UNITED NATIONS RC

UNEP/FAO/RC/CRC.7/7

Rotterdam Convention on the Prior Distr.: General 20 December 2010 Informed Consent Procedure for Certain Hazardous Chemicals and English only Pesticides in International Trade

Chemical Review Committee Seventh meeting Rome, 28 March–1 April 2011 Item 4 (c) (iv) of the provisional agenda∗ Technical work: review of notifications of final regulatory action: perfluorooctane sulfonate, its salts and its precursors

Perfluorooctane sulfonate, its salts and its precursors

Note by the Secretariat

1. Under Article 5 of the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, when the Secretariat has received at least one notification of final regulatory action to ban or severely restrict a chemical from each of two prior informed consent (PIC) regions containing the information required in Annex I to the Convention, it shall forward the notifications and accompanying documentation to the members of the Chemical Review Committee. The Committee shall review the information provided in such notifications and, in accordance with the criteria set out in Annex II to the Convention, recommend to the Conference of the Parties whether the chemical in question should be included in Annex III to the Convention and whether a decision guidance document should be drafted. 2. The Secretariat has received four notifications of final regulatory action relating to the use of perfluorooctane sulfonate, its salts and its precursors as industrial chemicals that meet the information requirements of Annex I from three PIC regions: North America (Canada), Europe (the European Union) and Asia (Japan). Japan has submitted two separate notifications: one for perfluorooctane sulfonate and its salts, and the other for perfluorooctane sulfonyl fluoride. Summaries of these notifications were included in PIC Circular XXXII of December 2010. The notifications, as received from the notifying countries, are set out in the annex to the present note. 3. The supporting documentation provided by Canada, the European Union and Japan is set out in documents UNEP/FAO/RC/CRC.7/7/Add.1, Add.2 and Add.3, respectively.

∗ UNEP/FAO/RC/CRC.7/1.

K1063376 040211 UNEP/FAO/RC/CRC.7/7 Annex

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2 Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade sÞffi@

FORM FOR NOTIFICATION OF FINAL REGULATORY ACTION TO BAN OR SEVERELY RESTRICT A CHEMICAL

Country: Canada

SECTION 1 IDENTITY OF CHEMICAL SUBJECT TO THE FINAL REGULATORY ACTION 1.1 Common name Perfluorooctane Sulfonate (PFOS), its salts and its precursors that contain one of the perfluorooctylsulfonyl moieties (CeFrzSOz, CBFTTSOg or CsF17SO2N) (N-EtFOSE, N-MeFOSE, N-EIFOSA, N-MeFOSA, PFOSA)

Note: PFOS may refer to any of its anionic, acid or salt form; precursors are incorporated in a variety of compounds which have the potential to transform or degrade back to PFOS in the environment.

1.2 Chemical name according PFOS salts: to an ¡nternat¡onally 1 -Octanesulfonic acid, recognized nomenclature 1 ,1 ,2,2,3,3,4,4,5,5,6,6,7 ,7 ,g,g,g-hepatdecf luoro- (e.9. IUPAC), (perfluorooctane sulfonate) potassium salt; where such nomenclature 1 -Octanesulfonic acid, exists 1,1,2,2,3,3,4,4,5,5,6,6,7,7,9,9,9- hepatdecf I u oro- (perfluorooctane sulfonate) ammonium salt; 1 -Octanesulf onic acid,

1,1,2,2,3,3,4,4,5,5,6,6,7,7,9,9,9- h epatdecf I uoro- (perfluorooctane sulfonate) diethanolamine salt Precursors: N-EtFOSE: 1 -Octanesulfonamide, N-ethyl- 1 ,1 ,2,2,3,3,4,4,5,5,6,6,7 ,7 ,g,g,g-heptadecaf luoro- N-(2-hydroxyethyl)-( N-ethylperf luorooctane sulf onam idoethanol); N-MEFOSE: 1 -Octanesulfonamide, 1 ,1 ,2,2,3,3,4,4,5,5,6,6,7 ,7 ,B,g,g-heptadecaf luoro- N-(2-hyd roxyethyl)-N-methyl-(N - methylperf luorooctane sulf onam idoethanol); N-EtFOSA: 1-Octanesulfonamide, N-ethyl-

1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,9,9-h eptadecaf I uoro- (N-ethyl perfluorooctane sulfonamide); N-MeFOSA: 1-Octanesulfonamide, N-ethyl- 1 ,1 ,2,2,3,3,4,4,5,5,6,6,7 ,7 ,g,B,g-heptadecaf luoro- N-methvl-(N-met erf luorooctane sulfonam ide PFOSAA: Glycine, N-ethyl-N- [(heptadecaf luorooctyl)-sulf onyl]-, potassium salt (potassium -N-ethyl-N((hetadecaf luorooctyl)- sulf onyl-glycinate); Ethanaminium, N,N,N-trimethyl-2-[(2-methyl-1 - oxo-2-propenyl)oxyl-, chloride, polymer with 2- ethoxyethyl 2-propenoate, 2- [[(heptadecaf luorooctyl)sulf onyl]m ethylam inolethyl 2-propenoate and oxiranylm ethyl 2-m ethyl-2- openoate

1.3 Trade names and names of PFOS: preparations PFOS (K.); PFOS (NHo*); PFOS (DEA)

Precu rsors: N-EIFOSE; N-MeFOSE; N-EIFOSA; N-MeFOSA; PFOSAA

1.4 Code numbers 1.4.1 CAS number PFOS (K.): 2795-39-3 PFOS (NHa"): 29081-56-9

PFOS (C¿Ht 1 NO2): 70225-1 4-B N-EIFOSE: 1691-99-2 N-MeFOSE: 24448-O9-7 Continued ... N-EIFOSA: 4151 -50-2 N-MeFOSA: 31506-32-B PFOSAA: 2991-51-7 Ethanam inium, N,N,N-lrimethyl-2-[(2-methyl-1 - oxo-2-propenyl)oxyl-, chloride, polymer with 2- ethoxyethyl 2-propen oate, 2- [[(heptadecaf luorooctyl)sulf onyl]m ethylam inolethyl 2-propenoate and oxiranylmethyl 2-m ethyl-2- noate : 92265-81-1 1.4.2 Harmonized System customs code 1.4.3 Other numbers (specif y the PFOS: numbering system) RTECS# KL2975OOO; EINECS# 203-860-0

1.5 lndication regarding previous notification on this chemical, if any

1.5.1 V '- This is a first time notification of final regulatory action on this chemical,

T 1.s.2 ' This notif ication replaces all previously submitted notif ications on this chem ical. Date of issue of the previous notif ication: sEcÏoN 2 FINAL REGULATORY ACTION

2.1 r The chemical is: banned OR Tv severety restricted

2.2 lnformation specific to the final regulatory action

2.2.1 Summary of the f inal regulatory action The Perfluorooctane Sulfonate and its Salts and Certain Other Compounds Regulations are under subsection 93(1) and section 319 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). PFOS, its salts and its precursors are listed in the List of Toxic Substances in Schedule 1 of CEPA 1999. The manufacture, use, sale, offer for sale or import of PFOS, its salts and its recursors is prohibited with some limited number of exemptions listed below.

2.2.2 Reference to the regulatory document, e.g. where decision is recorded or published. Perfluorooctane Sulfonate and its Salts and Certain Other Compounds Regulations (SOR/2008-178) under CEPA 1999.

2.2.3 Date of entry into force of the f inal regulatory action May 29, 2008

2.3 Gategory or categories where the f inal regulatory action has been taken

2,3.1 All rlse ôr usês of lhe cheminal in rrarrr nrinr ln tha final ¡aat |alartt ot All use or uses of the chemical in your ^.ìnnlrì,country prior to the f¡nal regulatory action The principal applications for PFOS, its salts and its precursors are water, oil, soil and grease repellents for use on surface and paper-based applications, such as rugs and carpets, fabric and upholstery, and food packaging. PFoS, its salts and its precursors also have specialized chemical applications, such as fire- fighting foams, hydraulic fluids, carpet spot removers, mining and oil well surfactants, fume suppressant and other specialized chemical formulations.

