Swimming Aids Regulations in the European Union: An Overview

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Swimming Aids Regulations in the EU

Swimming aids include flotation-type devices designed to help wearers learn how to swim and to keep them afloat in emergencies. Such products are subject to various substance regulations, safety standards, labelling, documentation, and lab testing requirements.

In this article, we cover some regulations and directives applicable to swimming aids. This includes the PPE Regulation, the GPSD, and REACH.

Covered Products

  • Buoyancy aids
  • Swimming suits with incorporated floats
  • Swimming armbands
  • Life jackets


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Personal Protective Equipment Regulation

The Personal Protective Equipment (PPE) Regulation establishes requirements that importers and manufacturers must follow to ensure that individuals wearing the PPE are protected from hazards in the workplace or while partaking in activities such as sports and swimming.

For example, consumers may wear swimming aids to protect themselves from drowning while swimming.

Product scope

The PPE Regulation covers buoyancy aids and similar products that users can wear to keep themselves safe while swimming, escaping from danger, or rescuing other people.

Different kinds of swimming aids may be classified into different categories of PPE, according to the level of risk they protect from. The PPE Regulation Guidelines place various swimming aids into one of the three distinct categories set by the PPE regulation:

  • Category I
  • Category II
  • Category III

In this section, we list various examples of products under their respective categories.

Category I PPE

Category I includes minimal risks such as contact with water for an extended amount of time. Products that fit this description include the following:

  • Swimming goggles and masks
  • Diving goggles and masks

Category II PPE

Category II covers PPE swimming aids that protect against risks not listed in Categories I and III, and includes products such as the following:

  • Swimming suits with incorporated floats
  • Swimming armbands
  • Immersion suits that provide thermal protection

Category III PPE

Category III covers PPE swimming aids that can protect against risks that may pose irreversible harm such as drowning or even death, and includes products such as the following:

  • Lifebuoys to prevent drowning
  • Life jackets to avoid drowning

Harmonised standards

Importers and manufacturers of swimming aids should ensure that their products comply with harmonised standards, as these standards offer a presumption of conformity with the PPE Regulation’s technical requirements.

Below, we provide several examples of harmonised standards that apply to personal flotation devices.

EN ISO 12402-2 – Personal flotation devices – Part 2: Lifejackets, performance level 275 – Safety requirements

This standard describes the safety requirements for lifejackets for adults, children, or infants.

These lifejackets are classed at performance level 275, and they are suitable for use in either of the following situations:

  • Offshore use under severe conditions
  • When an individual uses protective clothing
  • When an individual carries additional loads

EN ISO 12402-3 – Personal flotation devices – Part 3: Lifejackets, performance level 150 – Safety requirements

This standard outlines the safety requirements for lifejackets for the age groups mentioned in the standard above.

The lifejackets are classed at performance level 150, and they are suitable for use in the following situations:

  • General use
  • Offshore use
  • Rough water use
  • Users who are fully clothed

EN ISO 12402-4 – Personal flotation devices – Part 4: Lifejackets, performance level 100 – Safety requirements

This standard also specifies the safety requirements for lifejackets for adults, children, or infants.

However, these lifejackets are classed at performance level 100, and they are suitable for use in the following situations:

  • In sheltered or calm water
  • When users are fully clothed

EN ISO 12402-5 – Personal flotation devices – Part 5: Buoyancy aids (level 50) – Safety requirements

This standard describes the safety requirements for buoyancy aids at performance level 50. In particular, it covers buoyancy aids for adults and children whose body mass is greater than 25 kilograms only.

Performance level 50 buoyancy aids are for use in sheltered waters. Proper use of these aids requires the wearer to actively use them where help and rescue are nearby.

EN ISO 12402-6 – Personal flotation devices – Part 6: Special application lifejackets and buoyancy aids – Safety requirements and additional test methods

This standard specifies supplementary test methods and safety requirements for lifejackets and buoyancy aids, which are referred to as personal flotation devices (PFDs).

It covers special application lifejackets and buoyancy aids for adults, children, or infants. The standard is meant to be used in conjunction with the following standards, as applicable:

  • ISO 12402-2
  • ISO 12402-3
  • ISO 12402-4
  • ISO 12402-5

EN ISO 12402-8 – Personal flotation devices – Part 8: Accessories – Safety requirements and test methods

This standard outlines the safety requirements and test methods for accessories that are used for PFDs.

Labelling requirements

The PPE Regulation requires importers and manufacturers to provide items such as the following on their product’s labels:

a. CE marking (to be affixed permanently to the product, the packaging, or accompanying documents, e.g., user instructions)

b. Product traceability label

c. Pictogram indicating the risk that the PPE is meant to protect against (if appliable)

d. Identification number of the Notified Body (for Category III PPE)

Documentation requirements

The regulation mandates that importers and manufacturers provide a set of documentation as evidence that their products, such as swimming aids, comply with its technical requirements.

