CE - Mark - How Your PPE's Conform To Legal Standards

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EVERYTHING YOU NEED TO KNOW ABOUT

THE “CE” MARK


&
HOW YOUR P.P.E. CONFORMS TO LEGAL STANDARDS.
WHAT IS ?

The letters "CE" are an abbreviation and come from the French phrase
"Conformité Européene" which literal meaning is "European Conformity".
The Mark is mandatory for specific products that are sold in the
European Economic Area (EEA).

Marking on a product is a manufacturer's declaration that the product


complies with the essential requirements of the relevant European health,
safety and environmental protection legislation, in practice by many of the
so-called Product Directives.

Product Directives contains the "essential requirements" and/or "performance levels" and
"Harmonized Standards" to which the products must conform. Harmonized Standards are the
technical specifications (European Standards or Harmonization Documents) which are
established by several European standards agencies (CEN, CENELEC, etc).
OFFICIAL MARKING

The official mark comprises the letters C and E, with their shapes based
on a series of circles. There should be a specific amount of space between
the letters – if you imagine the inner curve of the C to be a complete
circle, the outer curve of the E should align with that circle.

The mark should always be at least 5mm high and, unless there’s a
reason the logo can’t be affixed to the product itself, it should be included
on the packaging or accompanying documents. The mark shall be
affixed to the product unit and its packaging and user instructions if any.
This shall be done during production, by the manufacturer. The mark
shall also be permanent, so a sticker is not enough.
OFFICIAL MARKING

Sometimes, alongside the mark can be seen a code which represents


the ID number of the respective Notified body needed for conducting the
product’s certification.

CE Logo

Commission Notified Body Number


WHICH COUNTRIES REQUIRE MARKING?

All of the 28 EU member states: Austria,


Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands,
Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden and the UK.
Three members of the European Free Trade
Association: Iceland, Liechtenstein and Norway.

In addition, Turkey has fully implemented many of the marking directives, even
though it’s not a member of the EU or the EEA.

Switzerland is also not an EU or EEA member. However, it is part of the European


Free Trade Association, so accepts marking as a presumption of conformity
with its own national technical regulations for some products.
THE "CHINESE EXPORT" MARKING

The “Chinese export” mark can be seen on some, not all, products
produced in and exported from China. The mark which looks almost
identical to the marking but with slightly different dimensions, and if
you don’t know how to distinguish it from the real CE mark, it can look
identical to you. As a result, you can think that your product is CE marked
and safe to use.

It is believe that the China Export symbol is meant to identify that a


product was exported from China. Some Chinese manufacturers say that
any similarities between the symbol on their product and the mark is
purely coincidental.

The “Chinese export” mark is not an official European mark and is


considered as fake. Such products haven’t had any risk assessment, safety
evaluation, or testing. They haven’t been certified against the relevant CE
standards, and their placing on the EU market.
HOW TO DISTINGUISH A REAL MARK FROM THE
CHINESE EXPORT MARK
Official European China
Conformance Mark Export Mark

The difference is not only in the meaning. The “Chinese export” mark
resembles the official European CE Mark, it doesn’t respect its dimensions
or proportions. The letters are formed identically, but the C and E will
appear much closer together than they do on the official symbol. The
correct CE mark has the E started on the circular profile drawn out by the
C character.
It’s not uncommon to find products with what appears to be a CE mark,
but with the wrong dimensions or proportions. This could mean one of
two things:
1. The product shouldn’t carry the CE mark (product doesn’t conform to
the relevant standards), & an illegitimate (incorrect) mark has been
applied to the product.
2. The product should carry the CE mark, but the manufacturer has used
the wrong symbol.
HOW TO DISTINGUISH A REAL MARK FROM THE
CHINESE EXPORT MARK
Conformité Européenne China Export

Manufacturer declares that the Manufacturer declares that


product conforms to EU standards. the product is made in China
ARE YOU SURE THAT YOUR PPE IS LEGAL, COMPLIANT
AND THEREFORE SAFE TO BE USED?
There are an increasing number of reported cases of non-compliant and,
by definition, illegal items of PPE being placed on the market. Counterfeit
PPE is also on the increase, with well-established product brands or
designs being the primary target. Often these products do not perform as
they should, endangering lives and exposing an organisation to risk of
prosecution.

