European Community law on the supply of new products
Christopher Pickup
CE Marking Authority specialising in CE and UKCA Certification
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CE Marking Requirements
Manufacturers wishing to supply goods into the single European market, comprising the EU and EEA member states, and Switzerland, must meet EU single market rules for product conformity and in many cases show this by CE marking. This guide describes the common requirements for industrial products that must be met, primarily from a product safety perspective.
However, other non-safety product legislation may also apply to a particular product and must also be met in full for product compliance (eg environmental provisions). Furthermore, this guide is not a substitute for the provisions of the relevant European legislation or other detailed guidance such as the EU Blue Guide or the RAPEX guidelines.
Placing industrial products on the single European market
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European product legislation is concerned with: the health and safety of people (and in many cases domestic animals), as well as the safety of property; the protection of the environment; correct product function; and other matters of public interest protection. Although this guide mentions some other legislation (eg on electromagnetic compatibility), its emphasis is on the health and safety of industrial products by design and construction.
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New products may not be placed on the single European market unless they fully meet the requirements of all product legislation relevant to the product. CE marking, which is a sign of compliance for many goods regulated under the New Approach, is required in most cases, as well as product labelling indicating the relevant economic operator(s). Manufacturers may only affix the CE marking when all of the requirements of all CE marking legislation applicable to the product have been met. Where CE marking is not required by any product legislation applicable to the product it must not be affixed (eg?industrial scaffolding towers): in these cases, manufacturers must meet all applicable national requirements for the particular product for the market(s) it is made available, and recognised standards may assist in helping meet these.
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It is the responsibility of economic operators, but particularly the manufacturer, to establish which, and all, legislation is applicable to their product, and apply it/ensure it has been applied before making a product available for the first time on the single European market. Enforcement of any non-compliance will be subject to the national provisions of each member state of the market on which a product is made available.
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Most of this product supply legislation has common:
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·???definitions for the terms used, like?Economic Operators ?manufacturer, importers, distributor, authorised representatives, placing on the market,
·???common obligations on the various economic operators, especially for safety
·???when placing or making goods available on the market, including
·???meeting essential requirements
·???showing this in a technical file
·???the provision of information to the user
·???issuing a (in some cases of Performance, or Incorporation)
·???marking and labelling of the product to enable traceability
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Products intended for the EU market must comply with the requirements of all applicable EU legislation, including those listed below, which require CE marking in order to be placed on the market in the EU. These documents which are used to demonstrate conformity is known as the Technical Construction File
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The manufacturer or the authorised representative established within the EU must draw up and sign a Declaration of Conformity as part of the conformity assessment procedure provided for in the EU Directives listed in the legislation.
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The format of the Declaration of Conformity should contain:
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·???A number identifying the product. This number does not need to be unique to each product. It could refer to a product, batch, type or a serial number. This is left to the discretion of the manufacturer.
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·???The name and address of the manufacturer or the authorised representative issuing the declaration.
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·???A statement that the declaration is issued under the sole responsibility of the manufacturer.
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·???The identification of the product allowing traceability. This is basically any relevant information supplementary to point 1 describing the product and allowing for its traceability. It may where relevant for the identification of the product contain an image, but unless specified as a requirement in the legislation this is left to the discretion of the manufacturer.
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·???All relevant EU legislation complied with the referenced standards or other technical specifications (such as EN standards and specifications) in a precise, complete and clearly defined way; this implies that the version and/or date of the relevant standard is specified.
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·???The name and identification number of the notified body or bodies when they have been involved in the conformity assessment procedure and the reference to the relevant certificate(s), if applicable.
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·???All supplementary information that may be required (for example grade, category), if applicable.
