DEHP (DOP, Dioctyl Phthalate): Properties, Uses in PVC and Regulatory Status

DEHP (bis(2-ethylhexyl) phthalate, sold for decades as DOP or dioctyl phthalate; CAS 117-81-7) is a low-molecular-weight ortho-phthalate used as a primary general-purpose plasticizer for flexible PVC, and it is the reference against which every other plasticizer's efficiency is measured. Because DEHP carries a harmonised reproductive-toxicity classification, its legal position in Europe now differs sharply from its technical position in a compound, which raises the question of where it may still be used.

DEHP carries the harmonised CLP classification Repr. 1B, H360FD, has been on the REACH Candidate List since 28 October 2008, sits on REACH Annex XIV as entry 4 with a general sunset date of 21 February 2015 and a medical-device sunset date of 1 July 2030, and is limited to a specific migration of 0.6 mg/kg in EU food-contact plastics under Regulation (EU) 2023/1442. DEHP is one of 56 plasticizer pages in our directory of plastic additives, each carrying the same identity, dosage and regulatory fields.

This page holds the formulation view and the compliance view in one place: the identity data that separates DOP from the n-octyl isomer DNOP, the solvation mechanism, the measured physical constants, the 2 to 35 wt% use range and its conversion from phr, the five application areas, the migration routes and their test standards, the dated matrix across REACH, EU 10/2011, RoHS, MDR, FDA, TSCA, Proposition 65, CPSIA, Canada and Japan, the 22-year authorisation timeline, the hazard classifications, the 6 plasticizers that replaced it and what a buyer can still source.

Table T1. DEHP identity card.

Footnote: identity and physical data from PubChem CID 8343; regulatory entries from the ECHA obligation lists and the EU, US, Canadian and Japanese legal texts cited in each section. Status as of 23 September 2026.

What Is DEHP (DOP, Dioctyl Phthalate)?#

DEHP is the bis(2-ethylhexyl) ester of phthalic acid (benzene-1,2-dicarboxylic acid), a primary plasticizer that softens PVC on its own without a second plasticizer. Both ester groups sit in the ortho position, on adjacent carbons of the aromatic ring, and each one carries a branched C8 chain supplied by 2-ethylhexanol. The systematic name encodes exactly those two raw materials, phthalic acid and 2-ethylhexanol, and the molecule they form has the formula C24H38O4 and a molecular weight of 390.6 g/mol. Which substance, then, does the trade name DOP actually cover?

A primary plasticizer is defined by function rather than by chemistry. ASTM D883 defines a plasticizer as a substance incorporated into a plastic or elastomer to increase its flexibility, workability or distensibility, and a primary plasticizer is compatible enough with the resin to do that alone, unlike a secondary plasticizer or extender that has to be blended with one. Plasticizers are the heaviest additive family used in polymers by weight, and the hub on plasticizers for plastics compares every class of them, from phthalates and terephthalates to trimellitates, citrates, adipates and epoxidised esters. DEHP was the default general-purpose PVC plasticizer in Europe until the REACH restriction, and it is still used outside the EU and under the EU medical-device derogation.

What does DEHP stand for?#

DEHP stands for di(2-ethylhexyl) phthalate, also written bis(2-ethylhexyl) phthalate or diethylhexyl phthalate, and the older trade abbreviation DOP stands for dioctyl phthalate. Two further synonyms appear on supplier paperwork and in chemical databases: bis(2-ethylhexyl) benzene-1,2-dicarboxylate, the fully systematic IUPAC form, and the bare word phthalate in consumer reporting, where DEHP is usually the substance meant.

Is DOP the same as DEHP?#

Yes: in the plastics trade, DOP and dioctyl phthalate mean DEHP, CAS 117-81-7, even though the name reads as if it described a straight-chain octyl ester. The straight-chain ester exists as a separate substance, di-n-octyl phthalate (DNOP, CAS 117-84-0), so a data sheet that prints 117-84-0 under the heading "dioctyl phthalate" is describing a different chemical with a different restriction entry. The linear isomer, DNOP (di-n-octyl phthalate), carries EC number 204-214-7, sits in REACH Annex XVII entry 52 rather than entry 51, and has no known commercial use as a pure substance. Reading the CAS number instead of the trade name is therefore the only reliable check on an incoming certificate of analysis.

Why is DEHP called dioctyl phthalate when DNOP is the n-octyl isomer?#

DEHP and DNOP are isomers: both have the formula C24H38O4 and a molecular weight of 390.6 g/mol, and the only difference is that DEHP's two C8 chains branch at the second carbon while DNOP's run straight. The name dioctyl phthalate reads as a count of carbon atoms rather than as a description of chain shape, and industry fixed it to the branched ester because the branched ester was the one made and sold in volume. Both esters are ortho-phthalates, so both react the same way to a phthalate screening method that reports a class rather than a substance.

