As mentioned in previous newsletters the Regulation (EU) 1025/2012, especially art. 10 par. 5, as well as the of the European Commission appointed HAS-Consultants (HAS: Harmonized Standards) will play an important role on the publishing of references of harmonized standards in the OJEU. Before the harmonized standards are published they pass through a compliance assessment done by the HAS-consultant which results in a noticeably delay of the publishing or even causes by CEN, CENELEC and ETSI ratified standards to fail by the HAS-consultant.
Another characteristic was recently announced from a HAS-consultant. In response to an enquiry to the Commission we received the following reply on March 5th 2019:
Dear Mr Loerzer,
Indeed publication of standards is now done via a Commission Decision published in L series of the OJ, therefore providing legal value. I am not specifically aware of standard on accessibility, but there have been other publications of standards in the OJEU L series already.
Luca DEL COLOMBO,
Desk Officer for the Low Voltage Directive
How this new practice of publication is illustrated in the OJEU is now explained in more detail in context of the Machinery Directive as well as Construction Products Regulation.
The Commission has published the Decision (EU) 2019/436 in the OJEU L 73, p. 108 in connection with the Guideline 2006/42/EC on March 19th 2019 and the Implementing Decisions (EU) 2019/450 und 2019/451 in the OJEU L 77, p. 78 to 82 for the Regulation (EU) 305/2011 on March 20th 2019. Thus these Implementing Decisions have a legally binding character. The consequences of this are illustrated in the Implementing Decision to the Machinery Directive:
- Annex I contains those harmonized standards which are newly listed in the OJEU and are leading to a presumption of conformity
- Annex II contains two harmonized standards whose presumption of conformity has been restricted since some paragraphs of the standard do not correspond with the protection requirements of Annex I of the Machinery Directive
- Annex III contains such harmonized standards which do not lead to the presumption of conformity and are hereby withdrawn since March 19th 2019
Important in this context is that there is no cumulative list of harmonized standards anymore. Thus the user has to read the original list of standards from the notice of the OJEU 2018/C92/01 in connection with this Implementing Decision to find out if the till now from the manufacturer applied harmonized standards lead to a presumption of conformity, a restricted presumption of conformity or no presumption of conformity. This new publishing process applies for the whole of the Harmonization Legislation.
In this respect, it will be interesting to observe which harmonized standards, e.g. the Low Voltage Directive, the EMC, ATEX or Radio Equipment Directive or the Medical Device Regulation, are published with which grade of presumption of conformity or even not because they fail the compliance assessment of the respectively HAS-consultant in the next few months.
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