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19 Things You Need to Know Regarding the PPE Regulation

 The new Personal Protection Equipment (PPE) Regulations are quite straight forward and do not change the responsibilities for end-users. Though, you may still have questions regarding the safety equipment you’re purchasing. We have put together the following guide of the most frequently asked questions regarding the new PPE regulations for you to use as a quick reference.

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What are the New Personal Protection Equipment Regulations?

The new PPE regulations detail new responsibilities all manufacturers distributors and importers of PPE products must follow. The additional/revised rules include a new definition of PPE, new classifications of products, additional testing and certification requirements, and added responsibilities for all economic operators in the PPE supply chain. As an end-user, your only responsibility is to be aware of the requirements to ensure the safety equipment you purchase complies with the new regulations that ensure optimal health and safety for your workers.

 

What Are The Main Changes to the PPE Regulation?

We highly recommend taking the time to thoroughly read through the new requirements set forth in the new PPE Regulation. However, as a crash course, the main changes include a new definition of Personal Protective Equipment, new classifications of PPE products, additional testing and certification requirements, and added responsibilities for all economic operators in the PPE supply chain.

Some additional changes to make note of include:

  • The new Regulation was changed from a Directive to a Regulation
  • The scope is larger
  • New responsibilities for economic operators which includes manufacturers, suppliers and distributors
  • The EU declaration of conformity must be easily accessible for Market Surveillance
  • More detailed conformity assessment procedures that require a risk assessment process and post-market surveillance
  • Requirements must be compliant at all times, including during the formal claim substantiation process
  • 5 year validity certificates
  • PPE products must be traceable via the traceability system
  • Single point of contact must accompany the product
  • Additional requirements for notified bodies
  • Old directive will be withdrawn on April 21, 2019

 

Why is there a New PPE Regulation?

Great question! After all, you’re likely wondering if the older products you still have in-house are safe to use – and yes, they are (as long as they follow the previous regulations).

The new PPE Regulations were put in place to ensure all manufacturers, suppliers and importers comply with the new safety measures. These regulations make it easier for dangerous PPE products to be detected and removed from the market, which brings trust and safety back into the entire PPE industry as a whole.

For end-users, this means that you can trust the PPE products you’re purchasing because any “bad” PPE products would have already been found and taken off the market. The new rules make it difficult for lower grade products to slip through the system.

 

What is the Objective of the New PPE Regulation?

The new Regulation was put in place to make it easier to detect and remove dangerous products from the market. It was also designed to:

  • Improve traceability
  • Reinforce market controls
  • Deliver a collaborative system for marketing surveillance

 

What Does Traceability Mean?

One of the main reasons for the revised Regulation is to make it easier to remove dangerous PPE products from the market. Traceability means that all PPE products must have:

  • A traceable history
  • Market surveillance authorities must be able to find the liable economic operators
  • Market surveillance authorities must be able to obtain evidence of product compliance

The requirements include labeling the PPE products and identifying economic operators in the distribution chain. This is crucial to make note of, as if public authorities recall products and are unable to distinguish between lot numbers, all products of that type must immediately be removed from the market. This can be detrimental and costly to your business.

 

Are Distributors Obligated to Keep Track of Lot Numbers for Products Sold?

All distributors must have their own traceability system put in place that allows them to keep track of lot numbers per products sold. Even if you sell to another economic operator, whether a reseller or another distributor, you need to know which products/batches of products are going where. Work gloves, chemical safe gloves, safety gloves, how the new safety standards affect you, how to prevent workplace hazards, easy ways to prevent workplace hazards, changes to EN374, new EN 374, EN ISO 374, how the new safety standards affect you,

 

Do Manufacturers Need to Identify Type, Batch or Lot Numbers of PPE Products?

Yes. Manufacturers of PPE products must identify the PPE with a clear link to the technical documentation that shows the conformity of that specific type of PPE. This can be done by adding the use of a product designation, and by adding the name and address of the manufacturer’s address onto the product.

 

Does the New PPE Regulation Requite a Date of Obsolescence?

As for the date of obsolescence for PPE products subject to aging, it doesn’t need to be mentioned on the product itself but it is recommended. However, if the product is not marketed itself, the packing must have the date of obsolescence which, according to the new regulation, includes the month and year of production, and/or the month and year of obsolescence.

If the PPE products are not affected by aging, you are not required to mention a date of obsolescence.   

 

Does the new PPE Regulation Affect My Company?

