Plastic food packaging uses 12 additive functions, and every one of them has to pass two gates: in the EU the additive must be on the Union list of Regulation (EU) No 10/2011, and in the United States it must be cleared by a 21 CFR regulation or an effective Food Contact Notification. So which additives are actually on those lists, and at what level may a converter use them?
The 12 functions, in the order a converter meets them in a formulation, are antioxidants and processing stabilizers, acid scavengers, slip agents, antiblock additives, antistatic agents, antifog additives, polymer processing aids, nucleating and clarifying agents, colorants and masterbatch, plasticizers, oxygen scavengers and barrier additives, and the PET-specific acetaldehyde scavengers, reheat additives and chain extenders. None of these limits apply to a single additive in isolation: the overall migration limit (OML) of 10 mg/dm² of food contact surface, reduced to 60 mg/kg of food for infants and young children, caps everything that migrates out of the finished article, on top of whatever specific migration limit (SML) an individual additive carries (Regulation (EU) No 10/2011, Art. 12).
This page works through both legal gates in detail, gives the complete FCM-and-SML table for the additives converters actually use, shows how a migration limit is built from an individual SML, a group restriction and the overall migration limit, matches the correct food simulant to each food type, explains non-intentionally added substances (NIAS), sets out the additive package each food-packaging polymer needs, walks through a 7-step selection procedure, dates what changes for these additives between 2026 and 2029, and covers the extra constraints recycled food-contact packaging adds. The full class of plastic additives runs to 43 families, and food packaging uses 12 of them; the substance-level detail for every one sits in the directory linked from the master table below.
Table T1. The 12 food-packaging additive functions at a glance
| Function | What it does in food packaging | Typical level | Where it is mainly used |
|---|---|---|---|
| 1. Antioxidants and processing stabilizers | Stop melt degradation during extrusion and oxidative degradation on the shelf | 0.05-0.4 wt% (phenolic), 0.05-0.2 wt% (phosphite) | Polyolefin film, trays, closures |
| 2. Acid scavengers | Neutralise acidic catalyst residues left in polyolefin resin | Up to 1,000 ppm (calcium stearate) | Polypropylene packaging |
| 3. Slip agents | Lower film-to-film friction so bags open and run on the machine | 500-1,200 ppm (0.05-0.12 wt%) | PE and PP film |
| 4. Antiblock additives | Roughen the film surface so two layers do not weld together in the roll | 2,500-10,000 ppm | PE and PP film |
| 5. Antistatic agents | Drain the static charge that makes film cling and attract dust | 0.1-1 wt% | Film and rigid packaging |
| 6. Antifog additives | Spread condensed water into a clear sheet instead of droplets | PE 0.2-0.6 %, PP 0.5-2.0 % | Lidding film, produce bags |
| 7. Polymer processing aids | Remove melt fracture from blown and cast food film | 0.2-1.0 wt% (fluoropolymer grades) | Blown and cast PE/PP film |
| 8. Nucleating and clarifying agents | Speed crystallisation and cut haze | 0.2-1 wt% (sorbitol types); up to 0.30 wt% NA-11 | PP trays and deli containers |
| 9. Colorants, masterbatch and carbon black | Set colour, opacity and light protection | Up to 2.5 % w/w (carbon black) | All packaging polymers |
| 10. Plasticizers in food-contact PVC and gaskets | Soften PVC cling film and PVC jar-lid gaskets | SML 0.6 mg/kg (DEHP) | PVC cling film, metal jar lids |
| 11. Oxygen scavengers and barrier additives | Remove or slow the oxygen reaching the food | Max 5 % w/w (FCM 979 in PET) | PET bottles, multilayer film |
| 12. PET additives (acetaldehyde scavengers, reheat additives, chain extenders) | Cut off-taste, speed preform reheat, restore melt strength | ~5 ppm reheat additive; scavenger up to 650 mg/kg | PET bottles and preforms |
Which Additives Are Allowed in Food Packaging?#
Only additives that appear on the Union list in Annex I of Regulation (EU) No 10/2011 may be used in a plastic food-contact material sold in the EU, and only substances cleared under 21 CFR parts 174 to 178, by a Food Contact Notification or by a prior sanction may be used in the United States. Colorants sit outside the EU Union list, so a pigment for food packaging is judged on purity and metal-migration rules instead, although a colorant that is also an authorised additive still keeps its own FCM entry, such as carbon black at FCM 411 and titanium dioxide at FCM 610. An unlisted, non-CMR substance is tolerated only through the functional-barrier route, where it must not be detectable in the food at more than 0.01 mg/kg.
The Union list and 21 CFR are not the only instruments a food-packaging additive has to clear: REACH restrictions, the POPs Regulation and, from 2026, the Packaging and Packaging Waste Regulation all layer on top of the food-contact framework, and the other jurisdictions are compared under plastic additive regulations.
