PPE 2016/425 for personal Protection Equipment

The PPE (EU) 2016/425 (hereinafter referred to as PPE Regulation) defines the essential requirements and regulations for personal protective equipment.

In addition to the terminology, it also defines the responsible authorities, security measures and obligations.

What is the significance of the PPE Regulation for protective gloves?

If disposable gloves are also defined as protective gloves by the manufacturer, they must conform to PPE 2016/425.

The PSA-VO differentiates between the hazards against which the glove protects. In general, gloves can protect against the following risks: mechanical injuries, heat / fire, cold, electric shocks, radiation, protection against substances and mixtures that are hazardous to health and harmful biological agents.

Depending on the risks to be protected, a glove is assigned to a corresponding category. Below are all the risks and categories that are defined for personal protective equipment in accordance with the PPE Regulation

Important information for entrepreneurs with employees

Only when the CE mark is affixed (which requires a corresponding declaration of conformity !!) are gloves considered to be protective gloves.

Just simple tests according to e.g. EN 374 without a corresponding declaration of conformity are not sufficient here.

Unfortunately, unsuitable gloves are often used as protective gloves.

This can have enormous effects and liability risks for companies with employees, as the provision of unsuitable protective equipment can mean a violation of employee protection regulations.

Especially in the context of the current pandemic, liability for the employer can arise in the worst case if employees fall ill due to incorrect protective equipment.

Requirements for protective gloves according to category III

If protective gloves protect against dangerous risks according to categories, at least the following requirements must be met:

Meet all general requirements for PPE such as ergonomics, degrees of protection, protection classes, harmlessness, comfort
Instructions and information from the manufacturer such as: storage, use, checking, limits of use, expiry date, reference to the underlying standards
Preparation of the technical documents
Preparation of a declaration of conformity
EU type examination by means of a notified body (Annex V, Module B) or
EU type examination based on an internal production control (Annex VI. Module C) or
EU type examination based on an internal production control with monitored product tests (Annex VII, Module C2) or
EU type examination based on quality assurance in relation to the production process (Annex VIII, Module D)

Infinitymed nitrile examination gloves have an EU type test according to module C2 issued by TÜV Rheinland LGA Products GmbH (Notified Body: 0197)

Important definitions of the (EU) 2016/425

It should be noted that different ordinances may have different definitions. We always refer to the respective original texts of the ordinances.

Important terms in connection with protective gloves:

"Personal Protective Equipment" (PPE): Equipment designed and manufactured to be worn or held by a person as protection against one or more risks to their health or safety
"Making available on the market": any supply, whether in return for payment or free of charge, for distribution or use on the Union market in the course of a business activity
"Placing on the market" means the first making available of a PPE on the Union market
“Manufacturer”: any natural or legal person who manufactures PPE or has PPE developed or manufactured and markets it under his name or trademark
“Authorized representative”: any natural or legal person established in the Union who has received a written mandate from a manufacturer to perform certain tasks on its behalf
"Importer": any natural or legal person established in the Union who places PPE from a third country on the Union market

The categories of the PPE Regulation

Category I.

Category I includes only the following minor risks:

a) superficial mechanical injuries
b) Contact with slightly aggressive cleaning agents or prolonged contact with water
c) Contact with hot surfaces, the temperature of which does not exceed 50 ° C
d) Damage to the eyes from solar radiation (except when observing the sun)
e) weather conditions that are not of an extreme nature

Category II

Category II includes risks that are not listed under Category I or Category II.

Category III

Category II includes only those risks that can lead to very serious consequences such as death or irreversible damage to health in conjunction with the following:

a) Substances and mixtures that are hazardous to health
b) Oxygen deficient atmospheres
c) harmful biological agents
d) ionizing radiation
e) warm environment that has effects comparable to an environment with an air temperature of 100 ° C or more
f) cold environment that has effects comparable to an environment with an air temperature of -50 ° C or less
g) falls from a height
h) Electric shock and work on live parts
i) drowning
j) Cuts from hand-held chainsaws
k) high pressure jet
l) Injuries from projectiles or knife wounds
m) harmful noise

Conclusion

The PPE regulation (EU) defines the basic framework for the manufacture and classification of protective equipment. Without a corresponding declaration of conformity, a glove may not be declared and used as protective equipment.

It is therefore advisable to ensure that the products are labeled accordingly when purchasing gloves.

References:

Original text (EU) 2016/425: https://eur-lex.europa.eu/legal-content/DE/TXT/PDF/?uri=CELEX:32016R0425