European regulation
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9th March 2016 covers the procedures for the certification of Personal Protective Equipment (PPE).
PPE is defined as:
“Equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety;
Based on the risk level against which it protects, PPE is classified in:
Category I PPE
PPE intended to protect against the minimal risks that can cause minor injuries: the procedure laid down to Annex IV (Module A) “Internal check on Production” applies.
Category II PPE
PPE intended to protect against non-minor injuries, but with no serious or mortal consequences: the certification by a Notified Body is necessary and the procedure laid down to annex V (Module B) “EU-Type Examination” applies.
Category III PPE
PPE intended to protect against risk of death or permanent serious injuries: the certification by a Notified Body is necessary and the procedure laid down to annex V (Module B) “EU-Type Examination” applies.
On category III PPE, one of the following regular monitoring procedures chosen by the manufacture applies:
- “Conformity to type based on internal production control plus supervised product checks at random intervals” (Annex VII (Module C2);
- “Conformity to type based on quality assurance of the production process”
ANCCP Service
ANCCP Certification Agency is a body, who is notified to European Union (n°0302) for granting the Category II and III PPE EU-Type Conformity Certificates according to the following procedures:
- Annex V (Module B);
- Annex VII (Module C2);
- Annex VIII (Module D)
Macro areas for which ANCCP grants certificates are:
- eyes protection;
- lower limbs protection (legs, feet);
- upper limbs protection (arms, hands);
- general body protection;
- protection against fall from a height;
- protection against radioactive contamination;
- Protectors for motorcyclists (head excluded)
ANCCP Certification Agency carries out also certification activities for industrial laundries for the conformity assessment of the control process of High visibility PPE after washing, according to the requirements 4.1, 5.1 and 6.1 of standard EN ISO 20471:2013/A1:2016. This activity is carried out voluntarily.
People concerned
Manufacturers, importers, distributors and economic operators who want to place on the market products defined as Personal Protective Equipment by Regulation (EU) 2016/425 have to get the conformity certification that allows placing the CE Marking on the finished product.
CE Marking allows selling PPE in all European Union countries. This together with the fulfilling of the EU Declaration of Conformity.
In addition, if the PPE placed on the market is category III PPE, it is necessary that the Manufacturer gets the conformity to type according to one of the following procedures:
- “Conformity to type based on internal production control plus supervised product checks at random intervals” (Annex VII (Module C2);
- “Conformity to type based on quality assurance of the production process”.
PPE Technical / Harmonized standards
- EN 342 – EN 14058 (protective equipment against cold);
- EN 343 – (protective equipment against rain)
- EN 353-1 (PPE against fall from height – rigid anchor line)
- EN 353-2 (PPE against fall from height – flexible anchor line)
- EN 354 (fall protective lanyards)
- EN 355 (energy absorbers)
- EN 358 (belts and lanyards for work positioning)
- EN 361 (full body harnesses)
- EN 362 (connectors)
- EN ISO 11393 (protection against hand-held chainsaw)
- EN 388 (gloves – mechanical risks)
- EN 407 (gloves – heat and fire)
- EN 659 (gloves – firefighters)
- EN ISO 21420 (gloves – general requirements)
- EN 420 (gloves – general requirements)
- EN 469 (fire-resistant clothing)
- EN 510 (protective clothing against entanglement)
- EN 511 (cold-resistant gloves)
- EN 795 (Anchor devices)
- EN 1073-2 (radioactive contamination)
- EN 13277 (protective equipment for martial arts)
- EN 1149-5 (electrostatic properties)
- EN ISO 11611 (welding clothing)
- EN ISO 1162(heat and flame)
- EN 13034 (liquid chemicals- limited protection)
- EN 13594 (gloves for motorcyclists)
- EN 17092 (clothing for motorcyclists)
- EN ISO 13688 (protective clothing – general requirements)
- EN ISO 13982-1 (solid particles)
- EN ISO 14116 (flaming – limited flame spread)
- EN 14126 (infective agents)
- EN 14404 (knee protectors)
- ISO 15384 (wildland fire-resistant clothing)
- EN 14605 (liquid chemicals – liquid/jet and spray)
- EN ISO 20471 (high-visibility)