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POPs

Scope

a) General

What will happen with substances already listed in REACH Annex XVII that will be listed in the POPs Regulation?
Substances already listed in REACH Annex XVII that will be listed in the POPs Regulation will be removed from Annex XVII by a separate amendment to REACH. Having two different restrictions in force at the same time covering the same substances would lead to legal uncertainty. The Commission therefore intends to adopt, in tandem with the amendments to the POPs Regulation, a revision of REACH Annex XVII so that these substances in the future are restricted / prohibited exclusively by the POPs Regulation.  
b. Presence of POPs as unintentional trace contaminants (UTC)

Why are there thresholds for unintentional trace contaminants in the POPs Regulation?
The Stockholm Convention and the POPs Regulation (cf. Article 4(1)(b)) generally exempt "substance[s] present as an unintentional trace contaminant in substances, mixtures or articles". The notion of “unintentional trace contaminant” comes from the Stockholm Convention, and is not applied in other pieces of EU chemicals legislation, which instead set fixed values below which a substance is not considered restricted. The POPs Regulation bridges the gap between the two approaches by defining a fixed threshold for substances occurring as an unintentional trace contaminant to facilitate uniform enforcement and control, and provide legal certainty to economic operators. The concrete threshold must be based on the specific properties of the restricted substance. The thresholds are an interpretation of the Stockholm Convention that fits into an EU law context.
Is it possible to manufacture, place on the market or use a substance not formulated intentionally with a substance listed in Annex I, but which contains traces of a POP substance above the unintentional trace contaminant threshold set in Annex I to the POPs Regulation?
The manufacturing, placing on the market and use of substances, whether on their own, in mixtures or in articles that contain POPs above the unintentional trace contaminant (UTC) threshold is prohibited, with the exemption of the specific purposes set in the entry for the substance in Annex I, or their use for laboratory-scale research or as a reference standard (Article 4(1)(a)).
Can a substance which is intentionally added to an article in a production process below the unintentional trace contaminant threshold set out by Annex I to the POPs Regulation be considered as an unintentional trace contaminant?

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”.

c) Waste

Is the recycling of wastes containing POPs permitted under the POPs Regulation and the Stockholm Convention?
For waste with a low POP content, other options than destruction or irreversible transformation are allowed under Article 6.1 of the Stockholm Convention. This principle was kept in the POPs Regulation (Article 7(4)(a)) and applies to waste containing or contaminated by any substance listed in Annex IV. 
 
By contrast, and as regards POP substances listed in Annex IV (not waste containing them), Article 7(3) stipulates that disposal or recovery operations leading to recycling, recovery, reclamation or reuse on their own of the substances shall be prohibited. For example, in cases where a process leads to the separation of a substance listed in Annex IV from the rest of the waste, the POP substance has to be destroyed (or irreversibly transformed). Therefore, a distinction has to be made between the POP substance and wastes containing POPs:
 
  1. POP substances on their own have to be destroyed or irreversible transformed (Article 7(3)). 
  2. 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. 
Can a POP substance be recycled if there is an exemption in Annex I that allows the manufacturing, placing on the market and use of that substance?
Operations aimed at recovering POP substances (contained in the waste) listed in Annex IV to the POPs Regulation are explicitly forbidden by Article 7(3), independently of whether an exemption exists under Annex I for the manufacturing, placing on the market and use of the substance.
Specific POPs entries

a) Perfluorooctanoic acid (PFOA)

What substances are included within the scope of the entry for ‘PFOA, its salts and PFOA-related compounds’ in Annex I to the POPs Regulation?

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.

To what substances do the concentration limits of 25 ppb and 1000 ppb apply that are referred to in the first and second point of the PFOA entry in Annex I to the POPs Regulation?

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.

What is meant by ‘textiles for the protection of workers from risks to their health and safety’ in the entry for PFOA in Annex I to 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.

Could you clarify the derogation under the POPs Regulation for fire-fighting foams containing PFOA?
This infographic developed by the German Industrial Fire Protection Association provides an interpretation on the derogation for firefighting foams containing PFOA.
Could you clarify the derogations under the POPs Regulation for medical devices containing PFOA?

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 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. 

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.

Does the derogation referred to in point 3 of the entry of PFOA in Annex I to the POPs Regulation apply to articles?
No. The derogation applies only to substances containing PFOA, its salts and PFOA-related substances as unintentional trace contaminants at a concentration equal or below 20 mg/kg when they are used as a transported isolated intermediate in the manufacturing of fluorochemicals with a perfluoro carbon chain equal to or shorter than 6 atoms, subject to the conditions specified in the entry.
Does the entry on PFOA under Annex I to the POPs Regulation apply to cosmetics?
Yes. Substances included in Annex I to the POPs Regulation shall not be placed on the market or used in the production of cosmetics, unless there is a specific derogation for that purpose indicated in the entry, which is not the case for PFOA.
b) Perfluorooctane sulfonic acid (PFOS)

How is the PFOS definition to be interpreted?
The definition covers any substance containing the PFOS moiety (C8F17SO2) with the potential to degrade to the anionic form C8F17SO3- in the environment. These substances include the acid form of PFOS, the metal salts, the halides and the amides of PFOS. Polymers including the PFOS moiety are also within the scope of the entry.
Why is the notion of "microstructurally distinct parts" indicated for PFOS and what does it refer to?

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.

Why was the threshold concentration for PFOS lowered for substances and mixtures under the POPs Regulation compared to REACH Annex XVII?

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).

Are there any current uses of PFOS in articles below the thresholds specified in the POPs Regulation?

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).

c) Polybrominated diphenyl ethers (PBDEs)

Why are PBDEs listed differently in the POPs Regulation compared to the Stockholm Convention?

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.
 

Why has octaBDE not been added to the POPs Regulation?
Commercial octaBDE is de facto prohibited as it contains BDE-congeners meeting the POP criteria, e.g. hexa- and heptaBDE. However, the specific octaBDE congener does not meet the POPs criteria in its own right. OctaBDE will continue to be restricted under REACH Annex XVII as it meets the PBT criteria.

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