2.3.2 Final regulatory action has been taken for the category F lndustrial

or uses rohibited b the f inal re ulat The Regulations prohibit the manufacture, use, sale, offer for sale or import of PFOS, its salts, its precursors or a product containing any such substance unless the substance is incidentally present. A limited number of exemptions are listed below. Use or uses that remain allowed (onlv in case of a severe restriction) The Regulations do not apply to PFOS, its salts and its precursors that are: (a) contained in a hazardous waste, hazardous recyclable material or non- hazardous waste to which Division 8 of Part 7 of CEPA 1999 applies; (b) contained in a pest control product within the meaning of subsection 2(1) of the Pest Control Products Act; (c) present as a contaminant in a chemical feedstock used in a process from which there are no releases of the substance and provided that, in that process, the substance is destroyed or completely converted to a substance other than one referred to in the section 1 of the Regulations; or (d) used in a laboratory for analysis, in scientif ic research or as a laboratory analytical standard. The manufacture, use, sale, offer for sale, or import of the following products containing PFOS, its salts or its precursors is permitted: (a) photoresists or anti-ref lective coatings for photolithography processes; and (b) photographic f ilms, papers and printing plates.

The use, sale, offer for sale or import of aviation hydraulic fluid containing PFOS, its salts or its precursors is permitted.

The use of PFOS, its salts or its precursors, or a product containing any such substance, as a fume suppressant in the following processes, as well as their sale, offer for sale or import for that use, is permitted until May 29,2013: (a) chromium electroplating, chromium anodizing and reverse etching; (b) electroless nickel-polyterafluoroethylene plating; and (c) etching of plastic substrates prior to their metalization.

The use, sale or offer for sale of a manufactured item containing PFOS, its salts or its precursors is permitted if manufactured or imported before May 29,2008.

The use of aqueous film forming foam (AFFF) containing PFOS, its salts or its precursors is permitted: (a) at any time, if the concentration of the substance is less than or equal to 0.5 ppm; or (b) until May 29, 2013, other than for testing or training purposes, if the concentration of the substance is greater than 0.5 ppm and the foam was manufactured or imported before May 29, 2008.

AFFF containing PFOS, its salts or its precursors may be: (a) used in a military vessel deployed, before May 29, 2008 or within five years after that day, for a military operation; or (b) used or imported in a military vessel or military fire fighting vehicle contaminated during a foreign military operation occurring after May 29, 2008.

2.3.3 Final regulatory action has been taken for the category T Pesticide

Formulation(s) and use or uses prohibited by the final regulatory action Formulation(s) and use or uses that remain allowed (only in case of a severe restriction

2.4 Was the final regulatory action based on l¿ a risk or hazard evaluation? '' Yes r No (lf no, you may also complete section 2.5.3.3)

2.4.1 lf yes, reference to the relevant documentation, which describes the hazard or risk evaluation The Canadian Environmental Protection Act, lggg (cEPA lggg) requires the federal Ministers of Health and the Environment to conduct screening assessments to determine, in an expeditious manner, whether a substance poses a risk to human health or the environment. On the basis of a screening assessment, the Ministers can propose to take no further action in respect of the substance, to add the substance to the Priority Substances List for a more in- depth assessment or to recommend that the substance be added to the List of Toxic Substances in Schedule 1 of the Act.

This assessment was undertaken on the basis that some of these compounds were identif ied as part of a Domestic Substances List (DSL) pilot for screening as they met the criteria for persistence, bioaccumulation and/or inherent toxicity, pursuant to Paragraph 73(1)(b) of cEPA 1999 and in response to a request to the Minister of the Environment to add these compounds to the priority Substance List (PSL) for assessment of ecological and human health.

Ref erence: Screening Assessment Report - Health. Perf luorooctane Sulfonate, lts Salts and Its Precursors that Contain the CeFrzSo2 or CsF17So3 Moiety. Health Canada. March 5,2004. Canadian Environmental Protection Act, 19gg (CEPA iggg): Ecological Screening Assessment Report on Perf luorooctane Sulfonate, lts Salts and lts Precursors that Contain the CaFrzSOz or CsF17SO3 or CsF17SO2N Moiety. Environment Canada. June. 2

2.4.2 Summary description of the risk or hazard evaluation upon which the ban or severe restriction was based.

2.4.2.1 ls the reason for the final regulatory action relevant to human T health? yes FNo lf yes, give summary of the hazard or risk evaluation related to human health, including the health of consumers and workers 2.4.2.2 ls the reason for the f inal regulatory action relevant to the 17 Yes environ m ent? TNo of the hazard or risk evaluation related to the environment An ecological screening assessment was undertaken on perf luorooctane sulfonate (PFOS), its salts and its precursors containing the perf luorooctylsulfonyl (CBFl7S02, CsF17503, or CsF17SO2N ) moiety.

PFOS is resistant to hydrolysis, photolysis, microbial degradation, and metabolism by vertebrates. PFOS has been detected in f ish, in wildlife worldwide and in the northern hemisphere. This includes Canadian wildlife located far from known sources or manufacturing facilities indicating that PFOS and/or its precursors may undergo long-range transport. Maximum concentrations in liver of biota in remote areãs of tñe Canadian Arctic include: mink (20 Ug.kg'1),. common loon (26 pg.kg'1), ringed seal (37 Ug.kg'1), brook trout (50 Ug.fg't), Arctic f ox (1400 ¡rg.kg'') and polar bear (>4000 Ug.kg''). Unlike many other persistent organic pollutants, certain perf luorinated substances, such as PFOS, are present as ions in environmental media and partition preferentially to proteins in liver and blood rather than to lipids. Therefore, the bioaccumulation potential of PFOS may not be related to the typical mechanisms associated with bioaccumulation in lipid-rich tissues. Discretion is required when applying numeric criteria for bioaccumulation such as those outlined in the Government of Canada's Toxic Substances Management Policy (TSMP) and in the Persistence and Bioaccumulation Regulations under CEPA 1999 when determining whether substances such as PFOS are bioaccumulative. These numeric criteria were derived f rom bioaccumulation data for aquatic species and for substances which preferentially partition to lipids. Ref erence: Canadian Environmental Protection Act, 1999 (CEPA 1999): Ecological Screening Assessment Report on Perf luorooctane Sulfonate, lts Salts and lts Precursors that Contain the C8F17SO2 or CeFrzSO3 or C6F17SO2N Moiety. Environment Canada. June. 2006.

effect of the final action The prohibition on manufacture, use, sale, offer for sale, or import of PFOS and its precursors will work towards the objective of virtual elimination of the substance. Therefore this regulatory action will also result in a reduction of risk for Canada's environment.

2.5 Other relevant information regarding the final regulatory action

2.5.1 Estimated quantity of the chemical produced, imported, exported and used Quantity per year (MT) Year produced 0 2006 imported 6 2006 exported 0 2006 used 6 2006 2.5.2 lndication, to the extent possible, of the likely relevance of the final regulatory action to other states and regions PFOS production has been identified in the United States, Australia, Norway, Italy, Japan, Belgium, Germany and Asia. A number of countries and organizations (including United States, Australia, European Union, Norway, Stockholm Convention on Persistent Organic Pollutants and Protocol to the 197g Convention on Long-Range Transboundary Air Pollution) have either put in place or are proposing management measures to control the manufacture, import, use and releases of PFOS and manufactured products containing PFOS. Therefore the countries aforementioned and many others would not be affected by these Regulations. PFOS has been identified as a Persistent Organic Pollutant (POP) under the Stockholm Convention. As a result of past releases to the environment due especially to human activities, PoPs are now widely distributed over large regions (including those where POPs have never been used) and, in some cases, they are found around the globe. POPs can be found in people and animals living in regions such as the Arctic, thousands of kilometres from any maior POPs source.

