When a hospital value-analysis committee, OEM/ODM specification holder or EU importer qualifies a polymer-heavy medical device, phthalate files rarely fail because a manufacturer openly ignores the law. They fail in two predictable ways. In the first, the device intentionally uses bis(2-ethylhexyl) phthalate (DEHP, CAS 117-81-7) above 0.1% weight by weight (w/w), and the supplier offers a short narrative—“PVC with DEHP is the industry standard”—instead of what the MDR asks for: an exposure estimate, an analysis of alternative substances, materials and designs, and argued reasons why those alternatives are inappropriate1. The European Commission's Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) turned those duties into a 10-step benefit-risk method in 2019 and adopted its first five-year update on 14 June 20242, 3.
In the second, the supplier claims the device is “DEHP-free” or below 0.1% w/w, and the buyer accepts a one-page certificate without asking whether a plasticized sub-component was averaged across a whole kit, or whether a tubing extruder, connector moulder or adhesive supplier introduced DEHP. Our review of US Food and Drug Administration (FDA) device recall records found that most recall events whose stated reason mentions DEHP or phthalates involved products labelled DEHP-free or phthalate-free that were not11. SCHEER's 2024 update also cites a laboratory study (Wang and Kannan, 2023) that detected DEHP in 99% of single-use intensive-care devices tested after ethanol/water extraction, “including those labelled DEHP-free”2—a detection finding, not proof that those devices exceeded 0.1% w/w.
This Buyer Guide gives regulatory, quality and procurement teams a four-gate protocol for both cases: (1) verifying the 0.1% w/w denominator and contact scope across the overlapping EU, US and procurement rules; (2) auditing a supplier's 10-step SCHEER justification and its Section 10.4.5 label and instructions-for-use (IFU) output; (3) testing multi-year supply contracts against the 2029–2035 EU REACH and California AB 2300 dates; and (4) verifying any “DEHP-free” claim with component-level analytical evidence.
Gate 1: Audit the 0.1% w/w Denominator and Contact Scope Before Reading the Justification
Before reviewing a single toxicological calculation, a buyer or regulatory reviewer must verify how the supplier calculated its 0.1% weight by weight (w/w) figure and which parts of the device fall inside the rule. Two recurring errors undermine supplier declarations at this first gate: citing the wrong subsection of the MDR, and using the total weight of a multi-component assembly as the denominator.
1. The Exact Structure of EU MDR Annex I Section 10.4
In the EUR-Lex text of Regulation (EU) 2017/745, Annex I, Chapter II, Section 10.4 (Substances), the requirements sit in five subsections1:
- Section 10.4.1 (Design and manufacture of devices): sets the
0,1 % weight by weight (w/w)condition for parts in three contact or fluid pathways and two hazard groups:(a)substances that are carcinogenic, mutagenic or toxic to reproduction (CMR) of category 1A or 1B in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CLPharmonised classifications), and(b)substances with endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health, identified under REACH Article 59 or, once the relevant delegated act applies, the Biocidal Products Regulation criteria1. - Section 10.4.2 (Justification regarding the presence of CMR and/or endocrine-disrupting substances): the justification must be based on
(a)patient or user exposure,(b)an analysis of alternative substances, materials or designs and their availability,(c)argumentation why substitutes or design changes are inappropriate for functionality, performance and benefit-risk—including for children, pregnant or breastfeeding women and other vulnerable groups—and(d)the latest relevant scientific committee guidelines where applicable1. - Section 10.4.3 (Guidelines on phthalates): required the Commission to mandate the relevant scientific committee to prepare benefit-risk guidelines on CMR/ED phthalates, ready before 26 May 2020 and updated when appropriate and at least every five years1, 2.
- Section 10.4.4 (Guidelines on other CMR and endocrine-disrupting substances): extends that mandate to other CMR/ED substances where appropriate1.
- Section 10.4.5 (Labelling): requires the presence of such substances above
0,1 % w/wto be labelled on the device and/or the unit or sales packaging with the list of substances, and residual-risk and precaution information in the instructions for use (IFU) where the intended use includes children, pregnant or breastfeeding women or other particularly vulnerable groups1.
Check which subsection a supplier's file cites for each claim. A label or IFU review should point to Section 10.4.5, and a justification should answer Section 10.4.2(a)–(d). Sections 10.4.3 and 10.4.4 describe the Commission's guideline mandate, not a manufacturer duty, so a file that cites them as the labelling rule has mapped its evidence to the wrong requirement1.
2. Why Whole-Device Weight Dilution Fails Section 10.4.1
Look at the exact wording of EU MDR Annex I Section 10.4.1 governing both the denominator and the clinical pathways covered1:
“Devices, or those parts thereof or those materials used therein that: — are invasive and come into direct contact with the human body, — (re)administer medicines, body liquids or other substances, including gases, to/from the body, or — transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body, shall only contain the following substances in a concentration that is above 0,1 % weight by weight (w/w) where justified pursuant to Section 10.4.2…”— Regulation (EU) 2017/745 (EU MDR), Annex I, Chapter II, Section 10.4.1
Because the text names “those parts thereof or those materials used therein”, the 0.1% w/w (1,000 ppm, or 1 gram per kilogram of material) threshold is assessed for each covered part or material—not averaged across a multi-part kit or a pump housing1. SCHEER's comparison table (Table 6) is to be completed “for every component of the medical device that contains CMR/ED phthalate(s) above the 0.1% w/w level”, although for some devices used as a system, such as a blood bag system, the whole system might be evaluated2. SCHEER puts typical DEHP content in plasticized PVC at around 30–40% by weight2. So a 5-gram flexible PVC administration tube plasticized with 30% w/w DEHP holds 1.5 grams of DEHP. Divided by a 2,000-gram procedure kit, that is 0.075%—an invalid calculation. At the level of the fluid-transporting PVC material the concentration is 30% w/w, 300 times the threshold, which triggers both the Section 10.4.2 justification and Section 10.4.5 labelling.
