FDA Food Contact Rules for Plastic Additives (21 CFR): 5 Clearance Routes and 10 Additive Sections

FDA food contact rules regulate a plastic additive as a food contact substance, not as part of the plastic, and a US-bound additive reaches lawful use through 1 of 5 clearance routes. Ten sections of 21 CFR part 178 carry the numeric limits for the main additive families used in food-contact plastics, so which section applies to which additive family a compounder is buying this year?

An FDA limit takes the shape of a maximum weight percent of a named polymer, restricted to listed food types and permitted conditions of use, and sometimes to a thickness or a container-volume restriction as well. Under the general rule of 21 CFR 174.5, no food contact substance is used in an amount greater than is reasonably required to produce its intended technical effect, and it must be of a purity suitable for that use under current good manufacturing practice.

This page works through the 5 clearance routes, the section map of 21 CFR part 178, how a limitation is read part by part, family-by-family limits with trade names next to their CFR chemical names, the 6 steps a compounder documents, the FDA actions open in 2026, and the structural difference between the US positive list and the EU Union list of Regulation (EU) No 10/2011. It is a technical reference for formulators and compliance staff, not legal advice.

US regulatory status verified: 22 September 2026.

Table T1. The 5 clearance routes at a glance. Routes 1, 4 and 5 are generic. Routes 2 and 3 belong to a named company, which is why a competitor's FCN cannot be cited for your own material.

How Does the FDA Regulate Plastic Additives?#

The FDA regulates a plastic additive as a food contact substance: any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting or holding food, where the use is not intended to have a technical effect in the food itself (21 CFR 170.3(e)(3)). The substance is therefore assessed by what it does to the packaging, not by what it does to the meal, and that distinction is what routes it into Title 21 rather than into the food-additive rules for ingredients.

Plastic additives, such as antioxidants, plasticizers, colorants, slip agents and blowing agents, are the largest practical group of food contact substances, and the complete 43-family inventory is described function by function on the plastic additives reference page, each entry carrying its own path back to the CFR section that applies to it.

That breadth is why a single federal definition is not the whole picture: 3 US agencies split responsibility for a food-contact plastic, each covering a different layer of the same compound. The FDA covers the food-contact layer, the additive as it sits in the packaging and what migrates from it; the substance itself, independent of its food-contact use, is separately assessed by the EPA under TSCA and plastic additives; and the CPSC applies the CPSIA to any article intended for children regardless of its food-contact status.

Food contact substance, indirect food additive and adjuvant: the 3 FDA terms#

Three FDA terms describe the same additive: food contact substance is the statutory term, indirect food additive is the older term for a substance that migrates from packaging, and adjuvant is the CFR heading under which part 178 lists antioxidants, colorants, plasticizers and release agents. The three are not formally interchangeable in law, but the CFR uses all three, and part 178 is the operative one for the additive families this page covers.

• Food contact substance is the current statutory term (21 CFR 170.3(e)(3)), defined by the absence of a technical effect in the food.
• Indirect food additive is the older US term for a food additive that migrates from packaging or equipment and is regulated in 21 CFR parts 174 to 178.
• Adjuvant is the CFR word for the production-aid substances in part 178, headed "Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers", which is where plastic additives sit.

Purity and use-level rules apply uniformly across all three labels. 21 CFR 174.5 requires that the quantity used stay within what is reasonably required for the technical effect and that the substance be of a purity suitable for its intended use, whichever of the three terms is applied to it.

Is there such a thing as an FDA approved plastic additive?#

No plastic additive is FDA approved: the FDA issues no approval certificate for a food contact substance, and the phrases "FDA approved" and "food grade" have no legal definition. Both phrases are marketing shorthand, and the FDA itself has stated that it does not use them for food-contact materials.

The correct wording depends on the clearance route, and 2 forms are quotable in a supplier email: "complies with 21 CFR 178.2010 for olefin polymers, conditions of use B to H" or "the subject of effective FCN No. 2211." An FCN-based statement always names the notifier, because an FCN is effective only for the manufacturer or supplier identified in it, not for every producer of the same chemical. Food-contact clearance is therefore one of 5 layers of plastic additive regulations a US-bound compound has to satisfy, alongside TSCA, CPSIA, state rules such as California Proposition 65 and, for export, the destination market's own positive list.

