FPE Guideline on Use of Isocyanate-based Polyurethane Adhesives in Packaging Laminates - Issue 2.7

Aug 22, 2026

Guideline explains why packaging laminates bonded with isocyanate-based polyurethane adhesives require a curing time before food contact to maintain safety and product quality. It covers the chemistry and migration behavior of isocyanates and primary aromatic amines, noting disappearance after complete curing under controlled conditions. The document summarizes relevant EU and US legislative requirements, including migration limits and regulatory handling considerations, and provides practical user guidance focused on consumer safety aspects.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages4

Reading Time10 min

AccessFree to download

1.0 Introduction and Scope

2.1 Regulatory status: Europe

2.2 Regulatory status: United States of America

3.0 Chemistry

3.1 Curing Process

FPE Guideline on Use of Isocyanate-based Polyurethane Adhesives in Packaging Laminates (Issue 2.7) 1.0 Introduction and Scope Flexible packaging materials used for foodstuffs frequently consist of multi-layer structures. Such materials may utilise isocyanate-based polyurethane adhesives to bond together different functional layers to give a high performance specification. These isocyanate-based adhesives use either aromatic (e.g. MDI, TDI) or aliphatic (e.g. IPDI, HDI) systems. It has to be underlined that only the aromatic isocyanates lead to the potential formation of primary aromatic amines which are of potential toxicological concern. The levels of isocyanates and primary aromatic amines are time dependent. They will be present in newly applied adhesive but will disappear when the adhesive is fully cured under controlled conditions. This is a fundamental aspect of their chemistry which is in contrast to other migrants of packaging which – once present in the packaging material – generally remain a potential source of migration. The aim of this document is to provide FPE members and their customers with information on why laminates made with isocyanate-based polyurethane adhesives require a curing time prior to food contact, thus maintaining the safety and quality of the packaged food. It provides an overview of the relevant EU and US legislation, an outline of the basic chemistry and use of isocyanate-based adhesives, and it provides simple guidance that all users of such materials should follow. Note that this document only deals with consumer safety aspects. It does not address any issues relating to the handling and use of such adhesives and safety in the workplace. 2.0 Legislative background 2.1 Regulatory status: Europe Commission Regulation (EU) No. 10/2011, as subsequently amended 1, states in Annex II 2:“Primary aromatic amines which are not listed in Table 1 of Annex I shall not migrate or shall not otherwise be released from plastic materials and articles into food or food simulant in accordance with Article 11(4). The detection limit referred to in the second subparagraph of Article 11(4) applies to the sum ofprimary aromatic amines released.”. 1 A consolidated version of the Plastics Regulation 10/2011, including all amendments to September 2016, is available at: [http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02011R0010-](http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02011R0010-)[ ](http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02011R0010-)[20160914&from=EN](20160914&from=EN) The text in the second subparagraph of Article 11(4) reads “…unless specific detection limits have been set for particular substances or groups of substances, a detection limit of 0,01 mg/kg shall apply.” Isocyanates are listed in Annex I of the Regulation and are subject both to a specific QM of 1 mg/kg and a group SML(T) of non-detectable. 2.2 Regulatory status: United States of America The US Food and Drug Administration (FDA) has specified within the Code of Federal Regulation (CFR)2 the circumstances under which adhesives may be safely used in food packaging materials and the substances that may be used3 : 2.2.1 The adhesive is either separated from the food by a functional barrier, which serves as a non-permeable obstacle to migration or used subject to the following additional limitations: 2.2.1.1 For dry foods, the quantity of adhesive that contacts packaged dry foodshall not exceed the limits of good manufacturing practice (GMP) . 2.2.1.2 For aqueous and fatty foods, where the risk of migration is greatest, FDA has specified that contacts shall not exceed trace amount at the seams and at the edge exposure between packaging laminates that may occur within the limits of GMP. 2.2.2 Packaging seams or laminates must remain firmly bonded without visible separation under normal conditions of use. FDA has also specified, within the CFR, requirements

FAQs

为什么使用基于异氰酸酯的聚氨酯胶黏剂的复合包装膜需要预固化时间？

因为胶黏剂中的异氰酸酯及可能形成的初级芳香族胺在新涂覆后会存在，并需在受控条件下完成固化后随时间消失，从而降低迁移风险。固化完成后，层合复合材料即可用于与食品接触。

哪些化学体系可能带来更高的毒理学关注？

仅芳香族异氰酸酯体系可能导致初级芳香族胺的形成，从而具有潜在毒理学关注。

欧盟与美国对异氰酸酯/芳香族胺迁移有哪些监管要点？

欧盟法规对初级芳香族胺迁移释放设置条件与检测限，并规定异氰酸酯在附录中受特定限值约束；美国FDA在法规中明确胶黏剂在食品包装材料中的安全使用条件，包括功能性屏障要求以及在特定食品类型下的接触限制与迁移控制要求。

Aug 22, 2026

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