Estimating total testing and EUPL Submission costs under the DWD framework in advance is inherently difficult, because they depend on many product-specific factors: material type and risk group, the number of starting substances and NIAS to be covered, how much existing data can be reused, whether it is a new EUPL application or a simple renewal, and how many product variants or assemblies are in scope. As a result, any generic budget figure can only be a broad indication and not a reliable basis for decision-making.
For that reason, we strongly recommend contacting us for a tailored quote based on your specific product(s), existing approvals and data situation. As a very rough benchmark, total costs for a straightforward renewal to the European Positive List (with limited new testing and no complex toxicology work) can start from around EUR 10,000, while large, complex portfolios requiring extensive migration testing and toxicological assessment can reach several hundred thousand euros and in exceptional cases go well over the EUR 1,000,000 mark. A short discussion with our team will allow us to narrow this down quickly and provide a transparent, itemised proposal.
Below is an illustrative overview of typical test methods, indicative cost ranges and timelines used in DWD conformity assessments. These figures are examples only, intended to support budgeting, and actual costs will depend on your specific material, product design and data situation. They are just for specific oECD tests usually seen.
Test Methods and Estimated Costs
Below is a breakdown of each required test method (as referenced in the DWD Implementing Decision guidance) by category, with estimated GLP cost ranges (EUR), durations, and key assumptions. Cost estimates are conservative, for a new substance under GLP (no waivers, ~3 replicates, advanced analytics as needed, etc.), suitable for budgeting.
Physico-chemical Properties
Test (Guideline) 【source】 | Category | Cost (EUR) | Duration | Notes/Assumptions |
|---|---|---|---|---|
Boiling point (EU A.2 / OECD 103) | Physico-chemical | €500–1 000 | ~1–2 days | Measure up to 360 °C at 1 atm (DSC can measure melt/boil together) . Few samples. |
Density (OECD 109) | Physico-chemical | €600–1 200 | <1 day | Liquid/solid density by pycnometry/buoyancy or gas law. 3 replicates. |
Vapour pressure (OECD 104) | Physico-chemical | €5 000–8 000 | 2–4 weeks | Typical isostatic or effusion methods; highly sensitive at low pressures. Multi-point curve often. |
Surface tension (EU A.5 / OECD 115) | Physico-chemical | €1 000–2 000 | ~1 week | Measured in aqueous solution (up to 1 g/L) . If surface-active, also measure CMC (adds time/cost). |
Water solubility (EU A.6 / OECD 105) | Physico-chemical | €5 000–8 000 | 2–4 weeks | Test at ~20 °C (and at 10 °C/30 °C if needed) . May require HPLC/GC-MS analysis of phases; for salts or sparingly soluble, use OECD 29 (see assumptions). |
Octanol–water partition (Kow) (OECD 107, 117, 123) | Physico-chemical | €5 000–10 000 | ~2 weeks | Shake-flask (107) or HPLC (117) methods . For extreme solubility, use limit values. Must consider both ionized and neutral forms if pKa in relevant range. |
Dissociation constant (pKa) (EU A.25 / OECD 112) | Physico-chemical | €5 000–8 000 | ~2 weeks | Potentiometric titration (if water-soluble) or spectrophotometric methods for pKa . Possibly multiple replicates for accuracy. |