The regulation follows the CAS number and not the trade name. DEHP sits in REACH Annex XVII entry 51 and in Annex XIV entry 4; DNOP sits in Annex XVII entry 52 and on neither authorisation list. DEHP carries the harmonised classification Repr. 1B, H360FD, while DNOP carries a notified classification of H361 in the ECHA classification and labelling inventory and no harmonised entry at all.

Is DEHP a low- or high-molecular-weight phthalate?#

European Plasticisers groups DEHP with the low-molecular-weight ortho-phthalates, alongside DBP, DIBP and BBP, and it is this group that carries harmonised reproductive-toxicity classifications and the REACH Annex XVII entry 51 restriction. The grouping is a regulatory convention rather than a carbon count: DEHP's 2-ethylhexyl chain has 8 carbon atoms, more than the short C4 chains of DBP and DIBP that the term was originally coined for. The high-molecular-weight group named by the same trade body contains DINP, DIDP, DPHP, DIUP and DTDP.

The split matters because it predicts the legal treatment more reliably than the structure does. All 4 low-molecular-weight members are Substances of Very High Concern and all 4 share one Annex XVII entry, while the high-molecular-weight members are registered without an SVHC listing and are restricted only in mouthable toys and childcare articles. How the two groups differ in chain length, classification and restriction is set out on phthalate plasticizers.

How Does DEHP Plasticize PVC?#

DEHP plasticizes PVC by placing its ester molecules between the polymer chains, weakening the dipole interactions that hold them together and lowering the glass transition temperature of the compound. The aromatic ortho-diester structure solvates PVC chains readily, which gives DEHP high compatibility and fast gelation, and compatibility itself follows the solubility parameters: a polymer and a plasticizer stay compatible when their solubility parameters lie within about 1.5 (cal/cm3)^0.5 of each other. Why is DEHP the yardstick for plasticizer efficiency? Because it is the substance the industry fixed its substitution factor scale to, at a reference value of 1.00, so every competing ester is quoted as a ratio against it.

DEHP is dissolved in the PVC matrix and not bonded to it, and that single structural fact drives the rest of this page. An unbound ester leaves the article over time through contact, heat and simple ageing, which is why every DEHP rule written since 2008 is a migration rule rather than a manufacturing rule. Below roughly 15 phr the effect reverses: antiplasticization raises stiffness instead of lowering it, and one PVC and wood-fibre study, a single secondary source, recorded yield strength still rising up to 3.75 phr DOP.

The 4 classic plasticization theories are listed below.

• Lubricity theory: the plasticizer acts as a lubricant between polymer chains, reducing internal friction.
• Gel theory: the plasticizer breaks and masks the gel points at which PVC chains attach to each other.
• Free volume theory: the plasticizer increases the free volume between chains, allowing segmental motion at lower temperature.
• Mechanistic theory: solvation and desolvation run as a dynamic equilibrium, with plasticizer molecules exchanging continuously between polar sites.

The four theories are explained with solubility parameters and compatibility windows on how plasticizers work, where the softener function is set out for every ester class.

What Are the Physical and Chemical Properties of DEHP?#

DEHP is a colourless to pale yellow oily liquid with a melting point of -55 °C (-58 °F), a boiling point of 384 °C (723 °F at 760 mmHg) and a flash point of 215 °C (420 °F, open cup). The measured constants that a formulator and a safety officer both need are compared in Table T2.

Table T2. DEHP physical and chemical properties.

A density of 0.981 g/cm3 at 25 °C (0.98 at 77 °F) puts DEHP just below water, which is why spilled DEHP floats and why an aqueous extraction separates cleanly in the laboratory. Values on this page follow PubChem CID 8343; older NTP data sheets print a flash point of 405 °F, so check which method and which source a supplier sheet quotes before comparing two documents. The boiling point above 380 °C (716 °F) is the property behind the low volatility that made DEHP usable in wire insulation and coated fabric for decades.

Which Polymers Use DEHP, and at What Dosage?#

DEHP is used almost entirely in flexible PVC, at 2 to 35 wt% of the plastic material in the ECHA plastic-additives mapping exercise and at up to 40 wt% in PVC medical devices. The Hazardous Substances Data Bank records a wider band of 1 to 40 wt% across consumer plastics, and the difference between the two ranges is application rather than chemistry: a film or a profile sits at the bottom of the range and a soft tube sits at the top. How do phr values convert to weight percent? Divide the plasticizer's phr by the total phr of the whole formulation and multiply by 100, so 50 phr DEHP in a compound of 100 phr PVC plus 50 phr DEHP gives 50 / 150 x 100 = 33.3 wt%.

Compound recipes give DEHP in PHR (parts per hundred resin), which converts to weight percent against the full formulation total, and a real recipe also carries heat stabilizer, filler and lubricant, so the denominator is always larger than resin plus plasticizer alone.

