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Guidance On Interpretation Of The Provisions Of Decree Legislativo2 February 2007, N. 22, Implementing Directive 2004/22 / Ec.

Original Language Title: Indicazioni interpretative delle disposizioni del decreto legislativo2 febbraio 2007, n. 22, attuativo della direttiva 2004/22/CE.

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Customs Agency At chambers of commerce, industry, handicrafts and agriculture Unioncamere At At Confindustria Federation ANIMA ACISM All'ANIE All'Unione oil All'UCISP All'Assoutensili The entry into force of Legislative Decree 2 February 2007 n . 22, implementing Directive 2004/22 / EC (Measuring Instruments Directive, in acronym MID), introduced in the national regulatory landscape and innovative Repealing provisions as well as' a defined transition period. This Circular and 'aimed at providing clarification on the application issues of the above provisions and to define the scope of the transitional period provided for in Article. 22 of Legislative Decree n. 22/2007, the period in accordance with similar cases involving the community, covers a period lasting ten years. In connection with this transitional period and 'be noted that the updating of admission measures to metric verification, issued under the rules in force before the date of 30 October 2006, remains at the Ministry of economic development and that power, as however, also reiterated by the European Commission, it can not 'be attributed to the notified bodies. In this regard it is noted that all updates of admission measures to metric verification issued by the Authority 'national of EU countries before October 30, 2006, the date of commissioning in the implementation of the MID provisions, are the exclusive responsibility'. In addition, during the transitional period, that will be able 'to last until no later than 30 October 2016, the instruments if they meet the requirements of the legislation in force before 30 October 2006 and which are equipped with the admission decision-verified under the same regulations, may continue to be subject to verification before the national or the EEC and, if successful, to be placed on the market and / or in service until the end of validity 'of the admission decision for verification or, in the case of validity 'indefinite, for a period of 10 years starting from 30 October 2006. the explanations relating to the matters concerning the implementation of the new provisions are provided in paragraph a, while section B clarifies operational aspects related to the transition period, with particular reference to 'identification of variants to a design approved under the previously applicable procedures to 30 October 2006. a - Issues relating to the measuring instrument that carries the CE marking and supplementary metrology marking in accordance with legislative decree n. 22/2007, implementing the EU Directive 22/2004 / EC (MID). 1. Applicability 'of the provisions. The date of entry into force of Legislative Decree n. 22/2007, and then from March 18, 2007, Community legislation transposed into it and 'became, in effect, the Italian law requiring, therefore, to its observance all those to whom it is addressed, as subjects, public or private, involved in the marketing, commissioning, control and any other activities' inherent in the manufacture, use and supervision on measuring instruments. In particular, it should be noted that the maintenance and / or the adoption of any administrative practice, or at least behavior incompatible with the aforementioned Community legislation matrix, can give rise, by the European Commission, the activation of the infringement procedure in art. 226 of the Treaty against the Member State which has implemented the violation, if reported and where the requirements are met. 2. Marketing and commissioning of measuring instruments MID. 2.1. Pursuant to and for the purposes of Legislative Decree n. 22/2007 shall apply: a) 'marketing' means the first making available on the Community market, for payment or free of charge, of an instrument intended for an end user; b) 'putting into service' means the first use of an instrument intended for the end user for the purposes for which it and 'intended. With the end-user term indicates all subjects using the measuring instruments regulated by MID and whose identification varies depending on the type. Such term includes, inter alia, the general category of household and consumers of professional users. With reference to the definition referred to in point b) and 'has to be specified that the "start-up" after a first regular use of the instrument himself' carried out as part of any calibration. Therefore in cases in which such a measuring instrument, placed on the market with the markings and the prescribed seals, are removed part or all of the above seals, after a first regular use, ancorche 'as part of the calibration operations, such removal must intended time since its commissioning, operated in accordance 'with the applicable rules. It follows that for the instruments concerned as specified in paragraph 5. below, apply the art. 6 of the Ministerial Decree n. 182/2000, concerning, inter alia, the repaired tools. 