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Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds

Category: Industrial CAS number 335-67-1

Import Responses


Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds

(Industrial)
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Party Party response Decision Date published
Argentina Final decision Consent to import only subject to specified conditions 12/12/2023
Conditions for import:
i. Photolithographic or etch processes in semiconductor manufacturing;
ii. Photographic coatings applied to films;
iii. Oil-repellent and water-repellent textiles for the protection of workers from dangerous liquids that comprise risks to their health and safety;
iv. Invasive and implantable medical devices;
v. Fire fightings foams for liquid fuel vapor suppression and liquid fuel fires (Class B fires) in installed systems, including both mobile and fixed systems, in accordance with the following:
- Do not export or import fire-fighting foams that contain or may contain PFOA, its salts and related PFOA compounds except for the purposes of their environmentally sound disposal;
- Do not use firefighting foam that contain or may contain PFOA, its salts and related PFOA compounds for training;
- Do not use firefighting foam that contain or may contain PFOA, its salts and PFOA related compounds for testing, unless all releases are contained;
- By the end of 2025, restrict uses of fire-fighting foams that contain or may contain PFOA, its salts and PFOA-related compounds to sites where all releases can be contained;
- Make determined efforts designed to achieve environmentally sound management of fire-fighting foam stockpiles and wastes that contain or may contain PFOA, its salts and PFOA-related compounds, as soon as possible.
vi. Use of perfluorooctyl iodide for the production of perfluorooctyl bromide for the purpose of producing pharmaceutical products;
vii. Manufacture of polytetrafluoroethylene (PTFE) and polyvinyldene fluoride (PVDF) for the production of:
- High-performance, corrosion-resistant membranes for gas filter membranes, water filter membranes and membranes for medical textiles;
- industrial waste heat exchanger equipment;
- Industrial sealants capable of preventing leakage of volatile organic compounds and MP2.5 particulates.
viii. Manufacture of polyfluoroethylene-propylene (FEP) for the production of high-voltage electrical wire and cables for power transmission;
ix. Manufactur of fluoroelastomers for the production of O-rings, V-belts and plastic accessories for automobile interiors.
Legislative or administrative measures:
Resolution MAyDS No. 451/2019.
Australia Final decision Consent to import only subject to specified conditions 12/12/2023
Conditions for import:
That the introduction has been approved by the Executive Director of the Australian Industrial Chemicals Introduction Scheme (AICIS) in writing before the industrial chemical is introduced; and that the person keep the records relating to the introduction of the chemical (Industrial Chemicals (General) Rules 2019, Chapter 6, Part 2, Sections 71 and 74).
Legislative or administrative measures:
Industrial Chemicals (General) Rules 2019 implemented on 1 July 2020.
Botswana Interim decision Consent to import 12/12/2023
Remarks:
To consult with relevant stakeholders.
Brazil Final decision No consent to import 12/12/2023
Legislative or administrative measures:
Legislative or administrative measures:
Brazil is a Party to the Stockholm Convention on Persistent Organic Pollutants, which was approved in Brazil through Decree n 5.472 of 20 June 2005.
Perfluorooctanoic acid (PFOA), its s alts and PFOA-related compounds was listed in Annex A (Elimination) of the Stockholm Convention under the group of industrial POPs.
Cabo Verde Interim decision No consent to import 12/06/2023
Canada Final decision Consent to import only subject to specified conditions 12/06/2023
Conditions for import:
The Prohibition of Certain Toxic Substances Regulations, 2012 (the Regulations) prohibit the manufacture, use, sale, offer for sale or import of perfluorooctanoic acid, which has the molecular formula C7F15CO2H, its salts, and its precursors (collectively referred to as PFOA) and products containing PFOA, unless the substance is incidentally present. A limited number of exemptions are listed below and in the Other remarks section.
