EU 10/2011: Plastic Food Contact Materials Regulation and Its 6 Requirements for Additives

Checked against the EUR-Lex consolidated text of Regulation (EU) No 10/2011 dated 14 July 2026. Status verified 22 September 2026.

Regulation (EU) No 10/2011 is the EU law that decides which substances may be used to make a plastic food contact material and how much of each may migrate into food, and it places 6 requirements on every additive in the compound. An additive that is not on its Union list cannot legally be used in a food-contact plastic in the EU, so which additives are listed, and at what limit?

Regulation (EU) No 10/2011 places 6 requirements on a plastic additive, in the order a formulator meets them: authorisation on the Union list with an FCM substance number, a specific migration limit, any group restriction that sums the substance with related additives, the overall migration limit of the finished article, the Annex II metal limits where the additive contains a metal, and a declaration of compliance. This sequence applies to every one of the plastic additives in the compound, from the antioxidant package to the slip agent, whether the finished part is a yogurt pot or a retort pouch.

This page works through all 6 requirements, then shows where 26 common additives sit on the Union list by function, from antioxidants and plasticizers to UV absorbers, colorants and slip agents. It sets out the current phthalate limits under Regulation (EU) 2023/1442, the 6 food simulants used in migration testing, the 3 routes available to a substance that is not on the Union list, and the amendment history from the 2020 metals update to the 2025 purity and reprocessing rules. It closes with what the regulation does not cover: recycled plastic, coatings and inks, and food contact outside the EU. This page explains the regulation for formulation, quality and compliance teams; it is not legal advice.

What Is Regulation (EU) No 10/2011?#

Regulation (EU) No 10/2011 is the Commission regulation that lists every substance allowed in a plastic food contact material in the EU and sets the limits on what may migrate from it into food. Article 3(7) defines an additive as a substance intentionally added to plastics to achieve a physical or chemical effect during processing or in the final material or article, and intended to be present in the final material or article. A plastic additive works inside the polymer matrix; a food additive works in the food itself and is governed by Regulation (EC) No 1333/2008, a separate instrument outside this page's scope.

What EU 10/2011 covers, and what it leaves out#

Regulation (EU) No 10/2011 covers materials and articles made only of plastic, plastic multi-layer materials held together by adhesives, and the plastic layers of multi-material packaging. These three categories define the regulation's technical scope under Article 2. The in-scope categories are:

• Materials and articles made entirely of plastic, such as a bottle, film or container
• Plastic multi-layer materials held together by adhesives, such as a laminated pouch
• Plastic layers within a multi-material, multi-layer article, such as the plastic film bonded to a carton or a foil

Three categories sit outside this page's remit and are covered in their own sections further down:

• Recycled plastic and reprocessed material, governed by Regulation (EU) 2022/1616
• Coatings, printing inks and adhesives that are not themselves a plastic layer, governed by the general safety requirement of Regulation (EC) No 1935/2004
• Food contact materials placed on the market outside the European Union, governed by each country's own rules

Nanoform variants of an authorised substance may be used only where Annex I explicitly authorises and specifies that nanoform, under Article 9(2). Colorants, solvents and aids to polymerisation are not on the Union list at all; that distinction is covered in the additive-family section below.

How EU 10/2011 sits under Regulation (EC) No 1935/2004 and beside REACH#

Regulation (EC) No 1935/2004 is the framework law for all food contact materials, and Regulation (EU) No 10/2011 is the specific measure that applies it to plastics. The framework regulation sets the general safety requirement that a food contact material must not endanger human health, alter food composition unacceptably or change its taste and odour; Regulation (EC) No 2023/2006 adds the good manufacturing practice a converter must follow while making that material. Regulation (EU) No 10/2011 turns the framework's general requirement into a specific, substance-by-substance authorisation system for plastics, with its own Union list, migration limits and testing rules.

Authorisation under Regulation (EU) No 10/2011 does not exempt the same substance from REACH. A plastic additive that carries an FCM number under 10/2011 can still be subject to registration, restriction or SVHC identification under Regulation (EC) No 1907/2006, the topic covered in full on REACH and plastic additives. REACH Annex XVII entry 51, which restricts four phthalates (DEHP, DBP, BBP and DIBP) in articles generally, explicitly excludes articles already within the scope of Regulation (EC) No 1935/2004, so the food-contact article is judged by the plastics regulation's own phthalate limits rather than by the general Annex XVII cap.

