PPE-3 means that hearing protection falls into risk Category III of the European PPE Regulation (EU) 2016/425. That is the category for risks with very serious or irreversible consequences, including harmful noise. EN 352 is the European series of standards with the requirements that hearing protectors such as earmuffs and earplugs must meet.
On the packaging or in the instructions for use of hearing protection, you come across all kinds of codes, such as CE followed by a number, EN 352-2, SNR and H, M and L. In this article, we explain what they mean, where they come from and what to look for as a user or buyer.
Audibling earplugs are PPE-3 hearing protection, compliant with EN 352. You have your ear impressions taken at a partner hearing centre. The ear impressions are included in the price and you pay at the hearing centre.
PPE, PBM and Regulation (EU) 2016/425
PPE stands for personal protective equipment. In Dutch, this is called PBM, short for persoonlijke beschermingsmiddelen. Throughout the European Union, the same law applies to PPE, Regulation (EU) 2016/425. It has applied since 21 April 2018 and replaced the old PPE Directive 89/686/EEC.
Among other things, the Regulation requires manufacturers to draw up technical documentation, carry out a conformity assessment or have one carried out, draw up an EU declaration of conformity and affix the CE marking. They must keep that documentation and declaration for ten years.
What does Category III (PPE-3) mean?
The Regulation divides all PPE into three risk categories. According to Annex I, Category III covers exclusively the risks that may cause very serious consequences, such as death or irreversible damage to health. In the list of those risks, harmful noise appears under point (m). That is why hearing protection always falls into Category III, the same category as, for example, protection against falls from a height or against hazardous substances.
| Category | Type of risk | Conformity assessment (Article 19) |
|---|---|---|
| I | Minimal risks | Internal production control by the manufacturer (Module A) |
| II | Risks not covered by I or III | EU type-examination (Module B) plus conformity to type based on internal production control (Module C) |
| III | Risks with very serious or irreversible consequences, including harmful noise | EU type-examination (Module B) plus supervised product checks at random intervals (Module C2) or quality assurance of the production process (Module D) |
The difference from the lower categories is that for Category III, a notified body is involved in the type-examination and also in supervising production. So a manufacturer cannot simply declare on its own that its hearing protection is safe.
The CE marking and the number after it
Under Article 17 of the Regulation, the CE marking is affixed visibly, legibly and indelibly to the PPE. If the nature of the product does not allow this, the marking is on the packaging and in the accompanying documents. With a small custom earplug, that makes sense.
For Category III PPE, the CE marking is followed by the identification number of the notified body involved in supervising production. If hearing protection only shows 'CE' without a number after it, ask for more information.
What is EN 352?
The Regulation describes the essential requirements, but not in detail how to test them. That is set out in harmonised European standards. For hearing protectors, that is the EN 352 series. Manufacturers that follow a harmonised standard get a presumption of conformity with the requirements of the Regulation that the standard covers. The European Commission publishes which standards are harmonised. For PPE, that list is in Implementing Decision (EU) 2023/941 (as amended).
| Part | Subject |
|---|---|
| EN 352-1 (2020) | Earmuffs |
| EN 352-2 (2020) | Earplugs |
| EN 352-3 (2020) | Earmuffs attached to industrial safety helmets |
| EN 352-4 (2020) | Level-dependent earmuffs |
| EN 352-5 (2020) | Active noise reduction earmuffs |
| EN 352-6 (2020) | Earmuffs with electrical audio input |
| EN 352-7 (2020) | Level-dependent earplugs |
| EN 352-8 (2020) | Earmuffs with entertainment audio |
| EN 352-9 (2020) | Earplugs with safety-related audio input |
| EN 352-10 (2020) | Earplugs with entertainment audio input |
For custom earplugs and other earplugs, EN 352-2 is the most relevant part. The references to the older versions (from 2001, 2002 and 2008) were withdrawn as of 21 July 2024. Since then, the 2020 versions apply.
Wondering whether wireless earbuds with active noise cancellation also count as hearing protection? Read AirPods Pro as hearing protection.