2.5.3 Other relevant information that may cover:

2.5.3.1 Assessment of socio-economic effects of the final regulatory action The costs associated with prohibiting AFFFs relate to the safe disposal of existing stocks, as well as the ¡ncremental costs of replacing the stock with alternatives. The costs associated with metal plating relate to the replacement of the stock with alternatives or the conversion to other control technologies. Costs incurred by the federal government rèlate to enforcement and compliance promotion activities.

The benefits of prohibiting PFOS, its salts and its precursors include protection f rom PFOS exposure of wildlife and ecosystems, including those in remote areas such as the Canadian Arctic, as a result of the reduction in the use of PFOS and protection of water supply sources through the avoidance of contamination as a result of handling, release and use of PFOS. Costs associated with tapping alternate water sources are thus avoided.

More information on the costs and benefits are outlined in the Regulatory lmpact Analysis Statement published with the Requlations.

2.5.3.2 lnformation on alternatives and their relative risks e.g. lPM, chemical and non-chemical alternatives Alternative for PFOS aqueous film forming foam (AFFF): PFOS-free AFFF. Alternatives for f ume suppressants in metal plating industries: non-PFOS-based fume suppressants; other control technologies such as composite mesh pads or closed covers.

2.5.3.3 Basis for the final regulatory action if other than hazard or risk evaluation Not applicable 2.5.3.4 Additional information related to the chemical or the final regulatory action, if any

sEcTtoN 3 PROPERTIES

3.1 lnformation on hazard classification where the chemical is subject to classif ication requirements

I nternational classif ication Hazard class systems e.g. WHO, IARC, etc.

Other classification systems Hazard class e.g. EU, USEPA

9.2 Further information on the properties of the chemical 3.2.1 Description of physico-chemical properties of the chemical The PFOS anion has the molecular formula CeFrzSOg-. The structural formula is CF3(CF2)7SOs-. While PFOS can exist in anionic, acid and salt forms, the PFOS anion is the most common form at pH values in the environment and in the human body.

PFOS and its precursors all belong to the larger class of fluorochemicals referred to as perf luorinated alkyl (PFA) compounds. Perfluorinated chemicals such as PFOS contain carbons that are completely saturated by fluorine. lt is the strength of the C-F bonds that contributes to the extreme stability and physical-chemical properties of these perf luorochemicals.

The precursors have the potential to degrade or metabolize to PFOS. Once PFOS is released to the environment, it is not known to undergo any f urther chemical, microbial or photolytic degradation and is, therefore, persistent. As well as being commercially produced. PFOS is the f inal degradation product from PFOS-derived fluorochemicals. Key physical/chemical properties of PFOS and some precursors that are useful in predicting environmental fate are listed in Table 1 (attached). Ref erence Canadian Environmental Protection Act, 1999 (CEPA 1999): Ecological Screening Assessment Report on Perfluorooctane Sulfonate, lts Salts and lts Precursors that Contain the CeFrzSOz or CBFITSOg or C6F17SO2N Moiety. Environment Canada. June,2006.

3.2.2 Description of toxicological properties of the chemical Although the identified data for some of the substances were variable and limited, the available information indicates that toxicological effects of these precursors of PFOS are similar to those of PFOS itself (described below and in Table 2, attached). Moreover, based upon the data identif ied, health-related effects associated with exposure to these substances would appear to be somewhat less severe and/or are observed at higher exposures (doses) than those associated with exposure to PFOS itself .

The toxicity of PFOS has been studied in a variety of aquatic and terrestrial species, including aquatic plants, invertebrates and vertebrates and terrestrial invertebrates, birds and mammals. Effects in laboratory mammals include: histopathological effects, increased tumor incidence, hepatocellular adenomas, hepatocellular hypertrophy, increased liver, kidney, brain and testes weight, reduced body weight, change in estrous cycling, changes in levels of neurotransmitters, decreased serum cholesterol, decreased bilirubin, and decreased triiodothynine. ln mammalian reproduction studies, effects include: decreased body weight of dams, reduced gestation time, delivery time and live litter size, transfer of PFOS to fetus and neonate via placenta and ingestion of maternal milk, and reduced survival, body weight gain and development of lactation in offspring of exposed females. Previous studies have shown that perfluorinated compounds are peroxisome proliferators and tumor promoters and may inhibit gap junction intercellular communication at environmentally relevant concentrations. Ref erence Screening Assessment Report - Health. Perfluorooctane Sulfonate, lts Salts and Its Precursors that Contain the C6F17SO2 or C8F17SO3 Moiety. Health Canada. March 5, 2004. Canadian Environmental Protection Act, 1999 (CEPA 1999): Ecological Screening Assessment Report on Perfluorooctane Sulfonate, lts Salts and lts Precursors that Contain the CsFlzSOz or CsF17SO3 or CsF17SO2N Moiety. Environment Canada. June.2006.

3.2.3 Description of ecotoxicological properties of the chemical Estimated steady state PFOS bioconcentration factors (BCF) of 1100 (carcass), 5400 (liver) and 4300 (blood) have been reported for juvenile rainbow trout. The corresponding 12-day accumulation ratios were 690 (carcass),3100 (blood), and 2900 (liver) in juvenile rainbow trout. ln fish livers collected from 23 different species in Japan, bioaccumulation factors (BAFs) were calculated to range from 274 - 41 600. Following an accidental release of f ire f ighting foam, BAFs were calculated in the range of 6300-125 000. Estimated BCFs for the precursors n- ETFOSEA and n-MeFOSEA were 5543 and 26 000, respectively. Species differences for the elimination half-life of PFOS in biota have been determined to vary significantly: 15 days (fish); 100 days (rats),200 days (monkeys) and years (humans). Elimination through the gills is an important route for fish which is not available to birds, terrestrial mammals (e.9., mink, polar bear, Arctic foxes) and marine mammals (e.9., seals and whales). There are three studies suggesting that PFOS biomagnif ies in the Great Lakes and Arctic food webs. For the water-algae- zebra mussel-round goby-smallmouth bass-bald eagle or mink f ood chain, a biomagnification factor (BMF) of 10 to 20 was calculated in mink or bald eagles. A benthic invertebrate/pelagic invertebrate-three forage f ish -top predator f ish food chain resulted in a multi-trophic level BMF of 5.88. lt was suggested that PFOS biomagnif ies through the Arctic marine food web. The trophic level BMFs for PFOS included walrus-clam (a.6); narwhal-cod (7.2); beluga-cod (8.4); beluga-redf ish (a.0); black-legged kittiwake-cod (5.1); glaucous gull-cod (9.0); and cod- zooplankton (0.4). Whole body aquatic BCFs or BAFs are below 5000. However, the weight of evidence f rom both laboratory and field-based BCFs and BAFs in conjunction with the field-based BMFs (avian and aquatic) indicates that PFOS is a bioaccum ulative substance.

Based on available toxicity tests, estimated no effect levels were determined for fish, birds (liver), birds (serum), and wildlife (0.491pg.L't, 0.609 ¡rg.g'1, 0.873 pg.mL-1 and 0.408 Ug.g-1, respectively). The resulting risk quotients for fish, a range of bird species (liver and serum), and wildlife were 0.25, 0.002 to 2.92,0.431o 2.54 and 9.2, respectively. Therefore, current levels show some wildlife oroanisms bear. bird species) could be near or at effect levels and I could be harmed bv current exposures to PFOS. I Ref erence Canadian Environmental Protection Act, 1999 (CEPA 1999): Ecological Screening Assessment Report on Perf luorooctane Sulfonate, lts Salts and lts Precursors that Contain the CaFrzSO2 or CeFrzSOg or CsF17SO2N Moiety. Environment Canada. June.2006.

