Comprehensive Guide On CE Certification: Check Now!
Have you ever looked at the backside of a product and noticed a bold black “CE” mark?
As humans, we always look for the best: the best place, the best price, and the best quality. We have standards for almost everything in life. And CE certification is one of these standards that confirms the quality of many products.
If you want to know more about CE certification, you have come to the right place.
Throughout the first section of this article, we will tell you all about CE certification.
- What is it?
- What countries require it?
- How to apply for it?
We will even tell you about the products that get certified.
In the second section, we will discuss the certification of Personal Protective Equipment (PPE). This includes the standards a PPE needs to meet.
Therefore, you will know almost everything about the EU 2016/425 as we will examine it closely. The EU 2016/425 offers information on the following:
- The categories of PPE
- Health and safety standards that the PPE must meet
- Additional requirements for particular types of PPE
- How to apply for a CE certification for your PPE
Finally, you will find some tips on how to know if a product is CE certified.
What is CE certification?
Have you ever wondered about the “CE” bold mark written on the backside of some products?
CE is an acronym for “Conformité Européenne,”; which comes from the French word “European Conformity.”
Thus, this mark indicates that the product conforms to European Union (EU) standards. Therefore, it can be sold in the European Economic Area (EEA).
Are you wondering about the process you must follow to certify your product?… Don’t worry. We will also take you through the certification process and standards.
The certificate of compliance
This certificate allows you to distribute and sell your product freely in the European market. CE certification doesn’t guarantee the product’s perfection.
However, it ensures the consumer that your product meets governmental safety standards.
Additionally, you will be surprised to know that your product doesn’t need to be manufactured in the EEA. The CE mark indicates that the product conforms with the EU standards. But it can be manufactured elsewhere.
CE certification is necessary to sell your product in the EEA. Furthermore, it ensures that your product meets the environmental and safety requirements set by the EU.
What are the countries that require CE certification?
All the countries of the European Union require CE certification. In addition to the EU countries, Switzerland also recognizes the CE bold mark. It accepts CE certification as an insurance stamp of quality.
But if you come from a non-EU country, why would you consider applying for CE certification?
Let us share the advantages of having your product CE certified.
Pros of CE certification
- It guarantees your product doesn’t face safety issues.
- The CE certification offers your product a competitive edge.
- The certificate of compliance allows you to sell your products in European Union countries.
- Boosts the public’s confidence in your product’s quality.
- It reduces the risk of product recall due to defects in manufacturing.
- It enhances your product’s manufacturing processes.
- The certification process offers you some positive feedback to improve your product’s quality.
CE certification is a requirement in all EU countries and Switzerland. Thus, having your product certified will increase the public’s confidence in your merchandise.
How to apply for CE certification?
The European Union sets the standards for the CE certificate of compliance. However, each country has the power to adjust these standards.
The main goal of this process is to ensure that only high-quality products are provided to consumers. Therefore, there are specific steps that a manufacturer needs to go through to acquire product certification.
Let us give you some information about the application process for CE certification.
- Different products are certified by various EU directives. Therefore, you should check which EU directive is responsible for ensuring your product. There are six main steps you can follow to apply for certification:
- Know the requirements and standards your products need to meet.
- Determine whether the product needs to be assessed by the certification directives.
- Ensure that your product conforms with the set standards.
- Gather your paperwork.
- Apply for the CE certificate of compliance.
What are the products that require CE certification?
Some products don’t require CE certification as they are subjected to other standards. For example, chemicals, pharmaceuticals, cosmetics, and food supplies are all monitored and audited by specialized governmental entities.
On the other hand, several other products require CE certification to be sold in the EEA. These products include:
- Electronic products
- Telecommunication and IT equipment
- Household appliances
- Electromagnetic compatibility products
- Equipment and protective systems intended for use in potentially explosive
- Refrigerators and freezers
- Machinery and measuring instruments
- Personal protective equipment
The following section will discuss CE certification for Personal Protective Equipment (PPE).
What is CE certification for PPE?
PPE is used to provide protection. These are equipment used or worn by a person to protect them from chemical, mechanical, or physical hazards.
Thus, these products need to be manufactured to the highest standards. Going through the process of CE certification guarantees this.
Therefore, PPE needs to follow the EU 2016/425 standards. These standards apply to almost all types of PPE. However, PPE used by the armed forces, on sea vessels, or by motorcyclists are subjected to other EU standards.
What types of PPE are CE certified?
Personal protective equipment comes in different shapes. For instance, PPE includes:
- Safety glasses
- Hard hats
- Coveralls and hazmat suits
- Vests and full-body suits
PPE is manufactured and tailored to fit comfortably. This encourages workers always to use them. Additionally, some of them are manufactured to be reused. Therefore, they can be disinfected and sanitized to reduce costs.
