Ref. Ares(2019)6546201 - 23/10/2019
The event organisers have requested that the following three major topics be
addressed during your intervention in the panel discussion:
x
New Legislative Framework (NLF)/James Elliott Judgment;
x
Harmonised Standards (HAS) Consultants;
x
New format of standardisation requests.
Industry is concerned that the Commission has drifted away from the essence of the
New Legislative Framework. In their view, the Commission’s policies make the
European standardisation system unnecessarily bureaucratic. The legal requirements
would generate unacceptable delays in requesting, producing, assessing and
publishing harmonised standards. These shortcomings would make the European
standardisation system less attractive to industrial stakeholders. This corresponds with
critical remarks from the industry on the functioning of the European standardisation
system at the June 2018 inter-institutional dialogue on standardisation. In the invitation,
the organisers mention in particular the approach of the Legal Service.
(
Details about the positions of the organisers are in the background notes and in their
position papers in your file.)
The
New Legislative Framework consists of:
x Regulation (EC) 765/2008 setting out the requirements for accreditation and the
market surveillance of products;
x Regulation (EC) 764/2008 laying down procedures relating to the application of
certain national technical rules to products lawfully marketed in another EU country;
x Decision 768/2008 on a common framework for the marketing of products, which
includes reference provisions to be incorporated whenever product legislation is
revised. In effect, it is a template for future product harmonisation legislation.
The package reinforces the application and enforcement of Internal Market legislation,
as it:
x improves market surveillance rules to better protect both consumers and
professionals from unsafe products, including those imported from outside the EU.
In particular, this applies to procedures for products which can pose danger to
health or the environment;
x sets clear and transparent rules for the accreditation of conformity assessment
bodies;
x boosts the quality of and confidence in the conformity assessment of products
through stronger and clearer rules on the requirements for the notification of
conformity assessment bodies;
x clarifies the meaning of CE marking ("
Conformité Européenne") and enhances its
credibility; and establishes a common legal framework for industrial products in the
form of a toolbox of measures for use in future legislation. This includes definitions
of terms commonly used in product legislation, and procedures to allow future
sectorial legislation to become more consistent and easier to implement.
In the “
James Eliott” judgment of the Court of Justice of 27 October 2017, the Court
upheld that the Commission, when it comes to the publication of voluntary harmonised
standards in the Official Journal, is bound by an obligation to:
x supervise thoroughly the development process of such standards
Steering brief
2/18
and in starting the business constitutes a major cost driver. Restrictions on State
subsidies make Europe less competitive as location for investment, especially
compared to North America and Asia. They see the event "Save the Single Market" as
a starting point for a still to be defined sequence of discussions on the New Legislative
Framework.
Objectives
x Underline the importance of the Single Market as one of the major achievements of
European integration, but important legislative files are still to be concluded and a
European perspective to enforcement is needed.
x Stress that the Commission highly values the New Legislative Framework and is
committed to safeguarding it.
x Acknowledge that European standardisation faces a number of important challenges
today, and underline that the Commission will continue the dialogue with industry
and support the competitiveness of EU industries.
Steering brief
4/18
Line to take
The Single Market and its challenges
x This year, we have celebrated 25 years since the creation of the Single Market,
which lifted numerous barriers and created new opportunities for citizens and
businesses alike.
x The Single Market has become one of the major achievements of European
integration, supporting EU industry's innovation and competitiveness.
x EU product rules cover a large share of manufactured products in the EU. These
have a value of EUR 2 400 billion and are produced or distributed by some 5 million
businesses.
x EU rules allow products to circulate freely across the Union while ensuring a high
level of environmental and health protection and consumer safety.
x Overall, the general principles of the "New Approach" and the "New Legislative
Framework" still stand.
x However, the Single Market also faces several challenges.
x We are living in a world increasingly affected by societal changes such as
globalisation and digitalisation.
x For the past 3 years, the EU has been implementing a Digital Single Market
Strategy to allow Europe to maximise the benefits while mitigating the challenges of
the digital revolution.
x With more than 60 initiatives launched by the European Commission, a lot has been
achieved in close cooperation with Member States and private stakeholders from
industry, academia and civil society.
x We need this cooperation to continue as there are still important legislative files to
conclude and further down at the level of implementation of the measures.
x Products and distribution chains across the EU are increasingly interlinked. Yet,
national market surveillance authorities lack resources and are confined to their
national territory. We need a European perspective to enforcement.
x Too often, investigations launched in one Member State end at the national border.
To overcome this challenge, market surveil ance must be consistent no matter
whether the product is made outside or inside the EU, or whether it is bought online
or offline.
The New Legislative Framework as an important Single Market tool and the role
of the European standardisation system
x The public-private partnership of the European standardisation system played an
important role by becoming an essential trade facilitator and enabler for creation of
jobs and growth in Europe.
x A central element in this success has been the development of the so-called New
Legislative Framework in the field of the free movement of goods.
x The Commission highly values the New Legislative Framework as an important
Single Market tool and is ful y resolved to safeguard it and continue building on its
achievements in a close cooperation with the industry.
x At the same time, we realise that European standardisation faces a number of
important chal enges today, one of them being to ensure appropriate implementation
of relevant EU legislation as wel as a smooth day-to-day functioning of the New
Legislative Framework in a rapidly evolving global context.
