Standards and requirements related to industrial products

Products subject to harmonised legislation

Industrial products subject to harmonised legislation are products to which harmonised European Union (EU) legislation applies, i.e. regulations, directives or decisions. The products may be of any origin (manufactured in the EU or in third countries), the only requirement being that they are intended for placement on the European market.

In order to be placed on the market and/or put into service in the EU (and therefore in Spain) for the first time, industrial products must bear the CE marking (or pi marking in the case of transportable pressure equipment) and come with the corresponding EU declaration of conformity in accordance with the relevant legislation (directive or regulation), which may provide for certain exceptions to its application.

Within the harmonised legislation, specific legislation applies to certain types of products and there is also some general legislation that covers several types of products. Each type of product may therefore be covered by more than one specific directive or regulation and/or more than one cross-cutting directive or regulation, depending on its characteristics.

The regulation, the general requirements that a product must satisfy in order for the manufacturer to affix the CE marking, and the conformity assessment procedures for affixing the CE marking can be found here:

• Simple pressure vessels
• Pressure equipment
• Transportable pressure equipment
• Aerosol dispensers
• Gas appliances
• Lifts
• Safety of machinery
• Noise emissions from equipment used outdoors
• Equipment for potentially explosive atmospheres
• Low voltage products
• Electromagnetic compatibility
• Ecodesign
• Personal protective equipment
• Construction products

Depending on the characteristics of the product, the manufacturer must be aware of the specific and/or cross-cutting rules applicable to the product it manufactures. Even if several directives and/or regulations apply, the product must bear a single CE marking and a single EU declaration of conformity must be issued.

In addition to the CE marking, when placed on the market for the first time in Spain, products must include the corresponding data and information indicated in the relevant legislation (such as certain data or technical information for correct and safe use).

Conformity assessment

Manufacturers must carry out a risk analysis and ensure that their products comply with certain rules before placing them on the EU market.

This procedure is called a conformity assessment and it is carried out during both the design and production phase. Even if manufacturers subcontract the design or production of their products, it is still their responsibility to ensure that the conformity assessment is carried out.

The information obtained from the conformity assessment must be included in the technical documentation.

In some cases, the manufacturer may carry out a self-assessment of its own product. In others, it must be assisted by a conformity assessment body (also known as a notified body).

The NANDO page shows the designated notified bodies for each directive and regulation.

If a notified body is required to intervene, the CE marking must be accompanied by the identification number of the notified body.

In the field of industrial products, conformity with harmonised standards is a way for manufacturers to demonstrate compliance with the essential requirements set out in the implementing directives and regulations.

Harmonised standards

Harmonised standards are a specific type of European standard developed by a European standardisation body following a request known as a ‘mandate’ from the European Commission. References to harmonised standards should therefore be interpreted as relating to harmonised standards whose references have been published in the Official Journal of the EU.

Unlike the essential requirements under EU legislation, which are mandatory, harmonised standards are voluntary. Manufacturers are free to choose other technical solutions to demonstrate compliance with mandatory legal requirements.

For more information, please consult the following link: Standards and specifications: Industrial products.

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Construction products

Harmonised regulations on construction products are set out in Regulation (EU) No 305/2011 laying down harmonised conditions for the marketing of construction products . This establishes conditions for placing construction products on the market and defines methods and criteria for assessing and expressing the performance of construction products, and conditions for using the CE marking.

Declaration of performance and CE marking

Where a manufacturer decides to place a construction product on the market and that product is covered by a harmonised standard or a European Technical Assessment has been issued for it, the manufacturer must draw up a declaration of performancecontaining, inter alia, the following information:

• The product reference,
• Systems for assessing and verifying constancy of performance of the product,
• A reference to the applicable harmonised standard or the European Technical Assessment,
• The intended use(s) of the device,
• The performance declared on the basis of the assessment according to the applicable harmonised standard or the European Technical Assessment.

Once the declaration of performance has been issued, the manufacturer must affix the CE marking to the product.

EU countries must designate Contact Points for Construction Products to provide information on construction product requirements.

More information and help guides on the European Construction Products Regulation can be found at the following link: Construction products regulation.

When selecting and using construction products on construction sites, designers must refer to the applicable building codes, such as, inter alia, the Technical Building Code , the Structural Concrete Instruction or the Regulation on fire safety in industrial establishments. They define the basic requirements, characteristics and performance to be met by each type of work or building and, on that basis, the performance to be met by the construction products which will be used.

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Products not subject to harmonised legislation

In the field of industrial products, most products are covered by harmonised EU legislation. However, products not covered by harmonised legislation and which therefore continue to be governed by national rules can still be found. In particular, national implementing legislation applies to the following products :

• Smooth and corrugated wires
• Active steel clamps for pre-stressing concrete
• Sanitary tapware
• Welded steel tubes
• Carbon monoxide detectors
• Hot galvanised products
• Certain types of cement used in the manufacture of concrete and mortars.

In such cases, national legislation lays down certain requirements. In order to place these products on the market it is necessary to have a certificate of conformity indicating compliance with those requirements. Such certification must be issued by an accredited inspection body. Applications for certification should therefore be sent to those bodies.

In cases in which, for the time being, there is still no supervisory body for a certain type of specific product, instead of providing a certificate, you must submit a self-declaration before the competent body of the corresponding autonomous community or autonomous city, which must be available to consumers.

The principle of mutual recognition also applies when these products are exported to or imported from other EU countries.

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Registers

Register of electrical and electronic equipment

Royal Decree 110/2015 of 20 February 2015 on waste electrical and electronic equipment (RD RAEE) maintains the obligation for all producers of electrical and electronic equipment (or their authorised representative) to register in the special section for producers of electrical and electronic equipment of the Integrated Industrial Register (RII-AEE) , provided for in Law 21/1992 of 16 July 1992 on Industry and the Regulation on the Integrated Industrial Register, approved by Royal Decree 559/2010 of 7 May 2010.

The Integrated Industrial Register (RII) is an informative register applicable in Spain and meets the requirements of Directive 2012/19/EU of 4 July 2012 on waste electrical and electronic equipment, which provides that each of the Member States should maintain a State register.

For more information, please consult the following link: Electrical and electronic equipment

Register of batteries and accumulators

This national register of producers of batteries and accumulators is unique and national and in line with the requirements of Directive 2006/66/EC on batteries and accumulators and waste batteries and accumulators, which provides for the creation of a national register in each of the Member States.

Royal Decree 106/2008 of 1 February 2008 on batteries and accumulators and the environmental management of their waste lays down the obligation for all producers of batteries, accumulators or battery packs to register with the Special Section of the Register of Industrial Establishments (REI) , established by Law 21/1992 of 18 July 1992.

For more information, please consult the following link: Batteries and accumulators

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Information for each Autonomous Community

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