|
1 |
2 |
3 |
4 |
|
P+B+T
|
vP+vB |
Additional criterion |
Additional criterion |
|
Substances that are persistent, bioaccumulative and have serious long-term effects on health (including carcinogenic, mutagenic or toxic for reproduction)
or are highly toxic for the environment |
Very persistent, and very bioaccumulative substances (documentation of toxicity is not required) |
Substances that are detected in the food chain at levels which give rise to an eqvivalent reason for concern |
Substances that give rise to an equivalent level of concern as substances that meet the criteria 1-3, such as certain metals and substances that have endocrine disrupting effects |
For these sets of criteria the following definitions are used:
| Criterion |
|
Defined by |
| Persistent |
P |
One of the following:
1) Fresh water: half-life ³ 40 days
2) Marine water: half-life ³ 60 days
3) Sediment, fresh water: half-life ³ 120 days
4) Sediment, marine: half-life ³ 180 days
5) Soil: half-life ³ 120 days
Other relevant information may be used if test results are lacking.1)
|
Bioaccumulative
|
B |
Bioconcentration factor (BCF) > 2000
Other relevant information may be used if test results are lacking.1)
|
Serious long-term effects on health
|
T |
One of the following:
1) Carcinogenic (Category 1 or 2 according to Directive 67/548/EEC), i.e. classified as T; R45 or T; R49
2) Mutagenic (Categori 1 or 2 according to Directive 67/548/EEC), i.e. classified as T; R46
3) Toxic for reproduction (Category 1, 2 or 3 according to Directive 67/548/EEC), i.e. classified as T; R60,T; R61, Xn; R62, Xn; R63 or R64. 2)
4) Chronic toxicity: i.e. classified as T; R48 or Xn; R48 |
| Highly toxic for the environment |
T |
One of the following:
1) Very high chronic toxicity for aquatic organisms: NOEC (aquatic, chronic) £ 0,01 mg/l
2) Very high chronic toxicity for
terrestric organisms: NOEC (bird, chronic) £ 30 mg/kg
3) Substances that are sufficiently documented in internationally accepted tests as causing endocrine disrupting effects
Other relevant information may be used if test results are lacking.1)
|
| Very persistent |
vP |
One of the following:
1) Fresh water and marine water: half-life ³ 60 days
2) Sediment, fresh water or marine: half-life ³ 180 days
3) Soil: half-life ³ 180 days
Other relevant information may be used if test results are lacking.1) |
| Very bioaccumulative |
vB |
Biocentration factor (BCF) ³ 5000
Other relevant information may be used if test results are lacking.1) |
| Additional critierion |
|
One of the following:
1) Metals that may cause serious long-term effects.
2) Substances that are traced in the food chain or in mother's milk at levels that may represent a risk to health or the environment.
3) Substances that are sufficiently documented in internationally accepted tests as causing endocrine disrupting effects at low levels.
4) Other substances that are shown to represent risks to health or the environment at similar levels as PBT- or vPvB-substances. |
1) Test results that show potential for persistency, toxicity and bioaccumulation may be used if tests of higher quality are lacking: a ) potentially high persistency: does not fulfil the criteria for ready or inherent persistency (OECD 301,302 or 306), b) potentially high chronic aquatic toxicity: L(E)C50 in acute test £ 0,1 mg/l. This is most relevant with regard to persistency, as half-life test has recently been internationally accepted and little test data therefore exists today.
2) The use of R64 in this connection should be limited to substances where the results from one- or two-generation tests on mammals indicate that adverse effects on the off-spring is due to transfer in mother's milk.