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Draft annual Union work programme for European standardisation for 2018

ID 4517 | | Visite: 1763 | Documenti Marcatura CE UEPermalink: https://www.certifico.com/id/4517

Draft annual Union work programme for European standardisation for 2018

Commissione Europea 11.08.2017

The Commission supports the voluntary application of standards and industry’s leading role in their development. At the same time, it considers as essential, to secure a high level of acceptance, that the standardisation process should benefit from the technical knowledge of industrial, governmental and scientific representatives and other stakeholders. The regulator can establish requirements in legislation and ask the European Standardisation System (ESS) to develop voluntary European standards (to be published in the Official Journal), which can be used for indirect reference and as a basis for a presumption of conformity or safety. An efficient standardisation system must therefore be based on close partnership between the regulator, standardisation bodies and industry.

The Commission set out a strategic vision for European standardisation in its 2011 Communication on A strategic vision for European standards: moving forward to enhance and accelerate the sustainable growth of the European economy by 2020. This was givenlegal form in Regulation (EU) N° 1025/2012 on European standardisation, which has been in force since 1 January 2013.
The Regulation requires the Commission to identify strategic priorities for European standardisation. These priorities, which reflect the Commission’s policy objectives, are published in annual Union work programmes for European standardisation (AUWPs). The AUWPs indicate what standards and standardisation deliverables the Commission intends to request from the European standardisation organisations (ESOs), i.e. how it intends to use standardisation in support of new or existing legislation and policies and what formal standardisation requests (mandates) this may involve.

Standardisation requests are essential for the functioning of the single market, since standards enable the implementation of legislative acts. This generates legal certainty for manufacturers and facilitates the development and commercialisation of products and services.

The standardisation activity prioritised in this 2018 AUWP reflects a number of the current Commission’s policy priorities, and supports recently approved major legislation and policy documents. Further important elements include action to enhance the visibility of European standardisation in other countries and international organisations, and action to improve the functioning, performance and delivery of the ESS. The Commission welcomes the European Parliament resolution of 4 July 2017 on European standards for the 21st century ("hereinafter EP report on standardisation "), and acknowledges and underlines "the opinion that standards are an important tool for the operation of the Single Market, to enhance European competitiveness, growth and innovation, to support quality, performance and protection of consumers, business, workers, and environment and to develop interoperability of networks and system". In particular, the
AUWP addresses and echoes the challenges and considerations surrounding Standards Essential Patents, on ICT standardisation, the international dimension of standardisation and on autonomous vehicles. Furthermore, the report is crucial in support of the inter-institutional reporting and dialogue and has served as an important reference for this AUWP.

The AUWP also reflects the joint initiative on standardisation (JIS), which was proposed by the Commission in 2015 (as part of the single market strategy) and signed in June 2016. The JIS sets out a shared vision that supports the Commission’s 10 policy priorities, and specific actions to be delivered by 2019 to improve the European standardisation system mobilising the EU institutions and the European standardisation community. It has been widely recognised as the way forward for European standard-setting in the light of technological development, political priorities and global trends. To date, it has been signed and endorsed by a total of 109 participants, including EU and EFTA Member States and organisations, representing a high level of engagement throughout the ESS.

This work programme:

-  is addressed to all Member states, ESOs, national standardisation bodies (NSBs), AnnexIII organisations (SBS, ANEC, ETUC and ECOS) representing respectively SMEs, consumers, workers and environmental interests in standardisation, industry and other stakeholders involved in the standardisation process, and calls for their active participation in the priority actions;

-  seeks to make the ESS more effective by concentrating available resources on the sectors that enable it to deliver on Commission priorities; and

-  calls on ESOs to base their work programmes on implementation of the key strategies, actions and policies highlighted here.

The AUWP has no budgetary impact over and above what is already foreseen in the financial perspectives for 2018.

...