Buyers importing into the EU or selling into California also need to track how the same 0.1% figure works under other rules that apply alongside Section 10.4:
| Regime & Legal Basis | Covered Phthalates / Chemicals | Covered Device or Component Scope | Exact Threshold & Denominator Basis | Buyer Consequence if Triggered |
|---|---|---|---|---|
| 1. EU MDR Annex I Section 10.4 (Reg. (EU) 2017/745) | CMR 1A/1B substances with a harmonised CLP classification, and EDs for human health identified under REACH Article 59 or the Biocidal Products Regulation criteria. For phthalates this includes DEHP, BBP, DBP, DIBP and DCHP (identified as EDs for human health under REACH Article 57(f)); check CLP Annex VI for current CMR entries. | Devices, or parts/materials thereof, that are (1) invasive with direct body contact, (2) (re)administer medicines, body liquids or other substances including gases to/from the body, or (3) transport or store them for (re)administration. | > 0.1% w/w in the covered part or material. | Section 10.4.2 justification (based on the latest SCHEER guidelines where applicable), Section 10.4.5 substance list on the label, and IFU residual-risk information where vulnerable groups are treated. |
| 2. EU RoHS (Dir. 2011/65/EU Annex II, as amended by Del. Dir. (EU) 2015/863) | DEHP, BBP, DBP and DIBP; applies to medical devices and IVDs from 22 July 2021. | Electrical and electronic medical devices and IVDs, including parts that never touch the patient (cable jackets, internal wiring, housings). | > 0.1% by weight in any homogeneous material. | Restricted substance: an MDR justification does not substitute for RoHS compliance; only a listed RoHS exemption applies. |
| 3. EU REACH Article 33(1) and the SCIP database (Reg. (EC) 1907/2006; Dir. 2008/98/EC Art. 9(1)(i)) | Any substance on the REACH Candidate List of substances of very high concern, which includes DEHP, BBP, DBP, DIBP and other ortho-phthalates. | Every article supplied in the EU, including each constituent article of a complex product such as a device or kit (Case C-106/14). | > 0.1% w/w of each article. | Supplier must give recipients enough information for safe use—at minimum the substance name—and, since 5 January 2021, notify the same information to ECHA (SCIP). |
| 4. California AB 2300 (Health and Safety Code §§ 109051–109052) | DEHP. Separately, DEHP may not be replaced, for revised or new products, with other ortho-phthalates (the statute names 11 others, such as BBP, DBP and DINP). | IV solution containers and IV tubing sold or distributed in California; human blood collection and storage bags and apheresis and cell therapy blood kits and bags (including integral tubing) are exempt. | No intentionally added DEHP; unintentionally added DEHP must be below 0.1% w/w. | Manufacturing, sales and distribution ban in California: IV containers from 1 Jan 2030 (1 Jan 2032 for manufacturers that met the notice conditions), IV tubing from 1 Jan 2035. |
| 5. Hospital purchasing criteria (Health Care Without Harm / Practice Greenhealth) | PVC and other chlorinated polymers, and DEHP. | Priority categories include enteral nutrition products and enteral tubes, general urological items, parenteral infusion sets and respiratory therapy disposables. | No PVC (very small components under 1% of product weight allowed; PVC tubing not exempt); DEHP de minimis 1,000 ppm (0.1%) in homogeneous materials. | Contract or tender preference, not law—but a 'DEHP-free' answer to such a questionnaire becomes a claim the supplier must be able to substantiate. |
Source: Compiled from Regulation (EU) 2017/745 Annex I Section 10.4; SCHEER 2024 guidelines; Delegated Directive (EU) 2015/863 (RoHS); REACH Article 33(1) as interpreted in Case C-106/14 and Directive (EU) 2018/851; California Health and Safety Code Sections 109051–109052 (AB 2300); and Health Care Without Harm / Practice Greenhealth criteria.
Two traps in Table 1. First, if the product is an electrical medical device—an infusion pump, electrosurgical generator or negative-pressure therapy unit—RoHS has restricted DEHP, BBP, DBP and DIBP above 0.1% in any homogeneous material, such as a PVC power-cord jacket or internal wiring, since 22 July 2021, even though those parts never touch the patient or carry fluids7, 2. Second, a part outside the three Section 10.4.1 pathways—for example the adhesive backing of a securement dressing on intact skin—needs no Section 10.4.2 justification, but a Candidate List phthalate above 0.1% w/w in that article still triggers REACH Article 33(1) communication and SCIP notification in the EU1, 18, 19. Do not assume drainage parts are out of scope: the second indent of Section 10.4.1 covers devices that (re)administer body liquids “to/from the body”, so ask the manufacturer to document its scope decision for drainage tubing and canisters1.
Gate 2: How to Audit a Supplier's 10-Step SCHEER 2024 Benefit-Risk Assessment
When a device or fluid-path component falls inside Section 10.4.1 and contains a CMR 1A/1B or ED phthalate above 0.1% w/w, Section 10.4.2(d) requires the justification to be based on, “where applicable and available, the latest relevant scientific committee guidelines”1. Since 14 June 2024 those are SCHEER's Update of the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties2, 3.
The guidelines are a scientific committee opinion—the document notes that committee opinions “do not necessarily reflect the views of the European Commission”—so the binding duty remains the MDR text2. But SCHEER states that the guidelines “shall be used by all relevant stakeholders, e.g., manufacturers, notified bodies and regulatory bodies” for the justification, and recommends a multidisciplinary team including a material scientist, medical device specialist, toxicologist and clinician2. The benefit-risk assessment (BRA) has three phases and 10 steps: Steps 1–3 describe the CMR/ED phthalate “use scenario”; Steps 4–7 inventory and assess alternatives (the “non-use scenario”); and Steps 8–10 compare functionality and performance, hazard and exposure, and overall benefit and risk, supported by an uncertainty analysis2.
What Changed in the June 2024 SCHEER Revision?
SCHEER itself describes the June 2024 changes as limited: the main text describing the selection and evaluation procedure “remains essentially the same as presented in the guidelines as published in 2019”, and most new material sits in added annexes2. A justification written against the 2019 guidelines is therefore not automatically obsolete, but the supplier should be able to show a dated gap review against these changes2, 3:
- “Most relevant” alternatives and a minimum of three: from Step 5 onward the framework speaks of “most relevant” rather than “potential relevant” candidates, suggests evaluating a minimum of three alternatives, and requires justification when fewer are evaluated2, 3.