Table T3. Reported DEHP levels by polymer and article.

DEHP in flexible PVC compounds#

In a flexible PVC compound DEHP sets the hardness: a total plasticizer content of 5 to 65 wt% covers roughly Shore A 50 to 90, and DEHP is the reference point every substitution calculation starts from. Hardness falls as plasticizer content rises, so a 0.5 mm calendered film for a shower curtain and a 3 mm gasket profile sit at opposite ends of the same range. Below about 15 phr the compound moves into the antiplasticization region, where the ester stiffens the matrix instead of softening it, and formulators therefore treat 15 phr as a practical floor rather than as a saving.

The substitution arithmetic is why the reference value matters. A compounder replacing DEHP at constant Shore A recalculates the loading by the substitution factor of the replacement, and DEHP now competes with DOTP, DINP, DINCH and TOTM across the plasticizers for PVC range.

DEHP in PVC plastisols#

DEHP is a general-purpose plastisol plasticizer that gels quickly because its aromatic ortho-diester structure solvates PVC readily, and plastisols based on it fuse in the usual 140 to 220 °C (284 to 428 °F) window. A plastisol is a dispersion of PVC paste resin in liquid plasticizer, so the plasticizer is the continuous phase and its solvating power governs both the storage viscosity and the fusion behaviour of the paste.

Comparative viscosity data for DEHP pastes is thin in the public record, and our source library holds no DEHP plastisol viscosity curve, gelation temperature or fusion profile. The one comparative statement available comes from BASF technical information, which reports that DINCH gives lower initial viscosity and better viscosity stability than DOP and DINP. Gelation speed and viscosity stability across ester classes are compared on plasticizers for PVC plastisol.

DEHP in PVC medical devices#

PVC medical devices carry the highest measured DEHP levels of any plastic article, up to 40 wt%, which is why the European rules for devices are written separately from the rules for every other article. A blood bag, an extracorporeal circuit and an infusion line all need a compound that stays soft at 4 °C (39 °F), survives steam sterilisation and welds cleanly, and DEHP delivered that combination at a cost no alternative matched for decades.

The European Union therefore split the timetable. Regulation (EU) 2023/2482 sets a latest application date of 1 January 2029 and a sunset date of 1 July 2030 for DEHP in medical devices, replacing the earlier dates of 27 November 2023 and 27 May 2025, while Annex I section 10.4 of Regulation (EU) 2017/745, the Medical Device Regulation, already requires a justification and specific labelling for any invasive or body-fluid-contact device containing more than 0.1 % w/w of a CMR category 1A or 1B substance. The MDR justification and labelling duties are set out on plastic additives in medical devices, and the full device formulation, including sterilisation stability, is on additives for medical plastics.

What Is DEHP Used For? Applications in Plastics#

DEHP is used in 5 plastics application areas: medical tubing and blood bags, flooring, wire and cable, coated fabrics and capacitor dielectric film. Three of the five, medical devices, flooring and cable, are legacy uses inside the European Union and remain current outside it, so a global bill of materials and a European one rarely match.

• Medical tubing and blood bags, under the EU derogation running to 1 July 2030.
• Flooring and wallcovering, a legacy use in Europe and a current one elsewhere.
• Wire and cable insulation and sheathing, a legacy use in Europe.
• Coated fabrics, including tarpaulins and synthetic leather.
• Capacitor dielectric film, sold to a purity grade.

Medical tubing and blood bags#

Blood bags and infusion tubing were the classic DEHP application, because a flexible PVC that stays soft at 4 °C (39 °F) and survives steam sterilisation was hard to match. The European Pharmacopoeia lists 4 alternatives for PVC blood containers: DINCH, BTHC, TOTM and DEHT. Those four are compared on plasticizers for medical devices, where the sterilisation and extractables data sit side by side.

Bernard and colleagues measured the substitutes in French infusion devices and reported plasticizer contents of 27 to 49 wt% in DEHP-free PVC tubing (PLoS One, 2018), which shows that removing DEHP changes the ester and not the loading. Inside the European Union the changeover is dated rather than voluntary: Regulation (EU) 2023/2482 sets the latest application date at 1 January 2029 and the sunset date at 1 July 2030.

Flooring and wallcovering#

PVC flooring is the market where the retreat from DEHP is best documented: Helene Wiesinger and colleagues at ETH Zurich (Environmental Science & Technology, 2024) trace the shift from DEHP to DINP and DIDP and then to DEHT, DEHA and EHDPP. Their survey of Swiss floorings placed on the market in 2021 and 2022 found restricted ortho-phthalates, mainly DEHP, in 21 % of samples, and other ortho-phthalates in a further 29 %.

The residues arrive with the recyclate rather than with the recipe. Wiesinger and colleagues report that 16 % of 151 new Swiss PVC floorings exceeded 0.1 wt% of regulated substances, mainly lead and DEHP. How recyclate carries restricted substances forward into new articles is covered under legacy additives in recycled plastic.

