Chemical name:

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:

Banned uses

Co-formulant in pesticide products (plant protection and biocide products)

Banned uses:

Institutional and industrial cleaning (severely restricted)

In household cleaning products (banned)

In cosmetic products (banned)

Textile and leather processing (severely restricted)

In agricultural teat dips (banned)

Metal working (severely restricted)

Paper and pulp manufacturing (banned)

Use or uses that remain allowed:

Institutional and industrial cleaning only in:

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

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

Textile and leather processing only in:

- 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)

Spermicides

Metal working only:

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

Pesticide use or uses that remain allowed:

Existing national authorisations of plant protection or biocidal products containing NPE as a coformulant which have been granted before 01/08/2005 (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:

It is prohibited to place the following product types on the market if their content of octylphenol (molecular formula C₁₄H₂₂O), nonylphenol (molecular formula C₁₅H₂₄O) or ethoxylates of these is equal to or greater than 0.1 % by mass:

a. laundry detergents

b. cleaning products

c. cosmetics

d. textiles processing products;

e. leather processing products;

f. metal working products;

g. auxiliary products for the manufacture of cellulose and paper;

h. agricultural teat dips containing these substances as emulsifiers;

i. biocidal products and plant protection products containing these substances as coformulants.

Exemptions:

a. spermicides;

b. textile and leather processing products if:

1. their processing does not result in the disposal of octylphenol ethoxylates or nonylphenol ethoxylates in waste water, or

2. for installations for special treatment, such as degreasing of sheep skin, the process water is pre-treated to remove the organic fraction completely prior to the biological waste water treatment;

c. metal working products intended for use in closed and controlled systems in which the cleaning liquid is recycled or incinerated.

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

Summary of known hazards and risks to human health:

Nonylphenol ethoxylates are microbially degraded. It is mainly the ethoxylate chain that is degraded to yield more stable and smaller molecules such as nonylphenol with 1 and 2 ethoxylate units, their carbonic acids and finally nonylphenols are formed.

Direct exposure of consumer to nonylphenols may occur by using products containing them. The estimated exposure level was low. It is estimated that the main indirect exposure of humans to nonylphenols occurs via food intake (mainly fish and root crops). Local exposure scenarios like vicinity to textile industry give high exposure levels. Contamination of crops with nonylphenols can occur via application of pesticides containing nonylphenol ethoxylates as coformulant (up to 5%). However there are no data on residue levels in the harvested crops.

Concerns for human health for workers in certain processes have been identified (ex. Spray application of specialty paint) (see EU Risk assessment¹, Ref 3).

The contamination with nonylphenol ethoxylates metabolites of·different fish tissues (from Swiss rivers) has been determined in 1984/85. A range of 0.03-7 mg/kg dw. has been measured (Ref 2).

Two studies on rodents show that subcutaneous injection of nonylphenols induce an increase of the uterus weight with a range of lowest observed effect (LOEL) from 100 to 333 mg/kg/day.

Another study on youthful rats report an increase of progesterone receptors in uterus at a LOEL of 15-30 mg/kg/day.

Another study on rats reports that males show a reduced density of sperm and reduced quantity of spermatids in testicles after oral concentration of 49 and 150 mg/kg/day respectively. Females show an early sexual maturity and reduced weight of ovaries and an extension in the oestrogenic cycle after oral concentration of 49 and 150 mg/kg/day respectively. The NOEL is 15 mg/kg/day.

Statistics on testicular cancer in Switzerland showed an increase of 13% between the periods 1974-1978 and 1983-1993 (Statistics comprised canton Vaud and Neuchatel). A second Study compared the occurrence of testicular cancer in the period 1984-1988 and 1989-1993: no significant increase could be observed (Ref 2).

Epidemiological studies show an increase of certain diseases in the last decades, however the studies often don't show the connection between the causes and the observed effects.

¹ For the regulation of chemicals Switzerland bases its risk evaluation inter alia on the EU risk assessment. Switzerland takes over most of the EU chemicals regulations and in certain cases adapt them to Swiss circumstances. This is due to the fact that Switzerland is geographically in the middle of Europe and is socially and economically similar to western Europe, EU is the most important trade partner of Switzerland.

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

Reduction of the risk to humans

Summary of known hazards and risks to the environment:

Final regulatory action was taken to protect the environment

Already in 1987 the marketing and use of nonylphenol ethoxylates in laundry detergents had been banned. As a consequence, concentrations of metabolites in waste water have decreased markedly. Because of other still permitted uses, in 1997 the compounds were still detected at concentrations of a few micrograms per litre in effluents from water treatment plants and also in sewage sludge. Elevated values were found in samples of drainage water and flowing water receiving waste water from the textile industry.

The nonylphenol concentrations that are considered to have no effect on aquatic organisms (PNEC= 0.3374 µg/l see Ref 3) are in certain cases exceeded (see Ref 1).

Concentrations of 0.03-0.3 µg/l of nonylphenols have been measured in Swiss rivers in 1997.

Nonylphenols have also been measured in the effluents of water treatment plants in 1997: the concentration ranged from 0.1 to 3.6 µg/l.

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

Reduction of the risk to the environment

Date of entry into force of the final regulatory action: 01/08/2005