I. Introduction
Per- and polyfluoroalkyl substances (PFAS) are in the regulatory spotlight.Footnote 1 Once heralded for their useful properties, they have been widely used in consumer goods. However, exposure to PFAS has adverse effects on consumers’ health such as an increased risk of infertility in women.Footnote 2 It has been linked to the suppression of the immune system, different types of cancer, thyroid diseases, and reproductive and developmental impairments.Footnote 3 For this reason, governments have been reducing exposure to these chemicals. Authorities in Denmark, Germany, Netherlands, Norway, and Sweden submitted a proposal to the European Chemicals Agency (ECHA) to impose restrictions concerning around 10,000 substances of the PFAS family.Footnote 4 If adopted, this would be the broadest restriction of substances in history.Footnote 5
Despite the regulatory efforts to limit exposure to toxic chemicals, certain products historically present in European households contain PFAS, such as perfluorooctanoic acid (PFOA), associated with endocrine disruption.Footnote 6 PFOA had been used in particular in cookware, such as frying pans, thanks to its resistance to fat and water and non-stick properties.Footnote 7 PFOA has a complicated regulatory history in the EU and worldwide.Footnote 8 Approximately two decades ago, PFOA started being replaced by other chemicals from the PFAS family.Footnote 9 However, some cookware and other products that contained PFOA remained with consumers: for example, the lifespan of a non-stick frying pan is on average 5 yearsFootnote 10 but some pans containing PFOA can still be found on second-hand markets, inherited or in use in European households. Such cookware may not be labelled to indicate whether they were coated with PFOA. Moreover, it is difficult to find consumer-friendly information on PFOA or other PFAS, such as, when manufacturers ceased using PFOA in cookware, or when the last frying pan containing PFOA was placed on the market in the EU. When shopping for new cookware today, some packaging contains labels such as “PFOA-free,” “NO-PFOA” or “Safe Non-Stick.” (as illustrated in Figure 1, see below). Some labels indicate that cookware does not contain perfluorochemicals (PFCS), perfluorooctanesulfonic acid (PFOS), or other PFAS. Others include voluntary producers’ information that they contain GenX coatings, such as ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate (FRD-902)Footnote 11 or PTFE,Footnote 12 both belonging to PFAS. Footnote 13 Shopping around for everyday domestic essentials, it seems as if one chemical of questionable safety is replaced by another.Footnote 14
Figure 1. Images of labels claiming the absence of PFOA in several advertised frying pans.Footnote 15
Employing cookware as a case study, this article examines how European Union (EU) law tackles the issue of toxic legacies in food contact materials. Specifically, it investigates whether EU law provides a basis for the organisation of recalls of cookware by competent authorities. The article examines whether such a basis exists in three regimes regulating the enforcement of obligations relating to food contact materials: EU chemical law, food law, and product safety law. The article identifies overlaps of these regimes that render their systemic interpretation difficult. As a result, a clear legal basis for recall of toxic cookware historically present in European households does not exist. The lack of clear legal basis impacts upon the level of protection afforded by EU legislature concerning health and the environment that emerge after the purchase of products newly identified as toxic based on recent scientific evidence.Footnote 16 Such a level of protection is determined, for example, by responding to consumers’ willingness to know whether PFOA is still used in food contact materials, including cookware, and if so, when it stopped being produced. Establishing a clear legal basis mandating recalls for cookware manufacturers, distributors, or retailers would increase such level of protection.Footnote 17 Conversely, a selective reading of certain provisions governing control and enforcement of health protection may seem to warrant the organisation of recalls. Such reading, although well-intentioned, would however encounter practical hurdles, such as feasibility challenges given the sheer number of affected consumers and products and effectiveness challenges in safeguarding human health. Consequently, the article explores the potential implications and obligations related to waste management that could arise in the absence of a recall obligation. By doing so, this article contributes to the ongoing debate surrounding consumer protection and regulatory governance in the EU as regards PFAS.
II. Recalls in chemical law
Chemicals used in cookware are subject to three regulatory regimes: REACH,Footnote 18 the Persistent Organic Pollutants (POP) Regulation,Footnote 19 and the Food Contact Materials (FCM) Regulation.Footnote 20 These regulations provide for specific pre-market authorisation regimes of substances and materials coming into contact with food. Although they provide for differing regulatory regimes, these may intersect in the case of PFAS. This is because PFAS are specific substances used in food contact materials whose regulation per the POP Regulation follows international harmonisation of the Stockholm Convention.Footnote 21 Those PFAS, which are not regulated by the POP Regulation fall under the general chemical law, i.e. REACH Regulation. If a substance’s authorised use under REACH is subsequently prohibited or otherwise restricted in the POP Regulation, the Commission must withdraw the authorisation for that use under REACH.Footnote 22 Moreover, under the FCM Regulation,Footnote 23 the Commission may draw a list of substances used in cookware authorised for use in manufacturing materials and articles.Footnote 24 Thus, in certain cases, the material scope of these three EU regulations overlaps.
