Swim equipment and buoyant aids

Product definition

Swim equipment and buoyant aids are products that are intended to assist users, in particular children, to learn to swim or to help users avoid drowning by providing positive buoyancy in water. This product group includes swim vests, life-vests and life-jackets intended to be worn by consumers engaged in activities in or near water, e.g. canoeing or sailing in small boats in shallow waters.

The products that are designed to provide protection to its user/wearer are usually regulated under the Regulation (EU) 2016/425 on personal protective equipment.

Personal Protective Equipment (PPE) are classified in three categories depending on the risk against which they protect. Swim equipment and buoyant aids are usually found in the two highest categories:

• Category II: all equipment designed and manufactured for use as buoyancy aids, including swimming aids and inflatable buoys which are not regarded as toys (such as swimming armbands).
• Category III: life-buoys and life-jackets to prevent drowning.

The appendix of the PPE Regulation Guidelines includes a guide for the categorization of PPE. 

Buoyancy aids that are not worn but held by the user (e.g. foam boards) are not considered to be PPE. Nor are buoyancy aids that aren’t designed to be kept in place while worn (e.g. “tyre type” buoys and floating belts). Depending upon the appearance and intended use of such products, they may fall under the Toys Safety Directive or the General Product Safety Regulation.

NB: For PPE in category II and III, it is mandatory to involve a notified body in the conformity assessment. More information on how to involve a notified body (a third party) can be found here.

Common risks of swim equipment and buoyant aids

The manufacturer shall carry out a risk assessment of the swim equipment in order to identify the essential health and safety requirements from Annex II in the PPE regulation that apply to it. These will address the intrinsic safety of the swim equipment to ensure that it doesn’t injure its user. They will also establish requirements for the intended protection so the equipment will protect the user adequately. 

The most obvious risk with buoyant equipment is that it fails to offer the level of buoyancy claimed or expected by the user or it fails to maintain a safe body position for the user. In either case, the user may be unable to keep his airways clear of the water. 

In addition, some products may present a risk to the wearer because of contents of dangerous chemicals can cause short- or long-term adverse health effects if they exceed allowed limits.

Examples of dangerous products

Specific examples of measures taken against dangerous swim equipment and buoyant aids offered for sale in the European Union are available on the Safety Gate website. Select the risk type ‘Drowning’ in the search page. A better understanding of mistakes made in the safety assessment of such products, or their manufacture can help avoid their repetition.

Main applicable legislation

These products are regulated mainly by the Personal Protective Equipment Regulation (EU) 2016/425. The legislation lays down requirements for the design and manufacture of PPE that are necessary to allow these products to be sold and used in the EU market.

Other guidance is also available:

• PPE Regulation guidelines, which includes a categorization guide with examples.

Applicable standards

“Harmonised standards” exist in the EU for swim equipment and buoyancy aids. A product claiming a particular level of protection and complying with those harmonised standards is presumed to be in conformity with the essential health and safety requirements set out in the Personal Protective Equipment Regulation if the standards are cited in the Official Journal of the European Union (OJEU). Further information on, and the list of harmonised standards for PPE is available from here.

Note: The site of CEN (the European standardisation organisation) provides links to the national standardisation bodies’ websites. In addition, the China Standards Information Services Network can be used to access European standards.

The following standards can be applied to swim equipment and buoyancy aids:

EN 13138-1:2021 incl. AC:2022

This standard specifies safety and performance requirements for swimming aids intended to be worn for swimming instructions. It only applies to swimming devices that are designed to be worn, to be securely attached to the body and which have either inherent buoyancy or can be inflated.

EN ISO 12402-4:2020

This document specifies the safety requirements for lifejackets, performance level 100. It is applicable to lifejackets used by adults, children and infants, for use in sheltered or calm water, or when the users are fully clothed.

OBS: The standard is cited in the OJEU with a restriction. Manufacturers are notified that application of certain clauses from the standard do not confer a presumption of conformity with the basic health and safety requirements from the PPE regulation as mentioned in the restriction. In that case, the manufacturer would need to prove the product’s compliance with the essential health and safety requirements by other technical means.

