BRIEFING

EU Legislation in Progress

Toy safety regulation

OVERVIEW
On 28 July 2023, the European Commission adopted a proposal to revise EU toy safety legislation,
by introducing a new regulation and repealing Directive 2009/48/EC. The proposal pursues two
main objectives: a higher level of child protection, including from the most harmful substances; and
fewer non-compliant and unsafe toys on the EU market. In relation to the first objective, the proposal
extends the definition of health to children's psychological and mental health and to their wellbeing
and cognitive development. It also extends the current ban on substances classified as carcinogenic,
mutagenic and toxic for reproduction to include endocrine disruptors and chemicals that are toxic
to a specific organ or affect the immune, neurological or respiratory system. To achieve the second
objective, the proposal seeks to establish a digital product passport to facilitate traceability.
In the European Parliament, the file was referred to the Committee on Internal Market and Consumer
Protection (IMCO). IMCO adopted its report on the proposal unanimously in February 2024.
Parliament voted on the report during its March 2024 plenary session, setting its first reading
position for trilogue negotiations with the Council during the next term. On 15 May 2024, Coreper
approved the Council's mandate for interinstitutional negotiations.
Proposal for a regulation of the European Parliament and of the Council on the safety of toys and repealing
Directive 2009/48/EC

Committee Internal Market and Consumer Protection COM(2023)462

responsible: (IMCO) 28.7.2023

Rapporteur: Marion Walsmann (EPP, Germany) 2023/0290(COD)

Shadow rapporteurs Brando Benifei (S&D, Italy) Ordinary legislative

Ernő Schaller-Baross (PfE, Hungary) procedure (COD)
Piotr Müller (ECR, Poland) (Parliament and Council
Anna Stürgkh (Renew, Austria) on equal footing –
Katrin Langensiepen (Greens/EFA, Germany) formerly 'co-decision')
Luke Ming Flanagan (The Left, Ireland)
Next steps expected: Trilogue negotiations

EPRS | European Parliamentary Research Service

Author: David Ashton
Members' Research Service
PE 754.600 – December 2024 EN
EPRS | European Parliamentary Research Service

Introduction
On 28 July 2023, the Commission adopted a proposal for a regulation on the safety of toys, repealing
Directive 2009/48/EC. Whilst the evaluation of the directive conducted by the Commission
substantiated shortcomings, such as a significant share of unsafe toys placed on the EU market, the
proposed overhaul of EU product safety and sustainability legislation also represents an opportunity
to update the legislation more generally.
The Commission explains the choice of a regulation to achieve these goals by the need to ensure the
uniform application of specific new provisions for timely and uniform implementation throughout
the single market, such as the proposed toy passport, and the related customs verifications. A
regulation also neutralises the risk of Member States creating supplementary obligations (gold
plating), and improves the legal certainty for stakeholders, not least manufacturers.

Existing situation
Toys belong to the 'harmonised products' category, which defines those goods subject to Union
harmonisation legislation (Annex I of Regulation (EU) 2019/1020 on market surveillance and
compliance of products provides a list of such legislation). This means that the relevant provisions
for toys are laid down in by the Toy Safety Directive, (pursuant with the requirements set in
Decision 768/2008 on a common framework for the marketing of products). In addition, the relevant
provisions of Regulation (EU) 2019/1020 and Regulation (EU) 2023/988 on general product safety
also apply.

Toy Safety Directive

The current Toy Safety Directive spells out the safety requirements for toys to be placed on the EU
market, as well as the processes to ensure their conformity with such requirements, regardless of
the place of their production in the EU or beyond. It qualifies as a total harmonisation directive on
safety requirements, in the sense that it does not allow Member States to include additional or
different safety requirements as part of their transposition into national legislation.
The directive, in particular Annex II, lays down a list of general requirements, which aim to ensure
that the appropriate use of a toy does not jeopardise the safety or health of users or third parties,
and takes a differentiated approach for children younger than 36 months. Annex II of the directive
then includes a set of particular safety requirements, relating to the physical, mechanical and
chemical properties of the toys. Substances classified as carcinogenic, mutagenic or toxic for
reproduction (CMRs) pursuant to Regulation EC) No 1272/2008 on classification, labelling and
packaging of substances and mixtures, as well as certain other substances classified as hazardous
under that Regulation, are forbidden by default.
The directive also prescribes the process to place toys on the EU market. A manufacturer can opt
either for self-verification by using the European harmonised standards, or for third-party
verification through a notified body. The European harmonised standards are technical
specifications, developed by one of the European standards organisations, which aim to ensure that
a product complies with the technical requirements defined by the EU legislation.