2.2. It follows that a marked measuring instrument according to MID legislation, hereinafter referred to as MID instrument, will be 'installed and put into service without having to intervene, simultaneously, the supervisory bodies so' as envisaged in the previous national legislation in cases of gages. In fact the requirements, under which 'allowed to MID instruments manufacturers market their products, they are promptly disciplined by Legislative Decree n. 22/2007, which, in this regard, states that: the assessment of conformity 'of the measuring instruments with the provisions of the decree, and' assigned to 'notified bodies', called to carry out such verification on the basis of the procedures described in Annexes A H1 to the same decree; CE marking and the supplementary metrology "M", applied on a measuring instrument, certify, pursuant to and for the effects of the decree, its conformity 'with the provisions of the decree; affixing on measuring instruments of the aforementioned markings - which presupposes the performance, with positive results, the procedure for determination of compliance '- and' the only condition required for the IMF 'marketing' and 'putting into service of the instruments' of measure. Totally alien to this regulatory framework, with regard to fixed measure MID instruments, such as automatic scales and meters of fuel, and 'therefore the testing of installation, covered by previous legislation, in specific cases provided for by the regulations, as a sine qua non for their commissioning. In fact, for MID and tools 'needed, and at the same time sufficient for commissioning the only compliance' with the regulations of Legislative Decree n. 22/2007, attested by the CE marking and supplementary marking "M". On the sidelines of this consideration can 'be appropriate to recall that the Legislative Decree n. 517/1992, implementing other Community directive of the new approach, eliminated the prediction of the laying site testing of weighing in non-automatic fixed, provided for by the previous legislation at the entrance into force of the decree. Legislative Decree n. 22/2007 has, however, provided - with the obvious purposes' to coordinate the rules in question with the one previously in force - the repeal of the provisions, as described in Royal Decree No. 7088/1890 ( 'the Consolidated Law on weights and measures'), as amended, conflicting or otherwise incompatible with the Legislative Decree n. 22/2007 itself. Concretely determined the inapplicability 'to MID instruments, the rules contained in the aforementioned Royal Decree (art. 12 and following) which required each measuring instrument, before being offered for sale or otherwise used for commercial purposes , it is subjected to an "initial verification", by the relevant metric Offices (now Chambers of commerce). The metrological control, by the Chambers of Commerce, aimed at verifying the compliance 'of the already' bearing the 'CE marking tools "- attesting to the implementation of such findings of compliance' on the part of the notified bodies, in accordance with the procedures established by Directive 2004/22 / EC - contrary in any case, not only with the wording of the legislative decree n. 22/2007 implementation, also with the purpose 'of its directive. Would not, in fact, the guarantee of "acceptance", by all Member States, the proof of conformity 'enforced in accordance with Community rules, which constitutes the primary objective. The rules introduced by Legislative Decree n. 22/2007 comes, finally, the inapplicability 'to the manufacturer of MID instruments of additional obligations under the Royal Decree n. 7088/1890 and the subsequent Ministerial Decree n. 179/2000. 3. Market surveillance: protection against modification - trademarks and protective seals. Implementing art. 14 of Legislative Decree n. 22/2007, by Ministerial Decree of 29 August 2007, the Ministry of Economic Development has identified the persons to whom and 'entrusted the performance of market surveillance, assigning this task to the chambers of commerce. The Ministerial Decree provides that where such persons riscontrino tools unduly bear the CE marking and supplementary metrology marking or which, however, do not meet the requirements of the said decree, should only inform the Directorate-General responsible for legal metrology at the Ministry of economic development, for the application of articles 16 and 17 of that legislative decree. Article. 16 provides that the Ministry of Economic Development can 'prohibit or restrict the further marketing and use of a measuring instrument bears the CE marking and supplementary marking, unless it meets the essential requirements relating to metrological performance set out in this decree, also when properly installed, taking all appropriate measures to withdraw these instruments from the market. The following art. 17 provides that if the Ministry establishes that the CE marking and the M supplementary metrology marking have been affixed unduly, to be allocated to the manufacturer (or his representative) a time limit for making the instrument, improperly marked, conform to the provisions of Legislative Decree No . 22/2007, after which, in case of persistence of the detected non-compliance ', should take all necessary measures to restrict or prohibit the marketing of the instrument or to ensure its withdrawal from the market, or prohibit or restrict its further use. The measuring instruments in accordance with the Legislative Decree n. 22/2007 bear the CE marking, the additional mark 'M' and yet, as a protection against modification, the seals indicated by a corresponding certificate or certificate of conformity 'and applied, as appropriate, by notified body or the relevant manufacturer. The MID does not specify the characteristics of the impressions related to such seals. When monitoring the market, all decisions about problematic aspects related to the markings and in any case any action or measure restricting regarding the use of the instruments concerned remains the responsibility of this Ministry, as a result of a special investigation will proceed ', where appropriate, under articles 16 or 17 of legislative decree n. 22/2007, as stated in paragraph 4 next on the market surveillance, without prejudice to the competence and obligations of the Chambers of Commerce. 