Regulation (EU) 2024/3190 — What Food-Contact Manufacturers Must Do Now
Commission Regulation (EU) 2024/3190, published in the Official Journal on 31 December 2024 and entering into force on 20 January 2025, bans the use of bisphenol A (BPA) and specified harmonised-classified bisphenols in a range of food contact materials. This practical guide explains what is covered, the key timelines and the concrete steps suppliers, packagers and manufacturers should take to stay compliant and protect business continuity.
Quick Answer
What it bans: BPA and certain other harmonised-classified bisphenols in plastics, varnishes & coatings, printing inks, silicones, adhesives, ion-exchange resins and rubber used in materials intended to come into contact with food.
When it takes effect: Regulation published 31 Dec 2024; enters into force 20 Jan 2025; phased transitional windows apply through 2029 for specific product groups. (See timeline below.)
1. What is Regulation (EU) 2024/3190?
This Commission Regulation updates the EU's set of specific measures under the general Food Contact Materials (FCM) framework. In plain terms: it prohibits the intentional use of BPA and other bisphenols with harmonised hazard classification for certain hazardous properties in specified FCM categories, and it amends Regulation (EU) No 10/2011 while repealing Regulation (EU) 2018/213.
2. Key Dates and Transitional Periods
Note: transitional terms allow a limited period for stocks already placed on the market or for specific industrial uses. Manufacturers must however retain full traceability and documentary evidence for items covered by transitional regimes.
3. Who Is Most Affected — Industry Impact Analysis & Response Strategies
Understanding which sectors bear the brunt of regulatory change helps prioritise resources. Below we list the sectors with the most immediate exposure and immediate tactical responses for each.
3.1 Most Affected Sectors
- Food packaging manufacturers — inner coatings, laminates and barrier layers often contain epoxy or phenolic chemistries that historically used BPA-based monomers.
- Metal can and lid producers — inner varnishes and sealing lacquers come under scrutiny; reformulation or migration evidence is needed.
- Large storage & transport equipment manufacturers — internal linings and coated surfaces in tanks and silos require reassessment for migration and durability.
- Coatings & adhesives suppliers — formula houses supplying FCM‑grade varnishes, inks and adhesives must provide declarations of conformity and test data.
- Cookware and kitchenware producers (coated aluminium/iron) — coating systems used on pans and bakeware must be checked for BPA-based components and migration behaviour.
3.2 Alternatives and Technical Pathways
Choosing a replacement requires balancing technical performance, cost, recycling and regulatory durability. Typical candidate routes include:
- Waterborne epoxy/polyester systems — lower migration potential but need compatibility testing with foodstuffs and process validation.
- Polyether sulfone (PES) or silicone-based resins — used for heat and chemical resistance in specific applications.
- Non-bisphenol monomers — commercial alternatives exist but must be screened for endocrine or other hazard endpoints.
Selection criteria: regulatory compliance (no harmonised classification), migration performance across intended use temperatures, durability under service life, compatibility with recycling streams and total cost of ownership (material cost + reformulation + testing + line changeover).
4. What the Regulation Means for Your Business (Practical Implications)
At the company level the regulation translates into four concrete areas of action: supply‑chain control, testing capacity, formulation strategy and market communication.
4.1 Supply‑Chain Responsibility
Procurement contracts should require suppliers to provide a declaration of conformity for raw materials and coatings used in FCM applications. Keep supplier contact information, batch numbers and third‑party test reports easily retrievable — regulators may request records for years after production.
4.2 Upgrading Testing & Laboratory Workflows
The new regulatory context tightens analytical requirements. Labs must validate LC‑MS/MS or equivalent methods to achieve the detection limits required for migration testing. Where in‑house capability is limited, plan accredited laboratory partnerships now.
4.3 Reformulation & Production Change Management
Set a staged reformulation roadmap: pilot batches, migration testing, accelerated ageing and process trials. For OEMs and co‑packers, consider dual‑sourcing for critical coatings during the transition window to avoid single‑supplier failure.
4.4 Market & Buyer Communications
Claims like “BPA-free” “BPA-free” indicates the product was manufactured without intentionally added Bisphenol A (BPA). This claim must be substantiated by representative migration testing under the product’s intended use conditions, supplier declarations for all relevant inputs and documented process controls. Be aware that some chemical substitutes (e.g., other bisphenols) may themselves have regulatory or toxicological concerns and require screening.
[EFSA reference] must be supported by data. Prepare a centred evidence pack for commercial buyers: tested migration data, supplier declarations, and a short usage guidance note that explains any use limitations.
5. How This Regulation Fits With Other EU Rules
Regulation 2024/3190 amends 10/2011 and repeals 2018/213; it sits alongside REACH and CLP. The immediate advantage is clarity — harmonised hazard classifications reduce the risk of inconsistent national interpretations. However, businesses must keep an eye on ongoing EFSA and DG SANTE assessments that could broaden the scope to other endocrine‑active substances.
6. Common Questions (FAQ)
- Q: Are BPS or BPF automatically allowed?
- A: No. Substitutes are not automatically permitted. If a bisphenol is subject to harmonised classification for the same hazardous properties or displays evidence of endocrine activity, it may be restricted. Conduct hazard screening before switching.
- Q: Can products manufactured outside the EU be sold in the EU?
- A: Yes — but they must comply. Importers and distributors carry responsibility to ensure conformity and to hold testing and supplier documentation on file for market surveillance checks.
- Q: Where can I find official test guidance?
- A: Official guidance and the regulation text are published in the Official Journal and on agency websites; accredited labs and notified bodies publish method notes and validation criteria.
- Q: What about stock already manufactured before the ban?
- A: Transitional provisions allow sale of certain stocks within defined windows. Maintain clear production and packing dates and ensure records are available to demonstrate eligibility for transitional provisions.
7. Step‑By‑Step Compliance How‑To
- Inventory & mapping — list all FCM articles, coatings, inks and adhesives by SKU and supplier.
- Supplier declarations — send a standardized request for conformity and retained certificates.
- Analytical testing — select accredited lab methods; validate for intended limit of quantification.
- Reformulation & trials — run pilot batches and ageing tests before full line conversion.
- Label & claim updates — ensure marketing language matches the technical evidence dossier.
- Archive & monitoring — establish retention timelines and a quarterly regulatory watch.
8. Mid‑To‑Long Term Trends & Strategy
The regulation accelerates two broader shifts: (1) substitution of legacy chemistries in favour of more circular, recyclable materials; and (2) closer integration of chemical safety and product design. Expect more stringent recycling‑compatibility requirements under the Packaging & Packaging Waste Regulation, and extend your compliance horizon to include potential restrictions on other endocrine disruptors.
9. Conclusion & Immediate Action Checklist
Short wrap: Regulation (EU) 2024/3190 tightens the regulatory landscape for FCMs. Prioritise supplier declarations, accredited migration testing and a staged reformulation plan. For most businesses the first 90 days after the regulation comes into force are about mapping and risk triage.
- Map your FCM exposure across SKUs and suppliers.
- Commission critical migration tests for representative batches.
- Prepare buyer evidence packs for major customers and tenders.
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