Plastic Additives in Medical Devices: EU MDR Annex I 10.4, DEHP Authorisation, ISO 10993 and USP Class VI (4 Requirements Compared)

Four requirements decide whether a plastic additive stays in a medical device, and USP Class VI, the one buyers quote most, is not one of the two that are law: those are EU MDR Annex I Section 10.4 and the REACH authorisation for DEHP, while ISO 10993 and USP Class VI are standards. So which of them does a compounder actually have to meet, and which ones does a buyer only ask about as proof of biocompatibility?

Section 10.4.1 of Annex I to Regulation (EU) 2017/745, the Medical Device Regulation (MDR), allows a substance that is carcinogenic, mutagenic or toxic for reproduction (CMR) in category 1A or 1B, or one with endocrine-disrupting properties, above 0.1 % by weight (w/w) in invasive and fluid-contact devices only where its use is justified and labelled. DEHP, the plasticizer behind legacy flexible PVC blood bags and tubing, can be used in EU devices without an authorisation until 1 July 2030, the sunset date that Regulation (EU) 2023/2482 set for device uses under REACH Annex XIV entry 4. ISO 10993 evaluates the biological safety of the finished device, and USP Class VI classifies a tested sample of a material; neither one certifies an additive.

This page covers who answers for an additive, the MDR 0.1 % rule and the twelve additives it catches, the DEHP dates from 2011 to 2030, ISO 10993 extractables, what USP Class VI proves, the device dates in REACH, RoHS and the POPs Regulation, the US position and the six documentation steps, treating biocompatibility as a property of the finished device. This is a technical reference, not legal or regulatory advice. Each of the four requirements reaches the same families of plastic additives through a different door.

Medical-device rules verified: 24 October 2026 (EUR-Lex, ECHA CHEM). Next scheduled check: 1 December 2026.

The four requirements differ in who sets them, whom they bind and what they ask of an additive.

Table T1. The 4 requirements at a glance

Which Rules Apply to a Plastic Additive in a Medical Device?#

Two EU laws bind a plastic additive in a medical device, the Medical Device Regulation and REACH, while ISO 10993 and USP Class VI are standards a device maker uses to show that the finished device is biologically safe. The Medical Device Regulation is Regulation (EU) 2017/745, and its counterpart for in vitro diagnostic devices is Regulation (EU) 2017/746. Who, in the supply chain, has to act on each of them?

Medical devices are one of the product rules in layer 4 of plastic additive regulations. Device risk classes and ISO 13485 quality management belong to the device maker and do not change what an additive must meet under Section 10.4, and "medical grade" is a commercial description, not a legal category.

Law and standard: what binds an additive and what only demonstrates it#

A law binds an additive whether anyone asks about it or not, while a standard only demonstrates something when a device maker chooses to apply it, and that is the line between the first two requirements and the last two. The four requirements sort into binding and demonstrating as listed below.

• EU MDR Annex I Section 10.4 binds: it sets the 0.1 % w/w line for CMR 1A/1B and endocrine-disrupting substances in invasive and fluid-contact devices.
• REACH Annex XIV entry 4 binds: it makes every device use of DEHP after 1 July 2030 subject to an authorisation.
• ISO 10993 demonstrates: the device maker applies ISO 10993-1:2025 to the finished device within a risk-management process.
• USP Class VI demonstrates: a tested sample of one formulation meets the most stringent of the six USP plastics classes.

Who answers for the additive: supplier, compounder or medical device maker?#

The device maker carries the legal duty under Section 10.4, but it can meet that duty only with data the compounder and the additive supplier hand over: the full substance list, the concentration of every additive in each part and the extractables that leave the compound. The three roles in that supply chain are listed below.

• Additive supplier: the CAS number, harmonised classification and Candidate List status of each additive, plus its residues and impurities.
• Compounder: the complete formulation, the weight percentage of every additive, and a formulation frozen against change.
• Device maker: the Section 10.4.2 justification, the Section 10.4.5 label and the ISO 10993 evaluation of the finished device.