Table T2. The two legal frameworks compared
| Aspect | EU (Regulation (EU) No 10/2011) | US (21 CFR) |
|---|---|---|
| Legal instrument | Regulation (EU) No 10/2011 | 21 CFR parts 174-178 plus Food Contact Notifications |
| Positive list | Union list, Annex I Table 1, with FCM numbers | Adjuvant sections (178.2010 etc.) plus the FCN inventory |
| Who a clearance belongs to | Anyone, once the substance is listed | An FCN covers only the notifier named in it |
| Limit type | SML per substance plus OML of 10 mg/dm² | Per-polymer use limit expressed in wt% |
| Colorants | Outside the Union list; named substances keep an FCM entry | 21 CFR 178.3297 |
| Unlisted substances | Functional barrier: non-CMR, not detectable above 0.01 mg/kg | Threshold of Regulation: 0.5 ppb dietary concentration |
| Simulants | Annex III: A, B, C, D1, D2, E | Food types and conditions of use A through H |
The EU rule: the Union list of Regulation (EU) No 10/2011#
An Annex I row gives the additive its FCM number, its permitted uses and either a specific migration limit or a group restriction that it shares with chemically related additives. Each row also carries a Ref number and, where relevant, a use restriction naming the polymer or the food type the substance may contact. Where Annex I gives no specific SML, the generic SML of 60 mg/kg applies instead (Art. 11(2)), on top of the 10 mg/dm² overall migration limit that always applies to the finished article.
Irganox 1010 is FCM 496 with no specific SML, so the generic 60 mg/kg limit and the 10 mg/dm² overall migration limit apply; Irganox 1076 is FCM 433 with SML 6 mg/kg; BHT is FCM 315 with SML 3 mg/kg. Several families share a group restriction instead of an individual SML: group 32 plasticisers carry SML(T) 60 mg/kg, group 7 ethoxylated amine antistats 1.2 mg/kg, group 14 thioester antioxidants 5 mg/kg and group 12 benzotriazole UV absorbers 30 mg/kg. Values on this page are checked against the consolidated text of Regulation (EU) No 10/2011; confirm the current consolidation before relying on a single figure, and the article-by-article reading is on EU 10/2011, the plastic food contact materials regulation.
The US rule: 21 CFR indirect food additives and Food Contact Notifications#
In the United States an additive in food packaging is an indirect food additive, and its clearance sits either in a 21 CFR adjuvant section with a numerical use limit for a named polymer, or in an effective Food Contact Notification that covers only the company named in it. Five adjuvant sections carry most of the additives this page covers:
- 178.2010, antioxidants and stabilizers, with a per-polymer weight-percent limit for each substance
- 178.3130, antistatic and antifogging agents
- 178.3295, clarifying agents for polymers, listing 8 substances
- 178.3297, colorants for polymers
- 178.3860, release agents, which covers slip additives
Alongside these five sections, 21 CFR 181.24 prior-sanctions BHT and BHA as antioxidants at a 0.005 % limit of addition to food, and the FDA's Threshold of Regulation lets a substance clear at a dietary concentration of 0.5 ppb without a full food additive petition.
Irganox 1010 may be used at up to 0.5 % of all polymers (up to 1.0 % in pressure-sensitive adhesives, can-end cements and hydrocarbon resins) under 178.2010; Irganox 1076 is capped at 0.25 % in listed olefin polymers and in polystyrene and high-impact polystyrene; Irgafos 168 is capped at 0.2 % in polystyrene and high-impact polystyrene, conditions of use B through H. None of these is ever "FDA approved": a supplier grade complies with a named 21 CFR section for a named polymer and condition of use, or it is the subject of an effective Food Contact Notification, and every relevant section is listed under FDA food contact rules for plastic additives.
What "food grade" and "FDA approved" do and do not mean#
There is no legal term "food grade" for a plastic additive: an additive is either on the EU Union list with an FCM number, or covered by a 21 CFR section or an effective FCN, and a supplier statement that a grade is "FDA approved" is not a legal status. An FCN covers only the company named in it, so a second compounder using the identical substance needs its own clearance route, not the notifier's. LDPE, polypropylene and PET are polymers, not additives, and a polymer's own food-contact status, such as 21 CFR 177.1520 for olefin polymers, is separate from the status of every additive compounded into it. A "food-contact masterbatch" claim is therefore only as good as the status of the carrier resin and of every additive in it, which is why a masterbatch supplier's compliance statement has to name both.
The 12 Additive Functions in Plastic Food Packaging#
Plastic food packaging uses 12 additive functions: antioxidants, acid scavengers, slip agents, antiblock additives, antistatic agents, antifog additives, polymer processing aids, nucleating and clarifying agents, colorants and masterbatch, plasticizers, oxygen scavengers and barrier additives, and the PET-specific acetaldehyde scavengers, reheat additives and chain extenders. Every packaging structure carries only the subset its format actually needs, and the order below follows the sequence a converter meets them in: first the additives every food-contact compound carries, then the surface and processing additives of film and rigid packaging, then colour, then the format-specific active and barrier additives.
1. Antioxidants and processing stabilizers#
Antioxidants are in almost every food-packaging polyolefin: hindered phenols and phosphites at 0.05 to 0.4 wt% stop the melt degrading during extrusion and the film degrading on the shelf. The primary antioxidants (hindered phenols) scavenge free radicals and the secondary antioxidants (phosphites) decompose hydroperoxides, and packaging compounds typically pair one of each.