Market Surveillance and Compliance of Products Regulation

Regulation (EU) 2019/1020 on market surveillance and compliance of products complements the EU
legislation on harmonised products. It notably extends the cooperation between national market
surveillance authorities, and updates their remit regarding the economic actors operating along the
value chain (manufacturers, importers, distributors). For instance, they can require economic
operators to take action to remediate a situation of non-compliance with EU legislation, to eliminate
an identified safety risk.

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General Product Safety Regulation

Regulation (EU) 2023/988 on general product safety (the General Product Safety Regulation, GPSR)
complements EU legislation on toy safety, not least by improving consumers' rights should a product
be recalled.

Parliament's starting position

The Parliament adopted a resolution on the implementation of Directive 2009/48/EC on toy safety
on 16 February 2022. It acknowledged the directive's positive contribution to improving the safety
of children throughout the EU, whilst ensuring enough legal certainty for economic operators
(manufacturers, importers, distributors). The Parliament particularly stressed the efforts undertaken
by those operators to ensure compliance. Regarding the processes laid down by the directive, the
key roles of the standards and of the notified bodies were highlighted, even if the need to increase
the presence of such notified bodies in some EU regions was flagged. The Parliament also
highlighted the opportunities to improve the involvement of online market places to strengthen the
implementation of the toy safety provisions. On the directive's substance, the Parliament supported
the extension of the generic ban on CMRs to include endocrine disruptors, on the basis of the World
Health Organization (WHO) definition. However, Parliament also flagged that derogations to the
generic ban on CMRs allow in specific cases for the presence of those chemicals in concentrations
that appear to be too high to ensure the protection of children. It then called on the Commission to
take into account children's combined exposure to chemicals as well as potential low-dose effects.
The Parliament also stressed that the differentiated approach towards children younger or older
than 36 months should not provide an opportunity to reduce child safety. It associated this call with
the request to the Commission to set up a public data repository of accidents involving toys across
the Union. With a view to the future of the legislation, the Parliament expressed its preference for a
regulation, rather than an amended directive, noting that the directive was already specific, as it
'acts as a de facto regulation'.

Preparation of the proposal

Several strategies adopted by the Commission since 2019 feed into the proposal. With the 2020
Commission communication on a chemicals strategy for sustainability, several commitments are
expected to contribute directly to the enhancement of toy safety, along the three complementary
priorities of promoting safe and sustainable chemicals, minimising human exposure and eliminating
the substances of concern. For instance, under the goal of minimising exposure, the objective to
extend the generic ban on specific substances ('the generic approach') in consumer products is
expected to reinforce protection against harmful chemicals affecting the immune, neurological, or
respiratory systems, as well as chemicals toxic to a specific organ. The communication also highlights
the specific relevance of international cooperation – 90 % of the dangerous products placed on the
EU market and signalled as posing a risk due to chemical content come from outside the EU. The
Commission therefore suggests to promote the sound management of chemicals in bilateral,
regional and multilateral forums. With its 2021 communication on the EU strategy on the rights of
the child, the Commission also identified health as one of the six priorities to enforce and promote
child rights in the EU.
The Commission held several public and stakeholder consultations during the preparation of the
proposal. For instance, on 26 April 2022, the Commission gathered 120 industry stakeholders,
together with representatives from consumer organisations and the Member States, to gather their
opinions on the update of the EU legislation on toy safety. The Commission services stress the
existence of a consensus on two relevant points: a) defining new limit values for toys for children
both under and beyond 36 months, and b) tackling the high number of non-compliant toys on the
Union market. In addition, between 2 March and 25 May 2022, the Commission organised a public
consultation on how to improve the Toy Safety Directive. Among the 196 respondents, businesses

