Certification for Inflatable Products in Europe: A Comprehensive Analysis ( Two )

5. The Role of European Standards Organizations and Harmonized Standards:

The development and application of standards are integral to the European Union’s regulatory framework for product safety, including inflatable products. Three primary European Standards Organizations (ESOs) are responsible for drafting these standards: CEN (European Committee for Standardization), which covers a wide range of technical fields; CENELEC (European Committee for Electrotechnical Standardization), focusing on electrotechnical products; and ETSI (European Telecommunications Standards Institute), specializing in telecommunications standards. These organizations operate based on principles of consensus, bringing together experts from national standards bodies, industry, and other stakeholders to create or modify standards. The process of developing a European Standard (EN standard) can be initiated by industry demand or mandated by the European Commission.  

A particularly important category of EN standards is “harmonized standards.” These are standards developed by the ESOs under a specific mandate from the European Commission and are published in the Official Journal of the European Union (OJEU). Compliance with harmonized standards provides manufacturers with a crucial advantage: a “presumption of conformity” with the essential safety requirements outlined in the corresponding EU directives or regulations. This means that if a product meets the technical specifications of a relevant harmonized standard, it is generally assumed to also meet the high-level safety requirements of the law. While the use of harmonized standards is typically voluntary, it offers a clear and efficient pathway for manufacturers to demonstrate that their products are safe and compliant with EU legislation. For inflatable products, examples of harmonized standards include various parts of the EN 71 series under the Toy Safety Directive and the BS EN 14960 series for inflatable play equipment.  

It is also important to recognize the existence of non-harmonized EN standards and international standards, such as those developed by the International Organization for Standardization (ISO). These standards may not automatically confer a presumption of conformity with EU law, but they can still be valuable tools for manufacturers to ensure the safety of their products, especially in cases where no specific harmonized standard exists for a particular type of inflatable product. In such instances, compliance with relevant non-harmonized or international standards can serve as evidence of adherence to the general safety requirements of the GPSR or other applicable legislation. While EU regulations and directives are generally available for free via platforms like EUR-Lex, access to the full text of specific product standards often requires payment through the respective standards organizations or national standards bodies. This financial aspect is a factor that manufacturers need to consider when seeking to ensure compliance with the relevant technical specifications.  

6. The CE Marking Process for Inflatable Products:

The CE marking is a mandatory conformity marking for many product categories sold within the European Economic Area (EEA), including certain inflatable products. By affixing the CE marking to a product, the manufacturer declares that the product meets all the applicable essential safety, health, and environmental protection requirements set out in the relevant EU directives or regulations. Obtaining CE marking is a multi-step process that generally involves the following:  

First, the manufacturer must identify all the EU directives or regulations that are applicable to their specific inflatable product. For example, an inflatable toy would fall under the Toy Safety Directive, while an inflatable boat might be subject to the Recreational Craft Directive. Second, the manufacturer needs to determine the essential requirements that are outlined in these applicable directives or regulations. These requirements are typically broad safety objectives that the product must meet. Third, the manufacturer should identify any relevant harmonized European standards that provide technical specifications for meeting these essential requirements. While compliance with these standards is usually voluntary, it offers a well-defined path to demonstrating conformity. Fourth, the manufacturer must choose the appropriate conformity assessment module as described in the applicable directive’s annex. The EU provides various modules, ranging from self-certification by the manufacturer (typically for lower-risk products) to mandatory third-party assessment by a Notified Body (for higher-risk products). Fifth, the manufacturer must conduct the necessary conformity assessment procedures, which may involve product testing, inspection of the manufacturing process, or a combination of both. Sixth, the manufacturer is required to create a Technical File that documents the product’s design, manufacturing process, and how it conforms to the applicable requirements. This file must be kept for a specified period and be made available to market surveillance authorities upon request. Seventh, the manufacturer must draw up and sign an EU Declaration of Conformity, a legally binding document stating that the product complies with all the relevant EU legislation. Finally, once all these steps are completed, the manufacturer can affix the CE marking visibly and legibly to the product.  