The POP Regulation stipulated that an article containing a prohibited substance could be allowed on the market only when notified by Member States and subsequently by the Commission to the Stockholm’s Convention Secretariat. The Commission made such a notification in February 2024 including the continued use of PFOA in non-stick cookware, pans, and kitchen utensils.Footnote 25 The Stockholm Convention does not require state parties to legislate for recalls of PFOA or other PFAS articles. However, it refers to the polluter pays principle and the precautionary principle, which call for measures to reduce possible releases of regulated substances and eliminate their sources. From these principles, one cannot infer an explicit obligation to recall affected products.Footnote 26 However, state parties can establish recall obligations in relation to old PFOA-coated cookware if these are identified as a source of exposure. For such an obligation to be established, it would need to be mentioned explicitly in the respective annex, for example as ex tunc elimination of uses without exemption unless remaining uses are notified.Footnote 27 An obligation to legislate for recalls of existing products could be in line with the spirit of the convention, which leaves a margin for its implementation.Footnote 28 The existing obligation to eliminate or restrict the use of certain substances concerns only future use; it does not follow from states’ practice that recalls are contained in that obligation. A state practice that did not involve legislating for recalls of PFAS articles or the absence of notification of continuous uses has not been disputed.Footnote 29
The POP Regulation, notably its annexes, is revised by the EU legislature to reflect new amendments agreed in the Stockholm Convention, such as new concentration limits of certain substances.Footnote 30 If a substance is listed in Annex I, it must not be manufactured, placed on the market, and used,Footnote 31 whether on its own, in mixtures, or in articles, unless specific exemptions, such as unintentional trace contaminants, in manufacturing, placing on the market or use apply.Footnote 32 Article 4(2) (first sentence) establishes that for substances added to Annex I after 15 July 2019, prohibitions do not apply for a 6-month transitional period if the concrete substance is present in articles produced before or on the date that substance becomes regulated per the POP Regulation.Footnote 33 Similarly, Article 4(2)(second sentence) establishes that for substances present in articles already in use before the date the POP Regulation came into effect for those substances, prohibitions do not apply (with no temporal limit).Footnote 34 Hence, the marketing and use of articles already produced or in circulation in the Union before or on 4 July 2020 containing PFOA, its salts and/or PFOA-related compounds, is allowed.Footnote 35
The FCM Regulation also provides for a pre-market authorisation procedure for new substances that may be used in the manufacture of materials and articles intended to come into contact with food.Footnote 36 As part of this authorisation procedure,Footnote 37 a safety assessment must be carried outFootnote 38 proving that substances must not release their constituents into food in quantities that could endanger human health under typical or foreseeable conditions of use.Footnote 39 The application of a specific pre-authorisation regime of food contact materials per the FCM Regulation the FCM does not exclude the application of Annex XVII of REACH Regulation.Footnote 40 This Annex sets out restrictions of certain hazardous substances, mixtures and articles for their marketing and use on the EU market, including substances found in food contact materials.Footnote 41 However, unlike authorisations under the FCM Regulation, REACH establishes that the chemical safety report of such substances does not need to take into account risks to human health arising from end uses.Footnote 42 This effectively bifurcates the protection against hazardous substances in food contact materials such as PFAS into two regulatory regimes.
Unlike recalls or withdrawals in product safety and food law, which must be perfected immediately, operators and competent authorities are given time to implement restrictions under EU chemical law. The Stockholm Convention, and the POP Regulation as a matter of the Convention’s implementation, as well as REACH require a socio-economic analysis, which, inter alia, determines the time limit in which a restriction needs to be implemented.Footnote 43 Furthermore, derogations from restrictions for the continuous use of a dangerous substance can be adopted.Footnote 44 These are justified by proving certain economic and technological conditions, such as an essential use, a lack of technically and economically feasible alternatives, and minimisation of emissions. Such derogations as well as any possible future restrictions are subject to continuous risk assessment and data gathering. Importantly, REACH does not contain any provision similar to Article 4(2) POP Regulation which would exclude the application of restrictions from the products already on the market.Footnote 45 On the contrary, alternative solutions are proposed for certain substances, and REACH leaves a certain leeway for the EU as well as Member States to regulate “creatively.”Footnote 46 Member States may, for reasons of protection of human health, restrict, prohibit or create subject-specific conditions for the use of such articles before they are disposed of or reach the end of their service life.
As for a first preliminary conclusion, the POP Regulation is the baseline norm for PFAS regulation in case of implementing the Stockholm Convention amendments, and REACH for all other cases of PFAS regulation, unless the FCM Regulation is not applicable by virtue of the Commission’s implementing regulations. However, these different pieces of legislation may include diverging approaches to products already marketed. If PFAS are considered under REACH, measures can be adopted to prohibit the use of products containing PFAS, not only the use of the substances in products ex nunc.Footnote 47 Regarding enforcement, REACH prescribes that Member States must maintain a system of official controls and other activities as appropriate to the circumstances.Footnote 48 Restrictions should not be conflated with recalls; nevertheless, specific restrictions under REACH may indeed necessitate recalls. This approach is precluded, however, under the POP Regulation which supersedes in cases where a substance is regulated under the Stockholm Convention.
III. Recalls in food law
Within the EU, the General Food Law (GFL)Footnote 49 is the cornerstone of food safety legislation.Footnote 50 To ensure an integrated approach to food safety, there is a broad definition of food law, covering a wide range of provisions with a direct or indirect impact on the safety of food and feed, including provisions on food contact materials, as stated in Recital 11 of the GFL. Its Articles 5 to 10 are the only ones that are horizontally applicable beyond the GFL to all measures taken within the ambit of food law.Footnote 51 None of them, however, refer explicitly to food contact materials.Footnote 52
Despite this limitation, the GFL contains provisions to address responses to food hazards through withdrawals or recalls. These measures, underpinned by Articles 19, 17 and 14 of the GFL,Footnote 53 serve as critical mechanisms for rapidly addressing potential risks posed by food on the market. Whether triggered by contamination concerns or other safety non-compliances, these provisions mandate food business operators (FBO) as well as public authorities to take action in order to ensure a high level of protection of human health and consumers’ interests in relation to food, which is the main aim of the GFL.Footnote 54
If, then, EU food law comprises food contact materials, but corrective measures of Articles 19, 17 and 14 GFL do not apply horizontally, it is questionable to consider recall mechanisms of the GFL as applicable to food contact materials. Certain applicability is evidenced by Articles 50 to 52 GFL as well as IMSOC RegulationFootnote 55 which serve as the basis of the EU Rapid Alert System on Food and Feed (RASFF), a system for notification of health and nutritional risks of foods.Footnote 56 In RASFF, incidents related to food contact materials are also reported, where those which relate to plastic materials and articles in contact with food per Commission Regulation (EU) No 10/2011 count among the most numerous. Footnote 57,Footnote 58 A migration of a food contact material may present a food hazard (e.g. physical, chemical, biological) which triggers an obligation to adopt a measure, such as to withdraw or recall a food. The decision whether to recall or withdraw a food affected by a food contact material depends on whether the food has reached consumers and whether there are no other sufficient measures “to achieve a high level of health protection,” that is, a necessity test.Footnote 59 However, it is evident from RASFF that some notifications concern exclusively food contact materials and not food per se. Also, cases of recalls can be noted.Footnote 60 It is, however, not possible to establish from the system’s interface on which basis the authorities acted in specific cases concerning food contact materials.