The 6 Requirements EU 10/2011 Places on a Plastic Additive#

Regulation (EU) No 10/2011 places 6 requirements on a plastic additive: it must be on the Union list, stay under its specific migration limit, stay under any group limit that applies to it, leave the article inside the overall migration limit, respect the metal limits of Annex II, and be covered by a declaration of compliance. Each requirement is enforced independently; passing one does not exempt an additive from the next.

1. The additive must be on the Union list and carry an FCM substance number#

The Union list in Annex I Table 1 of Regulation (EU) No 10/2011 is a positive list: a substance may be used to make a food-contact plastic only if it appears there with an FCM substance number, and a substance that is absent is not allowed unless one of the routes in Article 6 applies. Annex I Table 1 covers three categories together: monomers and other starting substances, additives, and polymer production aids, each carrying its own FCM substance number and, where relevant, a Ref number that links related entries such as a monomer and its polymerised form.

The FCM numbers and their identity and purity criteria are tied to the specification EFSA evaluated when the substance was added to the list, a link made explicit by Regulation (EU) 2025/351. A substance sold under a different purity or composition than the one EFSA assessed does not carry the Annex I authorisation, even if its trade name matches a listed entry. Colorants, solvents and aids to polymerisation are the three notable exceptions: none of them appears on the Union list, a point covered in the additive-family section further down this page.

2. It must stay under its specific migration limit (SML)#

A specific migration limit is the maximum amount of one substance that may pass from the plastic into the food, expressed in milligrams per kilogram of food, and where Annex I sets none the generic limit of 60 mg/kg applies (Article 11(2)). Most Union-listed additives carry their own SML because EFSA calculated a value tighter than the generic default; where Annex I is silent, the 60 mg/kg ceiling from Article 11(2) applies automatically, without a separate entry.

Four antioxidants illustrate the range: Irganox 1076 (FCM 433) is capped at 6 mg/kg, Irganox MD 1024 (FCM 675) at 15 mg/kg and Ultranox 626 (FCM 652) at 0.6 mg/kg, while Irganox 1010 (FCM 496) and Irgafos 168 (FCM 671) carry no specific migration limit of their own, so the generic 60 mg/kg applies to each. Article 11(3) adds a separate condition for dual-use substances: an additive that is also authorised as a food additive must not exert a technological effect in the food itself, only in the plastic. The full alphabetical table of every Annex I SML, including substances outside the 26 covered on this page, is maintained on specific migration limits (SML) of plastic additives.

3. Group restrictions: SML(T) and how shared limits are summed#

A group restriction sets a single total limit, the SML(T), for a set of substances that are measured together: the three thioester antioxidants DLTDP, DSTDP and DMTDP share one limit of 5 mg/kg under group restriction 14. Annex I Table 2 lists these group restrictions separately from the individual SMLs in Table 1, and a substance can be subject to both an individual limit and a group limit at the same time.

Ten group restrictions affect plastic additives directly, shown in Table 2 below. Group restriction 32 works differently from the others: it sums 22 separate plasticiser FCM numbers into one 60 mg/kg ceiling, so a formulation blending more than one plasticiser is checked against the combined total, not against each one individually. Group restriction 36, the phthalate group, is a weighted sum rather than a plain addition: it converts each phthalate present into a DEHP-equivalent value before adding them together, a calculation set out in full in the phthalate section below.

Group restriction 32 covers FCM 8, 72, 73, 138, 140, 157, 159, 207, 242, 283, 532, 670, 728, 729, 775, 783, 797, 798, 810, 815, 1078 and 1085.

4. The finished article must stay under the overall migration limit (OML)#

The overall migration limit caps everything that leaves the plastic together: 10 milligrams per square decimetre of food contact surface, or 60 milligrams per kilogram of food for materials intended for infants and young children (Article 12). The OML is a whole-article test, not a substance-by-substance one: it adds up the migration of every additive, oligomer, NIAS and residual monomer that crosses into the food simulant during the test, regardless of whether each individual substance stays under its own SML.

An additive can pass its specific migration limit by a wide margin and still contribute to an OML failure if the rest of the formulation is already close to the 10 mg/dm² ceiling. This is why the overall migration limit sits fourth in the sequence: it is checked only after the individual and group limits are confirmed, because it depends on the combined result of every substance in the compound rather than on any one of them. The 60 mg/kg alternative for infant and young-child food reflects the smaller body weight and higher relative food intake of that population, expressed in Article 12 as a distinct threshold rather than a surface-area limit.