The Regulations do not prohibit:
The import, manufacture, use, sale and offer for sale of PFOA or a product containing them, if PFOA are incidentally present;
The import, use, sale and offer for sale of aqueous film forming foam for fire-fighting operations that contain PFOA;
The import, use, sale or offer for sale of manufactured items containing PFOA. Under the Regulations, a manufactured item is a product that is formed into a specific physical shape or design during its manufacture and that has, for its final use, a function or functions dependent in whole or in part on its shape or design;
The use or import of products containing PFOA, if the product is for personal use.
Legislative or administrative measures:
The Prohibition of Certain Toxic Substances Regulations, 2012 (SOR/2012-285), the Regulations, made under subsection 93(1) of the Canadian Environmental Protection Act, 1999 (CEPA).
http://laws-lois.justice.gc.ca/eng/regulations/SOR-2012-285/index.html
The Regulations prohibit the manufacture, use, sale, offer for sale or import of perfluorooctanoic acid, which has the molecular formula C7F15CO2H, its salts, and its precursors (collectively referred to as PFOA) and products containing PFOA, unless the substance is incidentally present. A limited number of exemptions are listed in the specified conditions section and the other remarks section.
Remarks:
The Prohibition of Certain Toxic Substances Regulations, 2012 (the Regulations) do not apply to any toxic substance that is:
a)contained in a hazardous waste, hazardous recyclable material or non-hazardous waste to which Division 8 of Part 7 of Canadian Environmental Protection Act, 1999 applies;
b)contained in a pest control product as defined in subsection 2(1) of the Pest Control Products Act;
c)present as a contaminant in a chemical feedstock that is used in a process from which there are no releases of the toxic substance and on the condition that the toxic substance is destroyed or completely converted in that process to a substance that is not a toxic substance set out in either Schedule 1 or 2 of the Regulations; or
d)to be used in a laboratory for analysis, in scientific research or as a laboratory analytical standard.
Cuba Interim decision Consent to import 12/06/2023
Remarks:
Resolution adopted at a National level, pending publication of Official Law.
El Salvador Final decision No consent to import 12/12/2023
Legislative or administrative measures:
Substance regulated by the Stockholm Convention on Persistent Organic Pollutants. Import, manufacture, commercialization and use are prohibited under Agreement No. 152 of the Environment and Natural Resources Department, published in the Official Gazette No. 236, Volume 429, of November 26, 2020.
European Union Final decision Consent to import only subject to specified conditions 12/12/2023
Conditions for import:
Under Part A of Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.06.2019, p. 45), the placing on the market and use of perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds is only allowed, by way of derogation, for the following purposes:
(a) photolithography or etch processes in semiconductor manufacturing, until 4 July 2025;
(b) photographic coatings applied to films, until 4 July 2025;
(c) textiles for oil- and water-repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety, until 4 July 2023;
(d) invasive and implantable medical devices, until 4 July 2025;
(e) in fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems, including both mobile and fixed systems, until 4 July 2025, subject to the following conditions:
(i) fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall not be used for training;
(ii) fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall not be used for testing unless all releases are contained;
(iii) as from 1 January 2023, uses of fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall only be allowed in sites where all releases can be contained;
(iv) fire-fighting foam stockpiles that contain or may contain PFOA, its salts and/or PFOA-related compounds shall be managed in accordance with Article 5 of Regulation (EU) 2019/1021.
(f) the use of perfluorooctyl bromide containing perfluoroctyl iodide for the purpose of producing pharmaceutical products.
Legislative or administrative measures:
In the Union, the manufacturing, placing on the market and use of perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds are, subject to certain exemptions, prohibited pursuant to Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.06.2019, p. 45).
Remarks:
In accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p.1), which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the Union, perfluorooctanoic acid (PFOA) (CAS number 335-67-1) is classified as:
Acute Tox. 4 - H302 - Harmful if swallowed.
Eye Dam. 1 - H318 - Causes serious eye damage.
