{"id":3914,"date":"2026-05-07T02:58:34","date_gmt":"2026-05-07T02:58:34","guid":{"rendered":"https:\/\/kitech-recycling.com\/?p=3914"},"modified":"2026-05-07T02:58:34","modified_gmt":"2026-05-07T02:58:34","slug":"food-grade-rpet-fda-efsa-regulations","status":"publish","type":"post","link":"https:\/\/kitech-recycling.com\/es\/blog\/food-grade-rpet-fda-efsa-regulations\/","title":{"rendered":"Rpet de calidad alimentaria: hoja de ruta de cumplimiento de la FDA, la EFSA y los propietarios de marcas"},"content":{"rendered":"
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Food grade rPET FDA EFSA regulations are no longer just paper work. As of 12 August 2026, the Packaging and Packaging Waste Regulation (PPWR, Reg 2025\/40) will be in force within the EU and PET beverage bottles must contain 30% post consumer recycled (PCR) content by 2030. The U.S. FDA already has over 200 recycling processes listed through its non-objection letter pathway. Responsible Brand owners are now having to demonstrate at board level that the rPET resin used in their bottle originated from an approved process. This guide is helping to convert the regulatory office wall into a functional road map – what the FDA approves, what EFSA approves, what is tested and what a responsible brand owner should be asking for in writing.<\/p>\n

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Quick Specs \u2014 Food-Grade rPET Compliance at a Glance<\/h3>\n\n\n\n\n\n\n\n\n
Dietary intake ceiling<\/td>\n0.0025 \u00b5g per kg body weight per day (FDA & EFSA)<\/td>\n<\/tr>\n
Residual contaminant ceiling<\/td>\n< 3 mg per kg in the recycled flake\/pellet<\/td>\n<\/tr>\n
EU base regulation<\/td>\nReg (EC) 1935\/2004 + Reg (EU) 10\/2011 + Reg (EU) 2022\/1616<\/td>\n<\/tr>\n
U.S. pathway<\/td>\nFDA “Letter of No Objection” (LNO) on the recycling process \u2014 not the resin<\/td>\n<\/tr>\n
Standard surrogate cocktail<\/td>\nToluene, chlorobenzene, chloroform, methyl salicylate, phenylcyclohe\u00d7ane, benzophenone, methyl stearate<\/td>\n<\/tr>\n
PPWR PCR target (PET beverage bottles)<\/td>\n30% by 2030 \u2192 65% by 2040<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

What Is Food-Grade rPET? Material vs Process Distinction<\/h2>\n

\"What<\/p>\n

Food grade rPET is Post Consumer Recycled Polyethylene Terephthalate that has been fed through a process evaluated as suitable in terms of migrating contaminant levels according to the 0.0025 g\/kg\/bw\/d consumption threshold. That definition appears straight forward; it conceals the priciest misconception in the industry: regulators approve processes, not resin batches.<\/p>\n

A batch of rPET pellets is “food-grade” only if (a) the recycling process batch that produced it was considered by regulators to be suitable (FDA letter of no objection in the U.S., EFSA scientific opinion + EU Commission authorisation in the EU), (b) the input feedstock was previously used for food contact as a beverage bottle and (c) the resin batch itself passes migration limits upon testing. Remove any one of those three factors and the resin, or its supply batch, is not technically food-grade rPET \u2014 despite what the supplier may explicitly claim or print. The phrase “food-safe rPET” carries the same meaning in industry shorthand and must rest on the same evidence chain.<\/p>\n

This is how three identical semi loads of rPET pellets can have vastly different regulatory statuses. One passed with an EFSA-approved mechanical recycling process with appropriate single stream bottle input. The second passed with an FDA Letter of No Objection, but used mixed composition bottles with tray trimmings included. The third was supplied by an unidentified Asian recycler mimicking the process details, who still invited inspection. Visually they are indiscernible. Legally they are not even close, and by failing to differentiate process approval from material approval the brand owner will pay the wrong supplier. Recycled plastic as a product stream can cover the entire range of regulatory eligibility from bottle grade rPET to mixed PCR with zero food contact eligibility but regulator-approved subset is limited.<\/p>\n

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\u26a0\ufe0f<\/span> Common Misconception<\/strong><\/div>\n

“Recycled” does not mean “food grade”. Visually a generic drinking-bottle shaped pellet made by an anonymous process has identical chemistry to virgin PET but zero regulatory meaning.<\/p>\n<\/div>\n

The FDA Roadmap \u2014 Letter of No Objection & Food Contact Notification<\/h2>\n

\"The<\/p>\n

FDA does not “approve” rPET as a product. It assesses a recycling process to determine if it is suitable, then publishes a letter of non-objection to using such plastic for specific food-contact purposes. Chemistry framework details are explained in FDA’s Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations)<\/a>, which replaced the 1992 “Points to Consider” paper.<\/p>\n