The 5 Routes to Lawful Use of a Plastic Additive in Food Contact#

A plastic additive may be used in food-contact plastic through 5 routes: a food additive regulation in 21 CFR parts 175 to 178, an effective Food Contact Notification, a Threshold of Regulation exemption, a prior sanction, or GRAS status. 21 CFR 174.5(d) enumerates the first, second, fourth and fifth of these; the Threshold of Regulation exemption under 170.39 completes the set.

1. A food additive regulation in 21 CFR parts 175 to 178#

A food additive regulation is the generic route: the additive is named in 21 CFR parts 175 to 178 with a limitation, and any company may rely on it without holding a notification of its own. Part 177 lists the permitted resins while part 178 lists the adjuvants, so the resin and its additive package are cleared under two different parts of the same subchapter, each with its own composition and purity rule.

This is the route that carries the most volume for established additive families: antioxidants, heat stabilizers, plasticizers, colorants and slip agents are almost all cleared this way, because their regulations predate the FCN programme. The practical test is straightforward: find the CFR section, read the limitation, and confirm the polymer, food type and condition of use match. The plastic additives database indexes each family to its section for exactly this check.

2. An effective Food Contact Notification (FCN)#

A Food Contact Notification is a premarket notification under section 409(h) of the Federal Food, Drug, and Cosmetic Act that becomes effective for the notifier alone, not for every producer of the same chemical. The programme was created by the FDA Modernization Act of 1997, and its procedural rules were most recently amended by the revocation-procedures final rule published 22 March 2024 (89 FR 20306), effective 21 May 2024, which updated 21 CFR 170.102 and 170.105.

Most nucleating and clarifying agents cleared since the early 2020s have travelled this route rather than being added to part 178 by rulemaking. How an FCN is filed, how long it takes and how to read the inventory is covered separately on FDA Food Contact Notifications (FCN). A buyer who wants to rely on someone else's FCN cannot do so; the notification is proprietary to the company named in it, so a second supplier of the identical chemical must file its own.

3. A Threshold of Regulation exemption (21 CFR 170.39)#

A Threshold of Regulation exemption covers a substance whose migration gives a dietary concentration of 0.5 parts per billion or less, about 1.5 micrograms per person per day, calculated on a 1,500 g solid plus 1,500 g liquid daily diet (21 CFR 170.39). An alternative criterion applies where the resulting dietary exposure sits at or below 1 % of the acceptable daily intake of a substance already regulated for direct addition to food.

Neither criterion is available to every substance. The exemption is excluded outright for a known carcinogen or for a substance carrying a carcinogenic impurity with a TD50 below 6.25 mg/kg body weight per day. The document that proves this route is the TOR exemption letter itself, together with the exposure calculation that supported it; the FCN page above also covers the TOR mechanism, so it is not linked a second time here.

4. A prior sanction (21 CFR part 181)#

A prior sanction is a clearance the FDA or the USDA granted before 6 September 1958, and it still carries 3 additive groups relevant to plastics: antioxidants in 21 CFR 181.24, plasticizers in 181.27 and stabilizers in 181.29. These sanctions predate the modern food additive definition and survive as a separate legal category rather than being folded into part 178.

21 CFR 181.24 names 9 prior-sanctioned antioxidants, including BHT, BHA, DLTDP, DSTDP, gum guaiac, NDGA, propyl gallate, thiodipropionic acid and 2,4,5-trihydroxybutyrophenone, with a 0.005 % limit of addition to food. 21 CFR 181.29 covers prior-sanctioned stabilizers, with stannous stearate (calculated as tin) and zinc orthophosphate or zinc resinate (calculated as zinc) held to a 50 ppm migrant level; 181.27 names the prior-sanctioned plasticizers by section but its full substance list sits outside this page's scope.

5. GRAS status#

GRAS status removes a substance from the definition of a food additive, so a substance generally recognised as safe for its use in food needs no separate food-contact clearance under parts 174 to 178. The exclusion comes directly from the statute, FFDCA 201(s), which defines "food additive" in a way that GRAS substances do not meet.