Estratto:

Draft working document on implementation of the foreseen actions

A Resilient Energy Union with a Forward-Looking Climate Change Policy

Policy/legislative reference Objective Aim /impact of the action Type of action
Ambient air quality
directives (Directive
2008/50/EC and
Directive 2004/107/EC)

Support for the local and regional
monitoring of air quality with mobile
and portable monitoring devices that
meet the data quality objectives in the
Ambient Air Quality
Directives. Support fot the
implementation of the Ambient Air
Quality Directives. In order to ensure
that the information collected on air
pollution is sufficiently representative
and comparable across the Community,
it is important that standardised
measurement techniques and common
criteria for the number and location of
measuring stations are used for the
assessment of ambient air quality.
Techniques other than measurements
can be used to assess ambient air
quality and it is therefore necessary to
define criteria for the use  and required
accuracy of such techniques.


The standards for air quality sensors would support for the local and regional monitoring of air quality with
mobile and portable monitoring devices and the statistical processing of data in a user-friendly way. The
problem to be solved is that the performance of the current generation of air quality sensors does not meet
the data quality objectives in the Ambient Air Quality Directives. The standard is necessary because Member
states S have identified problems with the relatively cheap sensors used by the public to measure air quality,
because these sensors do not meet the data quality objectives in the Ambient Air Quality Directives . All over
Europe, citizen scientists, NGOs, companies and administrations are increasingly monitoring local and
regional air quality. They often use mobile monitors,portable devices and biological tools. These ways are
claimed to be useful to perform measurements in or near hotspots and to establish air quality benefits near
infrastructure projects to compare the situation before and after, especially if no official monitoring station is
nearby. Such ways could also raise awareness of e.g. school pupils and provide support among citizens for air
quality measures. The developement of a standard for air quality sensors would promote innovation, increase the
quality of the portable devices and impact on jobs and competitiveness in the EU market of these sensors.
Development of a
standard for the
local and regional
monitoring of air
quality with mobile
and portable
monitoring devices
that meet meet the
data quality
objectives in the
Ambient Air Quality
Directives.
Directive 2010/75/EU on
industrial emissions
(IED)

The Directive 2010/75/EU on industrial
emissions (IED) and the Commission
Decisions establishing conclusions on
Best Available Technique (BAT), require
suitable monitoring of:
the emissions of ammonia (HN3) to the
air; the emissions of chlorine (and
chlorine dioxide) to the air; hydrogen
fluoride or total gaseous fluorides from
different industrial sectors
and refer to EN (or where EN standards
not available ISO, national or other
international equivalent) standards.
There is therefore a need to develop EN
standard where no EN and ISO standard
are currently available.

• The standard will be used for the continuous monitoring of ammonia (NH3) to air from the use of
SCR/SNCR (e.g. in large combustion plants) and for continuous and periodic monitoring of emissions of
ammonia from other industrial sectors, includingproduction of cement, lime and magnesium oxide, glass,
non-ferrous metals, pulp, paper and board, refining mineral oil and gas, intensive rearing of poultry and pigs
and organic chemicals. Standardised methods for monitoring will contribute to harmonised and better
compliance assessment.
• The standard will contribute to the quality of the measurement equipment and of the reported data. The
standard on emissions of chlorine (and chlorine dioxide) to the air will be used for the periodic monitoring of
chlorine from different industrial sectors like production of chlor-alkali, organic chemicals, non-ferrous metals and
(possibly) also for monitoring of chlorine dioxide from chlor-alkali production. Standardised methods for
monitoring will contribute to improved and harmonised compliance assessment. The standard will contribute to
the quality of the measurement equipment and of the reported data.
• The standard on fluorides will be used for the periodic or continuous monitoring of hydrogen fluoride or total
gaseous fluorides from different industrial sectors like production of iron and steel, glass, non-ferrous metals,
large combustion plants and waste incineration plants. Standardised methods for monitoring will ensure
reliable, representative and comparable data and contribute to improved and harmonised compliance
assessment. The standard will contribute to the quality ofthe measurement equipment and of the reported data.