The DEHP authorisation is a REACH duty on every user of DEHP in a device, so it can reach the compounder as well as the device maker. Choosing the additive for medical plastics is a separate question: which additive each medical polymer needs is the subject of additives for medical plastics.

EU MDR Annex I 10.4: The 0.1 % Rule for CMR and Endocrine-Disrupting Additives#

Section 10.4 of Annex I to the EU Medical Device Regulation does not ban any plastic additive: it allows a CMR category 1A or 1B or an endocrine-disrupting substance above 0.1 % by weight in an invasive or fluid-contact device only where its use is justified, and it requires that presence to be labelled. Section 10.4 sits among the general safety and performance requirements of Annex I to Regulation (EU) 2017/745, and its endocrine-disrupting limb covers substances whose endocrine-disrupting properties are identified under Article 59 of REACH or under the criteria of the Biocidal Products Regulation. Which devices does that apply to, and which additives does it catch?

Which devices and parts does Section 10.4.1 cover?#

Section 10.4.1 covers three groups of devices, and a flexible PVC infusion line falls into two of them at once: invasive devices, devices that administer or remove medicines and body fluids, and devices that transport or store them. The three groups are listed below, each with the plastic parts our sources name.

• Invasive devices and invasive parts of devices, such as the end of an infusion line that enters the body.
• Devices that administer or re-administer medicines, body liquids or other substances, including gases, to or from the body, such as PVC infusion lines, medical tubing and neonatal respiratory devices.
• Devices that transport or store such medicines, body fluids or substances, including gases, such as blood bags, platelet storage bags and blood-collection tubes.

The rule follows the part and its contact, not the polymer: the same flexible PVC compound is in scope as a blood bag and outside Section 10.4.1 in a part that touches no body, medicine, body fluid or gas.

Which plastic additives cross the 0.1 % line?#

The plastic additives that cross the Section 10.4.1 line are the ones with a harmonised reproductive or carcinogenic classification or an identified endocrine-disrupting property, and the four low-molecular-weight phthalates, DEHP, DBP, BBP and DIBP, carry both. DEHP (CAS 117-81-7) holds a harmonised Repr. 1B classification with hazard statement H360FD under Regulation (EC) No 1272/2008 (CLP), and DBP, BBP and DIBP hold Repr. 1B with H360Df. Commission Implementing Decision (EU) 2017/1210 of 4 July 2017 identified all four under Article 57(f) of REACH for probable serious effects on human health. The same screen also catches a crosslinking peroxide, a phenolic antioxidant, lead and organotin heat stabilizers, two flame retardants and a pigment. Which additives hold a harmonised CMR entry is tracked on CLP classification of plastic additives.

The twelve additives in Table T2 reach Section 10.4.1 on a harmonised classification, a Candidate List ground or both.

Table T2. Plastic additives that reach Section 10.4.1 (screening view)

Candidate List grounds are shown as a screening signal; Section 10.4.1 refers to the harmonised CMR classification and to identified endocrine disruptors, which each device maker checks for its own compound. Bisphenol A is a monomer, not an additive, and is not listed here.

Seven of the twelve rows are also on the REACH Authorisation List: the four phthalates (Annex XIV entries 4 to 7), DOTE (entry 58), lead chromate (entry 10) and TCEP (entry 13).

The endocrine-disrupting identifications come from the SVHC Candidate List, which held 253 entries at its last update on 4 February 2026.

Do non-phthalate plasticizers trigger Section 10.4.1?#

No: DOTP, DINCH, TOTM, ATBC and DINP carry no harmonised CMR classification and no Candidate List entry, so their presence above 0.1 % does not by itself trigger the Section 10.4.1 justification or the label. DOTP/DEHT (CAS 6422-86-2) is a terephthalate, not an ortho-phthalate; DINCH (CAS 166412-78-8; US product 474919-59-0) is a ring-hydrogenated ester; TOTM (CAS 3319-31-1) is a trimellitate; and ATBC (CAS 77-90-7) is a citrate.

