On 20 April 2016, the 2-year transition period for the eight EU directives published in the Alignment Package in EU Official Journal L 96 of 29 March 2014 expired! These EU directives now all require an
‘appropriate risk analysis and assessment’ in the technical files.
‘appropriate risk analysis and assessment’.
The amendment of these directives was only one part of the planned amendments in line with the New Legislative Framework. The transitional period for the Pressure Equipment Directive 2014/68/EU also expired on 19 July 2016.
This list contains references in EC/EU directives that impose requirements for risk assessments, risk analyses, risk evaluations or safety assessments:
Machinery Directive:
ANNEX III, PROCEDURE FOR CONFORMITY ASSESSMENT, MODULE B, EU-type examination
3. The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.The application shall include:
c) the technical documentation. The technical documentation shall make it possible to assess the explosive’s conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s).
ANNEX II, CONFORMITY ASSESSMENT PROCEDURE, 1. EU-type examination (Module B)
1.3 The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice. The application shall include:
2014/30/EU
Annex II, CONFORMITY ASSESSMENT PROCEDURES, 1. Module B: EU-type examination
c) the technical documentation. The technical documentation shall make it possible to assess the instrument’s conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s)..
ANNEX II, MODULE A: CONTRôle interne de fabrication, 2. technical files:
The manufacturer shall establish the technical documentation as described in Article 18. The documentation shall make it possible to assess the instrument’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).
ANNEX IV, EU TYPE EXAMINATION FOR LIFTS AND SAFETY COMPONENTS FOR LIFTS, (Module B) A. EU-type examination of safety components for lifts,
2. The application for EU-type examination shall be lodged by the manufacturer, or his authorised representative, with a single notified body of his choice. The application shall include: The application shall include: c) The technical documentation shall make it possible to assess whether the safety component for lifts meets the conditions referred to in point 1 and shall include an adequate analysis and assessment of the risk(s).
ANNEX III, MODULE B: EU-TYPE EXAMINATION, point 3: The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice. The application shall include:
c) the technical documentation. The technical documentation shall make it possible to assess the product’s conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s).. [...]
ANNEX III, MODULE A, Internal production control, 2. Technical documentation:
TThe manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the electrical equipment’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). . [...]
Article 18: Safety assessments - Manufacturers shall, before placing a toy on the market, carry out an analysis of the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that the toy may present, as well as an assessment of the potential exposure to such hazards.
ANNEX IV, TECHNICAL DOCUMENTATION The [...] shall contain, in particular, so far as relevant for assessment: [...] (b) the safety assessment(s) carried out in accordance with Article 18 [...]
ANNEX I, ESSENTIAL SAFETY REQUIREMENTS, PRELIMINARY OBSERVATIONS
3. The manufacturer is under an obligation to analyse the hazards and risks in order to identify those which apply to his equipment on account of pressure; he shall then design and construct it taking account of his analysis.
ANNEX III, CONFORMITY ASSESSMENT PROCEDURES
At various points in this section, documentation of an appropriate risk analysis and assessment is required.
No claim to completeness!
Particularly attentive readers of the German editions of the new EU directives may have been surprised that the directives call for ‘an appropriate risk analysis and assessment’ and not a ‘risk assessment’. The terminology in the new directives comes from EU DECISION No. 768/2008/EC. This forms one of the legal bases for the New Legislative Framework. The English wording is ‘an adequate analysis and assessment of the risk(s)’. According to EN ISO 12100, these terms are defined:
The English edition thus requires a ‘Risk assessment’! According to EN ISO 12100, the ‘risk analysis’ and the ‘risk evaluation’ are parts of the risk assessment. The new EU directives therefore also require a risk assessment.
In the EEC/EC directives developed according to the ‘New Approach’, among other things
The New Legislative Framework was therefore adopted and implemented. Details can be found on the website of the European Commission.
There are two main questions regarding the pragmatic completion of the legally required risk assessments in accordance with the amended EU directives:
Posted on 2016-03-11
Ing. Helmut Frick Since 1994 CE consulting in mechanical and plant engineering with focus on CE organization and standards management. Managing director of IBF Holding GmbH and head of the business unit "Digital Standardization".
Email: helmut.frick@ibf-solutions.com |www.ibf-solutions.com
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