EU FCM numbers and SMLs include Irganox 1010 (FCM 496, no specific SML), Irganox 1076 (FCM 433, SML 6 mg/kg), Irgafos 168 (FCM 671, no specific SML) and BHT (FCM 315, SML 3 mg/kg); in the US, 21 CFR 178.2010 sets the per-polymer weight-percent ceiling for each of them. Irgafos 168 also carries an FDA cumulative estimated daily intake of 0.09 mg/kg body weight per day for the substance together with its oxidation product, the phosphate.
2. Acid scavengers#
Acid scavengers neutralise the acidic catalyst residues left in polyolefin resin, which would otherwise corrode the die and discolour a food film, and calcium stearate is used at up to 1,000 ppm in polypropylene. Hydrotalcite (CAS 12304-65-3) does the same job at a lower dosage and is preferred where a converter also wants a mild antistatic contribution.
The EU basis for metal stearates runs through stearic acid, which is FCM 106 under Article 6(3)(a) of Regulation (EU) No 10/2011, and the metal side of the stearate is capped by the Annex II metal limits: zinc 5 mg/kg, cobalt 0.05 mg/kg and copper 5 mg/kg. A converter switching acid-scavenger chemistry checks both halves of the molecule, the fatty acid and the metal, against these limits.
3. Slip agents#
Slip agents are fatty acid amides such as erucamide and oleamide that bloom to the film surface and cut its coefficient of friction, at 500 to 1,200 ppm in polyethylene food film. Most of the coefficient-of-friction drop happens in the first 24 to 48 hours as the amide blooms to the surface, and the final value, measured by ASTM D1894, is not reached until 7 to 10 days later.
Erucamide (FCM 271), oleamide (FCM 335), stearamide (FCM 306) and behenamide (FCM 458) carry no specific SML, while the C14 to C18 alkanamide mixture (FCM 1065) has an SML of 5 mg/kg and is restricted to polyolefins and to foods not assigned simulant D2. In the US, 21 CFR 178.3860 covers slip agents as release agents.
4. Antiblock additives#
Antiblock additives are mineral particles that roughen the film surface so two layers do not weld together in the roll, and diatomaceous earth or talc is used at 2,500 to 10,000 ppm. Precipitated silica works at under 0.5 wt%, while high-pore-volume silica needs only 1,000 to 1,500 ppm; calcium carbonate, the coarsest option, runs 2,500 to 20,000 ppm.
None of the EU entries for synthetic amorphous silica (FCM 504), diatomaceous earth (FCM 707), flux-calcined diatomaceous earth (FCM 734) or talc (FCM 615) carries a specific SML. Blocking is measured by ASTM D3354, and because silica also adsorbs slip and antistatic agents, it slows their migration to the surface, an interaction a formulator has to dose around rather than ignore.
5. Antistatic agents#
Antistatic agents are migrating surfactants, mostly glycerol monostearate and ethoxylated amines, that drain the static charge which makes film cling and attract dust, at 0.1 to 1 wt%. Glycerol monostearate (GMS, FCM 53) has a typical antistatic service life of 1 to 2 months before it needs replenishing from the bulk, while the bis(2-hydroxyethyl)alkylamines (FCM 19 and 20) fall under group restriction 7 at SML(T) 1.2 mg/kg expressed as the tertiary amine.
The oxidised bis(hydrogenated tallow alkyl) amines (FCM 768) are limited to 0.1 % in polyolefins and 0.25 % in PET and are not permitted for fatty foods. In the US, 21 CFR 178.3130 sets its own weight-percent ceilings per amine type and polymer; the US clearance for a given GMS grade is confirmed case by case against that section rather than assumed from the FCM entry alone.
6. Antifog additives#
Antifog additives are non-ionic surfactants that make condensed water spread into a clear sheet instead of droplets on a lidding film or a produce bag, at 0.2 to 0.6 % in polyethylene and 0.5 to 2.0 % in polypropylene. Polypropylene needs more antifog than polyethylene because its surface is less compatible with the surfactant, homopolymer PP needs more than random copolymer PP, and an antifog masterbatch is typically let down at 1 to 3 %.
Sorbitan monostearate (FCM 415) and sorbitan monooleate (FCM 416) carry no specific SML in the EU; in the US, 21 CFR 178.3130 also covers antifogging agents, and a glycerol ricinoleate ester mixture is capped at 1.5 wt% in plasticised PVC. Antifog is often built only into the thin sealant skin of a coextruded lidding film, and lamination can extract it, so extraction resistance is part of selecting the grade.
7. Polymer processing aids#
Polymer processing aids remove melt fracture from blown and cast food film, and the fluoropolymer grades that have done that job for decades are polymeric PFAS, which the EU packaging regulation starts to count from 12 August 2026. Under 21 CFR 177.1520, the fluoropolymer type with 65 to 71 % fluorine is limited to 0.2 wt% and the type with 87 % or more vinylidene fluoride to 1.0 wt%; the VDF-HFP copolymer type is limited to 0.2 % in olefin polymers.