- ISO 10993-18 in Step 1: characterization of the device composition now refers to
(EN) ISO 10993-18, including extractables and leachables, and the document points toISO 10993-18:2020/Amd.1:2022for the analytical uncertainty factor2, 13. - Endocrine-disruptor hazard classes: the update adds the CLP Category 1 and Category 2 ED classes created by Delegated Regulation
(EU) 2023/707, while noting that the 2017 MDR does not reference this categorisation and MDCG-endorsed documents do not yet include it2, 6. - Three new annexes: Annex 8 (exposure to currently used alternatives), Annex 9 (health hazards of alternatives) and Annex 10 (progress with alternatives in red blood cell storage bags)2.
- Updated evidence base and regulatory context: a literature search covering 1 January 2017 to 1 October 2023 (381 published articles), and an Annex 5 that reflects Regulation
(EU) 2023/2482moving the REACH dates for DEHP in medical devices to 2029 and 20302, 4.
Buyers should check Steps 4 and 5 of the supplier's alternatives assessment against SCHEER's minimum-candidate wording on page 272:
“Preferably a number of alternatives should be evaluated, and justification should be provided when fewer than three alternatives are evaluated.”— SCHEER, Update of the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices (Final version adopted 14 June 2024), Section 5, Step 5, p. 27
For a deeper look at how chemical characterization and toxicological risk assessment files fit together across an entire biological evaluation report, see our companion ISO 10993 Biocompatibility File Review Guide. Use Table 2 below as your line-by-line audit sheet when reviewing a supplier's Section 10.4.2 phthalate justification.
| SCHEER 2024 Step & Phase | Required Evidence in the Supplier's Technical File | Key Quantitative Metric or Standard | Common Supplier Shortcut (Red Flag) | Buyer / Notified Body Audit Verdict |
|---|---|---|---|---|
| Step 1 (CMR/ED Scenario): Device Composition & Phthalate Characterization | Exact chemical identity (IUPAC, CAS, EC/EINECS number), concentration (% w/w) in each invasive or fluid/gas-contacting part/material, and physical/chemical binding mechanism affecting migration. | (EN) ISO 10993-18 chemical characterization (extractables and leachables); substance identified by CAS, EINECS and IUPAC name. | Reporting % w/w against total device assembly mass, or relying solely on raw resin SDS ranges without component-level mass fraction. | Reject until % w/w is stated per contacting part/material and backed by analytical characterization. |
| Step 2 (CMR/ED Scenario): Use, Function & Clinical Benefit of the Phthalate | 2a: Specific material functionality/performance imparted by the phthalate (e.g., PVC tube kink resistance, optical clarity, sterilization stability, or RBC membrane stabilization). 2b: Resulting clinical benefit to targeted patient groups (including vulnerable groups). | Intended use and functionality described as for the Summary of Safety and Clinical Performance (MDCG 2019-9 rev.1); key function and performance criteria defined and justified. | Generic claim that 'DEHP makes PVC soft and cheap' without linking material properties to clinical safety or performance. | Require objective functional criteria (e.g., kink radius, Shore hardness; for blood bags, end-of-storage hemolysis below 0.8%) that alternatives will be tested against. |
| Step 3 (CMR/ED Scenario): Risk Assessment of the CMR/ED Phthalate | 3a: Realistic worst-case patient/user/donor exposure (simulated-use leaching per ISO 10993-12 / 10993-18 considering temperature, polarity, flow rate, duration, and repeated exposure). 3b–3d: Hazard PoD (NOAEL, LOAEL, BMDL) and risk ratio per subgroup. | MoS / MoE = PoD ÷ exposure, or RCR = exposure ÷ reference value (ISO 10993-17). Where several CMR/ED phthalates are present, justify each and their combination (EFSA's 2019 group TDI of 50 µg/kg bw/day, as DEHP equivalents, covers DBP, BBP, DEHP and DINP). | Using an oral route PoD for an intravenous device without toxicokinetic route-to-route extrapolation, or omitting neonates/pregnant women. | Reject if route of exposure mismatches clinical use or if vulnerable patient subpopulations are omitted. |
| Step 4 (Non-Use Scenario): Inventory of Possible Alternatives | Inventory across substances (4a), materials (4b) and designs or medical treatments (4c), e.g., alternative plasticizers, inherently flexible non-PVC polymers (polyolefins, silicone, TPU, EVA) and alternative device designs. | MDR 10.4.2(b) and SCHEER Step 4: marketed alternative devices, independent research, peer-reviewed studies, committee opinions and in-house R&D; SCHEER names the European Pharmacopoeia as an information source. | Restricting the inventory strictly to drop-in PVC plasticizers while ignoring non-PVC elastomers or already-marketed DEHP-free competitor devices. | Incomplete under MDR 10.4.2(b) unless substances, materials and designs (and, where relevant, treatments) were inventoried and documented. |
| Step 5 (Non-Use Scenario): Candidate Shortlisting & Exclusion Justification | Documented inclusion/exclusion screening against the Step 2 function, performance and toxicity criteria, plus availability (volumes on the market, access to proprietary alternatives, e.g., via licensing). | SCHEER Step 5 rule (p. 27): 'Preferably a number of alternatives should be evaluated, and justification should be provided when fewer than three alternatives are evaluated.' | Evaluating only a single straw-man alternative (or dismissing all alternatives as 'too expensive' without technical or supply-availability proof). | Require evaluation of ≥3 relevant alternatives or a documented scientific/market justification for why fewer than 3 exist. |
| Step 6 (Non-Use Scenario): Technical Feasibility & Benefit of Shortlisted Alternatives | 6a: Assessment of shortlisted candidates under actual processing, sterilization (EO, gamma, steam), shelf-life, and drug-interaction conditions. 6b: Inventory of clinical benefits of the alternatives per patient group. | Comparative bench testing (kink, tensile, sterilization aging, drug sorption) and clinical outcome equivalence. | Claiming an alternative fails sterilization or kinks based on 15-year-old literature when commercial medical grades have solved the issue. | Demand contemporary test data or current polymer supplier technical dossiers for the shortlisted candidates. |