This situation of unclear application of the GFL as regards food contact materials is also due to the fact that the FCM RegulationFootnote 61 does not make any reference to the GFL as regards withdrawal or recall obligations. The regulation also does not contain any specific provisions that would require competent authorities or operators to adopt measures in case materials or articles transfer their constituents to food in quantities that could endanger human health. The FCM Regulation, however, imposes specific obligations with respect to the traceability of materials and articles, which are intended to facilitate control, the recall of defective products, consumer information, and the attribution of responsibility.Footnote 62 Article 24 of the FCM Regulation prescribes Member States to carry out official controls in accordance with the relevant Union law. Currently, this is embodied in the Official Controls Regulation.Footnote 63 Article 138 of the Official Controls Regulation lists possible actions in a non-exhaustive fashion that competent authorities are authorised to take in the event of established non-compliance. The competent authorities take measures to ensure that the concerned operator rectifies the non-compliance and prevents further occurrences of such non-compliance. Such measures may include ordering the operator the recall, withdrawal, removal, and destruction of goods.Footnote 64
This is similarly stated in Article 17 GFL concerning the responsibilities of Member States. However, in the GFL, recalls ordered by the authorities are subsidiary to those carried out by FBOs Footnote 65,Footnote 66 (i.e., when the FBOs do not start taking action by themselves or their action is not appropriate to the circumstances). The GFL does not contain an explicit provision that empowers the authorities to “impose” obligations or to “order” a recall, although they have this faculty, indirectly mentioned in Article 50(3)(a) GFL.Footnote 67 In the GFL, enforcement is a broad term that encompasses a “system of official controls and other activities,” as well as measures and penalties that are “effective, proportionate and dissuasive.”Footnote 68 Under this wording the GFL frames national and EU enforcement laws, providing a wide umbrella for competent authorities to organise or order recalls in case operators fail to take action to achieve a high level of protection. In fact, Articles 19, 17 and 14 GFL prioritise withdrawals or recalls initiated by food business operators over those mandated by competent authorities.Footnote 69 This is a different approach than the one explicitly permitted by the Official Controls Regulation.
In addition to the GFL provisions on recall, the Official Controls Regulation also contains provisions in this regard. Indeed, it is also noteworthy that the Official Controls Regulation prescribes a different test for measures, including recalls, which is based on the notions of “appropriateness,” “nature of non-compliance” and operator’s history with regard to compliance, compared to the one laid down in the GFL.Footnote 70 Although the nature of non-compliance may be a factor in the necessity test under the GFL, the nature of non-compliance alone does not imply that various measures need to be analysed and ranked according to their effectiveness. In other words, while the nature of the non-compliance may include hazard and risk characterisation, it does not imply that a recourse to recall is only possible where other means cannot achieve the same level of protection. Secondly, the history of the operator’s actions in a situation of non-compliance is not mentioned in the GFL and the FCM Regulation. Furthermore, some measures that the competent authorities may take, such as the destruction of goods,Footnote 71 may be more severe than recalls from the perspective of operators. This consideration could also overhaul the necessity test in the GFL. It is, therefore, questionable whether Article 19(1) GFL should be or could be applied cumulatively to Article 138(1) of the Official Controls Regulation as regards food contact materials or whether the Official Controls Regulation functions as a lex specialis to Article 17(2) GFL as regards food contact materials but not as regards food in contact with hazardous food contact materials.
As for the second preliminary conclusion, despite EU food law comprising food contact materials, the necessity test applicable to recalls under the GFL would likely not be used for recalls of food contact materials. It would only be applicable where the food’s safety is directly affected by the material in contact with that food. Such food can be withdrawn or recalled because of migration of a food contact material containing substances above the limits set by the Commission’s implementing regulation. Instead of the GFL, the test under the Official Controls Regulation would likely apply as lex specialis, as a legal instrument to enforce provisions of the FCM Regulation. However, the Official Controls Regulation may be only applicable to enforce general requirements for the manufacture (and not use or placing on the market) of food contact materialsFootnote 72 or specific measures adopted by the Commission for the groups of materials and articles listed in Annex I FCM Regulation.Footnote 73 This would also suggest that a recall of hazardous food contact material would not be considered ultima ratio but a more permissive test based on appropriateness, nature of non-compliance and operator’s history. In the case of PFAS, this is tentatively supported also by the specific nature of the risk exerted by persistent pollutants, such as PFAS, which may typically materialise after the recall. If recalls are conceived as a last resort, the high level of health protection may not be guaranteed in light of the nature of the risk present in PFAS food contact materials. With a more permissive test, a recall may be justified upon the assumption of a continuous risk, increased by the passage of time and the use of food contact material. This may require the application of the precautionary principle to establish proper justification of the recall decision. Nonetheless, it is difficult to establish that the reference to the Official Control Regulation in the FCM Regulation is the vehicle for the enforcement of POP Regulation or REACH Regulation-based limits of substances used in food contact materials.
