What is the significance of the CE marking and the declaration of incorporation for HVAC units? What you need to know.

The CE marking represents a confirmation from the manufacturer of a product, stating that – in accordance with EU Regulation 765/2008 – the product fulfils the fundamental requirements of the directives that apply to it. It is not a seal of quality. In order to gain the CE marking, the manufacturer must perform a conformity assessment procedure; this must cover the points listed below, and the manufacturer is responsible for arranging it:

• Identifying the relevant EU legislation
• Compiling a list of the directives that apply
• Performing a risk assessment and ensuring that the product meets the requirements
• Drawing up technical documentation
• Checking the operating instructions
• Once the points above are complete, the final stage can take place: the declaration of conformity is issued and is then supplied with the product.

The risk assessment (performed in accordance with EN ISO 12100) is a fundamental part of this procedure. It indicates the risks that the unit may present as well as the potential sources of damage to health it may contain, and outlines measures that need to be put in place in order to prevent these scenarios from occurring. 

The customer does not receive the certificate documents associated with the first five points above: they remain with the manufacturer and may need to be presented to government agencies if doing so is requested and warranted. For example, this may happen if any objections to the product’s health and safety requirements are raised. If the documents cannot be presented on request, the product is not deemed to have CE certification, and is considered to have a material defect as a result.

So how does this apply to HVAC units? Following on from point 1 above, the European regulations and directives that apply to HVAC units are:

• Machinery Directive 2006/42/EC (regulates the harmonisation of health and safety requirements for machinery)
• ErP Directive 2009/125/EC, or the Ecodesign Directive for short (outlines general specifications for creating environmentally friendly designs of products that consume energy)
• Low Voltage Directive 2014/35/EU (regulates the declaration of conformity for built-in components, such as motors)
• EMC Directive 2004/108/EC (outlines requirements for the electromagnetic compatibility of components, such as immunity to the effects of external electromagnetic fields on electronic components, and preventing frequency inverters from emitting electromagnetic fields)

Additional directives may apply (point 2), depending on the equipment in the units and how the units are going to be used. These may include:

• Pressure Equipment Directive 97/23/EC (in cases where pressure levels are high and/or high temperatures (>120°C) arise in heat exchangers)
• Gas Appliances Directive 90/396/EC (relates to appliances that burn gaseous fuels)
• CPD/Construction Products Regulation EU 305/2011 (needs to be applied in the case of units with a smoke extraction function)
• ATEX Directive 2014/34/EU (covers units and protection systems that are intended for use in potentially explosive atmospheres)

The Machinery Directive describes the conformity assessment procedure that needs to be applied to machinery including HVAC units. It draws a distinction between:

• final machinery, which is ready for use, and
• partly completed machinery, which is not suitable for use as a stand-alone unit

HVAC units are considered to be final machinery if they are suitable for use and operation. This means that they must be equipped with

• measurement, control and regulation systems
• integrated heating and/or cooling systems, or
• entire regulation assemblies for heating and/or cooling (which means that the machinery is suitable for use and operation once it is connected to a media supply)

Only final machinery can be awarded conformity certificates and the CE marking.

Examples of partly completed machinery include HVAC units without measurement, control and regulation systems. According to the Machinery Directive, this kind of machinery cannot carry the CE marking. Instead, it is supplied with a declaration of incorporation and assembly instructions. In the declaration of incorporation, the manufacturer must state which Machinery Directive requirements apply to the partly completed machinery and therefore need to be adhered to. It is important to note that the partly completed machinery cannot be commissioned until it has been deemed to comply with the requirements of the declaration of incorporation after it has been converted into machinery that is suitable for use (for example, after a measurement, control and regulation system has been installed). What this means in practice is that the conformity procedure for obtaining the CE marking must be performed before commissioning takes place.

The ErP Directive sets out general criteria for assessing savings potential, defining minimum energy efficiency requirements, and considering resource efficiency over the entire lifecycle – from manufacturing and operation all the way through to disposal. EU Regulation 2014/1253 dictates the way in which the ErP Directive is implemented. You can find more information on this in the article entitled Requirements of the ErP Directive on HVAC systems.

The manufacturer is responsible for declaring that the units it is placing on the market comply with the requirements that apply to them. It is important to note that the term “manufacturer” has a wide scope; it does not just apply to the party who builds the HVAC unit. “Manufacturer” can also be used in reference to the party who constructs or plans the system – which means that even planners can be considered the “manufacturer” in the context of the Machinery Directive’s understanding of responsibility. If an HVAC unit is supplied without a measurement, control and regulation system, for example, and this system is subsequently installed in it as specified by the planner, it is possible to refer to the planner as the “manufacturer”. In cases like this, the planner is then the one who is responsible for performing the conformity assessment procedure in order to obtain the CE marking.

The scope of responsibility may also change if the customer supplies components that are subject to EU regulations – such as measurement, control and regulation systems, filters, heat recovery systems, or fans – and these components need to be installed by a third party either at the factory or at the construction site. It is not possible for the manufacturer to carry out the assessment if this happens. Instead, the plant manufacturer takes on the title of “manufacturer”, and is therefore responsible for performing the conformity assessment procedure in order to obtain the CE marking.

While the regulations and directives do provide a precise definition of the areas of responsibility that apply, we can see from this information that they do not specify which exact persons hold this responsibility. Each project has a person who is responsible for obtaining the necessary CE certification, and who is appointed on the basis of the system configuration. If the situation involves supplying an HVAC unit that is categorised as partly completed machinery, this person must be appointed before the contract is concluded. CE certification is a time-consuming, cost-intensive process, so any tendering documents need to itemise it as an additional service.

If the HVAC unit is considered to be final machinery, then the required declaration of conformity and the CE marking are supplied along with it. For this reason, it is a good idea to choose an HVAC unit configuration that will ultimately be delivered with CE certification. This is a more straightforward option – and it is safer too.

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