Step 1: Substance Identification
Enter basic information about the substance
Step 2: Persistence (P/vP) Assessment
Screening, Simulation Studies, Supporting Evidence, and Weight-of-Evidence
P Criteria (REACH Annex XIII): Marine/freshwater t½ > 60/40 d · Marine/freshwater sediment t½ > 180/120 d · Soil t½ > 120 d
vP Criteria: Any compartment (water/sediment/soil) t½ > 60 d (marine/freshwater) or > 180 d (sediment/soil)
vP Criteria: Any compartment (water/sediment/soil) t½ > 60 d (marine/freshwater) or > 180 d (sediment/soil)
A. Screening: Ready Biodegradation (Experimental)
R.11 Screening: Not readily biodegradable (< 60% ThOD or < 70% DOC removal within 10-day window) → indicates potential persistence and triggers higher-tier testing.
Not readily biodegradable (12% in 28 d) → indicates potential P/vP; higher-tier testing required
B. Screening: BIOWIN QSAR Models
Screening Criteria: BIOWIN 2 < 0.5 AND BIOWIN 3 < 2.25, OR BIOWIN 6 < 0.5 AND BIOWIN 3 < 2.25 → Indicates potential persistence
Does not biodegrade fast (< 0.5)
< 2.25 = months+, 2.25-2.75 = borderline, > 2.75 = weeks
Months or longer (< 2.25)
Does not biodegrade fast (< 0.5)
Combined BIOWIN Assessment
✓ Potential for persistence indicated (BIOWIN2+BIOWIN3 criteria met)
C. Assessment: Simulation Studies (Water / Sediment / Soil)
For each compartment, enter experimental half-life (OECD 307/308/309) OR QSAR-predicted half-life if experimental data are not available. Half-lives should be normalised to 12 °C for comparison against Annex XIII criteria.
C.1 Water Simulation (OECD 309)
vP criterion MET: 85 d > 60 d (marine)
C.2 Sediment Simulation (OECD 308)
Enter values to assess vs P/vP thresholds (P: > 120/180 d; vP: > 180 d)
C.3 Soil Simulation (OECD 307)
Enter values to assess vs P/vP thresholds (P: > 120 d; vP: > 180 d)
D. Additional Supporting Information (R.11)
Per R.11, the following lines of evidence may support the persistence conclusion. Activate each that is available and provide the relevant data.
Guidance: Hydrolysis half-lives must be provided at pH 4, 7 and 9 at 25 °C (or relevant environmental pH/T). Only hydrolysis leading to mineralisation or stable end-products that are themselves degradable can be counted as real removal.
Guidance: Photolysis can contribute to WoE only where realistic environmental conditions (surface water depth, latitude, light intensity) are reflected. Rarely sufficient on its own.
Guidance: Detection in remote regions (Arctic, deep sea, remote lakes), long-range transport modelling, or measured dissipation half-lives from field studies support P/vP.
Guidance: If stable TPs are formed at > 10 % of applied, they should be separately assessed for P, B, T. Persistence of the parent alone is not sufficient if relevant TPs are more persistent.
E. Weight-of-Evidence Persistence Assessment
WoE Guidance (R.11.4.1.1): Integrate all available lines of evidence — ready biodeg, BIOWIN QSAR, simulation studies (water/sediment/soil), hydrolysis, photolysis, monitoring, TPs, anaerobic, inherent, read-across — weighted by reliability, relevance and consistency.
Confidence Scoring Framework (Weighted): Confidence is determined by 3 factors. Data tier carries 2x weight because higher-tier experimental evidence supersedes lower-tier QSAR/screening (max 10 points):
1. Data Tier (0-3, ×2 weight = 0-6 pts): 3 = experimental guideline study (OECD TG) · 2 = non-guideline exp./HYBIT/in vitro/validated QSAR · 1 = QSAR/read-across/screening only · 0 = no data
2. Consistency (0-2 pts): 2 = all evidence concordant · 1 = mixed or single line only · 0 = conflicting evidence
3. Supporting Evidence (0-2 pts): 2 = ≥2 independent supporting lines · 1 = 1 supporting line · 0 = none
Score: 7-10 = HIGH · 4-6 = MEDIUM · 0-3 = LOW
Override rule: Where higher-tier experimental data conflicts with lower-tier QSAR/screening, the experimental conclusion prevails.
