Chemical name: Poly(oxy-1,2-ethanediyl), .alpha.-(nonylphenyl)-.omega.-hydroxy-

Final regulatory action has been taken for the category: Pesticide, Industrial

Final regulatory action: The chemical is Severely Restricted

Use or uses prohibited by the final regulatory action:

All applications of NPE as an active ingredient in plant protection products are not allowed.

It is prohibited to place on the market or use NP or NPE as a substance or constituent in concentrations equal to or higher than 0.1% by mass as a co-formulant in pesticides and biocides.

Placing on the market or use as a substance or constituent of preparations in concentrations equal or higher than 0.1% by mass for the following purposes:

(i) industrial and institutional cleaning except

- controlled closed dry cleaning systems where washing liquid is recycled or incinerated

- cleaning systems with special treatment where the washing liquid is recyled or incinerated

(2) domestic cleaning

(3) textiles and leather processing except:

- processing with no release into waste water

- systems with special treatment where the process of water is pre-treated to remove the organic fraction completely prior to biological waste water treatment (degreasing of sheepskin)

(4) emulsifier in agricultural teat dips

(5) metal working except:

- uses in controlled close systems where the washing liquid is recycled or incinerated

(6) manufacturing of pulp and paper

(7) cosmetic products

(8) other personal care products except spermicides

(9) co-formulants in pesticides and biocides

Use or uses that remain allowed:

Existing national authorisations of pesticides or biocidal products containing NPE as a co-formulant which have been granted before 18/07/2003 (entry into force of the regulatory action) shall remain valid until they expire.

Pesticide use or uses that remain allowed:

Existing national authorisations of pesticides or biocidal products containing NPE as a co-formulant which have been granted before 18/07/2003 (entry into force of the regulatory action) shall remain valid until they expire.

The final regulatory action was based on a risk or hazard evaluation: Yes

Summary of the final regulatory action:

Nonylphenol (NP) and nonylphenol ethoxylate(NPE) are included in Annex I to Council Directive 76/769/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations. Therefore, NP and NPE may only be placed on the market or used subject to the conditions specified in point 46 of Annex I to Directive 76/769/EC. Point 46 states that NP and NPE may not be placed on the market or used as a substance or constituentof preparations in concentrations equal or higher than 0.1% by mass for a list of purposes. Furthermore, NPE was not included in the list of authorised active ingredients in Annex I to Directive 91/414/EEC and therefore Member States had to withdraw all authorisations for plant protection products containing NPE as an active substance by 25 July 2003. A period of grace for the disposal of existing stocks that could be greanted by Member States expired on 31 December 2003.

The reasons for the final regulatory action were relevant to: Human health and environment

Summary of known hazards and risks to human health:

The final regulatory action was taken in order to protect the environment. However the risk evaluation concluded that:

there were some concerns with respect to the workers of the industry sectors involving the manufacture of NP andits use as an intermediate, the margin between the actual exposrue and the N(L)OAELS forrepeated dose toxicity and reproductive effects are low, giving risk to concerns for risksto human health. The corrosivity of the substance in relation to skin and eye is unlikely to be expressed when good occupational hygiene practices are in operation. However, because of the variation in hygiene practices for the spraying of paints, there are concerns for corrosivity, and the conclusion was reached that there was a need to limit risks. These results give rise to concerns for risks to human health.

Indirect environment exposure: There were some concerns for human helath with respect to local exposure, based on MOSs of about 3 forrepeated dose toxicity and reproductive effects.

Expected effect of the final regulatory action in relation to human health:

Reduction of risks to human health.

Summary of known hazards and risks to the environment:

Final regulatory action was taken to protect aquatic and terrestrial ecosystems.

Concerns were identified with regard to effects on local and regional environmental spheres as well as fish and earthworm predators.

