Council of theEuropean Union
Brussels, 15 May 2024
(OR. en)9740/1/24
REV 1Interinstitutional File:
2023/0290(COD)

MI 491
ENT 94CONSOM 188
SAN 269
COMPET 535
CHIMIE 32
ENV 500
CODEC 1266
NOTE
From:
To:

General Secretariat of the Council
Permanent Representatives Committee

No. prev. doc.:

9190/24

No. Cion doc.:

12234/23 + ADD1 -5

Subject:

Proposal for a Regulation of the European Parliament and of the Council
on the safety of toys and repealing Directive 2009/48/EC- Mandate for negotiations with the European ParliamentI.

INTRODUCTION

1.

On 28 July 2023, the Commission adopted a proposal for a Regulation of the European
Parliament and of the Council on the safety of toys and repealing Directive 2009/48/EC1.

2.

The Proposal is based on Article 114 of the Treaty on the Functioning of the European Union(TFEU) and aims at further improving the protection of children from potential risks in toys,
in particular from harmful chemicals, and strengthening enforcement, by requiring, among
other things, that all toys to have a Digital Product Passport.

1

ST 12234/23

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3.

On 5 September 2023, the European Parliament’s Committee on Internal Market andConsumer Protection (IMCO) appointed Mrs Marion Walsmann (EPP, DE) as rapporteur forthe proposal. The Committee on the Environment, Public Health and Food Safety (ENVI) of
the European Parliament delivered its opinion on the proposal on 12 February 2024. IMCO
voted on its final report on the proposal on 13 February 2024, which was adopted in theplenary on 13 March 2024.

4.

The European Economic and Social Committee gave an opinion on the proposal on 13
December 2023.

II.

WORK WITHIN THE COUNCIL

5.

The Working Party on Technical Harmonisation (Safety of Toys) started the examination of
the Proposal on 3 October 2023 under the Spanish Presidency. Since then, 9 additional
Working Party meetings took place under the Spanish and Belgian presidencies.

6.

Following the examination of the text in clusters, the Belgian Presidency prepared 5
compromise texts on the whole proposal2, based on Member States interventions in themeetings and their written comments.

7.

The work at Working Party level focused on the improvement of the provisions related to the
obligations of the economic operators, aligning the provisions on the digital product passportwith the framework for setting ecodesign requirements for sustainable products (ESPR)3, on
striking a balance between ensuring a high level of protection of children from possible risks intoys, in particular from risks posed by harmful chemicals, and on creating a predictable and wellfounded situation for the industry by allowing for derogations from the generic prohibition forcertain chemical substances in toys in justified circumstances .

2
3

ST 5268/24 on 16/01, ST 6165/24 on 08/02, ST 7867/24 on 18/03, ST 8533/1/24 REV 1 on
10/04 and 9190/24 on 24/04
ST 5147/23

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ENIII. MAIN CHANGES TO THE COMMISSION PROPOSAL
8.

The main changes to the Commission proposal are the following:a)9.

Obligations of economic operators

The obligations of economic operators have been more closely aligned with the General
Product Safety Regulation (GPSR) and to the new realities of the growing volume of online
sales.

10.

In Article 7, on the obligations of manufacturers, paragraph 7a was added to ensure that
manufacturers have the obligation to mark the warnings in a language or languages easily
understood by consumers and other end-users, as determined by the Member State concerned.
Additionally, the obligation for manufacturers to inform other economic operators in the
distribution chain of possible product conformity issues was spelled out in paragraph 12.

11.

In Article 9, the obligations of importers for cases where they consider, or have reason tobelieve, that a toy that they have placed on the market presents a risk were further clarified.

12.

A new Article 10a was introduced on obligations of fulfilment service providers as they are
considered as an economic operator, given their role in the placing on the market of toys fromthird countries bought online. They are however subject to limited obligations, tailored totheir role in the supply chain.
b)

13.

Providers of online marketplaces

Providers of online marketplaces play an important role when intermediating the sale orpromotion of toys between traders and consumers. Therefore, Article 10b was added to define
the toys not in conformity with the proposed Regulation as illegal content for the purposes ofDigital Services Act (DSA)4, and to clarify the responsibilities of providers of online
marketplaces .

4Regulation (EU) No 2022/2065

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14.

The provisions of Article 10b are aligned with Article 22 of the General Product Safety
Regulation (GPSR)5 and Articles 30 to 32 of the DSA. Toys-specific obligations of providersof online marketplaces are an addition to the existing legal framework, which does notinterfere with the framework itself.

15.

Furthermore, the text provides that the Commission may issue guidelines to assist economic
operators and providers of online marketplaces in applying the provisions of Article 10b.
c)

16.

Digital Product Passport

The provisions relating to the Digital Product Passport have been aligned with the final text of
ESPR.

17.

A definition of “digital product passport” was added in Article 3(14a) to clarify what
information must be contained in the digital product passports and the technicalcharacteristics of the data carrier.

18.

The scope of the technical requirements related to the digital product passport for toys will be
determined by the implementing acts adopted by the Commission pursuant to Article 17.
d)19.

Product requirements and warnings

The proposed Regulation sets a product requirement, pursuant to which toys can be placed on
the Union market only if they comply with the general safety requirements and particularsafety requirement. Considering that mental health requirements do not exist yet, specificprovisions on mental health aspects were removed from the general safety requirement.
Instead, safety related aspects are covered by the safety assessment.

20.

Provisions on warnings and the corresponding Annex III were clarified, including therequirements regarding the minimum size, visibility and legibility of such warnings.

5

Regulation (EU) No 2023/988

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e)
21.

Chemicals

Regarding the derogations to the generic prohibitions of most harmful chemical substances intoys, the text has been modified to refer to the “presence” of prohibited substances rather than“use” since “use” could be interpreted in different ways. Such presence is only possible where
the relevant substance is considered safe for children, where there are no commercially viable
alternatives for the substance and where the use presence of the substance is not subject torestrictions in consumer articles under Regulation (EC) No 1907/2006.

22.

In point 4 of Part III of Annex II, the general ban on the use of substances classified as
carcinogenic, mutagenic, or toxic for reproduction (CMR substances) in toys, is limited to
substances that have been subject to harmonised classification (i.e. those that are listed in Part
3 of Annex VI of Regulation (EC) No 1272/2008), as in the Commission’s original proposal,
because a general ban on all substances classified under Regulation (EC) No 1272/2008
would lead to a disproportionate burden for the bodies concerned, toys manufacturers andcompetent authorities with regards to testing.

23.

Furthermore, on the same point, a ban on skin sensitisers category 1A in toys has been
introduced.

24.

Point 9 of Part III of Annex II also introduces a ban on toys that have a biocidal function anda ban on the treatment of toys with biocidal products, except for toys that are intended to bepermanently placed outdoors.

25.

Point 10 of Part III of Annex II 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 theRegulation on cosmetic products, in accordance with the conditions laid down in the Annex V
to that Regulation.

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26.

Finally, regarding allergenic fragrances, specific rules are set out for their use in toys,
including a prohibition on the intentional use of fragrances in toys, and for the labelling ofcertain allergenic fragrances.
f) Transitional provisions

27.

The transitional period during which toys placed on the market in conformity with the current
Toys Safety Directive 2009/48/EC may continue to be made available on the market has been
fixed to 60 months after the day of the month following the date of application of the
proposed Regulation.

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IV.

CONCLUSION

28.

The Presidency considers that the text, as set out in the Annex, reflects a fair and balanced
compromise between the different views expressed by delegations.

29.

Consequently, the Permanent Representatives Committee is therefore invited to endorse theattached compromise text and instruct the Presidency to start negotiations with the European
Parliament as soon as possible, in order to reach an agreement at first reading on this basis.

30.

The Presidency suggests that, if no objections are raised, the mandate approved by theCommittee is made public, in accordance with the Council’s Rules of Procedure.

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ENANNEX
2023/0290 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on the safety of toys and repealing Directive 2009/48/EC(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114
thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee6,
Acting in accordance with the ordinary legislative procedure,

6

OJ C , , p. .

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Whereas:(1)

Directive 2009/48/EC of the European Parliament and of the Council7 was adopted toensure a high level of safety of toys and their free movement on the internal market.

(2)Children are a particularly vulnerable group. It is essential to ensure a high level of safety
offor children when playing with toys. Children should be adequately protected frompossible risks stemming from toys, in particular from the chemical substances that toys
maymight contain. At the same time, compliant toys should be able to move freely acrossthe internal market without additional requirements.

(3)

The Commission evaluation of Directive 2009/48/EC concluded that thethat Directive isrelevant and generally effective in protecting children. However, it also identified anumber of deficiencies that have emerged during the practical application of thethat
Directive since its adoption in 2009. In particular, the evaluation identified certain
shortcomings with regard to possible risks arising from harmful chemicals in toys. The
evaluation also concluded that many non-compliant and unsafe toys remain on the Union
market.

7

Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on thesafety of toys (OJ L 170, 30.6.2009, p. 1).

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(4)

The Chemicals Strategy for Sustainability8 called for strengthening the protection of
consumers from the most harmful chemicals and to extending the generic approach
towards harmful chemicals (based on generic preventive bans) to ensure that consumers,
vulnerable groups and the environment are more consistently protected. In particular, thestrategy commits to strengthen Directive 2009/48/EC with regard to the protection fromthe risks of the most harmful chemicals and possible combination effects of chemicals.

(5)

Since the rules setting out the requirements for toys, in particular the essential safety
requirements and the conformity assessment procedures, need to be of uniform application
across the Union, and not give room for divergent implementation by Member States,
Directive 2009/48/EC should be replaced by a regulation.

(6)

Toys are also subject to Regulation (EU) 2023/988 on general product safety9, whichapplies in a complementary manner in matters not covered by specific sectoral legislationon consumer products. In particular, Section 2 of Chapter III and Chapter IV in relation toonline sales, Chapter VI on the Safety Gate Rapid Alert System and Safety Business
Gateway and Chapter VIII on the right of information and remedy also apply to toys.
Therefore, this Regulation does not include specific provisions on distance and online
sales, accident reporting by economic operators and the right of information and remedy
but rather requires economic operators providing information on safety issues concerning
toys to inform authorities and consumers or other end-users in accordance with theprocedures set out in Regulation (EU) 2023/988.

8
9COM(2020) 667 final
OJ L 11, 15.1.2002, p. 4.

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(7)

Regulation (EC) No 765/2008 of the European Parliament and of the Council10 lays down
rules on the accreditation of conformity assessment bodies, and lays down the generalprinciples of the CE marking. That Regulation should be applicable to toys in order toensure that toys benefiting from the free movement of goods within the Union fulfil
requirements providing a high level of protection of health and safety of persons and inparticular children.

(8)

Decision No 768/2008/EC of the European Parliament and of the Council11 lays downcommon principles and reference provisions intended to apply across sectoral productlegislation in order to provide a coherent basis for such legislation. This Regulation should
therefore be draftedfollow, to the extent possible, in accordance with those common
principles and reference provisions.

(9)This Regulation should lay down essential safety requirements for toys to ensure a highlevel of protection of health and safety of children when playing with toys as well as thefree movement of toys in the Union. This Regulation should be applied taking due accountof the precautionary principle.

1011Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008
setting out the requirements for accreditation and market surveillance relating to themarketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p.
30).
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on
a common framework for the marketing of products, and repealing Council Decision
93/465/EEC (OJ L 218, 13.8.2008, p. 82).

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(10)

To facilitate the application of this Regulation by manufacturers and national authorities,
its scope should be clearly defined. It This Regulation should apply to all products
designed or intended for use in play by children under 14 years of age. A productmaycould be considered as a toy even if it is not exclusively intended for playing purposes
and has other additional functions. Whether a product has play value depends on the use
envisioned by the manufacturer or on the use of the product reasonably foreseeable by aparent or a supervisor. At the same time, it is necessary to exclude from its scope certain
toys which are not intended for domestic use, such as public playground equipment or
automatic machines intended for public use, or other toys equipped with combustion or
steam engines, as such toys may present risks to the health and safety of children that are
not addressed by this Regulation. In addition, a list of products that could be confused withtoys but are not to be considered toys within the meaning of this Regulation should be
provided.

(11)

This Regulation should apply to toys which are new to the Union market when placed on
the market, i.e. either new toys made by a manufacturer established in the Union orand totoys, whether new or second hand, imported from a third country. and placed on theUnion market. The safety of other second hand productstoys which were already on theUnion market falls within the scope of Regulation (EU) 2023/988 of the European
Parliament and of the Council12.

(12)

To ensure adequate protection of children and other persons, this Regulation should apply
to all forms of supply of toys, including distance sales as referred to in Article 6 ofRegulation (EU) 2019/1020 of the European Parliament and of the Council13.

1213Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023
on general product safety, amending Regulation (EU) No 1025/2012 of the European
Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament
and the Council, and repealing Directive 2001/95/EC of the European Parliament and of theCouncil and Council Directive 87/357/EEC (OJ L 135, 23.5.2023, p. 1).
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019
on market surveillance and compliance of products and amending Directive 2004/42/EC andRegulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).

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(13)

Essential safety requirements for toys should ensure protection from all relevant health andsafety hazards posed by toys, for users or third parties. Particular safety requirements
should cover the physical and mechanical properties, flammability, chemical properties,
electrical properties, hygiene and radioactivity to ensure that the safety of children isadequately protected against those specific hazards. Since it is possible that toys which
present hazards that are not covered by a particular safety requirement might exist or be
developed, it is necessary to maintain a general requirement of safety to ensure protectionof children in respect of such toys. The safety of toys should be determined by reference tothe intended use, while taking into account also the foreseeable use, and bearing in mind
the behaviour of children, who do not generally show the same degree of care as theaverage adult user. Together, the general safety requirement and the particular safety
requirements should form the essential safety requirements for toys. The obligation foreconomic operators to comply with those essential safety requirement does not affecttheir obligations to comply with other Union law that may be applicable to toys andwhich address other aspects such as cybersecurity, environmental protection, themaking available of hazardous substances and mixtures, or artificial intelligence.

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(14)

Relying on digital technologies has led to new hazards in toys. Radio toys are to comply
with essential requirements for the protection of privacy and internet-connected toys are toincorporate safeguards towards cybersecurity and protection from fraud in accordance with
Directive 2014/53/EU of the European Parliament and of the Council14. Toys with digitalelements are to comply with Regulation (EU) …/…[P.O. insert serial number for
Regulation on horizontal cybersecurity requirements for products with digitalelements]. Toys which include artificial intelligence are to comply with Regulation (EU)…/…[P.O. insert serial number for Regulation laying down harmonised rules on artificial
intelligence]15. Therefore, this Regulation should not lay down particular safety
requirements regarding cybersecurity, protection of personal data and privacy or otherhazards stemming from the incorporation of artificial intelligence in toys should not be setout. However, protecting the health of children should not merely ensure the absence ofdisease or infirmity and relying on digital technologies may pose risks to children which go
beyond their physical health. To ensure that children are protected from any risk comingfrom the use of digital technologies in toys, the general safety requirement should ensure
the psychological and mental health, as well as the well-being and cognitive development,of children.

14

15

Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on
the harmonisation of the laws of the Member States relating to the making available on themarket of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).
PO: Please insert in the text the number of the Regulation and insert the number, date, title
and OJ reference of that Regulation in the footnote.

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(15)

Toys should comply with physical and mechanical requirements that prevent children fromgetting physically injured when playing with toys and should not pose a risk of choking or
suffocation to children. In order to protect children from the risk of impaired hearing,
maximum values should be set out for both impulse noise and continuous noise emitted bytoys. Toys or their parts and their packaging which can be reasonably expected to bebrought into contact with food or to transfer their constituents to food under normal orforeseeable conditions of use are subject to Regulation (EC) No 1935/2004 of theEuropean Parliament and of the Council16. In addition, it is appropriate to lay down
specific safety requirements to cover the potential specific hazard presented by toys infood, since the association of a toy and food could cause a risk of choking which is distinct
from the risks presented by the toy alone and which is, therefore, not covered by any
specific measure at Union level. Specific safety requirements to cover the potential
hazard associated with the ingestion of strong magnets or expanding toy material thatare capable of causing intestinal perforation or blockage should be laid down. Toys
should also ensure sufficient protection as regards flammability or electric properties, inparticular to prevent burns or electric shocks. Moreover, toys should meet certain hygiene
standards to avoid microbiological risks or other risks of infection or contamination.

(15a)Some toys are designed to emit sound (percussion cap toys, cap-firing toys, drums,
rattles, toys that play music/sound etc). In order to protect children from the risk of
impaired hearing, maximum values should be set for both impulse noise andcontinuous noise emitted by toys which are designed to emit a sound. However, toysthat are not clearly designed to emit sound, but do emit a reproduceable sound whena child activates a mechanism such as a trigger on a toy gun, should also be designed
so as to protect children from the risk of impaired hearing.

16

Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27
October 2004 on materials and articles intended to come into contact with food andrepealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).

