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Formamide in Diapers: Understanding the EU Classification and Your Supply Chain Responsibility
Industry News

Formamide in Diapers: Understanding the EU Classification and Your Supply Chain Responsibility

2026-08-04

Recent news about the detection of formamide in diapers has sparked widespread public concern and created considerable confusion in the market. For trading companies exporting products to the European Union, clarifying the classification of this substance under EU regulations, its potential sources within products, and the corresponding supply chain responsibilities is essential for mitigating risks and maintaining market trust.

                                                                                                                         

1. EU Classification of Formamide: Why It Draws So Much Attention

    Formamide is classified as a "Category 1B Reproductive Toxicant" under EU regulations and is included on the REACH Substance of Very High Concern (SVHC) list. This classification indicates that, based on sufficient animal data, the substance is presumed to have the potential to impair human reproductive capacity or fetal development. Consequently, the EU imposes strict limits on its content in consumer products, particularly for items intended for prolonged contact with children, such as foam toys. Meanwhile, it has also been included in China's Safety Technical Specification for Cosmetics as a prohibited ingredient, demonstrating that its risks are already recognized by domestic regulatory authorities.

Baby Diaper of Customization Manufacturer - High Absorption Leak-proof Baby Diapers (2).jpg

⭐2. Sources of Formamide in Diapers and the Testing Gap

Sources: Formamide is not a deliberately added ingredient in diaper production, but rather a by-product or residue from certain manufacturing processes. Its potential primary sources include:

  1. Foam materials: To enhance the softness and loftiness of the waistband, leg cuffs, and other parts, some foam materials (such as elastic rubber strands) may decompose during high-temperature processing, releasing formamide from blowing agents like azodicarbonamide.

  2. Adhesives: Adhesives used to bond multi-layer materials, if formulated with low-cost solvents containing formamide, may also leave residues.

Testing Gap: China's current national standard for Baby Diapers (GB/T 28004.1-2021) has not yet included formamide as a mandatory test item, nor has it established a safe limit value. This means that even if a product complies with the national standard, the risk of containing formamide cannot be entirely ruled out, posing a compliance challenge for export to the more strictly regulated EU market.

Ultra Soft High Absorption Disposable Baby Diapers.jpg

3. Supply Chain Responsibility and Recommended Actions

For hygiene product manufacturers planning to export to the EU, the formamide risk should be incorporated into supply chain management considerations:

  1. Establish Source Control: Include formamide in the raw material risk monitoring list and impose clear formamide limit requirements on high-risk materials such as elastic components and adhesives during procurement, while requesting test reports.

  2. Implement Finished Product Testing: Although not currently required by national standards, proactively commissioning third-party laboratories (such as Intertek or SGS) to test for formamide content in finished products using methods aligned with EU REACH or the Toy Safety Directive (EN 71-15) can provide evidence of compliance.

  3. Monitor Regulatory Trends: In April 2025, the European Committee for Standardization approved a new standard, EN 17826:2025, concerning the chemical hazards of childcare articles. This standard explicitly includes formamide within its scope of control. Although its precise applicability is pending official publication, it clearly signals the EU's intention to impose more comprehensive chemical safety requirements on such products.

In the context of increasing global vigilance regarding consumer product safety, proactively identifying and addressing potential risks that fall within "regulatory gaps" is not merely a strategy to avoid trade disputes, but a fundamental step toward building brand reputation and long-term competitive advantage.

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