SECTION 4 DESIGNATED NATIONAL AUTHORITY

Environment Canada Environmental Stewardship Branch lnstitution Chemical Sectors Directorate Chemical Production Division Place Vincent Massey 351 St. Joseph Blvd., 19th Floor Address Galineau, Quebec, K1A 0H3 CANADA Name of person in Bernard Madé charge Position of person in Director, Chemical Production Division charge Telephone (819) 994-4404 Telef ax (81 9) 994-5030

E-mail address PlCPrograms @ ec.gc.ca

ocT 1 1 2010 Date, signature of DNA and official seal: z/*/¿:

PLEASE RETURN THE COMPLETED FORM TO: Secretariat for the Rotterdam Convention Secretariat for the Rotterdam Convention Food and Agricolture Organization United Nations Environment Programme(UNEP) of the United Nations ( FAO) 11'13, Chemin des Anémones Viale delle Terme di Caracalla/qrqvqrrq oR ^Hv - 1219 Châtelaine, Geneva, Swilzerland 00100 Rome, rtary Tel: (+41 22) g17 8177 Tel: (+39 06) 5705 3441 Fax: (+41 22) 917 8082 Fax: (+39 06) 5705 6347 E'mail: pic@pic,int E-mail: [email protected] ROTTERDAM CONVENTION

SECRETARIAT FOR THE ROTTERDAM CONVENTION ON THE PRIOR INFORMED CONSENT PROCEDURE FOR CERTAIN HAZARDOUS CHEMICALS AND PESTICIDES IN INTERNATIONALTRADE

FORM FOR NOTIFICATION OF FINAL REGULATORY ACTION TO BAN OR SEVERELY RESTRICT A CHEMICAL

Country: European Union Member States are: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, 1 Spain, Sweden, United Kingdom

SECTION 1 IDENTITY OF CHEMICAL SUBJECT TO THE FINAL REGULATORY ACTION

1.I Common name Perfluorooctane sulphonates (PFOS) C8Ft7SOzX I (X = OH, Metal salt (0-Me),halide, amide, and other derivatives including polymers)

1.2 Chemical name according to Synonyms (OECD, 2002) an internationally 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- recognized nomenclature heptadecafluoro-1-octanesulfonic acid (e.g. IUPAC), where such Heptadecafluoro-I-octanesulfonic acid nomenclature exists Perfluoro-n-octanesulfonic acid Perfluorooctanesulfonic acid Perfluorooctylsulfonic acid Ammonium perfluorooctane sulfonate Diethanolarnine perfluorooctane sulfonate Potassium perfluorooctane sulfonate Lithium perfluorooctane sulfonate

1.3 Trade names and names of PFOS preparations FC-95 1.4 Code numbers

1.4.1 CAS number The perfluorooctane sulphonate anion (PFOS) does not have a specific CAS number. The acid and salts have the following CAS numbers:

1763-23-1 (acid) 29081-56-9 (ammonia salt)

70225-14-8 (diethanolamine (DEA) salt)

2795-39-3 (potassium salt)

29457-72-5 (lithium salt)

1.4.2 Harmonized System customs code Comoined Nomenclat~recode of the European 1.4.3 Other numbers Community (CN code): 2904 90 20 (specify the numbering system)

1.5 Indication regarding previous notification on this chemical, if any 1.5.1 This is a first time notification of final regulatory action on this chemical.

1.5.2 This notification replaces all previously submitted notifications

on this chemical. Date of issue of the previous notification: SECTION 2 FINAL REGULATORY ACTION

2.1 The chemical is: banned OR severely restricted

2.2 Information specific to the final regulatory action

2.2.1 Summary of the final regulatory action

The placing on the market and the use of PFOS as a substance or in mixtures in concentrations equal to or greater than 50 mglkg (0.005 % by weight) is prohibited pursuant to Regulation (EC) I90712006 concerning the registration, evaluation, authorisation and restriction of chemicals (REACH) as amended by Commission Regulation (EC) No 55212009 amending Regulation (EC) No 190712006. In addition PFOS shall not be placed on the market in semi-finished products or articles, or parts thereof, if the concentration of PFOS is equal to or greater than 0.1 % by weight calculated 'with reference to the mass of structurally or microstructurally distinct parts that contain PFOS or, for textiles or other coated materials, if the amount of PFOS is equal to or greater than 1 pgl m2 of the coated material.

However, certain uses remain allowed, as mentioned in paragraph 3 to 5 of point 53 of the Annex to Commission Regulation (EC) No 55212009.

The European Commission is requested to review each of the derogations in paragraph 3 as soon as new information on details of uses and safer alternative substances or technologies for the uses become available. The Commission shall keep under review the ongoing risk assessment activities and the availability of safer alternative substances or technologies related to the uses of perfluorooctanoic acid and related substances and propose all necessary measures to reduce identified risks, including restrictions on marketing and use, in particular when safer alternative substances or technologies, that are technically and economically feasible, are available.

2.2.2 Reference to the regulatory document, e.g. where decision is recorded or published

Regulation (EC) I90712006 concerning the registration, evaluation, authorisation and restriction of chemicals (REACH) of 18 December 2006 (OJ L 396,31.12.2006, p. 1) htt~://eur-lex.eur0~a.eu/LexUriSe~/LexUriSew.d0?uri=0J:L:2007:136:0003:0280:EN:PDF as amended by Commission Regulation (EC) No 55212009 of 22 June 2009 amending Regulation (EC) No 190712006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVll (OJ L 164, 26.06.2009, p. 7) Date of entry into force of the final regulatory action

Commission Regulation (EC) No 55212009 amending Regulation (EC) No 190712006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVll entered into force on 27 June 2009.

Category or categories where the final regulatory action has been taken

All use or uses of the chemical in your country prior to the final regulatory action

The major use of PFOS and PFOS related substances in consumer applications was to provide grease, oil and water resistance to materials such as carpets, leatherlapparel, textileslupholstery, paper and packaging, coatings, and in industrial and household cleaning products. These uses have largely been abandoned following the decision of the main global producer 3M to phase out manufacture and use of PFOS consumer applications.

Ongoing industriallprofessional usage of PFOS in smaller volume is continuing and has been confirmed in the following sectors in the EU (current demand, 2004): / - Metal (chromium) plating(8600-10 000 kdlyear) I Fire fighting foams (estimated quantity held in stock, 122 tonnes) I - I 1 - Photographic industry (approximately 850 kglyear) I Semiconductor industry (436 kglyear) I - I - Aviation industry (hydraulic fluids, approximately 730 kglyear)

Final regulatory action has been taken for the category Industrial

Use or uses prohibited by the final regulatory action Firstly, PFOS may not be placed on the market or used as a substance or constituent of preparations in a concentration equal to or higher than 0.005% by weight.

Secondly, PFOS may not be placed on the market in semi-finished products or articles, or parts thereof, if the concentration of PFOS is equal to or higher than 0.1% by weight calculated with reference to the mass of structurally or microstructurally distinct parts that contain PFOS or, for textiles or other coated materials, if the amount of PFOS is equal to or higher than 1 vglm2 of the coated material.

These restrictions shall not apply to products that were in use in the European Community before 27 June 2008.

Form for notification of final regulatory action to ban or severely restrict a chemical Use or uses that remain allowed (only in case of a severe restriction) The use and the first placing on the market of the following items, as well as the use of the substances and preparations needed to produce them remain allowed: / (a) photoresists or anti reflective coatings for photolithography processes, I 1 (b) photographic coatings applied to films, papers, or printing plates, I (c) mist suppressants for non-decorative hard chromium (VI) plating and wetting agents for use in controlled electroplating systems where the amount of PFOS released into the environment is minimised, by fully applying relevant best available techniques developed within the framework of Directive 2008/1lEC of 15 January 2008 concerning integrated pollution prevention and control (OJ L 24, 29.01.2008, p. 8), / (d) hydraulic fluids for aviation. I Until 27 June 201 1 the fire-fighting foams that have been placed on the market before 27 December 2006 are also allowed, in order to limit emissions to that of the existing stocks of fire-fighting foams. It should also be noted that the ban shall apply without prejudice to Regulation (EC) No 64812004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 08.04.2004, p. 1).