DINP (CAS 28553-12-0) is an ortho-phthalate, yet ECHA's Committee for Risk Assessment (RAC) concluded in March 2018 that no reproductive-toxicity classification is warranted. All five findings are re-checked at every Candidate List update.

BTHC (CAS 82469-79-2) is a gap in the data: no harmonised classification and no REACH registration data are recorded in our knowledge base. How these non-phthalate plasticizers perform in PVC is compared separately.

What a Section 10.4.2 justification must contain#

A Section 10.4.2 justification is the device maker's written case that an additive above 0.1 % is still the right choice, and it has five parts that run from patient exposure to the alternatives that were rejected. The five parts are listed below.

1. Analyse the potential exposure of patients and users to the substance.
2. Analyse possible alternative substances, materials or designs.
3. Explain why those alternatives are inappropriate for the device.
4. Consider vulnerable groups of patients, including children and pregnant or breastfeeding women.
5. Apply the latest relevant guidelines of the scientific committee.

The device maker writes and holds the justification; the compounder and the additive supplier contribute the composition data the exposure analysis needs and the alternatives the second step weighs, such as the four DEHP replacements named below.

Whose guidelines does the justification have to follow?

The SCHEER phthalate guidelines under Section 10.4.3#

Section 10.4.3 is the one place in the regulation that names phthalates: it required the Commission to mandate benefit-risk guidelines on them by 26 May 2018, and the scientific committee SCHEER adopted those guidelines in 2019. The regulation set 26 May 2020 as the date by which the guidelines had to be ready. SCHEER, the Scientific Committee on Health, Environmental and Emerging Risks, built on two earlier scientific opinions on DEHP in medical devices, dated 2008 and 2015.

The guidelines are the benchmark a justification for DEHP, DBP, BBP or DIBP above 0.1 % is read against, weighing clinical benefit against the risk to patient health. The toxicology behind the guidelines is summarised under phthalates: health effects.

Labelling under Section 10.4.5#

Every device that keeps a CMR or endocrine-disrupting additive above 0.1 % after a justification must say so on the device or its unit packaging and explain the residual risk to children and pregnant or breastfeeding women in its instructions for use. Section 10.4.5 of Annex I sets the three items listed below.

• A presence statement on the device itself and/or on the packaging of each unit.
• The list of the substances concerned, such as DEHP in a flexible PVC tubing set.
• Residual-risk information in the instructions for use for children, pregnant or breastfeeding women and other patient groups considered vulnerable.

The regulation fixes the content of the label, not its design, and our sources record no mandatory symbol or wording. For the compounder, the label arrives as one request: an exact substance list with the concentration in each part.

DEHP in Medical Devices: The REACH Authorisation Deadline of 1 July 2030#

DEHP can still be used in EU medical devices without an authorisation until 1 July 2030, the sunset date Regulation (EU) 2023/2482 set for device uses, and anyone who wants to keep using it after that date has to apply by 1 January 2029. Both dates sit in REACH Annex XIV entry 4, the Authorisation List entry that has covered DEHP since Regulation (EU) No 143/2011, and they apply to uses in devices under Regulations (EU) 2017/745 and 2017/746. Why does a device have a DEHP deadline fifteen years after the general one? The general sunset date passed on 21 February 2015, and the device sunset falls fifteen years and four months later.

The full regulatory record of DEHP, from CAS 117-81-7 to its Prop 65 listing, sits on its substance page.

Three regulations set the DEHP dates that a medical device works to today.