Fluoropolymer PPAs are polymeric PFAS, and from 12 August 2026 the EU Packaging and Packaging Waste Regulation counts them toward its packaging-wide PFAS limits, which is why PFAS-free PPA chemistries are moving from a niche option to a mainstream specification for food film. The EU's universal PFAS restriction under REACH remains pending, so a converter reads "restriction pending", never "banned", into any PFAS news for this additive class.
8. Nucleating and clarifying agents#
Nucleating and clarifying agents give a polypropylene tray or deli container its clarity and shorten the moulding cycle, and sorbitol clarifiers work at 0.2 to 1 wt%. Sorbitol-type clarifiers such as DMDBS work in that same 0.2 to 1 wt% range but are capped by the FDA at 0.4 wt%, while the nonitol clarifier NA-11 (FCM 749, SML 5 mg/kg) is FDA-capped at 0.30 wt%.
Irgaclear XT 386 clarifies at a much lower 150 to 200 ppm. 21 CFR 178.3295 lists 8 substances cleared as clarifying agents for polymers, and a formulator selecting between them trades off clarity, cycle-time reduction and the FDA ceiling that applies to each.
9. Colorants, masterbatch and carbon black#
Colorants are the one additive class that the EU Union list does not cover, so a pigment for food packaging is judged on purity and metal-migration rules instead, with carbon black capped at 2.5 % w/w of the polymer. Carbon black is further limited to toluene extractables of no more than 0.1 % (ISO 6209) and benzo(a)pyrene of no more than 0.25 mg/kg of the carbon black itself, with primary particles between 10 and 300 nm.
In the US, 21 CFR 178.3297 accepts carbon black as channel-process or high-purity furnace black under the same total-PAH and benzo(a)pyrene ceilings, also capped at 2.5 wt% of the polymer; a conductive furnace black that falls outside that specification needs its own separate clearance. Titanium dioxide (FCM 610, plus surface-treated forms FCM 805, 873 and 1077), iron oxide (FCM 409), mica (FCM 597) and zinc sulphide (FCM 403) round out the pigments most used in food packaging, and the Annex II metal SMLs apply to a coloured article exactly as they apply to any other additive.
10. Plasticizers in food-contact PVC and gaskets#
Plasticizers reach food packaging in only two places, PVC cling film and the PVC gasket in a metal jar lid, and both are controlled by some of the lowest specific migration limits in Annex I. Since Regulation (EU) 2023/1442 entered into force on 1 August 2023, the SMLs are DEHP (FCM 283) 0.6 mg/kg, DBP (FCM 157) 0.12 mg/kg and BBP (FCM 159) 6 mg/kg, with DINP and DIDP under group restriction 26 at 1.8 mg/kg and group restriction 36 capping the sum of the four at 0.6 mg/kg DEHP-equivalents; DIBP is not authorised as a food-contact plasticizer.
DEHP and DBP may be used only in repeated-use articles for non-fatty food or as a technical support agent at very low residual levels. ESBO (FCM 532) carries an SML of 60 mg/kg, reduced to 30 mg/kg for the PVC gaskets that seal glass jars of infant formula, follow-on formula and baby food. REACH Annex XVII entry 51, which caps DEHP, DBP, BBP and DIBP at 0.1 % in articles generally, explicitly excludes food contact materials, because Regulation (EU) No 10/2011 already governs them with the lower SMLs above.
11. Oxygen scavengers and barrier additives#
Oxygen scavengers and barrier additives extend shelf life by removing or slowing the oxygen that reaches the food, and in PET they are built into the bottle wall rather than into a sachet. In PET bottles, the scavenger technology is an oxidisable polymer built into the bottle wall together with a cobalt catalyst; both are controlled tightly, since cobalt carries an Annex II SML of 0.05 mg/kg and cobalt neodecanoate is separately caught by FCM 819 at the same 0.05 mg/kg, expressed as neodecanoic acid, and is not permitted for fatty foods.
FCM 979, the PET / hydroxylated-polybutadiene / pyromellitic-anhydride copolymer scavenger, is limited to 5 % w/w and only in PET. The EFSA CEP Panel (2022) could not conclude on the safety of the PCOE-plus-cobalt-stearate scavenger system because of insufficient data on its oxidation products, which keeps that particular chemistry under review. Outside PET, nylon MXD6 works as a passive oxygen barrier at up to 5 wt% in clear or white three-layer bottles and 6 wt% in coloured ones without tie layers, and the European PET Bottle Platform (EPBP) accepts an oxygen scavenger in clear and light-blue bottles only if it stays thermally stable over 5 recycling loops and keeps non-PET content below 0.1 % (0.25 % in coloured bottles).
12. PET additives: acetaldehyde scavengers, reheat additives and chain extenders#
PET carries three additives that no other packaging polymer needs: an acetaldehyde scavenger so bottled water does not taste sweet, a reheat additive so the preform heats faster, and a chain extender when recycled PET has lost molecular weight. 2-Aminobenzamide, the scavenger with the longest track record, is FCM 164 with an SML of 0.05 mg/kg and is authorised only for use in PET for water and beverages; acetaldehyde itself becomes tasteable in water at 10 to 20 parts per billion, which is why even a small scavenger dose matters.