4. Verification of periodic MID instruments pending the issuance of the ministerial decrees in art. 19, paragraph 2, of Legislative Decree n. 22/2007. Pending the issue of the ministerial decrees in art. 19, paragraph 2, of Legislative Decree n. 22/2007, aimed at determining the criteria for the execution of subsequent checks on MID measuring instruments, in respect of such instruments, if belonging to the categories identified in the art. 1 of the ministerial decree n. 182/2000 on the periodic verification, and used in the uses specified in the same article, the provisions and instructions are operational, as applicable, in the aforementioned Ministerial Decree n. 182/2000, the circulars and related ministerial directives, including the Ministerial Directive of 30 July 2004 on security seals. In this regard it is noted that at the periodical verification of MID instruments are made, again as applicable, the following checks: a) a visual inspection in order to verify the integrity 'of the CE markings, inscriptions, seals and other protective elements; b) metrological tests to check the functioning and compliance of the maximum permissible errors. The maximum permissible errors are equal to those provided by the Annex to Legislative Decree n. 22/2007, specific to the respective category. In the execution of the sub-assemblies 'MID periodic verification they will observe the provisions specified for similar sub-assemblies' approved by national measures, as applicable. In particular, it refers to the circular ministerial n. 3 of 9 January 1997 on the conversion devices volume of gas associated with the measuring instruments. It is noted, finally, that for defective MID or repaired instruments applies the art. 6 of the Ministerial Decree n. 182/2000. Therefore, in the cases set in the preceding paragraph 2.2, with respect to instruments placed in service in accordance with the applicable requirements and subsequently of private security seals, both chambers of commerce both laboratories, hereby approved within the meaning of the aforementioned Ministerial Decree n. 182/2000, shall respond to requests for periodic verification of such instruments, in accordance 'with the procedure and mode' due to repaired instruments. 5. Documents for in the measurement instruments accompanying procedures of conformity 'assessment and information placed on the market or in service. Legislative Decree n. 22/2007 establishes the characteristics that must have the documents to be attached to applications submitted by manufacturers to the notified body chosen for access to the conformity of the 'assessment procedure which' concerned for their measuring instruments. The same decree also specifies, in Section 9.3. of Annex I, the information that must be accompanied, by the manufacturer, the measuring instruments placed on the market. This information, that metric users are obliged to keep pursuant to art. 7, paragraph 1, letter a) of the Ministerial Decree n. 182/2000, should be made available to those carrying out surveillance or of metrological control. 6. subunit 'and ancillary equipment associated with measuring instruments. Throughout the transitional period defined in the introduction, are to be considered compatible with the discipline of MID measuring instruments connected to each other, even on the net, in part subject to the existing national mark of 30 October 2006 and the remainder to the new markings provided by the MID. In the following paragraphs are a few examples of such links, such as fuel gauges, extensible still other categories of measuring instruments, including device regulated by law no. 22/2007. In the case of measuring systems approved under the MID, which, for example, fuel gauges and their associated ancillary equipment, apply the provisions of the EC-type examination certificates or project (assessment modules of compliance 'B and H1), including the case where these certificates explicitly allow the connection with fuel gauges approved in accordance 'with the national legislation of individual EU countries. The fuel gauges approved in accordance 'with the national law and forming part of the measuring system, of course, they will report the inscriptions and logos and seals provided by the order of admission to national metric verification and general legislation. In the case of measuring systems approved under national legislation at the October 30, 2006, such as fuel gauges and related auxiliary equipment, applies to them the provisions of the decree of admission to metric verification, and in cases where the connection of ' auxiliary equipment with duly approved fuel gauges, among these must be understood also those bearing the markings provided for by law no. 22/2007. In this case the fuel gauge approved to EU legislation will be 'applied a suitable label bearing the inscription provided for in Article. 2 of the Ministerial Decree of 17 January 1977, n. 330095. Said plate, self-adhesive, and destructible with the removal, will be 'applied in the vicinity' of the CE mark of conformity 'of said meter. Of course, each instrument is part of the measurement systems network shall apply the maximum permissible errors laid down in the basic regulation to which that instrument and 'was approved. B - Issues concerning the transitional period provided for by art. 22 of Legislative Decree n. 22/2007, including the identification of the updates within the scope of application of the same article. 1. Introduction. Fall within Article. 22 of Legislative Decree n. 22/2007 instruments admitted to official verification metrics, according to the legislation in force until 30 October 2006, following an order issued before that date, in accordance with Articles 6 and 7 of manufacturing regulation referred to in the Royal Decree of 12 June 1902, n . 