Food-Contact Adhesives: FDA 21 CFR 175.105, EU Framework Rules and Migration Testing

A food-contact adhesive is regulated through its components and its position in the package: 21 CFR 175.105 lists permitted components and conditions of use in the US, while EU law has no measure for adhesives as a whole. Every rule starts from the raw materials, so the adhesive chemicals of a packaging adhesive are checked one by one against a listing, a limit and a condition of use.

Four US sections govern adhesive layers directly: 21 CFR 175.105, 175.125 for pressure-sensitive adhesives (PSA) on food labels and tapes, and 177.1390 and 177.1395 for hot-use laminates. In the EU, Regulation (EU) 10/2011 covers plastic multilayers held together by adhesives, Regulation (EC) 1895/2005 limits bisphenol A diglycidyl ether (BADGE), Regulation (EU) 2024/3190 prohibits bisphenol A (BPA) in food-contact adhesives, and Regulation (EU) 2025/40 limits per- and polyfluoroalkyl substances (PFAS) in food-contact packaging.

The sections below sort the 175.105(c)(5) list by raw-material family and give the 175.125(a) caps (1.5, 0.05, 5 and 3.0 wt %), the 0.002 mg/kg limit per listed primary aromatic amine, the 9 mg/kg BADGE limit and every BPA date from 20 January 2025 to 20 January 2029.

Sources and checks: identities and hazard classifications are read at ECHA and the issuing regulator, standards at the body that publishes them, and grade values at the data sheet named next to them; methodology and fact-checking explains each step.

What Is a Food-Contact Adhesive?#

A food-contact adhesive is an adhesive used as a component of articles intended for packaging, transporting or holding food, and its status always depends on a jurisdiction, a listing and a condition of use. The wording comes from 21 CFR 175.105, which says adhesives "may be safely used as components of articles intended for use in packaging, transporting, or holding food" subject to the conditions of paragraphs (a)(1) and (a)(2).

FDA does not approve adhesives. A US adhesive complies with 175.105 when every component is listed in paragraph (c) and the finished package meets the conditions of use. An EU adhesive complies with the general rules of Regulation (EC) 1935/2004 and with the specific measures that name adhesives or the plastic layers next to them.

The table lists the nine instruments that reach food-contact adhesives, with their scope for adhesives and their date or status.

FDA 21 CFR 175.105: Adhesives in Food Packaging#

21 CFR 175.105 permits an adhesive in food packaging when it is made only from listed substances and is either behind a functional barrier or limited by food type, with "food-packaging adhesive" on its container label. The eCFR text of 21 CFR 175.105 (up to date as of 2026-10-30; current version dated 2026-10-01) carries its last substantive amendment of 20 May 2022; its substantive eCFR versions date from 22 November 2016 and 20 May 2022.

Scope and Conditions of Use Under 175.105(a)#

Paragraph (a)(1) requires the adhesive to be prepared from one or more substances named in paragraph (c), subject to any limitation that paragraph prescribes. A limitation can restrict the use rather than the amount: dibutyltin dilaurate is listed only as a catalyst for polyurethane resins, and 1,2-benzisothiazolin-3-one only as a preservative.

Paragraph (a)(2) adds the position condition. The adhesive is either separated from the food by a functional barrier or used within the dry-food and the fatty or aqueous food limits. The two routes are alternatives: behind a barrier no food-type limit applies; without one, the limit for the packaged food applies.

Functional Barrier, Dry Food and Fatty or Aqueous Food#

Three positions satisfy 175.105(a)(2): behind a functional barrier, in contact with dry food within good manufacturing practice (GMP), or as a trace at seams and edges for fatty and aqueous food. The eCFR wording of the three conditions is listed below.

• Functional barrier: the adhesive is separated from the food by a functional barrier.
• Dry food: "The quantity of adhesive that contacts packaged dry food shall not exceed the limits of good manufacturing practice."
• Fatty and aqueous food: the adhesive does not exceed "the trace amount at seams and at the edge exposure between packaging laminates" within GMP, and under normal conditions of use the seams or laminates "remain firmly bonded without visible separation".

"Functional barrier" is not defined in 175.105, and the section contains no temperature condition. GMP for parts 174 to 177 is defined in 21 CFR 174.5 as a quantity not more than reasonably required for the intended technical effect, with a purity suitable for the intended use. 21 CFR 170.3(e)(1) gives the logic of the barrier route: a packaging component that does not migrate to food does not become a component of food and is not a food additive.