A newer oligomeric scavenger, assessed by the EFSA CEP Panel in 2025 for use up to 650 mg/kg in PET, measured migration into 20 % ethanol of only 0.0038 mg/kg. The reheat additive is typically titanium nitride nanoparticles (FCM 807, up to 20 mg/kg, no migration of the nanoparticles themselves) dosed at about 5 ppm in carbonated-soft-drink PET, or activated charcoal (FCM 713, up to 10 mg/kg) in other grades. Chain extenders restore the melt strength that recycled PET loses during reprocessing; the function is established, but the food-contact clearance route for a specific chain-extender chemistry is not, so this page states the function only and makes no clearance claim for it.
Complete List: Food-Packaging Additives with FCM Number, SML and 21 CFR Section#
The table below lists the additives that food-packaging converters actually use, with their function, their EU FCM number and specific migration limit, their US clearance and the typical level in the compound.
Table T3. Master list of food-packaging additives
| Function | Example substance | EU FCM No. | EU SML or restriction | US 21 CFR section and limit | Typical level |
|---|---|---|---|---|---|
| Food contact antioxidants | Irganox 1076 | 433 | SML 6 mg/kg | 178.2010, ≤0.25 % listed olefin polymers and PS/HIPS | 0.05-0.4 wt% |
| Antioxidants for plastics | BHT | 315 | SML 3 mg/kg | 181.24, 0.005 % limit of addition to food (prior sanction) | 0.05-0.4 wt% |
| Antioxidants | Irgafos 168 | 671 | no specific SML | 178.2010, ≤0.2 % PS/HIPS conditions B-H | 0.05-0.2 wt% |
| Antioxidants | Irganox 1010 | 496 | no specific SML | 178.2010, ≤0.5 % all polymers | 0.05-0.4 wt% |
| Acid scavengers | Calcium stearate | not listed (via FCM 106 stearic acid basis) | Annex II metal SMLs apply (Zn 5, Co 0.05 mg/kg) | no dedicated 21 CFR section | up to 1,000 ppm in PP |
| Slip additives for plastic film | Erucamide | 271 | no specific SML | 178.3860 release agents | 500-1,200 ppm |
| Antiblock additives | Diatomaceous earth | 707 | no specific SML | see hub | 2,500-10,000 ppm |
| Antistatic agents for plastics | Glycerol monostearate | 53 | no specific SML | 178.3130 | 0.1-1 wt% |
| Antistatic agents | Oxidised bis(hydrogenated tallow alkyl) amines | 768 | not listed (not for fatty foods) | 178.3130 | 0.1 % (PE), 0.25 % (PET) |
| Antifog additives | Sorbitan monostearate | 415 | no specific SML | 178.3130 | PE 0.2-0.6 %, PP 0.5-2.0 % |
| Antifog additives for food packaging film | Glycerol monostearate | 53 | no specific SML | 178.3130 | 1-3 % masterbatch let-down |
| Polymer processing aids | Fluoropolymer PPA (65-71 % F type) | not FCM-listed | not listed | 177.1520, ≤0.2 wt% | ≤0.2 wt% |
| PFAS-free processing aids | non-fluorinated PPA chemistries | not listed | not listed | see hub | see hub |
| Nucleating agents | NA-11 | 749 | SML 5 mg/kg | 178.2010, ≤0.30 wt% | ≤0.30 wt% |
| Clarifying agents | DMDBS | not listed | see hub | 178.3295, ≤0.4 wt% | 0.2-1 wt% |
| Clarifying agents | Irgaclear XT 386 | not listed | see hub | 178.3295 | 150-200 ppm |
| Colorants for plastics | Carbon black | 411 | max 2.5 % w/w; toluene extractables ≤0.1 %; BaP ≤0.25 mg/kg | 178.3297, max 2.5 wt% | see masterbatch let-down |
| Colorants | Titanium dioxide | 610 (plus 805, 873, 1077) | not listed (no specific SML) | 178.3297 | see masterbatch let-down |
| Plasticizers in food contact materials | DEHP | 283 | SML 0.6 mg/kg; repeated-use non-fatty only | no single-use plasticizer route | see hub |
| Plasticizers | ESBO | 532 | SML 60 mg/kg (30 mg/kg for infant-formula jar gaskets) | see hub | see hub |
| Oxygen scavengers for plastic packaging | Cobalt neodecanoate | 819 | SML 0.05 mg/kg (as neodecanoic acid); not for fatty foods | see hub | catalyst level, see hub |
| Barrier additives for plastic packaging | PA MXD6 monomer | 421 | group restriction 34, SML 0.05 mg/kg | see hub | up to 5-6 wt% in PET multilayer |
| IR absorbers and reheat additives | Titanium nitride | 807 | up to 20 mg/kg; no nanoparticle migration | see hub | ~5 ppm |
| PET additives | 2-Aminobenzamide | 164 | SML 0.05 mg/kg; only PET for water and beverages | clearance route unverified | see hub |
| Chain extenders for PET and rPET | Epoxy-functional styrene-acrylic oligomer | not listed | not listed | function only, no food-contact clearance stated | 0.1-0.5 wt% (PLA reference) |
FCM numbers and SMLs were checked against the consolidated text of Regulation (EU) No 10/2011; confirm the current consolidation before relying on a single value, and the full regulatory matrix of each one is in the plastic additives database.
