Reading Time: 3 minutes Difficulty: MediumThe placing on the market and the disposal of an industrial machine within the Community market have to be carried out in accordance with the directives and regulations on compliance. Sometimes court cases emerge that give impetus to change by questioning the current processes of standardization. With what result? Read on to learn more.
The placing on the market and the disposal of an industrial machine within the Community market have to be carried out in accordance with the directives and regulations on compliance. Sometimes court cases emerge that give impetus to change by questioning the current processes of standardization. With what result? Read on to learn more.
The standard process for standardization
The European Union specifies in directives, transposed in EU countries, and regulations, of immediate implementation, which Essential Health and Safety Requirements must be respected in order to ensure conformity of the “machine” product.
The solution for the presumption of conformity lies in the need to follow the indications of the harmonized standards and EU Directives or Regulations, since, although it is not mandatory to apply the harmonized standards, these do represent an excellent guide.
Otherwise, if the manufacturer chooses not to comply with these requirements for the design and construction of the machine, it must assume direct responsibility for demonstrating the conformity of the product.
European standards are prepared, in accordance with Regulation 1025/2012, by the European Standardization Organizations:
• CEN (European Committee for Standardization)
• CENELEC (European Committee for Electrotechnical Standardization)
• ETSI (European Telecommunications Standards Institute)
The process is managed internally by the National Standardization Bodies, which transpose the content in the form of national standards, eliminating any conflicts or redundancies in the legislation.
Harmonized standards are particular insofar that they are developed on a mandate from the European Union. To date, about 20% of European standards arise in response to a request for standardization by the EU, followed by a step that establishes when the presumption of conformity will begin to produce effects, and the publication of the final version of the standard in the Official Journal of the European Union.
Do you need immediate assistance for compliance with the harmonized standards relating to the Machinery Directive?
Why legislation can be slowed down
In recent years, some shortcomings appear to have emerged in the European Commission’s process of publication and harmonization of standards.
The five-year report issued by the Commission under Regulation 1025/2012 showed, however, that in the period 2016-2020 the EU’s commitment was strongly focused on resuming a tight pace, in light of some court cases that resulted in carefully considered and significant changes to the process of harmonization of EU rules.
The following cases were of particular importance:
• JAMES ELLIOTT (Judgment of the European Court of Justice “ECLI:EU: C:2016:821” of 27 OCTOBER 2016, CASE “C-613/14”)
• GLOBAL GARDEN ITALIA (Judgment of the European Court of Justice “ECLI:EU: T:2017:36” of 26 January 2017, CASE “T-474/15”)
Both judgments helped to reaffirm the essential nature of harmonized rules in the EU legal order, by introducing the possibility of developing common specifications.
The common specifications represent alternative solutions for achieving conformity in cases where harmonized standards are not present or sufficient, it being understood that technical standards, although not mandatory, are confirmed as the most reliable tool for ensuring the conformity of a product, and must therefore be duly accessible to citizens and companies.
Would you like to know more about the principles that currently guide the work of the European Commission?
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