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(16)

Chemicals that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR
substances), chemicals that affect the endocrine system, the respiratory system or that are
toxic to a specific organ are particularly harmful for children and should be specificallyaddressed in toys. Given the essential role of the endocrine system during humandevelopment, early exposure during critical periods, such as early childhood, to endocrine
disruptors can lead to adverse effects even at very low doses and affect health at a laterstage of life. Respiratory sensitisers can lead to an increase of childhood asthma andneurotoxic substances are particularly harmful to the developing brain of children, which isinherently more vulnerable to toxic injury than the adult brain. Children should also be
adequately protected from allergenic substances and certain metals. The requirements forchemical substances set out in Directive 2009/48/EC need to be updated and strengthened.
Toys are to comply with general chemicals legislation, in particular Regulation (EC) No
1907/2006 of the European Parliament and of the Council. In order to provide further
protection of children, who are a vulnerable group of consumers, and other persons, thatlegal framework should be supplemented by generic prohibitions in toys covering certain
hazardous chemicals, as classified in accordance with Regulation (EC) No 1272/2008 of
the European Parliament and of the Council17. Those generic prohibitions should apply to
CMR substances, endocrine disruptors, respiratory sensitisers and, substances targeting a
specific organ and skin sensitizers, as soon as those substances are classified as hazardous
under Regulation (EC) No 1272/200818.

17

18

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16
December 2008 on classification, labelling and packaging of substances and mixtures,
amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation(EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18
December 2006 concerning the Registration, Evaluation, Authorisation and Restriction ofChemicals (REACH), establishing a European Chemicals Agency, amending Directive
1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p.
1).

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(16a)In order to ensure toy safety, prohibited substances should be acceptable at trace levels but
only if their presence at such levels is technologically unavoidable with good
manufacturing practices and if the toy is safe. To facilitate a practical, efficient andharmonised enforcement of the generic ban, the non intended presence level should
be as low as reasonably achievable according to the ALARA principle. In any case,these levels should not exceed a default concentration limit of 100 mg/kg. Genericconcentration limits triggering classification of mixtures are set in Regulation
1272/2008 at 1000 mg/kg for carcinogenic or mutagenic categories 1A or 1B
substances and at 3000 mg/kg for reprotoxic category 1A or 1B substances. While thegeneric concentration limits triggering classification of category 1 specific target
organ toxicant are set at 100.000 mg/kg. These limits may not be sufficiently
protective for children and therefore additional safety factors should be used to set
the default concentration limit.

(17)

In order to provide for flexibility where the safety of children is not compromised andwhere it is necessary for making certain toys available on the market, it should be possible
to derogate from the generic prohibitions of chemical substances in toys. Derogations togeneric prohibitions permitting the usepresence of prohibited substances should be ofgeneral application and should only be possible where the usepresence of the relevant
substance is considered safe for children, where there are no commercially viable
alternatives for the substance and where the usepresence of the substance is notprohibitedsubject to restrictions in consumer articles under Regulation (EC) No
1907/2006. The assessment of the safety of the substance in toys should be carried out by
the relevant scientific committees in the European Chemicals Agency (ECHA) in order toensure consistency and efficient use of resources in the assessment of chemical substancesin the Union.

(18)

Economic operators, industry associations or other interested parties should have thepossibility to submit a request for assessment for a permitted use concerning a certain
substance subject to a generic prohibition to ECHA. ECHA should draw up and makeavailable the format and medium for the submission of requests for assessment. In
addition, for reasons of transparency and foreseeability, ECHA should issue technical andscientific guidance on such requests for assessment.

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(18a)

Given the important and central role envisaged for ECHA, it is important that ECHA
has adequate resources to ensure that it can deliver timely and reliable data andopinions to support the decision-making process for adjustments to requirements on
chemical safety.

(19)

The usepresence of nickel and cobalt in stainless steel and in components that transmit
electric current hasand certain uses of titanium dioxide have been considered safe intoys by the Scientific Committee on Health, Environment and Emerging risks and shouldbe allowed. Other substances that are necessary to transmit electric current should bepermitted in toys to allow for the making available of electric toys if such substances arecompletely inaccessible for a child playing with the toy and therefore do not present a risk.

(20)

As batteries are regulated by Regulation (EU) …/…[P.O. insert serial number for
Regulation on batteries and waste batteries]19, the requirements regarding chemical
substances in toys should not apply to the batteries included in toys. However, toys that
include batteries should be designed in such a way that the batteries are difficult forchildren to access.

(20a)

In certain cases, it may be impossible to design the toy wherein the rechargeable
battery is both removable and replaceable by the consumer or other end-users, but at
the same time inaccessible to children. This can be the case when, due to size andnature of the toy, it would be impossible to use screws or other safeguardmechanisms. This can also be the case when the toy includes sensitive small
electronics which could be damaged when replacing the battery. In order to ensurechildren safety, manufacturers should have the flexibility to design the toy in such a
way that the rechargeable battery is inaccessible, and removal or replacement can
only be done by a professional, independent operator with specialized tools or
methods.

19

PO: Please insert in the text the number of the Regulation …. and insert the number, date,title and OJ reference of that Regulation in the footnote.

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(21)

Existing limit values for certain chemical substances and their corresponding test methods
have proven to be appropriate for the protection of children as regards those substances andshould be maintained. In order to adapt to new scientific knowledge, the Commission
should be empowered to revise those limit values where necessary. Limit values forarsenic, cadmium, chromium VI, lead, mercury and organic tin, which are particularly
toxic and which should therefore not be intentionally used in toys, should be set out at half
the values that are considered safe by the relevant scientific body, in order to ensure that
only traces that are compatible with good manufacturing practice are present in the toy.

(22)

Directive 2009/48/EC includes limit values for certain substances in toys intended forchildren under 36 months or intended to be put in the mouth. Those substances have shown
to also pose a risk to older children, as they could be equally exposed to such chemicals via
skin contact or inhalation. These limit values should therefore apply to all toys. Since theadoption of the limit values for bisphenol A in Directive 2009/48/EC, new scientific data
has emerged. The European Food Safety Authority (EFSA) re-evaluated the risks to publichealth from dietary exposure to bisphenol A in April 2023 concluding that exposure tobisphenol A is a health concern for consumers across all age groups. EFSA has establisheda new tolerable daily intake of bisphenol A which is significantly lower than the previous
one. In view of this scientific evidence, bisphenol A should fall under the genericprohibition for CMR substances in toys. In order to verify compliance with thisprohibition and to ensure that there is no exposure to any non intended presence ofbisphenol A in toys, a migration limit should be provided. The migration limit should
be set based on a limit of quantification with existing testing methods. For similarreasons, migration limits should also be introduced for some of the most commonlyused monomers in the production of plastics.

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(23)

To ensure adequate protection from specific chemical substances in case of new scientificknowledge, the Commission should be empowered to adopt delegated acts establishingspecific limit values for any chemical substance used in toys. If justified in cases of toys
involving a higher degree of exposure, those delegated acts should set out specific limit
values for toys intended for use by children under 36 months and in other toys intended tobe put in the mouth, taking into account the requirements set out in Regulation (EC) No
1935/2004 and the differences between toys and materials which come into contact withfood or articles from which risks may arise due to oral contact through their use as a foodcontact material.. Fragrances in toys entail special risks for human health. Therefore,
specific rules should be set out for the use of fragrances in toys, including a prohibitionon the intentional use of fragrances in toys, and for the labelling of certain allergenic
fragrances. The Commission should be empowered to adopt delegated acts to amend thoserules to allow for adaptations to technical and scientific progress.

(24)

Where the hazards that a toy may present cannot be completely addressed by design, theresidual risk should be addressed by product-related information directed at the supervisorsof the children in the form of warnings, taking into account the capacity of those
supervisors to take the necessary precautions.

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(25)

To prevent misuse of warnings to circumvent the applicable safety requirements, thewarnings provided for certain categories of toy should not be allowed if they conflict with
the intended or reasonably foreseeable use of the toy. To ensure that supervisors areaware of any risks associated with the toy, it is necessary to ensure that the warnings are
legible and visible.

(26)

EconomicAll economic operators shouldare expected to act responsibly and in fullaccordance with the legal requirements applicable when placing or making toys available
on the market.

(27)

In order to ensure a high level of protection of the health and safety of children and faircompetition on the internal market, economic operators should be responsible for thecompliance of toys with this Regulation, in relation to their respective roles in the supply
chain.

(28)

As certain tasks can be executed only by the manufacturer, it is necessary to distinguishclearly between the obligations of the manufacturer and the operators further down the
distribution chain. It is also necessary to distinguish clearly between the obligations of theimporter and the distributor, as the importer introduces toys from third countries to theUnion market. The importer should make sure that those toys comply with the applicable
Union requirements.

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(28a)

Information referring to an offer of toys placed on the market or made available on
the market which are not compliant with this Regulation should be considered illegal
content within the meaning of Regulation (EU) 2022/2065 and trigger the specific due
diligence obligations set out thereto for online intermediaries. The important role
played by providers of online marketplaces when intermediating the sale of products
between economic operators and consumers has justified the establishment of recent
sets of rules, imposing new due diligence obligations to online marketplaces. Firstly,
Regulation (EU) 2022/2065 of the European Parliament and of the Council regulates
the responsibility and accountability of providers of intermediary services online withregard to illegal content, including dangerous products. Secondly, Regulation (EU)2023/988 of the European Parliament and of the Council establishes specificresponsibilities in tackling the sale of dangerous products online. Building on thehorizontal legal framework provided by those Regulations, this Regulation should
specify the requirements, in relation to toy safety, with which providers of online
marketplaces are to comply in order to ensure compliance with certain provisions ofRegulation (EU) 2022/2065. Those requirements should not affect the application ofRegulation (EU) 2022/2065, which continues to apply to those providers of online
marketplaces.

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(29)

In order to facilitate communication between economic operators, market surveillanceauthorities and consumers or other end-users, manufacturers and importers should indicate
a website, email address or other digital contact in addition to the postal address.

(30)

The manufacturer, having detailed knowledge of the design and production process,isshould be responsible for the compliance of the toy with the requirements of thisRegulation and is best placed to carry out the complete conformity assessment procedure
for toys. Conformity assessment should therefore remain the obligation of the
manufacturer alone.

(31)

To facilitate compliance of the manufacturers with their obligations under this Regulation,
manufacturers should be allowed to appoint an authorised representative to carry out
specific tasks on their behalf. Moreover, to ensure a clear and proportionate distribution oftasks between the manufacturer and the authorised representative, it is necessary to set out
a list of tasks that manufacturers should be allowed to entrust the authorised representativewith. Further, to ensure the enforceability and compliance with this Regulation, where amanufacturer established outside the Union appoints an authorised representative, themandate should include the tasks set out in Article 4 of Regulation (EU) 2019/1020.

(32)

Economic operators intervening in the supply and distribution chain should takeappropriate measures to ensure that the toys they place on the market do not jeopardise thesafety and health of children under normal and reasonably foreseeable conditions of use,
and that they make available on the market only toys which comply with the relevant
Union legislation. law.

(33)

It is necessary to ensure that toys from third countries entering the Union market comply
with all applicable Union requirements, and in particular that appropriate conformity
assessment procedures have been carried out by manufacturers with regard to those toys.
Importers should therefore ensure that the toys they place on the market comply with theapplicable requirements, that conformity assessment procedures have been carried out andthat product marking and documentation drawn up by manufacturers are available forinspection by the competent market surveillance authorities.

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(34)

When placing a toy on the market, importers should indicate on the toy their name and theaddress at which they can be contacted. Exceptions should be provided for in cases where
the size or nature of the toy does not allow for such an indication, including whereimporters would have to open the packaging to put their name and address on the product.
In such cases, the name and address should be indicated on the packaging or an
accompanying document.

(35)

As the distributor makes a toy available on the market after the toy has been placed on themarket by the manufacturer or the importer, the distributor should act with due care toensure that the handling of the toy does not adversely affect the compliance of that toy withthis Regulation.

(36)

Distributors and importers are close to the market place and should therefore be involvedin market surveillance tasks carried out by competent national authorities, and should be
required to participate actively in such tasks and to provide those authorities with allnecessary information relating to the toy concerned.

(37)

Economic operators that either place a toy on the market under their own name ortrademark or modify a toy in such a way that compliance with applicable requirements ofthis Regulation may be affected, should be considered to be manufacturers and should
assume the obligations of manufacturers.

(38)

Ensuring traceability of a toy throughout the whole supply chain helps to make market
surveillance simpler and more efficient. An efficient traceability system facilitates market
surveillance authorities' task of tracing economic operators who made non-compliant toys
available on the market.

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(39)

In order to facilitate the assessment of conformity with the requirements of this Regulation
it is necessary to provide for a presumption of conformity for toys which are in conformity
with harmonised standards that are adopted in accordance with Regulation (EU) No
1025/2012 of the European Parliament and of the Council20 and published in the Official
Journal of the European Union.

(40)

In the absence of relevant harmonised standards, the Commission should be empowered toadopt implementing acts setting out common specifications for the essential safety
requirements of this Regulation, provided that in doing so it duly respects thestandardisation organisations’ role and functions, as an exceptional fall back solution tofacilitate the manufacturer’s obligation to comply with the essential safety requirements,
when the standardisation process is blocked or when there are delays in the establishmentof appropriate harmonised standards. If such delay is due to the technical complexity ofthe standard in question, this should be considered by the Commission before
contemplating the establishment of common specifications. With a view toestablishing, in the most efficient way, common specifications that cover the essential
safety requirements of this Regulation, the Commission should duly consult relevant
stakeholders in the process.

(41)

The CE marking, indicating the conformity of a toy, is the visible consequence of a wholeprocess comprising conformity assessment in a broad sense. General principles governing
the CE marking are set out in Regulation (EC) No 765/2008. Specific rules governing theaffixing of the CE marking with regard to toys should be laid down in this Regulation.
Those rules should ensure sufficient visibility of the CE marking in order to facilitate
market surveillance of toys.

20

Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25
October 2012 on European standardisation, amending Council Directives 89/686/EEC and93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC,
2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council
and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European
Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).

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(42)

Manufacturers should create a digital product passport to provide information on thecompliance of toys with this Regulation and with any other Union legislationlaw
applicable to toys. The digital product passport should replace the EU declaration ofconformity under Directive 2009/48/EC and include the elements necessary to assess theconformity of the toy with the applicable requirements and harmonised standards or otherspecifications. In order to facilitate checks on toys by market surveillance authorities andto allow the actors in the supply chain and consumers to access information on the toy, theinformation on the digital product passport should be provided digitally and in a directly
accessible manner, through a data carrier affixed to the toy, its packaging or theaccompanying documentation.. Market surveillance authorities, customs authorities,
economic operators and consumers or other end-users should have immediate access tothe information on the toy through the data carrier.

(43)

To avoid duplication of investment into digitalisation by all actors involved, including
manufacturers, market surveillance authorities and customs authorities, when other Union
legislationlaw requires a digital product passport for toys, a single digital product passportshould be available containing the information required under this Regulation and the other
Union legislationlaw. In addition, the digital product passport should be fullyinteroperable with any digital product passport required under other Union legislation.
law.

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(44)

In particular, Regulation (EU) …/… [P.O. insert serial number for the Regulation on
ecodesign requirements for sustainable products] of the European Parliament and of theCouncil21 also lays down requirements and technical specifications for a digital productpassport, the establishment of a Commission centraldigital product passport registry (the‘registry’) where passport information is stored and the interconnection of that registrywith the customs IT systems. That Regulation maymight include toys within its scope inthe medium term, thus requiring that a digital product passport is available for toys.
Therefore, it should be possible in the future to include more precise information in thedigital product passport, in particular information related to environmental sustainability,
such as the environmental footprint of a product, information useful for recycling purposes,
the recycled content of a certain material, information about the supply chain, and othersimilar information.. The digital product passport for toys created under this Regulation
should therefore comply with the same requirements and technical elements as those set
out in Regulation (EU) …/… [P.O. insert serial number for the Regulation on ecodesign
requirements for sustainable products], including the technical, semantic andorganisational aspects of end-to-end communication and data exchange.

(45)

As the digital product passport is to replace the EU declaration of conformity, it is crucial
to make clear that by creating the digital product passport for a toy and by affixing the CE
marking, the manufacturer declares that the toy is in compliance with the requirements ofthis Regulation and that the manufacturer takes full responsibility thereof.

21

PO: Please insert in the text the number of the Regulation establishing a framework for
setting ecodesign requirements for sustainable products and repealing Directive
2009/125/EC…. and insert the number, date, title and OJ reference of that Regulation in thefootnote.

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(46)

Where other information than the elements required for the digital product passport isprovided digitally, it is necessary to clarify that the different types of information need to
be provided separately and clearly distinguished from each other but through a single datacarrier. This will facilitate the work of market surveillance authorities but also provide
clarity to consumers or other end-users regarding the different types of information thatare available to them in a digital format.

(47)

Chapter VII of Regulation (EU) 2019/1020, setting up the rules for of controls on products
entering the Union market applies to toys. The authorities in charge of controls, which inalmost all Member States are the customs authorities, are to perform them on the basis ofrisk analysis as referred to in Articles 46 and 47 of Regulation (EU) No 952/2013 of theEuropean Parliament and of the Council22, its implementing legislation and thecorresponding guidance. This Regulation therefore does not modify in any way Chapter
VII of Regulation (EU) 2019/1020 and the way the authorities in charge of controls on
products entering the Union market organise themselves and perform their activities.

(48)

In addition to the framework of controls established by Chapter VII of Regulation (EU)2019/1020, customs authorities should be able to automatically verify that a digitalproduct passport exists for imported toys subject to this Regulation in order to strengthen
the controls at the Union’s external borders and prevent non-compliant toys from entering
the Union market.

22

Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October
2013 laying down the Union Customs Code (recast) (OJ L 269, 10.10.2013, p. 1).