| Step 7 (Non-Use Scenario): Comparative Risk Assessment of Shortlisted Alternatives | 7a–7d: Realistic worst-case leaching, hazard characterization (acute, repeated-dose, CMR/ED, and general ISO 10993 endpoints), and MoS/MoE or RCR calculation for each shortlisted alternative across patient/donor/user groups. | Simulated-use leaching under conditions identical to Step 3 (ISO 10993-12 / 10993-18); QSAR/read-across documented if PoD is lacking. | Dismissing an alternative because 'toxicological data are incomplete' without documenting any literature search, QSAR, or read-across effort. | Verify that leaching conditions match Step 3 and that missing PoDs are addressed per SCHEER p. 32. |
| Step 8 (Comparison): Functionality & Performance Comparison | Direct comparison between the CMR/ED phthalate baseline and each shortlisted alternative across critical functional and clinical performance criteria. | SCHEER Table 6 (p. 35): side-by-side comparison of the reference phthalate and each alternative—function, clinical and material benefit, concentration, leaching, exposure, hazard, point of departure, risk characterisation, confidence (Table 7) and technical feasibility. | Declaring any minor mechanical difference 'clinically unacceptable' even when no clinically relevant difference in patient outcome is foreseeable. | SCHEER p. 18: functionality need only be comparable to the extent that no clinically relevant difference in outcome is foreseen. |
| Step 9 (Comparison): Hazard & Realistic Worst-Case Exposure Comparison | Side-by-side comparison of hazard classifications, leaching rates, and resulting MoS/MoE or RCR values across all intended patient and user groups. | Direct comparison of MoS/MoE or RCR ratios per patient group (separating neonates, children, and pregnant/breastfeeding women). | Comparing total mass of plasticizer in the polymer rather than realistic worst-case clinical leachable dose and toxicological risk ratio. | Ensure comparison is normalized to patient internal dose and PoD/reference value, not raw formulation percentage. |
| Step 10 (Comparison & Conclusion): Overall Benefit-Risk Conclusion & Uncertainty Analysis | Integrated synthesis of functionality, performance, benefit, and risk (Table 6), accompanied by a structured uncertainty analysis (Section 10, Table 7) and periodic review triggers under ISO 14971 / PMS. | SCHEER Table 7 (p. 42): 5-level probability scale adapted from ISO/TR 24971 (Improbable <10%, Remote 10–33%, Occasional 33–66%, Probable 66–90%, Frequent >90%), plus the Section 10.4.5 label and IFU check. | Omitting the Section 10 uncertainty analysis, or failing to translate residual risks for vulnerable groups into the physical IFU under Section 10.4.5. | Verify Table 6 synthesis, Table 7 uncertainty analysis, unit/pack phthalate label, and matching IFU residual-risk warnings. |
Source: Adapted from Regulation (EU) 2017/745 Annex I Section 10.4.2 and the SCHEER guidelines update (adopted 14 June 2024; Sections 3–10, Tables 6 and 7, pp. 17–43).
How Buyers Should Evaluate the Supplier's Alternatives Analysis (Steps 4–6) Without Making Unverified Material Rankings
A common mistake in hospital procurement and OEM specification writing is demanding a specific replacement plasticizer by name without regard to the clinical fluid pathway or sterilization method. SCHEER's annexes show why no single alternative is a universal drop-in2:
- Tubing and platelet bags versus red blood cell bags: four alternative PVC plasticizers used in devices—n-butyryl-tri-n-hexyl citrate (BTHC), di(2-ethylhexyl) terephthalate (DEHT), diisononyl cyclohexane-1,2-dicarboxylate (DINCH) and trioctyl trimellitate (TOTM)—are included in the European Pharmacopoeia, and SCHEER reports that DEHP has been almost fully replaced with BTHC, DINCH and/or TOTM in platelet storage bags2. Red blood cell storage bags are harder: leached DEHP incorporates into the red cell membrane and reduces hemolysis, and EU rules require hemolysis below
0.8%at the end of shelf life, usually 5–7 weeks (Directive 2004/33/EC, Annex V)2. Phase I studies summarised in SCHEER Annex 10 kept hemolysis below that limit with DINCH, DEHT or BTHC bags, in several cases by pairing them with second-generation storage solutions such asPAGGSMorAS-3; SCHEER still calls for a careful benefit-risk assessment that goes beyond hemolysis before DEHP is replaced2. - Why buyers audit the method rather than rank plasticizers: SCHEER's Annexes 8 and 9 show that exposure differs by plasticizer and use and that toxicological information on the alternatives is less exhaustive than for DEHP2. California also bars replacing DEHP with other ortho-phthalates, so a switch to, say, DINP is not an option for a California IV product9. The buyer's job is to verify that the supplier screened at least three relevant candidates across substances, materials and designs (Step 5) and assessed them under the device's actual contact media and sterilization conditions (Steps 6–7)—not to prescribe a chemistry2.
Auditing the Section 10.4.5 Labelling and IFU Residual-Risk Output
Even when a supplier's justification passes technical review, EU MDR Annex I Section 10.4.5 requires two outputs a buyer can check directly on the product1:
“Where devices, parts thereof or materials used therein as referred to in Section 10.4.1 contain substances referred to in points (a) or (b) of Section 10.4.1 in a concentration above 0,1 % weight by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances. If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.”— Regulation (EU) 2017/745 (EU MDR), Annex I, Chapter II, Section 10.4.5 (Labelling)
Check that the unit or sales packaging names the substance (for example DEHP), not just a generic warning. Labels often carry a graphical symbol—ISO 15223-1:2021 includes a “contains hazardous substances” symbol (5.4.10)—but Section 10.4.5 requires the list of substances, so a symbol without the substance name is incomplete1, 21. If the intended use includes children, pregnant or breastfeeding women or other particularly vulnerable groups, the IFU must give information on residual risks and, if applicable, precautions. A justification whose Step 3 identifies higher exposure for neonates, paired with an IFU that is silent on it, is a mismatch to raise with the supplier1, 2.
