Understanding CE marking: our experts offer detailed explanations and advice to help you navigate personal protective equipment (PPE) clothing regulations and usage.

 

For PPE clothing users

The obligations are set out in the “PPE users” directive, namely Directive 89/656/EEC of 1989-11-30 and related legislation (2009/104/EC and 2019/1832).

Employers are required to put in place comprehensive measures to protect their employees. PPE provides protection against residual risks. The employer must ensure that the PPE is appropriate to the risks, in collaboration with the company’s various internal committees.

PPE that offers the appropriate level of protection must be made available to employees free of charge. It must include:

• CE marking to certify conformity;
• complete user information on each item of clothing;
• manufacturer’s declaration of conformity.

 

What does a CE-type examination involve?

 

PPE manufacturers and European Regulation (EU) 2016/425

The products that PPE clothing manufacturers [ST1] place on the market must comply with the essential requirements of European Regulation (EU) 2016/425.

To this end, the manufacturers must abide by the following procedure:

1. Characterise the level of risk against which their PPE is going to protect its user. This will define the certification rules (see A).
    
2. Precisely define all the risks. This will set all the necessary standards during the certification process (see B).
    
3. The manufacturer will choose its notified body, in this instance CTC.
   The majority of PPE clothing (see C) is Category II. For Category III PPE, an annual control system should be established (Module C2 with CTC or Module D with another notified body).
    
4. The manufacturer will send the notified body (NB) a product specification sheet, which includes:
   • the risks covered by the PPE as well as its field of use;
   • a complete description of production (materials, assembly site, etc.);
   • the results of tests confirming the conformity of the products (see B);
   • the final marking of the clothing (see D);
   • the PPE instruction manual.
      
5. Once the notified body (NB) has awarded an EU type- certification number, the manufacturer:
   • issues its declaration of conformity;
   • affixes the CE marking on its products;
   • may sell its PPE clothing throughout the European Union and in many other countries;
   • remains at the disposal of the market surveillance authorities;
   • undertakes an annual production control (Module C) to ensure that all production is homogenous, complies with the requirements of the regulation and achieves the performance levels set on the EU-type examination certificate.

 

A. Characterise the level of risk

Classification	Category I	Category II	Category III
	Minor risks	Other risks	Fatal or irreversible risks
Procedures	Module A	Module B and Module C	Module B, Module C and Module C2 or D
Examples	Professional rainwear	Clothing against mechanical risks	Clothing against chemical risks
Manufacturer's obligations
	Technical file Instructions for use Technical file	Technical file Instructions for use Technical file	Technical file Instructions for use Technical file
	N/A	CE examination by a NB	CE examination by a NB
	Monitoring of conformity of production by the manufacturer	Monitoring of conformity of production by the manufacturer	Monitoring of conformity of production by the manufacturer Annual production control by NB
	Declaration of conformity CE marking	Declaration of conformity CE marking	Declaration of conformity CE marking

 

B. Choose the applicable standard(s)

EN ISO 13688	Protective clothing - General requirements
EN 13034	Clothing against liquid chemicals - Requirements for chemical protective clothing offering limited protection against liquid chemicals (Type 6 and Type PB [6] equipment)
EN 14325	Protective clothing against chemicals - Test methods and performance classification of materials, seams, joints and assemblages of chemical protective clothing
EN 14404	Knee protectors for work in the kneeling position
EN 14605	Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items of clothing protecting parts of the body only (Types PB (3) and PB (4))
EN 17092-1 à -6	Protective clothing for motorcyclists - Class A / AA / AAA / B / C clothing
EN 17353	Enhanced vision equipment for moderate risk situations
EN 61482-2	Protective clothing against the thermal hazards of an electric arc
EN ISO 11611	Protective clothing for use during welding and allied processes
EN ISO 11612	Clothing for protection against heat and flame
EN ISO 20471	High visibility clothing
EN ISO 27065	Protective clothing worn by pesticide applicators and re-entry workers

 

C. Choose your notified body (NB)

In 1992, CTC became one of the very first PPE notified bodies (NB), assigned number 0075. Since this date, we have issued more than 45,000 EU type-examination certificates for safety footwear, protective gloves and protective clothing.  

Our competencies are assessed and guaranteed by our ISO 17025 (Testing) and ISO 17065 (Certification) accreditations. 

The professionalism and validity of our physical and technical tests help our clients make the safest PPE clothing.  [ST1] 

CTC has extensive and long-standing experience in the safety testing of materials and products. The European REACh legislation is the strictest in the world. CTC will help you determine which relevant critical substances to test for. Incorporating safety requirements helps to ensure that the products comply with Annex XVII of the REACh Regulation. 

CTC participates actively in PPE standardisation as well as in the coordination of notified bodies (NB).

	CTC Shanghai and CTC Dongguan CNAS-accredited laboratories CTC Shanghai: CNAS L4577 CTC Dongguan: CNAS L5912
CTC Asia, HKAS-accredited laboratories in Hong Kong

 

D. Marking system for protective clothing

 All CE-marked clothing guarantees a high level of protection, comfort and durability based on the following marking standards:   

The clothing must conform to the requirements of the European regulation. Conformity is established by the implementation of harmonised European standards applicable in all European Union countries. 

Use of CE marking: manufacturers accept their responsibility with regard to the conformity of their products. This conformity is verified by a notified body designated by its national authorities and registered with the European Commission (NANDO database). 

In addition to the CE marking, international standards impose a secondary indication identifying the protection claimed by the clothing

MECHANICAL RISKS EN 388 - WXYZα (P)	COLD RISKS EN 511 - XYZ	CHEMICAL HAZARDS EN ISO 374-1
IMPACT CUT  EN 1082	RISKS RELATED TO MICRO-ORGANISMS AND VIRUSES EN ISO 374-5	THERMAL RISKS EN 407 - EN 12477
		or
RADIOACTIVE CONTAMINATION EN 421	HEAT AND FIRE HAZARDS FOR FIREFIGHTERS EN 659	HAND-HELD CHAIN SAWS EN ISO 11393-4
MOTORCYCLISTS EN 13594	RISKS ASSOCIATED WITH PESTICIDES ISO 18889	INFORMATION

 

PPE clothing testing and analysis

Chemical and phytosanitary risks (PPE agriculture / viticulture)

Protective clothing against chemical and/or phytosanitary risks is Category III PPE in compliance with Annex I of the PPE Regulation (EU) 2016/425. It requires an EU-type examination certificate (Module B) and an annual production control (Module C2 or D)

 

Protection against chemicals - testing methods used by CTC  

The goal of these standards is the health and safety of operators who have to handle or be in the presence of chemicals on an occasional or permanent basis. Workers can be endangered through skin contact with these chemical substances.

 

 

Testing and compliance with PPE for farmers

The aim of EN ISO 27065 is to ensure the health and safety of farmers who handle liquid plant protection products. Professionals can be put at risk by skin contact with these chemicals.

 

CTC uses three testing methods to assess the performance of “Chemical Risk” PPE

ISO 22608	Measures the repellency, retention and penetration of a known volume of liquid applied to a protective clothing material.
EN ISO 19918	Enables the ability of PPE materials, closures and seams to resist the cumulative permeation of liquid chemicals characterised by low vapour pressure (less than 133.322 Pa at 25°C) and/or insolubility in water to be determined.
EN 16523-1	Determines the resistance of materials to chemical permeation.

 

CTC’s guarantees