1. Data Tier (0-3, ×2 weight = 0-6 pts): 3 = experimental guideline study (OECD TG) · 2 = non-guideline exp./HYBIT/in vitro/validated QSAR · 1 = QSAR/read-across/screening only · 0 = no data
2. Consistency (0-2 pts): 2 = all evidence concordant · 1 = mixed or single line only · 0 = conflicting evidence
3. Supporting Evidence (0-2 pts): 2 = ≥2 independent supporting lines · 1 = 1 supporting line · 0 = none
Score: 7-10 = HIGH · 4-6 = MEDIUM · 0-3 = LOW
Override rule: Where higher-tier experimental data conflicts with lower-tier QSAR/screening, the experimental conclusion prevails.
Evidence Integration
Lines of Evidence Included
Persistence WoE Conclusion (Output)
⚠️ OUTCOME: Substance fulfils vP criterion (HIGH confidence)
Step 3: Bioaccumulation (B/vB) Assessment
Log Kow (experimental & QSAR), BCF (all sources), Supporting Evidence, and Weight-of-Evidence
B Criteria: BCF > 2000 L/kg
vB Criteria: BCF > 5000 L/kg
Screening: Log Kow ≥ 4.5 triggers further bioaccumulation assessment
vB Criteria: BCF > 5000 L/kg
Screening: Log Kow ≥ 4.5 triggers further bioaccumulation assessment
A. Screening: Log Kow
Provide experimental Log Kow where available. QSAR Log Kow may be entered separately and used in WoE when experimental data are not available or need to be corroborated.
A.1 Experimental Log Kow
Log Kow ≥ 4.5 → bioaccumulation potential indicated
A.2 QSAR Log Kow
B. Assessment: BCF Data
Select ONE primary BCF source: Fish study, HYBIT, In vitro BCF, QSAR, or Read-across. Additional sources may be used within the Weight-of-Evidence.
BCF = 3800 L/kg → B criterion MET (> 2000)
C. Supporting Evidence for Bioaccumulation (R.11.4.1.2)
Activate each supporting parameter that is available. All activated lines will inform the Bioaccumulation Weight-of-Evidence.
Guidance: Dmax > 1.7 nm may hinder membrane passage; combined with Dmax > 1.7 nm and other evidence, uptake may be considered limited. NOT sufficient alone to waive B assessment.
BMF > 1 (lipid-normalised) supports B. Fish dietary studies (OECD 305-III) or field BMF values may be used.
TMF > 1 (statistically significant) in a well-characterised food web supports B/vB.
Detection of the substance in biota — particularly from remote/unexposed regions or upper trophic levels — supports bioaccumulation.
D. Weight-of-Evidence Bioaccumulation Assessment
WoE Guidance (R.11.4.1.2): Integrate Log Kow (exp. + QSAR), BCF (primary), and supporting evidence (Dmax, metabolism, BMF, TMF, biota monitoring, TK, chronic uptake, mammalian bioaccumulation).
Confidence Scoring Framework (Weighted): Confidence is determined by 3 factors. Data tier carries 2x weight because higher-tier experimental evidence supersedes lower-tier QSAR/screening (max 10 points):
1. Data Tier (0-3, ×2 weight = 0-6 pts): 3 = experimental guideline study (OECD TG) · 2 = non-guideline exp./HYBIT/in vitro/validated QSAR · 1 = QSAR/read-across/screening only · 0 = no data
2. Consistency (0-2 pts): 2 = all evidence concordant · 1 = mixed or single line only · 0 = conflicting evidence
3. Supporting Evidence (0-2 pts): 2 = ≥2 independent supporting lines · 1 = 1 supporting line · 0 = none
Score: 7-10 = HIGH · 4-6 = MEDIUM · 0-3 = LOW
Override rule: Where higher-tier experimental data conflicts with lower-tier QSAR/screening, the experimental conclusion prevails.
1. Data Tier (0-3, ×2 weight = 0-6 pts): 3 = experimental guideline study (OECD TG) · 2 = non-guideline exp./HYBIT/in vitro/validated QSAR · 1 = QSAR/read-across/screening only · 0 = no data
2. Consistency (0-2 pts): 2 = all evidence concordant · 1 = mixed or single line only · 0 = conflicting evidence
3. Supporting Evidence (0-2 pts): 2 = ≥2 independent supporting lines · 1 = 1 supporting line · 0 = none
Score: 7-10 = HIGH · 4-6 = MEDIUM · 0-3 = LOW
Override rule: Where higher-tier experimental data conflicts with lower-tier QSAR/screening, the experimental conclusion prevails.