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(49)

When toys coming from third countries are placed under the customs procedure of releasefor free circulation, the reference to a digital product passport for those toys should bemade available to the customs authorities by the economic operator. The reference to thedigital product passport should correspond to a unique productregistration identifier thatis stored in the communicated to the economic operator by the digital product passport
registry established under Article 1213 of [P.O. insert serial number for Regulation (EU)…/… on Ecodesign Requirements for Sustainable Products] (the ‘registry’). Customs
authorities should carry out an automatic verification of the product passport presented forthat toy, soverify as to ensurea minimum that only toys with a valid reference to a theunique productregistration identifier as included in the and the relevant commodity
code for the toy provided or made available to them corresponds to the data that are
stored in the registry are released . This would allow customs authorities to verify thata digital product passport for free circulationimported toy exists. To carry out that
automatic verification, the interconnection between the registry and the customs IT
systems as provided for in [Article 1315 of Regulation (EU) …/… on ecodesign
requirements for sustainable products] should be used.

(50)

Where other information than the unique product identifier and the unique operator
identifier is stored in the registry, the Commission should be empowered to adopt delegatedacts allowing customs authorities to verify the consistency between that additional
information and the information made available by the economic operator to customs, inorder to ensure the compliance of toys placed under the customs procedure of release forfree circulation with this Regulation.

(51)

The informationdata included in the digital product passport allowsare intended to allow
customs authorities to enrichenhance and facilitate risk management and enables moretargeted enable the controls at the Union’s external borders.border to be bettertargeted. Therefore, customs authorities should have the possibility to retrieve and use theinformationdata included in the digital product passport and the related registry forcarrying out their tasks in accordance with Union legislationlaw, including for risk
management in accordance with Regulation (EU) No 952/2013.

(52)

It is appropriate to provide for the publication of a notice in the Official Journal of theEuropean Union indicating the date when the interconnection between the registry and the
EU Customs Single Window Certificates Exchange System referred to in Article 13 of [P.O.
insert serial number for Regulation (EU) …/… on Ecodesign Requirements for Sustainable
Products] becomes operational in order to facilitate public access to that information.

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(53)

The automatic verification by customs authorities of the reference to the digital productpassport for toys entering the Union market should not replace or modify the
responsibilities of the market surveillance authorities but only complement the overall
framework for controls on products entering the Union market. Regulation (EU)2019/1020 should continue to apply to toys so as to ensure that market surveillanceauthorities carry out checks of the information contained in products passports, checks ontoys within the market in accordance with that Regulation and, in case of suspension of
release for free circulation by the authorities designated for controls at the Union’s externalborders, determine the compliance and risks of toys pursuant to Chapter VII of Regulation(EU) 2019/1020.

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(54)

Children are daily exposed to a wide range of different chemicals originating from various
sources. Significant progress has been made to close some knowledge gaps on the impactof the combination effect of those chemicals. However, the safety of chemicals is usuallyassessed through the evaluation of single substances and in some cases of mixturesintentionally added for particular uses. In order to provide the highest protection forchildren, the most harmful substances should be generally banned in toys to ensure that
there is no exposure to them in toys. The specific limit values for chemicals in toys should
account for combined exposure from different sources to the same chemical substance. In
addition, manufacturers should be required to carry out an analysis of the various hazards
that the toy may present and an assessment of the potential exposure to such hazards and,as part of the assessment of chemical hazards, to consider known cumulative or synergistic
effects of the chemicals present in the toy, to ensure that risks from simultaneous exposure
to multiple chemicals are taken into account. Furthermore, toys are to comply with generalchemicals legislation, in particular Regulation (EC) No 1907/2006 of the European
Parliament and of the Council; this Regulation does not modify the obligations for theassessment of the safety of the chemical substances or mixtures themselves that may be
applicable in accordance with that Regulation.

(55)

Manufacturers should prepare the technical documentation describing all relevant aspectsof toys including the safety assessment of all hazards that the toy may present and how
they have been addressed, to allow market surveillance authorities to perform their tasks
efficiently. The manufacturer should be required to make that technical documentation
available to national authorities on request or to notified bodies in the context of therelevant conformity assessment procedure.

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(55a)The safety assessment should take into account the health risk posed by digitallyconnected products, including the risk to mental health. Therefore, when assessing
the safety of digitally connected products likely to have an impact on children,
manufacturers should ensure that the products they make available on the market
meet the highest standards of safety, security and privacy by design, in the bestinterests of children.

(55b)

In the safety assessment, manufacturers should assess the chemical substancespresent in the toy and possible non intended presence of substances subject to genericbans or other restrictions. The assessment should determine the scope of possible
testing especially for those substances that can reasonably be expected to appear in
the toy, including as traces.

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(56)

To ensure that toys comply with the essential safety requirements, it is necessary to lay
down appropriate conformity assessment procedures to be followed by the manufacturer.
Internal production control based on the manufacturer’s own responsibility for theconformity assessment is adequate where it has followed the harmonised standards, thereference of which has been published in the Official Journal of the European Union, orcommon specifications covering all the particular safety requirements for the toy. In cases
where such harmonised standards or common specifications do not exist, the toy should besubmitted to third party verification, in this case EU-type examination. The same should
apply if one or more such standards has been published with a restriction in the Official
Journal of the European Union, or if the manufacturer has not followed such standards or
specifications completely, or only in part. The manufacturer should submit the toy to EUtype examination in cases where it considers that the nature, design, construction or
purpose of the toy necessitates third party verification.

(57)

Since it is necessary to ensure a uniformly high level of performance of bodies performing
conformity assessment of toys throughout the Union, and since all such bodies should
perform their functions to the same level and under conditions of fair competition,requirements should be set for conformity assessment bodies wishing to be notified inorder to provide conformity assessment services under this Regulation.

(58)

If a conformity assessment body demonstrates conformity with the criteria laid down inharmonised standards, itthe conformity assessment body should be presumed to comply
with the corresponding requirements set out in this Regulation.

(59)

The system set out in this Regulation should be complemented by the accreditation systemprovided for in Regulation (EC) No 765/2008. Since accreditation is an essential means ofverifying the competence of conformity assessment bodies, it should be used for the
purposes of notification. In particular, transparent accreditation as provided for in
Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates ofconformity, should be the only means of demonstrating the technical competence ofconformity assessment bodies.

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(60)

Conformity assessment bodies frequently subcontract parts of their activities linked to theassessment of conformity or have recourse to a subsidiary. In order to safeguard the levelof protection required for toys to be placed on the market, it is essential that conformity
assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies
in relation to the performance of conformity assessment tasks. Therefore, it is importantthat the assessment of the competence and the performance of bodies to be notified, andthe monitoring of bodies already notified, cover also activities carried out by
subcontractors and subsidiaries. In particular, excessive recourse to subsidiaries andsubcontractors, in a manner that would call into question the competence of the notified
body or its supervision by the notifying authority should be avoided.

(61)

In order to ensure a consistent level of quality in the performance of conformity assessmentof toys, it is necessary not only to consolidate the requirements that conformity assessment
bodies wishing to be notified must fulfil, but also, in parallel, to set requirements that
notifying authorities and other bodies involved in the assessment, notification andmonitoring of notified bodies must fulfil.

(62)

Since notified bodies may offer their services throughout the Union, it is appropriate togive the other Member States and the Commission the opportunity to raise objections
concerning a notified body. It is therefore important to provide for a period during which
any doubts or concerns as to the competence of conformity assessment bodies can beclarified before they start operating as notified bodies. The Commission should by way of
implementing acts request the notifying Member State to take the necessary corrective
measures in respect of a notified body that does not meet the requirements for its
notification.

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(63)

In the interests of competitiveness, it is crucial that notified bodies apply the conformity
assessment procedures without creating unnecessary burdens for economic operators. For
the same reason, and to ensure equal treatment of economic operators, consistency in thetechnical application of the conformity assessment procedures needs to be ensured. Thatcan best be achieved through appropriate coordination and cooperation between notified
bodies. Such coordination and cooperation should respect the Union competition rules.

(64)

Market surveillance is an essential instrument inasmuch as it ensures the proper anduniform application of Union legislationlaw. Regulation (EU) 2019/1020 sets out theframework for market surveillance of products subject to Union harmonisation legislation,
including toys. Since this Regulation replaces Directive 2009/48/EC, the rules on market
surveillance and controls on products entering the Union market set out in Regulation (EU)2019/1020, including the specific requirement set out in Article 4 of that Regulation thattoys are to be placed on the market only if there is an economic operator established in theUnion responsible for the tasks specified in that Article, continue to apply to toys. Member
States should therefore organise and carry out market surveillance of toys in accordancewith that Regulation.

(65)

Directive 2009/48/EC provides for a safeguard procedure allowing the Commission andother Member States to examine the justification for a measure taken by a Member Statesagainst toys that the Member State considers to be non-compliant. That procedure ensuresthat interested parties are informed of measures intended to be taken with regard to toys
posing a risk to the health or safety of persons and that such toys are consistently addressedby all market surveillance authorities in the Union market. The procedure should therefore
be maintained.

(66)

Where the Member States and the Commission agree as to the justification of a measuretaken by a Member State, no further involvement of the Commission should be required.
Where there are objections to such a measure, the Commission should, by means of
implementing acts, determine whether a national measure in respect of a toy is justified.

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(67)

Experience with Directive 2009/48/EC has shown that new toys available on the market
which were compliant with the applicable particular safety requirements when placed on
the market have in specific cases posed a risk to children and therefore do not comply withthe general safety requirement. Provisions should be made to ensure that market
surveillance authorities can take action against any toy presenting a risk to children, evenwhen it is compliant with the particular safety requirements. The Commission should, bymeans of implementing acts, determine whether a national measure in respect of compliant
toys which a Member State finds to pose a risk to the health and safety of children or otherpersons is justified.

(68)

In order to take into account technical and scientific progress or new scientific evidence,the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of
the European Union should be delegated to the Commission in respect of amending thisRegulation by adapting the specific warnings to be affixed on toys, adopting specificrequirements concerning chemical substances in toys and granting derogations to include
specific uses allowed in toys of substances subject to generic prohibitions.

(69)

In order to take into account technical and scientific progress as well as the level of digital
readiness of market surveillance authorities and of children and their supervisors, thepower to adopt acts in accordance with Article 290 of the Treaty on the Functioning of theEuropean Union should also be delegated to the Commission in respect of amending thisRegulation with regard to the information that is to be included in the digital productpassport and the information that is to be included in the digital product passport registry.

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(70)

In order to facilitate the work of customs authorities in relation to toys and theircompliance with the requirements set out in this Regulation, the power to adopt acts inaccordance with Article 290 of the Treaty on the Functioning of the European Union
should be delegated to the Commission in respect of supplementing this Regulation bydetermining the additional information stored in the registry to be controlled by customs
authorities, and in respect of amending the list of commodity codes and productdescriptions to be used for customs controls in accordance with this Regulation on thebasis of Annex I to Regulation (EEC) No 2658/87 of the European Parliament and of theCouncil23.

(71)

When adopting delegated acts under this Regulation, it is of particular importance that theCommission carry out appropriate consultations during its preparatory work, including at
expert level, and that those consultations be conducted in accordance with the principles
laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making24. In
particular, to ensure equal participation in the preparation of delegated acts, the European
Parliament and the Council receive all documents at the same time as Member States’
experts, and their experts systematically have access to meetings of Commission expert
groups dealing with the preparation of delegated acts.

23
24

Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statisticalnomenclature and on the Common Customs Tariff, OJ L 256, 7.9.1987, p. 1.
OJ L 123, 12.5.2016, p. 1.

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(72)

In order to ensure uniform conditions for the implementation of this Regulation,
implementing powers should be conferred on the Commission to establish the detailed
technical requirements for the digital product passport for toys, and to determine whether a
specific product or group of products is to be considered a toy for the purposes of thisRegulation. In exceptional cases where it is necessary in order to address new emerging
risks that are not appropriately addressed by the particular safety requirements, theCommission should be empowered to adopt implementing acts setting out specificmeasures against toys or categories of toys made available on the market which present arisk for children. Those powers should be exercised in accordance with Regulation (EU)No 182/2011 of the European Parliament and of the Council25.

(73)

Member States should provide for penalties applicable to infringements of this Regulation.
Those penalties should be effective, proportionate and dissuasive.

25

Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16
February 2011 laying down the rules and general principles concerning mechanisms forcontrol by Member States of the Commission’s exercise of implementing powers (OJ L 55,
28.2.2011, p. 13).

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(74)

In order to allow manufacturers and other economic operators sufficient time to adapt to
the requirements laid down by this Regulation, it is necessary to provide for a transitional
period during which toys which comply with Directive 2009/48/EC may be placed on themarket. In addition, the period during which t toys already placed on the market incompliance with that Directive may continue to be made available on the market after thisRegulation becomes applicable should be limited.

(75)

Since the objective of this Regulation, namely to ensure a high level of safety of toys witha view to ensuring the health and safety of children whilst guaranteeing the functioning of
the internal market, cannot be sufficiently achieved by the Member States and cantherefore, by reason of its scale and effects, be better achieved at Union level, the Union
may adopt measures, in accordance with the principle of subsidiarity set out in Article 5 of
the Treaty. In accordance with the principle of proportionality, as set out in that Article,
this Regulation does not go beyond what is necessary in order to achieve that objective.

HAVE ADOPTED THIS REGULATION:

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CHAPTER I

GENERAL PROVISIONS

Article 1
Subject matter
This Regulation lays down rules on the safety of toys, ensuring a high level of protection of healthand safety of children and other persons, and on the free movement of toys in the Union.

Article 2
Scope
1.

This Regulation applies to products which are designed or intended, whether or not
exclusively, for use in play by children under 14 years of age (‘toys’).
For the purposes of this Regulation, a product shall be considered to be intended for use inplay by children under 14 years of age, or by children of any other specific age group
below 14 years, where a parent or supervisor can reasonably assume, by virtue of thefunctions, dimensions and characteristics of that product, that it is intended for use in playby children of the relevant age group.

2.

This Regulation does not apply to the products listed in Annex I.

3.

The Commission shall beis empowered to adopt implementing acts determining whether or
not specific products or categories of products fulfil the criteria set out in paragraph 1 ofthis Article and therefore can or cannot be considered toys within the meaning of thisRegulation. Those implementing acts shall be adopted in accordance with the procedure set
out in Article 50(23).

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Article 3
Definitions
For the purposes of this Regulation the following definitions apply:(1)‘making available on the market’ means any supply of a toy for distribution, consumption
or use on the Union market in the course of a commercial activity, whether in return for
payment or free of charge;(2)‘placing on the market’ means the first making available of a toy on the Union market;(3)‘manufacturer’ means any natural or legal person who manufactures a toy or has a toy
designed or manufactured, and markets that toy under that person’s name or trademark;(4)‘authorised representative’ means any natural or legal person established within the Union
who has received a written mandate from a manufacturer to act on that person’s behalf in
relation to specified tasks;(5)‘importer’ means any natural or legal person established within the Union who places a toy
from a third country on the Union market;(6)‘distributor’ means any natural or legal person in the supply chain, other than the
manufacturer or the importer, who makes a toy available on the market;(7)‘fulfilment service provider’ means fulfilment service provider as defined in Article 23,
point (11,), of Regulation (EU) 2019/1020;(8)‘economic operator’ means the manufacturer, the authorised representative, the importer,
the distributor and the fulfilment service provider;

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(9)

‘provider of an online marketplace’ means a provider of an online marketplace as
defined in Article 3, point (14), of Regulation (EU) 2023/988;(10)‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1), ofRegulation (EU) No 1025/2012;(11)‘Union harmonisation legislation’ means Union legislationlaw listed in Annex I to
Regulation (EU) 2019/1020 and any other Union legislationlaw harmonising theconditions for the marketing of products to which that Regulation applies;(12)‘CE marking’ means a marking by which the manufacturer indicates that the toy is inconformity with the applicable requirements set out in Union harmonisation legislation
providing for its affixing;(13)‘toy model’ means a group of toys that meet the following conditions:(a)they are under the responsibility of the same manufacturer,(b)they have uniform design and technical characteristics,(c)they are manufactured using uniform materials and manufacturing processes,(d)they are defined by a type number or other element allowing them to be identified asa group;(14)‘data carrier’ means a linear bar code symbol, a two-dimensional symbol or otherautomatic identification data capture medium that can be read by a device;(14a)‘digital product passport’ means a set of data specific to a toy that contains theinformation set out in Annex VI and that is accessible via electronic means through adata carrier in accordance with Chapter IV;(15)‘unique product identifier’ means a unique string of characters for the identification of
toysa toy that also enables a web link to the digital product passport;(16)‘unique operator identifier’ means a unique string of characters for the identification ofactors an economic operator involved in the value chain of toysa toy;

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(16a)'digital product passport service provider' means a natural or legal person that is anindependent third-party authorised by the economic operator which is required tocreate a product passport for a toy and that processes the digital product passport
data for that toy for the purpose of making such data available to economic operatorsand other relevant actors with a right to access those data under this Regulation orother Union law;(17)

‘release for free circulation’ means the customs procedure laid down in Article 201 ofRegulation (EU) No 952/2013;(18)‘customs authorities’ means customs authorities as defined in Article 5, point (1), ofRegulation (EU) No 952/2013;(19)‘EU Customs Single Window Certificates Exchange System’ means the system referred toin Article 4 of Regulation (EU) 2022/2399 of the European Parliament and of theCouncil26;(20)‘conformity assessment’ means the process demonstrating whether the essential safety
requirements relating to a toy have been fulfilled;(21)‘conformity assessment body’ means a body that performs conformity assessment
activities, including calibration, testing, certification and inspection;(22)‘accreditation’ means accreditation as defined in Article 2, point (10), of Regulation (EC)No 765/2008;(23)‘national accreditation body’ means a national accreditation body as defined in Article 2,
point (11), of Regulation (EC) No 765/2008;26

Regulation (EU) 2022/2399 of the European Parliament and of the Council of 23 November
2022 establishing the European Union Single Window Environment for Customs andamending Regulation (EU) No 952/2013 (OJ L 317, 9.12.2022, p. 1).