Container Label Statement Under 175.105(b)#

Paragraph 175.105(b) requires the label of the finished adhesive container to bear the statement "food-packaging adhesive". The statement is a labeling duty of the adhesive maker, not a clearance; the barrier or food-type condition still has to hold in the finished package.

Five Routes to a Permitted Component Under 175.105(c)#

Paragraph 175.105(c) admits an adhesive component through any one of five routes, listed below in the order of the regulation.

1. Paragraph (c)(1): GRAS substances.
2. Paragraph (c)(2): prior-sanctioned substances.
3. Paragraph (c)(3): flavoring substances that volatilize during fabrication of the package.
4. Paragraph (c)(4): color additives approved for food.
5. Paragraph (c)(5): "Substances permitted for use in adhesives by other regulations in this subchapter and substances named in this subparagraph".

Each substance meets the specifications of its own regulation, so a rosin or a polymer admitted through (c)(5) keeps the identity and purity limits written for it.

Adhesive Raw Materials Named in 175.105(c)(5)#

A food-packaging adhesive is made only of components listed in paragraph (c), and the (c)(5) list names tackifiers, base polymers, curing agents, antioxidants, fillers, silanes, natural binders and solvents entry by entry. The table sorts a selection of (c)(5) entries by raw-material family and shows which common adhesive raw materials are absent from the 175.105 text.

Selection from the eCFR text of 21 CFR 175.105 (version 2026-10-01). Not named means absent from 175.105 only; other clearances may exist.

Absence from (c)(5) is absence from the 175.105 text only, as the antioxidant 168 and calcium carbonate rows show. The check is always the exact entry, its limitation and its specification, never the family name.

Numeric Limits and Removed Plasticizers in 175.105#

Five caps and use limits in 175.105(c)(5) bind formulators, listed below, and a 2022 notice removed 25 plasticizers.

• Total fluoride from ammonium bifluoride and ammonium silicofluoride: at most 1 wt % of the finished adhesive.
• Stabilizer CAS 32687-78-8, 1,2-bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)hydrazine: at most 2 wt % of the adhesive.
• Propylene glycol dibenzoate and polypropylene glycol dibenzoate: at most 20 % of the finished adhesive.
• Ethylene-vinyl acetate-carbon monoxide terpolymer (CAS 26337-35-9): at most 15 wt % carbon monoxide units.
• 1,2-Benzisothiazolin-3-one (CAS 2634-33-5): preservative use only.

Federal Register notice 87 FR 31080 of 20 May 2022 removed 25 plasticizers (23 ortho-phthalates and 2 others) as abandoned uses, among them dibutyl, diisobutyl and butyl benzyl phthalate. Di(2-ethylhexyl) phthalate, dicyclohexyl phthalate and diisodecyl phthalate remain named in 175.105, so a compliance letter for a plasticized adhesive is dated after that notice.

FDA 21 CFR 175.125: Pressure-Sensitive Adhesives on Labels and Tapes#

21 CFR 175.125 covers pressure-sensitive adhesives that form the food-contact surface of labels and tapes applied to food, with list (a) for poultry, dry food and processed produce and list (b) for raw fruit and vegetables. The chemistry of pressure-sensitive adhesives stays the same; what changes is that the PSA layer itself touches the food, so the section lists PSA components directly.

The section was last amended by 64 FR 48291 on 3 September 1999. It is not the default clearance for every label PSA: a PSA that does not form the food-contact surface is assessed under 175.105.

175.125(a): Poultry, Dry Food and Processed Produce#

Paragraph 175.125(a) admits PSA components for labels and tapes on poultry, dry food and processed, frozen, dried or partially dehydrated fruit and vegetables. Besides GRAS, prior-sanctioned and 21 CFR 172.615 substances and color additives, it names further components; the four capped ones are listed below.

• Antioxidant CAS 991-84-4: at most 1.5 wt % of the finished PSA.
• Optical brightener CAS 7128-64-5: at most 0.05 wt %.
• Photoinitiator CAS 106797-53-9: at most 5 wt % of the PSA.
• Surfactant CAS 144093-88-9: at most 3.0 wt %.