Steering brief
5/18
x The Commission is aware of the concerns raised by the industry representatives in
this respect.
x We are committed to continuing the dialogue with the industry in order to find a
common understanding on the critical issues and to identify the best ways of
addressing them.
x In this spirit, the Commission has already last year joined forces with the European
Standardisation Organisations to agree on an
Action Plan to tackle existing
problems in the process of production of harmonised standards and their
assessment and citation in the Official Journal by the Commission.
x This joint effort has already brought positive results with two thirds of the initially
delayed standards already published and further work is under way.
x The Action Plan also provides for a new system of consultants who assist the
Commission in the assessment of standards. This system started on 1 April 2018.
These consultants are an important communication bridge between Standardisation
Organisations and the Commission.
x The Commission will strive to ensure that any changes which might be necessary to
ensure a robust and correct implementation of EU legislation will not adversely
affect the functioning of the European standardisation system, but rather support
and develop the competitiveness of EU industries.
Contacts – briefing coordination:
, tel.:
Steering brief
6/18
Panel Questions
1. The New Legislative Framework has been a successful model since the
mid-80s. The EU has enacted about 30 directives and regulations under
NLF principles. Does the NLF strengthen the competitiveness of European
industry and, if so, what are the reasons for that?
x First of all, we should recall that the Single market for goods is a
success.
Ö In the last three decades, regulatory obstacles have been
removed for around 80 % of industrial products through the
adoption of common rules.
Ö We are talking about a value of €2,400 billion and 5 million
businesses involved.
x Standardisation and the New Legislative Framework (NLF) have
played a major role in this success, thanks to the partnership built
with the European Standardisation bodies.
x European Standards create a level playing field. They stimulate
innovation and decrease compliance costs. They have a positive
influence on our economies.
Ö This is reflected in studies commissioned in Member States
such as Germany, France and the UK, estimating that
standards contribute between 0,3% and 0,9% to their Gross
Domestic Product growth rate1.
Ö As one-third of European standards are developed at
international level, they are an opportunity for European
industry to gain leadership positions on innovative
technologies.
1 E.g. DIN German Institute for Standardization (2011) "The Economic Benefits of standardisation”
Steering brief
7/18
x The New Legislative Framework makes the standardisation process
swifter, more efficient and more flexible. Its contribution to the
competitiveness of the European industry is evident.
Steering brief
8/18
3. Harmonized standards must specify the essential requirements of the
relevant EU directives or regulations. Standardization experts are often
technical experts. In this respect, it makes sense to have an expert for
verifying compliance with legal requirements in the standardization
process (keyword: HAS Consultants). In the past, these two perspectives
were sufficient to list a standard in the Official Journal. Why is that no
longer the case in your view today?
x It is crucial to remember that a standard adopted and referenced in
the Official Journal gives a presumption of conformity for products
and services with the requirements of Union harmonisation
legislation.
x It is thus the responsibility of the Commission to carry out an ex-
ante assessment of the draft harmonised standards. The aim is to
check whether they meet the essential requirements set out in the
legislation and to avoid a situation where the Parliament or the
Council would object to them.
x To perform this task swiftly and efficiently, the Commission needs
experts to assist it.
x As of April 2018, the Commission has been supported by the
harmonised standards (HAS) consultants who will eventually
perform the majority of the assessments.
x They follow the technical requirements set out in the legislation and
the procedures agreed with the standardisation community.
x The Commission is convinced this makes the assessment process
more predictable and will reduce delays.
Steering brief
10/18
4. The EU Commission awards standardization mandates to the
European standardization organizations. According to the wording of the
European standardization regulation, a relatively open formulation of
these orders is sufficient. In the area of machine safety, for example,
there is only one such mandate, the elaboration of more than 750
harmonized standards is based on it. Serious problems have not yet
emerged. Never change a running system. Why has the EU Commission
changed the interpretation of the Standardization Regulation?
[
NB: According to Art. 10(1) of Standardisation Regulation "the
Commission shall determine the requirements as to the content to be met
by the requested document and a deadline for its adoption".]
x The reason of the new format of standardisation requests is the James
Elliott ruling, which the Commission is under an obligation to
implement.
x The aim of the new format is to simplify and accelerate the drafting
process through, inter alia, increasing legal clarity.
x This should make such process more transparent and more
predictable.
x The new format has not yet been finalised – the Commission is still
trying to reach the highest possible level of consensus within the
Committee on Standards.
x The priority of the Commission is to ensure that the new format of
standardisation requests does not negatively impact their execution
and preserves sufficient flexibility.
