Diving equipment imported or manufactured for sale in the European Union is subject to various safety standards, labelling, documentation, testing, and other requirements. Non-compliance can increase the risk of defective products which could lead to decompression sickness, drowning, or even death.
In this guide, we take a closer look at the PPE regulation, General Product Safety Regulation, and other compliance requirements relevant to diving equipment in the EU.
Note that we do not cover diving equipment containing electronic components or batteries. You can find more information about these topics in the following articles:
- Electronic Product Regulations in the European Union: An Overview
- EU Batteries Regulation: An Essential Guide
Content Overview
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Personal Protective Equipment (PPE) Regulation
The Personal Protective Equipment (PPE) Regulation sets requirements for protective equipment, which includes diving equipment.
The regulation defines “personal protective equipment” as equipment that is specifically designed and manufactured for a person to hold or wear so that they can protect themselves against risks to their safety or health.
It mandates that PPE meets certain design principles, and is made of suitable materials that provide adequate protection. It also requires manufacturers to:
a. Ensure that your product complies with essential health and safety requirements
b. Ensure that your product undergoes the necessary testing
c. Provide documentation (e.g. Declaration of Conformity, technical documentation, instructions)
d. Properly label your products (e.g. with CE marking, traceability information)
Risk categories
The PPE Regulation has three risk categories described in Annex I. Certain requirements differ according to which risk category the PPE belongs to.
General Definitions
PPE is classified into different categories according to the level of risk that they protect the user from:
a. PPE that protects users against minimal risks (e.g. superficial mechanical injury) is classified as Category I
b. PPE that protects users from risks not listed in Categories I and III is classified as Category II
c. PPE that protects users from more specific risks, such as drowning or permanent health damage resulting from exposure to hazardous substances, is classified as Category III
Diving Equipment
Here are some examples of diving equipment from each risk category, taken from the PPE Regulation Guidelines:
a. Category I – Diving suits, diving goggles, diving face masks with snorkel
b. Category II – Dry gloves for divers
c. Category III – Insulating clothing for diving, respiratory protective equipment for diving
Harmonised standards for diving equipment
When a product complies with the requirements of standards that are harmonised under the Regulation, it is presumed to be safe, at least against the risks that are covered by the standard. We found nine harmonised standards relevant to diving equipment, such as diving gases, suits, and apparatus:
EN 144-3 – Respiratory protective devices – Gas cylinder valves – Part 3: Outlet connections for diving gases Nitrox and oxygen
EN 250 – Respiratory equipment – Open-circuit self-contained compressed air diving apparatus – Requirements, testing and marking
EN 13949 – Respiratory equipment – Open-circuit self-contained diving apparatus for use with compressed Nitrox and oxygen – Requirements, testing, marking
EN 14143 – Respiratory equipment – Self-contained re-breathing diving apparatus
EN 14225-1 – Diving suits – Part 1: Wet suits – Requirements and test methods
EN 14225-2 – Diving suits – Part 2: Dry suits – Requirements and test methods
EN 14225-3 – Diving suits – Part 3: Actively heated or cooled suit systems and components – Requirements and test methods
EN 15333-1 – Respiratory equipment – Open-circuit umbilical supplied compressed gas diving apparatus – Part 1: Demand apparatus
EN 15333-2 – Respiratory equipment – Open-circuit umbilical supplied compressed gas diving apparatus – Part 2: Free flow apparatus
Essential Health and Safety Requirements
The PPE Regulation lists specific essential health and safety requirements for many types of personal protective equipment, including for some types of diving equipment.
For example, part 3.11 of Annex II states that breathing equipment must supply the user with “a breathable gaseous mixture”. When necessary, the equipment should include:
a. A suit protecting the user against the cold and depth pressure
b. An alarm designed to promptly warn the user of an upcoming lack of breathable oxygen
c. A lifesaving device that allows the user to return to the surface of the water
Documentation
In this section, we summarise the PPE Regulation’s documentation requirements.
| Document | Description |
| Technical documentation | The technical documentation specifies how the manufacturer ensures product compliance with the essential health and safety requirements. It should contain the information specified in Annex III. |
| Declaration of Conformity | Manufacturers should issue a Declaration of Conformity that contains the information specified in Annex IX. |
| Test report | The manufacturer should include test reports in the technical documentation to prove the PPE’s compliance with regulatory requirements. |
| Instructions | You should provide user instructions with your product. These instructions should be easily understandable in the language of the Member State where you sell your product.
Part 1.4 of Annex II specifies a list of information you should include in the manufacturer’s instructions. |
Labelling requirements
In this section, we summarise the PPE Regulation’s labelling requirements.
| Title | Description |
| CE marking | 
Importers and manufacturers should affix a CE marking to the product, its packaging, or accompanying documents. The CE mark should be permanent, clearly visible and readable. Category III PPE should also bear the notified body’s identification number following the CE mark. |
| Traceability information | Manufacturers should ensure they include the following traceability information on their label on the PPE, packaging, or accompanying document:
|
General Product Safety Regulation
The General Product Safety Regulation establishes safety requirements for consumer products in general, which should be safe. It also covers diving equipment, for risks that are not covered by the PPE Regulation or other relevant regulations.
The regulation generally requires you to:
1. Have your product lab tested
2. Provide technical documentation, use instructions, and test reports
3. Properly label your products or their packaging
4. Provide adequate warnings
EN 13319 – Diving accessories – Depth gauges and combined depth and time measuring devices – Functional and safety requirements, test methods
This standard is harmonised under the GPSR. It specifies safety and functional requirements for:
- Depth gauges
- Depth gauge features of covered devices
- Depth and time measurement features of covered devices
It does not apply to:
- Information displayed in the product (e.g. in the screen), other than depth and time
- Decompression obligations displayed on covered equipment
The time measurement requirements apply if the covered instruments count the dive time automatically.