Acute Tox. 4 - H332 - Harmful if inhaled.
Carc. 2 - H351 - Suspected of causing cancer.
Lact. - H362 - May cause harm to breast-fed children.
STOT RE 1 - H372 (liver) - Causes damage to organs through prolonged or repeated exposure.
Repr. 1B - H360D - May damage the unborn child.
Indonesia Interim decision Consent to import only subject to specified conditions 12/06/2023
Conditions for import:
This chemical has to complete the notification process prior to its import.
This chemical must be registered to Ministry of Environment and Forestry before being distributed or used.
Montenegro Final decision No consent to import 12/12/2023
Legislative or administrative measures:
Law on chemicals ('Official Gazette of Montenegro' No. 05 1/17), Article 44, Article 47, Article 48
Perfluorooctanoic acid is not entered in the list of registered chemicals in Montenegro.
On the basis of Article 40 of the Law on Chemicals ("Official Gazette of Montenegro", number 51 /17), the Government of Montenegro, at the session of October 4, 2018, adopted a REGULATION ON PROHIBITED AND PERMITTED METHODS OF USE, PRODUCTION AND PLACING ON THE MARKET H . WHICH REPRESENT AN UNACCEPTABLE RISK TO HUMAN HEALTH AND THE ENVIRONMENT
- The production and placing on the market of PFOA as an individual substance is prohibited from July 4, 2020. 2) It is prohibited from July 4, 2020 to use in the production and place on the market PFOA in: a) another substance, as its constituent part; b) mixes; c) the product in a concentration equal to or greater than 25 ppb for PFOA, including its salts, or 1,000 ppb for one of the substances related to PFOA or their combination. 3) Subpoint. 1 and 2 of this point apply from: a) July 4, 2022 equipment used in the production of semiconductors; - latex inks.
b) July 4, 2023 on: - textiles for the protection and health of employees; - membranes intended for use in medical textiles, filtration in water purification, production processes and effluent treatment; - plasma nanocoatings.
c) on July 4, 2023, to medical products except medical products for installation in accordance with special regulations.
4) Subpoint. 1 and 2 of this point do not apply to:
a) perfluorooctane sulfonic acid and its derivatives listed in Annex 3 of this regulation;
b) the production of substances that arise as an inevitable by-product of the production of fluorinated chemicals with a carbon chain length of no more than six atoms;
c) a substance that will be used or is being used as a transported isolated intermediate if the conditions established by the regulation governing the management of chemicals are met;
g) a substance, an integral part of another substance or a mixture that will be used or is being used: - in the production of medical products for installation in accordance with special regulations; - in photographic coatings that are applied to films, paper or printing plates; - in photolithographic procedures for semiconductors or in engraving procedures for complex semiconductors;
d) concentrated fire extinguishing foam mixtures that were placed on the market before July 4, 2020 and which will be used or are being used in the production of other fire extinguishing foam mixtures.
5) Subpoint 2 of subparagraph b) of this point does not apply to fire extinguishing foam mixtures that are:
a) placed on the market before July 4, 2020; or b) produced in accordance with subparagraph 4 of subparagraph e) of this point, with the condition that, if used for the purposes of improvement, the emissions in the environment are reduced and that the collected effluents are disposed of in a safe manner.
6) Subpoint 2 of paragraph c) these points do not apply to: a) products placed on the market before July 4, 2020; b) medical products for installation manufactured in accordance with subparagraph 4 of subparagraph g) of this point; c) products covered with photographic coatings from sub-item 4 indent g) of this item; g) semiconductors or compound semiconductors from sub-point 4 indent g) of this point.