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represented 34 %, citizens 22 %, public authorities 16 %, business associations 12 %, and consumer

organisations and non-governmental organisations 12 %. A majority of the respondents support the
definition of stricter rules, in comparison to the provisions currently in force. In particular, a majority
of national authorities and consumer organisations stressed a desire to see endocrine and immune
system disruptors tackled in the legislation. However, no such consensus was reached on the
approach to address these preferences: whereas a significant share of national authorities and
consumer organisations consider the option to include general bans without derogations to avoid
use of such substances, a majority of industry representatives disagreed with such an approach.
The Commission's impact assessment identifies two main objectives for the proposal: a) achieving
a higher level of protection of children, including from the most harmful substances; and b) reducing
the number of non-compliant and non-safe toys on the EU market. The Commission proposes three
policy options for each of the two main objectives.
To achieve the first objective, its preferred option is to empower the Commission to add and amend
limit values for chemicals in toys, as well as allowing it to include generic bans with possible
derogations. This would imply a one-off cost adjustment of €23.5 to €397 million to redesign
products, as well as a permanent increase in annual testing costs of a range of €7 to €11.5 million.
On the other hand, banning the most harmful substances is expected to lead to health benefits more
than proportional with the costs, measured annually in a range between €240 million and
€1.2 billion.
To achieve the second objective, the Commission's preferred option is to rely on the product
passport created by the proposal for a regulation establishing a framework for setting ecodesign
requirements for sustainable products. The data on compliance would be provided digitally with the
product passport, and would have to be presented to customs authorities as appropriate. This
option is expected to lead to a one-off administrative cost of €18 million, and to additional annual
costs of €10.5 million for the industry. At the same time, the digitalisation of the safety information
would generate annual savings between €2.6 million and almost €4 million for the industry.

The changes the proposal would bring

Scope of the regulation, and definitions
The scope of the proposed regulation remains almost unchanged in comparison with
Directive 2009/48/EC, with an exception regarding the inclusion of catapults and slings now
included. Similarly, 29 out of the 36 definitions correspond to the definitions set out in the directive.
The new definitions find their origin in other EU legislative acts adopted since 2019, in particular:
Regulation (EU) 2019/1020 on market surveillance, the GPSR and Regulation (EU) 2024/1781 on
ecodesign requirements for sustainable products (the Ecodesign Regulation).
Article 4 on free movement also sets out a new provision ensuring the free movement of compliant
toys. Article 4(2) even authorises the display of non-compliant toys at trade fairs, exhibitions and
demonstrations, provided they are identified with a visible explanatory sign.

Toy safety
Article 5 on product requirements defines two additional sets of compliance criteria:
• essential safety requirements, defined in Article 5(2). This provision includes an
obligation to ensure that the proper and foreseeable use of toys does not present a
risk to the safety or health of users and third parties. Health includes children's
psychological and mental health, well-being and cognitive development. The
assessment of the risk should take into account the users' ability, not least due to their
specific age group.
• particular safety requirements defined in Annex II to the proposal. These
requirements refer to six specific properties: physical and mechanical; flammability;

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chemical properties; electrical properties; hygiene; radioactivity. Among the chemical

properties, the proposal extends the ban on CMRs to include: endocrine disruptors,
specific target organ toxicity substances (either in single or repeated exposure) and
respiratory sensitisation substances. The appendix to Annex II contains the
19 substances subject to specific limit values, the maximum level for several of them,
such as aluminium, barium or lead, having been lowered. The list of substances subject
to specific labelling requirements is composed of 71 elements (instead of the
11 elements contained in the current Toy Safety Directive).

Roles and obligations along the toy value chain

The proposed regulation allocates the obligations to economic actors along the value chain
(manufacturers, importers and distributors), according to the principles set out in
Decision 768/2008 mentioned above. Article 7 obliges manufacturers to ensure that the design and
production of toys they want to place on the market comply with the essential safety requirements.
Consequently, manufacturers would be responsible for the drawing up of the technical
documentation, and the performance of the conformity assessment, including the creation of the
product passport. Article 8 on authorised representatives specifies that those tasks cannot be
delegated to an authorised representative. Article 9 and Article 10 would oblige importers and
distributors to ensure respectively that the toys they place or make available on the market are
compliant. Importers and distributors would also have to participate in market surveillance activities
as appropriate. Article 11 allows to shift manufacturer obligations to an importer or a distributor
where a specific toy is placed on the market under the name or trademark of the importer or
distributor, or where the toy already placed on the market is modified by the importer or distributor.