Evidence Integration
Lines of Evidence Included
Bioaccumulation WoE Conclusion (Output)
⚠️ OUTCOME: Substance fulfils B criterion (HIGH confidence)
Step 4: Toxicity (T) Assessment
Aquatic Toxicity, Full CMR, STOT RE, ED, Supporting Evidence, and Weight-of-Evidence
T Criterion met if ANY ONE of (Annex XIII §1.1.3):
• Long-term aquatic NOEC / EC10 < 0.01 mg/L (fish, daphnia, or algae)
• CMR: Carcinogenic / Mutagenic / Reproductive Tox Cat 1A, 1B, or 2
• STOT RE Cat 1 or 2 (repeated-dose target-organ toxicity)
• Endocrine disruptor (human health or environment)
• Other evidence of chronic toxicity (clearly established)
• Long-term aquatic NOEC / EC10 < 0.01 mg/L (fish, daphnia, or algae)
• CMR: Carcinogenic / Mutagenic / Reproductive Tox Cat 1A, 1B, or 2
• STOT RE Cat 1 or 2 (repeated-dose target-organ toxicity)
• Endocrine disruptor (human health or environment)
• Other evidence of chronic toxicity (clearly established)
A. Aquatic Toxicity (Chronic – Annex XIII §1.1.3(a))
Long-term NOEC or EC10 < 0.01 mg/L for any trophic level (fish / daphnia / algae) fulfils the T criterion.
A.0 Acute Aquatic Toxicity (Screening / Supporting)
Acute values are supporting only (not definitive for T under revised R.11)
A.1 Fish Chronic (OECD 210 / 215 / 234)
EC10 = 0.0085 mg/L < 0.01 → T criterion MET (fish chronic)
A.2 Daphnia Chronic (OECD 211, 21 d reproduction)
A.3 Algae Chronic / Growth Inhibition (OECD 201)
B. CMR Classification (CLP Annex VI / Self-classification)
DEFINITIVE: Classification as Carcinogenic Cat 1A/1B/2, Mutagenic Cat 1A/1B/2, or Reproductive Tox Cat 1A/1B/2 fulfils the T criterion per Annex XIII §1.1.3(b).
B.1 Carcinogenicity
Carc. Cat 1B (H350) → T criterion MET (CMR pathway)
B.2 Germ Cell Mutagenicity
B.3 Reproductive Toxicity
C. STOT RE — Specific Target Organ Toxicity (Repeated Exposure)
DEFINITIVE: STOT RE Cat 1 (H372) or Cat 2 (H373) fulfils the T criterion per Annex XIII §1.1.3(b).
Select STOT RE classification above
D. Endocrine Disruptor (Human Health / Environment)
Substances identified as endocrine disruptors for human health or the environment (per ECHA/EFSA criteria) fulfil the T criterion (Annex XIII §1.1.3).
E. Additional Supporting Points (R.11.4.1.3)
Activate each line of evidence that is available. These support the toxicity WoE beyond the aquatic chronic / CMR / STOT RE / ED pathways.
F. Weight-of-Evidence Toxicity Assessment
Confidence Scoring Framework (Weighted): Confidence is determined by 3 factors. Data tier carries 2x weight because higher-tier experimental evidence supersedes lower-tier QSAR/screening (max 10 points):
1. Data Tier (0-3, ×2 weight = 0-6 pts): 3 = experimental guideline study (OECD TG) · 2 = non-guideline exp./HYBIT/in vitro/validated QSAR · 1 = QSAR/read-across/screening only · 0 = no data
2. Consistency (0-2 pts): 2 = all evidence concordant · 1 = mixed or single line only · 0 = conflicting evidence
3. Supporting Evidence (0-2 pts): 2 = ≥2 independent supporting lines · 1 = 1 supporting line · 0 = none
Score: 7-10 = HIGH · 4-6 = MEDIUM · 0-3 = LOW
Override rule: Where higher-tier experimental data conflicts with lower-tier QSAR/screening, the experimental conclusion prevails.
1. Data Tier (0-3, ×2 weight = 0-6 pts): 3 = experimental guideline study (OECD TG) · 2 = non-guideline exp./HYBIT/in vitro/validated QSAR · 1 = QSAR/read-across/screening only · 0 = no data
2. Consistency (0-2 pts): 2 = all evidence concordant · 1 = mixed or single line only · 0 = conflicting evidence
3. Supporting Evidence (0-2 pts): 2 = ≥2 independent supporting lines · 1 = 1 supporting line · 0 = none
Score: 7-10 = HIGH · 4-6 = MEDIUM · 0-3 = LOW
Override rule: Where higher-tier experimental data conflicts with lower-tier QSAR/screening, the experimental conclusion prevails.