To help combat this ever increasing problem, the British Safety Industry
Federation (BSIF) has created the Registered Safety Supplier Scheme
(RSSS). Companies displaying the scheme’s shield have signed a binding
declaration that the safety equipment they offer meets the appropriate
product performance standards, is fully compliant with the PPE Directive
and is therefore legally carrying the mark.

All Registered Safety Suppliers are independently audited to confirm


compliance with the scheme’s requirements. A full list of registered
companies is available at www.bsif.co.uk
ARE YOU SURE THAT YOUR PPE IS LEGAL, COMPLIANT
AND THEREFORE SAFE TO BE USED?

CHECKLIST YES NO
Is the mark present on the product marking/labelling?
If present on the product, is the mark in the correct font and at least 5mm high?
For high risk products, including respirators and chemical protective clothing, is the mark
accompanied by a 4-digit number? (E.g. 0120)
Were written instructions for use provided with the product?
Are the instructions for use printed in clear and legible text*?
Are the instructions for use written in at least English*?
Is the name and address of the manufacturer detailed on the user instructions?

*It is a requirement of the PPE Directive that the instructions for use are precise, comprehensible and provided at
least in the official language(s) of the Member State of destination (i.e. the country in which the product is sold).

If you answered “No” to one or more of the questions then you should
immediately contact your PPE supplier. As a minimum the supplier of the
product should be able to provide you with an EC Declaration of
Conformity or EC-Type Examination Certificate for the specific product in
question.
WHAT ARE A MANUFACTURER’S RESPONSIBILITIES
WITH REGARD TO CE MARKING?
It is the manufacturer’s responsibility to ensure that products are designed and made in accordance with
relevant legislation. They must also draw up the required technical documentation and ensure that
appropriate assessment procedures are carried out.
Once compliance has been demonstrated, a manufacturer should then write up a declaration of
performance and/or certificate of conformity and affix the mark to the product.
Other responsibilities include:
• Maintaining records such as technical documentation and declarations of performance.
• Ensuring that suitable procedures are in place, so series productions remain in conformity. FPC Factory
Production Control
• Ensuring products bear a type, batch or serial number for identification purposes. This may also be
included on the packaging or a document accompanying the product.
• Indicating name, registered trade name and an address at which they can be contacted. This should be
on the product, the packaging or a document accompanying the product.
• Ensuring a product comes with instructions and safety information in a language that can be easily
understood by end-users.
• Taking appropriate steps if a product is believed to not conform with the relevant legislation. This could
mean correcting the problem, withdrawing the product or recalling it.
• Providing national authorities with information and documentation as necessary to demonstrate a
product’s conformity.
REVIEW ON MARKINGS ON ALL PPE

Be aware, there have been previous cases of marks being applied to


products which have not been assessed to meet high safety, health, and
environmental protection requirements of the EEA.

With this in mind, it is recommended that a general review is conducted


on the markings of equipment across sites.

All PPE shall meet the requirements of:


• BS,
• EN,
• ANSI,
• AS/NZ or DIN standards
• and be CE marked.

Remember that the importer / buyer is responsible for ensuring


compliance with the applicable directives.
HOW TO CHECK IF MY PRODUCT IS MARKED?

The easiest way to check that a product has marking is to look for the
symbol. It should be on the product itself, or on the packaging or
information that came with it.

