CE MARKING / MACHINERY DIRECTIVE / 4.0 TAX RELIEF

Access to 4.0 tax relief requires the marking of the machine and/or line of machines according to the following directives:

MACHINE DIRECTIVE: DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006 on machinery and amending Directive 95/16/EC (recast). LEGISLATIVE DECREE January 27, 2010, n. 17. Implementation of Directive 2006/42/EC on machinery and amending Directive 95/16/EC on elevators.

DIRECTIVE ELECTROMAGNETIC COMPATIBILITY: DIRECTIVE 2014/30/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the harmonization of the laws of the Member States relating to electromagnetic compatibility (recast).

LOW VOLTAGE DIRECTIVE: DIRECTIVE 2014/35/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the harmonization of the laws of Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits

ATEX DIRECTIVE: DIRECTIVE 2014/34/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014 on the harmonization of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres (recast)

In relation to the 4.0 defiscalization regarding the application of the directives:

  • for individual CE-marked machines it is necessary to submit to the party providing the 4.0 attestation: booklet, declaration of conformity, plate and test with respect to the correct application of the directives;
  • for machines lines it is necessary to submit to the person who provides the 4.0 certification: technical file of the line in which all interference problems between the individual machines are resolved, overall instruction booklet, declaration of conformity, plate and test.

Studio Gallian proposes itself for the CE marking according to the following path:

A: ANALYSIS OF THE SITUATION AND LOCATION: the location of the machine / line is analyzed and defined in order to decide the directives to be applied and the relevant harmonized and non-harmonized standards. This is done in relation to the environments and atmospheres. In addition, an outline data collection of materials and their characteristics is carried out.

B: TECHNICAL FILE (DIRECTIVES: MACHINES, BT, EMC AND ATEX)

The purpose of the file, in relation to the intended use of the same is to carry out the assessment of risks and establish actions to mitigate them. The mitigation actions concern the foreseen and unforeseen use and the management of ordinary and extraordinary maintenance (e.g. spare parts).

The technical file consists of the following sections:

00 description of method adopted and machine/line subject of the file: this section describes both the method adopted and the machine. In particular, it describes the intended use and contextualization of the conditions for which the technical file is issued.

01 risk analysis and solutions adopted

The analysis carried out, with respect to what was previously defined, consists of the following sections:

01.01 risk assessments: report with general assessment of framing and solutions adopted with respect to laws and standards in general.

This section also details

  • directives, harmonize standards, other applicable standards and any other applicable technical reference for the assessment;
  • classification and intended use of the machine;
  • safety distances according to 13.857 and crushing spaces 349
  • check list:
    • machinery directive;
    • low voltage;
    • electromagnetic compatibility;
    • ATEX explosive atmospheres (with software support for the detailed study of the zones);
    • and any other applicable condition (example: PED etc.)
  • and moreover
    • analysis of risks and signs on the machine
    • PPE / DPC identification
    • structural calculations (with modeling by means of PROSAP program and/or dimensional checks and/or control of structural compliance and stresses of the case)

01-02 Tests and measurements with emission single reports (all with own instrumentation):

  • electromagnetic compatibility through measurements of electromagnetic emissions generated by the machine / line (from electrical parts / electrical panel, wiring to actuators, data transmission, inverters and similar);
  • electrical insulation of live parts with respect to masses;
  • temperatures with thermographic chamber; the purpose is to detect if there are dangerous situations (regarding temperature) that can generate triggers and/or deterioration. This is done in general on the machine (wiring, friction, motors) and in particular on the electrical panels (opened after a suitable period of operation);
  • generation of environmentally harmful substances as a result of operation
  • noise. At the perimeter of the machine line, the emission is measured in different operating conditions (distance 1.00 meters, height 1.50 meters);
  • Humidity: This is used to check the conditions previously established;
  • Lighting: Checks that the work points are adequately lit;
  • vibration: Checks that there are no unsuitable conditions;

Continuous measurements: If necessary, in addition to point measurements, continuous measurements can also be carried out with thermometric probes, survey stations (NUVAP). The parameters, which are usually measured, are given by exposure to: noise, microclimate, electromagnetic fields high frequency and low frequency, Radon gas, ionizing nuclear radiation, radioactivity, wifi pollution, carbon monoxide, methane gas, volatile organic compounds, dust and smoke, air quality, formaldehyde, carbon dioxide, particulate matter and fine dust, humidity

01-02 Support for subsequent mitigation actions. 

They are collected in that section:

  • management of external parts and components conformity declarations
  • declarations of electrical panel and wiring according to CEI 60204 standards, etc.
  • photos/drawings
  • other electrical and non-electrical documentation
  • various

02 Instructions for use.

02-01 Instructions for use:

  • reasoned collection by individual installed component (vendor data);
  • electric motorization (included in the electrical system);
  • uniform wiring (included in the electrical system):
  • other;

02-02 instructions on board the machine

  • general safety signs;
  • pictograms;
  • detailed instructions displayed;

02-03 safety procedures:

  • safe working, tooling, cleaning, and maintenance;
  • access instructions;

02-04 overall:

  • stitching and integration of missing parts;

03 Declaration of conformity and testing.

In this section is issued:

  • overall declaration of conformity
  • overall testing of the machine / line

04 Nameplate.

Issuing of the overall CE marking plate.

 C RELATIONS WITH CERTIFICATION BODY

If necessary, it is proposed to manage relations with the certification bodies required for the following operations:

  • machinery directive if in annex 4
  • ATEX directive: filing of the dossier and/or testing activities for the relevant classification.