Wire and cable#

PVC cable insulation and sheathing used DEHP as the default general-purpose plasticizer until the Annex XVII restriction, and European cable compounds now run on DOTP, DINP or DIDP instead. TOTM covers the higher temperature classes, where a trimellitate's low volatility keeps the insulation flexible through long thermal ageing.

Our source library holds no DEHP-specific cable temperature rating and no limiting oxygen index value, so this page names the substitutes and quotes no rating. The full insulation package, from heat stabilizer to flame retardant and filler, is on additives for wire and cable compounds.

Coated fabrics and capacitor film#

Coated fabrics and capacitor dielectric film are the two smaller DEHP outlets, and both were served by the same general-purpose grade rather than by a specialty ester. Coated fabric covers tarpaulins, truck curtains and synthetic leather, where a plastisol or a calendered layer is applied to a woven or knitted substrate; capacitor film uses the plasticizer as the impregnating dielectric liquid rather than as a softener for a moulded part.

How Does DEHP Perform in PVC?#

DEHP is the reference for plasticizer efficiency: its substitution factor is set at 1.00, so a plasticizer with a typical factor of 1.04, such as DINP, needs about 4 % more material to reach the same hardness. The factors are quoted at Shore A 80 or at 50 phr, and they compound quickly at volume: at 40 phr DEHP, a switch to a 1.11 ester adds roughly 4.4 phr to the recipe. Is DEHP more volatile than its replacements? Our source library holds no DEHP volatility value for PVC under either ISO 176 or ASTM D1203, so this page names the methods and gives no number.

The test standards behind the indicators are fixed even where the values are not. ASTM D1203 Methods A and B and ISO 176 measure volatile loss, ISO 177 measures migration into a contacting material, and ASTM D1239 measures extraction by liquids. One rubber test series does carry a DEHP number: in an NBR compound of 34 % acrylonitrile content at 20 pphr, DOP lost 9.2 % of its weight after 70 hours at 125 °C (257 °F) and gave a brittleness point of -33 °C (-27 °F) as moulded under ASTM D2137. Substitution factors for the whole ester range, all referenced to DEHP, are listed on plasticizer efficiency and substitution factors.

Table T4. DEHP performance indicators and the standards that measure them.

Footnote: substitution factors are typical figures from one secondary source (Kanademy), not supplier data, and they are compared at Shore A 80 or at 50 phr. Empty values mean the figure is not in our source library; we do not estimate.

Why Does DEHP Migrate, and How Is It Measured?#

DEHP migrates because it is dissolved in the PVC matrix rather than bonded to it, so every route that removes a small molecule from a polymer, contact with fat, heat or simple time, removes DEHP. The ester keeps its own vapour pressure and its own solubility in the media it touches, and neither property is changed by the polymer around it. That is the reason the substance turns up in food, in dust and in urine while the article it came from still looks intact.

The 3 loss routes are listed below.

• Migration into a contacting material, such as a food, a fatty simulant or an adjacent polymer layer.
• Extraction by fatty or solvent media, including blood, lipid emulsions and cleaning solvents.
• Volatilisation at processing and service temperature, which drives fogging and weight loss.

Each route has its own method family. ISO 177 measures migration into a contacting material, ASTM D1239 measures extraction by liquids, and ASTM D1203 Methods A and B together with ISO 176 measure volatile loss. Why unbound esters leave the matrix at all is explained on plasticizer migration, in terms of the same solvation equilibrium described earlier on this page.

Food-contact compliance uses a different route again. A plastic article is tested against food simulants under standardised time and temperature conditions, and the result is compared with an overall migration limit of 10 mg/dm2, or 60 mg/kg for articles intended for infants and young children, before the substance-specific limit is applied. The simulants and conditions are set out under migration testing, and the DEHP-specific limit belongs to the regulatory section below.

What Is the Regulatory Status of DEHP?#

DEHP carries a harmonised reproductive-toxicity classification, has been on the REACH Candidate List since 28 October 2008, needs authorisation for EU use under Annex XIV entry 4, is restricted to 0.1 % in the plasticised material of all EU articles, and is limited to a specific migration of 0.6 mg/kg in EU food-contact plastics (status 23 September 2026). The restriction applies to the plasticised material and not to the article as a whole, so a compounder tests the compound rather than the finished part, and a soft gasket in a hard housing is assessed on the gasket.

Table T5. DEHP regulatory matrix, as of 23 September 2026.

Fifteen instruments across five jurisdictions reach DEHP, and they divide into three mechanisms: content limits in the article, migration limits into food, and authorisation with a date attached. How those instruments fit together, and which one binds first for a given article, is mapped on plastic additive regulations. Electrical and electronic equipment is governed by the fourth phthalate entry added by Delegated Directive (EU) 2015/863, which is covered on RoHS and plastic additives.