New Zealand Final decision No consent to import 12/06/2023
Legislative or administrative measures:
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds is listed as a persistent organic pollutant (POP) in Schedule 2A of the Hazardous Substances and New Organisms Act 1996 (HSNO Act). Under Section 25A of the HSNO Act it is prohibited to be imported or manufactured or used. This includes manufactured articles containing the substance. Exceptions apply to the import or manufacture of small quantities for use as an analytical standard or for research and development in a laboratory, or the import for environmentally sound disposal, or where it is present as an unintentional trace contaminant in products and articles. An 'articles in use' notification has been made to the Secretariat of the Stockholm Convention for articles where PFOA, its salts and PFOA-related compounds have been used as components, such as in coated textiles, papers, fluoropolymer membranes or medical devices, in New Zealand on or before 3 December 2020.
Specific exemption notifications have also been made to the Secretariat of the Stockholm Convention in accordance with Article 4 of the Convention for: (a) photographic coatings applied to films; and (b) fire-fighting foam for liquid fuel vapour suppression and liquid fuel fires in installed systems, including both mobile and fixed systems, in accordance with paragraph 2 of Part X of Annex A of the Stockholm Convention.
Remarks:
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds are also listed in Schedule 1: Stockholm chemicals of the Imports and Exports (Restrictions) Prohibition Order (No 2) 2004. It may not be exported unless a permit is issued by the Environmental Protection Authority, which is subject to particular conditions and restrictions.
Nicaragua Final decision No consent to import 12/06/2023
Legislative or administrative measures:
Resolution 001-2022; Published in Gaceta, Official Gazette of Nicaragua, on 26 April 2022.
North Macedonia Interim decision Consent to import only subject to specified conditions 12/12/2023
Conditions for import:
In Accordance with the provisions of part X of Annex A to the Stockholm Convention on the Persistent Organic Pollutants, specific exemptions are:
Photolithography or etch processes in semiconductor manufacturing
Photographic coatings applied to films
Textiles for oil and water repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety
Invasive and implantable medical devices
Fire-fighting foam for liquid fuel vapour suppression and liquid fuel fires (Class B fires) in installed systems, including both mobile and fixed systems, in accordance with paragraph 2 of part X of this Annex
Use of perfluorooctyl iodide for the production of perfluorooctyl bromide for the purpose of producing pharmaceutical products, in accordance with the provisions of paragraph 3 of part X of this Annex
Manufacture of polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF) for the production of:
oHigh-performance, corrosion-resistant gas filter membranes, water filter membranes and membranes for medical textiles
oIndustrial waste heat exchanger equipment
oIndustrial sealants capable of preventing leakage of volatile organic compounds and PM2.5 particulates
Manufacture of polyfluoroethylene propylene (FEP) for the production of high-voltage electrical wire and cables for power transmission
Manufacture of fluoroelastomers for the production of O-rings, v-belts and plastic accessories for car interiors
Remarks:
Law on chemicals (Official Gazette of RM Official Gazette of RM 145/10; 164/13; 116/15; 149/15; 37/16)
According to Article 4, paragraph 1, point 4, of the Law on chemicals, the List of banned and restrictions of the use of chemicals it is published.
The List of banned and restrictions of the use of chemicals beside others contain the list of POPs substances subject to banns and restrictions. The list it is amended continuously and Perfluorooctanoic acid (PFOA), it's salts and PFOA-related compounds will be added.
According to the Article 58 of the Law on chemicals, the legal entities which manufacture hazardous chemicals bust be licensed for manufacturing of dangerous chemicals.
According to Article 83, paragraph 1 of the Law on chemicals, placing certain hazardous chemicals on market must be performed by legal entities who have a permit for performing trade of extremely hazardous chemicals.
No one legal entities are licensed for Perfluorooctanoic acid (PFOA), it's salts and PFOA-related compounds.
Norway Final decision Consent to import only subject to specified conditions 12/12/2023
Conditions for import:
As specified in Regulation (EU) 2019/1021 with amendments Regulation (EU) 2020/787, 2021/115 and 2023/866.
These restrictions shall not apply to products that were in use in Norway before 4 July 2020.