Table T3. DEHP authorisation dates for medical devices

Why DEHP needs a REACH authorisation for devices only from 2030#

Medical devices received their own DEHP dates in 2021, when Regulation (EU) 2021/2045 added the endocrine-disrupting property to Annex XIV entry 4 and set a device sunset of 27 May 2025, which Regulation (EU) 2023/2482 then moved to 1 July 2030. Before 2021, entry 4 carried only the general dates set by Regulation (EU) No 143/2011 for DEHP's reproductive toxicity. Regulation (EU) 2021/2045, adopted on 23 November 2021 and published in the Official Journal the next day, added the endocrine-disrupting property for human health and the environment and gave device uses a latest application date of 27 November 2023.

Regulation (EU) 2023/2482 postponed both device dates, to 1 January 2029 and 1 July 2030. Each step changed a date, not DEHP's status: general uses have needed an authorisation since 21 February 2015. Every other sunset date sits on the REACH Annex XIV Authorisation List.

What changes on 1 January 2029 and on 1 July 2030#

1 January 2029 is the last day to file an authorisation application that keeps DEHP in a device beyond the sunset, and 1 July 2030 is the day from which every device use of DEHP in the EU needs an authorisation. An application received by the latest application date lets the applicant continue the use after the sunset date until the Commission decides on it.

From the 1 July 2030 sunset date, using DEHP in an EU medical device requires either a granted authorisation for that use or an application filed by 1 January 2029 that is still being decided.

Why REACH Annex XVII entry 51 does not apply to medical devices#

Entry 51 of REACH Annex XVII limits DEHP, DBP, BBP and DIBP to 0.1 % of the plasticised material in almost every article sold in the EU since 7 July 2020, but medical devices are expressly exempt, which is why the authorisation route is the limit that binds a device. Regulation (EU) 2018/2005 extended the entry to all articles from that date, and its exemptions list medical devices alongside food-contact materials, laboratory measuring devices, electrical and electronic equipment under RoHS and the immediate packaging of medicinal products. The entry's reach elsewhere is wide: even articles for industrial or agricultural use fall under it when they have prolonged skin contact, defined as more than 10 minutes continuous or 30 minutes intermittent contact per day. The full exemption list is set out under REACH Annex XVII restrictions.

Can DEHP still be used in medical devices after 2030?#

Yes, but only under a granted REACH authorisation: from 1 July 2030 DEHP is not banned from EU medical devices, it cannot be used in them without an authorisation for that specific use. An authorisation covers the use described in the application, so a holder continues that use and a user outside it does not. Marschner and colleagues (Vox Sanguinis, 2026) already treat July 2030 as the EU end date for DEHP in blood bags, which shows how the transfusion sector reads the date; whether any application is granted is a Commission decision this page does not predict.

Which plasticizers replace DEHP in medical devices, and what is their regulatory status?#

Four plasticizers are named in the European Pharmacopoeia as alternatives to DEHP for blood containers, DINCH, BTHC, TOTM and DOTP/DEHT, and three of them, DINCH, TOTM and DOTP/DEHT, carry no Candidate List entry, while BTHC's status is not recorded in our knowledge base. The European Plasticisers FAQ records the Pharmacopoeia list, and Bernard and colleagues (PLoS One, 2018) measured 26.7 to 48.7 wt% of these plasticizers and DINP in French PVC medical lines. At those contents, a CMR or endocrine-disrupting identification would put a plasticizer 267 to 487 times above the 0.1 % line, which is why regulatory status comes first in a device specification. The BEST Collaborative (Transfusion, 2025) published recommendations for evaluating non-DEHP blood bags.

Table T3b gives the regulatory status of each DEHP alternative and nothing about its performance.

Table T3b. DEHP alternatives: regulatory status for a device compound

Their performance in tubing and blood bags is compared on plasticizers for medical devices.

ISO 10993: How a Biological Evaluation Treats Plastic Additives#

ISO 10993 is the international series of standards for the biological evaluation of medical devices, and every plastic additive in a device compound enters that evaluation as a potential extractable, not as a pre-approved ingredient. Biocompatibility, in the sense the series uses, is a property of the finished device: ISO 10993-1:2025 frames the evaluation within a risk-management process that the device maker applies, and the other parts of the series supply the methods.

