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Directorate-General for Health and Food Safety
Opinion of the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) on the results of the Environmental Risk Assessment of Nonylphenol, straight chain [CAS N° 84852-15-3] and branched chain [CAS N° 25154-52-3], carried out in the framework of Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances - Opinion expressed at the 13th CSTEE plenary meeting, Brussels, 4 February 2000.
Terms of reference
The CSTEE on the basis of the examination of each Risk Assessment Report is invited to examine the following issues:
1. Does the CSTEE agree with the conclusions of each Risk Assessment Report?
2. If the CSTEE disagrees with such conclusions, the CSTEE is invited to elaborate on the reasons for this divergence of opinion.
General comments
The document available to the CSTEE, which dealt only with the environmental aspects of the risk assessment of nonylphenol, is of good quality.
It is based in general on a sufficient amount of information on exposure and on effects evaluation. Data has been critically and carefully evaluated.
The final evaluations have been performed by a correct application of the standard procedures proposed by the Technical Guidance Document (TGD).
Some minor comments can be made on specific items.
Specific comments
No particular comments on Chapter 1 (General substance information) and Chapter 2 (General information on exposure).
Chapter 3.1 - Environment exposure
No particular comments on Environmental releases (3.1.1.1)
Degradation data (3.1.1.2) are quite complex and sometimes controversial. This is not surprising, taking into account the variability of environmental conditions and the possibility of toxicity of nonylphenol to micro-organisms.
Inconsistencies are discussed in the report and the conclusions on environmental degradation are acceptable.
Distributions among environmental compartments and bioaccumulation (3.1.1.3) are correctly evaluated either theoretically or on the basis of experimental data.
Predicted environmental concentrations in water and sediments (3.1.2.) have been calculated on a local and regional basis, in general, by properly applying the TGD procedure. Only in a couple of cases experimentally measured data in specific sites has been utilised without applying the calculation. Obviously, the use of experimental data, if available, is to be encouraged. Nevertheless, also in these cases, a calculated PEC could be useful, at least for comparative purposes.
Predicted environmental concentrations in terrestrial and atmospheric compartments as well as in the food chain (3.1.3, 3.1.4 and 3.1.5) have been properly calculated and, whenever possible, compared with available experimental data.
The only exception is estimated PEC in agricultural soil due to the use in pesticide formulations. Due to several applications of different formulations containing nonylphenol, the PEC soil could be higher than estimated in the report.
The TGD does not consider the particularities of pesticide applications, while guidelines on the risk assessment of pesticides and pesticide formulations at EU level have been developed under Directive 91/414/EEC. These guidelines include several aspects, such as direct contact of spray with birds and mammals food items (grass, insects, etc.) which are not considered by the TGD but represent a relevant exposure route.
The emissions of nonylphenol ethoxylates will also contribute to environmental levels of nonylphenol due to transformation. The degradation in sewage treatment plants and in the aquatic environment is well discussed in an appendix in the Risk Assessment Report and the conclusions included in the document. The transformation of nonylphenol ethoxylates emitted to air is less studied and therefore a total instantaneous conversion to nonylphenol is suggested as a worst case assumption.
This gives a continental emission of almost a tonne nonylphenol/day, but when the terrestrial compartment is discussed it is mentioned that the impact of deposition is negligible. This may be true for agricultural areas where sewage sludge is applied, but may be a major source in areas with currently very low levels of contamination.
Chapter 3.2 - Effects assessment
Effects assessment for the aquatic compartment (3.2.1) is based on an extensive set of data, at least for fish, invertebrates and algae. The report presents a good review and an accurate critical evaluation of data. Some enclosure studies give an important confirmation at least for the order of magnitude of the effects measured in laboratory studies.
Oestrogenic effects, including vitellogenin induction in fish, are also evaluated in the report. However, no data appears to be available on the implications of enhanced vitellogenin induction on fish reproduction; this is important for the assessment of the consequences of the observed effects on the population level.
PNEC for water and sediments are calculated according to the TGD.
Fewer data are available for the terrestrial compartment (3.2.2). Anyway, a PNEC for soil has been calculated using suitable assessment factors.
Chapter 3.3 - Risk characterisation
On the basis of the ratio PEC/PNEC in different conditions, a detailed evaluation is made by assessing case by case (different release and production sites, different types of production and manufacture) the possible concern for the environment.
The report indicates, either for the aquatic or the terrestrial environment, a series of situations where there is a need for limiting the risk, as well as a series of cases where there is no need for risk reduction measures.
A potential risk for bioaccumulation in the aquatic and terrestrial trophic chains has also been assessed.
Conclusions
The risk characterisation made in the report is adequate and correctly performed, based on enough information.
The CSTEE agrees with the conclusions of the report with the only exception of the use in pesticide formulations.
In the opinion of the CSTEE, the risk derived from the use of nonylphenol in pesticide formulation is not adequately addressed. Aspects such as multiple applications during a short time period (cropping season) or exposure of terrestrial vertebrates due to consumption of contaminated food items during spraying (which obviously does not require a real bioaccumulation but only deposition on the surfaces) have not been addressed.
The CSTEE considers that the risk related to uses in pesticide formulations should be refined.