IV. Recalls in product safety and liability
1. Defective products
The FCM Regulation imposes traceability obligations on operators with respect to the “recall of defective products.”Footnote 74 Nonetheless, this provision is the only place where the term “defective products” is used in that regulation, which leaves room for interpretation as to what constitutes a “defective” food contact material.Footnote 75 The GFL stipulates that the provisions of Chapter II “General Food Law” are without prejudice to Product Liability Directive.Footnote 76 , Footnote 77 This creates additional ambiguity in determining whether the legal framework for addressing non-compliant food contact material should be qualified as a food law (bearing in mind Recital 11 GFL and horizontal applicability of certain provisions) or as being part of the product safety regime. This lack of clarity is apparent in the reporting of incidents related to food contact materials in RASFF as well as the Rapid Alert System for Dangerous Non-Food Products (RAPEX).Footnote 78 RAPEX is a European databaseFootnote 79 that reports dangerous products, which come into contact with food and do not comply with the current General Product Safety Directive or any other sector specific regulation, notably with both REACH and POP Regulations.Footnote 80
By virtue of Article 21 GFL, and the notion of “defective products” used by the FCM Regulation, the Product Liability Directive is applicable to the food law regime as well as to the general product safety regime. Article 6 of the Product Liability Directive considers a product as defective when it does not provide the safety a person is entitled to expect, taking into account, inter alia, the time when the product was put into circulation.Footnote 81 This invites multiple interpretations, one of which is hinted at in Article 7 of the Product Liability Directive.Footnote 82 Accordingly, producers may avoid liability by proving, for example, that the state of scientific and technical knowledge at the time could not have detected the defect, Footnote 83 including hazard and risk identification and characterisation. Notably, the Product Liability Directive applies solely to products that caused damage, rather than to products that exert risk.Footnote 84 Thus Article 6 of the Product Liability Directive, ratione temporis, provides for a limited scope of the notion of “defective product”; for this reason, neither the Product Liability Directive nor the FCM Regulation may be applicable in most cases, such as the present example of PFAS-containing cookware. Such a reading would however render the application of the Official Controls Regulation ineffective.
2. Presumption of safety
The scope of the notion of “defective product” under the Product Liability Directive can be contrasted with the presumption of safety of products under the General Product Safety Directive,Footnote 85 where a product is deemed to be safe if it complies with safety requirements set out by specific EU law.Footnote 86 The General Product Safety Directive introduced a broad definition of a safe productFootnote 87 as a product which does not present any risk or only the minimum risk compatible with the product’s use, considered to be acceptable with a high level of protection for the safety and health of persons (not the environment).Footnote 88 Both the presumption of safety of products as well as the concept of safe product remain the same under the recent General Product Safety Regulation (GPSR),Footnote 89 which will replace the General Product Safety Directive from 13 December 2024 onwards. Food has been explicitly excluded from the scope of the GPSR,Footnote 90 whereas food contact materials are explicitly covered by the regulation, insofar as risks concerned are not covered by the FCM Regulation or “by other food-specific legislation which only covers chemical and biological food-related risks.”Footnote 91 If the FCM Regulation nor the GFL are applicable, as explained above, the GPSR applies to food contact materials. The new GPSR provides for some important changes to the product recall regime, including its applicability to products covered by EU harmonisation legislation “to the extent that there are no specific provisions with the same objective in such Union harmonisation legislation” (as a general clause).Footnote 92 One of the noteworthy features of the newly enacted GPSR in this sense is that it has empowered competent authorities to employ all appropriate measures in instances where evidence suggests that, despite the initial presumption, the product is dangerous.Footnote 93 , Footnote 94
3. Discretion of national competent authorities under the GPSR
The GPSR therefore provides wide discretion to competent authorities to determine whether products are dangerous despite their conformity with the law in cases where products are suspected to be dangerous. The authorities may, for example, be considering evidence of hazards resulting from long-term exposure that goes directly against the standard to which a product conforms, as well as to consider a time dimension in the appreciation of “normal or reasonably foreseeable use” in the risk analysis. Under such considerations, a food contact material with long lifespan may change its characteristics over time;Footnote 95 for example, the propensity for migration of dangerous substances from the pan into the cooked food may increase. Such factors could pose an augmented risk rendering the product “unsafe.”Footnote 96 Statements such as “do not scratch” are often attached onto cookware packaging because scratching a frying pan is likely to increase exposure to PFAS substances.Footnote 97 Under the GPSR, any warnings and instructions for safe use of a product and disposal must be taken into account when assessing whether a product is safe.Footnote 98 Additionally, the GPSR contains a specific provision on the obligation to cooperate with market surveillance authorities, including to provide upon request a description of the risk presented by the product and any corrective measures taken to address that risk.Footnote 99 These considerations could have an important bearing on the assessment of safety of PFAS-containing food contact materials but it is difficult to predict in which way they would struck: whether, in a particular risk analysis, a warning on a food contact material is sufficient to lower a risk or, on the contrary, whether a particular warning is not susceptible to lower the risk.
4. Market Surveillance Regulation as lex specialis?
Currently, alongside the General Product Safety Directive, Regulation (EU) 2019/1020 on market surveillance and compliance of productsFootnote 100 (Market Surveillance Regulation) also applies to the POP and REACH Regulations. Recital 5 suggests that Market Surveillance Regulation is lex specialis to the General Product Safety Directive as regards different measures authorities may take in relation to dangerous products. This could change with Recital 60 of the new GPSR, which brings the two instruments into line and strives to create a coherent legal framework for market surveillance of products, both covered and not covered by Union harmonisation legislation. That recital prescribes application of certain articles of the Market Surveillance Regulation to products covered by the GPSR.
