REGULATORY SCRUTINY BOARD OPINION Proposal for a Regulation of the European Parliament and of the Council on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council, and repealing Council Directive 87/357/EEC and Directive 2001/95/EC

EUROPEAN COMMISSION
22.1.2021
SEC(2021) 280
REGULATORY SCRUTINY BOARD OPINION
Proposal for a Regulation of the European Parliament and of the Council
on general product safety, amending Regulation (EU) No 1025/2012 of
the European Parliament and of the Council, and repealing Council
Directive 87/357/EEC and Directive 2001/95/EC
{COM(2021) 346}
{SWD(2021) 168}
{SWD(2021) 169}
Europaudvalget 2021
KOM (2021) 0346 - SEK-dokument
Offentligt
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This opinion concerns a draft impact assessment which may differ from the final version.
Commission européenne, B-1049 Bruxelles - Belgium. Office: BERL 08/010. E-mail: regulatory-scrutiny-board@ec.europa.eu
EUROPEAN COMMISSION
Regulatory Scrutiny Board
Brussels,
RSB
Opinion
Title: Impact assessment / Revision of the General Product Safety (Directive
2001/95/EC)
Overall opinion: POSITIVE WITH RESERVATIONS
(A) Policy context
The General Product Safety Directive (GPSD) came into effect in 2002. It aims to ensure
safety for consumers for non-food products. It provides a “safety net” and applies when
other specific rules do not exist. The Directive established the EU Rapid Alert System to
facilitate exchange of information between EU/EEA Member States and the European
Commission on dangerous non-food products posing a risk to consumers.
An evaluation concluded that the Directive is not fit for purpose. The revision of the
Directive is a follow-up to a Commission proposal accompanying the 2013 Product Safety
and Market Surveillance Package. It aims to respond to challenges related to e-commerce
and the emergence of new technologies, better enforcement and the alignment of rules for
harmonised and non-harmonised products.
(B) Summary of findings
The Board notes the additional useful information provided in advance of and during
the meeting, and commitments to make necessary changes to the report.
However, the report still contains significant shortcomings. The Board gives a
positive opinion with reservations because it expects the DG to rectify the following
aspects:
(1) The report does not sufficiently explain how the horizontal and sectoral elements
of the product safety framework interact with each other in a coherent manner.
The fall-back function of the GPSD as safety net is not sufficiently elaborated.
The links to recent safety related sectoral initiatives are not sufficiently clear.
(2) The available policy choices are not sufficiently clear. The report presents only a
limited set of options and lacks detail on the content of the measures contained
therein. It does not explain sufficiently why some options are discarded.
(3) The report does not explain in a convincing manner why the estimated costs for
business under the integration option are much higher than those of the full legal
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revision option, although in terms of substance the options seem very similar.
(C) What to improve
(1) The report should explain upfront how the horizontal and sectoral elements of the
product safety policy framework fit together and how the GPSD general safety net fall-
back functions. It should better explain the coherence with Regulation 2019/1020 on
market surveillance, and the relevance of the recent changes to that Regulation for the
GPSD. It should better describe the links to recent initiatives, such as on digital platforms,
cybersecurity, circular economy and artificial intelligence.
(2) The report should better present the scope of the initiative, especially on which
consumer products are covered. In this sense, it may help to include a diagram presenting
the product safety regulatory framework. The safety concept needs elaboration. It is not
clear what types of risks and damages it covers, ranging from health to cyber issues. The
report should detail the specific mechanisms it will use to identify future product risks to
function as a safety net.
(3) The report should reinforce the problem analysis to better reflect the deficiencies and
gaps the initiative wants to solve. It should clarify to what extent self-regulatory measures
under the Product Safety Pledge have been effective and what lessons can be learned. It
should explain to what extent the Pledge helped to get information on emerging risks of
new technologies and improved recalls.
(4) The range of options analysed should be better linked with the specific objectives and
the problems the initiative aims to tackle. The report should provide more detail on the
content and functioning of the proposed policy measures under the various options. It
should explore whether there are alternative policy choices to the substantive measures
presented for each problem area under the preferred option. It should expand on how the
self-regulatory elements could be strengthened. It should provide more details about
discarded options and the reasons for their exclusion from the analysis.
(5) The full integration option comes with substantial additional costs as regards market
surveillance for business although there seem to be no real substantive differences on new
regulatory obligations, compared to the full legal revision option. The report should review
the robustness and reliability of the costs estimates provided in the support study given
their importance for the overall comparison and ranking of options.