Evidence Integration
T Criterion Pathways Evaluated
Toxicity WoE Conclusion (Output)
⚠️ OUTCOME: Substance fulfils T criterion (HIGH confidence)
Step 5: Mobility (M/vM) Assessment
For PMT / vPvM identification (ECHA PMT/vPvM guidance)
M Criterion (PMT): Log Koc < 4.0 at any relevant pH (4-9)
vM Criterion (vPvM): Log Koc < 3.0 at any relevant pH (4-9)
PMT: P + M + T | vPvM: vP + vM
Mobility is assessed in addition to PBT/vPvB to identify substances that may contaminate drinking-water sources.
vM Criterion (vPvM): Log Koc < 3.0 at any relevant pH (4-9)
PMT: P + M + T | vPvM: vP + vM
Mobility is assessed in addition to PBT/vPvB to identify substances that may contaminate drinking-water sources.
A. Adsorption Potential: Log Koc
Provide experimental Log Koc (OECD 106/121) where available. QSAR Log Koc may be used where experimental data are not available. The lowest reliable Log Koc across the environmentally relevant pH range (4-9) should be used.
A.1 Experimental Log Koc
Enter Log Koc value to assess against M / vM thresholds
A.2 QSAR Log Koc
B. Supporting Evidence for Mobility
Additional data points relevant to assessing environmental mobility and water treatment removal.
C. Weight-of-Evidence Mobility Assessment
Confidence Scoring Framework (Weighted): Confidence is determined by 3 factors. Data tier carries 2x weight because higher-tier experimental evidence supersedes lower-tier QSAR/screening (max 10 points):
1. Data Tier (0-3, ×2 weight = 0-6 pts): 3 = experimental guideline study (OECD TG) · 2 = non-guideline exp./HYBIT/in vitro/validated QSAR · 1 = QSAR/read-across/screening only · 0 = no data
2. Consistency (0-2 pts): 2 = all evidence concordant · 1 = mixed or single line only · 0 = conflicting evidence
3. Supporting Evidence (0-2 pts): 2 = ≥2 independent supporting lines · 1 = 1 supporting line · 0 = none
Score: 7-10 = HIGH · 4-6 = MEDIUM · 0-3 = LOW
Override rule: Where higher-tier experimental data conflicts with lower-tier QSAR/screening, the experimental conclusion prevails.
1. Data Tier (0-3, ×2 weight = 0-6 pts): 3 = experimental guideline study (OECD TG) · 2 = non-guideline exp./HYBIT/in vitro/validated QSAR · 1 = QSAR/read-across/screening only · 0 = no data
2. Consistency (0-2 pts): 2 = all evidence concordant · 1 = mixed or single line only · 0 = conflicting evidence
3. Supporting Evidence (0-2 pts): 2 = ≥2 independent supporting lines · 1 = 1 supporting line · 0 = none
Score: 7-10 = HIGH · 4-6 = MEDIUM · 0-3 = LOW
Override rule: Where higher-tier experimental data conflicts with lower-tier QSAR/screening, the experimental conclusion prevails.
Evidence Integration
Mobility WoE Conclusion (Output)
OUTCOME: Enter Log Koc to calculate mobility outcome
Step 6: Final Assessment Results
Integrated PBT / vPvB and PMT / vPvM Weight-of-Evidence Conclusions
Summary of WoE Outcomes
Persistence (P)
vP – Very Persistent (HIGH confidence)
Bioaccumulation (B)
B – Bioaccumulative (HIGH confidence)
Toxicity (T)
T – Toxic (HIGH confidence)
Mobility (M)
M – Mobile (to be finalised based on Log Koc)
Final WoE Conclusion — PBT / vPvB
Integrated Narrative
PBT / vPvB Outcome
⚠️ SUBSTANCE IS PBT
Substance fulfils all three criteria: Persistent (vP), Bioaccumulative (B), and Toxic (T) according to REACH Annex XIII.
Final WoE Conclusion — PMT / vPvM
Integrated Narrative
PMT / vPvM Outcome
⚠️ SUBSTANCE IS vPvM
Substance fulfils the vPvM criteria (very Persistent + very Mobile) per the ECHA PMT/vPvM guidance. Note: Toxicity is not required for vPvM.
Regulatory Implications:
• Potential SVHC identification under Article 57(d)/(e) (PBT/vPvB) and emerging PMT/vPvM provisions
• Authorisation / restriction considerations may apply
• Enhanced risk management and emission minimisation throughout the lifecycle
• Drinking water contamination risk if vPvM — consider treatment effectiveness
• Potential SVHC identification under Article 57(d)/(e) (PBT/vPvB) and emerging PMT/vPvM provisions
• Authorisation / restriction considerations may apply
• Enhanced risk management and emission minimisation throughout the lifecycle
• Drinking water contamination risk if vPvM — consider treatment effectiveness