Where in the evaluation does an additive actually show up? Twice: in the chemical characterisation of ISO 10993-18:2020 and in the toxicological risk assessment of ISO 10993-17:2023.

ISO 10993-1:2025: a risk-management framework, not a material test#

ISO 10993-1:2025 tells a device maker how to evaluate the biological safety of a finished device inside a risk-management process, so no additive, masterbatch or compound can be "ISO 10993 certified" on its own. Part 1 is the framework of the series: it decides which biological endpoints a device addresses and which other parts supply the methods, and it applies to the device as used, not to a raw material.

"ISO 10993 compliant" on a material datasheet is therefore a commercial shorthand, used by buyers alongside "USP Class VI" and "medical grade". It describes a supplier's test data, not a certification, and the device maker evaluates the material again inside its own finished device.

ISO 10993-18: chemical characterisation and additive migration#

ISO 10993-18:2020 is where a compound's additives become data: its chemical characterisation identifies and quantifies the substances that can leave the device material, and every intentionally added additive is one of the candidates it looks for. Chemical characterization, to use the US spelling, starts from the composition the compound supplier discloses. The four inputs a compound supplier provides are listed below.

• The full substance list, with the CAS number of every additive and of every substance a masterbatch carries in.
• The concentration of each additive in the part, in wt% or ppm.
• Known residues and degradation products, such as unreacted crosslinking peroxide or the breakdown products of an antioxidant.
• The processing history that can change them, such as the compounding and moulding conditions the part went through.

Extractables are the constituents an extraction draws out of the material; leachables are those that leave it during use, and additive migration links the two. Why an additive reaches the extract at all is explained under additive migration in plastics.

ISO 10993-17: toxicological risk assessment of additives, residues and NIAS#

ISO 10993-17:2023 takes the list that chemical characterisation produces and assesses each constituent toxicologically, which means a degradation product of an antioxidant or a residue of a crosslinking peroxide is weighed in the same way as the additive itself. The assessment works on whatever the extract contains, not on what the formulation sheet says was dosed.

Non-intentionally added substances (NIAS), such as residues, degradation products and impurities, are therefore assessed alongside the additives. Dicumyl peroxide, with its harmonised Repr. 1B classification, shows why: the residual peroxide in a crosslinked part needs checking.

The same residue logic governs food contact as NIAS from plastic additives.

The other ISO 10993 parts a compound data package cites#

Seven parts of ISO 10993 recur in the biological evaluation of a plastic device, and the two that concern additives most directly are Part 18 for chemical characterisation and Part 17 for toxicological risk assessment. Table T4 lists each part with its subject, its edition in our sources and the point at which an additive enters it.

Table T4. ISO 10993 parts cited for a plastic compound

Editions as recorded in our knowledge base on 24 October 2026, taken from a secondary source; confirm the current edition on iso.org before relying on it.

The material tests that sit outside the biological evaluation are indexed under testing plastic additives.

What is ISO 10993-5?#

ISO 10993-5 is the part of the series that tests the in vitro cytotoxicity of a device material, and its current edition in our sources dates from 2009. Part 5 tests an extract of the material on cultured cells, so an additive enters it through the same extract that Part 18 characterises chemically, never on its own.

USP Class VI: What the Plastics Classification Tests and What It Proves#

USP Class VI is the most stringent of the six plastics classes defined in General Chapter <88> of the United States Pharmacopeia, and it classifies a tested sample of a material rather than certifying the material, its additives or a finished device. It is the older US plastics classification that buyers still quote, beside "ISO 10993 compliant" and "medical grade". Which tests does a sample have to pass to earn it?

USP Class VI is not law in the EU or the US: no regulation in our sources requires it of a device or an additive, and a Class VI result on a compound does not replace the ISO 10993 evaluation of the finished device.