This route covers relatively few dedicated plastic additives, because most GRAS determinations were built for direct food ingredients rather than for packaging adjuvants. Where it does apply, the document that proves the route is the published GRAS notice, or, for a self-affirmed determination, the underlying safety dossier the supplier holds on file.

Which 21 CFR Section Covers Which Additive Family?#

Ten sections of 21 CFR part 178 carry the numeric limits for the main plastic additive families, from antioxidants in 178.2010 to release agents in 178.3860, and 3 sections of part 181 hold the prior-sanctioned antioxidants, plasticizers and stabilizers. Fluoropolymer processing aids are the one prominent exception: they are cleared inside the resin section 21 CFR 177.1520 rather than in part 178, because they function as extrusion aids for the resin itself.

Table T2. 15 rows: the 10 part-178 sections that carry limits for the main additive families, plus 3 part-181 prior-sanction sections and the 2 routes (FCN, resin section) that sit outside part 178. The count of 10 refers to these main-family sections and is not a claim that part 178 contains no other entries.

Each additive named in the table carries its own FDA row in the plastic additives database, which links the trade name to the CFR chemical name and the exact limitation text.

How an FDA Additive Limit Is Written: Polymer, Food Type, Condition of Use and Thickness#

An FDA additive limitation has 5 parts: the maximum weight percent, the named polymer, the permitted food types, the permitted conditions of use, and any thickness, density or container-volume restriction. All 5 parts have to be checked together; a limit that is correct for the wt% but wrong for the polymer or the condition of use is not a compliant use.

Ultranox 626 illustrates all 5 parts at once: cleared at 0.10 wt% of olefin polymers, conditions B through H, with polyethylene above 50 % ethylene needing a density of 0.94 g/cm3 or more. Cuprous iodide shows the thickness variable: 0.01 wt% in nylon 66T at a thickness of 0.001 inch or less, so the same substance at a thicker gauge falls outside the clearance. The limit is always a maximum weight percent of the finished polymer, never a migration limit and never converted to phr here; how much of that dosed level reaches the food is a separate question of additive migration.

Conditions of use A to H#

Conditions of use are 8 lettered service conditions, A to H, that run from heat sterilisation above 212 °F (100 °C) down to frozen storage with reheating in the container (H). They come from 21 CFR 176.170(c) Table 2 and describe the thermal and storage history the packaging will see, not the food itself.

Table T4. 8 conditions of use, exactly as set out in 21 CFR 176.170(c) Table 2. A limitation that reads "conditions of use B through H" excludes condition A, so the additive may not be used in a retort pouch.

Food types I to IX#

Food types are 9 numbered categories, I to IX, that describe what the plastic will hold, from nonacid aqueous products above pH 5.0 (type I) to dry solids with free fat or oil on the surface (type IX). They come from 21 CFR 176.170(c) Table 1 and are read together with the conditions of use to define exactly which foods a cleared additive may touch.

• Nonacid aqueous products, pH above 5.0 (type I)
• Acid aqueous products (type II)
• Aqueous acid or nonacid products containing free oil or fat (type III)
• Dairy products and modifications (type IV)
• Low-moisture fats and oils (type V)
• Beverages (type VI)
• Bakery products, other than types VIII and IX (type VII)
• Dry solids with no free fat or oil on the surface, no end test required (type VIII)
• Dry solids with free fat or oil on the surface (type IX)

Several of these 9 types carry lettered subdivisions in the CFR text itself, most notably beverages and dairy products, but this page names the 9 top-level categories only.

FDA Limits by Additive Family#

FDA limits for plastic additives are set family by family: stabilizers in 21 CFR 178.2010, plasticizers in 178.3740, colorants in 178.3297, clarifiers in 178.3295, surface additives in 178.3130 and 178.3860, and processing aids inside the resin sections of part 177. Each family below is read the same way: find the section, find the substance, and check the wt% against the polymer, food type and condition of use.