226, as amended and supplemented, or under the decree of President of the Republic n. 798/1982 implementing Directive 71/316 / EEC. For the purposes of defining the scope of the abovementioned transitional provisions, and 'be noted that a measure of approval of variations to a model already' recognized national or EEC metric verification, if the variations do not result in changes to the design concept of the instrument concerned model It provides a simple addendum to the original measure. It follows that in that case, the model of the instrument laying variants must be considered admitted to metric verification with reference to the date of the original decision. The cited art. 22 of Legislative Decree n. 22/2007 and 'applicable, altresi', to simple renewals, exclusively administrative, EEC pattern approvals expiring or already 'past due, on the understanding that the new validity' can not 'go beyond 30 October 2016. Below and 'defined an illustrative case study of the variants that may be the subject of addendum to the original one, in order to allow the instrument in question to be submitted for verification before under the previous legislation, in accordance with art. 22 of Legislative Decree n. 22/2007. 2. Definitions. For a better understanding of this Circular shall apply: - "Instrument": Measuring devices falling within the scope of Legislative Decree No. 22/2007; - 'Legislation previously in force ": National legislation prior to 30 October 2006; - 'Amended instrument Model ": Tool Model presenting variants compared to other already' approved in accordance with national legislation previously in force, including the implementation of Directive 71/316 / EEC; - "Measuring Range": Sequence of elements of a measuring apparatus or a measuring system which constitutes the measurement signal path from beginning to end. Examples: the set of devices formed from sensitive elements measuring (sensors, transducers, etc.), transformers elements / signal repeaters (amplified or not, of the A / D converters, etc.), mechanical, electrical or optical, indicator elements (provide the numerical value of the measure according to his Units). The signs and indicating devices can be analog or digital; - "Measuring range": Set of values ​​of the measurand for which the error of a measuring instrument, and 'regarded as falling within the established limits; - "Measurement module": Subset of a tool that competes with other subsets are identical or similar to the formation of the final measurement result. Examples: In measuring systems intended to the weighing of cement conglomerates or the preparation of paints, each of the measuring module provides for the weighing of one of the components of the final product (or conglomerate paint); in dosing weighers type partial weighings, for the preparation of pre-packages, each measuring module provides to weigh a fraction of the final dose. 3. Criteria for the classification of variants to a model of the instrument already 'admitted to metric verification under the previous legislation. Admission to metric verification of a modified model under the previous can 'be ordered only if the legislation made variants concern formal or functional characteristics, so' as specified in Sections 3.1 and 3.2. The models that are modified according to variations related to structural characteristics as specified in 3.3. Next, they are only approved in accordance 'with the provisions laid down by law no. 22/2007. 3.1 Design behavior. The formal characteristics of the measuring instrument are: - ownership 'of the instrument of approval decision; - Compulsory registration; - The name and version; - The destination and mode 'of use; - The legalization plan; - The shape of the casings; - The layout of the building elements and devices upstream and downstream of the measuring chain. Examples of variants that affect the formal characteristics: Variants of the trays to the conveyor devices in an automatic and in a checkweigher labeler. Variations in power devices in a weight metering. ; A display device Replacement or repeater of the measure or printer results, not intelligent or that receive digital metrological data and not using any metrological processing. Variants having a similar effect with regard to the measurement chain. Edit the planking of the measuring complex, and the shapes of containers and equipment Auxiliary. Unlike assembly and arrangement (mechanical, hydraulic and electronic) of the components of the measuring complex and auxiliary equipment. Replacement, due to technological change, obsolescence or changes of product, parts and components with others that do not change the instrument functions (viewers from monochrome to color, backlit or not, keyboards buttons rather than membrane, hoses, taps gun, hydraulic components not directly included in the measurement chain, pumps, solenoid valves, fuel-vapor transfer case, electronic boards). 3.2 Functional characteristics. The functional characteristics of the measuring instrument are: - the information and metrological data that the tool provides with respect to the measured value; - The measuring range, the limits and mode 'of operation; - The processing of information and data and their eventual release and management related to associated or associated devices; - The measurement function and characteristics of the model of the instrument in relation to its intended use; - The indicator elements; - The number of measurement modules competitors to the final measure purche 'the original design concept not be adversely affected by the reduction of the aforementioned measurement modules; - The printing, processing, displaying and / or printing of statistical variables and those still operating. Examples of variants that modify functional characteristics: In a price labeller and checkweigher with maximum and minimum capacity of 2000 g and 100 g, respectively, a variant that the change in 1800 g and 40 g. In a measuring instrument a substantial variation in the modification of viewers already 'FIP type for other type LCD. In a multihead dosing a variant that reduces the number of Units' weighers. Replacing parts of the measuring chain with other already 'approved techniques and having equivalent metrological characteristics. Replacement organ meter with another already 'approved. Self-service: replacement bill acceptors, printers