Umweltbundesamt
Click to enlargeThe final PMT and vPvM criteria are the result of several public consultations and the scientific and technical development under REACH. Over 100 scientists and institutions contributed with thorough scientific and technical comments. The following criteria were presented at the 30th Caracal meeting (01 - 02 July 2019) and are also published in UBA TEXTE 127/2019 (Neumann and Schliebner, 2019).
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A substance that fulfils the persistence, mobility and toxicity criteria shall be considered to be a PMT substance.
Persistent (P)
A substance fulfils the persistence criterion (P) in any of the following situations:
a) the degradation half-life in marine water at 9 °C is higher than 60 days;
b) the degradation half-life in fresh or estuarine water at 12 °C is higher than 40 days;
c) the degradation half-life in marine sediment at 9 °C is higher than 180 days;
d) the degradation half-life in fresh or estuarine water sediment at 12 °C is higher than 120 days;
e) the degradation half-life in soil at 12 °C is higher than 120 days.
Mobility (M)
A substance fulfils the mobility criterion (M) in the following situation:
a) the lowest organic carbon-water coefficient log KOC over the pH range of 4-9 is less than 4.0
Toxicity (T)
A substance fulfils the toxicity criterion (T) in any of the following situations. Point (a) to (c) are already set out in Annex XIII, 1.1.3 of REACH:
a) the long-term no-observed effect concentration (NOEC) or EC10 for marine or freshwater organisms is less than 0.01 mg/l;
b) the substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B, or 2) according to Regulation EC No 1272/2008;
c) there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification: specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008;
Beyond these T criteria already now set out in Annex XIII, 1.1.3 of REACH there might be cases, where it is necessary to identify persistent and mobile substances with other hazardous properties posing a risk to human health and the environment. These substances will be addressed as a separate category. In such cases it is proposed to demonstrate according to Art. 57 (f) an overall concern which is equivalent to Art. 57 (a) - (e). Aspects to be considered are comparable to the SVHC-identification for respiratory sensitizers:
Evidence (so called indicators) for significant risk to human health and the environment for persistent and mobile substances may arise in any of the following situations and need assessment to demonstrate fulfilling the equivalent level of concern of Art. 57 (f). These indicators are:
d) the substance meets the criteria for classification as carcinogenic (category 2), or germ cell mutagenic (category 2) according to Regulation EC No 1272/2008;
e) the substance meets the criteria for classification as additional category for "effects on or via lactation", according to Regulation EC No 1272/2008;
f) the Derived-No-Adverse-Effect-Level (DNEL) is ≤ 9 μg/kg/d (oral, long term, general population), as derived following Annex I;
g) the substance acts as an endocrine disruptor in humans and/or wildlife species according to the WHO/IPCS definition of an endocrine disruptor.
A substance that fulfils the persistence and mobility criteria shall be considered to be a vPvM substance.
Very Persistent (vP)
A substance fulfils the "very persistent" criterion (vP) in any of the following situations:
(a) the degradation half-life in marine (9 °C), fresh or estuarine water (12 °C and pH 4-9) is higher than 60 days;
(b) the degradation half-life in marine (9 °C) fresh or estuarine water sediment (12 °C and pH 4-is higher than 180 days;
(c) the degradation half-life in soil (12 °C and pH 4-9) is higher than is higher than 180 days.
Very Mobile (vM)
A substance fulfils the "very mobile" criterion (vM) in the following situation:
(b) the lowest organic carbon-water coefficient log KOC over the pH range of 4-9 is less than 3.0.
<– go back: Frequently Asked Question (FAQ) | –> go forward: Introduction to PMT/vPvM substance
Read the full story related to the development of the PMT/vPvM criteria under the EU´s chemical legislation REACH to identify PMT/vPvM substances: (01) –> Introduction to PMT/vPvM substances, (02) –> Emergence (2009 – 2015) of the PMT/vPvM criteria, (03) –> First PMT Workshop 2011 (04) –> Public Consultation (2016 – 2019) on the PMT/vPvM criteria, (05) –> Second PMT Workshop 2018, (06) –> Utilization (2019 – ongoing) of the PMT/vPvM criteria, (07) –> Third PMT Workshop 2021, (08) –> Media coverage and dissemination, (09) –> Frequently Asked Question (FAQ), (10) –> The final PMT/vPvM criteria
The UBA’s motto, For our environment (“Für Mensch und Umwelt”), sums up our mission pretty well, we feel. In this video we give an insight into our work.
