ERU, Alm.del - 2021-22 - Bilag 220: Notat og høringssvar om industriprodukter: evaluering af den nye rammelovgivning, fra erhvervsministeren

Erhvervsudvalget 2021-22
ERU Alm.del Bilag 220
Offentligt

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

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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.

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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.

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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.

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•

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

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

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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.