Gate 3: Stress-Testing Multi-Year Supply Contracts Against the 2029–2035 EU and US Phase-Out Clocks
A valid Section 10.4.2 justification supports CE marking a device that contains more than 0.1% w/w DEHP today. It does not settle whether the device can still be manufactured with DEHP in the EU after 2030, or sold in California, during a five-year tender or OEM agreement. Contracts signed in 2026 should be mapped against the dates below.
1. EU REACH Annex XIV Entry 4: The 2029 and 2030 Dates—and Why Imported Devices Differ
Commission Regulation (EU) 2021/2045 of 23 November 2021 updated REACH Annex XIV (the Authorisation List) entries 4–7 for DEHP, BBP, DBP and DIBP to add endocrine-disrupting properties for human health and, for DEHP only, endocrine-disrupting properties for the environment5. That environmental listing is what matters for devices. Uses in medical devices are exempt from authorisation for substances listed for human-health hazards only; once DEHP was also listed for an environmental hazard, its uses in medical devices became subject to authorisation, initially with a latest application date of 27 November 2023 and a sunset date of 27 May 20255, 2.
Regulation (EU) 2023/607 then extended the MDR transitional periods to 31 December 2027 for higher-risk devices and 31 December 2028 for medium- and lower-risk devices, subject to conditions4. Commission Regulation (EU) 2023/2482 explains the collision this created: replacing DEHP could be a significant change in design that ends a legacy device's transitional period, so a DEHP-free version could be placed on the market only once a notified body issued a new certificate4. So that limited notified-body capacity would not penalise companies substituting DEHP, Regulation (EU) 2023/2482 of 13 November 2023 moved the dates for uses of DEHP in medical devices within the scope of Regulations (EU) 2017/745 and (EU) 2017/7464:
- Latest application date: 1 January 2029 — the deadline for applying to ECHA for authorisation to keep using DEHP in EU device manufacturing after the sunset date4.
- Sunset date: 1 July 2030 — after this date such uses are not allowed unless an authorisation has been granted, or an application submitted before the latest application date is still awaiting a decision4.
A legal distinction for EU importers and OEM buyers: SCHEER's Annex 5 notes that “imported articles do not come under the authorisation requirement”2. An imported finished device containing more than 0.1% w/w DEHP is therefore not caught by the 2030 sunset date itself, but remains subject to (1) MDR Section 10.4 justification and labelling, (2) REACH Article 33(1) communication and SCIP notification, (3) RoHS if it is electrical equipment, and (4) any future REACH restriction1, 18, 19, 7. On the last point, ECHA's investigation report on PVC and PVC additives, announced on 28 November 2023, identified risks from PVC additives including ortho-phthalate plasticisers and pointed to regulatory action8. A MedTech Europe update circulated by BIVDA reports that the June 2025 revision of the EU Restrictions Roadmap changed the Commission's decision on whether to mandate a restriction of PVC and its additives from Q3 2025 to “TBD”20.
2. California AB 2300 (2030 / 2035) and the US Supply Debate
There is no federal US ban on DEHP in medical devices; SGS describes California as the first US jurisdiction to restrict ortho-phthalates in medical devices10. FDA evaluates leachable constituents such as DEHP through biocompatibility and toxicological risk assessment, and points manufacturers to its ISO 10993-1 guidance (final, September 2023)12, 15. Asked by Medical Design & Outsourcing, FDA said manufacturers should no longer rely on its earlier “Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices”, which “may not align with toxicological risk assessment practices used by the FDA today”15. State law is moving faster.
California Assembly Bill No. 2300 was approved by the Governor on 25 September 2024 (Chapter 562, Statutes of 2024). It adds Chapter 18, Chemicals in Medical Devices (Sections 109050–109052), to the Health and Safety Code; supporters call it the Toxic-Free Medical Devices Act9, 17. Section 109052 provides9:
- 1 January 2030 — IV solution containers: no person or entity may manufacture, sell or distribute into commerce in California IV solution containers made with intentionally added DEHP. A manufacturer delayed by pending FDA approval of its DEHP-free container, or by lacking adequate equipment, has until 1 January 2032 if it notified California customers by 1 July 2025 that development had started and, by 1 January 2028, notifies customers and posts on its website that it will miss the 2030 deadline9, 10.
- 1 January 2035 — IV tubing: the same prohibition applies to IV tubing made with intentionally added DEHP9.
- No ortho-phthalate substitution: DEHP may not be replaced, for revised or new products, with other ortho-phthalates. The statute defines ortho-phthalates as esters of ortho-phthalic acid, including 11 others it lists by name and CAS number (
BBP,DBP,DCHP,DEP,DIBP,DIDP,DINP,DnHP,DNOP,DnPPandDIHP)9. - Unintentionally added DEHP: an IV solution container or IV tubing product may not contain unintentionally added DEHP—DEHP with no functional or technical effect—at or above
0.1 percent weight per weight (w/w)9. - Exemptions: human blood collection and storage bags, and apheresis and cell therapy blood kits and bags, including integral tubing9.
Manufacturers' public statements frame the commercial risk. B. Braun, which says it was the first company to support AB 2300, reports that the bill passed the State Senate 40–0 and the Assembly 74–017. Baxter, which describes itself as the largest US supplier of IV fluids, welcomed “appropriate implementation timelines in the interest of protecting supply continuity”, said it is expanding a portfolio of more than 150 non-DEHP IV container and tubing products, and said it “stands behind the safety of our current products, which are FDA approved”16. For a hospital or OEM buyer the lesson is practical: you do not need to settle the toxicology debate to manage the commercial risk—you need to know whether a supplier's product line can lawfully and contractually ship into each target jurisdiction through 2035.