Is DEHP an SVHC, and does it need REACH authorisation?#

Yes to both: DEHP has been on the REACH Candidate List since 28 October 2008 and it sits on Annex XIV as entry 4, so any EU use after the sunset date of 21 February 2015 needs an authorisation unless an exemption or a derogation applies. The original listing ground was Article 57(c), the harmonised classification as toxic for reproduction category 1B. DEHP has been on the SVHC Candidate List since that date, and the entry has since been widened.

Endocrine-disrupting properties for human health and for the environment were added to the entry under Article 57(f), and Regulation (EU) 2021/2045, adopted on 23 November 2021 and published in OJ L 418 of 24 November 2021, carried those grounds into Annex XIV with derogation dates of 14 June 2023 and 14 December 2024. The derogations cover food-contact materials, the immediate packaging of medicinal products and mixtures containing 0.1 to 0.3 % DEHP. An authorisation is granted per use and per applicant, so a downstream user relies on an upstream holder's authorisation number rather than on a general permission.

The DEHP authorisation timeline: from Candidate List to the 2030 sunset#

The European timeline for DEHP runs over 22 years, from the 2008 Candidate List entry to the medical-device sunset date of 1 July 2030. Each step is a separate legal act with its own date, and Table T6 lists them in order.

Table T6. DEHP EU regulatory timeline.

Every plastic additive that carries a sunset date is listed on the REACH Annex XIV authorisation list, with its entry number and its latest application date. The pattern in the DEHP rows is worth reading twice: the 2015 sunset date did not end the substance, it moved it into a permission system, and the acts of 2020, 2021 and 2023 narrowed what that permission can cover.

Is DEHP restricted under REACH Annex XVII?#

Yes: REACH Annex XVII entry 51 limits DEHP, together with DBP, BBP and DIBP, to 0.1 % by weight individually or combined in the plasticised material of articles, and it has applied to all articles since 7 July 2020 under Regulation (EU) 2018/2005. The combined threshold is the point formulators miss most often, because four separate substances each below 0.1 % can still fail as a sum.

Five exemption classes sit in the entry: articles for exclusively industrial or agricultural use, motor vehicles, aircraft, laboratory measuring devices and medical devices. Entries 51 and 52 are set out side by side on REACH Annex XVII restrictions, which matters because entry 52 covers a different substance set at a different scope, namely DINP, DIDP and DNOP in toys and childcare articles that a child can put in the mouth.

Is DEHP allowed in food-contact plastics?#

Yes, under tight conditions in the EU: DEHP is listed in Annex I of Regulation (EU) No 10/2011 as FCM substance 283 with a specific migration limit of 0.6 mg/kg, and it may be used only as a plasticiser in repeated-use articles that contact non-fatty foods, or as a technical support agent at up to 0.1 % of the final product. Regulation (EU) 2023/1442 set that limit, entering into force on 1 August 2023 with a transition period running to 1 February 2025, and it replaced the earlier value of 1.5 mg/kg.

Two group restrictions apply on top of the individual limit. Group restriction 32 covers 22 plasticizer FCM numbers at 60 mg/kg, and group restriction 36 expresses DBP, DIBP, BBP and DEHP as DEHP equivalents with an SML(T) of 0.6 mg/kg, weighting DBP by 5, DIBP by 4, BBP by 0.1 and DEHP by 1. Group restrictions 32 and 36 and the overall migration limit are explained on EU 10/2011.

In the United States DEHP is one of the 8 ortho-phthalates that remained authorised as food-contact plasticizers after the FDA final rule of 20 May 2022 (87 FR 31080), with a prior sanction under 21 CFR 181.27 for foods of high water content, plus clearances under 21 CFR 175.105 for adhesives and 21 CFR 178.3910 for surface lubricants. A post-market review announced on 27 May 2026 proposes to place DEHP in a cumulative-assessment group with DCHP, DIOP and DINP under docket FDA-2026-N-5776, with the comment period extended to 26 July 2026; that is a proposal and not a restriction. Which 21 CFR sections cover each plasticizer is tabulated under FDA food contact rules.

Is DEHP allowed in toys and childcare articles?#

No, not above 0.1 %: DEHP is restricted in toys in the EU under REACH Annex XVII entry 51, in the United States under 16 CFR 1307.3(a), in Canada under SOR/2016-188 and in Japan under MHLW Notification 336. The four instruments use three different metrics, so a single test report rarely satisfies all of them at once.

