Understanding EN 455‑5:2025 – extractable chemical residues
The newest part of EN 455 standardises how chemical residues in gloves are measured, replacing plain-water extraction with 75 % ethanol. What it covers, what it deliberately does not, and how to specify it.
Healthcare workers have reported reactions to the chemicals left in medical gloves for decades, from mild irritation to disabling contact dermatitis. EN 455-5:2025, "Extractable chemical residues", is the European standard that finally says how those chemicals should be measured. It was published in September 2025 as a new fifth part of the series.
It is worth being precise about what that means, because the standard is easy to over-claim: EN 455-5 does not introduce a new requirement to test for chemical residues. That requirement has existed for years through EN 455-3 and its reference to EN ISO 10993-1. What EN 455-5 adds is a single, harmonised method for doing it, so that a result from one laboratory means the same thing as a result from another.
The change that matters: how the extraction is done
Before this standard, some laboratories extracted gloves in plain water on the assumption that water resembles clinical conditions. It does not. Water fails to extract many of the hydrophobic residues that actually cause problems, including accelerators and antioxidants, so those results systematically understated exposure.
EN 455-5 prescribes 75 % ethanol in water as the only approved medium for simulated-use extraction. It reproduces the leaching that occurs against skin far more faithfully, and it is the single most consequential line in the document.
The method is a simulated-use extraction, which produces a worst-case leachables profile: anything that could leach during use appears as an extractable, at a level equal to or above what would actually leach. Measure once, and you have bounded the real exposure.
The procedure in Annex A, which is normative, is specific enough to check a laboratory against. Eight gloves of the same size and lot are taken as four pairs; each cuff is marked 200 ± 10 mm from the middle fingertip and the pair weighed; one glove is inserted inside-out into the other; 25 ml of extraction medium at 23 ± 2 °C goes between the two layers, up to 50 ml for larger sizes; the assembly is agitated on an orbital shaker at not less than 3 Hz (180 rpm). Results are reported in µg per gram of glove material, as the mean of the four determinations.
The extraction medium is defined by mass, not by volume: 789 g of 95 % ethanol mixed with 211 g of water, stirred for an hour, giving 75 % by mass fraction.
Annex F also references an exaggerated extraction using stronger solvents such as acetone. This is not part of the standardised method. It is a research and validation tool for establishing total extractable content, including substances encapsulated in the elastomer that may still matter toxicologically.
What the standard does, and does not, do
It specifies the extraction medium, the extraction method, and quantitative assay procedures for residual chemicals, with a focus on Type IV allergenic substances.
It does not set maximum allowable levels for any residue, assess allergenic potential, or make determinations about biological evaluation or user safety. Those sit elsewhere in the regulatory framework, principally the EN ISO 10993 series.
This is the point most often misunderstood in tender documents. EN 455-5 gives you a number you can compare between suppliers. It does not tell you which number is safe.
Structurally, the 26-page document is unusual in having no normative references at all: it can be applied directly, without navigating a chain of dependent standards. Annex A carries the extraction method; Annexes B, C and D give three HPLC methods; Annex E lists relevant contact allergens and, in Table E.1, suitable assay methods; Annex F explains the rationale. No single reference method is designated, because no single assay can cover every residual chemical, so laboratories must validate and document whichever methods they use.
Nine terms are defined precisely, and two of them are worth knowing before you read a test report: an extractable is released under laboratory extraction conditions, a leachable is released during actual clinical use.
The chemistry the standard is aimed at
Accelerators make vulcanisation possible, which is what gives a glove its elasticity and strength. They are also the main cause of Type IV allergy in glove users.
Antioxidants are measured too. Wingstay L, a polyphenol antioxidant used at around 0.75 phr to maintain tensile properties, is specifically covered by the Annex B and C methods because of its widespread use and its reproductive-toxicity potential.
Two findings from that research are directly operational. 84 % of DPG leached into artificial sweat within ten minutes of donning, and alcohol-based hand disinfectant applied before gloving increased DPG exposure from polyisoprene gloves. In the same Belgian study, no subject reacted to accelerator-free gloves.