(6) The report should provide greater clarity on how this initiative will tackle safety issues
related to consumers’ online purchase from third countries as well as software updates. It
should explain how the sanction regime would work under the different options and clarify
whether alternatives with different deterrence effects can be assessed. It should better
describe how effective enforcement of the options will be ensured.
(7) The REFIT aspect should be clarified, explaining how the initiative would endeavour
to keep regulatory burdens to the minimum necessary. More information is needed on how
overlaps between lex generalis and lex specialis would be prevented.
The Board notes the estimated costs and benefits of the preferred option in this initiative,
as summarised in the attached quantification tables.
Some more technical comments have been sent directly to the author DG.
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(D) Conclusion
The DG must revise the report in accordance with the Board’s findings before
launching the interservice consultation.
Full title Proposal for a revision of the Directive 2001/95/EC on general
product safety
Reference number PLAN/2019/6283
Submitted to RSB on 18 December 2020
Date of RSB meeting 20 January 2021
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ANNEX: Quantification tables extracted from the draft impact assessment report
The following tables contain information on the costs and benefits of the initiative on which
the Board has given its opinion, as presented above.
If the draft report has been revised in line with the Board’s recommendations, the content of
these tables may be different from those in the final version of the impact assessment report,
as published by the Commission.
I. Overview of Benefits (total for all provisions) – Preferred Option
Description Amount Comments
Direct benefits
Increased safety of non-
harmonised products and
reduced product safety
risks covered by GPSD
(and related reduction of
number on injuries
caused by unsafe
products)
- Preventable detriment suffered by EU
consumers and society due to product-
related accidents estimated at EUR 11.5
billion per year.
- the current cost of health care utilisation
for product-related injuries in the EU is
approximately EUR 6.7 billion per year, with
hospitalisation accounting for the larger part
of the total health care costs at about EUR
6.1 billion.
These costs can be reduced under Option 3
Options 3 also expected to reduce consumer
detriment estimated on the basis of the
value of unsafe products by approximately
EUR 1.04 billion in the first year of
implementation, increasing to
approximately EUR 5.5 billion over the next
decade, This represents the decrease of
financial costs for consumers since they
would avoid buying unsafe products.
The GPSD Study also showed that
stakeholder consider that Option 3 provides
‘moderate’ to ‘significant’ benefits for
consumers.
Main impact on EU consumers via
broader coverage and greater
effectiveness of the GPSD in protecting
consumers from unsafe products, in
particular in online sales and for risks of
new technologies.
Impact also on MS (positive impact on
health care budget)
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Higher return rates
during recalls of unsafe
products
Reduced number of deaths and injuries
caused by products staying in hands of
consumers due to delayed and badly
managed recalls. Reduced amount of
consumer detriment.
Reduced consumer detriment related to the
value of unsafe products which were not
effectively recalled by EUR 410 million per
year.
Examples from ineffective recalls: faulty
Takata airbags (estimated to have cause 35
deaths and 300 injuries worldwide) and
Fisher-Price rock ‘n play baby sleepers
(associated with 59 baby deaths in the US).
Main impact on EU consumers via lower
exposure to unsafe products and on MS
(positive impact on health care budget).
Level playing field and a
better functioning EU
internal market
These potential benefits were assessed as
being ‘moderate’ to ‘significant’ in the
Study’s survey
Mainly via alignment of the market
surveillance rules for all products, a
clearer legal framework and deterrent
effect on rogue traders.
Main impact on EU businesses.
Reduced regulatory costs
and burdens for
businesses
Cost reductions for all businesses and in
particular for the 42% of businesses who
reported additional costs related to the
diverging implementation of the GPSD.
Cost savings for businesses of around EUR
59 million annually (EUR 34 million saved by
EU SMEs and 26 million EUR saved by EU
large businesses respectively) through more
harmonised implementation.
Study showed that companies and business
associations estimate the benefits between
‘minor’ and ‘moderate’ and MSAs and other
stakeholders to be mostly considerably
more than ‘moderate’ and close to
‘significant’.