This pathway is voluntary in form but commercially mandatory in practice. A recycler seeks FDA’s Office of Food Additive Safety review of submission data on source of the post-consumer feedstock (bottle-grade PET only); contamination history of that feedstock; decontamination steps; surrogate challenge testing data; and intended food-contact conditions of use (e.g., room-temperature aqueous, hot-fill, retort). If FDA staff decide the process can limit dietary intake of any potential migrant to below 0.0025 g\/kg body weight per day, they issue a non-objection. A recycler’s process number then appears on the publicly available FDA Recycled Plastics in Food Packaging<\/a> list of approved processes.<\/p>\n

Three things catch out first-time applicants. First, an LNO is process-specific, not material-specific – change the input feedstock or operating temperature and the LNO no longer covers your output. Second, FDA review timelines are not contractual; the agency targets a few months but can pause for clarification requests. Third, an LNO is not a Food Contact Notification (FCN). FCNs are filed separately for new food-contact substances under 21 U.S.C. 348(h); the LNO route applies specifically to recycling processes and lives adjacent to, not inside, the FCN system.<\/p>\n

Practically: if your packaging will be sold into the U.S., your rPET supplier must give you the LNO recycle number, the version of the process that received it, and a recent declaration the resin you are buying came from that exact process operating within its evaluated parameters. No number, no purchase order.<\/p>\n

The EFSA Roadmap \u2014 Regulation 2022\/1616 & the Authorisation Procedure<\/h2>\n

\"The<\/p>\n

EU’s regulatory stack is taller than the U.S. one. Regulation (EC) 1935\/2004 lays the stick: every food-contact material must not transfer constituents in quantities that endanger human health. Regulation (EU) 10\/2011 governs plastics specifically. Regulation (EU) 2022\/1616 – which entered into force on 10 October 2022 – covers recycled plastic materials and articles intended for food contact. Since 10 July 2023, no new PET recycling process can place EU-bound food-contact rPET on the market without passing EFSA’s evaluation route.<\/p>\n

Application procedure has four stages, all detailed on the EFSA Plastic Recycling Process page<\/a>: pre-submission registration in Connect.EFSA and study notification; submission and completeness check via the e-submission Food Chain platform; risk assessment by EFSA’s Panel on Food Contact Materials (CEF Panel); and post-adoption authorisation by the European Commission together with EU Member States. EFSA aims for a 6-month risk assessment when the dossier is complete, but the clock is paused if the panel requests further studies – applicants who plan as if “6 months” is a hard ceiling often miss launch windows.<\/p>\n

Scientific benchmark is laid by the EFSA Scientific Guidance on post-consumer mechanical PET recycling processes<\/a>, published on 30 July 2024. It lays down how the challenge test has to be set up, which surrogates to be used, and how the decontamination factor necessary to ensure dietary exposure remains below 0.0025 g\/kg body weight per day.<\/p>\n

Once approved by the Commission, the recycler can be registered on the EU Register of authorised recycling processes and must operate according to its conditions: input must be post-consumer PET containers only intended for food contact, operating parameters must be defined and contamination reduction verified with traceability to the converter. A public performance index of the EU regulatory package is the European Commission Plastic Recycling page<\/a>. However, as industry research by Paula Leardini and Carolina Perujo Holland at ICIS showed, dual track applicants consistently underestimate the extent to which the EFSA dossier differs in design from the FDA pathway – two mechanisms for evaluation do not mirror each other.<\/p>\n

Decontamination Technology \u2014 How rPET Achieves Food-Contact Safety<\/h2>\n

\"Decontamination<\/p>\n

Decontamination is the layer of process engineering that justifies the regulatory layer above it. Among recycling technologies, EFSA is currently only approving post-consumer mechanical PET recycling processes; chemical and advanced recycling routes (glycolysis, methanolysis, enzymatic depolymerisation) are approved under separate rationalities, as they convert PET to monomer and re-polymerise it. Within the mechanical world the common processes are vacuum-assisted solid state polycondensation (SSP) reactors and high temperature reactor lines.<\/p>\n

One detail is king: residence time temperature vacuum. Modern post-consumer PET (PCR-PET) lines pump flake or melt through a heated vacuum reactor for periods of hours and temperatures just below the melt range, at a high enough vacuum to drain away residual organic contaminants. Equipment lines such as Erema VACUREMA, Starlinger viscoSTAR \/ iV+, Polymetrix SSP, Bandera, and Krones MetaPure each have one or more EFSA opinions of scientific assessment and FDA Letter of Non-Objection covering a certain operating window. Adjust that window, and the regulatory coverage disappears.<\/p>\n\n\n\n\n\n\n\n\n\n
Dimension<\/th>\nMechanical (SSP \/ vacuum reactor)<\/th>\nChemical (depolymerisation)<\/th>\n<\/tr>\n<\/thead>\n
Decontamination mechanism<\/td>\nVolatilisation under vacuum + heat<\/td>\nBreak PET \u2192 monomer \u2192 re-polymerise<\/td>\n<\/tr>\n
EFSA evaluation track<\/td>\nReg 2022\/1616 \u2014 established<\/td>\nCase-by-case, monomer purity demonstration<\/td>\n<\/tr>\n
Typical input feedstock<\/td>\nPost-consumer food-grade PET bottles only<\/td>\nWider scope (films, trays, mixed PET)<\/td>\n<\/tr>\n
Energy intensity<\/td>\nLower \u2014 PET stays as polymer<\/td>\nHigher \u2014 polymerisation step required<\/td>\n<\/tr>\n
Maturity (industrial scale, 2026)<\/td>\nMany EFSA opinions; dominant route<\/td>\nFewer authorised plants; scaling up<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