175.125(b): The Closed List for Raw Fruit and Vegetables#

Paragraph 175.125(b) covers labels and tapes applied to raw fruit and raw vegetables and allows only the substances of its closed (b)(2) list, grouped below.

• Polymers: butadiene-acrylonitrile and butadiene-acrylonitrile-styrene copolymers, butadiene-styrene copolymer, butyl rubber, chlorinated natural rubber, isobutylene-styrene copolymer, cis-1,4-polyisoprene, natural rubber, polyisobutylene, polystyrene.
• Tackifiers: rosins and rosin derivatives complying with 21 CFR 178.3870, terpene resins.
• Softening components: petrolatum, polybutene-1, hydrogenated polybutene.
• Stabilizers: butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), propyl gallate, tetrasodium EDTA.

The list names no petroleum hydrocarbon, C9, dicyclopentadiene or coumarone-indene resin and no styrene-isoprene-styrene or styrene-butadiene-styrene block copolymer. A hydrocarbon-tackified block copolymer PSA therefore cannot rely on 175.125(b). Paragraph (c) adds that acrylonitrile copolymers comply with 21 CFR 180.22.

Other FDA Sections That Reach Adhesive Layers#

Beyond 175.105 and 175.125, eight FDA sections reach adhesive layers: laminates (177.1390, 177.1395), resinous and polymeric coatings (175.300), paper and paperboard (176.170, 176.180), rosins (178.3870), polymer antioxidants (178.2010) and styrene block polymers (177.1810). Laminates for use at 121 °C (250 °F) and above fall under 177.1390, laminates for 49 to 121 °C (120 to 250 °F) under 177.1395, and 178.3870(e) excludes rosins used under 175.105 in food-packaging adhesives. The table gives the scope of each section and the values that reach the adhesive.

EU Framework Rules for Food-Contact Adhesives#

EU food-contact law has no harmonized measure for adhesives as a whole: adhesives are group 2 of Annex I of Regulation (EC) 1935/2004, and two specific measures, Regulations (EC) 1895/2005 and (EU) 2024/3190, name adhesives in their scope. Plastic layers bonded by adhesives also fall under Regulation (EU) 10/2011, so a laminating adhesive meets EU rules through the framework, GMP, the plastics regulation and the bisphenol measures together.

Regulation (EC) 1935/2004 and the Missing Adhesives Measure#

Regulation (EC) 1935/2004 lists adhesives as group 2 of Annex I, the list of groups of materials and articles which may be covered by specific measures under Article 5. Article 3 applies to adhesives directly: materials are made under GMP so that, under normal or foreseeable use, they do not transfer constituents to food in quantities that could endanger human health, bring about an unacceptable change in its composition or deteriorate its organoleptic characteristics. The latest consolidated text of Regulation (EC) 1935/2004 is dated 27 March 2021.

EU specific measures exist for plastics, active and intelligent materials, ceramics and regenerated cellulose film, and none exists for adhesives as a whole. Where no specific measure exists, Article 6 leaves room for national provisions.

Good Manufacturing Practice Under Regulation (EC) 2023/2006#

Regulation (EC) 2023/2006 applies GMP to all Annex I groups, adhesives included, at all stages except the production of starting substances, and it applies from 1 August 2008. Article 5 requires a documented quality assurance system scaled to the size of the business, Article 6 a quality control system with corrective measures taken without delay, and Article 7 documentation of specifications, manufacturing formulae and records, available to authorities on request. The Annex has no adhesive section.

Laminating Adhesives in Plastic Multilayers Under Regulation (EU) 10/2011#

Regulation (EU) 10/2011 applies to plastic multilayer materials and articles held together by adhesives (Article 2(1)(b)), so the adhesive layer of a plastic laminate sits inside a plastics measure. Regulation (EU) 2025/351, adopted on 21 February 2025 and in force since 16 March 2025, clarifies that the compositional requirements do not apply to adhesive layers, while migration limits still apply to the plastic layers. Old-rule plastic materials first placed on the market before 16 September 2026 may be sold until stocks run out.

For laminating adhesives, the functional barrier defined in Article 3(15) carries the most weight. Process detail for laminating adhesives belongs to their application page; the rule here is Article 13(3), under which non-listed substances behind a barrier are not detectable at 0.01 mg/kg and are neither carcinogenic, mutagenic or toxic to reproduction nor in nanoform.

