Royal Decree 144/2016, of April 8, establishing the essential health and safety requirements for devices and protective systems for use in potentially explosive atmospheres and amending Royal Decree 455/2012, of March 5, establishing measures to reduce the amount of gasoline vapors emitted into the atmosphere during refueling of motor vehicles at service stations.
https://www.boe.es/boe/dias/2016/04/14/pdfs/BOE-A-2016-3539.pd
Single Transitional Provision. Transitional Period.
- Products that comply with the provisions of Royal Decree 400/1996, of March 1, may continue to be marketed or put into service until April 20, 2016.
- Certificates and decisions issued by control bodies in accordance with Royal Decree 400/1996, of March 1, shall be valid in accordance with this royal decree.
DEFINITIONS
- Devices: Machines, equipment, fixed or mobile devices, control organs, instrumentation, detection and prevention systems which, alone or combined, are intended for production, transportation, storage, measurement, regulation, energy conversion, and/or material transformation and which, due to their potential sources of ignition, can trigger an explosion.
- Protective Systems: Devices, other than components of devices, whose function is to immediately stop incipient explosions and/or limit the area affected by an explosion, and which are marketed separately as systems with autonomous functions.
- Components: Parts that are essential for the safe operation of devices and protective systems but do not have autonomous function.
- Explosive Atmosphere: The mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapors, mists, or dusts, in which, after ignition, combustion propagates throughout the unburned mixture.
- Potentially Explosive Atmosphere: An atmosphere that can become explosive due to local and operational circumstances.
- Group of Devices I: Devices intended for underground work in mines and in the parts of their surface installations where there may be danger due to firedamp and/or combustible dust, including categories of devices M1 and M2 as established in Annex I.
- Group of Devices II: Devices intended for use in other places where there may be a risk of explosive atmospheres forming, including categories of devices 1, 2, and 3 as established in Annex I.
- Device Category: The classification of the device, within each group of devices, specified in Annex I, determining the level of protection required to be ensured.
- Intended Use: The use of a product prescribed by the manufacturer by assigning the device to a specific group and category or by providing all necessary indications to ensure the safe operation of a protective system, device, or component.
- Marketing: Any supply, whether paid or free, of a product for distribution, consumption, or use on the European Union market in the course of a commercial activity.
- Placing on the Market: The initial marketing of a product on the European Union market.
- Manufacturer: Any natural or legal person who manufactures a product, or who has a product designed or manufactured, and markets it under their own name or brand or uses it for their own purposes.
- Authorized Representative: Any natural or legal person established in the European Union who has received written authorization from a manufacturer to act on their behalf in specific tasks.
- Importer: Any natural or legal person established in the European Union who introduces a product from a third country into the European Union market.
- Distributor: Any natural or legal person in the supply chain other than the manufacturer or importer who markets a product.
- Economic Operators: The manufacturer, the authorized representative, the importer, and the distributor.
- Technical Specification: A document defining the technical requirements of a product.
- Harmonized Standard: A standard harmonized in accordance with the definition of Article 2, point 1, letter c), of Regulation (EU) No 1025/2012 of October 25, 2012.
- Accreditation: Accreditation in accordance with the definition of Article 2, point 10, of Regulation (EC) No 765/2008 of the European Parliament and of the Council of July 9, 2008.
- National Accreditation Body: National accreditation body in accordance with the definition of Article 2, point 11, of Regulation (EC) No 765/2008 of the European Parliament and of the Council of July 9, 2008.
- Conformity Assessment: The process by which it is assessed whether the essential health and safety requirements established in this royal decree are met in relation to a product.
- Notified Body: A body performing conformity assessment activities, including calibration, testing, certification, and inspection, and notified to the European Commission and other Member States to carry out conformity assessment tasks referred to in Articles 14 and 15.
- Retrieval: Any measure aimed at obtaining the return of a product already made available to the end user.
- Withdrawal: Any measure aimed at preventing the marketing of a product that is in the supply chain.
- European Union Harmonization Legislation: Any European Union legislation harmonizing conditions for the marketing of products.
- CE Marking: Marking by which the manufacturer indicates that the product complies with all applicable requirements set out in European Union harmonization legislation providing for its affixation.
Article 3. Marketing and Placing on the Market.
- Only products specified in Article 1 may be marketed and placed on the market when, properly installed, maintained, and used in accordance with their intended use, they meet the requirements of this royal decree.
- The provisions of this royal decree shall apply without prejudice to national and regional regulations issued to ensure the protection of persons, and in particular, of workers using these products, provided that this does not involve modifications to them in a manner not specified in this royal decree.
- Products defined in Article 1 that do not comply with the provisions of this royal decree may be presented at fairs, exhibitions, demonstrations, and other similar events, provided that it is clearly indicated, by means of a visible sign, their non-compliance and therefore such products cannot be marketed or placed in service until they are compliant. Demonstrations must comply, in accordance with the requirements set by the autonomous communities, with adequate safety measures to ensure the protection and safety of individuals.