Antioxidants, heat stabilizers and UV stabilizers (21 CFR 178.2010)#

Antioxidants, heat stabilizers and UV stabilizers are cleared under 21 CFR 178.2010, which lists each substance with a maximum weight percent for each polymer: Irganox 1076 at 0.25 wt% of listed olefin polymers, Irgafos 168 at 0.25 wt% of propylene polymers and UV-234 at 3.0 wt% of polycarbonate. The section has 2 operative parts: paragraph (a) sets the general quantity rule and paragraph (b) carries the substance-by-substance list with its polymer-specific limitations.

A methyltin stabilizer used under this section must additionally meet the FDA's compositional definition: tin content of 15 to 21 % and mercapto sulfur content of 11 to 13.5 %. The full substance list, entry by entry, is on 21 CFR 178.2010, which extends the abridged table below with food types and thickness limits.

The FDA published a safety assessment of Irgafos 168 on 17 June 2023, setting an acceptable daily intake of 1 mg/kg body weight per day and a cumulative estimated daily intake of 0.09 mg/kg body weight per day for Irgafos 168 plus its phosphate degradation product. Which phenol and phosphite to pair, and at what level, is a formulation question covered separately on antioxidants for plastics, while the table below stays strictly to the FDA limitation values.

Table T3. Worked 21 CFR 178.2010 limits, 18 entries. Each entry is abridged. The full limitation, including food types, is in the eCFR text of 21 CFR 178.2010.

Plasticizers (21 CFR 178.3740 and 181.27)#

Plasticizers for food-contact plastics are cleared under 21 CFR 178.3740, which allows di(2-ethylhexyl) adipate at 24 to 35 wt% of PVC for nonfatty, nonalcoholic foods and diisononyl phthalate at up to 43 wt% of vinyl chloride polymers in limited food types. The full family, phthalate and non-phthalate, is described on plasticizers for plastics, which covers dosage and selection beyond the FDA limitation values given here.

DEHA is the adipate the section clears at 24 to 35 wt%, and DINP is one of 8 phthalate plasticizers that remain authorised after the FDA's final rule of 20 May 2022 (87 FR 31080 to 31089). That rule removed 25 authorisations, 23 ortho-phthalates plus 2 other substances, on abandonment grounds following a petition from the Flexible Vinyl Alliance. The 8 survivors are DINP, DIDP, DEHP, DCHP, BPBG, DEP, EPEG and DIOP, alongside diallyl phthalate, which is authorised as a monomer rather than as a plasticizer.

How the US position on these substances compares with the EU and Canada is set out on phthalate restrictions worldwide. 21 CFR 181.27 names the prior-sanctioned plasticizers by section only; its substance list is outside our source library, so this page states the section number and stops there.

Colorants, pigments and optical brighteners (21 CFR 178.3297)#

Colorants are cleared under 21 CFR 178.3297 on one overriding condition: the colorant must not migrate to food in amounts that contribute any colour apparent to the naked eye. Colorants already listed for food use in 21 CFR parts 73, 74, 81 and 82 may also be used in food-contact plastics under that separate listing.

The section's purity limits apply to the high-purity furnace black grades of carbon black, cleared up to 2.5 wt% of the polymer with total polycyclic aromatic hydrocarbons at or below 0.5 ppm and benzo[a]pyrene at or below 5 ppb. Several pigments carry their own caps within the same section: C.I. Pigment Red 254 at 1 wt%, chromium oxide green at 5 wt% of polymers and 10 wt% of rubber articles, manganese violet at 2 wt%, and zinc sulfide at 10 wt%. Optical brighteners sit far lower, OB-1 at 0.025 wt% and BBOT at 0.015 or 0.05 wt%, and filler minerals such as mica, barium sulfate, calcium carbonate and talc are listed here as colorants for polymers rather than as functional fillers.

Every listed pigment with its limit is tabulated on 21 CFR 178.3297: colorants for polymers. Pigment classes, dosage and dispersion practice are covered separately on colorants for plastics, which is the formulation-side companion to this section's regulatory table.

Nucleating and clarifying agents (21 CFR 178.3295 and FCNs)#

Nucleating and clarifying agents split between 2 routes: 8 clarifiers sit in 21 CFR 178.3295, while every nucleator cleared since the early 2020s has come through a Food Contact Notification held by one supplier. 178.3295 includes sodium di(p-tert-butylphenyl)phosphate at 0.35 phr and polyvinylcyclohexane at 0.1 wt% of the polyolefin.