Main impact on businesses via:
-legally binding clarifications and choice
of Regulation as instrument will reduce
regulatory uncertainty and even
implementation
-aligning the general market
surveillance and safety requirements
for harmonise and non-harmonised
products will reduce implementation
differences and improve the traceability
of supply chain
Efficiency gains in market
surveillance and
enforcement
Cost reductions for all MSAs and in
particular for the16% of MSAs who reported
related additional costs to the diverging
legal frameworks between harmonised and
Main impact on MSAs due to aligning
market surveillance provisions between
harmonised and non-harmonised
products, more aligned enforcement
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non-harmonised products.
Cost savings for MSAs estimated at EUR 0.7
million per year across the EU.
powers, increased deterrent effect and
arbitration mechanism.
Reduced administrative
burden of the
standardisation process
Not quantifiable Via the simplification of the
standardisation process will streamline
the related EU process. As it would
accelerate standardisation work, it
would increase legal certainty for
companies on the standards to comply
with.
Main impact on MSs and EC
Indirect benefits
Positive spill-over effects
on consumer trust,
demand, production and
employment
Not quantifiable Via increased safety of products and
free movement of goods in the Single
Market. Beneficial for all undertakings
Improved companies’
competitiveness
Additional competitiveness gains expected
to be very moderate as companies’ current
compliance costs with consumer product
safety legislation are already relatively low
and additional regulatory requirements
would level potential cost reductions.
Via a more harmonised regulatory level-
playing field within the EU
Main impact on EU businesses
Positive impacts on
competition-driven
innovation
Not quantifiable Via a greater degree of harmonisation
and greater legal certainty (e.g.
development of new innovative
information and traceability systems).
II. Overview of costs – Preferred option
Citizens/Consumers Businesses Administrations
One-off Recurrent One-off Recurrent One-off Recurrent
New
general
due
diligence
measures
of
economic
operators
Direct costs
- - Familiarisation
costs,
adaptation costs
to regulatory
changes
Total costs of
businesses in
the EU27 in the
Additional
regulatory
compliance
costs, related to
staff and
additional
resources (more
for
Only
relatively
moderate
one-off
adaptation
and
implementat
ion costs.
total
additional
recurrent
costs of
MSAs in
EU27 of
approx. EUR
6.7 million
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for
product
safety
first year of
implementation
are estimated at
EUR 196.6
million (one-
off + recurrent
costs in the first
year),
equivalent to
0.02% of
turnover of EU
companies for
manufacturing,
wholesale and
retail of non-
harmonised
consumer
products.
manufacturers
to adjust
different stages
of the value-
adding process
to new
regulatory
requirements)
Recurrent costs
amount to EUR
177.8 million
(0,02% of
companies’
turnover)
annually
Indirect costs - Potential impact
on consumer
prices in the
EU, expected to
be negligible
(potentially for
low-income
consumers). No
significant or
negative impact
on consumer
choice in the
EU expected
- - - -
Duty of
care
obligation
s for
online
marketpl
aces
Direct costs
- - Costs
estimation
included in the
total above
Additional
regulatory
compliance
costs, for all
online
marketplaces
and in
particular for
non-signatory
of the Pledge,
but likely less
efforts than
those of brick
and mortar
distributors for
fulfilling their
obligations
today.
Costs
estimation
included in the
total above
- -
Indirect costs - - - - - -
All safety
informati
on is
provided
Direct costs
- - - Costs to be very
limited for both
online
platforms and
- -
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online in
the same
vein as it
is
required
“offline”
online sellers
(information
already
available and
does not go
beyond what is
indicated on the
packaging)
Indirect costs - - - - - -
New
requirem
ents on
recalls
Direct costs Reduced
cost of
recall
(improved
remedy)
- Higher
administrative
burden for
recalls and
registration
systems. Costs
mainly limited
to situations
when recall
occurs (unsafe
product placed
on the market)
and in any case
operators
should already
carry out
effective
recalls.
-
Indirect costs - - - - - -
Integratio
n of food-
imitating
products
into
GPSD
Direct costs - - - Minimal effect
on producers of
food-imitating
products, and in
any case not
exceeding costs
supported by
other producers
- Potentially
some costs for
MSAs which
were applying
a ban per se
of these
products and
will have to
do a risk
assessment.
Considered as
minor in view
of the limited
amount of
these products
Indirect costs - - - - -
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This opinion concerns a draft impact assessment which may differ from the final version.
Commission européenne, B-1049 Bruxelles - Belgium. Office: BERL 08/010. E-mail: regulatory-scrutiny-board@ec.europa.eu
Electronically signed on 22/01/2021 13:04 (UTC+01) in accordance with article 11 of Commission Decision C(2020) 4482