What is USP Class VI?#

USP Class VI is the highest of six USP classes for plastics, and a "USP Class VI plastic" is a material whose tested sample met the requirements of that class, not a polymer type of its own. The result travels with the exact formulation tested, not with the polymer name. The differences between Class I and Class VI, and the meaning of "USP Class IV", are defined in the official USP-NF text of <88>, which has not yet been verified for this page, so they are not described here.

Which tests does USP Class VI require?#

The tests that place a sample in USP Class VI are defined in General Chapter <88> of the United States Pharmacopeia, and this page names them only once they have been verified against the official USP-NF text. Until then, the authoritative list is the current official text of <88> itself.

Is USP Class VI going away?#

This page does not yet confirm that USP Class VI is going away: no revision of General Chapter <88> has been verified against the official USP-NF text for this page, so it states no removal date and no list of withdrawn tests. A buyer that relies on a Class VI result checks <88> in the current USP-NF before reusing the data. This section is re-checked on 1 December 2026, when the verified answer, with the USP document and its official date, is added here.

What does "USP Class VI compliant" mean for an additive or masterbatch?#

"USP Class VI compliant" means that a sample of one specific formulation met the Class VI requirements, so the claim covers the masterbatch or compound as tested and nothing that differs from it by a single additive, grade or dosage. No source of ours describes an additive tested as such under <88>, so an additive cannot "be" USP Class VI, only part of a tested formulation. The three changes that take a compound outside a Class VI result are listed below.

• A changed additive or additive grade, such as a different antioxidant or a new grade of the same plasticizer.
• A changed dosage, such as a higher plasticizer content than the tested sample held.
• A changed colour masterbatch or supplier, because a new carrier resin, pigment or dispersant enters the formulation.

Device buyers ask compounders for a frozen formulation for this reason. A colour or additive masterbatch changes the tested formulation as much as a new resin does.

Is there a USP Class VI list of approved materials or additives?#

The "USP Class VI material lists" found online are supplier and distributor catalogues of their own tested grades, not a USP register of approved materials or additives. Each entry describes a grade a supplier had tested, so it covers that formulation only, and for an additive the useful document is the composition data the device maker needs.

USP Class VI vs ISO 10993: What Is the Difference for a Plastic Compound?#

USP Class VI classifies a tested sample of a material, while ISO 10993 evaluates a finished device, so a compound can carry a Class VI result and still have every one of its additives reassessed in the device's ISO 10993 evaluation. USP <88> is a pharmacopoeial classification with fixed classes; ISO 10993 is a risk-based evaluation in which the device maker decides which endpoints the device needs, starting from ISO 10993-1:2025. Neither is law, and neither certifies an additive.

Which one does a compounder need to support? The same data serves both: a frozen formulation that matches the tested sample, and the full composition and residue information the device maker needs for Parts 17 and 18. Table T5 sets the two side by side for a plastic compound.

Table T5. USP Class VI vs ISO 10993 for a plastic compound

Medical-Device Exemptions and Dates in REACH, RoHS and the POPs Regulation#

Three more EU instruments name medical devices directly, REACH, RoHS and the POPs Regulation, and each of them gives a device either a later date or an exemption that general plastic articles do not receive. Read in date order, with the DEHP dates added, they form a compliance calendar that runs from 7 July 2020 to 6 June 2031, plus two exemptions that last until the end of a part's service life.

Table T6 lists every dated medical-device provision for plastic additives in our sources, oldest first.

Table T6. Medical-device compliance calendar for plastic additives

REACH: phthalates, silicone siloxanes and microplastics in medical devices#

REACH treats medical devices differently in three Annex XVII entries: entry 51 exempts them from the phthalate limit, entry 70 gives silicone-derived siloxanes in devices until 6 June 2031, and entry 78 reaches them on 17 October 2029. Entry 70, set by Regulation (EU) 2024/1328, restricts the cyclic siloxanes D4, D5 and D6 at 0.1 % or more in substances and mixtures after 6 June 2026, with medical devices and medicinal products following on 6 June 2031. Entry 78 on synthetic polymer microparticles, set by Regulation (EU) 2023/2055, gives medical devices a transitional date of 17 October 2029. The siloxanes reach a compound as residues of silicone release and processing additives; where D4, D5 and D6 come from in a compound is explained under silicone mold release agents.