These include various provisions concerning enforcement measures taken by the authorities or operators. For example, as for the authorities, they must take appropriate and proportionate measures where the operator fails to take a corrective action:Footnote 101 (a) they have the power to require operators to take appropriate action to bring an instance of non-compliance to an end or eliminate the risk presented by the productFootnote 102 ; (b) they have the power to take appropriate action when an operator fails to take adequate corrective action or when non-compliance or risk persistsFootnote 103 , including the power to prohibit or restrict the marketing of a product or to order its withdrawal or recall.Footnote 104 Furthermore, a corrective action may include alerting the public to the risk presented, destroying the product or otherwise rendering it inoperable.Footnote 105 If a product presents a serious risk,Footnote 106 it must be withdrawn or recalled, where there are no other effective means available to eliminate the serious risk, or its marketisation must be prohibited.Footnote 107 Therefore, under the Market Surveillance Regulation, the recall obligation is subject to the interpretation of “seriousness” of a risk, that may entail such factors as health effects, the probability of effects materialising, the number of affected people and products, the estimated average product life, doses and the possibility of mix of substances to create “toxic cocktails.”Footnote 108 Here, according to the new GPSR, serious risk is considered to require rapid intervention by the market surveillance authorities, including cases where the effects of the risk are not immediate.Footnote 109 This phrasing may be read to render market surveillance authorities’ discretion more favourably in support of an obligation to interfere.Footnote 110 Depending on the particular risk assessment, competent authorities may perceive PFAS-coated food contact material as highly risky and order its recall. Furthermore, the products that have been deemed to be dangerous on the basis of a decision of a market surveillance authority in one Member State shall be presumed dangerous by market surveillance authorities in other Member States. In case different Member States may reach divergent conclusions, divergent risk assessment may be now referred to the Commission by any Member State, requesting its opinion on the matter.Footnote 111 Under the GPSR, products presenting serious risks may also warrant a Union action implemented via implementing regulations of the Commission. Such an action may include any appropriate measure “adapted to the gravity and urgency of the situation” if the risk cannot be dealt with by other procedures laid down by the specific Union law applicable to the products concerned and can only be eliminated effectively by the adoption of such measures.Footnote 112
As a third preliminary conclusion, a PFAS-coated food contact material would not become defective by virtue of setting concentration limits per the POP Regulation or REACH. It would be presumed to be safe per the General Product Safety Directive (soon Regulation). However, in the absence of the concentration limits or above such concentration limits, the product would not enjoy such presumption of safety. A PFAS-coated food contact material present, for example, in cookware could be considered not safe given new scientific evidence not yet incorporated in sector-specific legislation just as the POP Regulation or REACH. In that case, producers and distributors may organise recalls or be ordered to do so by competent authorities. As for the more specific measures available to competent authorities under the Market Surveillance Regulation, a recall of a product is linked to the assessment of seriousness of a risk exerted by the product. If competent authorities regard PFAS-coated food contact material as highly risky, they must consider its recall. Similarly, under the new GPSR, where a manufacturer considers or has reason to believe, on the basis of the information in their possession that a product which is placed on the market is a dangerous product, the manufacturer must immediately take a corrective action including recall, as appropriate.Footnote 113 This obligation is reinforced by the requirement placed on competent authorities to focus on the scrutiny of internal conformity procedures of the operators, in addition to traditional market surveillance activities,Footnote 114 as well as to take appropriate measures where the operator fails to take a corrective action.Footnote 115 There is no obvious hierarchy of action of an operator versus a competent authority similar to the GFL.Footnote 116
V. Disposal of non-recalled cookware containing PFOA
Given that operators carry out a risk analysis internally and assess the level of “seriousness” and “necessity,”Footnote 117 the question arises as to what happens if the operators do not order the recall of the products and neither do the competent authorities. There is no immediate link between risk and action, but whatever action is taken, it must be with a view towards proportionality and effectiveness. In the event a product (e.g., a frying pan) is not recalled, only some of the consumers will eventually become aware of the health risks that may be associated with cooking in it.Footnote 118 As pointed out above: most of the obligations of both the actors in the supply chain (ex Articles 32, 33, and 34 REACH) and downstream users (ex Article 38 REACH) to provide information on substances and mixtures or substances in articles (e.g., frying pan containing a substance) cease to exist as soon as the product is made available to consumers. In addition, there is no obligation to inform consumers of all the chemicals present in the product often because of confidential industry information. However, the frying pan could contain a substance for which (1) the potential adverse effects are not yet known; or (2) the risks are known but the substance is present below the maximum concentration limits; or (3) the risks are known and the substance is present above the maximum concentration limits because the concentration limit was higher or did not exist at the time when the article was first placed on the market. That said, there is little chance that the consumer could reasonably know that the frying pan in their possession contains these substances and that using it could endanger their health. If the consumer comes to know of the frying pan’s characteristics,Footnote 119 he or she can decide to dispose of the frying pan. As soon as the frying pan is discarded, it is considered waste and not a product, with corresponding changes in the applicable legal regime.
In the EU, Directive 2008/98/EC on wasteFootnote 120 and POP Regulation,Footnote 121 among other legislationFootnote 122 regulate the disposal of food contact materials containing POPs. Directive 2008/98/EC, the Waste Framework Directive (WFD), is the main EU legislation regulating waste management. It aims to reduce waste, promote reuse, and recycle, with a view to protect human health and environment, as well as to contribute to a circular economy,Footnote 123 and to the environmentally sound disposal of hazardous waste that is not to be reused.Footnote 124
The WFD defines “waste” in Article 3(1) and distinguishes between “waste” and “hazardous waste.” “Waste” is “any substance or object which the holder discards or intends or is required to discard.” This concept has been widely interpreted by the CJEU, establishing criteria to determine whether a substance or object, including materials, is to be considered as waste.Footnote 125 The holder’s behaviour is a key factor, leading to a distinction between subjective waste (voluntary disposal) and objective waste (compulsory disposal). Bearing this in mind, the concept of “intentionality” is crucial, as an item may be (still) considered a product or (already) waste, based on the holder’s intention. However, intention depends on each individual case and its interpretation may differ from one Member State to another.
