'Food imitating products' and 'child appealing products' can cause serious risks to vulnerable segments of the population - i.e. infants and children, elderly people and people with mental disabilities - which the General Product Safety Regulation (EU) No 2023/988 can help prevent and manage more effectively than the previous legislation. Provided that importers and manufacturers of 'non-food products' - as well as physical and digital 'retailers' - become aware of this.
1) 'Food imitating products', EU rules
Food Imitating Products Directive 87/357/EEC (FIPD) regulates the so-called 'food-like', defined as objects which 'although not being food products, have a shape, odour, appearance, packaging, labelling, volume or size such that consumers, especially children, are likely to confuse them with food products and therefore they put them in their mouth, suck them or ingest them with consequent risk of suffocation, intoxication, perforation or obstruction of the digestive tract'. (1)
The 'food-like' ('food imitating products') cannot be imported, manufactured and marketed in the European Union, nor exported to third countries. Member States are responsible for organizing and carrying out official controls on their territories. (2) Among the most common objects that fall into this category are cosmetics and household cleaning products, detergents and other liquids for technical use, furnishing elements (i.e. candles and furnishings), stationery (i.e. erasers).
2) The deceptions of the brain
Poisonings and choking caused by the ingestion of 'food imitating products' are much more widespread than one might believe, although their cases are much less visible in the 'media' than other accidents (ie food poisoning, road accidents). Why?
Some scientific studies (Basso F. et al., 2014, 2016) – based on research at poison control centers and subsequent behavioral experiments – suggest that 'food imitating products' can trigger inferences, at a brain level, stimulated by the influence of sight and other senses (ie smell, touch). (3)
The similarities of packaging - first of all in the shape, as well as in the labels, due to colors and images - are the first elements to induce an 'implicit association' between 'food' and 'non-food'. This is the case, for example, with the involuntary ingestion of shampoo or detergents (3,4).
3) SCCS scientific opinion (2011)
SCCS – Scientific Committee on Consumer Safety, European Commission – published a scientific opinion (2011) on the potential risks linked to the presence of chemical substances unsuitable for ingestion in 'food imitating products' (or 'consumer products resembling foods', CPRF) . With specific considerations on the widest range of products with characteristics capable of attracting children ('child-appealing properties', CAP). (5)
3.1) Elements of similarity
The 'food imitating products', by virtue of their characteristics, present a risk of ingestion not only by children, but also by elderly people and/or people with disabilities or mental fragility. At the time of publication of the SSCS opinion, however, dedicated studies such as those cited in the previous paragraph 2, which are the first ever on this specific research area, had not yet been published.
The 'child-appealing properties', on the other hand, can be influenced by a plurality of subjective factors whose analysis is much more complex. Children can in fact also be easily influenced by external factors, where the similarity of packaging and labels is accompanied by references to images of cartoons or TV characters, as already happens with 'junk food'. (6)
3.2) Determinants of adverse effects after ingestion
The SCCS committee identified – among the most involved household cleaning products, often causing poisoning – dish, cloth and bathroom detergents, bleach (sodium hypochlorite), as well as soda, alcohol and hydrogen peroxide (hydrogen peroxide).
The danger of ingestion of the product is linked to factors such as the concentration of the active substances and the pH (as an index of corrosivity), together with the contact time and the physical state of the products (i.e. solid/liquid, viscosity). The main risk factors are summarized as follows:
– harmful ingredients. Corrosive substances (e.g. acetic, nitric, sulfuric acid, sodium hypochlorite, sodium hydroxide), surfactants, alcohols and glycols (e.g. ethanol, isopropanol, butylene glycol), essential oils (e.g. pine oil, camphor),
– dangerous properties of the formulations. PH, with single acute exposure for products that have values > 9 (basic) and < 3 (acid), and viscosity. Low viscosity combined with high acidity can damage the gastro-intestinal tract, while high viscosity combined with high basicity stimulates regurgitation with an increased chance of lung damage from aspiration (due to foaming potential).
Serious uncertainties concern the risks linked to other ingredients (eg dyes, plasticizers, polymers), which can cause similar symptoms or even nausea and vomiting after ingestion, regardless of pH and viscosity.