EN ISO 12402-5:2020

This document specifies the safety requirements for buoyancy aids, performance level 50, to be worn by adults or children with a body mass greater than 25 kg only, used in sheltered waters.

EVS-EN 13138-2:2021

This standard specifies safety requirements for swimming devices and buoyancy aids intended to be held in the hands or by the body, while learning to swim. Typical devices include kick boards and pull/kick boards.

Note: This standard is not harmonised.

EVS-EN 13138-3:2021

This standard specifies safety and performance requirements for swim seats into which a user is positioned. These swimming devices are only intended for children aged up to 36 months with a body mass less than or equal to 19 kg.

Note: This standard is not harmonised.

Other legislation of relevance:

While manufacturer’s need to familiarise themselves with all the laws which apply to their specific products, the following summarises some further key applicable laws:

• The REACH regulation restricts chemical substances in goods. REACH stands for “Registration, Evaluation, Authorisation and Restriction of Chemicals”, and it places responsibility on the industry to manage the risks from chemicals and to provide safety information on the substances. The European Chemicals Agency (ECHA) maintains a list of substances of very high concern (the “SVHC list”). According to article 56(1) of the Regulation, manufacturers shall not place products containing any of the substances on this list on the market. The updated list of substances of very high concern can be found on ECHA’s website.
• Please note that every product must be safe for the consumers. If a particular safety aspect of a piece of PPE is not covered by the PPE regulation, then the General Product Safety Regulation (GPSR) applies.

Mandatory labelling & warnings

The following are obligatory:

• CE Marking is obligatory for all PPE. Before marking the PPE with the CE-marking, the manufacturer needs to identify all the applicable legal requirements, verify the conformity of the PPE with these requirements using the appropriate conformity assessment procedure including the mandatory intervention of a notified body for the conformity assessment if the PPE is category II or III.

Then the manufacturer must compile a technical documentation that evidences the compliance of the product and create a written declaration of conformity. When this has been done, he should affix the CE-marking on the product. When a notified body has been involved in the conformity assessment, its number should be affixed after the CE marking (when category III) and at least on the EU type examination certificate and instructions. Refer to the factsheet on CE marking. The NANDO information system includes the list of available notified bodies per legislation and product category.

• Information on the manufacturer and the importer in the EU is obligatory.

In addition, the following information must be provided with the PPE:

1. Instructions for storage, use, cleaning, maintenance, servicing and disinfection. Cleaning, maintenance or disinfectant products recommended by manufacturers must have no adverse effect on the PPE or the user when applied in accordance with the relevant instructions;
2. Performance as recorded during relevant technical tests to check the levels of classes of protection provided by the PPE;
3. Where applicable, accessories that may be used with the PPE and the characteristics of appropriate spare parts;
4. Where applicable, the classes of protection appropriate to different levels of risk and the corresponding limits of use;
5. Where applicable, the month and year of period of obsolescence of the PPE or of certain of its components;
6. Where applicable, the type of packaging suitable for transport;
7. The significance of any markings;
8. The risk against which the PPE is designed to protect;
9. The reference to the PPE Regulation and, where applicable, the references to other Union harmonisation legislation;
10. The name, address and identification number of the notified body or bodies involved in the conformity assessment of the PPE;
11. References to the relevant harmonised standard(s) used, including the date of the standard(s), or references to other technical specifications used;
12. The internet address where the EU declaration of conformity can be accessed.

The information in points (i), (j), (k) and (l) need not accompany the product if it is supplied with a copy of the EU declaration of conformity.

General safety requirements

To ensure safety of swim equipment and buoyancy aids, there is also a range of general requirements to be fulfilled. These are explained in the following factsheets and need to be read in conjunction with this factsheet:

• CE marking
• Conformity assessment
• Declaration of conformity
• EU consumer protection
• EU market surveillance
• Product safety checklist
• Recall procedures
• Risk management
• Safety Gate/RAPEX
• Selling online
• Technical documentation
• Testing
• Using a third party