2.3.3 Final regulatory action has been taken for the category Pesticide

Formulation(s) and use or uses prohibited by the final regulatory action Not relevant

Formulation(s) and use or uses that remain allowed (only in case of a severe restriction) Not relevant

2.4 Was the final regulatory action based on a risk Yes or hazard evaluation? No (If no, you may also complete section 2.5.3.3)

If yes, reference to the relevant documentation, which describes the hazard or risk evaluation

An OECD hazard assessment has been carried out on the basis of the information available by July 2002. The Environment Agency for England and Wales has issued in 2004 an environmental risk evaluation report on PFOS based on the requirements of Regulation No793193 of 27 March 1993 on the evaluation and control of the risks of existing substances. In addition to this report, another report outlining a risk reduction strategy for, PFOS was established by the Department for Environment, Food and Rural Affairs and the Environment Agency for England and Wales. However, there is no EU Risk Assessment Report but the EU "Scientific Committee on Health and Environmental Risks" (SCHER) adopted an opinion on the report outlining a risk reduction strategy forPFOS in 2005. Therefore, the relevant documents are: - OECD (2002): Co-operation on Existing Chemicals, Hazard Assessment of Perfluorooctane Sulfonate and its Salts. JT00135607. Environment Directorate Joint Meeting of thee Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology, Organisation for Economic Co-operation and Development. ENVlJMIRD(2002)17lFINAL.

- Environment Agency (2004): Environmental Risk Evaluation Report: Perfluorooctanesulphonate (PFOS). Environment Agency for England and Wales . htt~:Il~ublications.environment-aqencv.qov.uklpdflSCH01009BRBL-e-e.pdf

Risk and Policy Analysts Limited (2004): Perfluorooctane Sulphonate - Risk Reduction Strategy and Analysis of Advantages and Drawbacks. Report prepared for the Department for Environment, Food and Rural Affairs and the Environment Agency for England and Wales. http:Ilwww.defra.qov.uklenvironmentlquaIity/chemicals/documentsl~fos- riskstrateqv.pdf

1 - SCHER (2005): Opinion on RPA's report "Perfluorooctane Sulphonates Risk / reduction strategy and analysis of advantages and drawbacks" (Final Report - August 2004). European Commission Scientific Committee on Health and Environmental Risks, SCHER.

htt~://ec.eurooa.eu/health/ph risk/committees/04 scher/docs/scher o 014.pdf

2.4.2 Summary description of the risk or hazard evaluation upon which the ban or severe restriction was based. 2.4.2.1 Is the reason for thefinal regulatory action relevant to human yes health?

NO If yes, give summary of the hazard or risk evaluation related to human health, including the health of consumers and workers

Considering the oral assimilation in fish and mammals and the low elimination rate, the SCHER concluded that PFOS poses similar environmental concerns for bioaccumulation to substances which are very bioaccumulative. The toxicity associated with oral route exposure is confirmed as well as its high persistency. Therefore a scientifically based

Form for notification of final regulatory action to ban or severely restrict a chemical Page assessment of persistence, bioaccumulation and toxicity indicates that PFOS fulfils the criteria for very Persistent, very Bioaccumulative and Toxic substances. To be considered as a Persistent Organic Pollutant under the Stockholm Convention, a substance has to be persistent, bioaccumulative, have a potential for long range environmental transport and have the potential to give adverse effects. PFOS fulfils the criteria for all these properties given in Annex D of the Stockholm Convention. The OECD Hazard Assessment also concluded that PFOS is persistent, bioaccumulative and toxic in mammals. PFOS has been detected in the serum of occupational and general populations. There is a statistically significant association between PFOS exposure and bladder cancer and there appears to be an increased risk of episodes of neoplasm of the male reproductive system, the overall category of cancers and benign growths, and neoplasms of the gastrointestinal tract. . . The SCHER considered that the on-going critical uses in the aviation industry, the semiconductor industry and the photographic industry do not pose a relevant risk provided that releases into the environment and workplace exposure are minimised, while for fire-fighting foams, the risks of substitutes should be assessed before reaching a final I decision. It also considered that the use of PFOS in the plating industry shall also be I minimised by applying the best available techniques.

Expected effect of the final regulatory action The severe restriction is intended to cover the major part of the exposure risks, while the other minor uses exempted do not seem to pose a risk. Although PFOS is persistent, it is considered that, as long as re-occurrence of former major uses is not allowed, the concentrations of PFOS in the environment may eventually diminish.

2.4.2.2 Is the reason for the final regulatory action relevant to the [XI yes environment? NO If yes, give summary of the hazard or risk evaluation related to the environment Considering the oral assimilation in fish and mammals and the low elimination rate, the SCHER concluded that PFOS poses similar environmental concerns for bioaccumulation to substances which are very bioaccumulative. The toxicity associated with oral route exposure is confirmed as well as its high persistency. Therefore a scientifically based assessment of persistence, bioaccumulation and toxicity indicates that PFOS fulfils the criteria for very Persistent, very Bioaccumulative and Toxic substances. To be considered as a Persistent Organic Pollutant under the Stockholm Convention, a substance has to be persistent, bioaccumulative, have a potential for long range environmental transport and have the potential to give adverse effects. PFOS fulfils the criteria for all these properties given in Annex D of the Stockholm Convention. The OECD Hazard Assessment indicates that PFOS is persistent and bioaccumulative. It is highly, acutely toxic to honey bees and bioconcentrates in fish and it has been detected in tissues of wild birds and fish, in surface water and sediment, in wastewater treatment plant effluent, sewage sludge and in landfill leachate.

Expected effect of the final regulatory action The severe restriction is intended to cover the major part of the exposure risks. While the I other minor uses exempted do not seem to pose a risk. Although PFOS is persistent, it is I / considered that, as long as re-occurrence of former major uses is not allowed, the I concentrations of PFOS in the environment may eventually diminish. 2.5 Other relevant information regarding the final regulatory action

2.5.1 Estimated quantity of the chemical produced, imported, exported and used Quantity per year (MT) Year

produced More than 3000 tonnes of PFOS compounds were 2003 reported to be manufacturedlimported in OECD countries (OECD survey 2004). The EU estimated a volume of up to 10000 tonnes 2003 imported andlor manufactured per year (10 chemicals with up to 1000 tonnes each per year) (OECD survey 2004).

74-175 tonnes of PFOS compounds were reported to be 2005 manufacturedlimported in OECD countries (OECD survey 2006).

imported NIA

exported NIA used 500 tonnes in the European Union 1 2000 I 1400 tonnes (UK, all PFAS chemicals; RPA 2004) 1 2001 I 135 tonnes in the European Union (estimated; RPA 20041 1 I

2.5.2 Indication, to the extent possible, of the likely relevance of the final regulatory action to other states and regions

PFOS concentrations have been detected in water sources, animals and humans I in many parts of the world. Therefore, similar health and environment problems I I are likely to be encountered in other countries where the substance is used. I

I 2.5.3 Other relevant information that may cover: ~ Form for notlficatlon of final regulatory actlon to ban or severely restrict a chemical Page 8 2.5.3.1 Assessment of socio-economic effects of the final regulatory action

2.5.3.2 lnformation on alternatives and their relative risks, e.g. IPM, chemical and non- chemical alternatives

2.5.3.3 Basis for the final regulatory action if other than hazard or risk evaluation

2.5.3.4 Additional information related to the chemical or the final regulatory action, if anv

SECTION 3 PROPERTIES

lnformation on hazard classification where the chemical is subject to classification requirements

International classification Hazard class systems e.g. WHO, IARC, etc.