The new PPE Regulations only impact economic operators, which includes PPE manufacturers, importers, and distributors. If you are an economic operator, you must ensure all PPE products are fully compliant with the new requirements.
As an end-user, your responsibilities don’t change.

 

What Does the New PPE Regulation Mean for Distributors?

Prior to distributing any PPE products, you must verify that each product contains the correct markings as per the new PPE Regulation. This includes all certifications, cover designs, and marketing of PPE products. The new rules also mean that you will want to avoid putting any non-compliant products on the market, and any products found to be non-compliant must be reported to the competent authorities.

 

When Does the New Regulation Go into Effect?

The regulations went into full effect on April 21, 2019. Any PPE product certificates that already have the old PPE directive will be valid until April 21, 2023 or until they expire. Any new PPE products will need to be certified specific to the new regulation and new EN374 standards when it’s time to update old certificates, but this must be done prior to April 21, 2023, regardless.

 

What Areas Is the New PPE Regulation Applicable?

The new Personal Protective Equipment Regulations are applicable in all EU countries, including Iceland, Norway, Lichtenstein, Turkey and Switzerland.

 

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About Ansell’s PPE Products

Now that you understand the details of the new PPE Regulation, you may be wondering how Ansell safety products come into play. Here are your most commonly asked questions and the answers you’re looking for.

 

What Has Ansell Done to Support the New Regulation?

Amazing question! Ansell has already made all necessary changes required by the new PPE Regulation, despite the deadline being 2023. We support the new efforts put in place to ensure safe work equipment available on the market, we wanted to take initiative which resulted in us making the changes immediately.

Additionally, Ansell’s Global Regulatory Compliance Director, Guido Van Duren, was actively involved in the discussion regarding the changes. He is the former president of ESF and was one of the vital members in the discussions with the Commissions to ensure optimal safety measurements and PPE products.

 

Are There Requirements for Products That Are Purchased in Bulk but Sold in Smaller Quantities?

It is common practice to purchase PPE products in bulk and then sell them in smaller quantities. This may have caused some questions to arise regarding whether there are requirements needed to ensure the smaller quantity of products have the proper USE/CE markings. For example, if the supplier of your PPE products has marketed the case of products, but not the individual products.

If you are a distributor of PPE products, you are obligated to ensure the marking and documents are available with each first commercial packaging. If the original packing is altered, you must make sure that the new PPE is still in compliance.

 

If Distributors Sell PPE Products to a Country that Speaks a Different Language, Who Is Responsible to Provide Relevant Language?

All manufacturers, importers and distributors are obligated to ensure that all PPE products are provided with the IfU in a language that can be easily understood by end-users. This is determined by the Member States.

 

What if the Language Translation is “Bad” or Done Incorrectly?

You’ve decided to take the initiative and make the translations. You’ll want to ensure all information mentioned in the IfU is clear and understandable, as bad translations are considered to be non-compliant and will not be accepted.

 

Are EU Type Examination Certificates Invalid if Alternations Are Made?

Manufacturers must be informed and asked for a formal acceptance prior to making any changes, whether a repair, new logo, tags, etc.). Depending on the response, it is then the manufacturer’s responsibility to assess and accept (or refuse) the response. If accepted, the manufacturer needs to clearly describe the alterations in the technical file of the manufacturer.

 

What is the EU Declaration of Conformity?

The new PPE Regulations require that any PPE products must be accompanied with the EU Declaration of Conformity (EU DoC), which requires an internet address to be detailed in the Instructions for Use where the EU DoC can be accessed.

Additionally, the EU DoC must be available in all EU languages that are required by Member States.

 

Can a Distributor Return Unused PPE Products if the Packaging Is Unopened?

Any opened PPE products cannot be returned, as the integrity of the PPE is immediately affected once taken out of the packaging. However, if the PPE product is not opened, distributors can return the product. Though, the products must be in the original packaging and the packaging must be in good condition. More importantly, it is still up to the manufacturer or distributor to decide whether they will accept or refuse such returns.

  

In order to ensure compliance with the new PPE Regulations, we highly recommend taking time to thoroughly read through the documentation. However, these questions and answers are a great place to start that inform you of some of the most vital information for PPE manufacturers, suppliers and importers, as well as end-users.

All Ansell PPE products have already been updated for full compliance. So, if you’re looking for a trusted brand that you don’t have to conduct an abundance of research on to ensure it follows the new PPE Regulation, shop Ansell safety products today on Sentinel Laboratories.