Imagine three houses next to each other on the same street, in each of which a frying pan is left in the garage. However, in house A, a family living there does so with the intention to throw it away as waste; in house B, a family intends to sell it later as a second-hand item; in house C, a family intends to keep using it again, however it does not fit in their small kitchen. This example illustrates that, given the same factual situation (leaving a frying pan in a garage), the intention of each of the families living in these three imaginary houses differs. In the light of such interpretative difficulties and factual conundrums, the CJEU emphasised that, in assessing whether a substance or object is waste, all the circumstances of the individual case must be considered, taking into account the objective of the WFD and being careful not to undermine its effectiveness.Footnote 126 Therefore, it will fall to the national judge to determine the real intention, for which a number of indicia exist,Footnote 127 but a unified definition lacks.Footnote 128 Similar factual situations may render different legal status for the same product. Returning to the imaginary case, the frying pan would still be considered a product of use in houses B and C, and as such would be subject to recall obligation. On the other hand, the frying pan would be considered as waste in house A, so the recall obligation would be extinguished and other obligations under waste legislation would arise.
Once the frying pan is considered as waste, its subsequent treatment depends on its classification. If the frying pan contains PFOS it could be considered as hazardous waste.Footnote 129 This includes waste that contains one or more substances toxic to reproduction at or above one of the concentration limits listed in Table 7 of Annex III of the WFD. Since PFOS, a class of PFAS is classified as Repr. 1B in Annex VI of the CLP Regulation,Footnote 130 a frying pan containing PFOS could be legally considered as hazardous waste, but not necessarily.
It follows from the above that in the case of a food contact material such as a frying pan containing in particular PFOS, the general waste rules apply if the limit values in Table 7 are not equalled nor exceeded. In case such limit values are equalled or exceeded, Article 2(4) of the WFD allows for specific rules on the management of particular waste categories. This leads to the application of Article 1 of the POP Regulation, which stipulates specific provisions for waste consisting of, containing, or contaminated by POPs. On the other hand, two specific rules may concurrently apply, as illustrated by the recent Regulation (EU) 2022/1616 on recycled plastic materials and articles intended to come into contact with food which applies exclusively to recycled plastic.Footnote 131 A collision between regulations could occur if packaging made from recycled plastic contains or is contaminated with a substance identified as a POP.Footnote 132 To make things more entangled, a proposal for a regulation on packaging and packaging waste as currently debated in the legislative process proposes to prohibit any food contact packaging containing intentionally added PFAS from being placed on the market 18 months from the date of entry into force of the regulation, as a matter of a lex specialis.Footnote 133 Considering that a frying pan is usually made of aluminium, steel, iron or copper, it may be also considered “municipal waste,”Footnote 134 which definition includes mixed waste and separately collected waste from households, including paper and cardboard, glass, metals, plastics, bio-waste, wood, textiles, packaging, etc.Footnote 135 Thus, PFOS-containing frying pans could be considered at the same time both “municipal waste,” as well as “hazardous waste.” As a result, the way in which this waste is disposed of, collected, and further treated will be determined by these classifications.
In terms of how and where to dispose of a frying pan, consumers need to locate the nearest waste facilities. These are places where appropriate procedures should be in place to manage incoming hazardous waste. In relation to how the frying pan is collected and treated is in the hands of the various waste management operators, their task also seems to be challenging, because the difficulty of traceability remains at this stage. However, it is important for them to know whether the waste in question is hazardous, because depending on this classification, the waste must be treated in a special way.Footnote 136 On this point, the POP Regulation lays down specific requirements for the management and disposal of POPs. Notably, Article 7 outlines the conditions for waste management in connection with Annexes I, IV and V, all of which include PFOS. The Article lists several requirements for the disposal of waste containing or contaminated with POPs, with an emphasis on disposal or recovery operations that ensure the destruction or irreversibly transformation so that the remaining waste and releases do not exhibit the characteristics of POPs.Footnote 137
Under Article 20(1) of the WFD, EU Member States are required to set up a separate collection scheme for household hazardous waste fractions by 2025. This provision aims to ensure proper treatment in accordance with the waste hierarchy (Article 4) and to protect human health and the environment (Article 13) while preventing contamination of other municipal waste streams. Irrespective of whether this new scheme is established, its practical feasibility will probably be hindered by the persisting problem of traceability, which is likely to continue to challenge the performance of waste management.