5. Metals and salts: Annex II limits and the Article 6(3)(a) salt rule#

Annex II of Regulation (EU) No 10/2011 limits the metals that may migrate from a plastic, whatever additive they came from: zinc and copper at 5 mg/kg of food, aluminium and barium at 1 mg/kg, cobalt at 0.05 mg/kg and antimony at 0.04 mg/kg. These limits, set by Regulation (EU) 2020/1245, apply to the metal itself, independent of which additive delivered it, so a zinc stearate lubricant and a zinc oxide masterbatch are both checked against the same 5 mg/kg zinc ceiling.

Never write zinc's SML as 25 mg/kg: that older figure was replaced by the 5 mg/kg limit under Regulation (EU) 2020/1245. Article 6(3)(a) adds a separate salt rule: salts of already-authorised acids, phenols or alcohols are allowed with 17 specific metals, including aluminium, calcium, cobalt, copper, iron, magnesium, potassium, sodium and zinc, without each salt needing its own Annex I entry. Metal stearates built on calcium, zinc or magnesium have no FCM number of their own; they are covered as salts of stearic acid, FCM 106 (Ref 24550 as the monomer form, 89040 as the additive form), and the zinc portion of a zinc stearate is still bound by the 5 mg/kg zinc limit above.

6. The declaration of compliance and the supporting documentation#

A written declaration of compliance must travel with the material at every stage of marketing except retail sale to the consumer, and it names every substance subject to a migration limit or another restriction (Article 15 and Annex IV). The declaration is the paper trail that carries the regulation's substance-level detail down the supply chain, from resin producer to converter to the food business that fills the final package.

A declaration of compliance under Annex IV states:

1. The identity and FCM number of every substance subject to a restriction present in the material or article
2. The specific migration limit or group restriction that applies to each of those substances
3. The food types and conditions of use, including time and temperature, that the material was tested against
4. Whether any listed substance is a dual-use additive that must not exert a technological effect in the food
5. Confirmation that the declaration accompanies the material at every marketing stage other than retail sale to the consumer

Since Regulation (EU) 2025/351, an intermediate product that does not itself comply with the regulation must say so explicitly in its declaration, from 16 December 2025, and the supporting documentation behind the declaration must be made available to the competent authority on request. A worked template covering every Annex IV field is available on declaration of compliance (DoC).

Which Plastic Additives Are on the Union List? FCM Numbers and Migration Limits#

The Union list carries additives from every function group, from the antioxidant Irganox 1010 (FCM 496) and the phosphite Irgafos 168 (FCM 671) to the pigment carbon black (FCM 411) and the slip agent erucamide (FCM 271). Table 2 below selects 26 additives across the main function groups used in commercial plastics; Annex I Table 1 itself runs far longer, covering monomers and polymer production aids alongside additives.

Each substance above links to its own record in the plastic additives database, with the full regulatory matrix.

Antioxidants and stabilizers#

Antioxidants are the best-represented additive function on the Union list: the two workhorses of polyolefin stabilization, Irganox 1010 (FCM 496) and Irgafos 168 (FCM 671), carry no specific migration limit of their own, so the generic 60 mg/kg applies to each. The Union list runs well beyond these two: Irganox 1098 (FCM 631) is capped at 45 mg/kg, Irganox 245 (FCM 680) at 9 mg/kg, Irganox 3114 (FCM 661) at 5 mg/kg and Irganox 1035 (FCM 690) at 2.4 mg/kg, while alpha-tocopherol (FCM 110) carries no SML at all. Mechanisms, structures and dosage ranges for the full antioxidant family are covered on antioxidants for plastics.

Phosphite and phosphonite antioxidants form a distinct sub-class with their own migration behaviour. Ultranox 626 (FCM 652) is limited to 0.6 mg/kg, ADK STAB PEP-36 (FCM 746) to 5 mg/kg as the sum of its phosphite and phosphate forms, and Doverphos S-9228 (FCM 773) to 5 mg/kg, while the PEPQ main component (FCM 688) is capped at 18 mg/kg. Hydrolysis behaviour decides which NIAS appear from a given phosphite grade, a topic covered in full on phosphite antioxidants.