(Optionally) Hydrolysis (pH 4–9) (OECD 111 / EU C.7) | Physico-chemical | €3 000–6 000 | ~1–2 weeks | Identify degradation/NIAS under different pH . Not mandatory unless needed for NIAS. Use batch incubations and analytical monitoring (LC-MS) if performed. |
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Migration (Hygienic Safety)
Test (Guideline) 【source】 | Category | Cost (EUR) | Duration | Notes/Assumptions |
|---|---|---|---|---|
Migration (organics) – factory-made (EN 12873-1:2014) | Migration | €5000–15 000 | 10–31 days | Cold-water dynamic/static test for plastics & organic matrices . Includes periodic sampling (days 1,2,3 etc.) and analysis of all identified substances. |
Migration (organics) – site-applied (EN 12873-2:2021) | Migration | €5000–20 000 | 10–31 days | Similar to above but for in-situ applied materials (e.g. coatings). Usually more setup time, similar analysis workload. |
Metal release (dynamic) (EN 15664‑1) | Migration | €10 000–35 000 | 4–10 weeks | Long-term dynamic rig test for metals in contact with water . Often weekly sampling over weeks (~10 days = 2–3 weeks; extended up to 4+ wks). ICP-MS/AAS for multiple metals each interval increases cost. |
Passive metal test (EN 16056) | Migration | €3 000–6 000 | ~1 week | Short-term test for “passive” alloys (e.g. stainless steel) . Fewer samples/days. Simpler analysis than dynamic rig. |
Plating (galvanics) (see EN 15664-1 / relevant enamel standards) | Migration | €5 000–12 000 | 2–4 weeks | For metallic plating layers (Zn, Ni, etc.) . Use metal rig (EN15664) or enamel migration test (EN 12873). |
Note: All migration tests assume GLP sampling and analysis (e.g. multi-element ICP-MS, GC-MS for organics, etc.), 3 replicates of test pieces, and analysis of both targeted and “unexpected” species.
Identification of Relevant Species and Other Parameters
Test (Guideline) 【source】 | Category | Cost (EUR) | Duration | Notes/Assumptions |
|---|---|---|---|---|
GC–MS screening of NIAS(EN 15768:2015) | Identification | €2 000–4 000 | ~1–2 weeks | Non-targeted GC–MS of migration water to detect unexpected substances . Includes sample prep and library search; usually one cold-water sample set. |
Total Organic Carbon (TOC)(EN 1484:1997) | Identification | €500–1 000 | <1 day | TOC by non-purgeable organic carbon analysis . Typically quick instrument run. |
Odour (Threshold Odour Number) (EN 1420:2016 / EN 1622:2006) | Identification | €800–1 200 | 1 week | Olfactometry by trained panel or equivalent method . Often done after migration sampling. |
Flavour (Threshold Flavour Number) (EN 1420 / 1622) | Identification | €800–1 200 | 1 week | Similar to odour test (same standards) . |
Colour (ISO 7887:2011, method C) | Identification | €300–600 | <1 day | Colorimetry of migration water . Usually routine instrument (UV-Vis). |
Turbidity (ISO 7027-1:2016) | Identification | €300–600 | <1 day | Nephelometric turbidity of migration water . Simple instrument test. |
EMG (Enhancement of Microbial Growth) (EN 16421:2015) | Microbiology | €2 000–4 000 | ~3–4 weeks | Screen for biofilm-supporting properties . Method 1 (biofilm test) or 2 (ATP measurement) per EN 16421. |
Assumptions: All analyses are GLP-validated. If speciation of metals or organics is required, additional advanced analytics (e.g. LC-MS/MS) would increase cost. Odour/flavour tests require human panels or odour apparatus as per standards.
