According to Article 3 of the POPs Regulation, the manufacturing, placing on the market and use of substances listed in Annex I, whether on their own, in mixtures or in articles is prohibited. Therefore, by definition, the use of a substance listed in Annex I, including its use for the formulation of a mixture or production of an article is prohibited, except when a specific exemption for the use has been added to the relevant entry in the Annex I, or their use for laboratory-scale research or as a reference standard (Article 4(1)(a)).
The exemption set out under Article 4(1)(b) cannot apply to intentional uses of the substance, as indicated in the definition for “unintentional trace contaminant” in Article 2(12): “‘unintentional trace contaminant’ means a level of a substance that is incidentally present in a minimal amount, below which the substance cannot be meaningfully used, and above the detection limit of existing detection methods to enable control and enforcement”.
For those substances for which a maximum unintentional trace contaminant (UTC) value has not been defined in Annex I, the analytical limit of detection (LOD) shall apply; meaning that substances, mixtures, or articles containing these Annex I substances above the analytical LOD cannot benefit from the exemption defined in point (b) of Article 4(1).
- POP substances on their own have to be destroyed or irreversible transformed (Article 7(3)).
- For waste containing POPs, Article 7(2) lays down a general rule, according to which the waste should be treated in such a way that the POP content is destroyed (or irreversibly transformed). However, by way of derogation from Article 7(2), Article 7(4)(a) stipulates that for waste with a low POP content (i.e. below the concentration limits set in Annex IV), other treatments - leading to the destruction of the POP content or not - are possible. This means e.g. that plastic waste containing POPs below the concentrations defined in Annex IV can potentially be disposed of via non-destructive methods (e.g. in a non-hazardous waste landfill) or be recycled (but the resulting recyclate would have in addition to meet the applicable UTC limit value in Annex I in order to be placed on the market). It has to be noted that Article 7(3) is also applicable: this means that operations aimed at recovering POP substances (contained in the waste) are explicitly forbidden.
The substances affected by this entry are those described in column 1 of the entry in Annex I:
(i) perfluorooctanoic acid (PFOA), including any of its branched isomers;
(ii) PFOA salts;
(iii) PFOA-related compounds which, for the purposes of the Stockholm Convention, are any substances that degrade to PFOA, including any substances (including salts and polymers) having a linear or branched perfluoroheptyl group with the moiety (C7F15)C as one of the structural elements.
The following compounds are not included as PFOA-related compounds:
(i) C8F17-X, where X = F, Cl, Br;
(ii) fluoropolymers that are covered by CF3[CF2]n-R’, where R’=any group, n> 16;
(iii) perfluoroalkyl carboxylic acids (including their salts, esters, halides and anhydrides) with ≥ 8 perfluorinated carbons;
(iv) perfluoroalkane sulfonic acids and perfluoro phosphonic acids (including their salts, esters, halides and anhydrides) with ≥ 9 perfluorinated carbons;
(v) perfluorooctane sulfonic acid and its derivatives (PFOS), as listed in Annex I.
There are many substances that meet the criteria above and, as such, it is difficult to produce a comprehensive list of these substances. The POP Review Committee (POPRC) has prepared a draft indicative list of substances covered by the listing of ‘PFOA, its salts and PFOA-related compounds’ under the Stockholm Convention. The document (UNEP/POPS/POPRC.16/7) is available here.
From 4 July 2020, a maximum unintentional trace contamination (UTC) concentration of 25 ppb applies to the presence of PFOA and its salts as an impurity in a substance, in a mixture or in an article. The manufacturing, placing on the market and use of PFOA and its salts in concentrations above 25 ppb is prohibited in accordance with Annex I and subject to Article 4 of the POPs Regulation.
From 4 July 2020, a maximum unintentional trace contamination (UTC) concentration of 1 000 ppb applies to the presence of any individual PFOA-related compound or a combination of PFOA-related compounds as an impurity in a substance, in a mixture or in an article. In addition, the same concentration limit applies to the presence of PFOA and its salts 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. The manufacturing, placing on the market and use of such compounds above 1 000 ppb is prohibited in accordance with Annex I and subject to Article 4 of the POPs Regulation.
The entry for PFOA in Annex I provides, by way of derogation, a transition period allowing the manufacturing, placing on the market and use of PFOA, its salts and PFOA-related compounds for the production of 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. This transition period is thought to be sufficient time to allow the development of cost-effective alternatives for all relevant applications where the textiles are required to provide human health/ life protecting functions (e.g. due to very strong oil or chemical repellence).
The workers requiring this type of protection are e.g. firefighters, policemen that are exposed to risks from oil and chemicals and therefore need personal protective equipment, as well as workers in the healthcare sector.