RoHS: the 2021 phthalate date for medical devices#

RoHS reached electrically powered medical devices two years after other electrical equipment: its 0.1 % limit for DEHP, BBP, DBP and DIBP per homogeneous material has applied to them since 22 July 2021. Delegated Directive (EU) 2015/863 added the four phthalates to Annex II of the RoHS Directive from 22 July 2019 for most equipment, and from 22 July 2021 for medical devices, including in vitro diagnostic devices, and for monitoring and control instruments.

A plasticised part of a powered device therefore answers to the RoHS limit even where Section 10.4.1 does not apply. The other RoHS substances are covered under RoHS and plastic additives.

POPs: UV-328, Dechlorane Plus and MCCP in medical devices#

Three persistent organic pollutants used as plastic additives carry medical exemptions: UV-328 in blood-collection tube separators until 4 August 2030, Dechlorane Plus in medical imaging and radiotherapy until 26 February 2030, and MCCP in device cables under a listing that is adopted but not yet published. Regulation (EU) 2025/843 lists UV-328 under the POPs Regulation (EU) 2019/1021 and also exempts spare parts of liquid-crystal displays in medical devices until the end of their service life; Delegated Regulation (EU) 2025/1930 does the same for Dechlorane Plus in medical device spare parts.

For MCCP, Delegated Regulation C(2026) 6262 was adopted by the Commission on 11 September 2026 and is not yet published in the Official Journal; as adopted, it applies from 16 December 2026 and allows wires and cables in medical and in vitro diagnostic devices for up to 5 years, extendable by 5. The general limits for all three are set out under POPs in plastics.

United States: FDA, DEHP and the Limits of Food-Contact Clearances#

The United States has no list of permitted additives for medical devices: FDA reviews the finished device, and the US Pharmacopeia supplies the Class VI classification that buyers quote for its materials. Three US instruments touch a plastic additive in a device: the FDA's 2002 notification on DEHP, the food-contact clearances in 21 CFR, which do not transfer, and California's Proposition 65 list.

FDA and DEHP in PVC medical devices#

FDA's position on DEHP in devices dates from its public health notification of 12 July 2002, which put the upper-bound dose for a 4 kg newborn in intensive care at about 3,000 micrograms per kilogram per day, five times the 0.6 mg/kg/day parenteral reference it used. The arithmetic is direct: 3,000 µg/kg/day is 3 mg/kg/day, and 3 divided by the tolerable parenteral intake of 0.6 mg/kg/day gives 5. For a 4 kg infant, the upper bound equals about 12 mg of DEHP a day (3 mg/kg/day × 4 kg), from PVC tubing and bags, as reported by AAP News, the news publication of the American Academy of Pediatrics.

Why FDA food-contact clearances do not cover a device#

A 21 CFR food-contact clearance is written for food, so it neither approves an additive for a medical device nor rules it out, which is why DINCH, with no FDA food-contact clearance at all, can still be named as a device plasticizer. DINCH has no 21 CFR entry and no effective Food Contact Notification (checked 25 September 2026), yet it is one of the four European Pharmacopoeia alternatives to DEHP for blood containers.

What the food-contact clearances do cover is set out under FDA food contact rules for plastic additives.

California Proposition 65 and DEHP in devices#

DEHP has been on California's Proposition 65 list since 1 January 1988 for cancer and since 24 October 2003 for developmental and male reproductive toxicity, and the listing follows the substance into a device sold in California. What a listing requires is explained under California Proposition 65 and plastic additives.