Toxicological Testing
Test (Guideline) 【source】 | Category | Cost (EUR) | Duration | Notes/Assumptions |
|---|---|---|---|---|
Ames test – Bacterial reverse mutation (OECD 471 / EU B.12/13) | Genotoxicity – in vitro | €5 000–10 000 | 3–4 weeks | Salmonella/E. coli strains with/without S9 . Usually 5 strains; includes confirmatory plate counts. |
In vitro micronucleus (OECD 487 / EU B.49) | Genotoxicity – in vitro | €10 000–15 000 | 4–6 weeks | Mammalian cell assay (TK6 or CHO cells), with/without S9. Requires multiple slides and cytotoxicity screens. |
In vitro chromosome aberration (OECD 473 / EU B.10) | Genotoxicity – in vitro | €8 000–12 000 | 4–6 weeks | Cultured mammalian cells exposure . Typically two concentrations, scoring 100+ metaphases per dose. |
In vitro gene mutation (HPRT/XPRT) (OECD 476 / EU B.17) | Genotoxicity – in vitro | €6 000–10 000 | 4–6 weeks | Mouse lymphoma or similar (Hprt/Xprt) assay . Colony formation endpoint (usually 6-thioguanine resistance). |
In vitro TK gene mutation (TK+) (OECD 490 / EU B.67) | Genotoxicity – in vitro | €8 000–12 000 | 4–6 weeks | Thymidine kinase locus mutation (TK6 cells) . Similar workload to OECD 476. |
In vivo micronucleus (OECD 474 / EU B.12) | Genotoxicity – in vivo | €10 000–15 000 | 2–3 months | Rodent bone marrow micronucleus test . Requires dosing and two sacrifice time-points (48/72h). |
In vivo chromosomal aberration (OECD 475 / EU B.11) | Genotoxicity – in vivo | €10 000–15 000 | 2–3 months | Rodent (typically rat) bone marrow chrom aberration . Similar setup to OECD 474. |
Transgenic rodent mutation (TGR) (OECD 488 / EU B.58) | Genotoxicity – in vivo | €15 000–25 000 | 3–4 months | Uses transgenic mice (lacZ, etc.) . Two tissues (liver, etc.) usually analyzed. |
In vivo alkaline comet(OECD 489 / EU B.62) | Genotoxicity – in vivo | €15 000–25 000 | 2–3 months | Rodent (mouse/rat) assays on multiple tissues . Acute/short-term dosing, analysis of DNA damage. |
Spermatogonial chrom aberration (OECD 483 / EU B.23) | Genotoxicity – in vivo | €15 000–25 000 | 4–6 months | Rodent test on male germ cells . Long exposure to cover spermatogenic cycle (~35 days in rat). |
Toxicokinetics (OECD 417 / EU B.36) | Toxicokinetics | €50 000–100 000 | 4–6 months | Absorption/distribution study in rodents (often 90-day or shorter with blood/urine sampling) . Complex (LC-MS/MS of blood). |
90-day oral toxicity (OECD 408 / EU B.26) | Repeated-dose toxicity | €100 000–150 000 | 4–5 months | Standard subchronic rat study . Includes full histopathology. Typically high cost. |
Chronic/carcinogenicity(OECD 453) | Chronic toxicity | €200 000–300 000 | ~18–24 months | Combined chronic (2-year) rodent study . Expensive due to lifetime observation and pathology. |
Repro/developmental screen(OECD 421 / EU B.63) | Repro & Dev toxicity | €30 000–60 000 | 6–8 months | Rodent (one generation) screening for fertility and early development . |
Combined 28d + repro(OECD 422 / EU B.64) | Repro & Dev toxicity | €65 000–100 000 | 8–12 months | Repeated-dose (28d) plus reproduction/development study . Applies if 421 insufficient. |
Extended one-generation repro. (OECD 443) | Repro & Dev toxicity | €250 000-1 000 000 | ~18–24 months | Expands 421/422 with additional cohorts (developmental neuro, immuno) as per OECD 443. |
Prenatal developmental(OECD 414 / EU B.31) | Repro & Dev toxicity | €100 000–200 000 | ~12–18 months | Standard rat (or rabbit) prenatal study . Endpoints include maternal toxicity and fetal malformations. |
Notes: All in vivo studies assume GLP, full protocol (including controls, pathology, clinical chemistry, etc.), and typical rodent use. Costs include analytical confirmation of dosing, histopathology, etc. Nanoforms may require dispersion/characterization prior to dosing (increasing prep cost slightly).
Sources: ECHA guidance on DWD testing requirements (e.g. physico-chemical, migration, toxicology) , and standard test methods (OECD and EN) as cited. Cost estimates are based on industry GLP lab pricing and assume moderate complexity and replicates. As well as ample room for margins.
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