| Effective Date | Jurisdiction & Instrument | Affected Medical Devices or Substances | Operational Requirement | Buyer / Importer Action Item |
|---|---|---|---|---|
| In force (since 22 July 2021) | EU RoHS 2 Category 8 (Dir. 2011/65/EU + (EU) 2015/863) | Electrical and electronic medical devices and IVDs containing DEHP, BBP, DBP, or DIBP > 0.1% w/w in any homogeneous material. | Hard restriction on placing non-compliant electrical medical devices on the EU market. | Audit power cords, internal wire harnesses, and strain reliefs separately from the MDR Section 10.4 fluid-path file. |
| 17 June 2024 (adopted 14 June 2024) | EU MDR Section 10.4.2(d) / SCHEER guidelines update | Invasive direct-contact and fluid- or gas-path parts with CMR 1A/1B or ED phthalates > 0.1% w/w. | First five-year update becomes the latest relevant scientific committee guidelines for new and revised justifications. | Ask for a dated gap review of 2019-based justifications (most relevant alternatives, minimum of three, ISO 10993-18 characterization). |
| 1 May 2025 (substances) / 1 May 2026 (mixtures); products already on the market have until 1 Nov 2026 / 1 May 2028 | EU CLP Delegated Regulation (EU) 2023/707 | Substances and mixtures meeting the new ED HH 1 or ED HH 2 criteria. | Classification and labelling under the new endocrine-disruptor hazard classes, reflected in safety data sheets. | Collect updated resin, plasticizer and adhesive safety data sheets to spot newly classified endocrine disruptors. |
| 31 Dec 2027 / 31 Dec 2028 | EU MDR Transitional Deadlines (Reg. (EU) 2023/607) | Legacy MDD/AIMDD devices transitioning to EU MDR (Class III / IIb implantable by Dec 2027; other Class IIb / IIa / Is / Im by Dec 2028). | Full EU MDR Annex I Section 10.4.2 justification and 10.4.5 labelling audited by the Notified Body for MDR certificate issuance. | Confirm whether any planned DEHP substitution will be certified under the initial MDR application or post-certification change notice. |
| 1 January 2029 | EU REACH Annex XIV Entry 4 — Latest Application Date (Reg. (EU) 2023/2482) | Use of DEHP in the EU/EEA to manufacture medical devices within the scope of MDR (EU) 2017/745 or IVDR (EU) 2017/746. | Deadline to submit a REACH authorisation application to ECHA to continue EU manufacturing use of DEHP past July 2030. | Require EU-based contract manufacturers using DEHP to declare by 2027 whether they will reformulate or file for REACH authorisation. |
| 1 January 2030 (or 1 Jan 2032 with extension) | California AB 2300 (Health & Safety Code § 109052) | Intravenous (IV) solution containers sold or distributed in California (excluding blood and apheresis/cell-therapy bags). | Ban on IV containers made with intentionally added DEHP; unintentionally added DEHP must be below 0.1% w/w; DEHP may not be replaced with other ortho-phthalates. | Ensure US hospital and distributor contracts for IV containers include a DEHP-free SKU transition schedule before 2030. |
| 1 July 2030 | EU REACH Annex XIV Entry 4 — Sunset Date (Reg. (EU) 2023/2482) | Use of DEHP in the EU/EEA to manufacture medical devices (unless a REACH authorisation is granted or pending from a pre-2029 filing). | Prohibition on EU chemical use/placing on market of DEHP for medical device manufacturing without authorisation. | Verify EU manufacturing continuity or completed material substitution validation well before July 2030. |
| 1 January 2035 | California AB 2300 (Health & Safety Code § 109052) | Intravenous (IV) tubing sold or distributed in California (excluding integral blood/apheresis/cell-therapy tubing). | Ban on IV tubing made with intentionally added DEHP; unintentionally added DEHP must be below 0.1% w/w. | Verify non-ortho-phthalate tubing validation (kink resistance, pump peristaltic fatigue, drug sorption) for US IV administration sets. |
Source: Compiled from Delegated Directive (EU) 2015/863 (RoHS); the SCHEER guidelines update (June 2024); Delegated Regulation (EU) 2023/707 (CLP); Regulation (EU) 2023/2482 (REACH Annex XIV); Regulation (EU) 2023/607 as summarised in Regulation (EU) 2023/2482; and California AB 2300 (Chapter 562, Statutes of 2024).
Gate 4: Verify 'DEHP-Free' Claims—What FDA Recall Records Show
When a buyer refuses DEHP-plasticized PVC, or a supplier markets a device with a “DEHP-free” or “not made with DEHP” symbol, procurement teams often assume the phthalate question is closed. FDA recall records suggest otherwise: an unverified claim turns trace DEHP in a sub-component, or a label-artwork mistake, into a labelling problem that can end in a recall11.
To see how these failures surface, we searched the reason-for-recall field of FDA's device recall records (openFDA export of 24 July 2026, 58,785 product-level records) for “DEHP” or “phthalate”, and took recall classes from FDA's enforcement report export of 22 July 202611. The search returned 70 records. We excluded two where “Non-DEHP” appeared only in the product name and the recall concerned a drip-chamber leak or a luer occlusion (Z-1291-2024 and Z-1016-2017), leaving 68 product-level recall entries in 9 recall events (grouped by firm and initiation date); 5 of those events (11 entries) began between July 2023 and April 202611. A text search misses recalls whose stated reason does not name DEHP or phthalates, and recall counts do not measure how often mislabelling occurs.