The newer nucleators show how active this segment of the FCN inventory has been: calcium tert-butylphosphonate under FCN 2211 (Milliken, 2022) at 0.15 wt% in polyolefins, covering conditions A to H and J, including infant formula and human milk; calcium bicyclo[2.2.1]heptane-2,3-dicarboxylate under FCN 2095 (2021) at 0.25 wt% in HDPE and PP, conditions A to H; disodium N-benzoyl-L-aspartate under FCN 2357 (ADEKA, 2024) at 0.3 wt% in PP; calcium 4-cyclohexene-1,2-dicarboxylate under FCN 2369 (GCH, 2024) at 0.2 wt% in PP; and surface-treated quintinite under FCN 2476 (Kisuma, 12 February 2026) at 2,000 ppm in polyolefins. The newer FCN-cleared grades are compared in detail on clarifying agents for plastics.

Older FCN entries remain effective alongside these: sodium saccharin under FCN 1148 at 0.1 wt% in PET and boron nitride under FCN 970 at 1 wt% as a polyhydroxyalkanoate nucleator. Nucleating agents for plastics are compared for dosage and haze performance across both the section 178.3295 clarifiers and the FCN-cleared grades.

Slip, antistatic, antifog and release agents (21 CFR 178.3130 and 178.3860)#

Slip and release agents are cleared under 21 CFR 178.3860, which names erucamide, oleyl palmitamide, stearyl erucamide and the saturated fatty acid amides, while antistatic and antifogging agents sit in 21 CFR 178.3130. Erucamide is the first substance named in 178.3860, and rice bran wax is cleared in the same section at 1.0 wt%, restricted to dry foods only; N,N-dioleoylethylenediamine is capped at 0.055 mg per square inch in PVC films rather than by weight percent.

21 CFR 178.3130 covers the antistatic and antifogging side: glycerol ricinoleate ester mixture at 1.5 wt% in plasticised PVC, N-acyl sarcosines at 0.15 wt% in polyolefin film for meat and produce at a thickness of 0.003 inch or less, and alpha-(carboxymethyl)-omega-(tetradecyloxy)polyoxyethylene at 0.2 wt% in polyolefin film at 0.001 inch or less. Bloom rate and coefficient of friction targets for these chemistries are covered on slip additives for plastic film.

A related mould-release clearance sits outside part 178 entirely: pentaerythritol tetrastearate is limited to 0.5 wt% of the finished polycarbonate resin under 21 CFR 177.1580, because it is treated as part of the resin's own composition rather than as an adjuvant. Surface-resistivity targets and the migrating antistatic chemistries are set out on antistatic agents for plastics.

Processing aids, blowing agents, impact modifiers and organotin stabilizers#

Fluoropolymer processing aids are the exception to the part 178 pattern: they are cleared inside the resin section 21 CFR 177.1520, at 0.2 wt% of the polymer for a VDF-HFP copolymer with 65 to 71 % fluorine. A VDF-HFP copolymer with 87 % VDF or more and a PVDF homopolymer are cleared at up to 1.0 wt%, and polyoxyethylene-grafted polydimethylsiloxane (CAS 68937-54-2) is available as a non-fluorinated alternative at 0.3 wt%. Fluoropolymer and PFAS-free grades are compared on polymer processing aids, and EVA processing aids take the identical 0.2 % VDF-HFP limit under the separate resin section 21 CFR 177.1350.

Blowing agents for foamed food-contact plastics are cleared under 21 CFR 178.3010: azodicarbonamide is capped at 5 wt% of finished foamed polyethylene, with n-pentane, isopentane and 1,1-difluoroethane cleared as polystyrene blowing agents and toluene and tetrachloroethylene cleared as adjuvants at 0.35 wt% and 0.3 wt% respectively. Azodicarbonamide is the only one of these 4 with its own substance-level entry in our source library.

Impact modifiers for vinyl chloride plastics are cleared under 21 CFR 178.3790, option 1, which caps acrylic units at 5 wt% or less and butadiene-styrene units at 15 wt% or less of the finished article. Decomposition temperatures and kicker systems for the foaming chemistries above are on blowing agents.