Taking into account the demonstrated oestrogenic effect of the chemical, the CSTEE considers that more emphasis should be given on reproduction effects in fish in estimating PNEC.
Terms of reference
The CSTEE on the basis of the examination of each Risk Assessment Report is invited to examine the following issues:
1. Does the CSTEE agree with the conclusions of each Risk Assessment Report?
2. If the CSTEE disagrees with such conclusions, the CSTEE is invited to elaborate on the reasons for this divergence of opinion.
General comments
The document available to the CSTEE, which dealt only with the environmental aspects of the risk assessment of nonylphenol, is of good quality.
It is based in general on a sufficient amount of information on exposure and on effects evaluation. Data has been critically and carefully evaluated.
The final evaluations have been performed by a correct application of the standard procedures proposed by the Technical Guidance Document (TGD).
Some minor comments can be made on specific items.
Specific comments
No particular comments on Chapter 1 (General substance information) and Chapter 2 (General information on exposure).
Chapter 3.1 - Environment exposure
No particular comments on Environmental releases (3.1.1.1)
Degradation data (3.1.1.2) are quite complex and sometimes controversial. This is not surprising, taking into account the variability of environmental conditions and the possibility of toxicity of nonylphenol to micro-organisms.
Inconsistencies are discussed in the report and the conclusions on environmental degradation are acceptable.
Distributions among environmental compartments and bioaccumulation (3.1.1.3) are correctly evaluated either theoretically or on the basis of experimental data.
Predicted environmental concentrations in water and sediments (3.1.2.) have been calculated on a local and regional basis, in general, by properly applying the TGD procedure. Only in a couple of cases experimentally measured data in specific sites has been utilised without applying the calculation. Obviously, the use of experimental data, if available, is to be encouraged. Nevertheless, also in these cases, a calculated PEC could be useful, at least for comparative purposes.
Predicted environmental concentrations in terrestrial and atmospheric compartments as well as in the food chain (3.1.3, 3.1.4 and 3.1.5) have been properly calculated and, whenever possible, compared with available experimental data.
The only exception is estimated PEC in agricultural soil due to the use in pesticide formulations. Due to several applications of different formulations containing nonylphenol, the PEC soil could be higher than estimated in the report.
The TGD does not consider the particularities of pesticide applications, while guidelines on the risk assessment of pesticides and pesticide formulations at EU level have been developed under Directive 91/414/EEC. These guidelines include several aspects, such as direct contact of spray with birds and mammals food items (grass, insects, etc.) which are not considered by the TGD but represent a relevant exposure route.
The emissions of nonylphenol ethoxylates will also contribute to environmental levels of nonylphenol due to transformation. The degradation in sewage treatment plants and in the aquatic environment is well discussed in an appendix in the Risk Assessment Report and the conclusions included in the document. The transformation of nonylphenol ethoxylates emitted to air is less studied and therefore a total instantaneous conversion to nonylphenol is suggested as a worst case assumption.
This gives a continental emission of almost a tonne nonylphenol/day, but when the terrestrial compartment is discussed it is mentioned that the impact of deposition is negligible. This may be true for agricultural areas where sewage sludge is applied, but may be a major source in areas with currently very low levels of contamination.
Chapter 3.2 - Effects assessment
Effects assessment for the aquatic compartment (3.2.1) is based on an extensive set of data, at least for fish, invertebrates and algae. The report presents a good review and an accurate critical evaluation of data. Some enclosure studies give an important confirmation at least for the order of magnitude of the effects measured in laboratory studies.
Oestrogenic effects, including vitellogenin induction in fish, are also evaluated in the report. However, no data appears to be available on the implications of enhanced vitellogenin induction on fish reproduction; this is important for the assessment of the consequences of the observed effects on the population level.
PNEC for water and sediments are calculated according to the TGD.
Fewer data are available for the terrestrial compartment (3.2.2). Anyway, a PNEC for soil has been calculated using suitable assessment factors.
Chapter 3.3 - Risk characterisation
On the basis of the ratio PEC/PNEC in different conditions, a detailed evaluation is made by assessing case by case (different release and production sites, different types of production and manufacture) the possible concern for the environment.
The report indicates, either for the aquatic or the terrestrial environment, a series of situations where there is a need for limiting the risk, as well as a series of cases where there is no need for risk reduction measures.
A potential risk for bioaccumulation in the aquatic and terrestrial trophic chains has also been assessed.
Conclusions
The risk characterisation made in the report is adequate and correctly performed, based on enough information.
The CSTEE agrees with the conclusions of the report with the only exception of the use in pesticide formulations.
In the opinion of the CSTEE, the risk derived from the use of nonylphenol in pesticide formulation is not adequately addressed. Aspects such as multiple applications during a short time period (cropping season) or exposure of terrestrial vertebrates due to consumption of contaminated food items during spraying (which obviously does not require a real bioaccumulation but only deposition on the surfaces) have not been addressed.
The CSTEE considers that the risk related to uses in pesticide formulations should be refined.
Taking into account the demonstrated oestrogenic effect of the chemical, the CSTEE considers that more emphasis should be given on reproduction effects in fish in estimating PNEC.