A detail buyers should know
The Implementing Decision includes a note for EN 352-1, -2 and -3. These standards do not require a label with the noise attenuation level on the product. Yet Annex II (point 3.5) of the Regulation requires every PPE against noise to carry a label with the noise attenuation level, or the packaging if that is not possible on the product. So a manufacturer must state the attenuation either way.
SNR and HML show the attenuation on the packaging
That attenuation is usually shown with two kinds of numbers.
- SNR (Single Number Rating) is one number for the average attenuation across all frequencies, in dB. Handy for comparing products quickly.
- HML are three numbers for the attenuation of high (H), medium (M) and low (L) tones. They show whether a product reduces all tones evenly or mainly the high ones.
A detailed explanation with worked examples is in the SNR value of earplugs explained.
Bear in mind that the value on the packaging was measured under laboratory conditions. The guideline on occupational hearing loss from the NVAB, the Netherlands Society of Occupational Medicine, points out that the effective attenuation in practice is often lower than the instructions for use state. As a rule of thumb, the guideline suggests reducing the stated attenuation by twice the standard deviation, which manufacturers must also state. A good fit and correct use make the difference here.
What does this mean at Audibling?
Audibling custom earplugs are PPE-3 and compliant with EN 352. They are custom-made in our own lab, Audiform in Kilder, and have interchangeable membrane filters from Dynamic Ear Company. The attenuation of each filter is known.
| Filter series | Intended for | SNR |
|---|---|---|
| DR | General use | 7 to 19 dB |
| DM | Music and communication | 10 to 20 dB |
| DI | Industry and production | 22 to 26 dB |
| DIM | Impulse noise, level-dependent | 15 to 19 dB |
The H, M and L values for each filter are on our filter page. More background is in filters in custom earplugs explained and in our overview article what is an otoplastiek?
What employers and buyers look for
Under the Dutch Working Conditions Decree (Arbobesluit), an employer must provide hearing protection from a daily exposure of 80 dB(A), and from 85 dB(A) wearing it is mandatory (see decibels and hearing damage). When choosing, pay attention to these points.
- CE marking with the identification number of the notified body.
- Reference to the right part of EN 352, for example EN 352-2 for earplugs.
- SNR and HML that match the measured noise level. Not too little attenuation, but not unnecessarily much either.
- Instructions for use and EU declaration of conformity, or the web address where that declaration can be found.
- Fit and wearing comfort, because hearing protection that is not comfortable is worn less. The NVAB guideline recommends custom earplugs for continuous exposure.
- For impulse noise, the peak values too. See hearing protection against impulse noise.
Want custom earplugs for your team? For 10 or more people, we take the ear impressions on site, and from 10 pairs your own logo can be added. See Audibling Business or check the prices. For building sites there are, for example, earplugs for construction, and for production earplugs for food and pharma.
Frequently asked questions
What does PPE Category III mean?
It is the highest risk category of the PPE Regulation (EU) 2016/425, for risks with very serious or irreversible consequences. Harmful noise falls under it, so hearing protection is always Category III.
Is EN 352 mandatory?
The Regulation is mandatory. The standard is the means to show that you comply with it. Anyone who follows a harmonised standard such as EN 352 gets a presumption of conformity with the requirements that standard covers.
Where can I find the SNR of my hearing protection?
On the product label or, if that is not possible, on the packaging and in the instructions for use. At Audibling, the SNR of each filter is on the filter page.
What does the number after CE mean?
For Category III PPE, it is the identification number of the notified body that supervises production.
Sources
- Regulation (EU) 2016/425 on personal protective equipment (EUR-Lex, Dutch version)
- Implementing Decision (EU) 2023/941 with the harmonised standards for PPE (consolidated text, EUR-Lex, Dutch version)
- Arboportaal, Wat zegt de wet over lawaai op het werk? (what the law says about noise at work, in Dutch)
- NVAB, Multidisciplinaire richtlijn Preventie beroepsslechthorendheid (guideline on preventing occupational hearing loss, PDF in Dutch)
- Dynamic Ear Company, acoustic filters for custom moulds
More articles
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Design your earplugs
Choose your colour and filter online. The ear impressions are included in the price and you pay at the hearing centre.