3.3) Most probable risk circumstances
The risk of exposure to 'food imitating products' and 'child-appealing properties' may increase, according to SCCS, in relation to the following factors:
– socio-economic status. Precarious living conditions can lead to greater carelessness. Although cases are also recorded in more affluent contexts,
– inadequate supervision. As far as children are concerned, the lack of attention on the part of adults is generally associated with a greater risk of accidental poisoning, even if direct evidence is not established with absolute certainty,
– the low perception of risk adds to the above factors.
Further factors, in the elderly, are linked to the alteration of sensory perceptions which do not allow the 'inputs' of sight and taste to be correctly perceived.
3.4) Most observed adverse effects
Cases of ingestion observed mainly in children and the elderly, based on observations from national poison centers, have not been of high severity (i.e. fatal). Among them there are various symptoms, such as:
– gastrointestinal (e.g. vomiting, abdominal pain),
– neurological (e.g. alteration of consciousness, hypotonia, ataxia, convulsions),
– skin (e.g. skin rashes),
– respiratory (e.g. dyspnoea, cough),
– dysphagia.
The presence of surfactants, emulsifiers or aromatic oils can lead to the development of chemical pneumonia, due to their ability to inflame and damage lung tissues. This phenomenon can also occur due to inhalation of vomited material which, together with the ingestion of corrosive substances, can lead to lethal pneumonia in the most serious cases.
4) Review of the legislation
General Products Safety Regulation (EU) No 2023/988 (GPSR), in application from 13 December 2024, extends its field of application also to 'food imitating products'. Which thus fall within the general definition of 'product', the placing on the market of which requires an appropriate risk assessment. (7) And they must be precisely identified as dangerous, on the basis of the criteria already defined in the Food Imitating Products Directive. (8)
5) Court of Justice of the European Union, case law
Court of Justice of the European Union (CJEU) – with the ruling of 2 June 2022 in case C-122/21, also referred to in the GPSR (8) – clarified that 'it is not necessary to demonstrate with objective and proven data that the fact of putting into the mouth, sucking or ingesting products which, although not foodstuffs, have a shape, odour, colour, appearance, packaging, labelling, volume or size such that consumers, especially children, are likely to confuse them with products food and therefore put them in their mouth, suck them or ingest them, may result risks such as suffocation, intoxication, perforation or obstruction of the digestive tract. However, the competent national authorities must assess on a case-by-case basis whether a product meets the conditions listed in that provision and demonstrate this.' (9)
6) GPSR, risk analysis
The European Commission – DG for Justice and Consumers, as part of the 'Coordinated Activities on the Safety of Products (CASP) FIP2021 horizontal activity' – published a report (2022) and a manual aimed at 'stakeholders' and 'Member States Surveillance Authorities' to apply GPSR to 'food imitating products' and 'child-appealing products'. (10) The document considers:
– dutiful application of an approach based on risk analysis,
– identification of the elements useful for determining the status of 'food imitating product', to be assessed on a case-by-case basis by comparing each product with the corresponding food version. With additional precautions in the case of 'child-appealing products', if the products are not intentionally intended for this reference sub-population (11). With supporting decision trees,
– use of appropriate harmonized standards (where available),
– implementation of a system suitable for risk analysis and prevention, communication and management.
7) RAPEX, Safety Gate. Examples of recalls
The RAPEX system – renamed Safety Gate by GPSR – records alerts relating to products at risk or otherwise non-compliant. including 'food imitating products'. Below are some examples of recalls for non-compliance with FIPD, sector regulations (eg cosmetics, toys) and related harmonized standards (12,13):
– cherry-like, in the form of packaging or decorations of soaps (cosmetics), which can be totally or partially detached, with the risk of ingestion by children,
– grape-like plastic, with grapes and leaves subject to easy detachment and ingestion,
– biscuit-like plastic, with small parts that simulate grains of sugar and can be easily detached and swallowed.
In Italy, the Customs and Monopolies Agency (ADM) recently seized 7,6 tons of candy-shaped candles in the port of Genoa. The seized products, in addition to having a high resemblance to food, were characterized by the presence of easily detachable parts (in the absence, among other things, of suitable mechanical evaluation tests) and powders designed to simulate the sugar that they sometimes present the risk of inhalation or ingestion, with serious health risks. (14)
8) Provisional conclusions
The application of the General Product Safety Regulation (EU) No 2023/988, which repeals the General Products Safety Directive 2001/95/EC, involves an overall review of the responsibilities of operators in the production and distribution chains of 'non-food products', including 'food contact materials'. In addition to introducing draconian sanctions for failure to comply with the new requirements, which include recording product safety data sheets and accidents and/or complaints.