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·???The place where the technical file is stored in the EU, this can be the manufacturer, authorised representative or importer but they must reside in the EU
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·???The date of issue of the declaration; signature and title or an equivalent marking of authorised person; this could be any date after the completion of the conformity assessment
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Machinery
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Most new machinery is covered by the Machinery Directive 2006/42/EC (as amended in relation to machinery for applying pesticides by 2009/127/EC). The exceptions are listed at Annex 1 of the Directive (e.g. certain electrical equipment), or where other EU legislation covers the machinery in question.
These include:
·???the Lifts Directive for most goods and passenger lifts
·???the Cableways Regulation for cableway installations designed to carry people
·???the Medical Devices Regulation, which includes those essential health and safety requirements from the Machinery Directive relevant to machinery that is a medical device
·???the Personal Protective Equipment (PPE) Regulation for machinery which is also PPE in the scope of the PPE Directive
·???the Toys Safety Directive for machinery intended to be used as toys
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The scope of the Machinery Directive includes ‘machinery’ in the strict sense and other products which are treated in the same way for conformity assessment as machinery. That means they must be CE marked, and accompanied by a Declaration of Conformity and Instructions when first placed on the market (or first put into service if not placed on the market). These other products (as defined by Article 2 of the directive) are:
·???interchangeable equipment
·???safety components
·???lifting accessories
·???chains, ropes and webbing
·???removable transmission devices
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‘Partly complete machinery’ (PCM), as defined by Article 2g, are also in scope of the Machinery Directive but are subject to a different conformity assessment procedure – PCM must not be CE marked under the Machinery Directive (although may be under other applicable Directives) and must be accompanied by a Declaration of Incorporation and Assembly Instructions.
Some products which are machinery (in both the strict and general sense as explained above) may also be covered by other product legislation in addition to the Machinery Directive, including:
·???Electrically powered/controlled machinery where the Electromagnetic Compatibility Directive (EMC) also applies
·???Machinery incorporating radio equipment where the Radio Equipment Directive also applies
·???Machinery incorporating pressure vessels where the Pressure Equipment and/or Simple Pressure Vessels Directives may also apply
·???Construction products subject to the Construction Products Regulation which are machinery for permanent incorporation in construction works (buildings), such as powered gates, doors, windows, shutters and blinds, ventilation and air conditioning systems
·???Non-road mobile machinery with combustion engines, where the gaseous and particulate emissions are covered by the Non-road Mobile Machinery Directive
·???Noise emissions by equipment for use outdoors where the Outdoor Noise Directive also applies
For more detailed information go to
To view the full Directive please click on the link below:
A fuller explanation of the interfaces and overlaps between the machinery and other Directives is given in the following link:
Electrical equipment
The Low Voltage Directive 2014/35/EU (LVD) applies to most electrical equipment designed for use with a voltage rating of between 50 and 1000 volts for alternating current and between 75 and 1500 volts for direct current. This excludes the equipment and situations listed in its Annex II, largely because they are covered by other Directives and international agreements. The excluded items and situations are:
·???electrical equipment for use in an explosive atmosphere
·???electrical equipment for radiology and medical purposes
·???electrical parts for goods and passenger lifts
·???electricity meters
·???plugs and socket outlets for domestic use
·???electric fence controllers
·???radio-electrical interference
·???specialised electrical equipment, for use on ships, aircraft or railways, which complies with the safety provisions drawn up by international bodies in which the member states participate
·???custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes
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The safety objectives listed in Annex I of the LVD cover electrical hazards and information requirements, and include the protection of people, domestic animals and property from non-electrical dangers caused by electrical equipment (the LVD is a total safety directive). Although the LVD does not apply to most machinery, its safety objectives are covered by EHSR 1.5.1 of the Machinery Directive.
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CE marking of electrical equipment in scope is required, although it may exceptionally be attached to the packaging or included with the other information accompanying the product (eg where it may not be possible to legibly mark very small components). Although a Declaration of Conformity must be drawn up and kept by the manufacturer with the technical documentation, there is no requirement for it to be provided with the product.
