Chemical name: Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Severely Restricted Use or uses prohibited by the final regulatory action: The production, circulation, use, import and export of PFOS, its salts and PFOSF have all been banned in China except for the acceptable purpose or specific exemption. Pesticide use or uses that remain allowed: The specific exemption: Photo masks in the semiconductor and liquid crystal display (LCD) industries; Metal plating (hard metal plating); Metal plating (decorative plating); Electric and electronic parts for some color printers and color copy machines; Insecticides for control of red imported fire ants and termites; Chemically driven oil production. The acceptable purpose: Photo-imaging; Photo-resist and anti-reflective coatings for semi-conductors; Etching agent for compound semi-conductors and ceramic filters; Aviation hydraulic fluids; Metal plating (hard metal plating) only in closed-loop systems; Certain medical device (such as E TEE layer, radio shielding E TEE production, in vitro diagnostic medical equipment and CCD filter); Fire-fighting foam. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: Since March 26th 2014, the production, circulation, use, import and export of PFOS, its salts and PFOSFS have all been banned in China except for the acceptable purpose or specific exemption. The reasons for the final regulatory action were relevant to: Environment Summary of known hazards and risks to human health: On the Swedish population, the levels of PFOS in whole blood was higher (27.2 ng/g, 3.0 - 67, n=10) in females with a high consumption of fish (Berglund, 2004) compared to samples from females in the general population (17,8 (ng/g, 4.6 -33, n= 26). In humans, the highest concentrations of PFOS have been detected in workers at 3.M's manufacturing plant for per fluorochemicals in Decatur, US, where the levels in serum in the last year of measurement (2000) ranged between 0.06 -10.06 ug/g (n=263). In a study of the general population, blood samples from families including three generations living in 12 European countries were tested for a large number of chemicals including PFOS and PFOSA. P FOS was present in 37 of 38 samples with concentrations from 0.36 to 35.3 ng/g blood, while PEOSA was present in 36 of 38 samples with concentrations from 0.15 to 2.04 ng/g blood. Pooled serum samples from 3802 Australian residents, collected 2002-2003 and for analysed and region, gender divided in relation to age, gender and region, were analysed for perfluoroalkylsulfonates, and PFOSA. PFOS and PFOSA were quantified in all pooled serum samples with a total range of 12.7-29.5 ng/ml (mean 17.2 ng/ml) and 0.36-2.4 ng/ml (mean 0.81 ng/ml), respectively. For PFOS, a significant correlation between age and concentration was shown. No substantial difference was found in levels of per fluorinated compounds between the urban and rural regions. According to gender some differences were shown for some of the age groups. Expected effect of the final regulatory action in relation to human health: To protect the environment and human health. Summary of known hazards and risks to the environment: Studies on fish have shown that PFOS has bioconcentration properties. In studies on bluegill sunfish (Lepomis macrochirus) and rainbow trout (Oncorhynchus my kiss), bioconcentration factors (BCFs) have been estimated to be 2796 (whole fish) as well as 2900 (liver) and 3100 (plasma), respectively. The major route of uptake is believed to be through the gills. Since PFOS is released from sewage treatment plants to the environment i.e. through water, one major route for PFOS into local food chains could be through fish. PFOS has shown a high oral uptake (95%) within 24 hours in the gastro-intestinal (GI) tract instudies on rats (OECD, 2002). Taken together, this could constitutethe basis of the highly elevated levels that have been observed in top predators in food chains containing fish. Expected effect of the final regulatory action in relation to the environment: To protect the environment and human health. Date of entry into force of the final regulatory action: 26/03/2014 |