Plasticizers#

Plasticizers carry a collective ceiling: group restriction 32 caps the sum of 22 listed plasticizers at 60 mg/kg of food, whatever their individual limits are. DEHP (FCM 283) and BBP (FCM 159) each carry their own SML on top of that group sum, so a PVC compound blending more than one plasticiser has to clear both the individual limits and the combined 60 mg/kg ceiling before it passes. The full plasticizer family, including the non-phthalate alternatives, is compared on plasticizers for plastics.

UV absorbers and light stabilizers#

Light stabilizers reach the Union list one component at a time: the two halves of Tinuvin 111 are listed separately as FCM 791 (Chimassorb 119, SML 0.05 mg/kg) and FCM 716 (Tinuvin 622, SML 30 mg/kg). Benzotriazole and benzophenone UV absorbers cluster into two group restrictions: group 8 covers benzophenone-3 and four related entries (FCM 317, 318, 319, 359, 431, 464) at a combined 6 mg/kg, and group 12 covers UV-P, UV-327 and UV-326 (FCM 444, 469, 470) at a combined 30 mg/kg. The nylon HALS N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl)isophthalamide, CAS 42774-15-2, is listed separately as FCM 1051 at 5 mg/kg.

FCM 790 requires an average molecular weight of at least 2,400 Da under its Annex I entry. Tinuvin 770 is not in Annex I, so a formulation containing it cannot be used for EU plastic food contact. Classes, mechanisms and grade comparisons for the full family are on UV stabilizers for plastics.

Colorants, pigments and fillers: why colorants are not on the Union list#

Colorants are the one large additive function that Regulation (EU) No 10/2011 does not put on its Union list: pigments and dyes fall under the general safety requirement of Regulation (EC) No 1935/2004, national rules and Council of Europe Resolution AP(89)1 instead. Because colorants sit outside Annex I, there is no FCM-number system covering pigment chemistry as a class; a formulator checks a colorant's food-contact status against national law and the resolution's purity criteria rather than against a Union-list entry. Pigment classes and their food-contact status by chemistry are covered on colorants for plastics.

A small number of pigments are the exception: some are also authorised as additives in their own right and carry a conventional FCM entry, among them carbon black (FCM 411), titanium dioxide (FCM 610) and its surface-treated grades (FCM 805, 873 and 1077), and zinc sulphide (FCM 403). Nanoform pigment grades fall back under Article 9(2): a nanoform is usable only where Annex I explicitly authorises that specific nanoform. The purity criteria that apply to colorants generally are set out in Resolution AP(89)1, the Council of Europe instrument referenced above.

Slip, antistatic, antifog and other surface additives#

Surface additives migrate by design, which is why two of them carry a specific limit: stearyl erucamide (FCM 587) and oleyl palmitamide (FCM 622) are capped at 5 mg/kg, while erucamide (FCM 271) and oleamide (FCM 335) have no specific limit of their own. Ethylene bis-stearamide (FCM 250) and ethylene bis-oleamide (FCM 251) likewise carry no SML. Bloom rates and typical dosages for the slip agent family are covered on slip additives for plastic film.

Ethoxylated amines (FCM 19 and 20) are the largest antistatic class and sit under group restriction 7 at 1.2 mg/kg as tertiary amine. Lauric diethanolamide (FCM 923) is capped at 5 mg/kg with residual diethanolamine limited to 0.3 mg/kg of food, and glycerol esters with stearic acid (FCM 53, also present within FCM 9/10) carry no SML and double as an antifog agent. The ethoxylated amine class and its dosage ranges are covered on antistatic agents for plastics.

Which Phthalates Are Covered by EU Regulation 10/2011?#

Five phthalates carry limits under Regulation (EU) No 10/2011 since Regulation (EU) 2023/1442: dibutyl phthalate (FCM 157) at 0.12 mg/kg, benzyl butyl phthalate (FCM 159) at 6 mg/kg, DEHP (FCM 283) at 0.6 mg/kg, and diisononyl and diisodecyl phthalate (FCM 728 and 729) at 1.8 mg/kg as a group. These values replaced the pre-2023 limits (DEHP 1.5 mg/kg, BBP 30 mg/kg, DBP 0.3 mg/kg) when Regulation (EU) 2023/1442 entered into force on 1 August 2023. A sixth phthalate, diisobutyl phthalate (DIBP), is not authorised as an additive at all: it holds FCM 1085 only so that its presence, typically as a carryover from its role as an aid to polymerisation, can be counted inside group restrictions 32 and 36.