How The New EN374 for Dangerous Chemicals and Micro-Organisms Affects You

With all the talk surrounding the changes to the EN374 regarding dangerous chemicals and micro-organisms, you’re likely wondering how this will affect you. The new safety standards set forth in the EN374 pertain to, but are not limited to, new testing methods, innovative marks, and additional requirements in an effort to increase protection within the workplace.  

 

You Must Meet Standards In more Countries

The old EN requirements were created by the European Committee, thus it was only applicable in Europe and in a select few affiliate countries like Australia. The old ISO requirements were created by Standards Organizations and it was only accepted if it complied with the local regulations in European areas.

The new requirements have combined the EN and ISO, making it applicable in all of Europe, as well as any countries that accept ISO. Previously, only a select few of affiliate countries had to follow these requirements. As such, it’s imperative to do research to determine whether you’re in an area where the new standards are now mandatory. If so, you will be required to comply with new safety standards.

 

Additional Testing is Required

One of the major changes to the EN374 is the increased testing required for Work gloves, chemical safe gloves, safety glovesvarious components, such as permeation, degradation, and protection against bacteria and fungi. These new requirements will change the way you test your safety products. We have provided a detailed article on this topic specifically but here’s a quick breakdown:

Permeation Testing

All permeation testing now includes six additional categories from M through T, as well as 12 new chemicals. The way the testing is done has also changed, as any cuffs on safety gloves that are greater or equal to 400mm must be tested. 

Degradation Testing

Degradation tests are entirely new to the EN374. These tests, Puncture Degradation Resistance Test and the Weight Change Test, were implemented to ensure optimal production against chemicals that come into contact with safety gloves.

These new tests affect you, as they are not optional – you must complete these degradation tests and record the results as a percentage of any changes that occurred after exposure. This must be recorded in the ‘Instruction for Use’.

Micro-Organisms Testing

The new EN ISO 374 requires a new method for testing for micro-organisms to ensure optimal protection against fungi and bacteria. Additionally, there is “Method B” which has been added to the new standards that are supported with a new pictogram.

  

Restrictions on Work Gloves Claiming Protection Against Chemical Risk

Anytime you make a claim, there are many requirements to follow. The changes to the EN374 require that any work gloves claiming protection against chemical risk must include:

  • Type C, B or A performance with the permeation test method
  • Glove leakage proof must use the En374-2:2014 method
  • Chemicals tested against in the degradation performance test must be available
  • Chemicals tested against in the degradation performance test must be supplied by the manufacturer

 

New Markings on Protective Gloves

Once your workplace safety gloves have passed all the new requirements, the marking must be updated to meet the new EN ISO standards. Previously, there were only two markings – EN 374:2003 (AKL) and EN 374:2003.

Today, the markings are broken down into three types:

  • Type A: Permeation resistance on protective glove of at least 30 minutes each for at least 6 tested chemicals
  • Type B: Permeation resistance on protective glove of at least 30 minutes each for at least 3 tested chemicals
  • Type C: Permeation resistance on protective glove of at least 10 minutes each for at least 1 tested chemicals

Experts agree that the new classifications aren’t likely to generate changes between product categories that are already on the market. For new products, it’s imperative to ensure they have markings specific to the new standards. 

 

Optimal workplace safety is imperative and the new EN ISO 374 increases the standards to improve protection for workers and businesses dealing with chemicals. Please do not hesitate to contact us for Technical Advice from your independent distributor.

 

7 Common Workplace Hazards and How to Prevent Them

 Workplace hazards happen far too often, especially considering how preventable they are. It’s imperative to take the proper actions to ensure the safety of the people who make your company whole. We’ve put together the following list of the top workplace hazards and what you can do to prevent them from disrupting the lives of your employees and the success of your business.

 

Slips and Falls

The most common workplace hazards fall into the category of slips and falls. These can occur for many reasons – from wet floors to uneven floor surfaces; from loose cables to an unorganized workspace; from uneven stairs to faulty railings, and many more. These types of workplace hazards pose a threat to both your safety shoes employees and customers. Fortunately, they are easily avoidable.

How to Avoid Slips and Falls in the Workplace

To avoid slips and falls from occurring in your workplace, it’s imperative to put proper safety regulations in place and to reinforce them. This may be guidelines regarding putting away products, cleaning up pills and proper stacking processes, or requiring proper, slip-resistance footwear to be worn at all times.  