If you suspect that a manufacturer is misusing the mark, you can


request a certificate of conformity and/or a declaration of performance.
This should provide test results and other information about how the item
meets the relevant requirements as well as stating which harmonised
European Standard the product has been marked as conforming to.
HOW TO CHECK IF MY PRODUCT IS MARKED?
HOW TO CHECK IF MY PRODUCT IS MARKED?
HOW TO CHECK IF MY PRODUCT IS MARKED?
DOCUMENTATION REQUIRED:
1. DECLARATION OF CONFORMITY (DOC)

The Declaration of Conformity is a document issued by either the importer


or the manufacturer, which includes the following information:
• Product identification/SKU
• Product features
• Name and address of the manufacturer/importer
• List of EN standards or directives
• Location
• Responsible individual

The DoC is the primary document used to demonstrate compliance to


government bodies, retailers and even end-consumers.
DECLARATION OF CONFORMITY (DOC)
SAMPLE
DOCUMENTATION REQUIRED:
2. TECHNICAL FILE
In addition to the DoC, the importer is also required to set up a technical file. This document regards the
technical aspects of a product, combined with testing and quality control procedures and documents.
Below follows an overview of the information the technical file shall at a minimum include:
• Description of the items.
• Concept designs, drawings, wiring & circuit diagrams, component schemes,
sub-assemblies, part lists, etc.,
• List of standards applied in full or in part
• Testing (in house or made by third parties) and quality control procedures
• Test reports and quality control records
• Marking and labeling copies
• Risk assessment
However, the specific information a technical file shall include is outlined in the applicable EN or EC
directive. The technical file, unlike the Declaration of Conformity, must not be made public or shared with
retailers, or direct customer. The importer is required to present the technical file, only if requested by EU
or local authorities.
Thus, the importer is legally required to obtain copies of the technical file from the Chinese manufacturer.
But, as the technical file contains detailed product information such as circuit diagrams, virtually no
suppliers are willing to hand it over prior to the buyer placing an order.
As such, the only workable way to create a technical file is for you to create it entirely on your own. This is
not an issue when concerning custom designed products, but technical files for private label products
require a certain degree of reverse engineering.
TECHNICAL FILE
SAMPLE
DOCUMENTATION REQUIRED:
3. USER MANUAL

You must create a user manual including the following information:


• Instructions on how to install the product
• An overview of the relevant parts and part names of the product
• Safety instructions
• Instructions on how to use the product
• Instructions how to recharge and/or refill the product and
• Instructions on how to dispose of the product in an environmentally
friendly manner
USER MANUAL
SAMPLE
DOCUMENTATION REQUIRED:
4. TEST REPORT
While the test report is part of the technical file, I also want to highlight that you cannot
rely on test reports issued by the buyer. While lab testing is not mandatory for most
products, it’s the only way to verify that a product is compliant.
Further, test reports are ‘de facto’ mandatory in the
sense that the customs authorities and national consumer
market surveillance authorities often request test
reports to verify if the product is compliant. They have
the legal right to seize and order a recall for any product
they deem unsafe.
Test reports issued in the name of the supplier can in some cases be accepted. That
said, this is only the case if the test reports matches the following:
• Product name/SKU
• Manufacturer identity
• Applicable directive/EN standard
However, it’s extremely rare that a supplier can provide a complete set of verifiable test
reports. In virtually all cases, the importer has no choice but to book a lab test.
TEST REPORT
SAMPLE
TAKE ACTION NOW

Going forward, maintain a register of PPE which includes the following:


1. A list of all PPE in stock and in use.
2. Copy of declaration of conformance certificate for each item of PPE.
3. The product tester name for each item of PPE.
4. Copy of product tester European Commission registration as a
certification body.

Maintaining this register removes any doubt about PPE authenticity and,
by extension, any doubt about the ability of provided PPE to perform it’s
intended function. Where you cannot demonstrate certificates of
conformance for any item of PPE, you should risk assess the use of this
PPE in the immediate term, with a view to replacement in the short term.

Start by removing all critical non compliant PPE such as full body
harnesses & lanyards or full face shields used when grinding / cutting from
service immediately and replaced with compliant PPE and work your way
down the list of PPE. Don’t let the products you identified endanger the
life of the person/s who will be using it.

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