Chemical name: 1-Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-pentadecafluoro- PFOA, its salts and esters, and PFOA-related substances, 1-Octanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-pentadecafluoro-, and its salts and esters

Final regulatory action has been taken for the category: Industrial

Final regulatory action: The chemical is Severely Restricted

Use or uses prohibited by the final regulatory action:

1. Shall not be manufactured, or placed on the market as substances on their own from 4 July 2020.

2. Shall not, from 4 July 2020, be used in the production of, or placed on the market in:

(a) another substance, as a constituent;

(b) a mixture;

(c) an article, in a concentration equal to or above 25 ppb of PFOA including its salts or 1 000 ppb of one or a combination of PFOA-related substances.

3. Points 1 and 2 shall apply from:

(a) 4 July 2022 to: (i) equipment used to manufacture semi-conductors; (ii) latex printing inks.

(b) 4 July 2023 to: (i) textiles for the protection of workers from risks to their health and safety; (ii) membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment; (iii) plasma nano-coatings.

(c) 4 July 2032 to medical devices other than implantable medical devices within the scope of Directive 93/42/EEC.

4. Points 1 and 2 shall not apply to any of the following:

(a) perfluorooctane sulfonic acid and its derivatives, which are listed in Part A of Annex I to Regulation (EC) No 850/2004;

(b) the manufacture of a substance where this occurs as an unavoidable by-product of the manufacture of fluorochemicals with a carbon chain equal to or shorter than 6 atoms;

(c) a substance that is to be used, or is used as a transported isolated intermediate, provided that the conditions in points (a) to (f) of Article 18(4) of this Regulation are met;

(d) a substance, constituent of another substance or mixture that is to be used, or is used: (i) in the production of implantable medical devices within the scope of Directive 93/42/EEC; (ii) in photographic coatings applied to films, papers or printing plates; (iii) in photo-lithography processes for semiconductors or in etching processes for compound semiconductors;

(e) concentrated fire-fighting foam mixtures that were placed on the market before 4 July 2020 and are to be used, or are used in the production of other fire-fighting foam mixtures.

5. Point 2(b) shall not apply to fire-fighting foam mixtures which were:

(a) placed on the market before 4 July 2020; or

(b) produced in accordance with point 4(e), provided that, where they are used for training purposes, emissions to the environment are minimised and effluents collected are safely disposed of.

6. Point 2(c) shall not apply to:

(a) articles placed on the market before 4 July 2020;

(b) implantable medical devices produced in accordance with point 4(d)(i);

(c) articles coated with the photographic coatings referred to in point 4(d)(ii);

(d) semiconductors or compound semiconductors referred to in point 4(d)(iii).

Use or uses that remain allowed:

4. Points 1 and 2 shall not apply to any of the following:

(a) perfluorooctane sulfonic acid and its derivatives, which are listed in Part A of Annex I to Regulation (EC) No 850/2004;

(b) the manufacture of a substance where this occurs as an unavoidable by-product of the manufacture of fluorochemicals with a carbon chain equal to or shorter than 6 atoms;

(c) a substance that is to be used, or is used as a transported isolated intermediate, provided that the conditions in points (a) to (f) of Article 18(4) of this Regulation are met;

(d) a substance, constituent of another substance or mixture that is to be used, or is used: (i)in the production of implantable medical devices within the scope of Directive 93/42/EEC; (ii) in photographic coatings applied to films, papers or printing plates; (iii)in photo-lithography processes for semiconductors or in etching processes for compound semiconductors;

(e) concentrated fire-fighting foam mixtures that were placed on the market before 4 July 2020 and are to be used, or are used in the production of other fire-fighting foam mixtures.

5. Point 2(b) shall not apply to fire-fighting foam mixtures which were:

(a) placed on the market before 4 July 2020; or

(b) produced in accordance with point 4(e), provided that, where they are used for training purposes, emissions to the environment are minimised and effluents collected are safely disposed of.

6. Point 2(c) shall not apply to:

(a) articles placed on the market before 4 July 2020;

(b) implantable medical devices produced in accordance with point 4(d)(i);

(c) articles coated with the photographic coatings referred to in point 4(d)(ii);

(d) semiconductors or compound semiconductors referred to in point 4(d)(iii).

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

Summary of the final regulatory action:

Regulations to restrict the production, import, export or sale of the substances on their own, production of another substance as a constituent, a mixture or an article that contain PFOA-, its salts and esters or PFOA-related substances.

