EU adds four substances to plastic food contact positive list with narrow conditions of use from 18 November 2026

The EU plastic food contact materials positive list gains four substances on 18 November 2026 under Commission Regulation (EU) 2026/2412, published in the Official Journal on 29 October 2026 and amending Annex I to Regulation (EU) No 10/2011. There is no transition period. Each of the four entries — FCM Nos 1086, 1087, 1088 and 1090 — carries tight conditions of use including polymer-specific restrictions, concentration caps, specific migration limits of 0.05 mg/kg in two cases, and exclusions for infant formula and human milk; one entry is the first nanoform filler authorised for plastic food contact materials.

Regulation (EU) No 10/2011 — the plastics implementation measure, or PIM — works as a closed positive list. Under Article 5, only substances included in the Union list set out in Annex I may be intentionally used in the manufacture of plastic layers in plastic materials and articles intended to come into contact with food. Anything not on the list is, as a starting point, not permitted for intentional use.

That architecture is why an amendment to Annex I is operationally significant even when it only adds substances. A new FCM entry is not a general-purpose authorisation: it is an authorisation bounded by the restrictions and specifications recorded in the same Annex I row. Those columns — polymer, maximum concentration, specific migration limit (SML), permitted food types, time and temperature of contact — define the legal envelope. Use outside the envelope is non-compliant use of an authorised substance, which in practice is a harder defect to spot than use of an unlisted substance.

The second structural point concerns nanomaterials. Article 9(2) of Regulation (EU) No 10/2011 provides that substances in nanoform may only be used if explicitly authorised and specified in Annex I. Until this amendment, that provision functioned almost entirely as a prohibition in practice. The addition of a nanoform filler changes that position for one specific substance.

Four substances were added to the Union list of authorised monomers and additives. The new entries, with their conditions of use as set out in the amending regulation, are:

FCM No 1086 — chopped carbon fibres from carbonised polyacrylonitrile. Authorised as an additive only in polyether ether ketone (PEEK), at up to 40% w/w, with a minimum carbon content of 95%, and not at nanoscale.

FCM No 1087 — uncoated nano precipitated calcium carbonate. Authorised as a filler for all polymers, but not for contact with infant formula. The entry carries a compliance note warning that the overall migration limit may be exceeded in contact with acidic foods. This is the first nanoform filler authorised for plastic food contact materials under Article 9(2).

FCM No 1088 — poly(2-hydroxypropanoic acid) n-octyl/n-decyl esters. Authorised as an additive at up to 15% w/w only in polylactic acid (PLA) that does not contain starch, only for contact with water, fresh fruit and vegetables, and vinegar, for up to 10 days at 40 °C. SML 0.05 mg/kg.

FCM No 1090 — NMDA/MODA mixture. Authorised as a co-monomer with terephthalic acid for polyamides, not for contact with infant formula or human milk. SML 0.05 mg/kg, with an additional limit of 5 mg/kg for the oligomer fraction below 1 000 Da.

Two details are worth flagging for anyone reconciling records. First, the FCM numbering skips 1089; the amending regulation adds four substances, not five, and the sources reviewed do not explain the gap. Second, the consolidated text of Regulation (EU) No 10/2011 available on EUR-Lex carries the consolidation date 14 July 2026 and therefore does not yet incorporate this amendment. Work from the Official Journal text of Commission Regulation (EU) 2026/2412 until the consolidated version is refreshed.

Authorisation under Regulation (EU) No 10/2011 is substance-specific and condition-specific, and it sits beneath the general requirement in Article 3 of Regulation (EC) No 1935/2004 that materials and articles must not transfer constituents to food in quantities that endanger human health, change the composition of the food, or deteriorate its organoleptic characteristics. Being on the Union list does not exempt a finished article from that general obligation.

Three provisions of Regulation (EU) No 10/2011 govern how the new entries operate in practice. Article 5 establishes that only Annex I substances may be intentionally used in plastic layers. Article 9(2) requires explicit authorisation and specification in Annex I for substances in nanoform — which is why the uncoated nano precipitated calcium carbonate entry had to be written specifically and why the carbon fibre entry expressly excludes nanoscale material. Article 15 requires a written declaration of compliance at marketing stages other than retail, with the content set out in Annex IV.

Migration compliance is verified against the specific migration limits in Annex I and the overall migration limit in Article 12, using the food simulants in Annex III and the testing conditions in Annex V. The compliance note attached to FCM No 1087 is a direct pointer to that machinery: it tells the business operator that the overall migration limit may be exceeded with acidic foods, which is a signal to test with the acidic food simulant rather than assume a generic result transfers.

Four material families are directly in scope: PEEK components, PLA packaging, polyamide articles, and any polymer formulation using precipitated calcium carbonate as a filler.

The PLA exposure is the broadest commercially. PLA trays, cups, containers and films are the most likely place to encounter FCM No 1088, and the authorised uses are narrow — water, fresh fruit and vegetables, and vinegar, up to 10 days at 40 °C. A PLA article containing this additive cannot be placed on the market as a general-purpose food container. Hot-fill, fatty foods, dairy, long shelf-life ambient products and anything above 40 °C fall outside the authorisation as written.

The calcium carbonate entry has the widest material reach because it is authorised as a filler for all polymers. Practically, the constraints are the infant formula exclusion and the acidic food overall migration warning. Any SKU aimed at the infant nutrition channel needs a positive confirmation from the supplier that this nanoform filler is not present.

FCM No 1090 affects polyamide articles made with terephthalic acid, with the infant formula and human milk exclusion applying. The oligomer limit of 5 mg/kg for the fraction below 1 000 Da is the harder analytical requirement in this amendment, because oligomer determination is not a standard line item in many routine migration test packages.