Documentation
In this section, we list the key documentation requirements mandated by the regulation.
| Document | Description |
| Technical documentation | The technical documentation should contain information that includes:
a. A description of the product b. Elements necessary to assess product safety c. Analysis of product-related risks, and associated solutions to mitigate said risks (e.g. test reports) d. List of relevant EU standards applied |
| Instructions | Importers and manufacturers should provide user instructions with their products to ensure consumers can safely use and dispose of the products. |
| Register of complaints | The register of complaints is an internal document that should contain data that the importer and manufacturer can use to investigate complaints concerning dangerous products. |
Labelling requirements
The General Product Safety Regulation requires importers and manufacturers to provide traceability information, safety information, and warnings on the label of their products.
| Labelling item | Description |
| Traceability information | You should provide the following traceability information:
|
| Age suitability | You should provide age-suitability labelling for children on your product, if necessary. |
| Warnings and instructions | You should provide safety warnings and instructions so that consumers can safely use and dispose of the products. |
Importers and manufacturers should place the label on their product; if that’s not possible they should place the label on the packaging, or on an accompanying document.
Pressure Equipment Directive
The Pressure Equipment Directive sets design, manufacture, and other requirements for pressure equipment with a maximum permissible pressure (PS) exceeding 0.5 bar. According to the Pressure Equipment Directive Guidelines, the directive applies to “diving breathing apparatus” for pressure-related risks. The Guidelines also indicate that the PPE Regulation covers other risks.
Harmonised standards
We could not find any harmonised standards specific for breathing apparatus. You can find the list of harmonised standards in this page.
Documentation
The directive requires manufacturers to provide the following documents:
- Declaration of Conformity
- Technical documentation
- User instructions
- Safety information
- Test reports
- User instructions
Labelling requirements
You should label your pressure equipment, its packaging, or an accompanying document with a CE marking and traceability information, which includes:
- Type, batch, or serial number
- Name, registered trade name, or registered trade mark
- Postal address
You should include the notified body’s identification number after the CE marking, if necessary. You may also include a mark that indicates a special risk or use.
Simple Pressure Vessels Directive
The Simple Pressure Vessels Directive covers simple pressure vessels, such as diving cylinders, and may also cover other simple pressure vessels that are used in diving equipment.
Harmonised standards
We could not find any harmonised standards specific for diving cylinders, or similar products. However, you can find the list of standards harmonised under the directive in this page.
Documentation
You should provide at least the following documents with your vessel:
- Technical documentation
- Declaration of Conformity
- User instructions
- Safety information
- Test report
The instructions should contain:
- Inscription and traceability information (except batch identification)
- The vessel’s intended use
- Installation and maintenance requirements for vessel safety
Labelling requirements
The directive requires your vessels to carry the following labelling information:
a. CE mark, and the last two digits of the year the CE mark was affixed
b. Inscription and traceability information, which includes
- Maximum working pressure
- Maximum working temperature
- Minimum working temperature
- Vessel capacity
- Manufacturer’s name, registered trade name or registered trade mark
- Manufacturer’s address of the manufacturer
- Vessel’s type, serial, or batch identification
REACH
The REACH Regulation establishes substance restrictions regarding the use of hazardous substances in consumer products and their components. For example, plastic components may contain phthalates, and textile components may contain azodyes.
Annex XVII
Annex XVII contains harmful and therefore restricted substances. Diving equipment may contain substances listed in Annex XVII, such as:
a. Polycyclic-aromatic hydrocarbons (PAHs) – May be present in diving suits
b. Phthalates (e.g. DEHP) – May be present in dive masks, or diving flippers
c. Azo dyes – May be present in clothing such as diving suits
SVHC Candidate List
Diving equipment may also contain substances on the SVHC Candidate List. Here are two examples:
a. Bis(α,α-dimethylbenzyl) peroxide – May be present in plastic diving equipment, such as diving masks
c. Bumetrizole – May be present in plastic diving equipment, such as diving snorkels
You should submit a SCIP notification to the ECHA if your product contains more than 0.1% of a substance on the SVHC Candidate List.
Lab Testing
You should get your products tested to ensure compliance with requirements. Some regulations require you to have your product lab tested. For others, it may still be a practical necessity to test your products, for example, to ensure that it does not contain restricted substances above the limits.
When your product passes testing, you receive a test report that proves product compliance. Some regulations also require you to attach test reports to your technical documentation.
| Regulation | Lab testing |
| Personal Protective Equipment Regulation | Diving equipment must be tested to ensure compliance with the safety requirements. EN 14225-1, EN 14225-2, and EN 14225-3, for example, contain methods for testing diving suits. |
| General Product Safety Regulation | You should have your diving accessories (e.g. dive gauges and time measuring devices) tested against the requirements of relevant standards, such as EN 13319. |
| Pressure Equipment Directive | You should have your pressure equipment undergo the necessary test, for example hydrostatic pressure test, according to relevant standards. |
| Simple Pressure Vessels Directive | You should have your simple pressure vessels undergo the required tests (e.g. welding procedure test). |
| REACH | You should have your diving equipment tested to ensure it does not contain any banned substances or restricted substances over the allowed limits. |
Diving equipment testing companies
Here are a few testing companies that claim to provide testing services regarding diving equipment or the regulations and directives mentioned in this guide.
- Eurofins
- SGS
- TÜV Rheinland
