Certification and Consultancy Services for 2016/425/EU PPE Regulation

Personal Protective Equipment (PPE) refers to specialized design and production products used to protect the safety and health of workers. PPE products are commonly used in workplaces, construction sites, the healthcare sector, and many other industrial and commercial environments. As Sertifike we are providing solutions to PPE producers based on our 15+ years experience. The design, manufacturing, and marketing of these products are subject to strict regulation and standards within the European Union (EU). These regulations serve the purpose of protecting human health and safety and are encompassed under the 2016/425/EU PPE Regulation.

What Is the 2016/425/EU PPE Regulation?

The PPE Regulation is a legal framework that regulates the design, manufacturing, inspection, and marketing of personal protective equipment within the EU. This regulation sets minimum requirements to ensure the suitability of PPE products for human health and safety. The requirement for products to bear the CE marking defines PPE products that comply with the requirements established under this regulation. You can contact to any Sertifike expert to have more information about PPE directive.

PPE Certification and Consultancy Services

Manufacturers of PPE products must undergo a certification process when they wish to affix the CE marking to their products. This process can be complex, requiring manufacturers to understand and implement regulatory requirements. This is where PPE certification and consultancy services come into play.

These services provide the following benefits to manufacturers:

Compliance with Standards

The ability to assess whether PPE products conform to relevant standards.


Certification Process

Guidance on navigating the certification process, granting manufacturers the authority to affix the CE marking to their products.


Testing and Evaluation

Coordination and assistance with the testing and evaluation of products.


Documentation Preparation

Assistance in preparing the required documentation, including technical files and declarations.


Legal Compliance

Ensuring compliance with EU legal requirements.


Ongoing Monitoring

Monitoring and ensuring ongoing compliance with EU regulations, keeping products up to date.


Certification and CE marking under the 2016/425/EU PPE Regulation are essential for protecting workplace safety and human health. This intricate process may necessitate manufacturers to seek professional certification and consultancy services. These services not only ensure product compliance but also assist employers in safeguarding their employees. PPE certification and consultancy services contribute to a safer and healthier future for businesses and workers alike.

Which PPE are covered by this directive?

Personal Protective Equipment (PPE) refers to equipment, clothing, or devices used to protect the bodies, heads, eyes, ears, hands, and feet of workers from hazards in the workplace. PPE can be used for various purposes and types depending on the working conditions. Here are some common examples of personal protective equipment:

Head Protection:

  • Hard Hat: Used to protect the head from impacts.
  • Helmet: Provides protection against chemical splashes or electrical hazards.
  • Bump Cap (EN 397): Used for head protection in construction and industrial work.

Eye and Face Protection:

  • Safety Glasses: Offer eye protection against dust, particles, or chemical splashes.
  • Face Shield: Provides comprehensive protection against chemical splashes or acid vapors.
  • Goggles and Face Shields (EN 166): Used for broader face coverage.

Hearing Protection:

  • Earplugs: Provide protection against high noise levels.
  • Ear Muffs (EN 352): Used to protect ears in noisy workplaces.

Respiratory Protection:

  • Dust Mask: Offers respiratory protection against dust, smoke, or chemical particles.
  • Respiratory Mask (EN 149): Provides protection against gases, vapors, or toxic chemicals.

Hand and Arm Protection:

  • Gloves: Offer protection against chemicals, cuts, or hot surfaces.
  • Arm Guards (EN 388, EN 407, EN ISO 20420): Used to provide extra protection to the arms.

Foot Protection:

  • Steel-Toed Work Boots: Protect the feet from impacts and falls.
  • Safety Boots (EN ISO 20345): Offer protection against chemicals, hot surfaces, and slippery floors.

Body Protection:

  • Disposable Coveralls: Provide body protection against chemical splashes and dust.
  • Workwear (EN 14126, EN 13034, EN 14065, EN ISO 13688, and EN ISO 13982-1): Used for more durable body protection.

Personal protective equipment is crucial for protecting workers against workplace hazards and should be used in compliance with occupational health and safety regulations. Employers are responsible for providing suitable PPE and encouraging employees to use this equipment correctly to ensure their safety.


CE certification for Personal Protective Equipment (PPE) is essential because it indicates that these products meet specific safety standards in European Union (EU) countries. Obtaining CE certification is important for the following reasons:

Public Health and Safety

CE certification assures users that personal protective equipment meets necessary standards for safety and effectiveness. It contributes to a safer work environment, helping prevent serious accidents and injuries.


Legal Compliance

Companies selling or allowing the use of personal protective equipment in EU countries are legally obligated to have CE certification. Selling uncertified products can lead to bans and legal liabilities for businesses.


Market Access

CE certification allows products to move freely within the EU market. This opens doors to a wide market for companies that manufacture or sell PPE. Products without CE certification may face challenges in accessing the EU market.


Quality and Reliability

CE certification enhances the quality and reliability of products. This benefits users and employers by providing better protection and long-term cost savings.


In conclusion, obtaining CE certification for personal protective equipment plays a crucial role in ensuring user safety, legal compliance, market access, and product quality. This certification indicates that the product meets specific safety standards and is therefore essential.