To brand owners reading suppliers datasheets, the learned distinction here is: route is less important than proof. A mechanical line with a registered EFSA opinion, sound migration data, and a national authorisation is regulatorily equivalent to a chemical line with a registered authorisation, sound migration data, and a national authorisation. Food contact compliance is not about “we use the same type of equipment they do” – that is a technical story, not a regulatory document.<\/p>\n

Migration & Challenge Testing \u2014 The Compliance Proof Layer<\/h2>\n

\"Migration<\/p>\n

Challenge testing converts engineering into regulation. A recycler contaminates virgin PET (or post-consumer flake) with a test cocktail of surrogate molecules, feeds the contaminated material through the recycling process under worst-case operating conditions, and measures how much of those harmful substances remain in the output. That decontamination value is then entered into a model of dietary intake, which then asks: would any residual migrate into food at a level exceeds the prescribed intake ceiling? If not, the process is approved.<\/p>\n

\ud83d\udcd0 Engineering Note \u2014 Standard Surrogate Cocktail<\/strong><\/p>\n

The seven suspected surrogate molecules in the EFSA document and in the majority of FDA approvals: toluene (volatile non-polar), chlorobenzene (volatile polar), chloroform (volatile polar small), methyl salicylate (semi-volatile polar), phenylcyclohexane (heavy non-volatile non-polar), benzophenone (heavy aromatic), methyl stearate (heavy non-polar fatty). Those seven compounds encompass the number of molecules and the diversity of properties anticipated to occur with real world PET contaminants. With those seven compounds, the challenge test exposes the flake to specific initial concentrations, runs the recycling line, and samples residual concentrations.<\/p>\n<\/div>\n

What does a rPET Certificate of Analysis include?<\/h3>\n

A complete set of rPET Certificates of Analysis supports the batch-level proof in the regulatory documentation. The batch CoA should at least include: (1) the LNO number or EFSA scientific opinion number that authorizes the process; (2) input feedstock declaration (post-consumer food-grade PET, source of bottles, free of thermoform contamination); (3) intrinsic viscosity (IV), typically 0.72-0.84 dl\/g for bottle-grade; (4) residual moisture, often below 50 ppm before extrusion; (5) PVC contamination below 50 ppm and adhesive\/glue contamination below 50 ppm; (6) overall migration test result against the 10 mg\/dm limit in Reg 10\/2011; (7) specific migration results for the surrogate set against the dietary-intake model. If the CoA stops at “complies with FDA\/EFSA” without the LNO\/opinion number and the test data it is not a CoA it is marketing.<\/p>\n

Trade associations forums such as IFSQN<\/a> repeatedly comment on practitioner blind spots: the GC-MS panel ordered by the converter often does not include all seven surrogates used by the recycler in their challenge test. Ensure those test panels match otherwise the brand owner is verifying a different question than the one the regulator addressed.<\/p>\n

US vs EU vs FSSAI \u2014 Regional Compliance Comparison<\/h2>\n

\"US<\/p>\n

Three major rPET food-contact frameworks \u2014 FDA, EFSA, FSSAI \u2014 follow the 0.0025 \u00b5g\/kg threshold but differ in how they get there. None offers automatic mutual recognition, so suppliers serving multiple regions must demonstrate that one recycle line is safe for food contact under each set of global standards independently.<\/p>\n\n\n\n\n\n\n\n\n\n
Dimension<\/th>\nU.S. (FDA)<\/th>\nEU (EFSA \/ EC)<\/th>\nIndia (FSSAI)<\/th>\n<\/tr>\n<\/thead>\n
Output document<\/td>\nLetter of No Objection (LNO)<\/td>\nEFSA scientific opinion + EC authorisation in EU Register<\/td>\nFSSAI compliance approval<\/td>\n<\/tr>\n
Voluntary?<\/td>\nVoluntary in form, mandatory in commerce<\/td>\nMandatory since 10 July 2023 (Reg 2022\/1616)<\/td>\nMandatory under 2022 PET draft guidelines<\/td>\n<\/tr>\n
Public inventory<\/td>\nFDA Recycled Plastics list<\/td>\nEU Register of authorised recycling processes<\/td>\nFSSAI list (not as exhaustive)<\/td>\n<\/tr>\n
Mutual recognition<\/td>\nNo \u2014 FDA LNO is not EFSA-equivalent<\/td>\nNo \u2014 separate EFSA dossier required<\/td>\nNo \u2014 FSSAI runs its own evaluation<\/td>\n<\/tr>\n
Typical timeline (complete dossier)<\/td>\n~6-12 months<\/td>\n~6 months EFSA + Commission authorisation<\/td>\nVariable<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Decision Framework \u2014 Which Submission(s) Match Your Market?<\/strong><\/p>\n