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

Summary of known hazards and risks to human health:

PFOA and other perfluorinated organic compounds have been widely used and are present in various consumer products that are produced and used worldwide. A number of different perfluorinated compounds have been widely found in the environment. Extensive data in humans and animals demonstrate ready absorption of PFOA and distribution of the chemical throughout the body by non-covalent binding to plasma proteins. The liver is an important binding site, and increased liver weight in laboratory animals is one of the early, low-dose manifestations of exposure. PFOA is not readily eliminated from humans as evidenced by the half-life of 2.3 years. In contrast, half-life values for the monkey, rat, and mouse are 20.8 days, 11.5 days, and 15.6 days, respectively.

Human exposure to PFAS, including PFOA and PFOS, is likely to occur via a number of vectors and routes e.g. ingestion of non-food materials, dermal contact and inhalation. PFOA has been analyzed in a limited number of European environment and food samples, and has been detected in fish and eggs. Cereals were found to be the main source in a food-basket study (Haug et al., 2010a,b). Drinking water is estimated to contribute less than 16% to the indicative exposure. PFOA was also observed to leak from non-stick coatings on cookware and from food packaging of paper treated with oil- and moisture resistant chemicals. Based on the limited data available, the EFSA CONTAM Panel identified the indicative average and high level dietary exposures of 2 and 6 ng/kg b.w. per day, respectively. However, a higher estimate was found for dietary intake of PFOA (31 ng/day) in Norway by using consumption data given by Norkost 1997 (Haug et al., 2010a).

The importance of possible pathways of non-food human exposure to PFOA is of higher importance in childhood compared to adulthood. Dust has been identified as an important source of exposure, which put toddlers at risk due to their hand-to mouth behavior. For PFOA, the total contribution from the non-food sources, mainly indoor exposure, could be as high as 50% compared to the estimated average dietary exposure to PFOA.

PFOA has also been shown to be transferred from mother to the fetus, and the relatively high plasma concentration detected in blood samples from small children is of concern. Two studies show that PFOA levels in maternal blood decreased to 54% after six months and to 7% after 12 months of breast-feeding compared to their blood levels at birth, whereas PFOA levels in the serum of six-month-old infants were 4.6 times higher than maternal blood levels at birth (Thomsen et al., 2010, Fromme et al., 2010). Another Norwegian study estimated that breast-fed infants at around 6 months of age take up 4.1 ng PFOA per kg body weight, which is 15 times higher than the uptake in adults (Haug et al., 2011).

In a study from the Norwegian Mother and Child Cohort Study, Granum et al., (2013) found a positive correlation between the maternal concentrations of PFOA and PFNA and the number of episodes of common cold for the children, and between PFOA and PFHxS and the number of episodes of gastroenteritis. The results indicate that pre-natal exposure to PFAS may be associated with immunosuppression in early childhood.

In Norway the occupational exposure of professional ski-waxers to PFOA were shown to be higher than for non-occupational exposed; blood serum values were 25 fold higher (rang 15-175 ng/ ml) than previously measured among people with a high consumption of fish (Daae et al., 2009).

Epidemiology studies have examined occupational and residential populations at or near large-scale PFOA production plants in the United States in an attempt to determine the relationship between serum PFOA concentration and various health outcomes suggested by the standard animal toxicological studies. These studies have found a positive association between serum PFOA concentration and increased cholesterol levels in the general population and in worker populations but no consistent trends for the low- and high-density protein lipids. A positive association has been found between serum PFOA concentrations and increased liver enzymes and/or decreased bilirubin in both worker and general populations, chronic kidney disease in the general population, and the odds of experiencing early menopause. Epidemiology studies demonstrate an association of serum PFOA with kidney and testicular tumors among highly exposed members of the general population. Maternal or child plasma levels of PFOA were positively associated with decreased antibody titers in children after vaccination, obesogenic effects in female children at 20 years of age, and parent reported Attention Deficit Hyperactivity Disorders.

Based on a general concern for the high levels of PFOA found in environmental samples, a national action plan was initiated by the Norwegian authorities in 2002 (later updated in 2009). Furthermore, PFOA was in 2003 added to a Norwegian national target to substantially reduce the emission of certain hazardous substances by 2020, as described in a white paper to the parliament (ministry of the Environment, Norway, 2003).

In the Norwegian "Evaluation of consequences of regulating PFOA and selected salts and esters of PFOA in consumer products", the following concerns were put forward for the proposed regulation: PFOA is present in the blood of the general population, breast milk and in umbilical cord blood. PFOA is eliminated from the body very slowly. Humans are exposed to PFOA by consuming contaminated foods or water, by breathing air that is polluted as well as by ingesting dust. Fish is an important source of exposure via food. The foetus is exposed to PFOA via umbilical cord blood and newborns are exposed via breast milk. The intake for infants via breast milk can be greater than the intake via food for adults. Infants can also come into direct contact through carpeting, and swallowing dust can be an important contributor to exposure.

