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CE Certification Guide

What is the CE Mark?

The CE mark is a European conformity mark which indicates that a product
meets the essential requirements of the relevant EU directives and standards for that product.

What does it mean?

The CE mark is a mandatory requirement which enables free movement of products within
the European market to which the requirements apply.

http://europa.eu/about-eu/countries/

The manufacturer declares that the product is in conformity with all the essential health, safety and environmental requirements to achieve CE marking.

Products to which CE marking applies, must be CE compliant before they are “placed on the market” in the EU. This applies equally to products imported from outside the EU and to those manufactured within the EU. CE compliance is the responsibility of the person or company placing the product on the market e.g. manufacturer, importer, distributer, or retailer. An importer takes on the responsibilities of the manufacturer to ensure that the product continues to comply with the CE marking requirements.

N.B. “Placing on the market” is the point at which the product passes from the supply chain to the end user. The product does not have to be part of a financial transaction; it could also be a free gift or sample.

What does it not mean?

CE marking is not a certification, an approval or a quality mark. The term ‘CE compliance’ is a more accurate description, since in the majority of cases, this can be achieved by self-certification.

CE does not stand for China Export!

Benefits of CE marking

Products must comply with harmonised EU requirements. CE marked products have free movement within the EU; countries cannot impose additional national requirements to prevent a product being placed on the local market. This in turn brings cost benefits to the manufacturers and enhances the safety of products within the EU.

CE Marking – New Approach Directives

Products falling within the scope of one or more of the following directives must be CE marked:

Directives or Regulations and Standards

Reference of directive/regulation

Subject of directive/regulation

2000/9/EC

Cableway installations

(EC) 1907/2006

Chemical substances (REACH)

89/106/EEC

Construction products (CPD)

(EU) 305/2011

Construction products (CPR)

(EC) 1223/2009

Cosmetics

92/42/EEC

Eco design – hot-water boilers

2010/30/EU

Eco design and energy labelling

2009/125/EC

Eco design and energy labelling

(EC) 1221/2009

Eco-management and audit scheme (EMAS)

2004/108/EC

Electromagnetic compatibility (EMC)

94/9/EC

Equipment for explosive atmospheres (ATEX)

93/15/EEC

Explosives for civil uses

2009/142/EC

Gas appliances (GAD)

2009/128/EC

Inspection of pesticide application equipment

95/16/EC

Lifts

2006/95/EC

Low Voltage (LVD)

2006/42/EC

Machinery (MD)

2004/22/EC

Measuring instruments (MID)

93/42/EEC

Medical devices (MDD)

90/385/EEC

Medical devices: active implantable

98/79/EC

Medical devices: in vitro diagnostic

(EC) 765/2008

New legislative framework (NLF)

2009/23/EC

Non-automatic weighing instruments (NAWI)

94/62/EC

Packaging and packaging waste

89/686/EEC

Personal protective equipment (PPE)

97/23/EC

Pressure equipment (PED)

2007/23/EC

Pyrotechnic articles

1999/5/EC

Radio and telecommunications terminal equipment (RTTE)

2008/57/EC

Rail system: interoperability

94/25/EC

Recreational craft

2011/65/EU

Restriction of the use of certain hazardous substances (RoHS)

2009/105/EC

Simple Pressure Vessels

2009/48/EC

Toys safety

http://www.newapproach.org/Directives/DirectiveList.asp

CE Marking Standards

The list of applicable EU standards is extensive. The EU commission publishes lists of recognised standards in the Official Journal of the EU often referred to as the “OJ”. These standards are known as harmonised standards and meeting one or more of them will give ‘a presumption of conformity’ to apply the CE mark.

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/

How do I get “CE Certification”?

  1. Identify the directive(s) and harmonised standards applicable to the product

The essential requirements that products have to fulfil are harmonised at EU level and are set out in the general terms of the directives. The directives do not normally contain technical requirements, but in some cases where there are no relevant standards e.g. Eco-design, the directive may contain technical requirements. Harmonised EU standards are issued with reference to the applied directives and express in detailed technical terms the essential requirements.

  1. Verify the product-specific requirements

The manufacturer must make sure that the product complies with the relevant EU requirements. Full compliance with the harmonised standards gives a presumption of conformity with the relevant essential requirements. However, it is also possible to demonstrate conformance by providing details of the design, calculations, assumptions, certified components, etc. in the Technical Construction File.

  1. Identify if an independent conformity assessment is required from a Notified Body

In most cases there is no requirement for third party involvement in the CE marking process by a Notified Body. However, some directives do incorporate a Notified Body requirement for certain products, e.g. some products within the Machinery Directive, Medical Devices Directive, and ATEX Directive. This should not be confused with use of compliance specialists e.g. Product Approvals Ltd. to provide expert guidance and technical expertise to support the process.