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(23a)‘harm’ means physical injury or any other damage to health, including long-term
health effects;(24)‘hazard’ means a potential source of harm;(25)‘risk’ means the combination of the probability of an occurrence of a hazard and the degreeof severity of the harm caused by that hazard;(26)‘recall’ means any measure aimed at achieving the return of a toy that has already been
made available to the end user;(27)‘withdrawal’ means any measure aimed at preventing a toy in the supply chain from being
made available on the market;(28)‘market surveillance authority’ means a market surveillance authority as defined in Article
3, point (4), of Regulation (EU) 2019/1020;(29)‘functional toy’ means a toy which performs and is used in the same way as a product,appliance or installation intended for use by adults, and which may be a scale model ofsuch product, appliance or installation;(30)‘aquatic toy’ means a toy that is intended for use in shallow water and which is capable ofcarrying or supporting a child in the water;(31)‘activity toy’ means a toy for domestic use in which the support structure remains
stationary while the activity is taking place and which is intended for climbing, jumping,swinging, sliding, rocking, spinning, crawling, creeping, or any combination thereof;

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(32)

‘chemical toy’ means a toy intended for the direct handling of chemical substances andmixtures;(33)‘olfactory board game’ means a toy the purpose of which is to assist a child to learn torecognise different odours or flavours;(34)‘cosmetic kit’ means a toy the purpose of which is to assist a child to learn to makecosmetic products such as fragrances, soaps, creams, shampoos, conditioners, bath foams,
tooth pastes as well as glosses, lipsticks, nail polish and other make-up;(35)‘gustative game’ means a toy the purpose of which is to allow children to make sweets ordishes through the use of food ingredients, including liquids, powders and aromas;(36)‘substance of concern’ means substance of concern as defined in Article 2, point (2827), ofRegulation (EU) …/… [on Ecodesign Requirements for Sustainable Products].

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Article 4
Free movement
1.

Member States shall not impede, for reasons relating to health and safety or other aspects
covered by this Regulation, the making available on the market of toys which comply withthis Regulation.

2.

At trade fairs, exhibitions and demonstrations or similar events, Member States shall notprevent the display of a toy which does not comply with this Regulation, provided that avisible sign clearly indicates that the toy does not comply with this Regulation and will not
be available on the market until it has been brought into conformity.
During fairs, exhibitions and demonstrations, adequate measures shall be taken by
economic operators to ensure the protection of persons.

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Article 5
Product requirements
1.

Toys shall only be placed on the market if they comply with the essential safety
requirements which include the safety requirement set out in paragraph 2 (the ‘generalsafety requirement’) and the safety requirements set out in Annex II (the ‘particular safety
requirements’).

2.

Toys shall not present a risk to the safety or health of users or third parties, including thepsychological and mental health, well-being and cognitive development of children, when
they are used as intended or in a foreseeable way, bearing in mind the behaviour ofchildren.
When assessing the risk referred to in the first subparagraph, the ability of the users and,
where appropriate, their supervisors shall be taken into account. Where a toy is intended
for use by children under 36 months or by another specified age groups, the ability of users
in that specific age group shall be taken into account.

3.

Toys placed on the market shall comply with the essential safety requirements during theirforeseeable period of use.

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Article 6
Warnings
1.

Where necessary to ensure their safe use, toys shall bear a general warningwarnings
specifying appropriate user limitations. The user limitations shall include at least theminimum or maximum age of the user and, where appropriate, the required abilities of theuser, the maximum or minimum weight of the user and the need to ensure that the toy isused only under adult supervision.

2.

The following categories of toys listed in Annex III shall bear warnings in accordancewith the rules for each category set out in that Annex III:.
(a)toys not intended for use by children under 36 months;(b)

activity toys;(c)functional toys;(d)chemical toys;(e)skater, roller skates, inline skates, skateboards, scooters and toy bicycles;(f)aquatic toys;(g)

toys in food;(h)imitations of protective masks and helmets;(i)toys intended to be strung across a cradle, cot or perambulator by means of strings,
cords, elastics or straps;(j)packaging for fragrances in olfactory board games, cosmetic kits and gustative
games.

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Toys shall not bear one or more of the warnings set out in Annex III where such warnings
conflict with the intended use or reasonably foreseeable use of the toy, as determined byvirtue of its function, dimension and characteristics.
3.

The manufacturer shall mark warnings in a clearly visible, easily legible andunderstandable and accurate manner on the toy, on an affixed label or on the packaging
and, if appropriate, on the instructions for use which accompany the toy. Small toys which
are sold without packaging shall have appropriate warnings affixed to them.
Warnings as set out in paragraphs 1 and 2 shall be clearly visible to the consumer before
the purchase, including in cases where the purchase is made through distance sales.
Warnings shall be of sufficient size to ensure their visibility.printed in characters using afont size where the x-height is equal to or greater than 1,2 mm and with sufficient
contrast between the print and the background to ensure their visibility and legibility,
without prejudice to the minimum height of pictograms, which shall be not less than
10 mm as set out in Annex III.
In case of packaging or containers the largest surface of which has an area of lessthan 80 cm2, the x-height of the font size shall be equal to or greater than 0,9 mm.

4.

Labels and instructions for use shall draw the attention of children or their supervisors to
the inherent hazards and risks to the health and safety of children involved in using thetoys, and to the ways of avoiding such hazards and risks.

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CHAPTER IIOBLIGATIONS OF ECONOMIC OPERATORS

Article 7
Obligations of manufacturers
1.

When placing toys on the market, manufacturers shall ensure that they have been designed
and manufactured in accordance with the essential safety requirements.

2.

Before placing toys on the market, manufacturers shall draw up the required technicaldocumentation in accordance with Article 23 and carry out the applicable conformity
assessment procedure in accordance with Article 22 or have it carried out.
Where compliance of a toy with the applicable requirements laid down in this Regulation
has been demonstrated by the procedure referred to in the first subparagraph,manufacturers shall, before the toy is placed on the market:(a)create a digital product passport for the toy in accordance with Article 17;(b)affix the data carrier to the toy or to a label attached to the toy, in accordance with
Article 17(5);(c)

affix the CE marking in accordance with Article 16(1);(d)

upload the unique product identifier and the unique operator identifier of the toy inthe digital product passport registry referred to in Article 19(1), as well as any otheradditional information determined by a delegated act adopted in accordance with
Article 46(2).

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3.

Manufacturers shall keep the technical documentation and the digital product passport fora period of 10 years after the toy covered by that documentation and that digital productpassport has been placed on the market.

4.

Manufacturers shall ensure that procedures are in place for toys that are part of a series
production to remain in conformity with this Regulation. Changes in the design orcharacteristics of toys, and changes in the harmonised standards referred to in Article 13 or
the common specifications referred to in Article 14 by reference to which conformity of a
toy is declared or by application of which its conformity is verified, shall be adequately
taken into account.
When manufacturers,deemed appropriate with regard to the risks presented by a toy,
consider it necessarymanufacturers shall, for the protection of the health and safety of
consumers, manufacturers shall, or other end-users, carry out sample testing of marketed
toys.

5.

Manufacturers shall ensure that toys bear a type, batch, serial or model number or otherelement allowing their identification, or, where the size or nature of the toy does not allow
it, that the required information is provided on the packaging or in a document
accompanying the toy.

6.

Manufacturers shall indicate their name, registered trade name or registered trade mark andthe postal and electronic address at which they can be contacted on the toy or, where thatis not possible, on its packaging or in a document accompanying the toy. Manufacturers
shall indicate a single point at which they can be contacted.

7.

Manufacturers shall ensure that the toy is accompanied by instructions for use and safety
information in a language or languages easily understood by consumers and other endusers, as determined by the Member State concerned. Such instructions and information
shall be clear, understandable and legible.

7a.

Manufacturers shall ensure that the toy is marked with warnings in accordance with
Article 6 in a language or languages easily understood by consumers and other endusers, as determined by the Member State concerned.

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8.

Where manufacturers consider, or have reason to believe, that a toy which they haveplaced on the market is not in conformity with this Regulation, they shall immediately takethe corrective measures necessary to bring that toy into conformity, withdraw it or recall it,
as appropriate.
WhereFurthermore, where manufacturers consider, or have reason to believe, that a toy
presents a risk, they shall immediately provide information thereof to:(a)the market surveillance authorities of the Member States in which they have madethe toy available, via the Safety Business Gateway referred to in Article 2627 ofRegulation (EU) 2023/988, giving details, in particular, of any non-compliance andof any corrective measures taken; and(b)the consumers or other end-users, in accordance with Article 35 or 36 of Regulation(EU) 2023/988, or both.

9.

Manufacturers shall, further to a reasoned request from a competent national authority,
provide it, with all the information and documentation necessary to demonstrate theconformity of the toy, in a language which can be easily understood by that authority. They
shall cooperate with that authority, at its request, as regards any action taken to eliminate
the risks posed by toys which they have placed on the market.

10.

Manufacturers shall ensure that other economic operators, the economic operator referred
to in Article 4(1) of Regulation (EU) 2019/1020, and providers of online marketplaces, inthe supply chain concerned, are kept informed in a timely manner of any nonconformitycompliance that the manufacturers have identified.
The manufacturer shall ensure that the fulfilment service providers are provided withthe detailed information necessary for ensuring the safe storage, packaging, addressing
or dispatch.

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11.

Manufacturers shall make publicly available a telephone number, an electronic address, a
dedicated section of their website or another communication channel, allowing consumers
or other end-users to file complaints concerning the safety of toys and to inform the
manufacturers of any accident or safety issue they have experienced with such toys. In
doing so, the manufacturers shall take into account the accessibility needs for persons withdisabilities.

12.

Manufacturers shall investigate complaints and information referred to in paragraph 11 andshall keep an internal register of those complaints and that information, as well as of recalls
and any other corrective measures taken to bring the toys into conformity with thisRegulation.
Manufacturers shall keep the other economic operators and, where relevant,providers of online marketplaces informed in a timely manner of the investigation
performed and of the results of the investigation.

13.

The internal register referred to in paragraph 12 shall only contain personal data that arenecessary for the manufacturer to investigate the complaint or the information referred toin paragraph 11. Such data shall only be kept as long as is necessary for the purpose of theinvestigation and, in any event, no longer than 5 years after the data have been entered in
the register.

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Article 8
Authorised representatives
1.

A manufacturer may appoint an authorised representative by written mandate.

2.

The obligations laid down in Article 7(1), and the obligation to draw up technicaldocumentation referred to in Article 7(2), shall not form part of the authorised
representative’s mandate.

3.

An authorised representative shall perform the tasks specified in the mandate received
from the manufacturer and shall provide a copy of the mandate to the market surveillanceauthorities upon their request. within 15 working days of the receipt of such a request.
The mandate shall allow the authorised representative to do at least the following:(a)keep the technical documentation at the disposal of national surveillance authorities
and ensure that the digital product passport is available, in accordance with Article
17(2), for a period of 10 years after the toy covered by those documentsthat
documentation and that digital product passport has been placed on the market;(b)further to a reasoned request from a competent national authority, provide that
authority, with all the information and documentation necessary to demonstrate theconformity of a toy;(c)cooperate with the competent national authorities, at their request, on any action
taken to eliminate the risks posed by toys covered by the mandate.

4.

Where a manufacturer not established in the Union appoints an authorised representative as
referred to in paragraph 1 of this Article, the written mandate shall include the tasks set out
in Article 4(3) of Regulation (EU) 2019/1020.

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Article 9
Obligations of importers
1.

Importers shall only place on the market toys complying with this Regulation.

2.

Before placing toys on the market, importers shall ensure the following:(a)the manufacturer has carried out the appropriate conformity assessment procedureand drawn up the technical documentation referred to in Article 7(2);(b)

the toy is accompanied by instructions offor use and safety information inaccordance with in Article 7(7) and warnings in accordance with Article 6 in alanguage or languages which can be easily understood by consumers or other endusers, as determined by the Member State concerned;(c)the manufacturer has created a digital product passport for the toy in accordancewith Article 7(2);(d)

the toy bears a data carrier is affixed in accordance with Article 17(5);(e)

the relevant information in the digital product passport has been included in thedigital product passport registry in accordance with Article 19(1);(f)

the toy bears the CE marking is affixed in accordance with Article 16;(g)

the manufacturer has complied with the requirements set out in Article 7(5) and (6).

Where importers consider, or have reason to believe, that a toy is not in conformity withthe essential safety requirementsthis Regulation, they shall not place the toy on the market
until it has been brought into conformity.
WhereFurthermore, where importers consider, or have reason to believe, that the toy
presents a risk, theyimporters shall provide information thereof to:(a)immediately inform the manufacturer thereof;(b)

ensure that the market surveillance authorities, are informed via the Safety
Business Gateway referred to in Article 2627 of Regulation (EU) 2023/988 ; .

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(c)
3.

consumers or other end-users, in accordance with Article 35 or 36 of Regulation(EU) 2023/988, or both.

Importers shall indicate their name, registered trade name or registered trade mark and the
postal and electronic address at which they can be contacted on the toy or, where that is
not possible, on its packaging or in a document accompanying the toy.

4.

Importers shall ensure that, while a toy is under their responsibility, their storage ortransport conditions do not jeopardise the toy’s compliance with the essential safety
requirements.

5.

When importers,deemed appropriate with regard to the risks presented by a toy, consider
it necessaryimporters shall, for the protection of health and safety of consumers or otherend-users, they shall carry out sample testing of marketed toys.

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6.

Where importers consider, or have reason to believe, that a toy which they have placed on
the market is not in conformity with the relevant Union harmonisation legislationthis
Regulation, they shall immediately take the corrective measures necessary to bring thattoy into conformity, withdraw it or recall it, as appropriate.
WhereFurthermore, where importers consider, or have reason to believe, that a toy thatthey have placed on the market presents a risk to health and safety of consumers and otherend-users, they shall immediately inform the competent national authorities of the Member
States in which they made the toy available to that effect, giving details, in particular, ofthe non-compliance and of any corrective measures taken., they shall immediately:(a)inform the manufacturer thereof;(b)

ensure that the corrective measures necessary to bring that toy into conformity
are taken, including withdrawal or recall, as appropriate; where such measures
have not been taken, the importer shall immediately take them;(c)ensure that consumers or other end-users are immediately informed thereof inaccordance with Article 35 or 36, or both of Regulation (EU) 2023/988;(d)inform the market surveillance authorities via the Safety Business Gateway
referred to in Article 27 of Regulation (EU) 2023/988.

7.

Importers shall, for a period of 10 years after the toy has been placed on the market, keep
the unique product identifier of the toy at the disposal of the market surveillance authorities
and ensure that the technical documentation referred to in Article 23 can be made available
to those authorities, upon request.

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8.

Importers shall, further to a reasoned request from a competent national authority, provide
it with all the information and documentation necessary to demonstrate the conformity ofthe toy in a language which can be easily understood by that authority. They shallcooperate with that authority, at its request, as regards any action taken to eliminate therisks posed by toys which they have placed on the market.

9.

Importers shall verify whether the manufacturer has made a communication channel asreferred to in Article 7(11) publicly available to consumers or other end-users, allowing
them to present complaints concerning the safety of toys and provide information on any
accident or safety issue they have experienced with the toy. If a communication channel is
not available, importers shall provide for such a channel, taking into account accessibility
needs for persons with disabilities.

10.

Importers shall investigate complaints and information referred to in paragraph 9 of this
Article that they have received via a communication channel made available by the
manufacturer, or via a communication channel made available by the importers
themselves, and that concern the toys which they have made available on the market.
Importers shall file those complaints, as well as recalls and any other corrective measurestaken to bring the toys into conformity with this Regulation, in the register referred to in
Article 7(12), or in their own internal register.
Importers shall keep the manufacturer, distributors and, where relevant, providers of
online marketplaces informed in a timely manner of the investigation performed and of
the results of the investigation.

11.

Personal data contained in the internal register of the importers referred to in paragraph 10
shall only be those personal data that are necessary for the importer to investigate thecomplaint or the information referred to in paragraph 9. Such data shall only be kept aslong as is necessary for the purpose of the investigation and, in any event, no longer than 5
years after the data have been entered in the register.

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Article 10
Obligations of distributors
1.

When making a toy available on the market, distributors shall act with due care in relation
to the requirements of this Regulation.

2.

Before making a toy available on the market, distributors shall verify that the following
conditions have been met:(a)the toy is accompanied by instructions for use and safety information in accordancewith Article 7(7) and warnings in accordance with Article 6 in a language or
languages which can be easily understood by consumers or other end-users as
determined by the Member State in which the toy is to be made available on themarket;(b)

the toy bears a data carrier is affixed in accordance with Article 17(5) and the CE
marking in accordance with Article 16 and(c)the manufacturer and the importer have complied with the requirements set out in
Article 7(2), second subparagraph, Article 7(5), (6) and (11) and Article 9(3)respectively.

Where distributors consider, or have reason to believe, that a toy is not in conformity with theessential safety requirementsthis Regulation, they shall not make the toy available on themarket until it has been brought into conformity.