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) photolithography or etch processes in semiconductor manufacturing, until 4 July 2025;
(b) photographic coatings applied to films, until 4 July 2025;
(c) textiles for oil- and water-repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety, until 4 July 2023;
(d) invasive and implantable medical devices, until 4 July 2025;
Use of PFOA, its salts and PFOA-related compounds shall be allowed in firefighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems, including both mobile and fixed systems, until 4 July 2025, subject to the following conditions: (a) fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall not be used for training; ( b) fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall not be used for testing unless all releases are contained; (c ) as from 1 January 2023, uses of fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall only be allowed in sites where all releases can be contained.
The use of perfluorooctyl bromide containing perfluorooctyl iodide for the purpose of producing pharmaceutical products shall be allowed, subject to review and assessment by the Commission by 31 December 2026, every four years thereafter and by 31 December 2036.
Legislative or administrative measures:
In Norway PFOA, its salts and PFOA-related compounds are regulated according to Regulation (EU) 2020/787, 2021/115 and 2023/866 amending Regulation (EU) 2019/1021 in Chapter 4 of the "Regulations related to restriction on manufacture, import, export, sales and use of chemicals and other products hazardous to health and environment (Products Regulation)" by the Ministry of Environment. Act no 922 of 1 June 2004.
Production, placing on the market and use of PFOA or any of its salts is prohibited with a maximum concentration limit of 0,025 mg/kg (0,0000025 % by weight), or any individual PFOA-related compound or a combination of PFOA-related compounds of 1 mg/kg (0,0001 % by weight) where they are present in substances, mixtures or articles, is prohibited by Regulation (EU) 2020/787 amending Regulation (EC) No 2019/1021.
The prohibition does not apply when these substances (a) are used for laboratory-scale research or as a reference standard; (b) occur as an unintentional trace contaminant in substances, mixtures or articles.
Maximum concentration limit of PFOA-related compounds is 20 mg/kg (0,002 % by weight) where they are present in a substance to be used as a transported isolated intermediate within the meaning of Article 3 point 15(c) of Regulation (EC) No 1907/2006 and fulfilling the strictly controlled conditions set out in Article 18(4)(a) to (f) of that Regulation for the production of fluorochemicals with a perfluoro carbon chain equal to or shorter than 6 atoms. This exemption shall be reviewed and assessed by the Commission no later than 25 August 2023;
Maximum concentration limit of PFOA and its salts is 1 mg/kg (0,0001 % by weight) where they are present in polytetrafluoroethylene (PTFE) micropowders produced by ionising irradiation or by thermal degradation as well as in mixtures and articles for industrial and professional uses containing PTFE micropowders until 18 August 2023. All emissions of PFOA during the manufacture and use of PTFE micro-powders shall be avoided and, if not possible, reduced as far as possible. The limit of 1 mg/kg (0,0001 % by weight) shall apply only to manufacture, placing on the market and use of PFOA and its salts where they are present in PTFE micropowders that are transported or treated for the purpose to reduce the concentration of PFOA and its salts below the limit of 0,025 mg/kg (0,0000025 % by weight).
By way of derogation, the manufacturing, placing on the market and use of PFOA, its salts and PFOA-related compounds shall be allowed for the following purposes: (a) photolithography or etch processes in semiconductor manufacturing, until 4 July 2025; (b) photographic coatings applied to films, until 4 July 2025; (c) textiles for oil- and water-repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety, until 4 July 2023; (d) invasive and implantable medical devices, until 4 July 2025.
By way of derogation, the use of PFOA, its salts and PFOA-related compounds shall be allowed in fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems, including both mobile and fixed systems, until 4 July 2025, subject to the following conditions: (a) fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall not be used for training; (b) fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall not be used for testing unless all releases are contained; (c) as from 1 January 2023, uses of fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall only be allowed in sites where all releases can be contained; (d) fire-fighting foam stockpiles that contain or may contain PFOA, its salts and/or PFOA-related compounds shall be managed in accordance with Article 5.