The LVD imposes detailed and explicit obligations on all?Economic Operators :
·???manufacturers (and their authorised representatives)
·???importers placing goods on the market from a third country
·???distributors (who may be deemed manufacturers where rebranding goods made by another)
For more detailed information go to
To view the full Directive please click in the link below:
A fuller explanation of the Low Voltage Directive is given in the following link:
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Equipment for use in explosive atmospheres (ATEX)
Directive 2014/34/EU (ATEX) concerns equipment and protective systems intended for use in potentially explosive atmospheres. It also covers:
·???safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres but required for, or contributing to, the safe functioning of equipment
·???protective systems with respect to the risks of explosion
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Equipment in scope may be electrical and/or mechanical.
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ATEX may apply in addition to other directives, such as the Low Voltage and Machinery Directives (eg controlling devices under ATEX may also be electrical equipment, and a machine may include a protective system within scope of ATEX).
Certain equipment is excluded from the scope of ATEX, including:
·???medical devices intended for use in a medical environment
·???equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances
·???equipment intended for use in domestic and non-commercial environments where potentially explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of fuel gas
·???personal protective equipment covered by Regulation EU/2016/425 (previously Directive 89/686/EEC)
·???seagoing vessels and mobile offshore units, together with equipment on board such vessels or units
·???means of transport, ie vehicles and their trailers intended solely for transporting passengers by air or by road, rail or water networks, as well as means of transport that are designed for transporting goods by air, by public road or rail networks or by water (vehicles intended for use in a potentially explosive atmosphere are not excluded)
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In addition to CE marking, ATEX requires the specific explosion protection mark on products within scope.
To view the quick guide to ATEX Compliance go to
To view the full Directive please click on the link below:
A fuller explanation of the ATEX Directive is given in the following link:
Pressure Equipment
The Pressure Equipment Directive 2014/68/EU outlines the standards to which pressure equipment within the EU must conform - The Directive applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure greater than 0.5 bar it includes equipment such as pressure vessels, boilers, piping, and safety valves
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The purpose of the Pressure Equipment Directive is to ensure the free flow of stationary pressure equipment within the European Union. At the same time it is to ensure that all pressure equipment passes a high degree of safety.
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According to the Community Regime of the Directive, when pressure equipment and assemblies fall above a specified pressure and volume threshold they must adhere to these requirements:
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·???They must be safe
·???They must meet essential safety requirements covering design, manufacture and testing
·???They must satisfy suitable conformity assessment procedures
·???They must carry the CE marking
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The term assemblies in the sense of the Pressure Equipment Directive refers to several pieces of pressure equipment assembled to an integrated and functional unit that is placed on the market in an assembled state by a manufacturer. Assemblies are to be subjected to an overall assessment of conformity, taking the safety devices into consideration.
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For example, process control safety devices must also be included in the assessment as applicable. Assemblies may be intended for direct use by an end user or for installation as a sub-assembly in a larger assembly.
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Assemblies may range from simple assemblies (e.g. fire extinguishers) to complex assemblies in the chemical and energy industry (e.g. water tube boilers, refrigeration plants).
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The pressure equipment shall be classified in accordance with Annex II of the PED in the categories I to IV according to an ascending level of hazard, depending on pressure,
volume or nominal size, the fluid group and state of aggregation. This does not apply to pressure equipment that is to be classified below category I (Article 4 (3) pressure equipment). This pressure equipment is included within the scope of the PED. However, it does not need to comply with the essential safety requirements of the Directive and consequently shall not bear any CE-marking. Such equipment is to be designed and manufactured in accordance with sound engineering practice.
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For the purpose of classification, the fluids (media in the pressure equipment) are divided into two groups:
·???Group 1 > hazardous fluids; comprises of substances and mixtures contained in pressure equipment with a maximum allowable temperature TS which exceeds the flashpoint of the fluid.
·???Group 2 > comprise of substances and mixtures not referred to under group 1, within the definition of a fluid, including steam.