| Recall Initiated & FDA Recall No. | Recalling Firm, Recall Class & Product Code | Affected Device(s) | Reason Reported to FDA | Buyer Control That Would Catch It |
|---|---|---|---|---|
| 2026-04-23 (Z-2653-2026) | Covidien LLC · Class II · BTO | Shiley Disposable Decannulation Plug (REF DDCP) | Labelling change control: label carried the symbol indicating non-DEHP although the product includes 30 to 35% DEHP. | Artwork-to-BOM reconciliation: no DEHP-free symbol on artwork without a matching composition sign-off. |
| 2024-05-17 (Z-2131-2024 to Z-2134-2024; 4 entries) | B. Braun Medical Inc. · Class II · BXN | Stimuplex A insulated nerve-block needles (20G–24G, 25–150 mm; four catalogue numbers) | Component design/selection: labelled “not made with DEHP” or with the DEHP-free symbol, but the glue used contains traces of DEHP. | Composition disclosure and screening for adhesives, solvent cements and inks—not only resins and tubing. |
| 2023-10-13 (Z-0360-2024) | Avanos Medical, Inc. · Class II · BSY | BALLARD Closed Suction System for Adults, 14 Fr (product code 221038) | Labelling change control: certain lots labelled as not made with DEHP, but the tubing components contained DEHP. | Lot-level incoming verification (e.g., FTIR or GC-MS on tubing) where a tubing source runs both DEHP and non-DEHP compounds. |
| 2023-10-11 (Z-0349-2024 to Z-0351-2024; 3 entries) | Becton Dickinson & Company · Class II · FPA | BD Alaris pump infusion sets, gravity sets and extension sets | Error in labelling: sets labelled as free of DEHP actually contain DEHP. | Part-number-to-label matrix audit across multi-component sets (Y-sites, drip chambers, tubing segments). |
| 2023-07-27 (Z-2522-2023 and Z-2523-2023) | Aomori Olympus Co., Ltd. · Class II · FDS | Olympus distal attachments for endoscopes—disposable (in EMR kits) and reusable models | Nonconforming material/component: DEHP exceeded the permissible exposure level calculated according to ISO 10993-17:2002. | Updated ISO 10993-18 characterization and ISO 10993-17 risk assessment after any material or supplier change. |
| 2021-01-28 (Z-1409-2021) | OriGen Biomedical, Inc. · Class III · KJA | Evolve cell culture bags (EV1000N, EV3000N); ethylene vinyl olefin bag, optional tubing sets that can include PVC tubing | Labelling false and misleading: bags incorrectly labelled as free of phthalates. | Separate declarations for bag film and attached tubing sets before approving a whole-assembly claim. |
| 2017-07-31 (Z-2606-2018 to Z-2658-2018; 53 entries) | ICU Medical, Inc. · Class II · FMG | Blood sets and blood tubing accessories (53 catalogue entries) | Labelling mix-up: some devices labelled “Does not contain DEHP” even though the product may contain small amounts of DEHP. | Finished-device chemical verification before moving legacy SKUs to DEHP-free artwork. |
| 2011-01-07 (Z-1255-2011 and Z-1256-2011) | Convatec Inc. · class not in export · BYG, BYL | Face tents and aerosol/oxygen masks | Nonconforming material/component: sticky residue on the masks consisting of dioctyl phthalate, epoxidized soybean oil and glycerol monooleate. | Accelerated-ageing and exudation checks on plasticized PVC respiratory parts. |
| 2009-05-08 (Z-1420-2012) | Baxa Corporation · class not in export · LHI | EVA total parenteral nutrition bags (Exacta-Mix EVA bags, dual-chamber Halobag, calibration bags) | Labelling false and misleading: the spike port of the EVA TPN bags contains low levels of DEHP which could leach out. | Test spike ports, injection ports and tubing bonds before accepting a non-PVC or DEHP-free bag claim. |
Source: VEMERIX analysis of openFDA device recall records exported 24 July 2026 (58,785 rows; 70 matches, 68 entries in 9 events after excluding 2 product-name-only matches). Recall classes from the openFDA enforcement export of 22 July 2026, which does not cover the two oldest events. Reasons condensed from FDA's recall text.
The pattern in Table 4: 7 of the 9 events—and 4 of the 5 since July 2023—involved products labelled DEHP-free or phthalate-free that contained DEHP or phthalates11. The other two concerned an exposure-limit exceedance (Aomori Olympus) and a plasticizer residue on masks (Convatec)11. Three lessons stand out:
- A non-PVC body does not make a DEHP-free device: in Baxa (
Z-1420-2012) the bag was EVA but the spike port contained DEHP; in B. Braun (Z-2131-2024–Z-2134-2024) it was the glue; in Avanos (Z-0360-2024) the tubing components11. A DEHP-free claim has to cover every component and joining material. - Detection is not the same as exceeding a threshold: SCHEER cites Wang and Kannan (2023), who detected DEHP in 99% of single-use ICU and NICU devices extracted in ethanol/water—including devices labelled DEHP-free—and estimated exposure doses from
0.005 to 730 µg/kg bw/day, highest from cannulas for newborns2. Because trace detection is common, a contract should state which limit a DEHP-free claim means—for example California's 0.1% w/w for unintentionally added DEHP or a hospital programme's 1,000 ppm in homogeneous materials—and how it is tested9, 14. - Exposure limits apply to small accessories too: in Aomori Olympus (
Z-2522-2023andZ-2523-2023), DEHP in endoscope distal attachments exceeded the permissible exposure level calculated underISO 10993-17:200211.
What to Put in Your RFQ, Quality Agreement, and Incoming Inspection Protocol
Whether you are qualifying a private-label OEM manufacturer, onboarding a surgical-consumable supplier for EU distribution or answering a hospital value-analysis questionnaire, replace generic “phthalate compliance” checkboxes with four verifiable deliverables tied to change control. For change classification and contractual change-control provisions under the QMSR and ISO 13485:2016, see our design transfer and change-control guide.
- Component-level bill of materials (BOM) substance table: every invasive, fluid- or gas-contacting and skin-contacting component and sub-component (including ports, connectors, stopcocks, O-rings, solvent cements, UV adhesives and printing inks), with polymer family, plasticizer name, CAS number and maximum concentration in
% w/wper component material. - For devices declaring >0.1% w/w CMR/ED phthalates in a part covered by MDR Section 10.4.1: (a) the
Section 10.4.2justification with a dated gap review against the 14 June 2024 SCHEER update (10 steps, at least three most relevant alternatives or a justification for fewer, Table 6 comparison and uncertainty analysis); (b) the underlyingISO 10993-18chemical characterization andISO 10993-17toxicological risk assessment; (c) unit or sales packaging artwork that lists the substance; (d) IFU text on residual risks and precautions for children, pregnant or breastfeeding women and other vulnerable groups where relevant (Section 10.4.5); and (e) a written plan for the REACH 2029/2030 dates (for EU manufacturing sites) and California AB 2300 (for US IV products)1, 2, 4, 9. - For devices claiming “<0.1% w/w” or carrying a “DEHP-free / phthalate-free” claim: analytical results (for example GC-MS or LC-MS, with stated detection and reporting limits) covering every material of the assembled device, including ports and adhesives, showing DEHP and other specified ortho-phthalates below the agreed limit—for example
0.1% w/w(1,000 ppm) in each homogeneous material—plus lot-traceable certificates from resin, compound and tubing suppliers13, 14. - Prior change notification (contractual): ISO 13485:2016 purchasing controls (clause 7.4.2) provide for a written agreement that suppliers notify changes to purchased product before implementing them22. Set a contractual notice period—for example 90 days—for any change to resin grade, plasticizer, tubing extruder, adhesive or solvent cement, sterilization cycle, or phthalate-related labelling, and require the buyer's written approval before implementation.