PVC heat stabilization runs on a separate organotin clearance: 21 CFR 178.2650 limits total organotin content to 3 phr in vinyl chloride plastics. Tin, calcium-zinc and the other stabilizer systems used across this family are compared on PVC heat stabilizers.

How Do You Document That an Additive Is FDA Compliant? 6 Steps#

Document FDA compliance in 6 steps: identify the additive by CAS number, find its clearance route, check the limitation against your polymer and food type, confirm the resin clearance, collect the supplier letter of guarantee, and keep the use-level calculation.

1. Identify the additive by its CAS number and its CFR chemical name, not by trade name alone.
2. Find the clearance route and record its citation: the CFR section, the FCN number, or the part 181 section.
3. Check the limitation against your polymer, your food type and your condition of use.
4. Confirm the resin itself is cleared under part 177 and meets its own extractables specification.
5. Collect the supplier letter of guarantee naming the route relied on and, for an FCN, naming the supplier it covers.
6. Keep the calculation showing the use level stays at or below the limit and is no more than reasonably required, as 21 CFR 174.5 requires.

Step 4 depends on resin composition data specific to each polymer family. Polypropylene under 21 CFR 177.1520 item 1.1a needs a density of 0.880 to 0.913 g/cm3, a melting point of 160 to 180 °C and n-hexane extractables at or below 6.4 % by reflux. Polyethylene under item 2.1 needs a density of 0.85 to 1.00 g/cm3 and n-hexane extractables at or below 5.5 % at 50 °C; the reflux method used for PP does not apply to PE. The n-hexane and simulant protocols behind these numbers sit on migration testing of plastics for food contact.

Table T5. Resin sections a food-contact compound must also satisfy, alongside its additive package. The PVC resin section numbers are not cited here; the additive limits that matter for PVC are given from 21 CFR 178.2650, 178.3740 and 178.3790 only.

Steps 1 to 3 can be run one substance at a time in the additive regulatory status checker. What the supplier's declaration of compliance must contain, field by field, is set out separately. A US letter of guarantee also normally covers California Proposition 65 and plastic additives. This page is a technical reference; it does not replace legal review of a specific formulation.

Find suppliers who can document 21 CFR compliance for any additive through the plastic additive supplier finder, which lists plastic additive manufacturers and suppliers that issue letters of guarantee against a named CFR section or FCN.

Which Plastic Additives Is the FDA Reviewing in 2026?#

The FDA has 6 open reviews that touch plastic additives in 2026: the phthalate grouping proposal of 27 May 2026, the BHT and azodicarbonamide requests for information, the bisphenol A petition, the fluorinated HDPE container review and the titanium dioxide assessment. None of these actions has yet removed a clearance; they are evaluations and information requests, not final rules.

Table T6. Open FDA actions on plastic additives, as of 22 September 2026.

The 27 May 2026 phthalate action proposes treating DEHP, DCHP, DIOP and DINP as a chemically or pharmacologically related group for cumulative dietary assessment; it is a proposal, not a ban, and the existing individual clearances stay in force while the docket is open. The PFAS change is narrower than it sounds: it determined that 35 specific FCNs for grease-proofing agents were no longer effective after their holders' market exit was announced in February 2024, while non-stick cookware coatings, sealing gaskets in food-processing equipment and manufacturing aids for other food-contact polymers, including fluoropolymer processing aids, remain authorised.

Where every PFAS rule bites a specific plastic additive is mapped in full on PFAS restrictions and plastic additives. Recycled feedstock carries its own FDA framework, built around a negligible dietary concentration of 0.5 ppb, under which tertiary recycling of PET and PEN needs no individual evaluation or opinion letter; the FDA guidance for recycled feedstock is covered separately by recycled plastics regulations. Each new docket referenced in this section is reported as it is published in plastic additives news.

FDA 21 CFR and EU 10/2011: Why the Two Positive Lists Read Differently#

Both systems are positive lists, but they limit different things: 21 CFR sets a maximum weight percent of the additive in a named polymer, while Regulation (EU) No 10/2011 sets a specific migration limit in milligrams per kilogram of food. A US entry answers "how much may be in the plastic"; an EU entry answers "how much may reach the food," and the two questions do not convert into each other on a fixed factor.