FCM No 1086 is the narrowest: PEEK only, which in food contact terms means high-temperature technical parts rather than consumer packaging.

Importers sourcing finished PLA and polyamide food contact articles from China are a specific exposure point identified in the source material, because formulation changes at the resin or masterbatch stage frequently arrive without a corresponding update to the declaration of compliance.

The declaration of compliance must reflect the conditions attached to the new Annex I entries, not merely assert general compliance with Regulation (EU) No 10/2011. Annex IV requires, among other elements, the identity and address of the business operator issuing the declaration, the identity of the materials or articles, the date of the declaration, confirmation of compliance with the relevant requirements, adequate information on substances subject to restrictions, and specifications on the use of the material or article — including the food types, the time and temperature of treatment and storage, and the ratio of contact surface to food volume.

For the four new substances, that means the declaration must state the authorised food types and contact conditions where the entry restricts them, and must carry through the SML and any additional restriction so that the downstream converter or filler can verify compliance for the finished article. A declaration that says "complies with Regulation (EU) No 10/2011" without the use specifications is not sufficient where the authorised use is conditional.

Test the finished article under the conditions it will actually see, not under the generic conditions in a supplier's factory report. For FCM Nos 1088 and 1090 the SML is 0.05 mg/kg, which is a low limit requiring a method with adequate sensitivity and a documented limit of detection. For FCM No 1090, a separate determination of the oligomer fraction below 1 000 Da against the 5 mg/kg limit is required and should be specified explicitly when commissioning the laboratory, because it will not be covered by a standard SML screen.

The authorisation of uncoated nano precipitated calcium carbonate applies to that substance in that form, as specified in Annex I. It does not create a general permission for nanoform substances, which remain subject to Article 9(2). Note also the deliberate asymmetry in the carbon fibre entry: FCM No 1086 is authorised only on the condition that the material is not at nanoscale. Particle size is therefore a specification to be confirmed with the supplier and documented, not assumed.

Commission Regulation (EU) 2026/2412 enters into force on 18 November 2026. There is no transition period, because the amendment widens the Union list rather than restricting it — substances that were not previously authorised become authorised on that date, subject to their conditions.

The practical consequence is the inverse of a typical phase-out. No existing product becomes non-compliant on 18 November 2026 by reason of this amendment. What changes is that formulations containing these four substances may lawfully be placed on the market from that date, provided every condition in the Annex I entry is met and the documentation supports it. Products placed on the market before that date containing these substances would not have been covered by an Article 5 authorisation.

The enforcement exposure created by a permissive amendment is therefore documentary and conditional: a product using FCM No 1088 in a PLA tray sold for hot food, or a filler containing FCM No 1087 in an infant formula container, is non-compliant from day one of the authorisation. Official control sampling under the food contact materials framework targets exactly this type of conditional-use mismatch, although the sources reviewed do not set out a specific control plan for these substances.

The amendment applies in the EU. Earlier amendments to Regulation (EU) No 10/2011 — for example Commission Regulation (EU) No 202/2014 — are maintained on the UK legislation database as assimilated law, which reflects the pre-exit body of EU food contact rules carried into Great Britain. The sources reviewed do not confirm whether or when Great Britain will mirror the 2026 amendment, and this should be treated as an open question rather than an assumption of divergence or alignment. Northern Ireland continues to apply EU food contact rules under the applicable arrangements; practitioners should verify the current position against the relevant official text before relying on it.

For non-EU manufacturers, including suppliers in China, the obligation runs through the EU importer. The authorisation and its conditions apply to the product placed on the EU market regardless of where the resin, masterbatch or finished article was produced.

Send a direct written question to every resin, masterbatch, additive and finished-article supplier asking whether their formulations contain FCM No 1086, 1087, 1088 or 1090, by FCM number. Do not accept a general compliance statement in response — the entries are conditional, and a yes answer changes what the declaration of compliance has to say.

Where a supplier confirms use, request an updated declaration of compliance containing the full Annex IV information, including the food types, contact time and temperature, and the surface-to-volume assumptions. Compare the declared conditions against the actual intended use of your SKU. For PLA articles containing FCM No 1088, confirm that the product is marketed only for water, fresh fruit and vegetables or vinegar, at or below 40 °C for up to 10 days, and that the resin contains no starch and the additive level does not exceed 15% w/w.

Screen the infant nutrition portfolio separately. Any article intended for contact with infant formula must be confirmed free of FCM No 1087, and any polyamide article intended for infant formula or human milk must be confirmed free of FCM No 1090.

Commission migration testing on the finished article under realistic conditions of use rather than relying on generic supplier test reports. Specify the acidic food simulant where FCM No 1087 is present, given the overall migration warning attached to that entry, and specify the oligomer determination below 1 000 Da where FCM No 1090 is present. Build laboratory lead time into Q4 2026 and Q1 2027 planning; the sources reviewed do not report current queue times, so confirm capacity with your laboratory directly.

Finally, update your internal substance master list and your declaration of compliance template to carry the four new FCM numbers and their restrictions, so that incoming supplier documentation is checked against the correct conditions rather than against a pre-amendment reference.

18 November 2026 — entry into force of Commission Regulation (EU) 2026/2412. The next practical milestone is the refresh of the consolidated text of Regulation (EU) No 10/2011 on EUR-Lex; until that appears, the Official Journal text of the amending regulation is the operative reference for Annex I entries 1086, 1087, 1088 and 1090.

Commission Regulation (EU) 2026/2412 was published in the Official Journal of the European Union on 29 October 2026. Verify the entry details against the Official Journal text; the EUR-Lex consolidated version linked above predates the amendment.