The preliminary analysis performed in the CASP FIP2021 provides a valuable basis to enable the various stakeholders involved and the 'Market Surveillance Authorities' to prepare for the application of the new general rules contained in the GPSR. Which integrate sector regulations, prescribing a new approach to risk analysis which includes the evaluation of all mandatory and voluntary regulations useful for guaranteeing product safety. Especially for vulnerable categories such as children and the elderly.
Dario Dongo and Andrea Adelmo Della Penna
Footnotes
(1) Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers https://tinyurl.com/4kfw4zfx
(2) See for example, in Italy, the legislative decree of 25 January 1992, n. 73. Implementation of Directive 87/357/EEC relating to products which, by appearing different from what they actually are, compromise the health or safety of consumers https://tinyurl.com/jshnwpjj
(3) Basso F. et al. (2014). Why People Drink Shampoo? Food Imitating Products Are Fooling Brains and Endangering Consumers for Marketing Purposes. PLoS ONE 9(9):e100368, https://doi.org/10.1371/journal.pone.0100368
(4) Basso F. et al. (2016). Assessing the Role of Shape and Label in the Misleading Packaging of Food Imitating Products: From Empirical Evidence to Policy Recommendation. Front. Psychol. 7:450, https://doi.org/10.3389/fpsyg.2016.00450
(5) SCCS (2011). Opinion on the potential health risks posed by chemical consumer products resembling food and/or having child-appealing properties. Publications Office of the European Union SCCS/1359/10, https://data.europa.eu/doi/10.2772/31904
(6) It is no coincidence that the European Commission, in its latest project to revise the 'Audiovisual Media Service Directive', had proposed a ban on the use of images of TV and cartoon characters in food advertisements aimed at children and adolescents. The Big Food lobbies also managed to obtain the cancellation of this ban in the European Parliament. With consequences also on the (lack of) restrictions on the 'marketing to kids' of junk food. Yes see the previous article by the authors, 'Audiovisual Media Services Directive' and protection of minors from junk food marketing'. GIFT (Great Italian Food Trade).
(7) Dario Dongo, Alessandra Mei. General Product Safety Regulation, at the starting line in the European Union. The ABC. GIFT (Great Italian Food Trade). 13.5.23
(8) General Product Safety Regulation (EU) No 2023/988, recital 104
(9) Court of Justice of the European Union, judgment of 2 June 2022 in case C-122/21 Get Fresh Cosmetics Limited v. Valstybinė vartotojų teisių apsaugos tarnyba. Reference for a preliminary ruling - Directive 87/357/EEC - Article 1, paragraph 2 - Scope - Non-food products which may be confused with foodstuffs - Concept - Risk of suffocation, intoxication, perforation or obstruction of the digestive tract - Presumption of danger - Absence – Test http://foodtimes.eu/5c3k252y
(10) CASP FIP2021 HA. CASP Child appealing including food imitating products http://foodtimes.eu/yc639wm4
(11) Toys (i.e. products designed or intended, whether exclusively or not, to be used for play purposes by children under the age of 14) are regulated by the Toy Safety Directive 2009/48/EC (TSD). Particular attention must be paid to the verification of products not classified as toys, referred to in Annex I to the TSD, as possible 'child-appealing products'
(12) Harmonized standards are European standards developed by recognized European standardization bodies (eg CEN, CENELEC, ETSI), also developed at the request of the European Commission. Sector operators can refer to these standards to demonstrate compliance with the relevant EU legislation. The reference sectors can be consulted on http://foodtimes.eu/3vyfdm4n
(13) NB: GPSR extends the responsibility of operators to risk analysis, in the absence of EU rules and harmonized standards, also on the basis of national rules, voluntary application regulations and schemes applicable to individual product categories
(14) ADM. Press release – Port of Genoa-Prà: ADM seizes 7.600 kilos of candles in the shape of sweets. 21.11.23 http://foodtimes.eu/yfmun893