 

Electrical Hazards

In every business, you’ll find an abundance of electrical appliances, devices and wires. They are essential in today’s modern world but unfortunately, they are incredibly dangerous if not installed and maintained properly.

How to Prevent Electrical Hazards in the Workplace

The first step to avoiding electrical hazards from happening in your workplace is to educate your employees and to require proper workplace equipment to be worn at all times. Give your employees first aid training and a health and safety course to take.  The second step is to maintain all electrical installations in a timely manner, such as replacing damaged cables as soon as you notice them. Not only can electrical hazards be extremely dangerous for your employees but they can lead to fires which leads us into the next workplace hazards.

 

Fires

Fires happen significantly more than many people believe. They aren’t something you just see on the news and they can happen to anyone at any time, particularly if electrical units are faulty. However, fires can also stem from poor cleaning standards and a lack of education.

How to Prevent Fires in the Workplace

One of the first steps to preventing fires in the workplace is to ensure all employees are fully aware of any flammable materials and the proper steps for using them safely. It’s also imperative to have fire alarms, extinguishers and detectors spaced throughout the building, and possibly even fire sprinkler systems installed in the case of a fire happening. Additionally, your employees will need to know how these systems work and a detailed escape plan should be practiced to ensure everyone knows what to do in the case of a fire.

If your employees work around flames, fire-resistant workwear should be worn at all times to prevent injuries.

 

Inhalation of Dangerous Chemicals, Gases and Materials

Despite there being a vast array of face masks being on the market, illnesses linked to the inhalation of dangerous chemicals, gases and materials are still one of the top workplace hazards. This is particularly true for jobs that occur in small,inhalation safety masks poorly ventilated spaces. However, the hazard is there regardless of the ventilation system and space of the room. 

How to Prevent Inhalation of Dangerous Materials

If chemicals, gases or dangerous materials are being used, protective work gear must also be used at all times. It’s also crucial to take the time to educate your employees on the importance of wearing protective masks and safety gloves, and outline rules with regards to how far away from a substance they should be before removing the safety equipment.

 

Chemical Hazards

In addition to the inhalation of dangerous chemicals, gases and materials, every business has hazardous materials that can be dangerous to handle, such as basic cleaning supplies. Exposure to chemicals pose the risk of many potential chemical hazards which include, but are not limited to skin irritations, eye injuries, burns, blindness and even death. Unfortunately, these workplace injuries happen more than they should, especially considering how easy they are to prevent.

How to Prevent Chemical Hazards

Like most workplace hazards, education about the materials being handled by your employees is absolutely crucial. The more your employees can know about the chemicals in the products and workplace, the better. It’s just as important to then provide and enforce all employees to wear protective work gear for the specific chemicals they handle. For example, a pair of safety gloves for handling chemical A may not be as protective when handling chemical B. So, it’s imperative to know about the chemicals and to be fully aware of the protective gear that needs to be worn. It may even be required by the law in your area.

 

Physical Harm

For jobs in construction, fire and rescue, trades and many others, physical harm is a prominent risk that comes with the job. These jobs put employees in dangerous situations that can lead to fatal mistakes if proper safety gear is not worn.

How to Prevent Physical Harm in the Workplace

Education is always the best way to prevent hazards in the workplace. The more your employees know about the risks, the more prepared they’ll be to prevent them from occurring. However, mistakes do happen and some things are beyond full protective garmentsone’s control which is why it’s essential for all employees to wear protective work gear when on a job site. For some industries, this may be a full protective garment and for others, it may be a combination of safety gloves and hard hats, respiratory masks and disposable overshoes.

 

Excessive Noise

One of the most commonly forgot about workplace hazards is noise, which has resulted in this workplace hazard to be one of the worst yet most common occurrences in the workplace. Loud noises can cause a lot more damage than simply making your employees’ ears ring. It can result in damage to your employees hearing and even permanent hearing loss. Now, you may be thinking that your workplace isn’t loud on a regular basis but even if there is the odd loud sound, whether it’s peak sound waves from equipment or a machine that needs to be repaired, your employees should be wearing ear protection.

How to Prevent Hazards from Noise

Wearing protective ear equipment is the first step to eliminating workplace hazards caused by excessive noise. This may be as simple as requiring your employees, such as wearing industrial ear plugs or something more serious, noise-reducing headphones.