Where VEMERIX Fits — and What Buyers Should Request During Qualification
VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care.
VEMERIX's product pages make no “DEHP-free”, “phthalate-free” or “PVC-free” claims, and this guide makes none for any VEMERIX product. Whether a specific item—such as the Disposable NPWT Drainage Dressing Kit, whose drainage and extension lines are fluid-path parts, or the Medical Vacuum NPWT Pump, which is electrical equipment—falls under MDR Section 10.4, RoHS, REACH Article 33(1) or a hospital's material criteria depends on its component bill of materials, its contact pathway and the target market.
When qualifying VEMERIX for distributor onboarding or OEM/ODM supply, apply the same four-gate audit recommended here for any manufacturer: request component-level material declarations, sterilization and biocompatibility summaries, and change-control commitments for the specific SKU under review. You can review the ISO 13485 quality system on the quality and compliance page, download the product catalogue from the downloads page, and request SKU-specific technical documentation through the contact page.
Frequently Asked Questions (FAQ)
Does EU MDR Annex I Section 10.4 ban DEHP above 0.1% w/w in medical devices?
No. Section 10.4.1 sets a justification-and-labelling condition, not a ban1. A covered part may contain a CMR 1A/1B or identified ED substance above 0,1 % w/w where this is justified under Section 10.4.2—based, where applicable, on the latest SCHEER guidelines—and labelled under Section 10.4.51, 2. Separately, electrical and electronic devices fall under RoHS, which restricts DEHP, BBP, DBP and DIBP above 0.1% in homogeneous materials regardless of any MDR justification7, and using DEHP to manufacture devices in the EU requires REACH authorisation after 1 July 20304.
Is the 0.1% w/w threshold calculated against the entire device weight or each individual component?
Each covered part or material. Section 10.4.1 applies to “devices, or those parts thereof or those materials used therein” that meet the invasive-contact or fluid/gas pathway criteria, and SCHEER's comparison table is completed for every component above the threshold1, 2. You cannot dilute a plasticized PVC tube or connector below 0.1% w/w by dividing its phthalate mass by the weight of a kit or housing. Under REACH Article 33(1), the Court of Justice has held that the 0.1% threshold applies to each constituent article of a complex product18, and RoHS applies its limit to each homogeneous material7.
Which section of the EU MDR requires phthalate labelling on the package and residual-risk information in the IFU?
Annex I, Chapter II, Section 10.4.5 (Labelling) of Regulation (EU) 2017/7451. Section 10.4.3 is the Commission's mandate for scientific-committee guidelines on phthalates and Section 10.4.4 extends that mandate to other CMR and ED substances; neither imposes the labelling duty1.
Are the June 2024 SCHEER phthalate guidelines legally binding?
Not as law. They are a scientific committee opinion, and SCHEER notes that its opinions “do not necessarily reflect the views of the European Commission”2. But Section 10.4.2(d) requires the justification to be based on, “where applicable and available, the latest relevant scientific committee guidelines in accordance with Sections 10.4.3. and 10.4.4.”1, and the guidelines say they “shall be used by all relevant stakeholders, e.g., manufacturers, notified bodies and regulatory bodies”2. In practice, a justification that departs from the 10-step structure needs an equally rigorous argument.
How many alternatives must a supplier evaluate in a SCHEER 2024 benefit-risk assessment?
In Step 5 (page 27), SCHEER states: “Preferably a number of alternatives should be evaluated, and justification should be provided when fewer than three alternatives are evaluated.”2 Step 4 requires the initial inventory to consider not only substitute substances but also alternative materials (such as non-PVC polymers), alternative designs and alternative medical treatments2.
Does the 1 July 2030 EU REACH Annex XIV sunset date ban imported finished medical devices containing DEHP?
Not directly. Commission Regulation (EU) 2023/2482 moved the REACH Annex XIV entry 4 latest application date to 1 January 2029 and the sunset date to 1 July 2030 for uses of DEHP in medical devices4, and SCHEER's Annex 5 notes that imported articles do not come under the authorisation requirement2. Imported devices must still meet MDR Section 10.4 (justification and labelling), REACH Article 33(1) and SCIP notification, RoHS if electrical, and any future REACH restriction following ECHA's 2023 PVC investigation1, 18, 19, 7, 8.
What does California AB 2300 ban, and what are the compliance dates?
AB 2300 (Chapter 562, Statutes of 2024; Health and Safety Code Sections 109050–109052) prohibits manufacturing, selling or distributing into commerce in California (1) IV solution containers made with intentionally added DEHP from 1 January 2030—or 1 January 2032 for manufacturers delayed by pending FDA approval or equipment that met the 2025 and 2028 notice conditions—and (2) IV tubing made with intentionally added DEHP from 1 January 20359, 10. Unintentionally added DEHP must stay below 0.1% w/w, DEHP may not be replaced with other ortho-phthalates in revised or new products, and human blood collection and storage bags and apheresis and cell therapy blood kits and bags (including integral tubing) are exempt9.
Why have 'DEHP-free' medical devices been recalled by the US FDA since 2023?
In FDA recall records exported on 24 July 2026, four of the five DEHP-related recall events initiated from July 2023 onward—Becton Dickinson (Z-0349-2024–Z-0351-2024), Avanos Medical (Z-0360-2024), B. Braun Medical (Z-2131-2024–Z-2134-2024) and Covidien (Z-2653-2026)—involved products labelled DEHP-free or carrying a non-DEHP symbol that contained DEHP; the records name tubing components, assembly glue and labelling errors11. The fifth, Aomori Olympus, was an exposure-limit exceedance. Do not approve a DEHP-free claim from a resin sheet alone: ask for analytical results covering tubing, ports and adhesives, backed by artwork-to-BOM change control11, 13.