By way of derogation, the use of perfluorooctyl bromide containing perfluoroctyl iodide for the purpose of producing pharmaceutical products shall be allowed, subject to review and assessment by the Commission by 31 December 2026, every four years thereafter and by 31 December 2036.
Use of articles already in use in the Union before 4 July 2020 containing PFOA, its salts and/or PFOA-related compounds shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles.
By way of derogation, the manufacturing, placing on the market and use of PFOA, its salts and PFOA-related compounds shall be allowed until 3 December 2020 for the following purposes: (a) medical devices other than implantable ones, within the scope of Regulation (EU) 2017/745 (8); (b) latex printing inks; (c) plasma nano-coatings.
10. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of PFOA and its salts and/or PFOA-related compounds equal to or below 2 mg/kg (0,0002 % by weight) where they are present in medical devices other than invasive devices and implantable devices. This exemption shall be reviewed and assessed by the Commission no later than 22 February 2023.
Oman Final decision No consent to import 12/12/2023
Legislative or administrative measures:
According to:
1.Royal Decree No. 46/95 issuing the Law of Handling and Use of Chemicals.
2.Administrative Resolution No. (50/2023) issuing a regulation regulating hazardous chemicals.
Panama Interim decision No consent to import 12/06/2023
Serbia Final decision Consent to import only subject to specified conditions 12/12/2023
Conditions for import:
5. Manufacturing, placing on the market and use of PFOA, its salts and PFOA-related compounds shall be allowed for the following purposes:
(a) photolithography or etch processes in semiconductor manufacturing, until 4th July 2025;
(b) photographic coatings applied to films, until 4th July 2025;
(c) textiles for oil- and water-repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety, until 4th July 2023;
(d) invasive and implantable medical devices, until 4th July 2025;
(e) manufacture of polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF) for the production of:
(i) high-performance, corrosion-resistant gas filter membranes, water filter membranes and membranes for medical textiles;
(ii) industrial waste heat exchanger equipment,
(iii) industrial sealants capable of preventing leakage of volatile organic compounds and PM2.5 particulates;
until 4th July 2023.
6. Use of PFOA, its salts and PFOA-related compounds shall be allowed in fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems, including both mobile and fixed systems, until 4th July 2025, subject to the following conditions:
(a) fire-fighting foam that contains or may contain -PFOA, its salts and/or PFOA-related compounds shall not be used for training;
(b) fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA related compounds shall not be used for testing unless all releases are contained;
(c) as from 1st January 2023, uses of fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall only be allowed in sites where all releases can be contained;
(d) fire-fighting foam stockpiles that contain or may contain PFOA, its salts and/or PFOA-related compounds shall be managed in a manner that is safe for human health and the environment.
7. Use of perfluorooctyl bromide containing perfluoroctyl iodide for the purpose of producing pharmaceutical products shall be allowed until 31st December 2036.
8. Use of articles already in use before 4th July 2020 containing PFOA, its salts and/or PFOA-related compounds shall be allowed.
9. Manufacturing, placing on the market and use of medical devices other than invasive devices and implantable devices, containing PFOA, its salts and PFOA-related compounds in concentrations equal to or below 2 mg/kg (0,0002 % by weight), shall be allowed.
Legislative or administrative measures:
Law on Chemicals (Official Gazette of the RS No. 36/09, 88/10, 92/11, 93/12 and 25/15)
Rulebook on Restrictions and Bans of Production, Placing on the Market and Use of Chemicals (Official Gazette of the RS No. 90/13, 25/15, 2/16, 44/17, 36/18, 9/20 and 57/22), Annex 2, List of POPs substances subject to bans
1. Manufacturing, placing on the market and use of substances, mixtures or articles containing PFOA or any of its salts as impurity in concentrations equal to or below 0,025 mg/kg (0,0000025 % by weight) shall be allowed.