Non-intentionally added substances (NIAS), defined in Article 3(9), are assessed under Article 19, and the overall migration limit (OML) of the plastic layer is 10 mg/dm². Regulation 10/2011 has carried no generic specific migration limit (SML) since Regulation (EU) 2016/1416 deleted Article 11(2).

Primary Aromatic Amine Limit Under Regulation (EU) 10/2011#

Regulation (EU) 10/2011 requires that primary aromatic amines (PAA) listed in Appendix 8 of REACH Annex XVII entry 43 are not detectable in food or food simulant, at a detection limit of 0.002 mg/kg for each listed PAA. The sum of all other PAAs may not exceed 0.01 mg/kg. Both limits sit in Annex II point 2 as amended by Regulation (EU) 2020/1245 (consolidated text of 14 July 2026).

Aromatic polyurethane adhesives are tested for PAA because PAA migration from under-cured aromatic polyurethane laminating adhesive is the documented failure mode. Release of a laminate therefore rests on a migration test of the finished laminate, not on the adhesive's time to slit.

Bisphenols in Food-Contact Adhesives: Regulation (EU) 2024/3190 and 1895/2005#

Bisphenol A may not be used to manufacture food-contact adhesives in the EU since Regulation (EU) 2024/3190 entered into force on 20 January 2025, and Regulation (EC) 1895/2005 still limits bisphenol A diglycidyl ether in adhesives. The text of Regulation (EU) 2024/3190 names adhesives in its scope, and the older BADGE measure stays in force beside it.

BPA Prohibition and Transition Dates#

Regulation (EU) 2024/3190 brings adhesives into its scope (Article 1(2)(a)) and prohibits the use of BPA in their manufacture, with no Annex II derogation for adhesives. Regulation (EU) 2026/250 corrected the text and entered into force on 23 February 2026. The table gives the transition dates of the corrected text.

Food-contact materials made with another bisphenol derivative, such as a BADGE-based epoxy, contain no residual BPA, verified at a detection limit of 1 µg/kg (Article 9(2)(b)). The declaration of compliance (DoC) under Article 8 names the bisphenols used, and BADGE itself is not a hazardous bisphenol under 2024/3190.

BADGE, BFDGE and NOGE Limits Under Regulation (EC) 1895/2005#

Regulation (EC) 1895/2005 covers adhesives (Article 1(2)(c)) and, since 1 January 2006, limits migration of bisphenol A diglycidyl ether to 9 mg/kg as the sum of BADGE and its two hydrolysates. The identity and adhesive use of BADGE (CAS 1675-54-3, EC 216-823-5) sit on its substance page; the sum of its three chlorohydrins is limited to 1 mg/kg.

The regulation prohibits bisphenol F diglycidyl ether (BFDGE) and novolac glycidyl ethers (NOGE) in food-contact adhesives and requires a written declaration. It stays in force next to 2024/3190, which repeals only Regulation (EU) 2018/213.

Migration Testing for Adhesive Layers#

Migration testing of an adhesive layer measures what passes from the finished package into food or a simulant, against per-substance limits such as 0.002 mg/kg for each listed primary aromatic amine and 9 mg/kg for bisphenol A diglycidyl ether. The table collects the limits and simulants that reach adhesive layers in the EU and the US.

US extraction tests sit in the article sections, not in 175.105: 175.300 uses water, heptane and 8 % ethanol as simulants, and 177.1390 requires water extraction at 121 °C (250 °F) for 2 h without delamination. 175.105 sets no test of its own, because its control is the component list and the position of the adhesive in the package.

How Food-Contact Compliance of an Adhesive Is Documented#

Food-contact compliance of an adhesive is documented by its maker: in the US as a statement of listed components and conditions of use, and in the EU as information to the converter plus the declarations that specific measures require.

US: Component Statement and Conditions of Use#

A US adhesive maker documents 175.105 compliance through four duties, each tied to a paragraph of the section. The maker checks every component against paragraph (c) and its limitation, documents the barrier or food-type condition the formula is designed for, prints "food-packaging adhesive" on the container label and issues a component statement to the customer.

The component statement is the maker's own declaration against the listing text. A statement dated after 20 May 2022 reflects the removal of 25 plasticizers by 87 FR 31080, and a PSA that forms the food-contact surface of a label or tape is checked against 175.125.