Assessment of toy conformity

Two main conformity procedures are laid down in Article 22: one in-house process managed by the
manufacturer, and one process conducted by a third party to check manufacturer compliance.
When a manufacturer applies harmonised standards, the references to which have been published
in the Official Journal, or a common specification adopted by the Commission as an implementing
act, pursuant with Article 13, using the internal production control process laid down in Annex IV of
the proposal is permitted.
If the manufacturer does not apply such standards or common specifications, it would be requested
to undergo an EU-type examination, as laid down in Annex IV of the proposal. Such an examination
will be conducted by a third party, one of the notified bodies mentioned in Article 28, which shall
issue an EU-type examination certification in cases of compliance with the manufacturing process.
Subject to compliance with the appropriate conformity procedure, Article 16 of the proposed
regulation provides for affixing the CE marking, visibly, legibly and indelibly to the toy, to a label
attached to the toy, or to the packaging of the toy. Article 15 stresses that toys made available on
the market should bear the CE marking.

Digital product passport

Article 17 defines the granularity and purpose of a specific product passport for toys. It would have
to be created for each specific toy model, state the compliance of the toys with the requirements
set in the proposal, and be available through a data carrier, in the languages requested by the
Member State where the toy is made available, and for a period of 10 years. The data carrier should
be physically present on the toy, or on a label attached to the toy. It shall be visible to the consumer
before the purchase. Article 18 on technical design and operation of the product passport provides
for additional information technology (IT) requirements for such a tool, including its interoperability
with other product passports established under EU legislation. The information included in the
product passport would have to be available free of charge to economic operators and consumers,
and be based on open standards.

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Market surveillance
The proposal contains specific provisions regarding the market surveillance of toys, in addition to
the rules laid down in Regulation (EU) 2019/1020 on market surveillance. Article 45 on Commission
action concerning toys that present a risk, empowers the Commission to adopt implementing acts
setting out measures concerning toys compliant with the particular safety requirements but
nevertheless presenting a risk to individuals' health and safety. Such measures would include market
withdrawal or product recall.
Delegated powers and committee procedure
The proposal provides for significant delegation powers to be awarded to the Commission, under
Article 46 on delegated powers and Article 47 on the exercise of delegation. Under Article 46(1), the
Commission is empowered to adopt delegated acts to adapt the information contained in the
product passport, to reflect the scientific and technological developments. Under Article 46(3) and
Article 46(4), the Commission is empowered to adopt a delegated act to determine the information
and verification to be scrutinised by the custom authorities. Under Article 46(6) and Article 46(7),
the Commission is empowered to adopt delegated acts to permit derogations to the ban on
substances listed in Annex II of the proposal, provided among other conditions that the European
Chemical Agency has found the use of such a prohibited substance or mixture in toys to be safe.
Entry into force
Article 56 provides for the legislation to enter into force on the twentieth day following that of the
publication of the adopted regulation. It would apply for 30 months following the date of entry into
force. The proposal also provides for a specific entry into application of Article 17(10), Articles 24
to 40, and Articles 46 to 52, without setting a date. Article 54 provides for transitional provisions, in
particular for toys placed on the market in conformity with Directive 2009/48/EC, which could
continue to be made available on the market until the first day of the month following 42 months
after the entry into force of the regulation.

Advisory committees
The European Economic and Social Committee (EESC) adopted an opinion on the revision of the
Toy Safety Directive (Directive 2009/48/EC) on 13 December 2023 (rapporteurs: Ileana
Izverniceanu de la Iglesia (Diversity Europe – GR III/Spain) and Tymoteusz Adam Zych (Diversity
Europe – GR III/Poland)). While expressing its support for the proposal and its objectives, the
opinion stresses points of concern related to the digital product passport. On the one hand, the
EESC considers that the digital passport 'cannot balance (...) the price difference' between
compliant and non-compliant toys, which means that it does not expect it to reduce the presence
of non-compliant toys on the EU market. On the other hand, the EESC highlights the specific
situation of the economic operators of traditional and personalised non-serial toys, which should not
be 'disproportionately' negatively impacted by the new provisions.