For certain higher-risk inflatable products, such as some inflatable medical devices classified as Class I sterile, measuring, or reusable surgical instruments, Class IIa, IIb, or III, and certain categories of recreational craft, the involvement of a Notified Body is mandatory. These independent, accredited organizations assess the product’s conformity with the applicable requirements and issue a CE certificate if compliance is verified. Regardless of whether self-certification or Notified Body involvement is required, the ultimate responsibility for ensuring product compliance and for maintaining the Technical File and Declaration of Conformity rests with the manufacturer. These documents must be retained for a specified duration, typically ten years after the last product has been placed on the market, to be available for inspection by regulatory authorities.  

7. Recent and Emerging Regulatory Developments Affecting Inflatable Products:

The regulatory landscape for inflatable products in Europe is continuously evolving, with several recent and emerging developments that businesses need to be aware of to ensure ongoing compliance. One significant development is the Ecodesign for Sustainable Products Regulation (ESPR), which aims to establish a framework for setting ecodesign requirements for a wide range of physical goods placed on the EU market. While the ESPR itself does not yet contain specific requirements for inflatable products, it empowers the European Commission to adopt delegated acts that will set detailed sustainability criteria, including aspects like durability, reusability, recyclability, and repairability. It is anticipated that sectors with high environmental impact will be prioritized, and inflatable products, particularly those made from plastics and textiles, could be subject to these new requirements in the future. A key component of the ESPR is the introduction of a Digital Product Passport (DPP), which will provide easy access to information about a product’s sustainability characteristics for consumers and other stakeholders. Certain products will only be allowed on the EU market if a DPP is available, necessitating manufacturers to prepare and provide this digital documentation.  

Another important regulatory development is the Restriction of Microplastics (Commission Regulation (EU) 2023/2055), which began applying on 17 October 2023. This regulation restricts the placing on the market of synthetic polymer microparticles that are intentionally added to products, aiming to reduce environmental pollution. While articles are generally not in the scope, loose plastic glitter, which can be found in some inflatable toys and decorative items, is considered a mixture under REACH and is therefore subject to the restriction. The sale of loose plastic glitter for uses such as arts and crafts and toys is now banned, unless it is biodegradable, soluble, or otherwise exempted. Manufacturers of inflatable products need to ensure that any components or decorative elements they use comply with these new restrictions on microplastics.  

The European Union is also increasingly focused on restricting the use of Per- and Polyfluoroalkyl Substances (PFAS) in consumer products due to their potential environmental and health risks. While there is not yet a comprehensive ban on all PFAS, the EU is working on a roadmap to restrict a wide range of hazardous chemicals, including PFAS, by 2030. These potential future restrictions could impact the materials used in the manufacturing of some inflatable products, particularly those requiring water resistance or specific performance characteristics. Businesses should monitor these developments closely and explore alternative materials where necessary.  

The proposed Toy Safety Regulation, which aims to replace the existing Toy Safety Directive, is another significant emerging development. This new regulation is expected to introduce even stricter bans on several hazardous substances found in toys, such as certain chemicals and heavy metals. It also proposes new labelling requirements, including minimum size and visibility for warnings, and will mandate access to the Digital Product Passport for all toys sold in the EU. These changes will require toy manufacturers, including those producing inflatable toys, to adapt their product designs, materials, and labelling practices to ensure compliance with the updated regulatory framework.  

Finally, there are ongoing developments in standards for specific types of inflatable products. For example, the EU Commission published a revised version of guidance document number 7 on the classification of toys intended to be used in or on the water in December 2023. This revised guidance provides additional clarification on the classification of different types of aquatic toys, including inflatable bath toys and floating leisure articles, helping manufacturers to determine which regulations and standards are applicable to their products. Staying informed about these evolving standards and guidance documents is crucial for manufacturers to ensure their inflatable products meet the latest safety and regulatory expectations in the European market.