Navigating the Regulations for Personal Protective Equipment

At Together Comply, we specialize in helping companies understand and apply product regulations in Spain and the European Union.

In this brief summary, we will address a topic that affects a wide range of everyday products: The Regulations for Personal Protective Equipment (hereinafter PPE). From swimming goggles to carabiners used in outdoor activities, this regulation ensures that the products we use for our protection are safe and effective.

What are the Regulations for Personal Protective Equipment?

The regulation for personal protective equipment (Regulation (EU) 2016/425) is a European Union regulation designed to ensure that all PPE on the market offers the appropriate level of protection.

This regulation is crucial not only for consumer safety, but also for trust in the products used daily by millions of people in Europe.

Objectives of the Regulation

The regulation establishes strict requirements for the design, manufacture and commercialization of PPE. The main objectives include:

• Ensure the quality and safety of PPE
• Provide a clear framework for conformity assessment.
• Facilitate the free movement of these safe products in the European single market.
• Application of the Regulation to Common Products
• Products such as swimming goggles and carabiners, although they seem simple, must comply with this regulation if they are intended to protect the user from risks. This includes protection against physical, chemical or even biological hazards, depending on the environment in which they are used.

Compliance with the Regulations for Personal Protective Equipment

To ensure compliance with the regulations for personal protective equipment, manufacturers must follow a detailed process that includes risk assessment, appropriate design to minimize those risks, and rigorous product testing.

• Risk Assessment: Identify all possible risks that could be caused.
• Design and manufacturing: Develop the product to specifically meet the identified protection needs.
• Test reports: Perform tests to ensure that the product meets protection requirements.
• Technical Documentation: Prepare comprehensive documentation that demonstrates compliance with all legal requirements.
• Declaration of Conformity: Issue a declaration assuring that the product complies with the regulations.

Importance of CE Marking

All personal protective equipment must bear the CE marking, which must be visible, legible and indelible. The CE marking indicates that the product has been evaluated before being placed on the market and complies with EU legal requirements in terms of safety.

Regulations for Personal Protective Equipment in Spain

In Spain, the European Regulation for personal protective equipment is applied in the same way as in any other member state of the EU, which is directly applicable and is also complemented by Royal Decree 773/1997.

Without a doubt, working hand in hand with a regulatory expert will help you navigate the intricate world of regulatory compliance, ensuring that your products meet all the necessary compliance requirements, to be marketed in Spain and throughout the EU.

Challenges and Considerations

Although the process may seem daunting, compliance brings significant benefits, including access to the European market, one of the largest and most regulated in the world, in addition to establishing an entry barrier for new competitors who decide to enter the market. However, manufacturers must be prepared to face challenges such as:

• Keep up to date with changes in legislation
• Ensure that the entire supply chain meets the required safety standards.
• Efficiently manage the documentation and tests necessary for compliance.

How Together Comply Can Help You

As specialists in regulatory compliance, Together Comply we are dedicated to simplifying all this related process, carrying out regulatory studies of your products, analyzing the regulations that affect them and even preparing complete technical documentation, to evaluate their compliance.

We understand that each product and each market has its own challenges and requirements, and we're here to help you ensure that your products not only meet these requirements, but also exceed safety and quality expectations.

In addition to complying with regulations, adequate compliance with the Regulations for personal protective equipment improves the perception of your brand and strengthens consumer confidence in your products. This can translate into a significant competitive advantage, especially in a market as security-conscious as the EU.

Navigating the EU's regulatory framework doesn't have to be a daunting process. With the right support, compliance can be managed in a way that not only protects consumers, but also supports and encourages the growth of your business.

EPI on Amazon

If you sell on Amazon or on any Marketplace, including your own website, any type of product considered to be EPI, you must also comply with all the obligations imposed on you by the Regulations and carry out the conformity assessment of your product.
Marketplaces such as Amazon are already starting to ask for documentation related to product compliance, such as instruction manuals, safety warnings, SDS documents or declarations of conformity.
If Amazon, bol.com or any Marketplace is asking you for compliance documentation for your products, contact us and we'll be happy to help, because good advice guarantees a good result.