PFOA, PFOA salts and PFOA-related substances shall not be used in the production of, or placed on the market in medical devices other than invasive and implantable medical devices within the scope of Regulation (EU) 2017/745 from 3 December 2020. The placing on the market of medical devices other than invasive and implantable ones containing PFOA and its salts and/or PFOA-related compounds as unintentional trace contaminants at a concentration equal to or below 2 mg/kg is permitted. For medical devices which consist of an assembly of several articles (complex objects) the concentration limit shall be determined at the article level. This exemption shall be reviewed and assessed by the Commission no later than 22 February 2023.
There is a derogation in point 5(d) of the entry for PFOA in Annex I for invasive and implantable medical devices that are within the scope of Regulation (EU) 2017/745). According to this derogation, the restricted substances are allowed to be manufactured and placed on the market and used, or placed on the market as a constituent of another substance or in a mixture for the production of these devices. These invasive and implantable medical devices can be placed on the market without specific concentration limits. This derogation expires on 4 July 2025.
The notion of "the mass of structurally and microstructurally distinct parts" was taken over from the provisions of Annex XVII to REACH. The interpretation of this term should be the same as under REACH. For further information, see Question And Agreed Answers Concerning The Implementation Of Directive 76/769/EEC On The Restrictions To Marketing And Use Of Dangerous Substances - 15 January 2009.
The term “structurally or microstructurally distinct parts” was introduced as a generic way of referring to the part of the article that contains PFOS, and is intended to avoid uncertainties that might arise by referring simply to, for example, “articles or parts thereof”.
The above considerations also apply to PFOS in coatings. However, the coatings are not structurally distinct in the sense that they cannot be easily separated from the substrate. Nevertheless, they are microstructurally distinct in the sense that they can be identified when a cross-section of the coated surface is viewed though a microscope.
Coatings on textiles usually concern mainly the surface fibres. Each of the surface fibres could be considered either to be a structurally distinct part, or the coating on each fibre could be considered to be a microstructurally distinct part, as described above. However, analysis for control purposes using either of those two approaches would be difficult to achieve in practice. The analysis is therefore simplified by calculating the concentration per square meter using sampling, extraction and analysis methods developed by CEN.
The threshold was lowered to 10 mg/kg (0.001 % by weight) in the POPs Regulation compared to 50 mg/kg (0.005 % by weight) in Annex XVII to rule out the intentional use of PFOS-related substances. There was evidence to suggest that PFOS-related substances might be intentionally used at concentrations very close to or even below the previous threshold of 0.005 % in mixtures.
Information on concentrations used in mixtures and articles can be found in the Draft Guidance on alternatives to PFOS and its derivatives [UNEP/POPS/POPRC.6/INF/8] (prepared by a contractor for the Stockholm Convention Secretariat).
There are some indications of uses of PFOS-related substances below the thresholds specified e.g. certain medical devices such as in vitro diagnostic kits and colour filters for endoscopes, but so far no written evidence is available.
However, it should be noted that the use of PFOS and PFOS-related substances in the production of articles is prohibited, even if the resulting concentration in the article is below the unintentional trace contaminant threshold. The only permitted use of PFOS and PFOS-related substances is as mist suppressants for non-decorative hard chromium (VI) plating in closed loop systems.
Further information is available in the Draft Guidance on alternatives to PFOS and its derivatives [UNEP/POPS/POPRC.6/INF/8] (prepared by a contractor for the Stockholm Convention Secretariat).
“Coated leather” is defined in Directive 94/11/EC as “leather where the surface coating applied to the leather does not exceed one third of the total thickness of the product but is in excess of 0,15 mm”. For the article or part of the article that fulfils the definition of “coated leather” and where the coating cannot be separated from the leather substrate, the limit of 1 µg/m2 applies. For the article or part of the article that does not fulfil the definition of “coated leather”, the limit of 0.1% by weight applies.
The test method EN ISO 23702-1:2018 can be used for the detection and quantification of extractable neutral, ionic, long, medium and short chain perfluorinated and poly-fluorinated substances (including PFOS) in leather and coated leather.
The PBDEs are listed in the POPs Regulation using the same approach followed under REACH Annex XVII for octaBDE, i.e. using the chemical formula. The popular names for the substances have been taken from the COP4 decisions as they more accurately describe what is covered by the formula than the wording used in REACH. The basis for the COP4 decisions were the nominations. Commercial mixtures of octaBDE and pentaBDE were nominated, but during the evaluation it was proved that it was more correct and precise to list the dominant individual congeners of the commercial mixtures that in fact were proven to meet the POPs criteria rather than just the commercial mixtures.
The COP4 decisions are available on the Stockholm Convention website.