Europaudvalget 2021-22
EUU Alm.del Bilag 364
Offentligt
2539943_0001.png
NOTAT
01 March 2022
2022 - 2345
otfruh
The Danish Government’s response to the public consultation on the
evaluation of the New Legislative Framework
General remarks
The Danish Government looks forward to the evaluation of the New Leg-
islative Framework (NLF). The NLF is still a vital tool that needs to be
updated in a technologically neutral way to continuously support the safety
and compliance of industrial products throughout their life-cycle. There-
fore, the Danish Government supports the ambition of the evaluation to
encompass the broader context of the performance of the NLF, in particular
the digital and green transitions as well as recent market trends.
The Danish Government notes that the digital and green transitions create
certain challenges for the general principles of the NLF. First, the emer-
gence of new digital and circular business models results in increased com-
plexity and makes it increasingly demanding for innovative businesses to
comply with the principle that products made available on the EU market
shall comply with all applicable legislation. This has many reasons, includ-
ing the gradual integration of goods and services and more frequent
changes to products post market placement that comes with the twin tran-
sitions. Second, the emergence of new economic operators in ecommerce
and refurbishment value chains has sparked legal uncertainty. The roles and
responsibilities of online marketplaces and remanufacturers should be ad-
dressed, and a “catch-all”-clause
could be considered to ensure that there
is always a responsible economic operator in the EU, even if new actors
emerge that are not listed in the NLF. The overall view of the Danish Gov-
ernment is that these developments can only be accommodated in the ex-
isting NLF to a small, unsatisfactory extent, despite the technology-neutral
approach.
Continuity of the basic principles of the NLF is a fundamental precondition
to EU’s competitiveness.
Therefore, it is vital that the evaluation analyses
both the needs and impacts of potential changes in as much depth as possi-
ble. On one hand, the basic principles must not be changed unnecessarily,
as they function well and because unnecessary changes would risk negative
impacts to effective compliance in all ecosystems concerned. Businesses
are already familiar with and recognise the basic principles. On the other
hand, it should be updated where necessary to achieve the twin transitions
 EUU, Alm.del - 2021-22 - Bilag 364: Notat og høringssvar vedr. Kommissionens offentlige høring om industriprodukter: Evaluering af den nye rammelovgivning
2/6
and sustain the well-functioning single market for goods as a driver and a
global springboard for European companies. This includes changes needed
in light of new business models and developments in global supply and
distribution chains.
Further, the Danish Government believes that finding long-term solutions
to current challenges within the European system for harmonised standards
will be another cornerstone to future-proofing the NLF. Overall, the Danish
Government believes that the current standardisation regulation is fit for
purpose and should not undergo a general revision. The Danish Govern-
ment welcomes a horizontal approach to ensure that common technical
specifications will only be adopted as a last resort alternative to harmonised
standards in emergency situations.
Specific remarks
In the following, we have listed our main points to the public consultation
on the NLF.
•
The NLF should be applied per default and deviations should be
explained
The NLF is a valuable tool for sustaining the internal market for goods to
the benefit of the whole EU economy. It has potential to ensure consistency
and predictability via reuse of well-known methods for new EU product
rules, minimising barriers for businesses. Therefore, the NLF should be ap-
plied continuously, and its mandate should be strengthened to ensure that
the Commission uses the NLF per default whenever making a legislative
proposal for harmonisation of product rules.
Further, to improve transparency, the Commission should explain it thor-
oughly in the proposal whenever they find reason to deviate from the NLF
for specific purposes. A similar practice could be endorsed by the Parlia-
ment and the Council. The principle of comply or explain should be clearly
stated in article 2 of Decision 768/2008.
•
Terminology and conformity assessment procedures should be up-
dated in light of new business models to accommodate ‘adjust-
ments’ and ‘additions’ to products
The NLF should be able to accommodate products that undergo changes
during their lifetime, as this is a rising trend in new business models. In the
digital sphere, software upgrades and updates are increasingly important,
including for artificial intelligence and cybersecurity purposes. In the cir-
cular sphere, remanufacturing, refurbishment, upcycling and repairs are
also on the rise. Terminology should be defined in the NLF to avoid frag-
mentation. Essentially, the NLF should make it easy and attractive for in-
novative businesses, especially SMEs, to engage in these practices and
make safe, secure and sustainable products available on the single market
without unnecessary burdens. But the focus on the ‘making available’ of a
product offsets more agile practices that come with innovation.