Group restriction 36 is a weighted sum, not a plain addition: the DEHP-equivalent total is calculated as DBP times 5, plus DIBP times 4, plus BBP times 0.1, plus DEHP times 1, and the result must stay at or below 0.6 mg/kg. This weighting reflects the group tolerable daily intake the EFSA CEP Panel set in a 2019 opinion, "Update of the risk assessment of di-butylphthalate (DBP), butyl-benzyl-phthalate (BBP), bis(2-ethylhexyl)phthalate (DEHP), di-isononylphthalate (DINP) and di-isodecylphthalate (DIDP) for use in food contact materials," at 50 micrograms per kilogram of body weight per day in DEHP equivalents. Non-compliant materials already on the market before 1 February 2025 could continue to be sold until existing stocks ran out. Food-contact limits are only one layer of phthalate regulation: the wider picture across REACH, the US and Asia is covered on phthalate restrictions worldwide.

How Is a Food Packaging Plastic Tested? Food Simulants and Migration Testing#

Compliance with Regulation (EU) No 10/2011 is demonstrated by migration testing into 6 food simulants that stand in for real foods, from 10% ethanol for aqueous foods to vegetable oil for fatty foods. Annex III assigns each simulant to a food category so that a single laboratory test can represent an entire class of packaged products rather than every individual recipe. Test times, temperatures and article-to-simulant ratios for each product category are set out in full on migration testing of plastics for food contact.

Two Annex I notes matter specifically for additives: note (2) flags a risk that the SML or OML could be exceeded in fatty food simulants, and note (12) flags the equivalent risk from polyolefins. Note (13) restricts testing to content-in-polymer and starting-substance-in-simulant methods where no simulant-migration method is available for that substance. What controls how fast an additive actually leaves the polymer, independent of the test method, is covered on additive migration in plastics.

Since Regulation (EU) 2025/351, migration is determined with methods meeting Article 34 of Regulation (EU) 2017/625, and the laboratory's own standard measurement uncertainty is applied to the result rather than a fixed tolerance. Typical formulations and the additive packages used in packaging applications are set out on additives for food packaging.

What If the Additive Is Not on the Union List?#

A substance that is missing from the Union list is not automatically out: Regulation (EU) No 10/2011 allows it behind a functional barrier, as an aid to polymerisation, or as a non-intentionally added substance that has been risk-assessed. These three routes exist because the Union list cannot enumerate every substance that could ever be present in a plastic food contact material, from trace impurities to reaction products formed during processing:

• Behind a functional barrier, provided its migration is not detectable above 0.01 mg/kg of food (Articles 13 and 14)
• As an aid to polymerisation that is not itself required to appear on the Union list, under national law (Article 6(4)(b))
• As a non-intentionally added substance (NIAS) that has been risk-assessed under Article 19

Functional barriers, aids to polymerisation and dual-use additives#

A functional barrier is a layer that keeps migration of the substances behind it below 0.01 mg/kg of food, and behind such a barrier an unlisted substance may be used as long as it is not classified as mutagenic, carcinogenic or toxic for reproduction (Articles 13 and 14). The barrier concept lets a multi-layer structure use a functional layer, for example a regrind or recycled core, that would not pass Union-list authorisation on its own, as long as an outer layer keeps its migration undetectable at the 0.01 mg/kg threshold.

Article 6(4)(b) covers a separate route: an aid to polymerisation that is not on the Union list may still be present in a plastic layer, subject to national law rather than a harmonised EU limit. Substances that fail both routes stay unusable; UV-328, for example, is not on the Union list and has no functional-barrier exemption recorded in our source library. Dual-use additives, substances that are also authorised as food additives, sit under a related but distinct rule: Article 11(3) requires that they not exert a technological effect in the food itself, and the declaration of compliance must name them explicitly.

NIAS: impurities, degradation products and reaction products#

Non-intentionally added substances are the impurities, reaction intermediates and breakdown products that arrive with an additive rather than instead of it, and Article 19 requires them to be risk-assessed even though they are not on the Union list. Article 3(9) defines a NIAS as an impurity in the substances used, a reaction intermediate formed during the production process, or a decomposition or reaction product, and Article 19 requires that each one be assessed in accordance with internationally recognised scientific principles on risk assessment and comply with the general safety requirement of Article 3 of Regulation (EC) No 1935/2004.