As a fourth preliminary conclusion, non-recalled products that become waste and are considered hazardous waste due to their reprotoxic properties, as well as products of household origin, need to be managed and disposed of in an environmentally sound manner. For this purpose, the Member States must take measures to encourage the options that deliver the bestFootnote 138 overall environmental outcome.Footnote 139 However, the current labelling and identification regime for these products represents an impediment in terms of traceability, which could hinder both corrective actions, in the event of an effective consumer recall when the item was still a product, and waste management once the item has already become waste. This ultimately puts the environment and consumers at risk, calling into question the regulatory effectiveness of these various EU regulations, which have as their primary self-proclaimed objective the protection of the environment and human health.Footnote 140
VI. Economics and effectiveness of recalls and waste collection
One of the key questions in the context of recalls is whether a recall is effective, i.e. whether recalls successfully remove potentially harmful or defective products from the consumer’s use. Once having eventually overcome the difficulty in establishing the obligation to recall, the next obstacle is to enforce it. The crucial question to be asked by competent authorities revolves around the feasibility of recalling potentially millions of food contact articles, such as cookware, from the EU market.Footnote 141 In case of a theoretical recall obligation of historical articles containing food contact materials surpassing current PFOA (or other PFAS) limits, effectiveness could be measured by the current level of consumer awareness and participation in a recall (through actual return rates); risk perceptions of the recalled product (e.g. from the number of customer complaints); level of awareness about the recall among other businesses in the supply chain, including online platforms; or levels of safe reworking/destruction.Footnote 142
However, effectively conveying information to consumers can be challenging, especially in the case of PFAS-coated cookware. Challenges include ensuring that consumers know that the information provided relates to the products they own. This is exacerbated by difficulties in identifying and tracing the product in violation of Article 17 FCM Regulation.Footnote 143 Such difficulties are linked to the practice of businesses to frame the information provided on cookware’s labelling in negative (e.g., “PFOA-free”) rather than positive terms (e.g., “This product contains PFAS”). Furthermore, the traceability information is usually included on the packaging, as the FCM Regulation provides a choice as to where to attach the mandatory information,Footnote 144 and it is reasonable to assume that consumers discard the packaging shortly after the purchase. To avoid this difficulty, warning labels or improved instructions of safe use can be added to the product.Footnote 145 It may be also remembered that REACH gives consumers certain rights, such as to ask the operator about the information concerning the safe use of the product.Footnote 146 Moreover, per Article 11 POP Regulation, the Commission, ECHAFootnote 147 and Member States are mandated to promote awareness programmes for regulated substances, such as PFOA, targeting policy- and decision-makers and particularly vulnerable groups. Notably, although there is an emphasis on promoting the provision of information to the public,Footnote 148 the POPs Regulation does not explicitly mention the “right to information”Footnote 149 as the REACH Regulation. Another possibility is to provide consumers with information that certain products exceed newly established PFAS levels, although, as a matter of law, the set levels apply only to the products not yet marketed. But even with this information, it may be nearly impossible for consumers to determine whether their product is part of the batch affected by the risk in question. In this regard, it may be noteworthy that the GPSR states in its recitals that “the information about the identification of the product and of the economic operators, as well as instructions and safety information, could in addition be provided by the economic operators in a digital form by means of electronic solutions, such as a QR or data matrix code.”Footnote 150 Such requirements “could be made stricter” in the case of products likely to present a serious risk “by [implementing] a system of collection and storage of data enabling the identification of the product’s components,Footnote 151 although it is hardly conceivable how this could be perfected without the a priori knowledge of such risk at the time of the production. With that information, it would also be possible to carry out “targeted recalls.”Footnote 152 However, the problem of product information vis-à-vis emerging new risks and risks in certain grey zones, i.e. awaiting regulatory action due to the emerging body of evidence as to their gravity, remains. In order to improve recall effectiveness even further, “consumers should be encouraged to register products” in order to be directly notified about recalls, and the Commission is supposed to adopt implementing acts to that purpose; however, given their lifecycle, it is likely that food contact materials will constitute a category of products for which such a requirement is installed.Footnote 153
A recall involves considerable economic costs. The cost distribution will affect the risk aversion of producers or other supply chain actors putting products into circulation. In this respect, the GPSR highlights that operators have differentiated responsibilities depending on the role they play in the supply chain.Footnote 154 Economic operators initiating a product recall are expected to offer consumers at least two options between repair, replacement, or adequate refund of the value of the recalled product, except where impossible or disproportionate.’Footnote 155 Remedies offered must be effective, cost-free and timely, without a time limitation to activate the remedy.Footnote 156 In the case of food contact materials, replacement or adequate refund could be only two options realistically considered. These could be coupled with additional incentives to motivate consumers to participate in a recall, such as vouchers, discounts, or complementary products. While the regulation reasons that, “offering consumers a choice between remedies can improve the effectiveness of a recall,”Footnote 157 it could be subject to interesting behavioural research whether consumers would opt for PFAS-free cookware from the same producer or a refund.Footnote 158 Recalls could benefit the food business operator’s reputation by demonstrating their responsibility to consumers.Footnote 159 If consumers largely stick with the operator’s brand, a recall could be beneficial to the operator’s reputation. Marketing measures may therefore complement the recall obligations and soothe its economic (reputational) impacts. Also, recalls could be incentivised by economic subventions if replacements can be shown to be free of risks.Footnote 160 Such subventions could align the precautionary principle with the support for innovation, offering precautionary consumer protection while providing a means of introducing new (higher quality) products to the market.Footnote 161 Also, customers are affected due to trust issues and economic considerations potentially resulting in participation as well as non-participation in the recall.Footnote 162 Therefore, remedies offered in case of recalls cannot place an excessive burden on consumers.Footnote 163 According to the new GPSR, it is best to contact the affected consumers directly, and operators must, “use any customer data already at their disposal to inform consumers of recalls and safety warnings.”Footnote 164 However, consumers must agree to such contact before, either at the time of the purchase or entering into a loyalty programme. Therefore, despite targeted recalls, operators should make all their customers aware of the recall notice.Footnote 165 Moreover, the effectiveness of a recall may depend on the share of the cost of the recalled product in the average household income. If the recalled product costs only a small fraction of a consumer’s monthly income, it could make it difficult for the consumer to cooperate in the recall of the product, as substituting the product with a new purchase would be the preferred option. Also, if a consumer needs to invest a significant time and resources to participate in the recall (i.e., finding out how, where and when, placing the recalled product, collecting the replacement, etc.), he or she may tend to just purchase a new product and dispose of the old one. On the other hand, if the recalled product costs a significant fraction of a consumer’s monthly income, this could make it difficult for the consumer to cooperate in the recall of the product, if a replacement product is not provided. This could presumably be exacerbated by the fact that, according to behavioural economics, consumers appear to have an emotional attachment to products they already own.Footnote 166
However, the question is also one of who is responsible for acting in the event of risk present in a food contact material. If authorities are mandated to intervene, initially by ensuring compliance from operators and subsequently by implementing their own measures, it prompts further questions on whom (which operators) they impose corrective measures. An obvious answer would be on operators who violated a general requirement not to place on the market a dangerous product, i.e. persons who brought the product into circulation. If however such persons are no longer existing, such obligations remain unenforceable. Consequently, competent authorities may take charge by orchestrating recalls, running information campaigns, ordering retailers to retrieve recalled products for compensation and even providing compensation directly to consumers themselves. However, one may query whether these actions resemble more policy interventions rather than corrective measures outlined in the Market Surveillance Regulation or the GPSR. The challenges related to traceability and the considerable costs with organising recalls, particularly of cookware tainted with toxic PFAS raise significant doubts about the feasibility of such recalls in that context.