National parliaments
The deadline for the national parliaments to submit reasoned opinions on the grounds of subsidiarity
was 2 November 2023. The Portuguese Assembleia da República submitted a written opinion stating
that the proposal did not raise any concerns from the perspective of subsidiarity and proportionality.
On 22 November 2023, the EU Policies Committee of the Italian Senate adopted a resolution stating
that the proposal respected the principle of subsidiarity, but highlighting some critical issues relating
to the principle of proportionality.

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Stakeholder views 1
The Commission published a call for feedback on the proposal, with a deadline of 31 October 2023.
Following the consultations on and the Commission's adoption of the proposal, stakeholders already
shared their views on the new propositions. The European Consumer Organisation (BEUC), and the
European consumer voice in standardisation (ANEC) adopted statements on 28 July 2023,
welcoming the proposal, not least by praising the extension of the generic ban on endocrine
disruptors. The organisations consider the ban to be a 'milestone to protect the health of children'.
Industry stakeholders convey more nuanced opinions. In an interview on 18 September 2023,
European toy industry representatives approve the choice of the legal instrument, considering that
a regulation would limit divergences of interpretation between national authorities. However, they
voice concern over the transition costs associated with the extension of generic bans on substances.
They also flag the need for the digital passport to safeguard trade secrets. The interview largely
reiterates the early assessment of the proposal, published by Toys Industries of Europe earlier in
2023.
On 19 September 2023, the IMCO committee organised a public discussion with the Commission
and stakeholder representatives on the state of play on toy safety legislation. Beyond the
stakeholders mentioned above, the European Committee for Standardization (CEN) and the
European Committee for Electrotechnical Standardization (CENELEC), two of the three European
standardisation organisations, provided their views on the proposed regulation. They stressed
standardisation should remain the primary solution to defining harmonised technical specifications,
whereas the adoption of common specifications by EU implementing act should be exceptional, and
justified.

Legislative process
Council of the EU
In the Council, the Working Party on Technical Harmonisation began its examination of the proposal
on 3 October 2023. A negotiating mandate was approved by Coreper I on 15 May 2024.
The Council's mandate aligns the obligations of economic operators more closely to the GPSR and
to the new realities of the growing volume of online sales. The Council adds a new provision, Article
10b, which defines toys which are not in conformity with the proposed regulation as illegal content
for the purposes of the Digital Services Act. Furthermore, the Council's position provides that any
toy that does not comply with safety requirements, or that otherwise poses a risk to the health and
safety of children and other persons, shall be considered a dangerous product for the purposes of
the GPSR. In this way, the toy-specific obligations of providers of online marketplaces added by the
Council's position are an addition to the existing legal framework.
The Council aligns the digital product passport provided for under the proposed regulation to the
final text of the Ecodesign Regulation.
The Council removes risk to mental health as a mandatory element of the general safety
requirement. Instead, risk to mental health is to be taken into account as a type of health risk for the
purposes of the safety assessment undertaken to demonstrate that a toy complies with the essential
safety requirements under the proposed regulation. This is a non-binding requirement.
The Council extends the transitional period during which toys placed on the market in conformity
with the current Toy Safety Directive may continue to be made available on the market to up to
5 years from the date of application of the proposed Regulation, i.e. 9.5 years from the date of its
entry into force. Under the Commission proposal, it was 3.5 years from the date of entry into force.

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As regards chemicals, the ban on the use in toys of CMRs and certain other hazardous substances is
limited to substances that have been subject to harmonised classification under Regulation (EC) No
1272/2008.
The Council also introduces a ban on skin sensitisers category 1A in toys. Skin sensitisers category
1A are substances showing a high frequency of occurrence in humans or a high potency in animals
which can be presumed to have the potential to produce significant sensitisation in humans.
In the Council's position, bans on substances in toys is clarified from the Commission proposal for a
ban on 'use' to a ban on the 'presence' of such substances.
The Council introduces a ban on toys that have a biocidal function and a ban on the treatment of
toys with biocidal products, except for toys that are intended to be permanently placed outdoors.
Finally, the Council introduces restrictions for the use of preservatives in toys. A preservative can
be used in toys only if it is allowed for use in cosmetics as listed in Regulation (EC) No 1223/2009
on cosmetic products, in accordance with the conditions laid down in Annex V to that Regulation.