Secondly, you must take proper action to eliminate any sudden loud noises in the workplace. For example, if a machine is “acting up” and making extremely loud sounds, it should be turned off until it can be repaired.

 

Proper education and wearing the right protective work gear are key to ensuring the safety of your employees and business. Sentinel Laboratories manufactures and supplies laboratory equipment and disposable products that help you provide a safe work environment that reduces the risk of common workplace hazards occurring.  

 

  • Chantal McCulligh

Shocking Workplace Safety Statistics That Will Remind You To Take Proper Safety Measures

 

No one likes to be the barer of bad news but when it comes to workplace safety, ignorance isn’t bliss. In order to provide proper protection in the workplace, one must understand just how common workplace injuries and hazards are. After all, unless you’ve experienced a workplace hazard yourself, it seems like a foreign topic that you only hear about on the news. However, workplace injuries are happening right in your very own backyard and to prevent them from happening in your company, you must acknowledge the risks.

 

Unhealthy Working Conditions Contribute To The Burden of Disease

World Health Organization conducted a study to determine the health impacts associated with unhealthy work conditions. They found that at least 1.6% of the burden of disease was caused by unhealthy work conditions and although that number may seem small, it’s frightening. The same study also found that the following workplace factors that contribute to the burden of disease include:

  • Injuries: 40% of the occupational burden of disease
  • Noise: 22% of the occupational burden of disease
  • Carcinogens: 18% of the occupational burden of disease
  • Airborne Particulate Matter: 17% of the occupational burden of disease
  • Ergonomic Hazards: 3% of the occupational burden of disease

 

Construction, Transportation and Storage, and Manufacturing Have The Highest Incidence Rate of Non-Fatal Accidents At Work

Studies have found that the three industries with the highest incidence rate of non-fatal accidents at work are in the following industries:

  1. Construction
  2. Transportation and storage
  3. Manufacturing industries

What’s shocking is that these three industries have remained as the top industries for non-fatal accidents at work from 2010 to 2015, when the data was last updated. Thus, it’s safe to say that enough isn’t being done to prevent non-fatal accidents at work, particularly in these three industries.

 

62.4% of Accidents At Work Resulted in the Worker Being Unable to Work for Less Than Three Months

The same study reported that 64.4% of accidents that occurred at work in 2015 resulted in the victim being unable to work for less than three months. These accidents happened mainly in the human health and social work activities (68.9%), 71.2% were in the accommodation and food service industries and 78.8% were in the public administration and defense industries.  Additionally, 8% were off work for longer periods with some experiencing permanent incapacity. 0.1% of these accidents were fatal. Aside from the morale issue of not being able to provide a safe environment for workers, having victims off work for extended periods of time can be costly and even detrimental to your business.

 

Mining and Quarrying Industry Results in 15.9% of Victims Being Off Work for Three Months or More

In comparison, the non-fatal accidents that required the victim to be off work for three months or more occurred in the mining and quarrying field with 15.9% of incidences requiring prolonged periods of time off.

 

Agriculture, Forestry, Fishing and Mining Have The Highest Fatal Rates

Of the accidents that were recorded in the 2015 study, 0.2% resulted in death. The agriculture, forest and fishing industries accounted for 0.3% of these fatalities, and the mining and quarry industries were responsible for 0.7%.

 

Shoulders, Arms, Hands, Hips, Legs and Feet Are The Most Common Body Parts Injured in Non-Fatal Workplace Accidents

Studies revealed that of the non-fatal workplace accidents that occur, the most common body parts injured were the to the upper body which includes shoulders, arms and hands (39.4%), and to the lower extremities which includes hips, legs and feet (28.9%). Notably, back injuries also accounted for 12.7% of all non-fatal workplace injuries.  

 

And that’s only to name a few of the most recent statistics pertaining to workplace injuries. Needless to say, it’s imperative that a stronger approach is taken towards providing a safe work environment for workers. Shop Sentinel Laboratories for premium safety gear for workers and together, let’s decrease the statistics.

  • Chantal McCulligh

The Crucial Changes Made to EN374 for Dangerous Chemicals and Micro-Organisms

Times have changed and so have the safety standards for safety work gloves. As of 2016, the EN ISO provides new standards for gloves that workers use to protect their hands from dangerous chemicals and/or micro-organisms. These include but are not limited to new testing methods, increased protection, innovative marks and vast requirements. Today, we discuss the most important EN374 changes and what they mean for workers and businesses operating with dangerous materials.

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