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Exploring the regulation for CE Marking of Surfing, Canyoning, Water Skiing and Diving Wetsuits in the EU
State of the art diving and surface wetsuits
- General concepts of Regulation (EU) 2016/425.
This article aims to explain the state of the art of the regulation of diving wetsuits and "surface suits" for aquatic activities within the framework of the European Union. Before starting to explain the specific details of the subject, it is necessary to explain the different concepts that will be mentioned throughout the article. The first concept, and the one that initiates all regulatory issues, is the European regulation.
More specifically, the regulation that will be addressed herein is the regulation on personal protective equipment; Regulation (EU) 2016/425 (entry into force in 2018). This regulation applies to all types of PPE (Personal Protective Equipment) designed to be used by an individual to protect against one or more risks to his/her health or safety. Some of the points that are defined are the scope of application, manufacturer obligations, CE marking, health and safety risks, etc.
Another important concept is the standardsand harmonised standards. Defined respectively:
When a European standard is harmonised, it is complemented by an Annex; called ZA, which sets out the technical requirements of European legislation covered by the standard.
- Conformity assessment under EN 14225-1.
Currently, in the European framework, diving wetsuits are considered to be category II PPE. The categorisation of diving wetsuits as category II entails certain conformity assessment requirements, such as the involvement of a notified body, among others. TECNALIA Certificación is an accredited body to assess the conformity of such a product, i.e. it is a notified body to assess wetsuits. For more details, see Article 19 of the regulation, which lists the conformity assessment procedures to be followed.
The decision to categorise it in this way can be derived from the recommendations made by the "PPE Regulation (EU) 2016/425 Guidelines" in Appendix 20 (point 6).
The guidelines provided by the "PPE Regulation (EU) 2016/425 Guidelines" explain in detail how to interpret and apply the requirements of the regulation, including information on risk assessment, conformity assessment procedures, CE marking requirements, technical documentation, etc.
Furthermore, a family of standards covering the technical specifications of diving wetsuits is also available:
- EN 14225-1 Wet diving suits. Requirements and test methods.
- EN 14225-2 Dry diving suits. Requirements and test methods.
- EN 14225-3 Actively heated or cooled diving suit systems and components - Requirements and test methods
EN 14225-1 is a harmonised standard (it has an Annex ZA), and therefore its technical specifications listed in the annex are considered sufficient to meet the technical requirements of the regulation. By applying this standard, TECNALIA and TECNALIA Certificación are able to complete the compliance process for diving wetsuits.
To date, the compliance process for wetsuits to be used for diving activities is quite precise and clear for all actors involved (manufacturers, notified bodies, consumers, etc.).
However, there is one type of product family that has many similarities to the scope of the standard, but whose end use differs from that set out in EN 14225: surface water suits. This type of product is mentioned in the PPE Regulation (EU) 2016/425 Guidelines, but in an ambiguous way, so its applicability has been the subject of debate.
- Surface suits within the regulatory framework
Surface water activity suits cover suits used in sports ranging from surfing and water skiing to canyoning. To group the suits of these varied activities as a family is due to the similarity in construction of the suits available on the market (mostly neoprene suits). The uncertainty in the applicability of the regulation on this product intended for surface activities was a matter of debate and was finally mentioned in the Vertical Recommendation for Use sheets5 under code PPE-R/08.04. Before going into detail, it is worth mentioning what an RFU is.
The response of the RFU PPE-R/08.04 specifies the requirements of EN 14225-1 to be used for surface suits (the requirements and exceptions are defined in picture 1 which belongs to the test diagram proposed by TECNALIA Certificación in its certification scheme).
The RFU does not explicitly confirm that surface suits should be assessed as category II, but does so implicitly, by answering the question, it can be inferred that they should be assessed as category II.
Since then, the market has not taken a clear view on the categorisation of surface suits. We can find surface suits on the market, such as surfing wetsuits, that have CE marking and others that do not.
Another relevant aspect is the thermal performance classification set out in EN 14225-1. This classification classifies suits into four categories depending on the results of the thermal performance test (associated with requirement 4.3 of the standard and essential health and safety requirement 1.1.2.2 of Regulation (EU) 2016/425). The current classification does not classify those suits scoring less than 0.5 m2KW-1. This means that many of the suits on the market (mainly those with a thickness of less than 3mm) cannot obtain satisfactory conformity from the notified bodies;
TECNALIA and TECNALIA Certificación accreditations for conformity assessment
Currently, TECNALIA and TECNALIA Certificación have the necessary accreditation from ENAC (National Accreditation Body) to work on both diving wetsuits and surface suits.
TECNALIA's accreditation as a laboratory (under EN 17025) enables it to issue accredited tests for diving wetsuits and surface suits, and, respectively Tecnalia Certificación (under EN 17065) has accreditation to work as a notified body in the same families.
- Certification scheme and test sequence
The certification scheme defined by TECNALIA Certificación can be consulted by manufacturers wishing to be accredited for these products. Figure 1 below defines the testing process carried out to certify diving wetsuits and surface suits. Note the exceptions marked with a red cross by the RFU for surface suits.
Navigating into the future
As has been seen throughout this article, the regulations applicable to surface suits are still in a state of uncertainty and there are issues to be resolved by the actors involved. However, the various regulatory steps that have been taken so far, including RFUs, application guidelines and open certification processes by manufacturers, suggest that regulation is aiming at the categorisation of surface suits as Category II PPE.
One of the aspects that is currently being actively worked on is an RFU that clarifies how to deal with surface suits that do not exceed the thermal performance class.
There are also initiatives to develop a specific product standard for surface suits, as, in addition to the main problems discussed above, there are others that complicate its effective implementation across the whole range of surface suits.
*See Test sequence diagram EN 14225 (surface suit)