GHS Carc. 2 - H351 Repr. 1B - H360D*** STOT RE 1 - H372** Acute Tox. 4* - H332 Acute Tox. 4* - H302 Lact. - H362 Aauatic Chronic 2 - H411 I

Other classification systems Hazard class e.a. EU. USEPA

EU Carcinogen Category 3; R40 - Limited evidence of a carcinogenic effect. Toxic for Reproduction Category 2; R61 - May cause harm to the unborn child. T; R48125 -Toxic: danger of serious damage to health by prolonged exposure if swallowed. Xn; R20122 - Harmful by inhalation and if swallowed. R64 - May cause harm to breastfed babies. N; R51-53 -Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

3.2 Further information on the properties of the chemical

Description of physico-chemical properties of the chemical

Minimum purity: FA0 Specification: Molecular Formula: C8F,,S02X (X = OH, Metal salt (0-M+), halide, amide, andother derivatives including polymers)

I I Molecular Mass:

1 1 PFOS acid (ChemlD, 2008) Appearance: Odour: 1 Melting Point: ->4OO0C I Boiling Point: Not calculable Vapour Pressure: 3.31 ~10.~Pa at 20"~(3.27 ~10.' atm) I Volatility: Henry's Law Constant: 3.5 XIO-' atm.m31mole (pure water) 4.7 x10-' atm.m3/mole (freshwater) 1.4 XI0.' atm.m3/rnole (unfiltered seawater) 2.4 x10-* atm.m3/mole (filtered seawater) 4.43 ~10.' atm.m31mole at 20°C (pure water) 1Solubility in Water: 570 mgll (pure water)

Form for notification of final regulatory action to ban or severely restrict a chemical Page 370 mgll (freshwater) 12.4 mgll (unfiltered seawater) 25 mgll (filtered seawater)

Solubility in Organic Solvents:

Reference

OECD (2002). Co-operation on existing chemicals. Hazard assessment of perfluorooctane sulfonate (PFOS) and its salts, JT00135607. Environment Directorate Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology. Organisation for Economic Co-operation and Development. ENVlJMIRD(2002)17lFINAL.

3.2.2 Description of toxicological properties of the chemical Absorption, Distribution, Excretion and Metabolism in Mammals:

PFOS is reported to be well absorbed following oral administration. Following oral administration of radiolabelled PFOS to rats, approximately 95% of the total radioactivity was absorbed after 24 hours. Approximately 86% of the radioactivity was found in the carcass after 24-48 hours. There is no evidence of selective retention in red blood cells. Urinary excretion is reported to be the primary route of excretion in rats; 89 days after administration of a single intravenous dose of radiolabelled PFOS, 30.2 t 1.5% of the total radiolabel was recovered in urine. Mean cumulative faecal excretion was 12.6 + 1.2%. The half-life of elimination of PFOS from the plasma of male rats is reported to be 7.5 days. There is evidence of enterohepatic recirculation of PFOS. In two separate occupational exposure studies in humans, serum PFOS half-lives of approximately 4 years and 8.67 years have been calculated.

Acute Toxicity: LD50 (rat, oral, male) 233 mglkg bw (95% C.I. of 160-339 mglkg bw) LD50 (rat, oral, female) 271 mglkg bw (95% C.I. of 200-369 mglkg bw) LD50 (rat, oral) 251 mglkg bw (95% C.I. of 199-318 mglkg bw) LD50 (rat, oral) >50-

Irritation and Sensitisation: PFOS is reported to be non-irritating to the skin of rabbits. In an eye irritation study, rabbits were observed 1, 24, 48 and 72 hours after treatment with PFOS. Maximum irritation was reported after 1 and 24 hours, however, the severity of irritation was not reported. 1 Subchronic Toxicity: Rat (diet. 90 days): LOAEL = 30 mglkg diet (approximately 1.5 mglkg bwlday) (decreased bodyweight and food consumption, increased absolute and relative liver weight (females)) / Monkey (gavage, 90 days): LOAEL = 10 mglkg bwlday (death of all animals) Monkey (gavage, 90 days): LOAEL = 0.5 mglkg bwlday (occasional gastrointestinal tract toxicity, occasional decreased activity) Monkey (oral capsule, 6 months): NOAEL = 0.03 mglkg bwlday (alterations. in lipoprotein cholesterol levels (both sexes) and triiodothyronine levels (females))

I Chronic Toxicity: Rat (diet, 2 years, male): NOAEL = 0.5 mglkg diet (approximately 0.025 mglkg bwlday) (hepatotoxicity) Rat (diet, 2 years, female): NOAEL = 2 mglkg diet (approximately 0.1 mglkg bwlday) (hepatotoxicity)

I Genotoxicity: Negative results have been reported in in vitro reverse mutation assays in Salmonella typhimurium and Escherichia coli, with and without metabolic activation. Negative results were reported in an unscheduled DNA synthesis assay conducted in rat hepatocytes, and in a chromosomal aberration assay conducted in human lymphocytes, with and without metabolic activation. Negative results have been reported in vivo in mice bone marrow micronucleus assays. Negative results have also been reported for T-2247 CoC (50% by weight solution of diethanolammonium salt of PFOS) in in vitro assays with Salmonella typhmurium and Saccharomyces cerevisiae.

Carcinogenicity: Rat: lncidences of hepatocellular adenomas, thyroid follicular cell adenomas, and combined thyroid follicular cell adenomas and carcinomas were increased in both sexes. lncidences of combined hepatocellular adenomas and carcinomas, mammary fibroadenomaladenomas, and combined mammary fibroadenomaladenomas and carcinomas were increased in females.

Reproductive Toxicity:

Rat (developmental study): Maternal NOAEL = 5 mglkg bwlday (reduced

bodyweight)

Developmental LOAEL = 1 mglkg bwlday (abnormalities

of the lens of the eye).

Form for notification of final regulatory action to ban or severely restrict a chemical Page 1' The abnormalities of the lens of the eye were initially considered to be treatment .elated, however, it was later concluded to be an artefact of sectioning.

?at (developmental study): Maternal NOAEL = 1 mglkg bwlday (reduced bodyweight, haunched posture, anorexia, bloody vaginal discharge, uterine stains, alopecia, rough coat)

Developmental NOAEL = 1 mglkg bwlday (decreased foetal weight) ?at (developmental study): Maternal NOAEL = 1 mglkg bwlday (reduced bodyweight) Developmental NOAEL = 1 mglkg bwlday (pup mortality)

?at (2 generation study): FO males NOAEL = 0.1 mglkg bwlday (reduced bodyweight gain and food consumption)

FO females NOAEL = 0.1 mglkg bwlday (reduced bodyweight gain and food consumption)

F1 parental males LOAEL = 0.1 mglkg bwlday (reduced food consumption F1 parental females NOAEL = 0.1 mglkg bwlday (reduced bodyweight gain and food consumption)

F1 offspring NOAEL = 0.4 mglkg bw/day (reduction in number of implantation sites, litter size, pup viability, pup bodyweight and pup survival)

F2 offspring NOAEL = 0.1 mglkg bwlday (reduced bodyweight gain) douse (developmental study): Maternal NOAEL = 1 mglkg bwlday (increased liver weight)

Developmental NOAEL = 5 mglkg bwlday (foetal mortality) tabbit (developmental study): Maternal NOAEL = 0.1 mglkg bwlday (reduced bodyweight gain) Developmental NOAEL = 1 mglkg bwlday (decreased foetal weight and reduction in ossification of the sternum) Neurotoxicity: No data.

Safety Values: EU Risk Assessment Acceptable Daily Intake (ADI): No value derived.

EU Risk Assessment acute Reference Dose (aRfD): No value derived.

Reference I OECD (2002) Co-operation on Existing Chemicals, Hazard Assessment of 1 Perfluorooctane Sulfonate and its Salts. JT00135607. Environment Directorate Joint Meeting of thee Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology, Organisation for Economic Co-operation and Development. ENVlJMIRD(2002)17/FINAL.

3.2.3 Description of ecotoxicological properties of the chemical 1 Persistence properties of PFOS I PFOS is persistent in the environment. It does not hydrolyse, photolyse or volatilise from the aquatic environment. PFOS does not undergo biodegradation; no significant biodegradation of PFOS was observed over 28 days, either as net oxygen loss, loss of total organic carbon or loss of primary compound identity. In the following tests, no evidence of biodegradation was observed: I . Activated sludge I Acclimated activated sludge (including added soil and sediment materials) I in both aerobic and closed vial exposures 1 Aerobic soil and sediment cultures I I Anaerobic sludge from sludge digester I 1 Pure microbial cultures I The conclusion drawn is that PFOS meets the P, persistent and vP, very persistent criteria.