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Where distributors consider, or have reason to believe, that the toy presents a risk, they shallimmediately provide information thereof to:(a)immediately inform the manufacturer or the importer, as applicable, thereof;(b)

ensure that the market surveillance authorities are informed through the Safety
Business Gateway referred to in Article 2627 of Regulation (EU) 2023/988;(c)3.

consumers or other end-users, in accordance with Article 35 or 36 of Regulation(EU) 2023/988, or both.

Distributors shall ensure that, while a toy is under their responsibility, storage or transportconditions do not jeopardise its compliance with the essential safety requirement.

4.

Where distributors consider, or have reason to believe, that a toy which they have madeavailable on the market is not in conformity with this Regulation, they shall ensure that thecorrective measures necessary to bring that toy into conformity, to withdraw it or recall it,
if appropriate, are taken.
WhereFurthermore, where distributors consider, or have reason to believe, that a toy thatthey have made available on the market presents a risk, they shall immediately inform themarket surveillance authorities of the Member States in which they made the toy available
to that effect, giving details, in particular, of the non-compliance and of any corrective
measures taken.

5.

Distributors shall, further to a reasoned request from a competent national authority,
provide it, with all the information and documentation necessary to demonstrate theconformity of the toy, in a language which can be easily understood by that authority. They
shall cooperate with that authority, at its request, as regards any action taken to eliminate
the risks posed by toys which they have made available on the market.

Article 10a
Obligations of fulfilment service providers
1.

A fulfilment service provider shall act with due care in relation to the requirements ofthis Regulation.

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2.

A fulfilment service provider shall ensure that the conditions during warehousing,packaging, addressing or dispatching, do not jeopardise the toy’s conformity with theessential safety requirements.

3.

A fulfilment service provider shall cooperate as regards product withdrawals or
recalls, regardless of whether initiated by authorities, the manufacturer, theauthorised representative or the importer.

4.

Where a fulfilment service provider considers or has reason to believe, on the basis of
the information provided by authorities or economic operators, that the toy is not in
conformity with this Regulation, the fulfilment service provider shall not support themaking available of the product on the market until it has been brought into
conformity.

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Article 10b
Specific obligations of providers of online marketplaces related to toy safety
1.

Information referring to an offer of toys sold or promoted in online marketplacesintermediating between economic operators and consumers which are not in
conformity with this Regulation shall be considered illegal content for the purposes ofRegulation (EU) 2022/2065 and subject to the measures established therein.

2.

For the purposes of this Regulation, providers of online marketplaces shall comply
with the requirements set out in Articles 30 to 32 of Regulation (EU) 2022/2065 andArticle 22 of Regulation (EU) 2023/988. The compliance with such requirements shallbe enforced within the enforcement structure set out in those Regulations.

3.

For the purposes of compliance with Article 31(2)(c) of Regulation (EU) 2022/2065,
and in addition to the information required in Article 22(9) of Regulation (EU)2023/988, providers of online marketplaces shall ensure that their online interface isdesigned and organised in a way that it allows economic operators to provide:(a)the CE marking referred to in Article 16;(b)

any warning to be clearly visible to the consumer before the purchase inaccordance with Article 6(3) of this Regulation;(c)the data carrier or weblink through which the digital product passport referred
to in Article 17 is accessible.

4.

Any toy that does not comply with the particular safety requirements, or thatcomplies with the particular safety requirements but which poses a risk to the healthand safety of children and other persons, shall be considered a dangerous product forthe purposes of compliance with Article 22 of Regulation (EU) 2023/988.

5.

The Commission may issue guidelines to assist economic operators and providers of
online marketplaces in the application of paragraphs 1 and 2.

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Article 11
Cases in which obligations of manufacturers apply to importers and distributors othereconomic operators
An importer or a distributorAny other economic operator shall be considered a manufacturer forthe purposes of this Regulation, and shall be subject to the obligations of the manufacturer under
Article 7, where such importer or distributoreconomic operator places a toy on the market under
its name or trademark or modifies a toy already placed on the market in such a way that compliancewith the applicable requirements of this Regulation may be affected.

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Article 12
Identification of economic operators
1.

Economic operators shall, on request and within 15 working days of the receipt of sucha request, identify the following to the market surveillance authorities:

2.

(a)

any economic operator who has supplied them with a toy;(b)

any economic operator to whom they have supplied a toy.

Economic operators shall be able to present the information referred to in the paragraph 1
for a period of 10 years after the toy has been placed on the market, in the case of the
manufacturer, and for a period of 10 years after they have been supplied with the toy, inthe case of other economic operators.

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CHAPTER III
CONFORMITY OF TOYS

Article 13
Presumption of conformity
Toys which are in conformity with harmonised standards or parts thereof, the references of whichhave been published in the Official Journal of the European Union, shall be presumed to be inconformity with the essential safety requirements to the extent that those requirements are coveredby those standards or parts thereof.

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Article 14
Common specifications
1.

Toys which are in conformity with the common specifications referred to in paragraph 2 ofthis Article or parts thereof shall be presumed to be in conformity with the essential safety
requirements to the extent that those requirements are covered by those common
specifications or parts thereof.

2.

The In exceptional cases, the Commission may, by means of adopt implementing acts,
establish establishing common specifications for the covering requirements that provide
a means to comply with the applicable essential safety requirements.
Those implementing acts shall only be adopted where the following conditions are
fulfilled:(a)there is no harmonised standard covering those requirements the reference of
which is published in the Official Journal of the European Union or the standard
does not satisfy the requirements it aims to cover; and no such reference is
expected to be published within a reasonable period;(b)

the Commission has requested, pursuant to Article 10(1) of Regulation
1025/2012, one or more European standardisation organisations to draft or torevise European standards for those requirements and either of the following
conditions is fulfilled:(1)

the request has not been accepted by any of the European standardisation
organisations to which the request was addressed; or(2)

the request has been accepted by at least one of the European standardisation
organisations to which the request was addressed, but the European standards
requested:(a)haveare not been adopteddelivered within the deadline set in therequest;(b)
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do not comply with the request; or
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(c)

do not satisfy the requirements they aim to cover.

Those implementing acts shall be adopted in accordance with the examination procedurereferred to in Article 50(3).
2a.

Before preparing the draft implementing act referred to in paragraph 2, theCommission shall inform the committee referred to in Article 22 of Regulation (EU)No 1025/2012 that it considers that the conditions in paragraph 2 have been fulfilled.
When preparing the draft implementing act referred to in paragraph 2, theCommission shall take into account the views of the Expert Group on Toys Safety andshall duly consult all relevant stakeholders.

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3.

Where a harmonised standard is adopted by a European standardisation
organisation and proposed to the Commission for the purpose of publishing its
reference in the Official Journal of the European Union, the Commission shall assess
the harmonised standard in accordance with Regulation (EU) No 1025/2012. Whenreference of a harmonised standard is published in the Official Journal of theEuropean Union, the Commission shall repeal or amend the implementing acts
referred to in paragraph 2, or parts thereof which cover the same essential safety
requirements as those covered by that harmonised standard. When references of aharmonised standard are published in the Official Journal of the European Union, theCommission shall assess whether the implementing acts referred to in paragraph 2 of this
Article which cover the same essential safety requirement need to be repealed or amended.

4.

When a Member State considers that a common specification does not entirely satisfy
the essential safety requirements, it shall inform the Commission thereof bysubmitting a detailed explanation. The Commission shall assess that detailed
explanation and may, if appropriate, amend the implementing act establishing thecommon specification in question.

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Article 15
General principles of the CE marking
Toys made available on the market shall bear the CE marking.
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC)No 765/2008.

Article 16
Rules and conditions for affixing the CE marking
1.

The CE marking shall be affixed visibly, legibly and indelibly on the toy or on a label
attached to the toy. Where this is not possible on account of size or nature of the toy,
it shall be affixed to the packaging, if any, or on documentation accompanying thetoyto the toy, to a label attached to the toy or to the packaging of the toy.
By way of derogation from the first subparagraph, in the case of small toys and toys
consisting of small parts, the CE marking may be affixed to a leaflet accompanying thetoy.
By way of derogation from the first subparagraph, in the case of toys sold in counter
displays where it is not technically possible to affix the CE marking to each individual toy,
the CE marking may be affixed to the counter display on the condition that the counter
display was originally used as packaging for the toy.
Where the CE marking affixed to the toy is not visible from outside the packaging, it shallalso be affixed to the packaging.

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2.

The CE marking shall be affixed before the toy is placed on the market.

3.

The CE marking shallmay, where applicable in accordance with Article 6, be followed bya pictogram or any other warning indicating a special risk or use.

4.

Member States shall build upon existing mechanisms to ensure correct application of theregime governing the CE marking and shall take appropriate action in the event of
improper use of that marking.

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ENCHAPTER IV

DIGITAL PRODUCT PASSPORT

Article 17
ProductDigital product passport
1.

Before placing a toy on the market, manufacturersthe manufacturer shall create a digitalproduct passport for that toy. The digital product passport shall meet the requirements laid
down in this Article and Article 18.

2.

The digital product passport shall:(a)correspond to a specific toy model;(b)state that compliance of the toy with the requirements set out in this Regulation and,in particular, the essential safety requirements, has been demonstrated;(c)contain at least the informationdata set out in Part I of Annex VI;(d)be accurate, complete and up to date;(e)

be available in the language or languages required by the Member State where thetoy is made available on the market;(f)

be accessible to consumers or other end-users, market surveillance authorities,
customs authorities, notified bodies, the Commission and other economic operators;(g)

be available for a period of 10 years after the toy is placed on the market, also incases of insolvency, a liquidation or a cessation of activity in the Union of theeconomic operator that created the digital product passport;

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(h)

be accessibleconnected through a data carrier; to a persistent unique productidentifier;(i)
3.

fulfil the specific and technical requirements laid down pursuant to paragraph 10.

In addition to the informationdata referred to in paragraph 2, the digital product passport
may contain the informationdata set out in Part II of Annex VI.

4.

By creating the digital product passport, the manufacturer shall assume responsibility forthe compliance of the toy with this Regulation.

5.

The data carrier shall be physically present on the toy or on a label attached to the toy.
Where this is not possible on account of size or nature of the toy, it shall be affixed tothe packaging, if any, or on documentation accompanying the toy, in accordance with
the implementing act adopted in accordance with paragraph 10. In the case of small toys
and toys consisting of small parts, the data carrier may alternatively be affixed to its
packaging. It shall be clearly visible to the consumer or other end-users before any
purchase and to market surveillance authorities, including in cases where the toy is madeavailable through distance sales.

6.

Where other Union legislationlaw requires information on the toy to be available via a datacarrier, a single data carrier shall be used to provide the information required under thisRegulation and such other Union legislation. law.

7.

Where other Union legislationlaw applying to toys requires a digital product passport, asingle digital product passport shall be created for toys containing the informationdata
required under this Regulation as well as any other informationdata required for thedigital product passport by that other Union legislation. law. By way of derogation fromparagraph 2, point (a), where that law requires that the digital product passport
corresponds to a batch or an item level, the digital product passport for the purposesof this Regulation can be issued to that level.

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8.

By way of derogation from paragraph 2, point (c), where information requirements relating
to substances of concern in toys are established in a delegated act adopted in accordancewith Article 4 of Regulation …/… [OP please insert: the Ecodesign for Sustainable
Products Regulation], the informationdata referred to in Part I, point (k), of Annex VI tothis Regulation isshall no longer be required.

9.

Economic operators may, in addition to the informationdata referred to in paragraphs 6
and 7, make other information accessible through the data carrier referred to in paragraph
5. Where this is the case, that information shall be clearly separated from the information
required under this Regulation and, where relevant, under other Union legislationlaw.

10.

The Commission shall adopt implementing acts determining the specific and technicalrequirements related to the digital product passport for toys. Those requirements shallcover in particular the following:(a)the types ofone or more data carriercarriers to be used;(b)

the layout in which the data carrier is to be presented and its positioning;(c)the technical elements of the passport for which defined European or international
standards are to be used;(ca) the actors that are to have access to data in the digital product passport and towhat data they are to have access;(d)the actors that may introduceare to create a digital product passport or update theinformation in the product passport, including where needed the creation of a new
passport, including manufacturers, notified bodies, competent national authorities,
and the Commission, or any organisation acting on their behalf,data in a digitalproduct passport and the types of informationwhat data they may introduce or
update. Except where they act on behalf of the manufacturer, the actors that
update data in a digital product passport shall be responsible for the accuracyof the data they provide;

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(e)

the detailed arrangements for introducing or updating data referred to in point(d) .

Those implementing acts shall be adopted in accordance with the procedure set out in
Article 50(3).
11.

The economic operator placing the toy on the market shall:(a)provide distributors and providers of online marketplaces with a digital copy ofthe data carrier or the unique product identifier, as relevant, to allow them tomake the data carrier or the unique product identifier accessible to potential
customers where they cannot physically access the product;(b)

provide the digital copy referred to in point (a) or a webpage link free of charge
promptly and in any event within 5 working days of receiving a request to do so.

12.

The economic operator, when placing the toy on the market, shall make available aback-up copy of the digital product passport through a digital product passport
service provider.

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ENArticle 18
Technical design and operation of the digital product passport
1.

The digital product passport shall be fully interoperable with other digital productpassports required by other Union legislationlaw in relation to the technical, semantic andorganisational aspects of end-to-end communication and data exchangetransfer.

2.

All informationdata included in the digital product passport shall be based on open
standards developed with an interoperable format and shall be, as appropriate, machinereadable, structured and, searchable. and transferable through an open interoperable
data exchange network without vendor lock-in.

3.

Consumers or other end-users, economic operators, notified bodies, competent national
authorities and other relevant actorscustoms authorities, civil society organisations,researchers, trade unions, and the Commission, or any organisation acting on theirbehalf shall have free of charge and easy access to the digital product passport free ofcharge.based on their respective access rights set out in the implementing act referred
to in Article 17(10).

4.

The data included in thedigital product passport shall be stored by the economic operator
responsible for its creation or by operators authorised to act on their behalfdigital productpassport service providers.

4a.

Where a new digital product passport is created for a toy that already has a digitalproduct passport, the new digital product passport shall be linked to the original
digital product passport or passports.

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5.

Where If the data included in the digital product passport is stored pursuant toparagraph 4 of this Article or otherwise processed by an certified independent thirdparty digital product passport service providers operator authorised pursuant to
Article 17(12), to act on behalf of the economic operators placing the toy on the market,
those certified independent third-party digital product passport service providersthat
other operator shall not be allowed to sell, re-use or process such data, in whole or in part,beyond what is necessary for the provision of the relevant storing or processing services
unless specifically agreed with the economic operator placing the toy on the market.

5a.

Data authentication, reliability and integrity shall be ensured.

5b.

Digital product passports shall be designed and operated so that a high level of
security and privacy is ensured and fraud is avoided.

6.

Economic operators may not track, analyse or use any usage information for purposes
other than what is absolutely necessary for providing the information on the productpassport onlinedigital product passport online. In particular, personal data related tothe customer of the product shall not be stored in the digital product passport without
the explicit consent of the consumer or other end-user in compliance with Article 6 ofRegulation (EU) 2016/679.

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Article 19
ProductDigital product passport registry1.

Before placing a toy on the market, the economic operatorsoperator placing the toy on
the market shall upload, in the registry established under Article 1213(1) of Regulation(EU) …/… [PO insert serial number for Ecodesign Requirements for Sustainable Products](the ‘registry’), the unique product identifier and unique operator identifier for that toy. In
the case of toys intended to be placed under the customs procedure ‘release for freecirculation’, the registry shall store the commodity code of the toy.

1a.

Upon the uploading by the economic operator the data referred to in paragraph 1 in
the registry, the registry shall automatically communicate to that economic operator
a unique registration identifier associated with the unique identifiers uploaded in theregistry for a specific toy. That communication by the registry shall not be deemed to
be proof of compliance with this Regulation or other Union law.
The Commission may adopt an implementing act specifying the implementation
arrangements for the registry, including for the communication of the uniqueregistration identifier referred to in this paragraph. This implementing act shall be
adopted in accordance with the examination procedure referred to in Article 50(3).

2.

The Commission, market surveillancenational competent authorities and customs
authorities shall have access to the information stored in the registry referred to inparagraph 1 for the purpose of carrying out their duties pursuant to this Regulation.

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ENArticle 20
Customs controls relating to the digital product passport
1.

Toys entering the Union market shall be subject to verifications and other measures laid
down in this Article. This Article is without prejudice to any other Union law, inparticular Regulation (EU) 952/2013 and Chapter VII of Regulation (EU) 2019/1020.

2.

Any person intending to place a toy under the customs procedure ‘release for freecirculation’ shall provide or make available to customs authorities the uniqueregistration identifier as referred to in Article 19(1a). This paragraph shall apply
from the moment the registry is operational. Declarants as defined in Article 5, point(15), of Regulation (EU) No 952/2013 shall include the unique product identifier in thecustoms declaration for release for free circulation of any toy.

3.

Customs authorities shall verify whethermay release a toy for free circulation only after
having verified as a minimum that the unique productregistration identifier and thecommodity code provided or made available to them indicated by the declarant inaccordance with paragraph 2 of this Article corresponds to the data stored a uniqueproduct identifier included in the registry in accordance with Article 19(1). The release forfree circulation shall not be deemed to be proof of compliance with this Regulation orother Union law.

4.