How Food-Contact Limits Work: SML, OML and Migration Testing#
A food-contact limit works in three layers: the specific migration limit of the individual additive, the group restriction that chemically related additives share with each other, and the 10 mg/dm² overall migration limit of the whole article. Migration modelling is allowed for screening under Annex V Chapter 2.2.3 and Art. 18(3), but a screening failure must always be confirmed by verification testing before a supplier can act on it.
Repeated-use articles, such as a reusable PVC gasket, undergo three successive migration tests with fresh simulant each time; compliance is judged on the third test, and migration must not increase between the three, a criterion formalised in Regulation (EU) 2025/351. The individual SML, the group restriction and the overall migration limit interact rather than stack independently, which is why a food-packaging compound can pass its group restriction and still fail the overall migration limit if enough low-level migrants add up; the full SML table is on specific migration limits of plastic additives.
Which food simulant applies to which food?#
The simulant is chosen from the food, not from the packaging: a dry food is tested against simulant E, an acidic food below pH 4.5 against simulant B, and a fatty food against simulant D2, vegetable oil.
Table T5. Food simulants under Annex III
| Simulant | Composition | Food it stands for | Additive restriction that depends on it |
|---|---|---|---|
| A | Ethanol 10 % (v/v) | Aqueous foods | (none of the additives above is simulant-specific here) |
| B | Acetic acid 3 % (w/v) | Acidic foods below pH 4.5 | (none of the additives above is simulant-specific here) |
| C | Ethanol 20 % (v/v) | Alcoholic foods up to 20 % and more lipophilic foods | (none of the additives above is simulant-specific here) |
| D1 | Ethanol 50 % (v/v) | Alcoholic foods above 20 % and oil-in-water emulsions | (none of the additives above is simulant-specific here) |
| D2 | Vegetable oil | Foods with free fat at the surface | C14-C18 alkanamide slip mixture (FCM 1065) not permitted; oxidised tallow-amine antistat (FCM 768) not for fatty foods |
| E | Poly(2,6-diphenyl-p-phenylene oxide), 60-80 mesh, 200 nm pore size | Dry foods | Organoclay (FCM 1030) cleared only for dry foods under simulant E |
Where simulant D2 is not practical to test directly, EU test protocols allow 95 % ethanol or isooctane as substitute fatty simulants, and simulant E is also used above 100 °C where D2 cannot be tested safely. The test conditions and standards behind each simulant assignment are on migration testing for food contact.
NIAS: the substances nobody added on purpose#
A non-intentionally added substance is an impurity, a reaction intermediate or a decomposition product that ends up in the packaging without anyone putting it there, and Article 3(9) of Regulation (EU) No 10/2011 makes the converter assess it anyway. 2,4-Di-tert-butylphenol illustrates the problem: it is not on the Union list, forms as a degradation product of phosphite antioxidants, and has been measured in BOPP and LDPE food-contact products at up to 45.568 ± 31.513 mg/kg.
Irgafos 168 itself oxidises to its phosphate during processing, a routine and expected NIAS in polyolefin packaging rather than a sign of a formulation fault. Because a NIAS was never added on purpose, it cannot carry its own FCM number, so a converter assesses it under the general safety requirement of Regulation (EU) No 10/2011 instead, a qualitative risk-assessment step rather than a fixed legal limit. How to assess them is on NIAS from plastic additives, and the diffusion models behind the whole migration process are on additive migration in plastics.
Which Additives Does Each Food-Packaging Polymer Need?#
Each food-packaging polymer needs an additive package set by its format: polyethylene film needs slip and antiblock so the bag opens, polypropylene needs an acid scavenger and a clarifier, PET needs an acetaldehyde scavenger, and PVC needs a heat stabilizer before anything else.
Table T4. Additive package by food-packaging polymer
| Polymer | Typical packaging format | Additive package | One number that matters |
|---|---|---|---|
| additives for polyethylene | Bags, liners, lidding film | Slip, antiblock, antistatic, antifog where needed, antioxidant | Slip agent 500-1,200 ppm |
| additives for polypropylene (and BOPP) | Trays, deli containers, snack film | Acid scavenger, nucleator or clarifier, antiblock, slip, antioxidant | Calcium stearate up to 1,000 ppm |
| additives for PET resin | Bottles, thermoformed trays | Acetaldehyde scavenger, reheat additive, oxygen scavenger where needed, chain extender for rPET | Intrinsic viscosity 0.70-0.78 dL/g (general bottles) |
| additives for PVC | Cling film, jar gaskets | Heat stabilizer in every compound, plasticizer, lubricant | HCl elimination starts at 100-120 °C |
| additives for polystyrene (and EPS) | Yoghurt pots, foam trays | Residual-styrene control, blowing agent for EPS | Residual styrene ≤1 wt% (0.5 % for fatty foods) |
| additives for PLA | Compostable cups and trays | Nucleating agent, plasticizer, chain extender, hydrolysis stabilizer | Chain extender 0.1-0.5 wt% |
BOPE and BOPP masterbatch types most used in food packaging are antiblock, antistatic, antifog, migrating and non-migrating slip, and white; a formulator building one of these films selects across that list rather than from a single all-purpose grade.