Bioaccumulative properties of PFOS There are limited studies available on the bioaccumulation of PFOS. In a flow- through study on bluegill sunfish (Lepomis macrochirus), the bioconcentration factor (BCF) for edible tissue, non-edible tissue and whole fish were calculated from the rates of uptake and depuration because steady state had not been reached after 56 days of exposure. The BCF values obtained were 1124 (edible), 4103 (non-edible) and 2796 (whole fish). The exposure concentration was 0.086 mgll.

Form for notification of final regulatoly action to ban orseverely restrict a chemical Page 1. A flow-through study on carp (Cyprinus carpio), resulted in lower BCF values of 720 at 20 pgll exposure and 200-1500 at 2 pgll.

Higher BCF values of 6300-125000 have ben reported for in situ measurements at the scene of a spill of firefighting foam, but these were considered to be due to the uptake of derivatives which were then metabolised to PFOS, hence the values were overestimated.

In summary, BCF values up to 2800 have been measured in laboratory studies, and this meets the B = bioaccumulative criterion. The occurrence of PFOS in a range of biota supports this conclusion. PFOS has been found in a range of higher organisms in Europe, including seals, dolphins, whales, cormorants, eagles, swordfish, tuna and salmon. The Global Biophase Monitoring Programme found PFOS in liver, blood and other tissues of animals, especially in fish-eating animals.

Ecotoxicology

Bacteria Photobacterium phosphoreum: 15 minute EC50 = >250 mgll (PFOS lithium salt) Photobacterium phosphoreum: 30 minute EC50 = >250 mgll (PFOS lithium salt)

Activated sludge: 3 hour IC50 = >905 mgll (PFOS potassium salt) Activated sludge: 3 hour IC50 = >245 mgll (24.5% PFOS potassium salt)

Activated sludge: 7 minute IC50 = >250 mgll (25% PFOS DEA salt)

Terrestrial birds Mallard duck (Anas platyrhynchos): NOEC (bodyweight) = 73 mglkg food (PFOS potassium salt, 5 days exposure followed by

3-17 days observation)

Mallard duck (Anas platyrhynchos): NOEC (mortality) = 146 mglkg food (PFOS potassium salt, 5 days exposure followed by

3-17 days observation)

Mallard duck (Anas platyrhynchos): LC50 = 628 mglkg food (PFOS potassium salt, 5 days exposure followed by 3-17 days

observation)

Northern bobwhite quail (Colinus virginianus): NOEC (bodyweight) = 73 mglkg food (PFOS potassium salt, 5 days

exposure followed by 3-17 days observation) Northern bobwhite quail (Colinus virginianus): NOEC (mortality) = 73 mglkg food

(PFOS potassium salt, 5 days exposure followed by 3-17 days

observation) Northern bobwhite quail (Colinus virginianus): LC50 = 220 mglkg food (PFOS potassium salt, 5 days exposure

followed by 3-17 days observation)

Honev bee

Honey bee (Apis mellifera): 72 hour NOEL = 0.21 pglbee (PFOS potassium salt) Honey bee (Apis mellifera): 72 hour LD50 = 0.40 pglbee (PFOS potassium salt) Honey bee (Apis mellifera): 96 hour NOEL = 1.93 pglbee (PFOS potassium salt) Honey bee (Apis mellifera): 96 hour LD50 = 4.78 pglbee (PFOS potassium salt)

Earthworm

Earthworm (species not stated): 14 day LC50 = 373 mglkg dw soil (artifical soil

substrate)

Freshwater species

Algae: Acute, static

Green algae (Selenastrum capricornutum): 96 hour EC50 (cell density) = 71 mgll

(PFOS potassium salt) Green algae (Selenastrum capricornutum): 96 hour EbC50 (area under the curve) =

71 mgll (PFOS potassium salt) Green algae (Selenastrum capricornutum): 96 hour ErC50 (growth rate) = 126 mgll

(PFOS potassium salt) Green algae (Selenastrum capricornutum): 96 hour NOEC (cell density, growth rate

and area under the curve) = 44 mgll

(PFOS potassium salt) Green algae (Selenastrum capricornutum): 72 hour EC50 (cell density) = 70 mgll

(PFOS potassium salt) Green algae (Selenastrum capricornutum): 72 hour EbC50 (area under the curve) =

74 mgll (PFOS pot'assium salt)

Form for notification of final regulatory action to ban or severely restrict a chemical Page 1: Green algae (Selenastrum capricornutum): 72 hour ErC50 (growth rate) = 120 mgll (PFOS potassium salt) Green algae (Selenastrum capricornutum): 72 hour NOEC (cell density, growth rate and area under the curve) = 70 mgll (PFOS potassium salt) Green algae (Selenastrum capricornutum): 96 hour EC50 (cell density) = 82 mgll (PFOS potassium salt) Green algae (Selenastrum capricornutum): 96 hour EC10 (cell density) = 10 mgll (PFOS potassium salt) Green algae (Selenastrum capricornutum): 96 hour NOEC (cell density) = 35 mgll (PFOS potassium salt) Green algae (Selenastrum capricornutum): 96 hour EC50 (cell density) = 71 mgll (PFOS potassium salt)

Algae: Acute Blue-green algae (Anabaena flosaquae): 96 hour NOEC (growth rate) = 94 mgll (PFOS potassium salt) Blue-green algae (Anabaena flosaquae): 96 hour EC50 (growth rate) = 176 mgll (PFOS potassium salt) Diatom (Navicula pelliculosa) 96 hout NOEC (growth rate) = 206 mgll (PFOS potassium salt) Diatom (Navicula pelliculosa) 96 hout EC50 (growth rate) = 305 mgll (PFOS potassium salt)

Algae: Chronic, static Green algae (Selenastrum capricornutum): 14 day NOEC (cell density) = <26 rngll (PFOS potassium salt) Green algae (Selenastrum capricornutum): 14 day EClO (cell density) = 16 mgll (PFOS potassium salt) Green algae (Selenastrurn capricornutum): T4 day EC50 (cell density) = 95 mgll (PFOS potassium salt)

Plant: Chronic Duckweed (Lemna gibba): 7 day IC50 = 108 mgll (PFOS potassium salt) Invertebrates: Acute, static

Waterflea (Daphnia magna): 48 hour NOEC = 33 mgll (PFOS potassium salt) Waterflea (Daphnia magna): 48 hour EC50 = 61 mgll (PFOS potassium salt) Waterflea (Daphnia magna): 48 hour EC50 = 27 mgll (PFOS potassium salt) Waterflea (Daphnia magna): 24 hour EC50 = >42 mgll (PFOS potassium salt) Waterflea (Daphnia magna): 48 hour EC50 = 14 mgll (PFOS potassium salt) Waterflea (Daphnia magna): 48 hour EC50 = 49.2 mgll (PFOS potassium salt)

Waterflea (Daphnia magna): 48 hour NOEC = 100 mgll (PFOS lithium salt) Waterflea (Daphnia magna): 48 hour EC50 = 210 mgll (PFOS lithium salt) Waterflea (Daphnia magna): 48 hour NOEL = 2.2 mgll (35% PFOS

didecyldimethylammonium salt) Waterflea (Daphnia magna): 48 hour EL50 = 4.0 mgll (35% PFOS I didecyldimethylammonium salt)

1 Invertebrates: Acute, semi-static I Mussel (Unio complamatus): 96 hour NOEC = 50 (PFOS potassium salt) Mussel (Unio complamatus): 96 hour EC50 = 59 (PFOS potassium salt)

Invertebrates: Chronic, semi-static

Waterflea (Daphnia magna): 21 day NOEC (reproduction) = 12 mgll (PFOS potassium salt)

Waterflea (Daphnia magna): 21 day NOEC (survival) = 12 mgll (PFOS potassium

salt) Waterflea (Daphnia magna): 21 day NOEC (growth) = 12 mgll (PFOS potassium

salt)

Waterflea (Daphnia magna): 21 day EC50 (reproduction) = 12 mgll (PFOS

potassium salt) Waterflea (Daphnia magna): 28 day NOEC (reproduction) = 7 mgll (PFOS

potassium salt) Waterflea (Daphnia magna): 28 day EC50 (reproduction) = 11 mgll (PFOS potassium salt)

