Guide

PFAS, BPA & Phthalates: The Chemical-Restriction Floor in Plastics

The chemical-restriction floor for food-contact and consumer plastics is moving upward year on year. The 2023 EU PFAS restriction proposal under REACH — submitted jointly by Germany, the Netherlands, Denmark, Sweden and Norway — proposes a class-based restriction on PFAS in articles and uses. The 2024 EU Regulation 2024/3190 on BPA in food-contact applications effectively bans BPA in food-contact materials with narrow exceptions, replacing the previous 0.05 mg/kg SML and the 2018/213 varnish/coating measure. Annex XVII of REACH restricts DEHP, DBP, BBP and DIBP (entry 51), DINP/DIDP/DNOP in toys (entry 52) and four phthalates (DEHP, DBP, BBP, DIBP) in articles broadly (entry 51, RoHS-aligned). Across the Atlantic, California AB 1200 and AB 1817 ban PFAS in food packaging and apparel respectively, Maine LD 1503 imposes statewide PFAS reporting, and Washington's Safer Products law lists priority chemicals across packaging and consumer products. A plastics or resin manufacturer needs one operating model for the chemical-restriction floor across all three regions.

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PFAS — the EU REACH proposal and the US state patchwork

The 2023 EU PFAS restriction proposal, currently in evaluation by RAC and SEAC, defines PFAS as any substance with at least one fully fluorinated methyl (-CF3) or methylene (-CF2-) carbon atom (without H/Cl/Br/I attached). It proposes a general restriction with use-specific derogations under evaluation. In parallel, the EU food-contact PFAS direction under 10/2011 is tightening, the EU Toy Safety Regulation (replacing 2009/48/EC) restricts CMR-class PFAS, and the EU drinking-water directive sets a 0.5 µg/L PFAS limit. The US state landscape is already enforceable: California AB 1200 (2023, food packaging), Maine LD 1503 (PFAS in all products, reporting from 2025), Washington Safer Products Act (priority PFAS uses), New York S8817 (food packaging), Vermont S20, Connecticut HB 6486, Minnesota HF 2310 (extended PFAS ban from 2032). Treating PFAS as a controlled substance across the portfolio is no longer optional.

BPA and the EU 2024/3190 step-change

EU Regulation 2024/3190 (December 2024) bans BPA from food-contact materials — varnishes, coatings, polycarbonate, plastics, printing inks, adhesives — with narrow exceptions for specific industrial uses where no alternative exists, and an 18-month transitional period. This replaces the previous 0.05 mg/kg SML under 10/2011 and the 2018/213 measure on varnishes and coatings. Bisphenol S (BPS), BPF and other bisphenol analogues are explicitly captured. The recurring compliance failure is a can-coating supplier or polycarbonate maker reformulating to BPS without recognising that the new regulation covers the broader class. Outside the EU, US state-level BPA restrictions exist (California Prop 65, Connecticut, Minnesota, Washington baby-bottle laws) but no federal ban.

Phthalates — Annex XVII REACH and US state laws

REACH Annex XVII entry 51 restricts DEHP, DBP, BBP and DIBP in articles (food-contact, toys, childcare and broader) at 0.1 % w/w of the plasticised material. Entry 52 restricts DINP, DIDP and DNOP in toys and childcare articles that can be placed in the mouth. The 2018/2005 amendment expanded entry 51 to broader articles in line with REACH endocrine-disruption work. US CPSIA Section 108 restricts DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP and DCHP in children's toys and childcare articles at 0.1 %. California Prop 65 lists DEHP, DBP, BBP, DIBP, DnHP and others as reproductive-toxicity substances requiring warning labels above the safe-harbor levels. A PVC compounder serving children's articles, food-contact tubing or medical devices needs phthalate status documented at the additive level, not just the finished compound.

Heavy metals and the Annex II 2023 SML refresh

Annex II of 10/2011 was amended in 2023 to add Specific Migration Limits for lead (0.010 mg/kg), antimony (0.04 mg/kg), arsenic (0.002 mg/kg), mercury (0.003 mg/kg), barium (1 mg/kg), cobalt (0.05 mg/kg), copper (5 mg/kg), iron (48 mg/kg), lithium (0.6 mg/kg), manganese (0.6 mg/kg), nickel (0.02 mg/kg) and zinc (5 mg/kg). The amendment is bedding into supplier qualification audits — a colour masterbatch declaration that gives only the colourant Union List status, without the heavy-metal SML compliance evidence, no longer survives. CPSIA / ASTM F963-23 / EN 71-3 cover the parallel toy and children's product heavy-metal restrictions.

A 60-day chemical-restriction readiness path

Days 1–15: PFAS inventory — process aids, polymerisation aids, fluoropolymer components, residuals; analytical screening method confirmed; supplier declarations refreshed. Days 16–30: BPA / BPS / BPF / bisphenol-class status across every grade and additive against EU 2024/3190. Days 31–45: phthalate inventory by individual substance and class; CPSIA / Annex XVII / Prop 65 evidence assembled. Days 46–55: Annex II heavy-metal SML evidence per grade. Days 56–60: DoC reissue, customer-facing chemical-restriction declaration, watch-list set up for the moving EU PFAS proposal and US state bills.

Where this lives in V5 Ultimate

The clauses above aren't theoretical — every one maps to a shipped module and an industry profile. Jump to the parts of the product that turn this guide into evidence on a Monday morning.

Modules that do the work

Polymer QMS

PFAS, bisphenol, phthalate, heavy-metal status on one record.

Additive declarations

Supplier-side chemical-restriction evidence linked to grade.

Industries this hits hardest

Plastics & resins

Frequently asked

Is the EU PFAS restriction in force?

Not yet as of mid-2026. The 2023 proposal is in RAC/SEAC evaluation; sectoral derogations are under review; a final restriction is expected to enter force across 2026–2028 with use-specific transition periods. The US state laws are already enforceable and effectively set the floor today.

Does EU 2024/3190 cover BPS?

Yes. The regulation captures bisphenol analogues including BPS, BPF and others in scope of the food-contact ban, not just BPA. A reformulation to BPS does not escape the regulation.

What about phthalates in medical devices?

The Medical Device Regulation (EU 2017/745) Annex I Section 10.4 requires justification and labelling for CMR-class phthalates above 0.1 % w/w in invasive devices. This is independent of REACH Annex XVII and applies regardless of food-contact use.

Are recycled plastics held to the same chemical-restriction floor?

Yes — and often harder. Recycled streams can concentrate legacy substances (PFAS in firefighting-foam-impacted streams, phthalate plasticisers in PVC streams, BPA in polycarbonate streams). EU 2022/1616 and EFSA opinions require explicit assessment of legacy-substance carryover.

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