In addition to the verification referred to in paragraph 3 of this Article, customs authorities
shall verify the consistency of information made available to customs by declarants withother information stored in the registry and listed in the delegated act referred to in Article
46(3).

5.

The verification referred to in paragraph 3 shall take place electronically and automaticallyusingvia the interconnection between the registry referred to in Article 19(1) and the EU
Customs Single Window Certificates Exchange System referred to in [Article 1315(3) of[P.O. insert serial number for Regulation (EU) …/… on Ecodesign Requirements for
Sustainable Products]]. This paragraph shall apply as from the moment thatinterconnection is operational.

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6.

Paragraphs 3, 4 and 5 of this Article shall apply from the day when the interconnection
between the registry and the EU Customs Single Window Certificates Exchange Systemreferred to in [Article 13 of [P.O. insert serial number for Regulation (EU) …/… on
Ecodesign Requirements for Sustainable Products]] becomes operational.
The Commission shall publish a notice in the Official Journal of the European Union tothat effect indicating the date when the interconnection is operational.

7.

The Commission and the Ccustoms authorities may retrieve and use the informationdata
on toys included in the digital product passport and in the registry for carrying out theirduties pursuant to Union legislationlaw, including for risk management, customs controls
and release for free circulation in accordance with Articles 46 and 47 of Regulation (EU)No 952/2013.

8.

The verifications and other measures laid down in this Article shall be carried out on thebasis of the list of commodity codes and product descriptions set out in Annex VII.

9.

The verifications and measures laid down in this Article shall not affect the application ofother Union legal acts governing the release for free circulation of products, including
Articles 46, 47 and 134 of Regulation (EU) No 952/2013, and the controls referred to in
Chapter VII of Regulation (EU) 2019/1020.

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CHAPTER VCONFORMITY ASSESSMENT

Article 21
Safety assessment
1.

In order to demonstrate that a toy complies with the essential safety requirements,
manufacturers shall, before placing a toy on the market, carry out a safety assessment
including an analysis of the hazards that the toy may present, as well as an assessment of
the potential exposure to such hazards.

2.

The safety assessment shall in particular :(a)cover all the chemical, physical, mechanical, electrical, flammability, hygiene andradioactivity hazards and the potential exposure to such hazards;(b)in relation to chemical hazards, take account of the possible exposure to individual
chemicals, and any known additional hazards from combined exposure to thedifferent chemicals present in the toy, taking into account the obligations under
Regulation (EC) No 1907/2006 and the conditions set out therein;(c)be updated whenever additional relevant information is available.

The safety assessment shall be included in the technical documentation referred to in
Article 23.

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ENArticle 22
Conformity assessment procedures
1.

Manufacturers shall use the conformity assessment procedures referred to in paragraphs 2
andor 3.

2.

If the manufacturer has applied harmonised standards, the reference of which has been
published in the Official Journal of the European Union, or common specifications,covering all relevant safety requirements for the toy identified in the safety assessment
referred to in Article 21, the manufacturer shall use the internal production control
procedure set out in Part I of Annex IV.

3.

In the following cases, the manufacturer shall use the EU-type examination procedure set
out in Part II of Annex IV together with the conformity to type procedure set out in Part IIIof that Annex:(a)where harmonised standards, the reference of which has been published in the
Official Journal of the European Union, or common specifications, covering all
relevant safety requirements for the toy, do not exist;(b)

where harmonised standards or common specifications referred to in point (a) exist
but the manufacturer has not applied them or has applied them only in part;(c)where one or more of the harmonised standards referred to in point (a) has been
published with a restriction and the restriction is applicable to the toy;(d)where the manufacturer considers that the nature, design, construction or purpose of
the toy necessitates third party verification.

4.

The EU-type examination certificate issued in accordance with Part II, point 6, of Annex
IV shall be reviewed whenever necessary, in particular in case of a change to the
manufacturing process, the raw materials or the components of the toy, and, in any case,every five years.

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ENArticle 23
Technical documentation
1.

The technical documentation shall contain all relevant data or details of the means used by
the manufacturer to ensure that the toy complies with the essential safety requirements. It
shall, in particular, contain the documents listed in Annex V.

2.

The technical documentation shall be drawn up in one of the official languages of theUnion.

3.

Following a reasoned request from the market surveillance authority of a Member State,
the manufacturer shall provide a translation of the relevant parts of the technicaldocumentation into the language of that Member State.
When a market surveillance authority requests the technical documentation or a translationof parts thereof from a manufacturer, it may fix a deadline for receipt of such file ortranslation, which shall be 30respectively 15 and 30 working days, unless a shorter
deadline is justified in the case of serious and immediate risk to health and safety.

4.

If the manufacturer does not comply with the requirements set out in paragraphs 1, 2 and 3,
the market surveillance authority may require the manufacturer to have a test performed bya notified body at its own expense within a specified period in order to verify compliancewith the essential safety requirements.

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ENCHAPTER VI
NOTIFICATION OF CONFORMITY ASSESSMENT BODIESArticle 24
Notification
Member States shall notify the Commission and the other Member States of bodies authorised tocarry out third-party conformity assessment tasks under this Regulation.

Article 25
Notifying authorities
1.

Member States shall designate a notifying authority that shall be responsible for setting up
and carrying out the necessary procedures for the assessment and notification ofconformity assessment bodies for the purposes of this Regulation, and for the monitoringof notified bodies, including compliance with Article 30.

2.

Member States may decide that the assessment and monitoring referred to in paragraph 1
shall be carried out by a national accreditation body within the meaning of and inaccordance with Regulation (EC) No 765/2008.

3.

Where the notifying authority delegates or otherwise entrusts the assessment, notification
or monitoring referred to in paragraph 1 of this Article to a body which is not agovernmental entity, that body shall be a legal entity and shall comply mutatis mutandis
with the requirements laid down in Article 26. In addition, that body shall havearrangements to cover liabilities arising out of its activities.

4.

The notifying authority shall take full responsibility for the tasks performed by the bodyreferred to in paragraph 3.

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ENArticle 26
Requirements relating to notifying authorities
1.

A notifying authority shall be established in such a way that no conflict of interest with
conformity assessment bodies occurs.

2.

A notifying authority shall be organised and operated so as to safeguard the objectivity andimpartiality of their activities.

3.

A notifying authority shall be organised in such a way that each decision relating to
notification of a conformity assessment body is taken by competent persons different fromthose who carried out the assessment.

4.

A notifying authority shall not offer or provide any activities that conformity assessment
bodies perform, nor shall they offer or provide consultancy services on a commercial orcompetitive basis.

5.

A notifying authority shall safeguard the confidentiality of the information they obtain in
accordance with Union and national law.

6.

A notifying authority shall have a sufficient number of competent personnel at theirdisposal for the proper performance of their tasks.

7.

A notifying authority shall monitor the nature and amount of tasks performed bysubsidiaries of or subcontractors to notified bodies in accordance with Article 30.

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Article 27
Information obligation of notifying authorities
Member States shall inform the Commission of their procedures for the assessment and notificationof conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.
The Commission shall make that information publicly available.

Article 28
Requirements relating to notified bodies
1.

For the purposes of notification under this Regulation, a conformity assessment body shallmeet the requirements laid down in paragraphs 2 to 11. It shall be accredited in accordancewith Regulation (EC) No 765/2008.

2.

Conformity assessment bodies shall be established under the national law of a Member
State and shall have legal personality.

3.

A conformity assessment body shall be a third-party body independent of the organisationor the toy it assesses.
A body belonging to a business association or professional federation representing
undertakings involved in the design, manufacturing, provision, assembly, use or
maintenance of toys which it assesses, may, on condition that its independence and theabsence of any conflict of interest are demonstrated, be considered a third-party body forthe purposes of the first subparagraph.

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4.

A conformity assessment body, its top level management and the personnel responsible forcarrying out the conformity assessment tasks shall not be the designer, manufacturer,
supplier, installer, purchaser, owner, user or maintainer of the toys which they assess, nor
the authorised representative of any of those parties. This shall not preclude use of theassessed toys that is necessary for the operations of the conformity assessment body or theuse of those toys for personal purposes.
A conformity assessment body, its top level management and the personnel responsible forcarrying out the conformity assessment tasks shall not be directly involved in the design,
manufacture, marketing, installation, use or maintenance of those toys, or represent theparties engaged in those activities. They shall not engage in any activity that may conflictwith their independence of judgement or integrity in relation to conformity assessment
activities for which they are notified. This shall in particular apply to consultancy services.
Conformity assessment bodies shall ensure that the activities of their subsidiaries or
subcontractors do not affect the confidentiality, objectivity or impartiality of theirconformity assessment activities.

5.

Conformity assessment bodies and their personnel shall carry out the conformity
assessment activities with the highest degree of professional integrity and the requisite
technical competence in the specific field and shall be free from all pressures andinducements, particularly financial, which might influence their judgement or the results of
their conformity assessment activities, especially as regards persons or groups of persons
with an interest in the results of those activities.

6.

A conformity assessment body shall be capable of carrying out the conformity assessment
tasks assigned to it by Annex IV and in relation to which it has been notified, whether
those tasks are carried out by the conformity assessment body itself or on its behalf andunder its responsibility.

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ENAt all times and for each conformity assessment procedure and each kind or category of
toy in relation to which it has been notified, a conformity assessment body shall have at its
disposal, or in place, the following:(a)personnel with technical knowledge and sufficient and appropriate experience toperform the conformity assessment tasks;(b)descriptions of procedures in accordance with which conformity assessment iscarried out, ensuring the transparency and ability of reproduction of those
procedures;(c)appropriate policies and procedures that distinguish between tasks it carries out as a
notified body and other activities;(d)procedures for the performance of activities which take due account of the size of anundertaking, the sector in which it operates, its structure, the degree of complexity ofthe technology of the toy in question and the mass or serial nature of the production
process.

A conformity assessment body shall have the means necessary to perform the technical andadministrative tasks connected with the conformity assessment activities in an appropriatemanner and shall have access to all necessary equipment or facilities.
7.

The personnel responsible for carrying out the conformity assessment activities (the‘assessment personnel’) shall have the following:(a)sound technical and vocational training covering all the conformity assessment
activities in relation to which the conformity assessment body has been notified;(b)satisfactory knowledge of the requirements of the assessments they carry out andadequate authority to carry out those assessments;

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(c)

appropriate knowledge and understanding of the requirements set out in thisRegulation, of the applicable harmonised standards referred to in Article 13 of thisRegulation and the common specifications referred to in Article 14 of thisRegulation;(d)the ability to draw up certificates, records and reports demonstrating that assessments
have been carried out.

8.

The impartiality of conformity assessment bodies, their top level management andassessment personnel shall be ensured.
The remuneration of the top level management and assessment personnel of a conformity
assessment body shall not depend on the number of assessments carried out or on the
results of those assessments.

9.

Conformity assessment bodies shall take out liability insurance unless liability is assumed
by the Member State in accordance with its national law, or the Member State itself isdirectly responsible for the conformity assessment.

10.

The personnel of a conformity assessment body shall observe professional secrecy inaccordance with applicable Union and national law with regard to all information
obtained in carrying out their tasks under Annex IV, except in relation to the competentauthorities of the Member State in which its activities are carried out.
IntellectualProprietary rights, intellectual property rights and trade secrets shall beprotected.

11.

Conformity assessment bodies shall participate in, or ensure that their assessment
personnel are informed of, the relevant standardisation activities and the activities of thenotified body coordination group established under Article 40, and shall apply as generalguidance the administrative decisions and documents produced as a result of the work ofthat group.

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ENArticle 29
Presumption of conformity of notified bodies
Where a conformity assessment body demonstrates its conformity with the criteria laid down in therelevant harmonised standards or parts thereof, the references of which have been published in the
Official Journal of the European Union, it shall be presumed to comply with the requirements set
out in Article 28 insofar as the applicable harmonised standards cover those requirements.

Article 30
Subsidiaries of and subcontracting by notified bodies
1.

Where a notified body subcontracts specific tasks connected with conformity assessment
or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meetsthe requirements set out in Article 28, and shall inform the notifying authority accordingly.

2.

Notified bodies shall take full responsibility for the tasks performed by subcontractors or
subsidiaries, wherever these are established.

3.

Notified bodies shall be capable of reviewing the tasks performed by the subcontractors or
subsidiaries in all their elements.

4.

Activities may be subcontracted or carried out by a subsidiary only with the agreement of
the client.

5.

Notified bodies shall keep at the disposal of the notifying authority the relevant documents
concerning the assessment of the qualifications of the subcontractor or the subsidiary andthe work carried out by them under Annex IV.

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Article 31
Application for notification
1.

A conformity assessment body shall submit an application for notification under thisRegulation to the notifying authority of the Member State in which it is established.

2.

The application referred to in paragraph 1 shall be accompanied by a description of theconformity assessment activities and the toys for which that body claims to be competent,
as well as by an accreditation certificate issued by a national accreditation body attestingthat the conformity assessment body fulfils the requirements laid down in Article 28.

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ENArticle 32
Notification procedure1.

Notifying authorities may only notify conformity assessment bodies which have satisfied
the requirements laid down in Article 28.

2.

Notifying authorities shall notify conformity assessment bodies to the Commission and theother Member States using the electronic notification tool developed and managed by theCommission.

3.

The notification shall include full details of the conformity assessment activities and therelevant accreditation certificate. The notification shall also include information on any
tasks to be performed by subsidiaries and subcontractors.

4.

The body concerned may perform the activities of a notified body only where no
objections are raised by the Commission or the other Member States within two months ofa notification.
Only such a body shall be considered a notified body for the purposes of this Regulation.

5.

The notifying authority shall inform the Commission and the other Member States of any
subsequent relevant changes to the notification.

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ENArticle 33
Identification numbers and lists of notified bodies
1.

The Commission shall assign an identification number to each notified body.
It shall assign a single identification number even where the same body is notified under
several Union acts.

2.

The Commission shall make publicly available a list of bodies notified under thisRegulation, including the identification numbers that have been assigned to them and theactivities for which they have been notified.
The Commission shall ensure that the list is kept up to date.

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Article 34
Changes to notifications
1.

Where a notifying authority has ascertained or has been informed that a notified body nolonger meets the requirements laid down in Article 28, or that it is failing to fulfil its
obligations, the notifying authority shall restrict, suspend or withdraw the notification as
appropriate, depending on the seriousness of the failure to meet those requirements or fulfil
those obligations. It shall immediately inform the Commission and the other Member
States accordingly.

2.

In the event of restriction, suspension or withdrawal of notification, or where the notified
body has ceased its activity, the notifying Member State shall take appropriate steps toensure that the files of that body are either processed by another notified body or kept
available to the responsible notifying authorities and market surveillance authorities, attheir request.

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Article 35
Challenge to the competence of notified bodies
1.

The Commission shall investigate all cases where it doubts, or doubt is brought to its
attention regarding, the competence of a notified body or the continued fulfilment by a
notified body of the requirements and responsibilities to which it is subject.

2.

The notifying authority shall provide the Commission, on request, with all information
relating to the basis for the notification or the maintenance of the competence of the bodyconcerned.

3.

The Commission shall ensure that all sensitive information obtained in the course of its
investigations is treated confidentially.

4.

Where the Commission ascertains that a notified body does not meet the requirements for
notification, it shall, by means of an implementing act, request the notifying authority totake the necessary corrective measures, including the withdrawal of the notification if
necessary.

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Article 36
Operational obligations of notified bodies
1.

A notified body shall carry out conformity assessments in accordance with the conformity
assessment procedure provided for in Annex IV.

2.

Notified bodies shall carry out the conformity assessment activities set out in thisRegulation in a proportionate manner, avoiding unnecessary burdens for economic
operators. They shall perform their activities under this Regulation taking due account of
the size of an undertaking, the sector in which it operates, its structure, the degree ofcomplexity of the technology of the toy in question and the mass or serial nature of the
production process.
When performing their activities, the notified bodies shall respect the degree of rigour andthe level of protection required for the compliance of the toy with this Regulation.

3.

Where a notified body finds that the toy does not meet the essential safety requirements,
the requirements in corresponding harmonised standards, where such standards are appliedor the requirements in corresponding common specifications referred to in Article 14,
where such specifications are applied, it shall require that manufacturer to take appropriate
corrective measures and shall not issue an EU-type examination certificate as referred to inPart II, point 6, of Annex IV.

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4.

Where, in the course of the monitoring of conformity following the issue of a EU-type
examination certificate, a notified body finds that a toy is no longer incompliancecomplies, it shall require the manufacturer to take appropriate corrective
measures, and shall suspend or withdraw the EU-type examination certificate if necessary.

5.

Where corrective measures are not taken or do not have the required effect, the notified
body shall restrict, suspend or withdraw any EU-type examination certificates, as
appropriate.

6.

Where a notified body is informed by a market surveillance authority that a toy for which
the notified body has issued a EU-type examination certificate isdoes not in
conformitycomply with the essential safety requirements, it shall withdraw the EU-type
examination certificate in respect of that toy.

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Article 37
Appeals against decisions of notified bodies
A notified body shall ensure that a transparent and accessible appeals procedure against its
decisions is available.

Article 38
Information obligation of notified bodies
1.

Notified bodies shall inform the notifying authority of the following:(a)

any refusal, restriction, suspension or withdrawal of an EU-type examination
certificate;(b)

any circumstances affecting the scope of and conditions for their notification;(c)

any request for information which they have received from market surveillanceauthorities regarding conformity assessment activities;(d)on request, conformity assessment activities performed within the scope of theirnotification, and any other activity performed, including cross-border activities andsubcontracting.