Two additive-derived NIAS illustrate the mechanism: 2,4-di-tert-butylphenol forms from the oxidation and hydrolysis of Irgafos 168, and 7,9-di-tert-butyl-1-oxaspiro[4.5]deca-6,9-diene-2,8-dione forms from the oxidation of Irganox 1010 and Irganox 1076. The use of azodicarbonamide as a blowing agent in plastic food contact materials has been suspended since 2 August 2005, an example of a substance removed from acceptable use rather than a NIAS, but it illustrates the same principle that a substance's regulatory status can change independently of its Union-list entry. Screening approaches for additive-derived NIAS are covered in full on NIAS: non-intentionally added substances.

How Has EU 10/2011 Changed? Phthalate, Bisphenol and Purity Amendments#

Four amendments since 2020 changed what a plastic additive may do under Regulation (EU) No 10/2011: the metals and testing update of 2020, the phthalate limits of 2023, the bisphenol ban of 2024 and the purity and reprocessing rules of 2025. Each amendment narrowed or clarified a specific part of the regulation rather than replacing it wholesale.

• Regulation (EU) 2020/1245 (2020): rewrote the Annex II metal limits, updated the migration-testing rules and clarified repeated-use conditions
• Regulation (EU) 2023/1442, in force 1 August 2023: tightened the phthalate limits, deleted wood flour (FCM 96) and salicylic acid (FCM 121), and allowed non-compliant stock already on the market before 1 February 2025 to be sold until it ran out
• Regulation (EU) 2024/3190, OJ 31 December 2024, in force 20 January 2025: prohibits BPA and other hazardous bisphenols in the manufacture of food contact materials and deletes FCM 151 (BPA) and FCM 154 (BPS), with transition periods running to 20 July 2026 and, for specific applications such as fruit, vegetable and fishery preservation, to 20 January 2028
• Regulation (EU) 2025/351, OJ 24 February 2025: introduced the purity, reprocessing and GMP quality-control rules described throughout this page, with products first placed on the market before 16 September 2026 sellable until stocks run out

The bisphenol transition dates and the substances they replace are set out in full on EU bisphenol rules.

What is the latest amendment to Regulation (EU) 10/2011?#

The most recent amendment recorded in the consolidated text used for this page, dated 14 July 2026, is Regulation (EU) 2025/351, which tightened the purity requirements, defined the reprocessing of off-cuts and scrap, and updated the compliance-testing rules. This page states the answer by the consolidated text's date rather than by an amendment number, because our sources do not hold the ordinal numbering some other sources use, and it has not been checked against any act published after 14 July 2026. Readers tracking a specific later amendment should confirm its status directly against the EUR-Lex consolidated text before relying on it.

What EU 10/2011 Does Not Cover#

Regulation (EU) No 10/2011 stops at three borders: it does not cover recycled plastic, it does not cover the coatings, inks and adhesives that sit on or between plastic layers, and it has no force outside the EU. Each border is governed by its own instrument rather than by an exception written into 10/2011 itself.

Recycled plastics and reprocessed PET off-cuts#

Recycled plastic is governed by Regulation (EU) 2022/1616, not by Regulation (EU) No 10/2011, and since Regulation (EU) 2025/351 the line is explicit: reprocessing a converter's own off-cuts and scrap stays under 10/2011, while post-consumer material is recycling. Regulation (EU) 2022/1616 was adopted 15 September 2022, published in the Official Journal on 20 September 2022, and entered into force on 10 October 2022; it repeals the earlier Regulation (EC) No 282/2008, and its Articles 6(3)(c) and 13(2) apply from 10 October 2024. The authorisation route for recyclers, including the technologies it accepts, is covered in full on recycled plastics regulations.

Two recycling technologies are explicitly recognised as suitable under the regulation: post-consumer mechanical PET recycling, limited to at most 5% non-food-contact input with output restricted from microwave or conventional-oven use, and closed, controlled product loops. Which additives survive the PET recycling process, and which need to be reintroduced after reprocessing, is covered on additives for PET.

Packaging rules, coatings and printing inks#

Coatings, printing inks and adhesives are outside the plastics regulation even when they are printed on or laminated into a plastic food contact material, and they are judged against the general requirement of Regulation (EC) No 1935/2004 instead. A converter cannot rely on a food-contact plastic's Union-list compliance to clear the ink printed on its surface; the ink is assessed under the framework regulation's general safety requirement and, where applicable, national ink-specific guidance.