How Do You Select an Additive for Food Packaging? 7 Steps#
Select a food-packaging additive in 7 steps: define the food and the contact conditions, assign the simulant, check the Union list, check the US clearance, check the use-level ceiling, check the interactions inside the package, then set the dosage and confirm it by migration testing.
- Define the packaging format, the food it will hold and the contact time and temperature.
- Assign the food simulant and the test conditions from Annex III.
- Check the EU Union list for an FCM number and read its SML, group restriction and use restriction.
- Check the US clearance: the 21 CFR section for the polymer, or an effective FCN held by your supplier.
- Check the use-level ceiling, which is often lower than the technical optimum.
- Check the interactions inside the package, since silica antiblock adsorbs slip and antistatic agents and amine antistats react with acidic additives.
- Set the dosage, then confirm compliance by overall and specific migration testing and document it in the Declaration of Conformity.
Step 6 deserves particular care in a food-contact compound: amine and amide antistatic agents also react with acidic additives and with halogenated flame retardants, and amine antistats attack polycarbonate, so a formulator should check every additive pair in the recipe, not only each additive against the resin. A converter who follows all 7 steps in order rarely discovers a compliance gap after the compound is already running, and the general framework behind them, covering non-food applications too, is on how to select plastic additives.
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What Changes for Food-Packaging Additives in 2026 and Beyond#
Four dated changes reach food-packaging additives between 2026 and 2029, and the first of them, the PFAS limits of the EU Packaging and Packaging Waste Regulation, applies from 12 August 2026. Regulation (EU) 2025/40, Article 5(5), sets 25 ppb for any single targeted PFAS, 250 ppb for the sum of targeted PFAS and 50 ppm for total PFAS including polymeric PFAS, with proof of PFAS against non-PFAS fluorine required above 50 mg/kg total fluorine. The same regulation's Article 5(4) caps the sum of lead, cadmium, mercury and hexavalent chromium at 100 mg/kg, and its Article 7 sets recycled-content targets that reach 30 % for contact-sensitive PET bottles by 2030 and 50 % by 2040 (10 % and 25 % for other contact-sensitive packaging, 30 % and 65 % for single-use beverage bottles more broadly, 35 % and 65 % for other packaging). The article-by-article summary is on the EU Packaging and Packaging Waste Regulation (PPWR) and additives.
Table T6. Compliance timeline for food-packaging additives
| Date | Instrument | What changes for additives | Who it hits |
|---|---|---|---|
| 20 Jan 2025 | Reg. (EU) 2024/3190 | Bisphenol regulation in force; FCM 151 and FCM 154 deleted | All bisphenol-containing food-contact materials |
| 16 Dec 2025 | Reg. (EU) 2025/351 | Declaration of Conformity must declare non-compliant intermediates | Converters and resin producers |
| 20 Jul 2026 | Reg. (EU) 2024/3190 | First bisphenol transition period ends | Single-use and repeat-use bisphenol articles |
| 12 Aug 2026 | Reg. (EU) 2025/40 (PPWR) | PPWR applies: PFAS and heavy-metal limits start | All food-contact packaging |
| 16 Sep 2026 | Reg. (EU) 2025/351 | Placing-on-market window for pre-existing stock closes | Converters and resin producers |
| 31 Dec 2026 | Reg. (EU) 2025/40, Art. 5(2) | Commission report on substances of concern due | Regulators and converters |
| 20 Jan 2028 | Reg. (EU) 2024/3190 | Second bisphenol transition period ends | Remaining bisphenol uses (fruit, vegetable and fishery preservation; professional food-production equipment) |
| 12 Feb 2028 | Reg. (EU) 2025/40, Art. 9 | Tea bags, coffee pods and fruit stickers must be compostable | Format-specific converters |
| 2030 / 2040 | Reg. (EU) 2025/40, Art. 7 | Recycled-content targets step up (30/10/30/35 % then 50/25/65/65 %) | PET and beverage bottle producers |
PFAS restrictions do not stop at the PPWR: a universal PFAS restriction under REACH remains pending at the EU level, so "restriction pending" is the accurate description, never "banned", and the status of every PFAS measure is on PFAS restrictions and plastic additives.
Bisphenols are the second dated change on the timeline: Regulation (EU) 2024/3190 entered into force on 20 January 2025, deletes FCM 151 and FCM 154 from the Union list, and phases out single-use bisphenol-containing articles by 20 July 2026 (20 January 2028 for fruit, vegetable and fishery preservation and certain other uses) and repeat-use articles on the same two dates. Bisphenol A is a monomer, not an additive, so it never carried an FCM number in the first place; see bisphenols in plastics.
Regulation (EU) 2025/351 adds purity, off-cut reprocessing, testing and GMP requirements: products already on the market before 16 September 2026 may stay until stocks run out, and from 16 December 2025 a Declaration of Conformity must already declare any non-compliant intermediate used upstream. A Commission report on substances of concern under PPWR Article 5(2) is due by 31 December 2026, and no list or substance count from that process is final before then.