2.

Notified bodies shall provide the other bodies notified under this Regulation which carryout similar conformity assessment activities covering the same toys with relevant
information on issues relating to negative and, on request, positive conformity assessment
results.

3.

Notified bodies shall, further to a reasoned request from a market surveillance authority,
provide it with all the information and documentation that relates to any EU-type
examination certificate which they have issued or withdrawn, or that relates to any refusal
to issue such a certificate, including test reports, and the technical documentation referred
to in Article 23.

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ENArticle 39
Exchange of experience
The Commission shall provide for the organisation of exchange of experience between the Member
States' national authorities responsible for notification policy.

Article 40
Coordination of notified bodies
The Commission shall ensure that appropriate coordination and cooperation between bodies
notified under this Regulation are put in place and properly operated in the form of a sectoral groupor groups of notified bodies.
Notified bodies shall participate in the work of that group or groups, directly or by means ofdesignated representatives.

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ENCHAPTER VII
MARKET SURVEILLANCE

Article 41
Procedure for dealing with toys presenting a risk at national level
1.

Where the market surveillance authorities of one Member State have sufficient reason tobelieve that a toy covered by this Regulation presents a risk to the health or safety of
persons, they shall carry out an evaluation in relation to the toy concerned covering all therequirements laid down in this Regulation. The relevant economic operators shallcooperate, as necessary, with the market surveillance authorities for that purpose.
Where, in the course of that evaluation, a market surveillance authority finds that a toy
does not comply with the requirements laid down in this Regulation, it shall without delay
require the relevant economic operator to take appropriate corrective action in accordancewith Article 16(3) of Regulation (EU) 2019/1020 within a reasonable period of timeprescribed by the market surveillance authority and taking into account the nature of therisk.
The market surveillance authorities shall inform the relevant notified body accordingly.

2.

Where the market surveillance authorities consider that non-compliance is not restricted totheir national territory, they shall inform the Commission and the other Member States of
the results of the evaluation and of the actions which they have required the relevant
economic operator to take.

3.

The economic operator shall ensure that appropriate corrective action is taken in respect of
all the concerned toys that the economic operator has made available on the market
throughout the Union.

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4.

Where the relevant economic operator does not take adequate corrective action within the
period referred to in paragraph 1, secondfirst subparagraph, the market surveillanceauthorities shall take appropriate provisional measures to prohibit or restrict the toy being
made available on their national market, to withdraw the toy from that market or to recall
it.
The market surveillance authorities shall inform the Commission and the other Member
States, without delay, of those measures.

5.

The information referred to in paragraph 4, second subparagraph, shall include all available
details, in particular the data necessary for the identification of the non-compliant toy
including the unique product identifier, the origin of that toy, the nature of the alleged noncompliance and the risk involved, the nature and duration of the national measures taken
and the arguments put forward by the relevant economic operator. In particular, the market
surveillance authorities shall indicate whether the non-compliance is due to any of thefollowing:

6.

(a)

failure of the toy to meet the essential safety requirements;(b)

shortcomings in the harmonised standards referred to in Article 13;(c)shortcomings in the common specifications referred to in Article 14.

Market surveillance authorities of Member States other than the Member State initiating
the procedure under this Article shall without delay inform the Commission and the otherMember States of any measures adopted and of any additional information at their disposal
relating to the non-compliance of the toy concerned, and, in the event of disagreement with
the notified national measure, of their objections.

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7.

Where, within 3 months of receipt of the information referred to in paragraph 4, second
subparagraph, no objection has been raised by either a market surveillance authority of a
Member State or the Commission in respect of a provisional measure taken by a Member
State, that measure shall be deemed to be justified.

8.

Market surveillance authorities of other Member States shall ensure that appropriate
restrictive measures, such as withdrawal of the toy from their market, are taken without
delay in respect of the toy concerned, and shall inform the Commission and the otherMember States of those measures.

9.

The information referred to in paragraphs 2, 4, 6 and 8 of this Article shall be
communicated through the information and communication system referred to in Article
34 of Regulation (EU) 2019/1020. That communication shall not affect the obligation onmarket surveillance authorities to notify measures taken against products presenting aserious risk in accordance with Article 20 of Regulation (EU) 2019/1020.

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Article 42
Union safeguard procedure
1.

Where, on completion of the procedure set out in Article 41(3) and (4), objections areraised against a measure taken by a Member State, or where the Commission has reasons
to believe that a national measure could be contrary to Union legislationlaw, theCommission shall without delay enter into consultation with the Member States and therelevant economic operator or operators and shall evaluate the national measure.
On the basis of the results of that evaluation, the Commission shall adopt an implementing
act determining whether the national measure is justified or not.
The Commission shall address its decision to all Member States and shall without delay
communicate it to them and the relevant economic operator or operators.

2.

If the national measure is considered justified, all Member States shall take the measuresnecessary to ensure that the non-compliant toy is withdrawn or recalled from their market,
and shall inform the Commission accordingly.
If the national measure is considered unjustified, the Member State concerned shallwithdraw it.

3.

Where the national measure is considered to be justified and the non-compliance of the toy
is attributed to shortcomings in the harmonised standards referred to in Article 13 of thisRegulation or the common specifications referred to in Article 14 of this Regulation, theCommission shall apply the procedure provided for in Article 11 of Regulation (EU) No
1025/2012 or amend the common specifications as appropriate.

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ENArticle 43
Formal non-compliance1.

Without prejudice to Article 41, where a market surveillance authority makes one of thefollowing findings with regard to a toy, it shall require the relevant economic operator to
put an end to the non-compliance concerned:(a)the CE marking has been affixed in violation of Article 15 or 16;(b)

the CE marking has not been affixed;(c)the digital product passport has not been drawn up in accordance with Article 17;(d)

the data carrier through which the digital product passport is accessible has not been
affixed in accordance with Article 17(5);(e)

the technical documentation referred to in Article 23 is either not available or notcomplete.

2.

Where the non-compliance referred to in paragraph 1 persists, the market surveillanceauthority concerned shall take appropriate measures to restrict or prohibit the making
available on the market of the toy, or ensure that the toy is recalled or withdrawn from themarket.

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Article 44
National measures concerning toys which are compliant with the particular safety requirements
but which present a risk
1.

Where, having carried out an evaluation under Article 41(1), a market surveillanceauthority finds that, although a toy made available on the market is in compliance with theparticular safety requirements it poses a risk to the health and safety of persons, it shallrequire the relevant economic operator to take all appropriate measures, within areasonable period of time prescribed by the market surveillance authority taking into
account the nature of the risk to ensure that the toy, when made available on the market, nolonger presents that risk, to withdraw the toy from the market or to recall it.

2.

The economic operator shall ensure that corrective action is taken in respect of all the toys
concerned that the economic operator has made available on the market throughout theUnion.

3.

The market surveillance authority of the Member State shall immediately inform theCommission and the other Member States of its findings and any subsequent actions takenby the economic operator. That information shall include all available details, in particular
the data necessary for the identification of the toy concerned including the unique productidentifier, the origin and the supply chain of the toy, the nature of the risk involved and thenature and duration of the national measures taken.

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4.

The Commission shall without delay enter into consultation with the Member States andthe relevant economic operator or operators and shall evaluate the national measures taken.
On the basis of the results of that evaluation, the Commission shall adopt an implementing
act determining whether the national measure is justified or not and, where necessary,
propose appropriate measures.
The Commission shall address its decision to all Member States and shall immediately
communicate it to them and the relevant economic operator or operators.

5.

The information referred to in paragraph 3 of this Article shall be communicated throughthe information and communication system referred to in Article 34 of Regulation (EU)2019/1020. That communication shall not affect the obligation on market surveillanceauthorities to notify measures taken against products presenting a serious risk inaccordance with Article 20 of Regulation (EU) 2019/1020.

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Article 45
Commission action concerning toys that present a risk
1.

Where the Commission becomes aware of a toy or a specific category of toys madeavailable on the market which presents a risk to the health and safety of persons but isnonetheless either in compliance with the particular safety requirements or raising doubts
about such compliance, it is empowered to adopt implementing acts setting out measures toensure that the toy or category of toys, when made available on the market, no longer
presents that risk, to withdraw it from the market or to recall it where all of the following
conditions are met:(a)it emerges from prior consultations with the market surveillance authorities that theirapproaches to dealing with the risk differ from one market surveillance authority toanother;(b)

the risk cannot, in view of its nature, be dealt with under other procedures laid downby this Regulation.

2.

Those implementing acts shall be adopted in accordance with the examination procedurereferred to in Article 50(3). On duly justified imperative grounds of urgency relating to theprotection of the health and safety of persons, the Commission is empowered to adopt animmediately applicable implementing act in accordance with the procedure referred to in
Article 50(4).

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CHAPTER VIII

DELEGATED POWERS AND COMMITTEE PROCEDURE

Article 46
Delegated powers
1.

The Commission is empowered to adopt delegated acts in accordance with Article 47 toamend Annex VI as regards the informationdata to be provided in the digital productpassport, in order to adapt it to technical and scientific progress and to the level of digital
readiness of market surveillance authorities and of users and their supervisors.

2.

The Commission is empowered to adopt delegated acts in accordance with Article 47 toamend Article 19(1) by setting out that additional information among the information listed
in Annex VI or that information on the non-compliance of the toy when measures are takenin accordance with Articles 41(2) or (4) and Article 44(1) is to be stored in the registry.
When adopting the delegated acts in accordance with the first subparagraph, theCommission shall take into account the following criteria:(a)coherence with other relevant Union acts, where relevant;(b)

the need to allow for the verification of the authenticity of the digital productpassport;(c)the relevance of the information for improving the efficiency and effectiveness ofmarket surveillance checks and customs controls for toys;(d)the need to avoid disproportionate administrative burden for economic operators andcustoms authorities.

3.

The Commission is empowered to adopt delegated acts in accordance with Article 47 tosupplement this Regulation by determining which of the information stored in the registry
is to be controlled by customs authorities, in addition to the information set out in Article
20(3).

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4.

The Commission is empowered to adopt delegated acts in accordance with Article 47 toamend Annex VII to this Regulation in order to adapt the list of commodity codes andproduct descriptions to be used for the purposes of Article 20(8). Those adaptations shallbe based on the list set out in Annex I to Regulation (EEC) No 2658/87.

5.

The Commission is empowered to adopt delegated acts in accordance with Article 47 toamend Annex III in order to adapt it to technical and scientific progress.

6.

The Commission is empowered to adopt delegated acts in accordance with Article 47 toamend Part C of the Appendix to Annex II, while taking into account the conditions set
out in Annex II, Part III, point (7a), in order to permit a certain usepresence in toys of a
specific substance or mixture that is prohibited under Part III, point 4, of Annex II, or tolimitamend or withdraw a certain usepresence that has been permitted.

7.

The use in toys of a substance or mixture prohibited under Part III, point 4, of Annex II
may only be permitted when all of the following conditions are met:(a)it has been found to be safe by the European Chemicals Agency (ECHA), in
particular in view of exposure, including the overall exposure from other sources,
and taking particular account of the vulnerability of children;(b)there are no suitable alternative substances or mixtures available, as established by
ECHA based on an analysis of alternatives;(c)the substance or mixture is not prohibited for use in consumer articles under
Regulation (EC) No 1907/2006.

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8.

The Commission is empowered to adopt delegated acts in accordance with Article 47 toamend Parts A and B of the Appendix to Annex II in order to adapt them to technical andscientific progress, by :(a)introducing conditions for the presence of substances or mixtures in toys and, inparticular, limit values for specific substances or mixtures in toys, including limit
values for tracesthe non intended presence of prohibited substances or mixtures asreferred to in Part III, point 45, of Annex II;(b)modifying the conditions or limit values for the presence of substances and mixturesin toys.

9.

For the purposes of paragraphs 6 and 76and 8, the Commission shall systematically andregularly evaluate the occurrence of hazardous chemical substances or mixtures in toys. In
those evaluations, the Commission shall take into account reports of market surveillancebodies and scientific evidence presented by Member States and stakeholders.

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Article 47
Exercise of the delegation
1.

The power to adopt delegated acts is conferred on the Commission subject to theconditions laid down in this Article.

2.

The power to adopt delegated acts referred to in Article 46 shall be conferred on theCommission for an indeterminate period of time. a period of five years from … [the dateof entry into force of this Regulation]. The Commission shall draw up a report inrespect of the delegation of power not later than nine months before the end of the
five-year period. The delegation of power shall be tacitly extended for periods of an
identical duration, unless the European Parliament or the Council opposes suchextension not later than three months before the end of each period.

3.

The delegation of powers referred to in Article 46 may be revoked at any time by theEuropean Parliament or by the Council. A decision to revoke shall put an end to thedelegation of the power specified in that decision. It shall take effect the day following the
publication of the decision in the Official Journal of the European Union or at a later datespecified therein. It shall not affect the validity of any delegated acts already in force.

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4.

Before adopting a delegated act, the Commission shall consult experts designated by each
Member State in accordance with the principles laid down in the Interinstitutional
Agreement of 13 April 2016 on Better Law-Making.

5.

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to theEuropean Parliament and to the Council.

6.

Delegated acts adopted pursuant to Article 46 shall enter into force only if no objection has
been expressed either by the European Parliament or by the Council within a period of
twothree months of notification of that act to the European Parliament and the Council or
if, before the expiry of that period, the European Parliament and the Council have bothinformed the Commission that they will not object. That period shall be extended by twomonths at the initiative of the European Parliament or of the Council.

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Article 48
Requests for assessment for the purposes of Article 46(6)1.

Requests for an assessment of a substance or mixture prohibited under Part III, point 4, ofAnnex II for the purposes of Article 46(6) shall be submitted to ECHA using the format
and submission tools referred to in paragraph 3 of this Article.

2.

Any person submitting a request for assessment under paragraph 1 may request that certain
information is not to be made publicly available. The request for confidentiality shall beaccompanied by a justification as to why the disclosure of the information could be
harmful to the commercial interests of the person submitting the request for assessment orof any other party concerned.

3.

ECHA shall draw up and make publicly available a format and tools for the submission ofrequests for assessment referred to in paragraph 1 as well as technical and scientificguidance on how to submit such requests.

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ENArticle 49

Opinions from ECHA
1.

For the purposes of Article 46(6), ECHA shall provide opinions to the Commission on theusepresence in toys of substances or mixtures that are prohibited under Part III, point 4 ofAnnex II, where a request for an assessment is submitted to it in accordance with Article
48(1). ECHA shall assess in its opinions whether the criteria set out in Article 46(6),second subparagraph,Annex II, Part III, point 7a, points (a) and (b), are met for a specific
use.

2.

ECHA may request the person submitting the request for assessment or any third party tosubmit additional information within a specified period. ECHA shall take into account any
information submitted by third parties.

3.

The opinions referred to in paragraph 1 shall be sent to the Commission within a period of
12 months from the receipt of the request for an assessment.

4.

That period may be extended once by a period of up to 6 months if ECHA needs to request
information from a third party or if a high number of requests for assessment are submitted
to ECHA under Article 48(1).

5.

ECHA shall re-evaluate its opinions on the usepresence in toys of substances or mixtureslisted in Part C of the Appendix to Annex II at least every 5 years from the date of entry
into force of a delegated act adopted in accordance with Article 46(6).

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6.

The Commission shall request an opinion from ECHA on the usepresence in toys of
substances or mixtures listed in Part C of the Appendix to Annex II as soon as newscientific information that may affect the permitted use of a specific substance or mixture
in toys becomes known to the Commission.

7.

For the purposes of Article 46(78), the Commission may request an opinion from ECHA
on the safety of a specific substance or mixture in toys, which shall take into consideration
the overall exposure to the substance or mixture from other sources and the vulnerability ofchildren.

8.

When preparing an opinion in accordance with the provisions set out in this Article, ECHA
shall make publicly available the information on the start of the assessment, the adoptionof the opinion as well as any intermediate steps in the assessment procedure. In particular,
ECHA shall make the draft opinions publicly available and provide an opportunity for any
interested party to comment on those opinions within a period of at least 4 weeks.

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Article 50
Committee procedure
1.

The Commission shall be assisted by a Committee on Toy Safety. That committee shall be
a committee within the meaning of Regulation (EU) No 182/2011.

2.

Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shallapply.

3.

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shallapply. Where the committee delivers no opinion, the Commission shall not adopt thedraft implementing act and the third subparagraph of Article 5(4) of Regulation (EU)No 182/2011 shall apply.

4.

Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in
conjunction with Article 5 thereof, shall apply.

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CHAPTER IXCONFIDENTIALITY AND PENALTIESArticle 51
Confidentiality
1.

Competent national authorities, notified bodies and the Commission shall respect theconfidentiality in accordance with Union and national law of the following informationand data obtained in carrying out their tasks in accordance with this Regulation:(a)personal data;(b)commercially confidential information and trade secrets of a natural or legal person,
including intellectual property rights, unless disclosure is in the public interest.

2.

Without prejudice to paragraph 1, information exchanged on a confidential basis between
the competent national authorities and between competent national authorities and theCommission shall not be disclosed without taking into account the opinion ofpriorconsultation with the originating competent national authority.

3.

Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission,
Member States and notified bodies with regard to the exchange of information and thedissemination of warnings, or the obligations of the persons concerned to provide
information under criminal law.

4.

Member States and the Commission may exchange confidential information withregulatory authorities of third countries with which they have concluded bilateral or
multilateral confidentiality arrangements, when those arrangements ensure that any
exchange of information is in accordance with applicable Union and national law.