The US entry under 16 CFR 1307.3(a) is the permanent prohibition, shared with DBP and BBP, at more than 0.1 % in children's toys and child care articles; the 2018 additions under 1307.3(b) cover DINP, DIBP, DPENP, DHEXP and DCHP from 25 April 2018. Canada's SOR/2016-188 limits DEHP to 1,000 mg/kg in the vinyl of toys and child care articles and has been in force since 22 June 2016, while Japan's MHLW Notification 336 under the Food Sanitation Law limits DEHP to 0.1 % in designated toys, issued on 6 September 2010 and applicable from 6 September 2011. The permanent prohibitions and the 2018 additions are separated on CPSIA phthalate limits.

Is DEHP listed under California Proposition 65?#

Yes: DEHP has been on the California Proposition 65 list for cancer since 1 January 1988 and for developmental and male reproductive toxicity since 24 October 2003. Two listings on one substance mean two warning grounds, and the later listing is the one that reaches consumer articles made of flexible PVC. Listing dates for every plasticizer are on California Proposition 65.

Neither a no-significant-risk level nor a maximum allowable dose level for DEHP is recorded in our source library, so this page states none; a warning decision is taken against the current OEHHA safe-harbor list rather than against a figure quoted here. State rules that reach plastic additives beyond Proposition 65 are collected under US state laws on plastic additives.

What did the US TSCA risk evaluation conclude?#

The US EPA published its final TSCA risk evaluation for DEHP in December 2025, and the Federal Register notice of availability of 6 January 2026 (91 FR 373) finds unreasonable risk driven by specific conditions of use. EPA had designated DEHP a high-priority substance for risk evaluation in December 2019, and the agency reported US production of 100 to 250 million pounds for 2015 in the prioritisation record.

Risk-management rulemaking follows an unreasonable-risk determination under section 6 of TSCA, and no rule text exists yet, so no compliance date can be given. The number of conditions of use behind the determination is not established by the Federal Register notice, so this page states none. How EPA runs a risk evaluation and what follows it is explained on TSCA and plastic additives.

Is DEHP Safe? Hazard Classification, Exposure and Evidence#

DEHP carries a harmonised classification under the EU CLP Regulation as a category 1B reproductive toxicant, H360FD, meaning it may damage fertility and may damage the unborn child. The harmonised entry in Annex VI of Regulation (EC) No 1272/2008 is the legal statement of hazard, and it is the ground on which the 2008 Candidate List entry was made. IARC classifies DEHP in Group 2B, possibly carcinogenic to humans.

The 3 strands a specifier has to keep separate are listed below.

• Classification: harmonised Repr. 1B, H360FD under CLP; IARC Group 2B; California Proposition 65 listings for cancer (1 January 1988) and for developmental and male reproductive toxicity (24 October 2003).
• Exposure: diet dominates intake for DEHP and the high-molecular-weight phthalates, as Ami Zota and colleagues reported in Environmental Health Perspectives in 2016, and urinary metabolite half-lives are under 24 hours, so biomonitoring measures recent exposure rather than a lifetime burden.
• Evidence: the FDA Public Health Notification of 12 July 2002 on DEHP in PVC medical devices gave an upper-bound neonatal intensive-care dose of about 3,000 µg/kg/day for a 4 kg neonate against a parenteral tolerable intake of 0.6 mg/kg/day.

Two study strands are cited most often. Paul Foster described the rodent phthalate syndrome in the International Journal of Andrology in 2006, a cluster of reduced fetal testosterone, hypospadias, cryptorchidism, shortened anogenital distance and nipple retention observed in rats. In human epidemiology, Leonardo Trasande, Buyun Liu and Wei Bao at New York University reported in 2021 a hazard ratio of 1.14 (95 % confidence interval 1.06 to 1.23) for all-cause mortality in adults with high-molecular-weight phthalate metabolites, which is an association and not causation.

This page states the classifications, the listings and the cited results and stops there. The exposure, biomonitoring and epidemiology evidence is assessed on phthalates: health effects, where the dose-response literature is weighed rather than listed. Why the Article 57(f) endocrine-disrupting grounds matter beyond DEHP itself is covered under endocrine disruptors in plastics.

What Are the Alternatives to DEHP?#

The 6 plasticizers that replaced DEHP are DOTP (DEHT), DINP, DIDP, DINCH, TOTM and, in medical and toy applications, the citrates ATBC and BTHC. None of them carries a harmonised reproductive-toxicity classification or an Annex XIV entry, and that single difference, rather than any performance gain, is what moved the volume.

Table T7. DEHP compared with its main replacements.

Footnote: SF values are typical figures from one secondary source (Kanademy), not supplier data. Empty cells mean the value is not in our source library; we do not estimate. Status as of 23 September 2026.

All six sit in the group regulators handle separately from the ortho-phthalates, and the terephthalates, cyclohexanoates, trimellitates and citrates among them are set out as non-phthalate plasticizers.

