CE Marking

(Conformitè Europëenne)

Overview

There are two groups of UK law that deal with the provision

of work equipment:

Supply law that places requirements on manufacturers and suppliers. An important example is the Supply of Machinery (Safety) Regulations 2008. These regulations require manufacturers and suppliers to ensure that machinery meets relevant Essential Health & Safety Requirements and is safe when supplied.
User law that places requirements on the users of machinery and other work equipment. Provision and Use of Work Equipment Regulations 1998 (PUWER 98) apply to most pieces of work place equipment.

In relation to these requirements, CE Marking is an important consideration during manufacturer and procurement of workplace equipment. CE marking requirements may also apply where equipment with applicable EU directives is manufactured for in-house use.

The CE mark is required for all new products which are subject to one or more of the European product safety Directives. CE marking is the manufacturer's declaration that the product is safe and meets the requirements of the applicable EU directives. The CE mark supports the free movement of goods within the European Economic Area (EEA).

Products that require CE marking include machinery, pressure equipment, personal protective equipment, construction products and low voltage electrical equipment. The definition of machinery is included in the Supply of Machinery (Safety) Regulations 2008 and includes:

safety components (e.g. guards), independently placed on the market;
a complex production line made up of individual machines and equipment;
interchangeable equipment that only works when attached to a tractor or machine, such as a plough or lifting attachment;
lifting equipment and lifting accessories; and
chains, ropes and webbing for use in or with machinery.

There are some specific exclusions in the regulations. Important exclusions include:

machinery specially designed or put into service for nuclear purposes although some European member states do not exclude nuclear equipment; and
machinery for research purposes for temporary use in laboratories.

Not all work equipment has associated EU directives and, therefore, not all equipment requires CE marking. Examples of work equipment not requiring CE marking are non-powered hand tools, racking and ladders.

Brexit Implications

UK law will change due to the UK’s departure from the EU. However, the CE Mark will continue to be a legal base mark for products on the UK market for a period of time.

UK guidance on CE marking is provided on both the GOV.UK pages and the Health & Safety Executive (HSE) pages. These pages will be updated to reflect the progressive impact of Brexit.

Manufacturer Responsibilities related to CE Marking

New Legislative Framework

The New Legislative Framework was a larger initiative by the European Union to align several EU “New Approach” directives. It improves market surveillance rules, conformity assessment and establishes a common legal framework for industrial products.

Economic Operators

There are four types of economic operator:

Manufacturer
Authorized Representative
Importer
Distributor

Each Economic Operator has specific obligations which they must meet. CE marking responsibility rests with the Responsible Person which in most cases is either the manufacturer or the manufacturer's authorised representative. The Responsible Person can be the Importer for non-CE marked products imported from outside the European Economic Area (EEA).

CE Marking Steps

There are six basic steps that Manufacturers need to follow to affix a CE marking to a product:

Identify the applicable directive(s) and harmonised standards.
Verify product specific requirements including hazard and risk assessment
Identify whether an independent conformity assessment (by a notified body) is necessary.
Test the product and check its conformity ensuring all relevant Essential Health & Safety Requirements are met
Draw up and keep available the required technical documentation.
Affix the CE marking (and where necessary, other marking) and draw up the Declaration of Conformity.

Manufacturer responsibilities are considered in more detail in the sections below.

Conformity Assessment

Before placing new products on the market, or bringing them into service, for the first time the manufacturer (or their authorised representative) must carry out a conformity assessment.

There are three basic types of conformity assessment:

Self-assessment
Product Verification involving EC Design or Production type-examination. This requires product assessment by a Conformity Assessment Body (CAB) often a notified body. (A notified body, in the European Union, is an organisation that has been designated by a Member State to assess the conformity of certain products.) The notified body issues an EC Design or Production type-examination certificate.
Full quality assurance. The management system used to manufacture a product is assessed by a CAB.

The type of conformity assessment required depends on the relevant Directive and the nature of the product. The manufacturer follows a risk categorisation process to select an appropriate conformity assessment procedure. Full details of the required assessment procedures are normally within the Annexes, of each European product safety Directive.

CE Marking of Products

The CE mark must be permanently affixed on a product and is required to conform to certain rules;

the initials "CE" must be in the prescribed form;
the letters must be at least 5mm tall (unless this is not possible due to product size);
the prescribed proportions must be maintained whatever the size;
the mark must be attached to the product visibly, legibly and indelibly; and
the mark must be in the immediate vicinity of the name of the manufacturer or his authorised representative.

The information that accompanies a CE mark on a product varies. Space and size restrictions may limit the amount of information that can be included on a product. Where space is restricted the remaining information is included in the product information or on packaging. Typically, the information provided is:

the CE mark;
notified body reference (if there is a notified body);
details of the manufacturer;
notified body certification reference (if applicable);
the standard or specification that the product complies with;
product data;and
safety or warning information.

Declaration of Conformity

The Declaration of Conformity is a legal document which needs to be completed for all CE Marked products sold in the European Union with few exceptions. This document contains key information, including:

the name and address of the organisation taking responsibility for the product;
a description of the product;
Year of manufacture
a list which product safety Directives the product complies with;
may include details of relevant standards used; and
be dated and signed by a representative of the organisation.

For most new products the Declaration of Conformity must accompany the product through the supply chain to the end user but there are exceptions such as electrical equipment within scope of the Low Voltage Directive 2014/35/EU.

Technical Files

Manufacturers (or their authorised representative) must compile a technical file, which must be kept for a specified period up to ten years. The file is required to demonstrate how the product complies with all relevant Directives. Typical contents of the technical file are:

information concerning the products design assessment and construction, including information showing how relevant essential safety requirements have been met;
the conformity assessment procedure applied to the product;
a copy of the Declaration of Conformity (and any other Declarations of conformity or Incorporation relevant to the product or its subassemblies);
a copy of the User Instructions (in English);
details of relevant research and test reports;
and where a series of products are made, details of the quality systems to assure the safety of those products.

Normally the technical file does not have to be permanently available in material form. The Responsible Person (manufacturer or the manufacturer's authorised representative) must be able to assemble and provide the technical file to any European market surveillance authority (MSA). In the UK, the MSA is the Health & Safety Executive. Purchasers are not entitled to see the technical file but they must be provided with adequate User Instructions.

User Instructions

Manufacturers are legally obliged to provide instructions with equipment to ensure safe installation, maintenance and operation.

The detailed content of User Instructions depends on the relevant product safety Directive. All User instructions need to include sufficient detail regarding:

intended use including ways the product should not be used;
the manner of installation;
correct use to ensure health and safety, including details of residual hazards; and
safe maintenance, including cleaning.

Purchaser Responsibilities related to CE Marking

When buying new equipment users are required by PUWER to confirm compliance with relevant supply laws. The following checks should be carried out for CE marked equipment before use:

examination of CE marking to confirm that it is authentic and not counterfeit;
examination of the Declaration of Conformity and user instructions to confirm that all necessary information is included and instructions are of an acceptable standard; and
inspection to check that the equipment is free from any obvious defect (such as missing or damaged guards).

CE marking, information and instruction deficiencies are an indication of sub-standard or unsafe equipment. Counterfeit products, for example, may bear what appears to be a CE mark but with the wrong dimensions or proportions. Most often the C and E will appear much closer together then they do on the official symbol.

The CE “Chinese export” mark can be seen on some products produced in and exported from China. This mark is very similar to the authentic CE mark but the C and the E are closer together. The “Chinese export” mark merely means manufactured in China.

GOV.UK

HSE Pages

Authentic CE Mark

CFSI Info