Therefore, where recall serves as a last resort, there may be alternative corrective actions available.Footnote 167 One must be also mindful of the opportunity costs of using resources for a recall rather than other activities that may yield better health or environmental outcomes, e.g. consumer information campaigns, pricing, and subvention strategies that incentivise consumers to buy new products without health risks, such as PFAS-free pans, or swap old cookware for new one. In order to fully assess the effectiveness of recalls, the costs and benefits of recalls coupled with a disposal of the recalled product as a remedy should be weighed against any costs and benefits associated with a system of waste collection of hazardous products that would normally be recalled, yet, are now subject to special waste treatment. In the case of PFAS, an inspiration for analysis can be found in the EU rules on treating waste electrical and electronic equipment.Footnote 168 Furthermore, it must be acknowledged that generic risk assessment opens way to imposing restrictions on many thousands of substances, potentially affecting millions of products simultaneously.Footnote 169 If such a restriction would not exclude its applicability to the products already marketed, it is important to revisit the question of the feasibility of potential recall of dangerous food contact materials. A potential answer could be found in prioritising Union action concerning seriously dangerous products per Article 28 of the GPSR.
VII. Conclusion
The POP Regulation serves as the fundamental standard for regulating PFAS. Concerning food contact materials, EU food law can only trigger recalls under the GFL if the safety of the food is directly impacted by the material in contact with it. Instead of relying on the GFL, the Official Controls Regulation would likely apply as the lex specialis, functioning as a legal instrument for enforcing provisions outlined in the POP Regulation or REACH. Consequently, a recall of PFAS-containing food contact materials would not be viewed as a last resort, but rather as a more permissive measure based on appropriateness, the nature of non-compliance, and the operator’s track record.
However, if recalls are perceived as a last resort, the level of health protection may not be adequately guaranteed, especially considering the inherent risks associated with food contact materials, such as those posed by PFAS. Specifically, these risks often manifest after the recall, assuming a continuous and increasing risk over time with the continued use of the food contact material. In such cases, the precautionary principle may need to be invoked under the necessity test to justify the recall decision properly.
Setting concentration limits per the POP Regulation or REACH would not render a PFAS-coated food contact material defective. It would still be presumed safe under the General Product Safety Directive. However, in the absence of concentration limits, this presumption of safety would not apply. For instance, a PFAS-coated food contact material, like that found in cookware, might be deemed unsafe due to new scientific evidence not yet incorporated into sector-specific legislation like the POP Regulation or REACH. In such instances, under the Market Surveillance Regulation, producers and distributors may initiate recalls or be mandated to do so by competent authorities, but only as resorted to the risk is serious enough.
It is worth noting that the POP Regulation restricts the application of PFOA limits to articles already on the market, creating a presumption of the safety based on temporal limitations. Nevertheless, this presumption of safety can pose problems, as exemplified by PFOA frying pans. It fails to adapt to evolving scientific knowledge and can jeopardise public health and the environment. Moreover, it is crucial to underscore that different pieces of legislation, such as the POP Regulation and REACH, may adopt distinct approaches to articles already in circulation. If PFAS are addressed under REACH, measures can be implemented to prohibit the use of articles containing PFAS, not just the use of the substances in articles going forward. As for the current state of the FCM Regulation, it lacks meaningful provisions for regulating recalls or PFAS used in food contact materials.
Although setting concentration limits per the POP Regulation or REACH would not render a PFAS-coated food contact material defective, it may render it hazardous once a product becomes waste. Consequently, the applicable legislation changes as well. Several pieces of EU legislation ensure that products classified as hazardous waste, due to their reprotoxic properties or originating from households, are managed and disposed of in an environmentally responsible manner. Article 4(2) of the WFD mandates Member States to promote options that yield the best overall environmental outcome. This results in the paradoxical situation that millions of products containing PFAS enter a grey zone, whereas they are left to free circulation due to the temporal limitations of newly established maximum concentration limits, yet with the mere intention of a consumer to dispose of such products, they would be considered hazardous. However, Member States cannot recall anything considered waste, even hazardous. This situation ultimately jeopardises the environment and consumer safety, casting doubt on the regulatory effectiveness of these various EU regulations, which profess to prioritise environmental and human health protection.
Acknowledgments
CRO acknowledges funding from the University of Lleida, linked to the project “Public Health in Transformation: Disinformation, Food and Climate Change (SPenT)” (PID2019-107212RA-I00), funded by the Spanish Ministry of Science and Innovation; KP and AM acknowledge funding by the Deutsche Forschungsgemeinschaft (DFG), grant agreement 465588286, by the Oberfrankenstiftung, grant agreement No. FP00535, as part of the project “Regulating Food Innovation - Technical Innovation requires Regulatory Innovation” conducted at the Chair of Food Law at the University of Bayreuth.
Competing interests
The authors declare no conflicts of interest.
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