialists guide you through the Bisphenol A transition. Contact us for a confidential consultation to secure your EU market access.