All of this is governed by a set of standards that a PPE must meet. Meeting these standards will provide both comfort and safety to the consumer.
Workers face all sorts of threats in their workplace. These threats include chemicals, heat, radiation, and biological hazards. Thus, PPE needs to be made to specific standards.
CE certification ensures the quality of face shields, eye goggles, coveralls, and other PPE.
What is the EU 2016/425?
The EU 2016/425 (1) is a regulation guide for PPE. This regulatory guide provides you with all the information you might need to get your PPE certified.
Thus, the guide includes the following:
- Personal protective equipment definition
- Market placement
- Information for manufacturers
- Authorized representative
- Information for importers and distributors
- Technical specification
- Harmonized standard
- The accreditation process and the national accreditation body
- Conformity assessment and conformity assessment body
- What happens when there is a need for recalls or withdrawals
- CE marking
Now, allow us to shed light on some of the sections of the EU 2016/425.
The guide categorizes PPE according to the hazards they combat. Therefore, the following three categories are available:
This category includes PPE that can withstand the following:
- Mild mechanical injuries
- Some cleaning chemicals
- Wet environments
- Hot environments (temperature can reach 50oC)
- Some atmospheric conditions
- Exposure to sunlight
This category entails all the hazards that lie between classes I and III. Any threat that doesn’t fit into the other two types is considered a category II risk.
This category offers the highest level of protection. The risks that need to be combated at this level are life-threatening.
These risks include:
- Oxygen deficiency
- Electric shocks
- Extreme temperatures (100oC and – 50oC)
- Harsh chemicals and biohazards
- Sharp blades
- Falling from a height
PPE categories offer protection against hazardous environmental, mechanical, chemical, and biological conditions. This categorization helps manufacturers and consumers determine their PPE’s expected protection.
Health and safety standards for PPE CE certification
The standards set by this guide are essential for applying for the CE certification. Therefore, you shouldn’t only adhere to them and consider developing them as much as possible.
Among the standards set by the EU 2016/425 are:
The PPE should be designed in a manner that can provide optimum protection. The designer should take into consideration any possible hazards the user might face.
Thus, when designing the product, you should aim to provide a level of protection that surpasses any possible risks.
Additionally, it would be best if you considered the different levels of protection your product will offer.
This section focuses on the safety of the PPE product itself. For instance, it states that the PPE design shouldn’t place the user in any harm. Therefore, the materials used in the manufacturing process should be safe.
The PPE surfaces that contact the user’s skin must also guarantee comfort.
Furthermore, the PPE aims to ensure the user’s safety, but it can’t hinder his flexibility. Thus, it should be designed in a manner that minimizes this risk.
Comfort and efficacy
To ensure the user’s safety, you should consider the size of your PPE. It would be best if you also thought about its ability to conform to the user’s body.
For example, gloves need to be of a snug fit to ensure they won’t come off while using them. Respirators have attachments that help them stay in place and ease breathing.
Thus, your PPE design should be adaptable and adjustable. This means that they should be compatible if you provide different types of PPE.
Additionally, your PPE must be strong enough to provide protection. Yet, it should be light so as not to hinder the movement.
Instructions provided by the manufacturer
This section guide’s the manufacturers on the information that should be offered to the user. The manufacturers should specify to the user the storage, maintenance, and cleaning procedures of the PPE.
Additionally, they should enlist the expiry date of the product and the level of protection it offers. The information about the CE certification body should be listed on the product’s packaging.
To acquire your PPE CE certification, you need to conform to the standards set by the EU 2016/425.
As a manufacturer, you must consider your PPE’s design. You are expected to test your product to ensure it offers the highest level of protection against possible hazards.
Additionally, your product should be harmless. The materials used and the design should be thoroughly examined to guarantee this.
Thus, it is expected that your PPE should be comfortable and adjustable to facilitate its use. However, you should list all the product information on the packaging.
Additional certification requirements for several types of PPE
The guide offers some specific requirements for certain challenging situations in this section. So, let’s take a look at some of these situations.
Among the requirements of PPE certification is the need for detailed information on the aging of your PPE. The manufacturer needs to warn the user of any substances that can lead to the deterioration of the product.
Rapid interventions and the risk of PPE getting caught
Some of the parts of your PPE might need to be detachable. This will protect the user in case these parts get caught up in anything.
Additionally, if you work in an environment that requires you to act fast, you must consider time. Your PPE must be easily worn and taken off to minimize time loss.
Your PPE should be inert. This means that the PPE’s material should not cause sparks that can lead to ignitions.