Declaration of Conformity

Importers and manufacturers are required to provide a Declaration of Conformity (DoC), which should contain information such as the following:

1. PPE information (e.g. batch, product, serial number, or type)

2. Manufacturer’s name and address

3. Statement of responsibility

4. References to relevant harmonised standards used or other technical specifications

5. Notified Body information, if applicable

EU type-examination certificate

The regulation requires importers and manufacturers of Category II and III swimming aids to request the involvement of a Notified Body, who in turn is required to perform an EU-type examination (Module B) and provide the importers and manufacturers with an EU-type-examination certificate.

Importers and manufacturers of Category II swimming aids are also required to adhere to the internal production control (module C).

Additionally, importers and manufacturers of Category III swimming aids are required to request the services of a Notified Body to ensure that their products are subject to either of the following:

a. Random supervised product checks (Module C2)

b. Quality assurance of the production process (Module D)

Other requirements

The PPE Regulation requires importers and manufacturers of swimming aids to provide additional documentation such as the following:

  • User instructions
  • Technical documentation
  • Test reports
  • A written mandate from an Authorized Representative (if necessary)

General Product Safety Directive (GPSD)

The General Product Safety Directive (GPSD) was enacted to make sure that general consumer products, such as swimming aids, are safe before they are sold on the market. The directive covers products and their risks that aren’t already covered by other directives or regulations.

Product scope

The GPSD covers consumer products, including swimming aids, such as the following:

  • Floating leisure articles for use on and in the water
  • Buoyant aids for swimming instruction

Harmonised standards

One way that importers and manufacturers of swimming aids can assess if their products comply with the directive’s technical requirements is to ensure that said products conform to the requirements contained in relevant harmonised standards, such as those listed below.

In cases where no harmonised standards exist for specific products, importers and manufacturers may use other EN, international, or national standards to assess the safety of their products.

EN ISO 25649 – Floating leisure articles for use on and in the water (Parts 1 to 7)

The EN ISO 25649 standard comprises 7 parts, each focusing on a different aspect related to floating leisure articles for use on and in the water.

Part 1 covers classification, materials, general requirements, and test methods.

Part 2 covers consumer information.

Parts 3 to 7 cover additional specific safety requirements and test methods for devices in Classes A to E, respectively.

EN 13138-2 – Buoyant aids for swimming instruction – Part 2: Safety requirements and test methods for buoyant aids to be held

This standard details safety requirements for swimming devices meant to help first-time swimmers move through the water while learning how to swim, or while learning part of a swimming stroke.

The safety requirements cover the following regarding the safety devices mentioned above:

  • Construction
  • Performance
  • Sizing
  • Marking

Additionally, EN 13138-2 provides test methods to verify the requirements within.

This standard only covers Class C swimming devices designed and meant for users to hold in their hands or on their bodies, which include kick boards and pull/kick boards. Users can make use of these swimming aids in the following situations:

  • When learning to swim
  • To help with swimming strokes
  • To improve specific stroke elements

The Class C swimming devices may either be inherently buoyant or inflated for use.

The standard does not apply to the following swimming aids:

  • Pull buoys
  • Swim rings
  • Lifebuoys
  • Buoyancy aids
  • Lifejackets
  • Aquatic toys

Requirements

The GPSD requires importers and manufacturers to affix product traceability labelling to their products. Additionally, it might require them to provide one or more of the following documents:

a. Risk assessment report

b. User instructions for the product (not mandatory, but recommended as it increases safety by specifying how the product is to be used)

c. Technical documentation (may not be compulsory, but is helpful when the relevant authorities assess the product’s conformity)

d. Test reports

Toy Safety Directive

The Toy Safety Directive was enacted to reduce the safety risks associated with children’s toys in the EU market. The directive provides safety criteria for children’s toys, such as the following:

  • Mechanical properties
  • Chemical properties
  • Flammability

Product scope

The directive covers toys, including aquatic toys, defined in Article 2 of the directive as a toy meant to carry or support a child in shallow water. The design and manufacture of these aquatic toys must result in as little loss of buoyancy as possible for the child.

Additionally, Annex I of the Toy Safety Directive provides a list of products that the directive does not regard as toys. These products include aquatic equipment for use in deep water and swimming devices such as swim seats and swimming aids for children learning how to swim.