2. Manufacturing, placing on the market and use of substances, mixtures or articles containing PFOA-related compounds or a combination of PFOA-related compounds as impurity in concentrations equal to or below 1 mg/kg (0,0001 % by weight) shall be allowed.
3. Manufacturing, placing on the market and use of substances as a transported isolated intermediate used for the production of fluorochemicals with a perfluoro carbon chain equal to or shorter than 6 atoms, containing PFOA-related compounds as impurity in concentrations equal to or below 20 mg/kg (0,002 % by weight) shall be allowed.
4. Manufacturing, placing on the market and use of PFOA and its salts as impurity in concentrations equal to or below 1 mg/kg (0,0001 % by weight) where they are present in polytetrafluoroethylene (PTFE) micropowders produced by ionising irradiation or by thermal degradation as well as in mixtures and articles for industrial and professional uses shall be allowed. All emissions of PFOA during the manufacture and use of PTFE micropowders shall be avoided and, if not possible, reduced as far as possible.
The rest of the legislative measure is listed in point 4.3.
Singapore Final decision Consent to import only subject to specified conditions 12/06/2023
Conditions for import:
A hazardous substance licence is required for the import of the chemical.
Legislative or administrative measures:
The chemical is controlled as a hazardous substance under the Environmental Protection and Management Act (EPMA) and its regulations. A hazardous substance licence is required for the import, export, storage, use and sale.
Remarks:
The National Environment Agency does not have a chemical registration regime but requires companies to possess a valid hazardous substances (HS) licence for the import, export, storage, use and sale of chemicals that are regulated as hazardous substances under the Environmental Protection and Management Act (EPMA) and EPM (HS) regulations. This includes PFOA, its salts and PFOA-related compounds.
Some illustrations for the application of the imported chemical include wafer fabrication, medical device manufacturing, R&D and laboratory analytical purposes.
Thailand Final decision Consent to import only subject to specified conditions 12/12/2023
Conditions for import:
Imports of PFOA, its salts and PFOA-related compounds (8 substances with CAS numbers: 335-67-1; 3825-26-1; 335-95-5; 2395-00-8; 335-93-3; 335-66-0; 376-27-2 and 3108-24-5) are prohibited, except for some specific uses that are allowed under the Stockholm Convention.
Imports of PFOA, its salts and PFOA-related compounds for allowable uses under the Stockholm Convention require registration and licensing from the Department of Industrial Works.
Legislative or administrative measures:
According to the Hazardous Substance Act, B.E.2535 (1992) and its amendments, and the Notification of Ministry of Industry Subject: List of Hazardous Substances (No.7), B.E. 2565 (2022), PFOA, its salts and PFOA-related compounds, 8 substances as follows:
Perfluorooctanoic acid (CAS No. 335-67-1)
Ammonium perfluorooctanoate (CAS No. 3825-26-1)
Sodium perfluorooctanoate (CAS No. 335-95-5)
Potassium perfluorooctanoate (CAS No. 2395-00-8)
Silver perfluorooctanoate (CAS No. 335-93-3)
Perfluorooctanoyl fluoride (CAS No. 335-66-0)
Methyl perfluorooctanoate (CAS No. 376-27-2)
Ethyl perfluorooctanoate (CAS No. 3108-24-5)
are classified as Category 4 Hazardous Substances, of which the production, import, export, transit or having in possession are prohibited, except for some specific uses that are allowed under the Stockholm Convention, namely,
Photolithography or etch processes in semiconductor manufacturing.
Photographic coatings applied to films.
Textiles for oil and water repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety.
Fire-fighting foam for liquid fuel vapour suppression and liquid fuel fires (Class B fires) in installed systems, including both mobile and fixed systems.