 EUU, Alm.del - 2021-22 - Bilag 364: Notat og høringssvar vedr. Kommissionens offentlige høring om industriprodukter: Evaluering af den nye rammelovgivning
3/6
Therefore, updated terminology may be necessary to accommodate
‘changes’
to a product after it is made available on the market, some of
which take form of ‘adjustments’ or ‘additions’ within a well-defined,
lim-
ited scope. The evaluation should also consider to what extent changes
could be accommodated without requiring the conformity assessment pro-
cess to start over in every circumstance, for example by adding new mod-
ules for conformity assessment. As another partly solution to this question,
this could be achieved by limiting the responsibility of a repairer to the part
of the product they have repaired, rather than making the repairer respon-
sible for the full product after performing their service. Like other ‘adjust-
ments’ or ‘additions’, repairs are usually well-defined
and limited in scope.
Thus, the evaluation should consider experiences with this model and to
what extent it could be harmonised and/or applied in a broader sense.
•
Economic operator roles and divisions of responsibilities should be
suited for digital and circular supply and distribution chains
The NLF aims to ensure that all involved economic operators take appro-
priate measures in accordance with a distribution of obligations corre-
sponding to their roles in the supply and distribution process. However,
new economic operators play increasingly important roles and should be-
come responsible for certain new activities. This is especially the case for
fulfilment service providers and online marketplaces in ecommerce, but
also remanufacturers and other operators
performing various ‘changes’ to
a product after it is first made available on the market (as illustrated above).
The current NLF does not address the roles and responsibilities of these
operators directly, and while some operators mentioned may fit certain cat-
egories, the legal uncertainty is a hindrance for effective enforcement and
an opportunity for ‘free riding’ in the single market for goods.
Therefore, it should be considered in the evaluation whether there is a need
to integrate and elaborate existing roles and responsibilities connected with
new activities articulated in related legislation, such as Fulfilment Service
Providers covered in Regulation 2019/1020 and online marketplaces cov-
ered in the General Product Safety Regulation currently under negotiation.
Addition and elaboration of new roles and responsibilities related to vari-
ous ‘changes’ of products should also be considered.
•
Align online marketplace roles and responsibilities
with importers’
in global ecommerce
Special dynamics are at play in global supply and distribution chains, es-
pecially in ecommerce. Effectively, online marketplaces act as a gateway
for third country sellers to place their products on the EU-markets from a
distance, like importers have traditionally done. However, there is a com-
pliance deficit connected with the lack of a responsible importer in the EU
and it is not clear how online marketplaces can be held responsible for their
contribution to this development.
 EUU, Alm.del - 2021-22 - Bilag 364: Notat og høringssvar vedr. Kommissionens offentlige høring om industriprodukter: Evaluering af den nye rammelovgivning
4/6
Therefore, the roles and the responsibilities of online marketplaces in
global ecommerce should be modernised to improve legal certainty and
compliance. We suggest aligning online marketplace roles and responsibil-
ities with those of importers. Further, the Commission could consider add-
ing a “catch-all”-clause
to ensure that there is always a responsible eco-
nomic operator in the EU, even if new actors emerge that are not listed in
the NLF.
•
Digital information ‘by default’ should be considered as an enabler
for new digital services and market surveillance tools
A clear framework for provision of information in a digital format could be
a driver for new data-driven business models and greatly reduce adminis-
trative burdens for businesses, for example making it easy to update to rel-
evant information and provide it in various languages. Further, the availa-
bility of digital product information would support more efficient, risk-
based market surveillance, including new tools to cover a larger volume of
products and perform data-driven prioritisation of activities. Positive con-
sumer impact would result from these improvements in form of derived
consequences such as cost-reductions and improved safety of products.
Therefore, we recommend that the Commission evaluate whether product
information for the purpose of market surveillance (CE-marking, other
traceability information and product information) could be provided digi-
tally by default. We welcome the analysis on to what extent information
affixed on the product remains necessary and invite the Commission to
thoroughly explore the potential of providing digital information instead or
in parallel. In this context, on-going initiatives such as the upcoming prod-
uct passport should be taken into account.
•
Further harmonisation of the accreditation process may be needed
to ensure an effective and consistent competence assessment of no-
tified bodies
Notified bodies help shape the trust in products made available on the sin-
gle market in accordance with applicable harmonised legislation, but dif-
ferent procedures are used across Europe to establish their competences
and ensure the continuous quality of their assessments. The lack of a har-
monised approach creates an un-level playing field for Notified Bodies and,
in extension, risks lowering the trust, validity and consistency of certifi-
cates issued and conformity assessment procedures.
Therefore, the Commission should consider options for further harmonisa-
tion of the accreditation process and assess the feasibility of deciding on a
harmonised approach. For example, the intensity of controls could be
streamlined through more collaboration between accreditation units, and
further instruments could be added such as peer-reviews (with which we
have positive experience in Denmark) and sanctions in case of recurrent
incompetence.