Additives in Recycled Food-Contact Packaging#
Recycled content is the fastest-growing constraint on food-packaging additives, because Regulation (EU) 2022/1616 allows only two routes into food contact: post-consumer mechanical PET recycling and a closed product loop. Adopted on 15 September 2022, published in the Official Journal on 20 September 2022 and in force from 10 October 2022, it repealed the earlier Regulation (EC) No 282/2008 and caps non-food input to a mechanical PET recycling process at 5 %, with the recycled output barred from microwave or oven use. EFSA assumes a worst-case misuse contamination of 3 mg/kg for recycled PET, against an FDA negligible dietary concentration of 0.5 ppb, a gap that shows how conservative the EU assumption is. The legal detail behind both routes is on recycled plastics regulations.
Recyclate needs its own additive package on top of the virgin-resin one: restabilization with an antioxidant blend at 0.1 to 0.3 wt% restores the oxidative protection that degrades during the first processing life, and design for recycling covers the APR and EPBP conditions per additive in full. An oxygen scavenger destined for a bottle-to-bottle stream has to meet both the EPBP compatibility conditions and the APR PET protocol PET-CG-01 after ageing per PET-P-12 to earn Design Recognized status; APR separately rates the workhorse rigid-PP additives, and antifog in PE film, as Design Preferred. The full recyclate package by polymer is on additives for recycled plastics, and dosage specifically for recyclate is on restabilization of recycled plastics.
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Are the Additives in Plastic Food Packaging Harmful?#
A few food-packaging additives are restricted precisely because they migrate, such as DEHP with a specific migration limit of 0.6 mg/kg, while most carry no specific limit at all and are controlled by the 10 mg/dm² overall migration limit that applies to the finished article. Two examples anchor that range: bisphenol A never had an SML at all, because as a monomer rather than an additive it sat outside Regulation (EU) No 10/2011's scope from the start, while cobalt in oxygen-scavenger catalysts carries one of the tightest SMLs on the Union list, 0.05 mg/kg.
In a 2021 study titled "Deep Dive into Plastic Monomers, Additives, and Processing Aids", Martin Wiesinger, Zhanyun Wang and Stefanie Hellweg at ETH Zurich (Environmental Science & Technology, 55:9339-9351) counted more than 10,000 substances associated with plastics globally, of which more than 2,400 are of potential concern and 901 are approved for food-contact plastics in at least one jurisdiction. A separate inventory, the Food Contact Chemicals database compiled by Ksenia Groh and colleagues in 2021, lists 12,285 intentionally used food-contact chemicals drawn from 67 regulatory and industry lists.
This page is one of 27 applications covered under plastic additives by application, which sits alongside the packaging-specific reading for additives for packaging film, the converter reading for additives for plastic bottles and additives for caps and closures, and the consumer-health reading of these same chemicals, reviewed in full on chemicals migrating from plastic food packaging.
Which additives have actually been measured in food packaging?#
Analytical surveys find a short and repetitive list: the compounds most often measured in plastic food packaging are plasticizers, phenolic antioxidants and their degradation products, and a small set of UV stabilizers. In a 2026 study by Tan and colleagues in Food Chemistry X, researchers measured BHT migrating at 2.3 micrograms per litre from take-out containers and DIBP at 2.5 to 5.0 micrograms per litre from containers and bags, using an SPME-GC method.
2,4-Di-tert-butylphenol, the phosphite-antioxidant degradation product discussed above, has been found in BOPP and LDPE food-contact products at up to 45.568 ± 31.513 mg/kg. On PFAS specifically, the FCCmigex database compiled by Phelps and colleagues in 2024 detected 68 individual PFAS substances in food contact materials, 87 % of them either perfluorocarboxylic acids or fluorotelomer-based compounds.
Are plastic additives the same as food additives?#
No: a food additive is put into the food, while a plastic additive is put into the packaging and is only ever meant to stay there, which is why the two are regulated under completely different instruments. The one substance that genuinely straddles both worlds is BHT, cleared as a plastic antioxidant at FCM 315 with SML 3 mg/kg and, separately, prior-sanctioned as a direct food antioxidant under 21 CFR 181.24 at a 0.005 % limit of addition to the food itself; every other substance on this page belongs to only one side of that line.
What are some examples of plastic additives?#
Typical plastic additives in food packaging are the antioxidants Irganox 1010 and Irgafos 168, the slip agent erucamide, diatomaceous earth as an antiblock, glycerol monostearate as an antistatic and antifog agent, carbon black and titanium dioxide as colorants, and epoxidized soybean oil in jar-lid gaskets. DEHP and 2-aminobenzamide are two further examples, used respectively as a PVC gasket plasticizer and as a PET acetaldehyde scavenger.
Do plasticizers leach out of plastic over time?#
Yes: plasticizers are not chemically bound to the PVC chain, so they migrate slowly to the surface and into fatty food, which is why the EU limits DEHP migration into food to 0.6 mg/kg and allows it only in repeated-use articles for non-fatty food. Migration accelerates with heat, with the fat content of the food and with contact time, which is why the EU's control point is specific migration testing under real or simulated conditions rather than a one-time approval; the health side of chronic low-level exposure is on phthalates: health effects and regulation.