What is new in Royal Decree 244/2016 on Metrology?

The Metrology Law grants the power to carry out the State's metrological control work to the verifying bodies, although it was the Autonomous Communities that established how this function was to be organised. Thus, some regions (such as Andalusia, Valencia or Galicia) granted a concession to a single company; in others, such as Asturias or La Rioja, metrological control was carried out directly by the regional administration, and in the rest, this function could be carried out by any authorised body.

One of the main novelties of the new RD is that the authorisations, regardless of the Autonomous Community that has granted them, are valid throughout the national territory and, therefore, all the verifying bodies can act in the national territory.

The authorisations of the verification bodies will be valid throughout the national territory.
 

RD 244/2016 of 3 June 2016 fulfils two basic functions:

• It transposes Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the placing on the market of non-automatic weighing instruments (recast), Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014, on the harmonisation of the laws of the Member States relating to the placing on the market of measuring instruments (recast) and Commission Delegated Directive (EU) 2015/13 of 31 October 2014 amending Annex III to Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 as regards the flow range of water meters, and
• Develops chapters II, III and V of Law 32/2014, of 22 December, on Metrology, which, in several of its articles, refers to its regulatory development.

The new regulation regulates the following aspects, which are summarised below:

• The Legal System of Measurement Units and, specifically, the traceability, accuracy and uncertainty of standards, measuring instruments and the traceability and certification of reference materials.
  State metrological control, in its different phases: Conformity assessment, periodic verification and verification after modification or repair. To this end, the obligations of economic agents are established, provisions relating to surveillance and inspection are included and the specific regulation of measuring instruments affected by modifications in the harmonised legislation of the European Union is updated.
• The organisation of metrology in Spain.
• MetrologyRoyal Decree 584/2006, of 12 May, which determines the structure, composition and operation of the High Metrology Council and Royal Decree 1342/2007, of 11 October, which approves the Statute of the Spanish Metrology Centre, regulate the institutions of the metrological structure in Spain.

This royal decree complements their regulation by developing the role of the rest of the agents involved in the same, establishing the actions of the competent Public Administrations and the agents involved in the State metrological control.

The register of metrological control is regulated and provisions are included relating to the designation and notification of notified bodies, metrological control bodies and metrological verification authorisation bodies. In this aspect, important modifications are included in relation to the previous regulation, such as, for example, that the designations are valid at national level.

The new Royal Decree is structured in 5 chapters (comprising 68 articles), 3 transitional provisions, 1 derogatory provision and 6 final provisions, as well as 16 specific annexes to the instruments regulated by Directives 2014/31/EU and 2014/32/EU:

• Chapter I, "General Provisions", describes the object of the Royal Decree and contains the definitions applicable to its content.
• Chapter II, "Legal System of Units of Measurement", develops the part corresponding to the Legal System of Units of Measurement, the maintenance and metrological traceability of standards and reference materials and the existence of supplementary indications on measuring instruments.

• Chapter III, "State metrological control", is carried out in eight sections, the content of which is as follows:

     - Section 1: scope of application of the chapter.

     - Section 2: explains the phases of metrological control and their execution.

     - Section 3: develops the conformity assessment phase of instruments subject to State metrological control.

     - Section 4: regulates the metrological control of instruments in service and develops the possibility of establishing a useful life for certain instruments in service and the regulation of control instruments, new features introduced in Law 32/2014, of 22 December.

     - Section 5: regulates State metrological control for reference materials.

     - Section 6: establishes the obligations of economic agents.

     - Sections 7 and 8: determine and develop the aspects relating to market surveillance and the procedures for its application, including the safeguard procedure, of the European Union.

• Chapter IV, "Organisation of Metrology in Spain", consists of twelve articles, 41 to 51, divided into three sections.

     - Section 1: deals with the capacity of the Consejo Superior de Metrología (CSM) to draw up Guides and Guidelines and the functions and relations between the Spanish Metrology Centre (CEM) and the associated and collaborating laboratories.

     - Section 2: determines the status of the Ministry of Industry, Energy and Tourism as notifying authority, the cooperation activities between Administrations, regulating the information obligations to and from the Administrative Cooperation Body and within and between the members of the Legal Metrology Commission of the Higher Council of Metrology.

     - Section 3: the Metrological Control Register is regulated.

• Chapter V, "Notified bodies, metrological control bodies and authorised metrological verification bodies", comprises articles 52 to 68 and refers to the system of authorisation and incompatibilities of notified bodies, metrological control bodies and authorised metrological verification bodies.
• Transitional provisions 1, which refer to the period of validity of conformity assessment certificates that existed prior to the entry into force of the Royal Decree.
• Transitional provision 2, referring to the applicable deadlines for the adaptation of the metrological control bodies and authorised metrological verification bodies to the provisions of this royal decree.
• Transitional provision 3, in relation to the references to Law 30/1992, of 26 November, on the Legal Regime of the Public Administrations and Common Administrative Procedure.
• Repealing provision, which repeals Royal Decree 889/2006 regulating the metrological control of measuring instruments and the Order of 22 December 1994 determining the operating conditions for non-automatic weighing instruments.
• Final provisions
• Annexes. Sixteen annexes are included. Thus, Annex I refers to conformity assessment procedures, Annex II refers to the essential requirements common to measuring instruments, except for non-automatic weighing instruments, Annex III refers to the identification of markings, labels and seals, Annex IV regulates the legally relevant software, Annex V establishes a model declaration of conformity and Annexes VI to XVI update the State metrological control regulation for instruments subject to European harmonisation regulation.