Why this is an occupational-health question, not a paperwork one
Dermatitis accounts for around 35 % of all workplace disease, and contact dermatitis leads that group. Type IV reactions account for up to 28 % of glove-related reactions, and they behave quite differently from the latex allergy most people think of first:
Type IV reactions rarely threaten life, but they end careers. Repeated exposure moves a wearer from redness and small blisters to thickened, cracked, peeling skin, and staff who develop it may be unable to keep working in a gloved role.
Risk is driven by three things: how much chemical is available and how readily it releases, how long and how often skin is in contact, and how the glove traps moisture against the skin. Only the first is something a purchaser can specify.
What it means for procurement
Manufacturers are expected to keep residual chemical levels as low as possible, retain test results, and make results and method details available on request. Where a product makes a specific claim about chemical content, the chemical names must appear on the packaging per Table E.1, along with the process limits measured by the standard methods.
For a buyer, that translates into four things worth writing into a specification:
Do not, however, write a maximum permitted residue level into a tender and cite EN 455-5 as the authority for it. The standard sets no such limits, and a supplier can legitimately challenge the clause.
Timeline
CEN approved EN 455-5 on 30 June 2025 and it was published on 27 August 2025. Member nations must adopt it, either by publishing an identical text or by endorsement, and withdraw conflicting national standards, by February 2026.
Laboratories need time to gain accreditation for a first-edition standard, so availability of accredited testing lags publication by some months. A revision of EN 455-3 to incorporate EN 455-5 requirements was already planned at publication. Separately, EN 455-3:2023 replaced EN 455-3:2015, which expired on 29 November 2025.
Key takeaways
Frequently asked questions
Does EN 455-5 create a new requirement to test for chemical residues, and are our current gloves now non-compliant? No to both. The requirement to evaluate residual chemicals already existed through EN 455-3 and its reference to EN ISO 10993-1. EN 455-5 is a test method standard: it supplies one harmonised procedure so results from different laboratories are comparable. Products already tested under EN 455-3 remain compliant; what changes is how future residue testing is performed and reported.
Is EN 455-5 harmonised under the MDR? Not as at July 2026. EN 455-1:2020+A2:2024 and EN 455-2:2024 were harmonised by Commission Implementing Decision (EU) 2025/681; EN 455-5:2025 was not included. It is a published European standard and a legitimate specification reference, but compliance with it does not by itself confer presumption of conformity.
Can we specify a maximum residue level and reference EN 455-5 in a tender? You can require the method, but not a limit from the standard – it deliberately sets none. Specify EN 455-5 testing, require declared values with the limits of detection and quantification, and assess those against your own risk criteria. Allow time in the timetable: accredited capacity for a newly published method takes a while to build, so an absent report is not yet evidence of non-compliance.
Is a water-extraction test report still acceptable? It is not comparable to an EN 455-5 result and will understate hydrophobic residues. Ask for the extraction medium explicitly.
A report says "not detected" – is that enough? Not on its own. EN 455-5 requires the limit of detection and limit of quantification in the report. "Not detected" at a high detection limit is a weaker statement than a measured low value.
Which chemicals should we ask about? Thiurams, dithiocarbamates and DPG cover most Type IV risk, with antioxidants such as Wingstay L where relevant.
Does a low extractable result mean the glove will not cause contact dermatitis? No, and the standard does not claim it. EN 455-5 measures what can be extracted under defined conditions. It does not establish a threshold below which sensitisation will not occur, and someone already sensitised to a specific accelerator may react to a glove with a low total residue. See chemical accelerators in glove production for why accelerator-free by formulation is the stronger claim.
Which part of EN 455 should a specification cite for skin safety? Both. EN 455-3:2023 sets the biological evaluation requirement; EN 455-5:2025 supplies the extraction and quantification method behind it.
Seventeen years sourcing and supplying medical gloves and PPE to governments, UN agencies, NGOs and healthcare systems. Writes on glove standards, quality management and responsible sourcing for institutional buyers, working from the source standards rather than secondary summaries.
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