Aquatic compartment: the risk evaluation calculated predicted environmental concentrations (PECs) using default release estimations from the Technical Guidance Document (TGD), use category documents, information supplied by industry and from consultations with end users. the Regional PEC_{surface water} ^{is calculated as 0.6 ug/l. When compared to the PNEC of 0.33 ug/l the PEC/PNEC ratio is 1.8 indicating concern for the aquatic environment. the measured data suggest that local concentrations may be higher where waters are receiving inputs from industries which use either NP or NPE. NP in water courses is strongly adsorbed to sediments and sludges. The PNEC}_sediment ^{is 0.039 mg/kg. This has been calculated from the PNEC}_water ^{using an equilibrium partition method. The comparison of the PECs and PNECs and subsequent PEC/PNEC ratios suggest that the NP may have adverse effects on sediment dwelling species.}

^{Terrestrial compartment: The calculated PECs impley high concentrations of NPE in all the soil types due to teh application of sewage sludge. In calcuating the PECs default estimations based on the TGD and information on use supplied by industry have been used. NP is strongly absorbed to sludge in the WWT process. High concentrations of NP may therefore occur in soils where sewage sludge is applied. A PNEC}_soil ^{of 0.3mg/kg was calculated using terrestrial toxicity data. A comparison of the calculated PEC/PNEC ratios indicates that for other uses there is alevel of concern for the terrestrial environment. The report levels on soil (arising from sludge application) range from 0.3 to 4.7 mg/kg following application. This would give PEC/PNEC ratiosof 1 to 15.6}

^{Risk for fish and earthworm predators by secondary poisoning: NPEOs show a high bioconcentration potential in aquatic organisms. A PEC}_oral ^{of 10 mg/kg food was derived for the secondary poisoning scenario. The experiments carried out indicate bioconcentration factors for fish of 10 to 1300 (with most values 100) on a whole body fresh weight basis and of 0.03 to 1.65 mg/kg dry weight. The average concentration of NP in the river during teh sampling period was 3.9 ug/l. EUSES has been used to calculate the concentration of NP in fish and earthworms resulting in similar figures. Much higher values were calculated for local concentrations based on the default emissions to water. A further possible route of exposure for higher animals which might be considered is the consumption of plants sprayed with pesticides containing NPEOs. This gave a PEC in food of 6 mg/kg. Compared to the PNEC, the PEC/PNEC ratio is 0.6. As this calucation includes several additive worst-case assumptions, this indicates there should not be any concern for exposure via consumption of plants.}

^{The risk evaluation conclusion reached for the environment is that there is a need for limiting the risks for the aquatic (surface water) compartment for the following life cycle stages:}

^{Production of nonylphenol, phenol/formaldehyde resins, epoxy resins, other plastic stabilizers, phenolic oximes, nonylphenol ethoxylates formulation and production}

^{Nonylphenol ethoxylate use in all applications i.e. agriculture except veterinary medicines, captive use by the chemical industry, civil and electrical engineering, industrial and institutional cleaning, leather processing, metal extraction and processing, mineral fuel and oil industry, paint production and use, photographic industry, polymer industry, pulp, paper and board industry, textile industry.}

^{This conclusion also applies to the following life cycle stages for the terrestrial compartment and for secondary poisoning:}

^{Production and formulation of nonylphenol ethoxylates, production of paint containing nonylphenol ethoxylates.}

^{Nonylphenol ethoxylate use in all applications (including veterinary medicines), captive use by the chemical industry, civil and electrical engineering, industrial and institutional cleaning, leather processing, metal extraction and processing, mineral fuel and oil industry, paint production and use, photographic industry, polymer industry, pulp, paper and board industry, textile industry.}

Expected effect of the final regulatory action in relation to the environment:

Reduction of risks to the environment

Date of entry into force of the final regulatory action: 17/01/2005

The provisions adopted and published by the Member States to comply with Directive 2003/53/EC had to be applied from 17 January 2005. However, existing national authorisations of pesticides or biocidal products containing NPE as a co-formulant, which had been granted before the entry into force of the Directive (therefore before 18/07/2003) will not be affected by the provisions of the Directive until they expire. Moreover, Member States had to withdraw all authorizations for plant protection products containing NPE as an active substance by 25 July 2003.