DEHP vs DOTP (DEHT)#

DOTP is the direct replacement for DEHP in most new flexible PVC compounds: it is an isomer with the same formula and molecular weight and a typical substitution factor of 1.03, but it carries no harmonised classification, no SVHC listing and no authorisation requirement. Moving the two ester groups from the ortho position to the para position changes the regulatory class from ortho-phthalate to terephthalate while leaving C24H38O4 and 390.6 g/mol untouched.

The gap shows in one food-contact number. DOTP is FCM substance 798 with a specific migration limit of 60 mg/kg, against 0.6 mg/kg for DEHP, a factor of 100 in the same regulation. DOTP / DEHT (dioctyl terephthalate) is the isomer with the ester groups in the para position, and it now carries most of the volume DEHP lost in Europe.

DEHP vs DINP and DIDP#

DINP and DIDP are the high-molecular-weight ortho-phthalates that took the volume DEHP lost: both are registered, neither is a Substance of Very High Concern, and REACH Annex XVII entry 52 restricts them only in toys and childcare articles that a child can put in the mouth. DINP (diisononyl phthalate) is restricted only in mouthable toys and childcare articles in the EU, carries CAS 28553-12-0, a molecular weight of 418.6 g/mol and a typical substitution factor of 1.04, and holds a US food-contact clearance under 21 CFR 178.3740 at up to 43 wt% in vinyl chloride polymers.

The two differ on the US side rather than the European one. DINP was listed under California Proposition 65 for cancer on 20 December 2013 with a no-significant-risk level of 146 µg/day and restricted under 16 CFR 1307 from 25 April 2018, while DIDP (diisodecyl phthalate) shares group restriction 26 with DINP at an SML(T) of 1.8 mg/kg, was listed under Proposition 65 for developmental toxicity on 20 April 2007 and is not restricted under 16 CFR 1307. Both carry TSCA risk evaluations finding risk to workers only, notified on 15 January 2025 (90 FR 3828) for DINP and on 6 January 2025 (90 FR 638) for DIDP.

DEHP vs DINCH#

DINCH is DINP with the aromatic ring hydrogenated to a cyclohexane ring, which removes the phthalate structure entirely and gives a plasticizer with no SVHC listing and no Annex XVII restriction. It carries CAS 166412-78-8, a US product CAS of 474919-59-0 and a molecular weight of 424.7 g/mol, and it is FCM substance 775 in Annex I of Regulation (EU) No 10/2011 with no individual specific migration limit and a place in group restriction 32.

BASF technical information reports lower initial plastisol viscosity and better viscosity stability for DINCH than for DOP and DINP, which matters for spread coating and slush moulding rather than for extrusion. DINCH (Hexamoll DINCH) is DINP with the ring hydrogenated, and it is one of the 4 alternatives the European Pharmacopoeia lists for PVC blood containers.

DEHP vs TOTM and BTHC in medical devices#

For medical PVC the European Pharmacopoeia names 4 DEHP alternatives, DINCH, BTHC, TOTM and DEHT, and the choice between them is driven by what the device has to do rather than by hardness alone. TOTM (trioctyl trimellitate) is the low-volatility option for tubing and high-temperature cable, with CAS 3319-31-1, a molecular weight of 546.8 g/mol, three ester arms instead of two and a typical substitution factor of 1.11; it is not listed in Annex I of Regulation (EU) No 10/2011, so a food-contact use needs a different justification route.

One alternative beats DEHP on function rather than on compliance. BTHC (butyryl trihexyl citrate) is the citrate used in platelet-storage containers, and BTHC-plasticised PVC shows higher oxygen and carbon dioxide permeability than DEHP-plasticised PVC, which benefits platelet storage and is the reason it appears in the PL 2209 platelet-storage container. Bernard and colleagues measured replacement plasticizers at 27 to 49 wt% in DEHP-free infusion devices (PLoS One, 2018), so the substitution changes the ester without lightening the compound.

What does "DEHP-free" mean on a label?#

"DEHP-free" means that DEHP was not used as the plasticizer, not that the article contains no plasticizer: DEHP-free PVC tubing still carries 27 to 49 wt% of a substitute such as TOTM, DEHT, DINCH or DINP, as Bernard and colleagues measured in French infusion devices (PLoS One, 2018). No legal definition of the claim and no numeric threshold for it are recorded in our source library, so the only quantified figure available is the regulatory one: 0.1 % by weight in the plasticised material under REACH Annex XVII entry 51, which belongs to the restriction and not to the marketing claim.

Two neighbouring claims say different things. "Phthalate-free" excludes the whole ortho-phthalate family, including DINP and DIDP, which a DEHP-free article may well contain; "PVC-free" changes the polymer itself, usually to polyolefin or to a thermoplastic elastomer, and therefore changes the whole additive package. What the broader claim covers, and where it is checked, is analysed on phthalate-free plastics. In the European Union a device claim is also backed by a legal duty: Annex I section 10.4 of Regulation (EU) 2017/745 requires labelling where a CMR 1A or 1B or endocrine-disrupting substance exceeds 0.1 % w/w in an invasive or body-fluid-contact device.