EU: Declarations of Compliance and Food Contact Status Declarations#

Adhesives need no declaration of compliance under Regulation (EU) 10/2011, but its recital 30 requires the adhesive supplier to give the plastic-article maker adequate information on substances with migration limits. That information is the basis of the food contact status declaration. Article 16 of Regulation (EC) 1935/2004 requires a written declaration of compliance only where a specific measure requires one, and no EU specific measure covers adhesives as such.

A DoC is required where 2024/3190 applies (Article 8, naming the bisphenols used), and 1895/2005 requires a written declaration for BADGE, BFDGE and NOGE. The information an adhesive maker passes to the converter covers the five items below.

• GMP system under Regulation (EC) 2023/2006.
• Dual-use additives in the formula.
• Substances with a specific migration limit.
• PAA potential of aromatic polyurethane systems.
• Barrier assumptions behind the assessment.

Upcoming Dates: Bisphenol Transitions and the Packaging Regulation#

Four dated changes lie ahead: BPA repeat-use articles leave the EU market on 20 July 2027, listed single-use cases end on 20 January 2028, fruit labels turn compostable by 12 February 2028, and professional equipment follows on 20 January 2029. The Packaging and Packaging Waste Regulation (PPWR, Regulation (EU) 2025/40) has applied since 12 August 2026 and already limits PFAS in food-contact packaging to 25 ppb for any targeted PFAS, 250 ppb for their sum and 50 ppm for total PFAS (Article 5(5)). Label design, recyclability and the other duties for adhesives fall under the Packaging and Packaging Waste Regulation page. The table lists the four upcoming dates with their instrument.

Every date in the table comes from the instrument texts, Regulation (EU) 2024/3190 as corrected by 2026/250 and Article 9(1) of the PPWR, not from industry readings.

A migration test plan for a laminate or label can be scoped through the request below.

Each request is passed straight to independent companies of that trade, and no company pays AdhesiveAdditives.com to be named or to receive requests; the editorial policy explains how.

Food-Contact Adhesive Regulation in Packaging Practice#

In packaging practice, the same adhesive can meet 21 CFR 175.105 in a dry-food carton and fail 21 CFR 175.125(b) on a raw-fruit label, because each rule lists different components for a different position. Food contact is one part of adhesive regulation; the adhesive regulation overview adds REACH, VOC, labeling and formaldehyde rules.

The raw materials to check first are the ones a rule names conditionally: hydrocarbon resins and styrene block copolymers for raw-produce labels, and catalysts and preservatives that 175.105 allows for one use only.

Which Packaging Uses Fall Under Food-Contact Adhesive Rules?#

Food-contact adhesive rules reach cartons, flexible laminates, labels and tapes, the four packaging positions in which an adhesive meets food at a seam, an edge or a surface.

Each position has its own packaging adhesives and test plan; the packaging adhesives hub covers all of them, and three topics have pages of their own, listed below.

• Label adhesives: PSA labels, where 175.125 applies when the adhesive forms the food-contact surface.
• Hot melt adhesives: the chemistry whose food-packaging formulas are built from 175.105 components.
• Case and carton sealing adhesives: carton closures for dry food within GMP.

Is 175.105 Limited to Food Below a Set Temperature?#

No: 21 CFR 175.105 contains no temperature condition, and laminates used at 49 °C (120 °F) and above are governed by 21 CFR 177.1395 and 177.1390. The 120 °F figure seen on some compliance pages is the lower bound of 177.1395, not a condition of 175.105; 177.1390 starts at 121 °C (250 °F) and allows food contact up to 135 °C (275 °F).

Which Adhesive Raw Materials Lack an FDA Listing?#

Common adhesive raw materials not named in 21 CFR 175.105 include N-methyl-2-pyrrolidone (NMP), dimethylformamide (DMF), cyanoacrylates, the photoinitiators TPO and benzophenone, and resorcinol. The silanes 3-glycidoxypropyltrimethoxysilane (GPTMS), 3-methacryloxypropyltrimethoxysilane (MPS) and vinyltrimethoxysilane (VTMO) are not named either; absence from 175.105 does not exclude another clearance. Methylene chloride is the reverse case: it is named in 175.105, but its US industrial and commercial use is prohibited after 28 April 2026 under 40 CFR 751 subpart B.