Navigating the EU Bisphenol A (BPA) Blanket Ban for food contact materials

Navigating the EU Bisphenol A (BPA) Blanket Ban for food contact materials

Midas Safety is closely monitoring all developments related to the new restrictions on Bisphenol A (BPA) under Regulation (EU) 2024/3190 and the Commission Guidance Note C/2025/6721. As a responsible and forward-looking manufacturer, we are committed to ensuring our operations—and those of our partners—meet these updated food safety standards. This document provides a structured overview of the regulation’s scope, timelines, and practical implementation steps, with a focus on how Midas Safety supports your compliance.

 

1. What is Bisphenol A (BPA) & Why is it Restricted?

Commonly known as BPA, the substance 4,4’-isopropylidenediphenol has historically been used to manufacture specific food contact materials. Following a comprehensive scientific re-evaluation spanning from 2016 to 2023, the European Food Safety Authority (EFSA) concluded that dietary exposure to BPA poses a definitive health concern for all population groups.

Historically, BPA has been heavily utilized in three major industrial food processing pipelines:

• Polysulfone Resins: Used in specialized filtration membranes to remove food pathogens and contaminants; no technically feasible commercial alternatives currently exist.
• Varnishes & Coatings: Applied to large industrial tanks, vessels, and piping systems used for food processing, transport, and storage.
• Chemical Precursors: Used as a building block in the chemical synthesis of other raw starting substances or monomers before final manufacturing.

 

2. The Regulatory Framework: Regulation (EU) 2024/3190 & Guidance C/2025/6721

To eliminate these exposure risks, the European Commission enacted Regulation (EU) 2024/3190, establishing a blanket ban on BPA and its hazardous derivatives in all Food Contact Materials (FCMs).

• The Prohibition (Article 3): Under Article 3 of the regulation, the use of BPA and its salts in manufacturing FCMs, as well as placing these items on the EU market, is strictly prohibited. Regulation (EU) No 10/2011 for plastic FCMs has been amended to reflect this complete alignment.
• Expanded Bisphenol Restrictions: Under Guidance Note C/2025/6721, the ban explicitly covers any other bisphenol derivative with a harmonized classification
• as CMR 1A/1B (Carcinogenic, Mutagenic, or Reprotoxic) or ED 1 (Endocrine Disruptor) under Regulation (EC) No 1272/2008.

 

3. Intentionally vs. Non-Intentionally Added Substances

Crucially, this regulation distinguishes between:

• Intentionally added BPA: Direct use of the substance in the manufacturing or formulation process.
• Non-Intentionally added BPA (NIAS): Potential cross-contamination, residues, or impurities introduced via raw material supply chains.

Midas Safety Statement of Compliance:

At Midas Safety, we do not use Bisphenol A, its salts, or any restricted bisphenol derivatives in any of our production processes to manufacturer gloves for food contacts. Furthermore, we have executed comprehensive due diligence with specialized testing laboratories to ensure absolute compliance with this regulation.

 

4. Explicit Testing Logic for Non-Intentionally Added BPA

To help your quality teams navigate the compliance audit verification process, the regulation and subsequent guidance outline exactly how testing applies to non-intentional presence or alternative substance use:

Pathway 1: Pure Environmental Traces / True NIAS (Recital 12)

If an article is manufactured completely without BPA or alternative bisphenols, the primary mechanism of proof is documentation.

• The Rule: In accordance with Recital 12, supporting documentation accompanying the Declaration of Compliance (such as a list of raw monomers and starting substances) is sufficient to demonstrate compliance in the first instance.
• Testing Sufficiency: As explicitly designated under Recital 12, further verification of compliance by testing is entirely at the discretion of the business operator. A migration test is highly valuable for market reassurance but is not a rigid legal prerequisite for non-use pipelines.

Pathway 2: If Alternative Bisphenols are Used (Article 4 & Recital 11)

If a manufacturer substitutes BPA with alternative bisphenols or derivatives, a standard migration test is not sufficient on its own. Under Article 4 and Recital 11, the material must not contain any residual BPA. Compliance must be verified via analytical testing for residual BPA within the material itself, or by utilizing data on the presence of BPA as an impurity.

Because Midas Safety completely avoids the use of alternative bisphenol derivatives, our finished products are completely free of Article 4 residual BPA risks.

 

5. Timeline, Supply Chain Obligations & The DoC Framework

This regulation becomes strictly enforceable on July 20, 2026. After this effective date, it will be prohibited to import any Food Contact Materials into the European Union without a valid, accompanying written declaration proving compliance with the BPA ban.

While laboratory testing remains at our discretion under Recital 12 because BPA is not intentionally added, Midas Safety operates with a higher standard of quality assurance. We have proactively conducted analytical migration testing in accredited independent laboratories on our food contact gloves.

Mandatory Declaration of Compliance (DoC) Requirements (Article 8 & Recital 14)

Per Article 8 and Guidance Note C/2025/6721, a DoC is mandatory even if no BPA or bisphenols are used in manufacturing. Under Recital 14, this document must accompany the FCM at all marketing stages except retail. It must explicitly list all bisphenols used, providing an absolute commercial advantage to Midas Safety’s 100% clean formulation. Supporting documentation must be kept on hand and made available to competent authorities immediately upon demand.

As laid down in Annex III of the regulation, our Declaration of Compliance (DoC) contains all mandatory technical information:

• Issuer Details
• Manufacturer/Importer Details
• Product Identification
• Date: The exact date of issuance.
• Substance Declaration: A clear list of any bisphenols or derivatives used during manufacturing.
• Compliance Statement: A formal statement confirming the final article complies with this regulation

 

6. Conclusion & Next Steps

Starting July 20, 2026, a formal DoC is legally required for all FCMs entering Europe. Upon request, we will provide the specific DoC for your product, giving your compliance team the verified data needed to confidently issue your own downward declarations to European end-users. Please feel free to reach out if your quality teams require further information, laboratory threshold reports, or additional material specifications.