PFOA is a substance of very high concern with respect to its health and environmental properties. PFOA is harmful to the reproductive system, carcinogenic, toxic and harmful to human health through repeated exposure and is also an irritant. PFOA does not degrade in the environment. PFOA is a substance similar to persistent, bio-accumulating and toxic (PBT) substances or a substance of equal concern. It is impossible to establish an acceptable level for substances with such properties in the environment, and emissions and exposure should be limited to the greatest extent possible.

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

Reduced risk to the human health.

Summary of known hazards and risks to the environment:

PFOA is an anthropogenic compound widely found in the environment including the Arctic. The long-range air and ocean transport of PFOA to the Arctic give detectable levels in sea birds, seal and polar bear. The levels in polar bears have significantly increased the last 20-30 years (Smithwick et al., 2006). Furthermore, it has been shown that other more volatile perfluorated compounds can be degraded to form PFOA and thus contribute to the increased levels observed (ECHA 2013). Calculation-models has indicated that PFOA levels in the Arctic will continue to increase up to 2030 despite the voluntary actions taken to phase-out production and use of this compound (Dietz et al., 2008).

The monitoring data show that PFOA in soil leaches can be a long term source to contaminating underlying groundwater (ECHA, 2013). Sewer and leachate are significant, human-made primary sources for emissions and dispersion of PFOA into the Norwegian environment (TA-2354). In a Nordic study of perfluorinated compounds in the environment, PFOS and PFOA dominated in the sewer samples from all six Nordic countries (ref. TemaNord 2004). PFOA was dominating in leachate samples from waste deposit sites in Norway and Finland. The presence of PFOS and PFOA was also detected in sludge from processing plants (Tom Erik Økland and Kristina Skoog; TA-2450/2008). A new study has established that PFOA is only bound to sludge to a small degree and that it mainly follows the water phase through the Nordic water treatment plants (Aquateam, 2010).

Evenset et al. (2005) established PFOS and PFOA as the most common perflourinated compounds in sediments from Isfjorden on Svalbard, Norway. A study of sediments from the Barent's Sea from 2007 shows the presence of PFOA in a number of samples with a general prevalence of PFOS and perfluorocarboxylic acids with long chain lengths over PFOA. (Bakke et al., 2007).

Measurements of PFOA in air started in the autumn of 2006 at Birkenes in Southern Norway and Zeppelin on Svalbard (Manø et al., TA-2408/2008). The values at Birkenes was on average 1.04 pg/m3, Zeppelin 0.44 pg/m3, which were lower than, for example, the west coast of Ireland and in the English Channel. PFOA is also transported long distances to the Artic via sea currents. PFOA has been detected in sea water; this confirms that long-range transboundary transport via sea currents can occur (AMAP 2009).

A study of samples from polar bears in Greenland collected during the period 1984-2006 showed a significant annual increase in the levels of PFOS and some perfluorocarboxylic acids. For PFOA there was an average annual increase of 2.3%. The sum of the concentrations of perflourinated compounds was higher than the concentration of known chloro-organic priority substances. It is assumed that if the most marked increase continues, the level for harmful effect could be exceeded in 2014-2024 (Dietz et al. 2008).

The Norwegian Government has established national goals for discharge and emission reductions and cessation for 2010 and 2020, (Prop. 1 S (2009-2010) from the Norwegian Ministry of the Environment, Proposition to the Storting (Storting bill) for the 2010 budget year for the priority substances hazardous to health and the environment (the Priority List). Perfluorooctanoic acid (PFOA) is one of the substances included in those national goals.

In the Norwegian "Evaluation of consequences of regulating PFOA and selected salts and esters of PFOA in consumer products", the following concerns were put forward for the proposed regulation: PFOA is a man-made substance that does not occur in nature. PFOA is currently widely dispersed in the environment, including in the Arctic. PFOA is transported long distances with air and sea currents, and its presence has been detected in the Arctic in (among other things) sea birds, seals and polar bears. In polar bear a significant increase in the levels of PFOA has been detected over the past 20-30 years. Other more volatile, perflourinated compounds have also been detected, which can slowly degrade to produce PFOA. Model calculations show that concentrations of PFOA in the Arctic will continue to increase until 2030 in spite of the voluntary measures that have been taken.

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

The regulation proposal may result in some increased costs but will result in significant reductions in how much PFOA is introduced into the environment and it will reduce the risk of health and environmental damages. The benefits are therefore expected to outweigh the costs on the basis of the proposals anticipated positive effects for health and the environment.

Date of entry into force of the final regulatory action: 04/07/2020

This notification replaces all previously submitted notifications on this chemical.

Date of issue of the previous notification: 28/04/2015.