Who Supplies DEHP? Grades, Trade Names and Sourcing#

DEHP is sold under long-established trade names including Palatinol AH, Vestinol AH, Kodaflex DOP, Flexol DOP, Genomoll 100 and Sansocizer DOP, although European supply has contracted since the Annex XVII restriction took effect for all articles in 2020. Producers by region and product line are listed in our directory of plasticizer manufacturers; this page names only the brand owners our source library records, and leaves the other cells open rather than filling them from a search result.

Table T8. DEHP trade names and brand owners.

Footnote: we list a company only where our source library records it. Missing owners are being verified; see our methodology.

Price signals point one way. ResourceWise reports that the China DOP price fell by 1,700 to 1,750 RMB per tonne between January and November 2025, and that Chinese DOP imports fell 42 % while exports rose 35 % year on year over January to September 2025. No absolute price level for DEHP sits in our source library, so this page publishes none, and the drivers for DOP and its replacements are tracked on plasticizer prices. Buyers should ask the supplier for the technical data sheet, the safety data sheet and a written statement of the intended end use, because an EU buyer needs an authorisation or an exemption for almost every article application.

How Does DEHP Fit into the Wider Phthalate Family?#

DEHP is the historical centre of the ortho-phthalate class, the ester group that still accounts for most of the 8.4 million tonnes of plasticizer consumed each year worldwide, according to European Plasticisers. More than 85 % of European plasticizer use goes into flexible PVC, which is why a change in one phthalate's legal status moves an entire polymer market rather than a niche. Ceresana estimated global DEHP production at about 3.24 million tonnes for 2018, a figure reported through a secondary source and quoted here with that qualification. Full property data for the five leading plasticizers sit on the plasticizer comparison page.

Low-molecular-weight and high-molecular-weight ortho-phthalates#

DEHP shares its regulatory fate with 3 other low-molecular-weight ortho-phthalates: DBP, BBP and DIBP all sit on REACH Annex XIV with the same 21 February 2015 sunset date and in the same Annex XVII entry 51. The Annex XIV entry numbers run DEHP 4, BBP 5, DBP 6 and DIBP 7, and all four share the latest application date of 21 August 2013. DBP (dibutyl phthalate) carries Annex XIV entry 6 and the same sunset date, while the high-molecular-weight group of DINP, DIDP, DPHP, DIUP and DTDP carries no Annex XIV entry at all.

DEHP in recycled PVC and legacy articles#

DEHP is the clearest case of a legacy additive: Wiesinger and colleagues at ETH Zurich found in 2024 that 16 of every 100 new Swiss PVC floorings still exceeded 0.1 wt% of regulated substances, mainly lead and DEHP, because the recyclate carried them. A restricted substance enters a new article through the recycled fraction rather than through the recipe, which makes the compounder's incoming-material check the control point.

Klotz and colleagues modelled the persistence in Environmental Science & Technology in 2024 and find that without an active phthalate-removal step DEHP can stay above 0.1 wt% in recycled flooring for decades. The authorisation granted in 2016 for DEHP in recycled soft PVC has expired, so that route is no longer open in the European Union.

The "DOP test" for HEPA filters is a different subject#

A search for the "DOP test" usually means filter-integrity testing of HEPA filters with an aerosol, which is a cleanroom procedure and not a plastics-additive topic. This page covers DOP as a PVC plasticizer only, and it gives no filter-test method, aerosol or acceptance criterion.

Is DEHP banned worldwide?#

No: DEHP is restricted rather than banned, and the scope differs by jurisdiction, from the EU 0.1 % limit in the plasticised material of all articles since 7 July 2020 to toy-only limits in Canada and Japan (status 23 September 2026). The United States restricts it above 0.1 % in children's toys and child care articles under 16 CFR 1307.3(a) while leaving eight ortho-phthalates, DEHP among them, authorised for food contact, and the EU keeps a dated derogation for medical devices to 1 July 2030. Country by country rules are compared on phthalate restrictions worldwide.

How much DEHP is in a PVC product?#

Between 2 and 35 wt% in general plastic materials according to the ECHA plastic-additives mapping exercise, and up to 40 wt% in PVC medical devices, against a regulatory limit of 0.1 % in the plasticised material of EU articles. The gap between a formulation level and a restriction threshold is roughly a factor of 300, which is why a legacy article cannot be brought into compliance by dilution.

Does an article containing DEHP need a SCIP notification?#

Yes, above 0.1 % by weight: DEHP is on the REACH Candidate List, and Article 9(1)(i) of the Waste Framework Directive has required a SCIP notification for articles containing a Candidate List substance above that threshold since 5 January 2021. A substance on the REACH Candidate List above 0.1 % triggers the notification for every article supplier in the EU chain, importer and producer alike.