Development of a
Standard to support
the implementation
of the Industrial
Emissions Directive
Directive 2009/125/EC
establishing a
framework for the
setting of ecodesign
requirements for
energy-related products
and associated
implementing
Regulations

Standards meeting the requirements
which the below listed energy-related
products covered by implementing
measures must fulfil in order to be
placed on the market and/or put into
service: computers, displays, servers and
data storage devices, commercial
refrigeration, electric motors, fans,
lighting products, household cold
appliances, standard air compressors,
machine tools and external power
supplies

The standards will decrease the energy consumption of the products thus reducing the environmental impacts
and achieving energy savings which also leads to economic savings for businesses and end-users

Development pf
standards

A Deeper and Fairer Internal Market with a Strengthened Industrial Base

Policy/legislative reference Objective Aim /impact of the action Type of action
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)
Mainly related to new (emerging)
technologies and machinery, standards
necessary for specific machinery below, as a
market need identified via the open public
consultation for the evaluation study of the
Directive on machinery: 1) Additive
manufacturing machinery (3D printing); 2)
Collaborative robots; 3)Automated machines
and vehicles; 4)Wind turbines; 5)Food
machines
New harmonised standards for specific types of machinery mentioned
hereafter will fill in the existing gap for such innovative products which are
developed at a fast pace and their spread on the European market
becomes increasingly wider. In order to overcome the current situation of selfcertification
conformity procedures and as such, availability of European
harmonised standards is highly important both for ensuring safety and
market access. Further to this, relevant international standardisation activities
should be taken into account.

Develop harmonised
standards
Regulation (EU)
2017/745 of the
European Parliament
and of the Council of 5
April 2017 on medical
devices and;
Regulation (EU)
2017/746 of the
European Parliament
and of the Council of 5
April 2017 on in vitro
diagnostic medical
devices
The new Regulation reinforces safety and
performance requirements for medical
devices, to keep pace with technological and
scientific progress. It further harmonises and
clarifies the regulatory requirements to
support their uniform application by the
operators. Therefore, the review of the
existing standards is necessary in order to
align them to the requirements of the new
Regulation.
New standardisation requests may be
considered for new types of devices, new
regulated practices, or in view of the more
detailed safety and performance
requirements.
uniform application of the legal requirements for placing medical
devices on the market facilitation of the free movement of medical devices in
the internal market

review / update of all the
existing standards (in
particular, review of the
scope of each standard in
the light of the
requirements of the new
Regulation)
possible development of
new standards, in order
to cover such matters as:
(i) new types of devices;
(ii) new regulated
practices; (iii) more
detailed safety and
performance
requirements
Regulation 1907/2006
(REACH)
Harmonisation of an analytical method to
determine the migration of polycyclic
aromatic hydrocarbons (PAHs) from plastic
and rubber. The restriction in entry 50 of
Annex XVII will be reviewed in late 2017 and
may include a migration based derogation
from the content limit already established.
This standard will support the implementation of the restriction
defined in entry 50 of Annex XVII to REACH, relative to PAHs in consumer
articles containing plastic and rubber components
Development of a
harmonised standard. The
standard would rely on
initial method
development work
currently being
undertaken by DG JRC
Directorate D, which
should conclude in late
2017
Directive 2014/34/EU of
the European Parliament
and of the Council of 26
February 2014 on the
harmonisation of the
laws of the Member
States relating to
equipment and
protective systems
intended for use in
potentially explosive
atmospheres.
European harmonised standards in the ATEX
sector are currently developed under the
Mandates M/BC/CEN/92/46 and
M/BC/CEN/92/8 issued for the previous
Directive 94/9/EC. It is necessary to
consolidate and update the mandate for the
new Directive 2014/34/EU taking into
consideration the Standardisation Regulation
(EU) No 1025/2012

As for the other EU harmonisation legislation for products in the internal
market, referred to the "New Approach" and the "New Legislative
Framework", harmonised standards are a very useful mean to get presumption
of conformity with the essential requirements they aim to cover. A new
consolidated and updated mandate would improve the legal and technical
bases for the work to be developed by the European Standardisation
Organisations (CEN and CENELEC)
Development of
harmonised standards for
the ATEX legislation

Fonte: Commissione Europea

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