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Assistance with identifying the hazard classes of substances can be found by contacting the team at the CE Marking Authority
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The manufacturer of pressure equipment must subject each item of pressure equipment to the conformity assessment procedure described in Annex III of the Directive, before it is placed on the market. This procedure is determined by the category in which the equipment is classified.
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For further information
View the full Directive please click on the link below:
Simple Pressure Vessels
The Regulations apply to simple pressure vessels manufactured in series with the following characteristics:
The vessels are welded, intended to be subjected to an internal gauge pressure greater than 0,5 bar and to contain air or nitrogen, and are not intended to be fired;
The parts and assemblies contributing to the strength of the vessel under pressure are made either of non-alloy quality steel or of non-alloy aluminium or non-age hardening aluminium alloys;
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The vessel is made of either of the following elements:
·???a cylindrical part of circular cross-section closed by outwardly dished and/or flat ends which revolve around the same axis as the cylindrical part; and
·???two dished ends revolving around the same axis;
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The maximum working pressure of the vessel does not exceed 30 bar and the product of that pressure and the capacity of the vessel (PS × V) does not exceed 10 000 bar.L; and
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The minimum working temperature is no lower than – 50 °C and the maximum working temperature is not higher than 300 °C for vessels constructed of steel and 100 °C for aluminium or aluminium alloy vessels
Further information
To view the quick guide to SPV Compliance go to
To view the full Directive please click in the link below:
Electromagnetic compatibility
The Electromagnetic Compatibility Directive 2014/30/EU (EMC) will apply to much equipment with an electrical aspect, mainly to prevent interference with, and from, other electrical equipment.
It applies alongside other Directives (for example Machinery and Low Voltage), although in some cases the Radio Equipment Directive (RED) applies instead of EMC.
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Note the EMC requirements can be meet by testing or putting justification in the technical file detailing how the regulations have been met.
The aim of employing EMC measures is to ensure that a variety of different items of electronics equipment can operate in close proximity without causing any undue interference.
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The interference that gives rise to impaired performance is known as Electromagnetic Interference, EMI. It is this interference that needs to be reduced to ensure that various items of electrical equipment are compatible and can operate in the presence of each other
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There are two main elements to EMC:
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Emissions: The EMI emissions refer to the generation of unwanted electromagnetic energy. These need to be reduced below certain acceptable limits to ensure they do not cause any disruption to other equipment.
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Susceptibility & immunity: The susceptibility of an item of electronics to EMI is the way it reacts to unwanted electromagnetic energy. The aim of the design of the circuit is to ensure a sufficiently high level of immunity to these unwanted signals.
To view the quick guide to EMC Compliance go to
To view the full Directive please click on the link below:
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Radio Equipment
Directive 2014/53/EU concerns radio equipment. Where electrical equipment in scope of the Low Voltage and/or Electromagnetic Compatibility Directives incorporates radio equipment as defined by Directive 2014/53/EU, the provisions of the Low Voltage and Electromagnetic Compatibility
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Directives do not apply separately to that equipment, but are covered by the Radio Equipment Directive, which (unlike the Low Voltage Directive), has no voltage limitations.
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The EU Radio Equipment Directive applies to all equipment placed on the market in the EU that uses the radio spectrum below 3THz for communication and for radiodetermination. The requirements apply to both transmitters and receivers.?This means that if you manufacture any product that transmits or receives radio frequencies over the air your product will almost certainly be subject to the Directive.
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This includes connected devices such as those that transmit and receive radio signals including WiFi and Bluetooth devices. This could include medical devices, fire detection and suppression products, or many other products used throughout the built environment.
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Further information
To view the quick guide to RED Compliance go to
To view the full Directive please click on the link below:
Noise Emissions by Equipment for Use Outdoors
Directive 2000/14/EC is concerned with noise emission by equipment used outdoors (which may include machinery subject to the Machinery Directive).