Falls and mechanical impacts
You should consider its grip if your PPE is used in slippery environments. As a manufacturer, you may consider attaching a harness to your PPE. This will prevent the user from falling from high places.
However, more instructions must be followed if you manufacture PPE for falls.
On the other hand, to protect the user from mechanical impacts, your PPE should be shock-absorbent.
This section guides you with information on manufacturing PPEs that are used in wet environments. For instance, if you’re PPE is used to protect from drowning.
Thus, it needs to be made from a material that allows you to float and quickly inflate.
Additionally, your PPE is required to be light enough to facilitate your movement in such environments.
Cold, heat, and fire
It needs to be insulated if your PPE is meant to protect you from heat, cold, or fire.
Therefore, PPE used in hot environments is made using materials that can withstand thermal blasts. They are also designed to endure molten metal splashes. Additionally, PPE used to combat flames needs to be flame-resistant to ensure the user’s safety.
On the other hand, those used in cold environments need to offer protection from cold splashes. The products need a guide on how to use them in low temperatures.
Electrical shock and radiation
It must be thoroughly marked whether your product is intended to insulate or conduct electricity. The user must be able to find all the information needed on the PPE’s usage on the package.
On the other hand, radiation-protective PPE are manufactured according to the wavelength of the material they combat. Radiation-protective PPE is manufactured to protect the whole body.
Thus, the guide offers information on PPE used to protect against non-ionizing and ionizing radiation.
The additional requirement section includes information on PPEs that protect you from several conditions. These conditions include extreme temperatures, falling from high altitudes, and being struck by an object. These conditions are explained in detail in the EU 2016/425.
Additionally, you will find information on PPE used in wet environments, explosive atmospheres, and while diving.
How to get your PPE CE certification?
To get your PPE certified, you can adhere to the following steps.
Internal production control
During this step, the manufacturer ensures that his product complies with the EU standards previously mentioned. Then, the manufacturer declares that their products adhere to these standards.
In this step, the manufacturer will submit the paperwork needed for the certification. This paperwork should at least include the following:
- Description of the PPE, its use, and the tests they will be subjected to.
- The design of the PPE.
- A list of standards that the PPE was manufactured in compliance with.
- The results of all the tests the PPE will go through must be documented.
- Documentation of how the product complies with EU standards.
The manufacturer will adhere to the technical documents provided during this step. They will ensure they follow the same procedures and designs to offer a superior product.
The PPE is evaluated and examined to determine its conformity. Additionally, all the documents supplied by the manufacturer will be reviewed.
The committee will issue a declaration of conformity if the product passes the EU inspection.
After getting your product CE certification, you are required to add the CE mark on the product. Additionally, they must keep their EU declaration of conformity for ten years.
However, this step may be finalized by a representative of the manufacturer.
To certify your PPE, you need to know the required standards for its manufacturing and adhere to them. Additionally, you must document every step of the manufacturing and testing process. Then, it would be best to have your product tested to ensure its quality.
How to be sure that a PPE is CE certified?
If you’re a consumer, your head is probably spinning after reading all this. And you’re possibly wondering how to recognize CE-certified products?
Look for the CE mark.
You will find the CE mark on the packaging of the PPE you want to purchase. However, the mark alone is not enough. Next to the CE mark, you should find the numbers of the governmental body responsible for certifying the product.
Thus, if one of these two items is missing, the product is not certified.
Find the health safety instructions
All CE-certified PPE come with detailed information on how to use them. You can also find information on cleaning and maintaining them in more than one language.
Request the CE certificate or the declaration of conformity
As previously stated, the manufacturer must keep these documents for ten years. Therefore, you can request to see copies of them to guarantee that the product has been validated.
Contact the British Safety Industry Federation (BSIF)
The BSIF audits PPE annually to determine its status. Thus, you are encouraged to contact them if you have questions about the product you wish to buy.
To make sure the product you are purchasing is certified, you can check its package for the CE mark. However, if you still have doubts, we recommend contacting either the manufacturer or the BSIF.
CE certification doesn’t mean that the product is of the highest quality. It simply means that this product conforms to EU standards.
Thus, CE certification of PPE means that they can be sold in the EEA. It also creates a competitive advantage for your product.
However, being CE-certified does guarantee the product’s effectiveness. These products must meet specific standards for them to be certified.
The EU 2016/425 is a comprehensive guide on the standards PPE needs to meet to be certified. It also offers information on the certification process and how to apply for it.
Additionally, the EU 2016/425 includes all the needed information about special hazards and the requirements to face them.
Therefore, if you are in the production of PPE, we encourage you to look at the EU 2016/425.
But if you want to buy one, that’s another story. If you read through this article, you are ready to go ahead and buy what you want.