  1. Test the product and check its conformity

Often the best way to demonstrate conformity with the essential requirements is to perform tests in accordance with the relevant technical standards. A recently introduced requirement for all products is a risk assessment. Dependant on the outcome of the risk assessment, the necessary level of testing and technical evidence can be determined. However, as noted above, it is also possible to reduce the testing required by including design calculations and assumptions in the technical file. Whichever route you choose, you are still required to “demonstrate conformity”; a Declaration of Conformity which is not supported by evidence is not acceptable.

N.B. An initial documentation and construction check, and pre-compliance test of the product will often indicate potential compliance issues prior to starting any formal testing. This can save considerable time and cost in the CE compliance project. Product Approvals can offer this as a “CheckTest” service.

  1. Draw up and keep available the required technical information

The relevant directives list the information which should be included in the Technical File. Until recently this has varied between directives, but the introduction of the New Legislative Framework (see below) has started to align the compliance requirements between the most frequently used directives, e.g. LVD, EMC, R&TTE, Machinery, Medical devices, etc.

In general the Technical File should include the following information:

  • Technical description and colour photographs of the product

  • Design documents: schematics, construction drawings, parts lists and certificates.

  • List of standards applied and details of solutions used to comply with the essential requirements.

  • Construction review against harmonised standard

  • Results of design calculations and assumptions.

  • Test reports

  • User and installation instructions

  • Marking and labelling information

  • Declaration of Conformity

The Technical File must be made available on demand by the national regulatory authorities.

  1. Affix the CE mark to the product and EU Declaration of Conformity

The CE mark must be affixed to the product by the manufacturer or by an authorised representative in the EU. The CE mark must conform to the size >5mm, and format of the CE mark in the CE Marking Directive. Where the size or nature of a product precludes the application of the CE mark directly to the product, it may be applied to the packaging or in some cases may be reduced in size if it is still visible and legible to the naked eye.

Placing the CE mark on a product is a visible indication that the manufacturer has declared that the product meets the applicable health, safety and environmental requirements for that product in the EU.

Declaration of Conformity (DoC)

The EC (European Community) DoC is a document which is required to be made available on request; in which the manufacturer or his authorised representative within the EEA (European Economic Area) indicates that the product meets the essential requirements of the directives applicable to the specific product. The DoC shall also contain name and address of the manufacturer together with information about the product, such as brand and serial number. The DoC must be signed by an individual working for the manufacturer or his authorised representative, and the employee’s function shall also be indicated.

EC DECLARATION OF CONFORMITY TEMPLATE

1. Model number … (unique identification of the product(s))

2. Name and address of the manufacturer or his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the manufacturer:

4. Object of the declaration (identification of product allowing traceability). It shall include a colour image of sufficient clarity to enable the identification of the product.

5. The object of the declaration described in point 4 is in conformity with the relevant Community harmonisation legislation:

6. References to the relevant harmonised standards used, or references to the specifications in relation to which conformity is declared including issue or revision level of standards:

7. Where applicable: the notified body ... (name, number)… performed … (description of intervention)… and issued the certificate:

8. Additional information:

Signed for and on behalf of:

(place and date of issue)

(name, function)(signature)

N.B. The person signing the DoC must have sufficient understanding of the technical requirements to make a valid declaration. The person signing will be held legally responsible for the compliance of the product. If that person leaves the company, a new DoC must be drawn up for the new person to sign or the person leaving may still be held liable.

CE Mark

ce mark

CE + CE = ?

It is a common misconception that a product constructed of CE compliant sub-systems will be compliant. Whilst this may be true in some cases, this does not take account of any interaction between components. E.g. Safety and EMC issues. It is also important to recognise that the CE compliance of a component or subsystem may have operating conditions attached to it. This is particularly important for example, when considering pre-compliant wireless modules incorporated into a product or when considering machine assemblies

The General Product Safety Directive (GPSD)

The GPSD is intended to ensure a high level of product safety throughout the EU for consumer products that are not covered by specific sector legislation. The Directive also complements the provisions of sector legislation which do not cover certain matters, for instance in relation to producers’ obligations and the authorities’ powers and tasks. The GPSD provides a safety net for products which do not fall within the scope of other directives.

N.B. 1 The Trading Standards Institute frequently invoke the GPSD when removing unsafe products from the market.

N.B. 2 It should be noted that the GPSD is not a CE marking directive.

Ongoing Compliance

CE compliance is not a one off event. There is a specific requirement in the EU CE Marking Directives for ongoing compliance of products. Manufacturers’ should monitor the product during its lifetime to ensure that any changes do not cause the product to become non-compliant. Examples would be substitution of safety or compliance critical components and materials with non-compliant parts. EU regulations also require that products should comply with the latest directives and standards. If a change to a standard takes place, manufacturers should assess the impact of the change and re-assess the product if there is a possibility of non-compliance. It should be noted that products must comply with the most up to date standards and regulations even if they have already been assessed for CE compliance. This does not apply to products which are in the possession of end users, but it does apply to products in production or which have not passed from the manufacturer into the supply chain.