Manufacture of polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF) for the production of:
- High-performance, corrosion-resistant gas filter membranes, water filter membranes and membranes for medical textiles
- Industrial waste heat exchanger equipment
- Industrial sealants capable of preventing leakage of volatile organic compounds and PM2.5 particulates
Manufacture of polyfluoroethylene propylene (FEP) for the production of highvoltage electrical wire and cables for power transmission.
Manufacture of fluoroelastomers for the production of O-rings, v-belts and plastic accessories for car interiors.
Such allowable uses were classified as Category 3 Hazardous Substances, of which the production, import, export, transit or having in possession require registration and licensing from the Department of Industrial Works.
Remarks:
N/A
United Kingdom of Great Britain and Northern Ireland Final decision Consent to import only subject to specified conditions 12/12/2023
Conditions for import:
1. Substances, mixtures or articles with concentrations of PFOA or any of its salts equal to or below 0,025 mg/kg (0,0000025 % by weight) where they are present as unintentional trace contaminants.
2. Substances, mixtures or articles with concentrations of any individual PFOA-related compound or a combination of PFOA-related compounds equal to or below 1 mg/kg (0,0001 % by weight) where they are present as unintentional trace contaminants.
3. For unintentional trace contaminant concentration of PFOA-related compounds equal to or below 20 mg/kg (0,002 % by weight) where they are present in a substance to be used as a transported isolated intermediate within the meaning of Article 3 point 15(c) of Regulation (EC) No 1907/2006 and fulfilling the strictly controlled conditions set out in Article 18(4)(a) to (f) of that Regulation for the production of fluorochemicals with a carbon chain equal to or shorter than 6 atoms.
4. For unintentional trace contaminant concentration of PFOA and its salts equal to or below 1 mg/kg (0,0001 % by weight) where they are present in polytetrafluoroethylene (PTFE) micropowders produced by ionising irradiation of up to 400 kilograys or by thermal degradation as well as in mixtures and articles for industrial and professional uses containing PTFE micropowders. All emissions of PFOA during the manufacture and use of PTFE micropowders shall be avoided and, if not possible, reduced as far as possible.
5. By way of derogation, the manufacturing, placing on the market and use of PFOA, its salts and PFOA-related compounds shall be allowed for the following purposes:
(a) photolithography or etch processes in semiconductor manufacturing, until 4 July 2025;
(b) photographic coatings applied to films, until 4 July 2025;
(c) textiles for oil- and water-repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety, until 3 December 2025;
(d) invasive and implantable medical devices, until 4 July 2025;
6. By way of derogation, the use of PFOA, its salts and PFOA-related compounds shall be allowed in fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems, including both mobile and fixed systems, until 4 July 2025, subject to the following conditions:
(a) fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall not be used for training;
(b) fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall not be used for testing unless all releases are contained;
(c) as from 1 January 2023, uses of fire-fighting foam that contains or may contain PFOA, its salts and/or PFOA-related compounds shall only be allowed in sites where all releases can be contained;
(d) fire-fighting foam stockpiles that contain or may contain PFOA, its salts and/or PFOA-related compounds shall be managed in accordance with Article 5 of Regulation (EU) 2019/1021.
7. By way of derogation, the use of perfluorooctyl bromide containing perfluoroctyl iodide for the purpose of producing pharmaceutical products shall be allowed, subject to review and assessment by the appropriate authority by 31 December 2026, every four years thereafter and by 31 December 2036.
8. Use of articles already in use in the European Union before 4 July 2020 containing PFOA, its salts and/or PFOA-related compounds shall be allowed. Article 4(2), third and fourth subparagraphs of Regulation (EU) 2019/1021 shall apply in relation to such articles.
Legislative or administrative measures:
The manufacturing, placing on the market and use of perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds are regulated in the UK under retained Regulation 2019/1021 on persistent organic pollutants.
Yemen Final decision No consent to import 12/12/2023
Legislative or administrative measures:
This substance is included in the lists of industrial chemicals, pesticides and hazardous waste that are banned and severely restricted in the Republic of Yemen.