Requirements

Importers and manufacturers are required to provide the documentation and labels such as the following:

  • Declaration of Conformity
  • Technical documentation
  • User instructions
  • EC Type-Examination certificate (if applicable)
  • Test report
  • CE marking
  • Product traceability label
  • Warning labels

Additionally, Annex V of the directive requires aquatic toys to carry the following warning:

“Only to be used in water in which the child is within its depth and under adult supervision.”

REACH

The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation bans, limits, and requires importers and manufacturers to notify relevant authorities regarding chemicals, heavy metals, and other hazardous substances in consumer products in general.

Product scope

The REACH regulation covers a wide range of products, including swimming aids that might be manufactured with materials that contain chemicals that are regulated by REACH. We list a few of these materials below:

  • Neoprene
  • Latex
  • Silicone
  • Thermoplastic polyurethane

SVHC

Substances of Very High Concern (SVHCs) are defined by the European Chemicals Agency (ECHA) as substances that may have permanent and negative consequences on the environment and human health. REACH regulates any substance that is on the SVHC Candidate list.

Below we list a few SVHCs that may be present in swimming aids:

Just because a substance is on the SVHC Candidate list does not automatically mean it is banned. However, importers and manufacturers of products containing a concentration exceeding 0.1% weight by weight (w/w) of an SVHC are required to notify ECHA about the presence of the SVHC by registering and entering the relevant information into the SCIP database.

REACH also requires importers and manufacturers to notify customers, when requested, about their products having SVHC if the substance’s weight exceeds 0.1% of the product.

Restricted substances

Annex XVII to REACH lists articles, hazardous substances, or mixtures that are either restricted or banned from being used in consumer products for the EU market.

While REACH requires SCIP notification if the SVHC in the product exceeds 0.1% by weight, substances listed on Annex XVII are subject to different restrictions, such as being banned (asbestos) or limited to certain concentration levels (phthalates) or weekly migration limits (nickel).

Below we list a few examples of restricted substances that may be present in swimming aids:

  • Polycyclic aromatic hydrocarbons (PAHs)
  • Phthalates (DEHP, DBP, BBP, DIBP)

Lab Testing

Lab testing allows importers and manufacturers to prove that their products, such as swimming aids, comply with technical requirements from various relevant standards and directives.

They may ensure that their products are safe by having them tested for properties such as the following:

  • Buoyancy
  • Design
  • Fit
  • Mechanical properties
  • Chemicals

Testing companies

We list below a few companies that offer lab testing services for swimming aids:

  • Intertek
  • SGS
  • UL Solutions

Directive 94/62/EC on Packaging and Packaging Waste

Directive 94/62/EC on Packaging and Packaging Waste Directive harmonises how packaging and packaging waste of any product, such as swimming aids, is managed across the European Union to minimise how packaging waste negatively impacts the environment.

The directive covers all packaging (regardless of the material used) and packaging waste (used or released) at levels that include the following:

  • Commercial
  • Household
  • Industrial
  • Office
  • Shop

Substance restrictions

The directive restricts the following four heavy metals in packaging and packaging waste to 100 ppm by weight:

  • Cadmium
  • Hexavalent Chromium
  • Lead
  • Mercury

Extended Producer Responsibility (EPR) requirements

The Extended Producer Responsibility (EPR) scheme is a policy tool in the European Union that mandates importers and manufacturers to extend their financial responsibility past the post-consumer stage. They do this by paying a fee to an EPR organisation to collect and recycle discarded packaging and packaging waste.

Every country in the EU has different EPR organisations, of which the examples given below are but a few:

  • Afvalfonds Verpakkingen (Netherlands)
  • Citeo (France)
  • Der Grüne Punkt (Germany)
  • EcoEmbes (Spain)
  • FOST Plus (Belgium)
  • FTI (Sweden)
  • (USA & EU)

    FREE CONSULTATION CALL (US, EU & UK)

    • Request a free 30-minute call with Ivan Malloci to learn how we can help you with:
    • Find product requirements
    • Certification and labeling
    • Lab testing

    REQUEST A CALL



    Disclaimer: The Site cannot and does not contain legal advice. The legal information is provided for general informational and educational purposes only and is not a substitute for professional advice. Accordingly, before taking any actions based upon such information, we encourage you to consult with the appropriate professionals. We do not provide any kind of legal advice. THE USE OR RELIANCE OF ANY INFORMATION CONTAINED ON THE SITE IS SOLELY AT YOUR OWN RISK.

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    Sources: Our articles are written in part based on publicly available information, and our own practical experience relating to product compliance. These are some of the primary sources we use:

    • ec.europa.eu
    • echa.europa.eu
    • ecfr.gov
    • cpsc.gov
    • ftc.gov
    • fcc.gov
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