 EUU, Alm.del - 2021-22 - Bilag 364: Notat og høringssvar vedr. Kommissionens offentlige høring om industriprodukter: Evaluering af den nye rammelovgivning
5/6
•
Supplementary market surveillance activities should be encouraged
as light options for risk-based market surveillance
Efficient monitoring is a key component to effective market surveillance.
Supplementary activities that focus on
businesses’ knowledge and ability
to ensure safety as well as their internal quality assurance processes has
proven a valuable tool in this respect. For example, authorities and busi-
nesses may cooperate on a voluntary basis to review internal processes and
enter into dialogue about guidelines that may strengthen the ability of indi-
vidual businesses to comply with applicable legislation.
Businesses may welcome such supplementary activities as a supplement to
traditional procedures for market surveillance that focus on compliance of
each product. This may be especially impactful for surveillance of new
green and digital business models, where products more often change
throughout their life-cycle. Authorities also stand to benefit from the op-
portunity to use insights to perform data-driven prioritization based on
overall risk assessments per company. Therefore, we invite the Commis-
sion to explore and encourage such practices in the evaluation and raise
caution that adaptations to the NLF should not preclude them.
•
Maintain the European system for harmonized standards
A well-functioning standardisation system is vital for delivering harmo-
nised standards in time to support new EU legislation, helping businesses
and authorities to ensure compliance. On a larger scale, a future proof
standardisation system can support the green and digital transitions as well
as Europe’s global competitiveness
and enhance the European footprint on
international standardisation in strategic areas, such as critical new tech-
nologies - in alignment with the objectives in the Commission's new EU
standardisation strategy.
The evaluation must consider the recommendations of 17 Member States
at the COMPET Council on 25 May 2021 to 1) find the right balance in
standardisation requests between qualitative requirements set by EU legis-
lation and flexibility for the European Standardisation Organisations re-
quired for state-of-the-art standards; 2) publish clear criteria for technical
evaluation of harmonised standards to align expectations between involved
parties; and 3) ensure a short processing time for citation of new harmo-
nised standards in the Official Journal of the European Union, for example
by introducing key performance indicators. Furthermore, the Commis-
sion’s empowerment to adopt technical/common specifications should
be
based on horizontal requirements that ensure that this remains a last resort
for emergency situations, and not a way to circumvent the NLF system. We
refer to our incoming response to the Standardisation Strategy for more
detailed comments.
•
The NLF has performed well during the COVID-19 Pandemic
 EUU, Alm.del - 2021-22 - Bilag 364: Notat og høringssvar vedr. Kommissionens offentlige høring om industriprodukter: Evaluering af den nye rammelovgivning
6/6
We appreciate the intention of the Commission to ensure that the NLF re-
mains adequate to perform in crisis situations. It should be noted that the
NLF performed well during the first wave of coronavirus in Europe in
spring 2020, where parties within the European system for harmonised
standards cooperated to deliver relevant harmonised standards for personal
protective equipment and medical devices within a very short timeframe.
We hope that this experience can serve as inspiration for joint efforts in
times of a new crisis and for finding long-lasting solutions to the current
challenges mentioned regarding standardisation.
However, it is not possible for us to assess to what extent the lack of a crisis
instrument rendered the NLF less effective in supporting fight against the
COVID-19 pandemic, as we still need to see more details about the con-
tents of such an instrument. We look forward to further dialogue about the
upcoming proposal for a Single Market Emergency Instrument, which we
generally find is the right place to improve the free movement of goods on
the single market in times of crisis.
•
Avoid legal uncertainty by aligning reference provisions with Reg-
ulation 2019/1020 on Market Surveillance
We would like to highlight that recent proposals for harmonised legislation
based on the NLF (including the Battery Regulation and the Machinery
Product Regulation) have contained provisions overlapping with Regula-
tion 2019/1020 on Market Surveillance. Such overlaps should be avoided
in order not to create legal uncertainty, unless it is intended to regulate in a
more specific manner (in accordance with the
lex specialis
rule in article
2(1) of Regulation 2019/1020).
It seems that the overlaps stem from the fact that the reference provisions
in the NLF Framework Decision (Decision 768/2008/EC) have not been
updated to fit recent changes in Regulation 2019/1020. Therefore, an up-
date is needed to avoid legal uncertainty going forward.
We look forward to contributing further to the evaluation, and we
anticipate that any changes to the NLF could be performed through a
revision of Decision 768/2008 and implementation of the changes
across NLF legislation in an omnibus.