European Parliament
In Parliament, the file was referred to the Committee on the Internal Market and Consumer
Protection (IMCO). Marion Walsmann (EPP, Germany) was appointed as rapporteur. The Committee
on Environment, Public Health and Food Safety (ENVI) was associated pursuant to Rule 57, and
adopted its opinion. The IMCO committee adopted its report unanimously on 13 February 2024, with
37 votes in favour. The amendments provided in the report aim to a) improve further children's
protection, and b) achieve a level playing field for economic operators.
To optimise children's protection, the report amends Article 6(3) to specify that warnings on the toy
packaging (or affixed to the toy or to its label in the absence of packaging) should be immediately
visible and also readable online. The report includes an amendment to Articles 7(3) and 17(2)
specifying that the digital product passport should be kept available for a period of 10 years after
the last item has been placed on the market. Then, an amendment to Articles 7 and 18 would ensure
that the digital passport includes a link to the Safety Gate Portal, to enable consumers or economic
operators to signal a risk to the Commission, in line with Regulation (EU) 2023/988. An amendment
to Article 46(6), in line with the opinion voted by ENVI, restricts the possibility for the Commission
to adopt delegated acts to permit the use of prohibited substances or mixtures pursuant to Part III,
point 4, of Annex II. The report provides for such delegated acts to be adopted only for a 'specified
period of time'. In addition, the scope of such prohibited substances or mixtures defined in Annex II
is extended to six more categories, including 'skin sensitisation category 1', polyfluoroalkyl
substances (PFAS), and bisphenols.
To enhance legal certainty, the report includes targeted amendments to support transition efforts
by small and medium-sized enterprises (SMEs), as well as amendments to mitigate the transition
costs for economic operators. On the first point, a new Article 20a on assistance for SMEs would
require the Commission to support them in establishing digital product passports. On transition
costs, an amendment to Article 17(10) on the digital product passport requires the Commission to
adopt the delegated acts on the basis of the technical requirements to be adopted for such a
passport, 12 months after the entry into force of the proposed regulation. This is to be read together
with the amended Article 56 on entry into force and application, which specifies that – while Article
17(10) would enter into application at the same time as the proposed regulation enters into force –
the entry into application would be set at 30 months after the entry into force. In addition, Article 54
on transitional provisions is amended to allow toys placed on the market under
Directive 2009/48/EC to be available on the market until 50 months after the entry into force of the
proposed regulation.
On 13 March 2024, Parliament adopted its first reading position with 603 votes in favour, 5 against
and 15 abstentions. The plenary vote modified the IMCO report in certain respects. Parliament's first
reading position proposes a ban on the use of cadmium, chromium VI, lead and mercury in toys,

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unless their presence is technically unavoidable in accordance with good manufacturing practice.
Parliament's first reading position also proposes to extend the ban on nitrosamines and nitrosatable
substances to cover all toys, while not amending the migration limits 2 proposed by the Commission.
The Commission's empowerment to amend the proposed regulation in order to permit the use of
CMRs and certain other hazardous substances is limited in time, and indeed any exemption from the
prohibition on the use of such substances is to be time-limited. The Commission is constrained to
adopt delegated acts specifying the time limit for the permitted use of nickel within 6 months of the
entry into force of the proposed regulation.

EUROPEAN PARLIAMENT SUPPORTING ANALYSIS

Evroux, C., General Product Safety Regulation, EPRS, European Parliament, February 2023.
Madiega, T., Digital services act, EPRS, European Parliament, November 2022.
Binder, E., Revision of the General Product Safety Directive, EPRS, European Parliament, June 2021.
E-commerce rules, fit for the digital age, Policy Department for Economic, Scientific and Quality of
Life Policies, European Parliament, May 2020.
Šajn, N., Strengthening market surveillance of harmonised industrial products, EPRS, European
Parliament, July 2019.

OTHER SOURCES
European Parliament, General Product Safety Regulation, Legislative Observatory (OEIL).

ENDNOTES
1
This section aims to provide a flavour of the debate and is not intended to be an exhaustive account of all different
views on the proposal. Additional information can be found in related publications listed under 'European Parliament
supporting analysis'.
2
'Migration limit' is the amount of an element that can be released from a toy material when (ingested and) present in
the stomach. The Commission uses this definition in its evaluation of the current Toy Safety Directive.

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Third edition, based on an earlier briefing by Clément Evroux. The 'EU Legislation in Progress' briefings are
updated at key stages throughout the legislative procedure.