and the association to road fuel distributors. Reorganization of the software or firmware or both, due to technological progress obsolescence and / or use of new development tools, without alteration of the structure of the instrument as the adoption and its adaptation to new operating systems (Windows XP to Windows Vista , etc.). software or firmware or hardware modifications (no metrological significance electromechanical and / or electronic), even in parts that perform metrological important functions: for example programs containing metrological relevance routine, bill acceptors, readers in payment or loyalty cards. software changes, firmware and hardware (electromechanical and / or electronic) of metrological relevance to correct the instrument malfunctions or imperfections. software and firmware changes for the replacement of peripherals: drivers and interfaces. software and firmware amendments to extend the operation of the instrument for use in combination with auxiliary devices (Terminals Self Service, Management Systems): protocols and communication devices. Tax functional changes by adding / editing functions made mandatory by regulatory and legislative measures in the relevant regulatory forums equipment: a bank transaction management functions, safety devices. 3.3 Structural Features. The structural characteristics of the measuring instrument pertaining to operating principle and the measurement chain, the architecture of the functional blocks and software that enables the creation of an instrument with superior metrological characteristics. Taken together the above characteristics identified the conception / design of an instrument and, if changed even partially, determine the construction of a new measuring instrument that, therefore, and 'subject to the general rules of the Legislative Decree n. 22/2007 of the MID transposition. Examples of variants of the structural characteristics: The replacement in a weighing instrument organ transducer type strain gauge load cell with another electromagnetic netting. Tool with superior metrological characteristics. 4. Test system for the EEC initial verification of the water meters. Legislative Decree 2 February 2007 n. 22, art. 21, letter e), repealing the decree of the President of the Republic August 23, 1982, n. 854, transposing Directive 75/33 / EEC of 17 December 1974 on the approximation of the Member States relating to cold water meters, 'as regards the meters defined in Annex MI-001 ", referred to in the decree of the President of the Republic n. 854/1982. Taking into account that the specific annex MI-001 only covers the 'water meters intended for the measurement of volumes of clean water, cold or heated, ............... "then it appears clearly, the repeal does not affect the part of the decree of the President of the Republic August 23, 1982, n. 854, which refers to the approval of the testing required to run the EEC initial verification of the meters approved under the previous Community legislation, so 'as are regulated by the decree of the President of the Republic also cold water meters "not clean. " 5. Requirements of the application for approval of a modified instrument, acceptable to the verification according to the previous law. The manufacturer or its legal representative is interested in obtaining the metrological approval of variants of a model of the instrument already 'approved, in addition to the documentation already' provided by law, and in particular, where issue of approval under the said Technical Regulation n . 226/1902, the circular ministerial n. 342263/48 of 12 July 1985 must attach to the application the following: - a comparative table, with detailed description of the changes made; - A detailed report on the hardware changes made to the approved design model, namely the effect of the changes on the instrument; - A statement, in case of the software variants, concerning the membership class of said variants in conformita 'to the CM n. 62/552689 of 17 September 1997; - A report, to be attached to the relationship of the tests performed, where the requests variants, concerning an electronic instrument, involving the execution of appropriate tests such as, for example, that relating to any change in the spatial configuration of the measurement chain components organs ; - Any other document capable of proving that the design of the original model, and not 'been changed. 6. Acceptance questions. 6.1 For the purposes of art. 22 of Legislative Decree n. 22/2007, for applications submitted before 30 October 2006: - by the date the Protocol entered the chamber of commerce; - The decision concerning the admission to national or EEC initial verification of new instruments or amended in accordance with variations of any type or renewal of type approvals already past due or in the process of maturing. 6.2 For the purposes of art. 22 of Legislative Decree n. 22/2007, for applications submitted after 30 October 2006: - by the date the Protocol entered the chamber of commerce; - The measure only covers admission to verification of instruments that show variations referred to in paragraphs 3.1 and 3.2 above or renewal of the model already 'approvals expired or pending expiration. 6.3 Procedural aspects. Measures offices Chamber, in accordance with the rules in force before October 30, 2006 they mediate for onward transmission to the Ministry of Economic Development - Department for the adjustment of the Directorate-General for market supervision and technical standards - Office IV and measurement instruments precious metals - of the questions put to get the approval of variations in models of instruments already 'accepted for verification. Applications must be submitted to that Office IV, which shall have the responsibility for assessments of the case both with regard to the same admissibility 'that the suitability' of the documentation. Rome, October 22, 2008 Minister: Scajola