It is a requirement of the Low Voltage Directive that the manufacturer has a robust quality system in place covering the component procurement, assembly and end of line testing of the product. In addition manufacturers should schedule routine reviews of the status of the relevant standards and directives and to review the compliance status of the product accordingly.

Ongoing compliance is one of the measures reinforced by the New Legislative Framework, see below.

http://www.productapprovals.co.uk/standards-update

Restriction of Hazardous Substances Directive (RoHS)

The RoHS directive became a CE marking directive in 2013. The RoHS Directive bans the placing on the EU market of new electrical and electronic equipment containing more than the agreed levels of lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants.

The UK enforcement body for the RoHS directive is the National Measurements Office (NMO) whom are taking a proactive approach to enforcement.

Where enforcement is necessary, the regulations give the NMO a range of powers, including:

  • The power to make test purchases

  • Powers of entry in to premises

  • Warrants

  • The power to inspect, seize and detain EEE

  • The power to request technical documentation and other evidence

  • A range of sanctions, including fines of up to £5,000 per non-compliant product.

Responsibility for compliance with the RoHS directive lays with the Economic Operators e.g. the supply chain, responsible for placing products on the market.

Batteries Directive (Non CE marking directive)

The Batteries Directive came into force on 2008. It is a EU directive which aims to control the use of mercury and cadmium in batteries. It states that batteries must be marked appropriately and can be easily removed form appliances for end of life disposal. The regulation applies to all types of batteries and those placing them on the market. This does not include automotive (starter) batteries for which different regulations apply. This is not a CE marking directive, but it is an important regulation which applies to many products.

Waste Electrical and Electronic Equipment Directive (WEEE) (Non CE marking directive)

The Waste Electrical and Electronic Equipment (WEEE) Regulations apply to all Electrical and Electronic Equipment (EEE) placed on the market in the UK covered by the scope of the Regulations. The WEEE Directive applies to businesses, public and third sector organisations and individuals involved in the sale, purchase and disposal of electrical and electronic equipment (EEE). They are required to register with a national Take Back Scheme and to log the quantities of materials recovered for recycling. The WEEE Directive is not a CE marking directive, but must be applied to all Electrical and Electronic Equipment place on the market in the EU.

New Legislative Framework

The concept of self-certification implemented in the CE marking directives has been very successful. It has resulted in a more freedom to innovate and a level playing field across Europe which in turn has resulted in higher volumes and lower prices particularly for consumer goods. However, lack of understanding of the requirements, fraudulent CE marks, and weak enforcement have resulted in abuses of the CE marking scheme.

The New Legislative Framework has addressed these issues by re-visiting the directives to ensure that they do not provide conflicting information, strengthening enforcement across the EU and making everyone in the supply chain responsible for product compliance.

This is summarised as follows:

  • The DoC and evidence of conformity must be available to everyone in the supply chain.

  • Contact information for the importer must be included on the products and in the user guides.

  • Closer co-operation between distributers, importers and the national authorities e.g. Trading Standards. Pro-active enforcement not reactive.

  • Mandatory minimum levels of surveillance in the market place.

  • Requirements for ongoing product compliance

This is a significant movement away from allowing the market to self-regulate and peer enforcement!

Enforcement

Enforcement has often been seen as the weak link in policing CE marked products. The level of enforcement activity varies across Europe. Germany and France in particular have made a point of secret shopping for products where there is a low rate of compliance. Whereas, the UK has tended to work on the basis of complaints. In recent EU Commission surveys of electronic equipment across the whole of the EU, the worst compliance was found in low power wireless products, followed closely by phone and tablet battery chargers. There have been a number of significant incidents involving chargers exploding particularly where cheap copies of top brands have been involved.

In recent times, the authorities in the UK have increased their vigilance particularly at ports. Trading Standards, HMRC and the HSE have shared their market intelligence to try and stop the import of known non-compliant products. The rogue importers have tried to get around this by moving the point of entry into the EU, but the authorities across Europe are now closely co-operating to resolve this issue.

Where a product has been found to be dangerous the authorities will work with the supplier to resolve the issue, but if the supplier fails to co-operate an EU wide ban on the product can be made and heavy penalties incurred. Products which have been removed from the EU market are shown on the RAPEX website which is updated on a daily basis. The current top products notified in RAPEX are: Toys, clothing, chargers and hair care products. The top country for nonconforming product is China with about 60% of all products notified to RAPEX.

Cheap chargers putting people and homes at risk:

https://www.youtube.com/watch?v=JjEjlh5Sehs

RAPEX webpages:

http://ec.europa.eu/consumers/safety/rapex/alerts/main/index.cfm

The NLF will make it possible to remove products from circulation in all EU countries quickly and simultaneously.

For further information please contact us:

Product Approvals Ltd.

Email: info@productapproval.co.uk

Tel: +44 (0)1588 620192