Packaging itself carries a separate substance layer under the Packaging and Packaging Waste Regulation (EU) 2025/40, which applies from 12 August 2026. It sets its own limit of 100 mg/kg for the sum of lead, cadmium, mercury and hexavalent chromium in packaging, alongside PFAS limits for food-contact packaging of 25 ppb for any single targeted PFAS, 250 ppb for the sum of targeted PFAS, and 50 ppm for total PFAS. These limits apply on top of, not instead of, the plastics regulation's own migration limits. Full coverage of the packaging-level rules is on the EU Packaging and Packaging Waste Regulation (PPWR).

Food contact outside the EU#

A substance authorised under Regulation (EU) No 10/2011 has no status in the United States, China or Japan: each keeps its own list, and an additive can be cleared in one and absent from another. In the United States, plastic additives for food contact are cleared under 21 CFR Parts 174 to 178, through food contact notifications and the Threshold of Regulation; the exact scope of clearance for a given polymer is covered on FDA food contact rules.

China applies its own positive list, GB 9685-2016 together with Amendment No. 1 (XG1-2025), approved 16 March 2025 and effective immediately, covering approximately 1,294 permitted additives. Japan's positive-list system for food contact materials has been in force since 1 June 2020. A substance's US clearance is never described as "FDA approved"; the accurate phrasing states compliance with a specific regulation, such as "complies with 21 CFR 178.2010 for polyolefins, conditions of use B through H." The full side-by-side comparison across all four systems is on food contact rules for plastic additives worldwide.

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Does a Migration Limit Mean the Additive Is Unsafe?#

No: a specific migration limit is not a warning; it is the level EFSA calculated as safe for lifetime dietary exposure, but hazard classification does enter the picture separately, through REACH. An SML is derived from a toxicological evaluation combined with an exposure assumption, not from a hazard classification, so an additive with a low limit reflects a potent or well-studied substance rather than a dangerous one on its own. The phthalate limits described above rest on exactly this logic: the EFSA CEP Panel's 2019 group tolerable daily intake of 50 micrograms per kilogram of body weight per day sets the ceiling, and the individual SMLs are engineered back from it. Food contact is one of five layers of plastic additive regulations that apply to any given additive at the same time.

Can an additive be on the Union list and an SVHC at the same time?#

Yes: the two regimes run in parallel, and an additive can sit on the Union list of Regulation (EU) No 10/2011 and on the REACH Candidate List at the same time, as the antioxidant AO-2246 does. AO-2246 (DBMC, CAS 119-47-1) was added to the SVHC Candidate List on 17 January 2022 as toxic for reproduction under Article 57(c), and it remains authorised under Regulation (EU) No 10/2011 as FCM 285 under group restriction 13, at an SML(T) of 1.5 mg/kg. TNPP, FCM 69 with an SML of 30 mg/kg, was added to the Candidate List on 16 July 2019 where it contains 0.1% or more 4-nonylphenol, and melamine, FCM 239 with an SML of 2.5 mg/kg, was added on 17 January 2023. Every additive on the SVHC Candidate List is tabulated separately, with its inclusion date and hazard basis.

The two regimes stay independent because REACH Annex XVII entry 51 explicitly excludes articles within the scope of Regulation (EC) No 1935/2004 from its general phthalate restriction, leaving the food-contact regulation's own limits as the controlling rule for that use. The full set of Annex XVII entries that touch plastic additives is covered on REACH Annex XVII restrictions.

Is the European Union banning plastics?#

No: Regulation (EU) No 10/2011 is an authorisation regime, not a ban, and it works by listing what may be used and capping what may migrate. It restricts individual substances and applications rather than the material as a whole, and a plastic food contact article stays legal for as long as every additive in it meets the 6 requirements set out on this page. The one outright product ban that touches this space sits in a different instrument: Article 5 of Directive (EU) 2019/904 prohibits products made from oxo-degradable plastic, applied from 3 July 2021.

How this page is kept current#

Every FCM number, migration limit and date on this page was read from the consolidated text of Regulation (EU) No 10/2011 dated 14 July 2026 and re-checked on 22 September 2026. Any amendment published in the Official Journal after that date is not yet reflected here. This page is re-checked whenever a new amending regulation affecting additives appears in the Official Journal.

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