Steering brief
11/18
x The Commission is engaged in a regular dialogue with
the industry to discuss all the steps planned by the
Commission, consult all relevant stakeholders in the
relevant fora, and reach the highest possible level of
consensus.
x Moreover, if this dialogue identifies specific problems, the
Commission addresses them in cooperation with the
standardisers, like for example through the Action Plan
on citation of harmonised standards.
The James Elliott Judgment is limited to construction
products and should not be applied to other areas of
the New Legislative Framework.
x The facts of the James Elliott case are specific to the
sector of construction products. However, the Court does
not make any reference to the fact that the construction
sector is a specific case.
x On the contrary, the Court of Justice concluded that
harmonised standards are part of EU law. Therefore, the
ruling applies also to other areas of Union legislation with
harmonised standards.
Steering brief
13/18
2.
CONSULTANTS ON HARMONISED STANDARDS
The newly introduced system of assessing draft
standards by the Commission’s consultants on
harmonised standards (HAS Consultants) will delay the
citation of standards in the Official Journal of the EU.
x The new system of Harmonised Standards (HAS)
Consultants aims at avoiding delays in the citation of the
final standards in the Official Journal.
x In fact, the Commission’s proposal of introducing a
system of technical experts that support it in assessing
draft standards is the result of an opinion of Member
States in the Committee on Standards.
x Conducting the assessment throughout the drafting
process of standards allows for identifying and solving
issues at an early stage. These issues could otherwise
prevent citation in the Official Journal at the stage of the
final Commission assessment.
x It is still too early to know how successful the new system
will be in facilitating timely citation of standards in the
Official Journal. Preliminary data on the performance of
the system are very promising. The Commission is
constantly monitoring and will regularly evaluate the
functioning of the HAS Consultants system.
Steering brief
14/18
Will the system of Consultants on Harmonised
Standards be fully compatible with the standardisation
system, as requested by the industry?
x The system of Consultants on Harmonised Standards
(HAS Consultants) will be compatible with and integrated
in the European standardisation system.
x Consultants on Harmonised Standards can participate in
the meetings of the technical bodies in charge of drafting
the standards.
x The Consultants are requested to be in continuous
dialogue with these technical bodies. The assessment
conducted by the Consultants is aligned to the internal
processes and working deadlines of the European
Standardisation Organisations to avoid any negative
impact in the process of developing standards.
How will the current backlog of non-cited standards
(currently 200) be solved?
x Thanks to the very good cooperation with the European
Standardisation Organisations and the Action Plan, there
has been very good progress already and the initial
backlog has been reduced by two thirds.
x This being said, the Commission is of course doing all it
can to avoid any backlog at all. But this has to be a joint
effort: The better the Standardisation Organisations and
the Commission work together, the faster there will be
standards that are ready for citation. A very important
element in this collaboration is the new consultants
system that will serve as a bridge between the
Standardisation Organisations and the Commission.
Steering brief
15/18
3. NEW FORMAT OF STANDARDISATION REQUESTS
The new format of standardisation requests is
prescriptive and procedurally burdensome. It is
incompatible with the system of the New Legislative
Framework, which requires that standardisation
organisations should be flexible enough to react to
latest market and scientific developments.
x The Commission is finalising the wording of the proposed
new format of standardisation requests. It is trying to
reach the highest possible level of consensus by
involving the stakeholders in the Committee on
Standards.
x The Commission will ensure that the new format of
standardisation requests does not negatively impact the
execution of the standardisation requests and maintains
the necessary degree of flexibility.
x Once agreed, the new format of standardisation requests
will significantly simplify and speed-up the drafting
process. In addition, it should increase the predictability
and transparency of the drafting process and the legal
clarity of the standardisation requests.
Steering brief
16/18
The voice of the industry has not been sufficiently
heard during the drafting process.
x The final wording of the standardisation requests will be
the result of an inclusive and transparent consultation
process. The Commission seeks to reach a consensus
with the relevant stakeholders. It has consulted the
Member
States,
the
European
standardisation
organisations, as well as industry representatives. Their
views will be duly taken into account.
x The industry is consulted on all draft standardisation
requests in the Standards Market Relevance Roundtable
(SMARRT). The Commission set up this forum in 2016
within the framework of the Joint Initiative on
Standardisation. The aim of SMARRT is to improve the
exchange of information and dialogue with the industry.
Steering brief
17/18
4. CYBERSECURITY
How is Cybersecurity taken into account in the context
of the New Legislative Framework?
x Trust and cybersecurity are key elements of a thriving
Digital Single Market. To this end, the Cybersecurity
Regulation proposes the introduction of a European
Cybersecurity Certification Framework for products and
services in the area of Information and Communication
Technology.
x The proposed Cybersecurity Act follows the New
Legislative Framework (NLF).
x On
the cybersecurity of vehicles (in particular
autonomous cars), the Commission proposed on 17 May
2018 in the new Vehicle Safety Regulation that protection
against cyberattacks becomes part of the vehicle
approval legislation. The proposal is being discussed
between the Parliament and the Council. The legislative
bodies intend to reach an agreement early next year.
Steering brief
18/18