I

Form for notification 01 final regulatory action to ban or severely restrict a chemical Page 1' Fish: Acute, static Fathead minnow (Pimephales promelas): 96 hour NOEC = 3.3 mgll (PFOS

potassium salt)

Fathead minnow (Pimephales promelas): 96 hour LC50 = 9.5 mgll (PFOS

potassium salt)

Fathead minnow (Pimephales promelas): 96 hour LC50 = 37.6-51 mgll (PFOS potassium salt) Fathead minnow (Pimephales promelas): 96 hour LC50 = 4.7 mgll (24.5% PFOS

lithium salt)

Fathead minnow (Pimephales promelas): 96 hour LC50 = 21 mgll (PFOS

ammonia salt) Fathead minnow (Pimephales promelas): 96 hour LC50 = 25 mgll (PFOS ammonia salt) Fathead minnow (Pimephales promelas): 96 hour NOEL =

didecyldimethylammonium salt, 5%

residual perfluorochemicals)

Bluegill sunfish (Lepomis macrochirus): 96 hour NOEC = 4.5 mgll (25% PFOS DEA salt)

Bluegill sunfish (Lepomis macrochirus): 96 hour LC50 = 7.8 mgll (25% PFOS DEA salt)

Bluegill sunfish (Lepomis macrochirus): 96 hour LC50 = 68 mgll (25% PFOS potassium salt)

Rainbow trout (Oncorhynchus mykiss): 96 hour LC50 = 11 mgll (PFOS potassium salt)

Rainbow trout (Oncorhynchus mykiss): 96 hour LC50 = 7.8 mgll (PFOS potassium salt)

Rainbow trout (Oncorhynchus mykiss): . 96 hour LC50 = 22 mgll (86.7% PFOS

potassium salt)

Fish: Chronic, flow-through Fathead minnow (Pimephales promelas): 42 day NOEC (survival) = 0.3 mgll (PFOS potassium salt) Fathead minnow (Pimephales promelas): 42 day NOEC (growth) = 0.3 mgll (PFOS potassium salt) Fathead minnow (Pimephales promelas): 5 day NOEC (hatch) = >4.6 mgll (PFOS

potassium salt)

Fathead minnow (Pimephales promelas): 30 day NOEC (early life stages) = 1 mgll

(PFOS potassium salt)

Bluegill sunfish (Lepomis macrochirus): 62 day NOEC (survival) = >0.086 to ~0.87mgll (PFOS potassium salt)

Amphibians: Acute

African clawed frog (Xenopus laevis): 96 hour EC50 (malformation) = 12.1 mgll

(PFOS potassium salt) African clawed frog (Xenopus laevis): 96 hour LC50 = 13.8 mgll (PFOS potassium

salt) African clawed frog (Xenopus laevis): MIC (growth) = 7.97 mgll (PFOS potassium

salt)

Marine species

Algae: Acute

Diatom (Skeletonema costatum): 96 hour NOEC (growth rate) = >3.2 mgll (PFOS potassium salt)

Diatom (Skeletonema costatum): 96 hour EC50 (growth rate) = >3.2 mgll (PFOS potassium salt)

Invertebrates: Acute, static

Mysid shrimp (Mysidopsis bahia): 96 hour NOEC = 1.1 mgll (PFOS potassium

salt)

Mysid shrimp (Mysidopsis bahia): 96 hour EC50 = 3.6 mgll (PFOS potassium salt)

Eastern oyster (Crassostrea virginica): 96 hour NOEC = 1.9 mgll (PFOS

potassium salt)

Eastern oyster (Crassostrea virginica): 96 hour EC50 = >3.0 mgll (PFOS potassium salt)

Brine shrimp (Artemia sp.) 48 hour LC50 = 8.9 mgll (PFOS potassium

salt)

Form for notification of final regulatoryaction to ban or severely restrict a chemical Page 1' Invertebrates: Chronic, flow-through

Mysid shrimp (Mysidopsis bahia): 35 day NOEC (reproduction) = 0.25 mgll (PFOS

potassium salt) Mysid shrimp (Mysidopsis bahia): 35 day NOEC (survival) = 0.55 mgll (PFOS

potassium salt) Mysid shrimp (Mysidopsis bahia): 35 day NOEC (growth) = 0.25 mgll (PFOS

potassium salt)

Fish: Acute, semi-static

Sheepshead minnow (Cyprinodon variegatus) LC50 = >I5 mgll (86.7% PFOS potassium salt)

Fish: Acute

Rainbow trout (Oncorhynchus mykiss) LC50 = 13.7 mgll (PFOS potassium salt)

Reference OECD (2002) Co-operation on Existing Chemicals, Hazard Assessment of Perfluorooctane Sulfonate and its Salts. JT00135607. Environment Directorate Joint Meeting of the Chemicals Committee and the Working Party on Chemicals. Pesticides and Biotechnology, Organisation for Economic Co-operation and Development. ENVIJMlRD(2002)171FINAL.

Environment Agency (2004): Environmental Risk Evaluation Report: Perfluorooctanesulphonate (PFOS). Environment Agency for England and Wales.

Risk and Policy Analysts Limited (2004): Perfluorooctane Sulphonate - Risk Reduction Strategy and Analysis of Advantages and Drawbacks. Report prepared for the.Department for Environment, Food and Rural Affairs and the Environment Agency for England and Wales. htt~:llwww.defra.qov.uklenvironmentlqualitvlchemicals/documents/~fos- riskstrateqv.pdf

SCHER (2005) Opinion on RPA's report "Perfluorooctane Sulphonates Risk reduction strategy and analysis of advantages and drawbacks" (Final Report - August 2004). European Commission Scientific Committee on Health and Environmental Risks, SCHER. http://ec.euro~a.eu/health/ph risk/committees/04 scher/docs/scher o 014.pdf

SECTION 4 DESIGNATED NATIONAL AUTHORITY

Institution European Commission

B-1049 Brussels Address I Belaium I Name of person in charge I Juergen Helbig I Position of person in charge I Policy Officer I Telephone Telefax

E-mail address [email protected]

Form for notification of final regulatory action to ban or severely restrict a chemical Page 2 PLEASE RETURN THE COMPLETED FORM TO: Secretariat for the Rotterdam Convention Secretariat for the Rotterdam Convention Food and Agriculture Organization United Nations Environment of the United Nations (FAO) Programme (UNEP) Viale delle Terme di Caracalla 11-13, Chemin des Anemones 0 R 00100 Rome, Italy CH - 1219 Chitelaine, Geneva, Switzerland Tel: (+39 06) 5705 3441 Tel: (+41 22) 917 8177 Fax: (+39 06) 5705 6347 Fax: (+41 22) 917 8082 E-mail: [email protected] E-mail: [email protected]

Definitions for the purposes of the Rotterdam Convention according to Article 2:

(a) 'Chemical' means a substance whether by itself or in a mixture or preparation and whether manufactured or obtained from nature, but does not include any living organism. It consists of the following categories: pesticide (including severely hazardous pesticide formulations) and industrial;

(b) 'Banned chemical' means a chemical all uses of which within one or more categories have been prohibited by final regulatory action, in order to protect human health or the environment. It includes a chemical that has been refused approval for first-time use or has been withdrawn by industry either from the domestic market or from further consideration in the domestic approval process and where there is clear evidence that such action has been taken in order to protect human health or the environment;

(c) 'Severely restricted chemical' means a chemical virtually all use of which within one or more categories has been prohibited by final regulatory action in order to protect i human health or the environment, but for which certain specific uses remain allowed. It includes a chemical that has, for virtually all use, been refused for approval or been withdrawn by industry either from the domestic market or from further consideration in the domestic approval process, and where there is clear evidence that such action has been taken in order to protect human health or the environment;

I (d) 'Final regulatory action' means an action taken by a Party, that does not require

I subsequent regulatory action by that Party, the purpose of which is to ban or severely restrict a chemical.