How Does a Compounder Document an Additive for a Medical Device?#

Documenting an additive for a medical device is a data exercise before it is a legal one, and it takes six steps that start with the full formulation and end with a frozen one. The six steps are listed below in the order a compounder runs them.

1. List every intentionally added substance with its CAS number, including everything a masterbatch carries in.
2. Express each substance as a weight percentage of the part it sits in. For PVC dosed in parts per hundred resin, wt% = phr of the additive ÷ total phr × 100, so 50 phr of plasticizer in a compound totalling 160 phr is 31.25 wt%.
3. Screen each CAS number against the harmonised CMR classifications and the SVHC Candidate List as published on the day of the check.
4. Record the check date and the Candidate List version, which held 253 entries at its last update on 4 February 2026.
5. Supply the composition and residue information the device maker needs for the ISO 10993-18 chemical characterisation.
6. Freeze the formulation and notify the device maker before any change of additive, grade, dosage or supplier.

Screen one additive against REACH, FDA and EU 10/2011. One additive at a time can be screened for its regulatory status with the additive regulatory status checker.

A compounder issues no MDR certificate and no ISO 10993 certificate for an additive, because neither exists. The device maker documents compliance with Section 10.4 and the biological evaluation, using the supplier's composition, dated Candidate List check and change commitment.

The same data serves the DEHP dates and the Section 10.4.5 label: DEHP in a device part after 1 July 2030 needs an authorisation, and a CMR or endocrine-disrupting additive above 0.1 % w/w in scope needs a justification and a label.

Classifications change over time, which is why the check date matters as much as the result. The classification of each substance is recorded in the plastic additives database.

Why Device Rules for PVC Additives Are Stricter Than Food-Contact Rules#

Device rules for PVC additives are stricter than food-contact rules because the exposure route is different: an infusion line delivers its plasticizer into the bloodstream, where a food package delivers it into a meal. Section 10.4.1 targets exactly the devices that administer, transport or store medicines and body fluids, and its 0.1 % w/w line applies to the content of the material. Food-contact law limits what migrates into the food, in milligrams per kilogram.

Every other use of the same PVC formulation is covered under additives for PVC.

Exposure: an infusion line is not a food package#

The exposure that shaped device rules is parenteral, not dietary: the FDA's 2002 upper-bound figure for a newborn in intensive care came from tubing and bags, not from food. Parenteral exposure bypasses the gut, and the 3 mg/kg/day upper bound sat five times above the 0.6 mg/kg/day parenteral reference. Cleys and colleagues (Journal of Applied Toxicology, 2026) found relevant amounts of TOTM, DEHT and DEHP in neonatal respiratory devices, so the exposure question reaches beyond DEHP, the one plasticizer here identified as an endocrine disruptor. The wider evidence is reviewed under endocrine disruptors in plastics.

Food-contact approval under EU 10/2011 is a different question#

A specific migration limit under EU 10/2011 answers a food question, so DEHP's 0.6 mg/kg limit for food contact says nothing about whether it may stay in a blood bag. Regulation (EU) No 10/2011 has set that specific migration limit (SML) of 0.6 mg of DEHP per kg of food since Regulation (EU) 2023/1442 entered into force on 1 August 2023. Food-contact materials are, like medical devices, exempt from REACH Annex XVII entry 51, so each answers to its own instrument. The food-contact limits themselves are set out under EU 10/2011.

Medicinal-product packaging is a separate exemption under REACH#

The immediate packaging of a medicine is not a medical device under REACH: it has its own exemption in Annex XVII entry 51 and its own treatment in the phthalate authorisation entries. Entry 51 lists the immediate packaging of medicinal products separately from medical devices among its exemptions, and the Annex XIV entries for DEHP, BBP and DBP (entries 4 to 6) treat that packaging as a category of its own rather than as a device. A PVC bag that holds a medicine therefore follows a different line from the infusion set that delivers it. How the two categories are defined is explained under REACH and plastic additives.