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The Directive contains two lists of equipment in articles 12 and 13. Equipment in article 12 must meet specific noise limits, and must be marked with their maximum noise level. Complying with this part of the Directive requires notified body involvement, either to approve a manufacturer's quality control system or approve the noise tests performed on the product. Equipment in article 13 is not subject to noise limits, but must still be marked with its maximum noise level. This equipment can be self-certified by following the test procedures and documentation requirements set out in the Directive and harmonized standards.
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The Directive defines the test methods which have to be used to determine the noise level from a machine and these are based on a number of harmonised standards, as well as detailed conditions given in the Directive. Manufacturers of equipment in either list are responsible for ensuring that the noise measurements on their equipment are made according to the requirements of the standards and are documented accordingly.
Both types of equipment covered by this Directive require a technical file, a declaration of conformity and the products to be marked with the CE logo. Uniquely, a copy of the declaration of conformity containing the noise test results must be sent to the European Commission and national governments of EU states in which the product will be sold.
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To view the full Directive please click on the link below:
RoHS Directive
Restriction of the use of certain hazardous substances in electrical and electronic equipment
Directive 2017/2102/EU is concerned with the use of certain hazardous substances (lead, cadmium etc) in electrical and electronic equipment.
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The expanded list for RoHS 3 is thus as follows:
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·???Cadmium (0.01 %)
·???Lead (0.1 %)
·???Mercury (0.1 %)
·???Hexavalent chromium (0.1 %)
·???Polybrominated biphenyls (PBB) (0.1 %)
·???Polybrominated diphenyl ethers (PBDE) (0.1 %)
·???Bis(2-ethylhexyl) phthalate (DEHP) (0.1 %)
·???Butyl benzyl phthalate (BBP) (0.1 %)
·???Dibutyl phthalate (DBP) (0.1 %)
·???Diisobutyl phthalate (DIBP) (0.1 %)
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To view the full Directive please click on the link below:
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Ecodesign for energy related products
The EU Ecodesign Directive (Directive 2009/125/EC - ERP) establishes a framework to set mandatory environmental requirements for energy-using and energy-related products sold in all 27 Member States. Its scope currently covers more than 40 product groups.
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The ultimate aim of the Ecodesign Directive is that manufacturers of energy-using products will, at the design stage, be required to reduce the energy consumption and other environmental impacts of products. While the Directive's primary aim is to reduce energy use, it is also aimed at enforcing other environmental considerations including: materials use; water use; polluting emissions; waste production, end of life management and recyclability.
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The Ecodesign Directive is a framework directive, meaning that it does not directly set minimum environmental requirements. These are adopted through specific implementing measures for each group of products in the scope of the Directive. The implementing measures are adopted through the so-called comitology procedure. Implementing measures are based on EU internal market rules governing which products may be placed on the market
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To view the full Directive please click on the link below:
General product safety
The General Product Safety Directive (GPSD) 2001/95/EC concern consumer products which are not covered by any other product legislation. Enforcement of these regulations falls to the relevant local trading standards service.
Where a product is already subject to other existing regulations (for example, toys) then those regulations will apply to that product. The GPSR do not apply to the safety of a product where there are specific provisions of EU law governing all aspects of its safety; instead, they operate as a kind of 'mop-up' set of regulations.
However, they do apply to all second-hand consumer products, including toys and electrical equipment.
The GPSR do apply where they go further than the existing regulations in terms of the specific aspects of safety covered and the extent of the obligations on producers. The GPSR apply to all products intended for or likely to be used by consumers (even if not intended for them) that are supplied or made available; the test would be whether a consumer can purchase the product without challenge. This includes products supplied or made available to consumers for their own use in the course of a service
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To view the full Directive please click on the link below:
If you require CE Marking assistance Contact the team below;
CE Marking Authority
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Tomorrows Certification Today
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Tel: +44 (0) 1779 841842
Tel; +44 (0) 7910 523528