Table T7. FDA and EU 10/2011 compared, 8 features.

Regulation EU 10/2011's generic SML of 60 mg/kg and its overall migration limit of 10 mg/dm2 have no US counterpart; specific migration limits (SML) are simply not the FDA's unit of measure, a distinction worth holding onto when a supplier quotes an EU value against a US clearance. The same substance can be compliant in one jurisdiction and not the other for this reason: Tinuvin 770 is not on the EU Union list and is limited to adhesive uses under 21 CFR 178.2010, while Irgafos 168 and Chimassorb 119 are listed under both systems with different numeric controls. Degradation products and impurities fall outside both positive lists and are handled separately as NIAS.

This comparison is deliberately limited to the structural contrast between the 2 largest food-contact regimes. China, Japan, Korea, India and Mercosur each run their own positive lists, compared jurisdiction by jurisdiction on food contact rules for plastic additives worldwide.

Does FDA Clearance Mean a Plastic Additive Is Safe?#

FDA clearance means the expected dietary exposure from one specific, stated use was judged acceptable; it does not mean the substance carries no hazard classification of any kind. The FDA reopened its review of phthalates in 2026 and of BHT in 2026, decades after both groups were first cleared, which shows that clearance is a decision tied to a use, not a permanent verdict on the chemical.

The Irgafos 168 assessment that closed on 17 June 2023 illustrates how that judgement is made: it set an acceptable daily intake of 1 mg/kg body weight per day against a cumulative estimated daily intake of 0.09 mg/kg body weight per day for Irgafos 168 plus its phosphate. The Irganox 1076 assessment reported a chronic rat no-observed-adverse-effect level of 64 mg/kg body weight per day against a cumulative estimated daily intake of 4.5 mg per person per day. Which additives carry a genuine hazard classification, separate from their food-contact clearance status, is examined on toxic plastic additives.

Which plastics are FDA approved for food contact?#

No plastic is FDA approved for food contact: the FDA clears resins in 21 CFR part 177, and a polyethylene or polypropylene grade complies only if it meets the composition and extractables specification of 21 CFR 177.1520 and if every additive in it is separately cleared as well. The same pattern applies polymer by polymer: polycarbonate under 177.1580, PET under 177.1630, ABS under 177.1020 and POM under 177.2480 each carry their own composition and extractables specification.

Polycarbonate carries an added restriction: 21 CFR 177.1580(d) excludes it from infant feeding bottles and sippy cups. The package each host polymer needs, resin plus additives together, is covered polymer by polymer on additives by polymer.

What is FDA indirect food contact?#

FDA indirect food contact describes a substance that reaches food only by migrating from the packaging or the equipment, which is why every plastic additive is regulated as an indirect food additive in 21 CFR parts 174 to 178 rather than as an ingredient. The distinction is what keeps additive regulation inside Title 21's packaging chapters instead of the direct food-additive rules that apply to something added straight to the recipe.

How this FDA guide is kept current#

Every section, limit and date on this page was checked against the current eCFR text and the Federal Register on 22 September 2026, and the page is reviewed each January and June, plus after every Federal Register action in the FDA food-chemical dockets. Corrections are logged and independence is maintained under the site's editorial policy; how every fact was sourced and cross-checked is described in the methodology and fact-checking process linked from the byline below.

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Primary sources for this page: eCFR 21 CFR 170.3, 170.39, 174.5, 176.170, 177.1020, 177.1350, 177.1520, 177.1580, 177.1630, 177.1660, 177.2480, 178.2010, 178.2650, 178.3010, 178.3130, 178.3295, 178.3297, 178.3740, 178.3770, 178.3790, 178.3860, 181.24, 181.27 and 181.29; the FDA Food Contact Notification inventory; the FDA "List of Select Chemicals in the Food Supply Under FDA Review"; Federal Register notices 87 FR 31066, 87 FR 31080, 87 FR 31090 and 89 FR 20306; and dockets FDA-2026-N-5776, FDA-2026-N-2526, FDA-2026-N-4126 and FDA-2022-F-1108.