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Article 52
Penalties
Member States shall lay down the rules on penalties applicable to infringements of this Regulationand shall take all measures necessary to ensure that they are implemented. The penalties provided
for shall be effective, proportionate and dissuasive... Member States by … [P.O. insert date: the firstday of the month following 30 months after the date of entry into force of this Regulation] notify theCommission of those rules and shall notify it without delay of any subsequent amendment affecting
them.

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ENCHAPTER XFINAL PROVISIONS

Article 53
RepealDirective 2009/48/EC is repealed with effect from … [OP: please insert the date = the first day ofthe month following 3054 months after the date of entry into force of this Regulation].
References to the repealed Directive 2009/48/EC shall be construed as references to this Regulationand shall be read in accordance with the correlation table in Annex VIII.

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Article 54
Transitional provisions
1.

Toys placed on the market in conformity with Directive 2009/48/EC before … [OP please
insert the date = the first day of the month following 3054 months after the date of entry
into force of this Regulation] may continue to be made available on the market until …fora period of 60 months after … [OP please insert the date: the first day of the monthfollowing 4254 months after the date of entry into force of this Regulation].

2.

Chapter VII of this Regulation shall apply mutatis mutandis instead of Article 42, 43 and45 of Directive 2009/48/EC to toys which were placed on the market in conformity withthat Directive before … [PO insert date: the first day of the month following 3054 months
after the date of entry into force of this Regulation], including toys for which a procedure
has already been initiated under Article 42 or 43 of Directive 2009/48/EC before … [POinsert date: the first day of the month following 30 months after the date of entry into forceof this Regulation].

3.

EC type-examination certificates issued in accordance with Article 20 of Directive
2009/48/EC shall remain valid until … [PO insert date: the first day of the monthfollowing 4260 months after the date of entry into force of this Regulation], unless they
expire before that date.

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Article 55
Evaluation and review
1.

By … [OP please insert the date = the first day of the month following 60 84 months after
the date of entry into force of this Regulation] and every 5 years thereafter, theCommission shall carry out an evaluation of this Regulation, including about theeffectiveness of this Regulation regarding the obligations of providers of online
marketplaces. The Commission shall submit a report to the European Parliament and to
the Council on the main findings.

2.

Where the Commission finds it appropriate, the report shall be accompanied by alegislative proposal for amendment of the relevant provisions of this Regulation.

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Article 56
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the
Official Journal of the European Union.
It shall apply from … [OP please insert the date = the first day of the month following 3054 months
after the date of entry into force of this Regulation].
However, Articles 17(10), 24 to 40, and 46 to 52, shall apply from … [OP: please insert the date ofentry into force of this Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,

For the European Parliament

For the Council

The President

The President

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ANNEX IPRODUCTS TO WHICH THIS REGULATION DOES NOT APPLYPart I – Toys excluded from the scope of this Regulation
1.

Playground equipment intended for public use;2.

automatic playing machines, whether coin operated or not, intended for public use;3.

toy vehicles equipped with combustion engines;4.

toy steam engines.

Part II- Products that are not considered as toys within the meaning of this Regulation1.

Decorative objects for festivities and celebrations that do not have a play value;

2.

products for collectors, provided that the product or its packaging bears a visible andlegible indication that it is intended for collectors of 14 years and above. Examples of thiscategory are:

3.

(a)

detailed scale models;(b)kits for the assembly of detailed scale models;(c)folk dolls and decorative dolls and other similar articles;(d)historical replicas of toys; and(e)reproductions of real fire arms;

sports equipment, including roller skates, inline skates, and skateboards intended forchildren with a body mass of more than 20 kg;

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4.

bicycles with a maximum saddle height of more than 435 mm, measured as the verticaldistance from the ground to the top of the seat surface, with the seat in a horizontal position
and with the seat pillar set to the minimum insertion mark;5.

scooters and other means of transport designed for sport or which are intended to be used
for travel on public roads or public pathways;

6.

electrically driven vehicles which are intended to be used for travel on public roads, publicpathways, or the pavement thereof;

7.

aquatic equipment intended to be used in deep water, and swimming learning devices forchildren, such as swim seats and swimming aids;

8.

puzzles with more than 500 pieces;9.

guns and pistols using compressed gas, with the exception of water guns and water pistols,
and bows for archery over 120 cm long;10.

fireworks, including percussion caps which are not specifically designed for toys;

11.

products and games using sharp-pointed missiles, such as sets of darts with metallic points;

12.

Functional educational products, such as electric ovens, irons or other functional products
operated at a nominal voltage exceeding 24 volts which are sold exclusively for teaching
purposes under adult supervision.;13.

products intended for use for educational purposes in schools or other pedagogical contexts
under the surveillance of an adult instructor, such as science equipment;

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14.

electronic equipment, such as personal computers and game consoles, used to accessinteractive software and their associated peripherals, unless the electronic equipment or the
associated peripherals are specifically designed for and targeted at children and have a playvalue on their own, such as specially designed personal computers, key boards, joy sticks
or steering wheels;

15.

interactive software, intended for leisure and entertainment, such as computer games, andtheir storage media;

16.

babies’ soothers;

17.

continuously wired child-appealing luminaires;

18.

electrical transformers for toys;

19.

fashion accessories for children which are not for use in play.;20.

paint ball equipment;

21.

ordinary reading books and ordinary educational books.

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ANNEX IIPARTICULAR SAFETY REQUIREMENTS
Part I Physical and Mechanical Properties
1.

Toys and their parts and, in the case of fixed toys, their anchorages, shall have the requisite
mechanical strength and, where appropriate, stability to withstand the stresses to which
they are subjected during use without breaking or becoming liable to distortion at the riskof causing physical injury.

2.

Accessible edges, protrusions, cords, cables and fastenings on toys shall be designed andmanufactured in such a way that the risks of physical injury from contact with them are
reduced as much as possible.

3.

Toys shall be designed and manufactured in such a way as not to present any risk to healthand safety or only the minimum risk inherent to their use which could be caused by the
movement of their parts.

4.

(a) Toys and their parts shall not present a risk of strangulation.
(b)

Toys and their parts shall not present a risk of asphyxiation by closing off the flow of
air as a result of airway obstruction external to the mouth and nose.

(c)

Toys and their parts shall be of such dimensions as to not present a risk ofasphyxiation by closing off the flow of air as a result of internal airway obstruction
by objects wedged in the mouth or pharynx or lodged over the entrance to the lower
airways.

(d)Toys which are clearly intended for use by children under 36 months and toys
which, although not foodstuff, resemble foodstuff such that it is likely that they
are confused with foodstuff by children, and their component parts and any of theirdetachable parts, shall be of such dimensions as to prevent them being swallowed orinhaled. This also applies to other toys which are intended to be put in the mouth,
and to their component parts and any of their detachable parts.

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(e)

The packaging in which toys are contained for retail sale shall not present a risk of
strangulation or asphyxiation caused by airway obstruction external to the mouth and
nose.

(f)

Toys contained within food or co-mingled with food shall have their own packaging.
This packaging, as it is supplied, must be of such dimensions as to prevent it frombeing swallowed and/or inhaled.

(g)

Toy packaging, as referred to in points (e) and (f), which is spherical, egg-shaped or
ellipsoidal, and any detachable parts of this or of cylindrical toy packaging withrounded ends, shall be of such dimensions as to prevent it from causing airway
obstruction by being wedged in the mouth or pharynx or lodged over the entrance tothe lower airways.

(h)Toys firmly attached to a food product at the moment of consumption, in such a waythat the food product needs to be consumed in order to get direct access to the toy,
shall be prohibited. Parts of toys otherwise directly attached to a food product shallfulfil the requirements set out in points (c) and (d).

(i)

Toys must not cause a risk to the obstruction of the intestines due to the
expansion of the toy if swallowed.

5.

Aquatic toys shall be designed and manufactured so as to reduce as much as possible,
taking into account the recommended use of the toy, any risk of loss of buoyancy of the toy
and loss of support afforded to the child.

6.

Toys which it is possible to get inside and which thereby constitute an enclosed space foroccupants shall have a means of exit which the intended user can open easily from theinside.

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7.

Toys conferring mobility on their users shall, as far as possible, incorporate a braking
system which is suited to the type of toy and is commensurate with the kinetic energy
generated by it. Such a system shall be easy for the user to operate without risk of ejection
or physical injury for the user or for third parties.
For electrically driven ride-on toys, the maximum representative potential operating speed
determined by the design of the toy shall be limited so as to minimise the risk of injury.

8.

The form and composition of projectiles and the kinetic energy they may generate when
fired from a toy designed for that purpose shall be such that, taking into account the natureof the toy, there is no risk of physical injury to the user or to third parties.

9.

Toys shall be manufactured so as to ensure that:(a)the maximum and minimum temperature of any accessible surfaces does notcause injury when touched;(b)liquids and gases contained within the toy do not reach temperatures orpressures which are such that their escape from the toy, other than for reasons
essential to the proper functioning of the toy, might cause burns, scalds or otherphysical injury.

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10.

Toys which are designed to emit a sound and toy mechanisms that are activated by achild and emit reproduceable sound, shall be designed and manufactured in such a way,in terms of the maximum values for impulse noise and continuous noise, that the soundfrom them is not able to impair children’s hearing.

11.

Activity toysToys shall be manufactured so as to reduce the risk of crushing or trapping ofbody parts or trapping of clothing and the risk of falls, impacts and drowning as much as
possible. In particular, for activity toys any surface of such a toy that is accessible for one
or more children to play on shall be designed to bear their load.

12.

Toys that contain magnets or magnetic parts shall be designed and manufactured insuch a way that the size and strength of the magnets do not present a risk of intestinal
perforation or blockage.

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Part II Flammability
1.

Toys shall not constitute a dangerous flammable element in the child’s environment. They
shall therefore be composed of materials which fulfil one or more of the following
conditions:(a)they do not burn if directly exposed to a flame or spark or other potential
source of fire;(b)they are not readily flammable (the flame goes out as soon as the fire cause
disappears);(c)

if they do ignite, they burn slowly and present a low rate of spread of theflame;(d)irrespective of the toy’s chemical composition, they are designed so as tomechanically delay the combustion process.

Combustible materials in the toy shall not constitute a risk of ignition for other materials usedin the toy.
2.

Toys meeting both conditions below shall not, as such, contain substances or mixtures
which may become flammable due to the loss of non-flammable volatile components:(a)toys which, for reasons essential to their functioning, contain substances or mixturesthat meet the classification criteria of any of the following hazard classes or
categories set out in Annex I to Regulation (EC) No 1272/2008:

9740/1/24 REV 1
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(1)

hazard classes 2.1 to 2.4, 2.6 and 2.7, hazard class 2.8 types A and B;(2)

hazard classes 2.9, 2.10 and 2.12, hazard class 2.13 categories 1 and 2;(3)

hazard class 2.14, categories 1 and 2, hazard class 2.15 types A to F;
hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function andfertility or on development;(4)

hazard class 3.8 effects other than narcotic effects;(5)

hazard classes 3.9 and 3.10;(6)hazard class 4.1;

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(7)
(b)

hazard class 5.1;

andToys, in particular toys containing materials and equipment for chemistry
experiments, model assembly, plastic or ceramic moulding, enamelling, photography, toy
foam soap or similar activities, shall not, as such, contain substances or mixtures which
may become flammable due to the loss of non-flammable volatile components.

3.

Toys other than toy percussion caps shall not be explosive or contain elements or
substances likely to explode when used as specified in Article 5(2), first subparagraph.

4.

Toys and, in particular, chemical games and toys, shall not contain as such substances or
mixtures:(a)which, when mixed together, may explode through chemical reaction or
through heating;(b)which may explode when mixed with oxidizing substances; or(c)which contain volatile components which are flammable in air and liable toform a flammable or explosive vapour/air mixture.

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Part III Chemical Properties
1.

Toys shall be designed and manufactured in such a way that there are no risks of adverse
effects on human health due to exposure to the chemical substances or mixtures of which
the toys are composed or which they contain, when the toys are used as specified in Article
5(2), first subparagraph.
Toys shall comply with the relevant Union legislation relating to certain categories of
products or to restrictions for certain substances and mixtures. Toys or their parts and theirpackaging that can reasonably be expected to be brought into contact with food or totransfer their constituents to food under normal or foreseeable conditions of use, shall also
comply with Regulation (EC) No 1935/2004.

2.

Toys that are themselves substances or mixtures shall comply also with Regulation (EC)No 1272/2008 .

3.

Toys shall comply with the specific requirements and conditions for chemical substances
set out in part A of the Appendix and with the labelling requirements set out in part B of
the Appendix.

4.

The usepresence in toys, components of toys or micro-structurally distinct parts of toys, of
substances or mixturesin the form classified in Part 3 of Annex VI to Regulation (EC)No 1272/2008 in any of the following categories is prohibited:(a)carcinogenicity, germ cell mutagenicity or reproductive toxicity (CMR)
category 1A, 1B or 2;(b)

endocrine disruption for human health category 1 or 2;(c)specific target organ toxicity category 1, either in single exposure or in
repeated exposure;(d)

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respiratory sensitisation category 1.;

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(e)
5.

skin sensitizers category 1A.

The non- intended presence of a substance or mixture referred to in point 4 that stems from
impurities of natural or synthetic ingredients, or from the manufacturing process and that is
technically unavoidable in good manufacturing practice, shall be permitted provided that,
despite such presence, toys remain in conformity with the general safety requirement. andthat the individual concentration limit of 100 mg/kg shall not be exceeded.

6.

By way of derogation from point 4, substances or mixtures prohibited under that point may
be used in toys if they are listed in Part C of the Appendix, under the conditions specified
therein.

7.

Points 4 to 6 shall not apply to:(a)materials that comply with the conditions set out for specific substances in Part
A of the Appendix, as regards those substances;(b)batteries in toys; or(c)

toy components necessary for electronic or electric functions of the toy where
the substance or mixture is fully inaccessible to children, including byinhalation. ;(d)materials that comply with a substance specific restriction for toys inAnnex XVII of Regulation (EC) No 1907/2006 concerning the registration,
evaluation, authorisation and restriction of chemicals (REACH) under theconditions specified therein, as regards those substances.

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7a.

By way of derogation to point 4, the presence in toys of a prohibited substance or
mixture may only be permitted when all of the following conditions are met:(a)it has been found to be safe by the European Chemicals Agency (ECHA), in
particular in view of exposure, including the overall exposure from othersources, and taking particular account of the vulnerability of children;(b)there are no suitable alternative substances or mixtures available, as establishedby ECHA based on an analysis of alternatives;(c)the substance or mixture is not prohibited for use in consumer articles under
Regulation (EC) No 1907/2006.

8.

Cosmetic toys, such as play cosmetics for dolls, shall comply with the compositional andlabelling requirements laid down in Regulation (EC) No 1223/2009 of the European
Parliament and of the Council1.

1Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30
November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).

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9.

Toys shall not:(a)have a biocidal function insofar as the toy would thereby be considered abiocidal product according to the definition set out in Article 3(a) ofRegulation (EU) 528/2012, or(b)

be treated with, or intentionally incorporate, one or more biocidal products,
as defined in Article 3(a) of Regulation (EU) 528/2012, insofar as the toy
would thereby be considered a treated article according to Article 3(l) of that
Regulation.

This Point shall not apply where the toy is intended to be permanently placed
outdoors.

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10.

By way of derogation from points 4 and 9, preservatives may be used in toys where
the preservative is allowed for use in leave-on cosmetics as listed in Annex V ofRegulation (EC) 1223/2009 on cosmetic products in accordance with the conditions
set out in that Annex, except those that are not to be used for children under 3 or 10
years of age, or those that are not allowed to be used in products applied on mucous
membranes or for which contact with the eyes should be avoided.

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Part IV Electrical Properties
1.

Toys shall not be powered by electricity of a nominal voltage exceeding 24 volts direct
current (DC) or the equivalent alternating current (AC) voltage, and their accessible parts
shall not exceed 24 volts DC or the equivalent AC voltage.
Internal voltages shall not exceed 24 volts DC or the equivalent AC voltage unless it isensured that the voltage and the current combination generated do not lead to any risk forhealth and safety or anyharmful electric shock, even when the toy is broken.

2.

Parts of toys which are connected to, or liable to come into contact with, a source ofelectricity capable of causing electric shock, and any cables or other conductors throughwhich electricity is conveyed to such parts shall be properly insulated and mechanicallyprotected so as to prevent the risk of such a shock.

3.

Electric toys shall be designed and manufactured in such a way as to ensure that the
maximum temperatures reached by all directly accessible surfaces are not such as to causeburns when touched.

4.

Under foreseeable fault conditions, toys shall provide protection against electrical hazards
arising from an electrical power source.

5.

Electric toys shall provide adequate protection against fire hazards.

6.

Electric toys shall be designed and manufactured in such a way that electric, magnetic andelectromagnetic fields and other radiations generated by the toy, are limited to the extent
necessary for the operation of the toy, and shall operate at a safe level in compliance withthe generally acknowledged state of the art, taking account of specific Union measures.

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7.

Toys which have an electronic control system shall be designed and manufactured in sucha way that the toy operates safely even when the electronic system starts malfunctioning or
fails due to failure of the system itself or an outside factor.

8.

Toys shall be designed and manufactured in such a way that they do not present any healthhazards, or risk of injury to eyes or skin, from lasers, light-emitting diodes (LEDs) or any
other type of radiation.

9.

The electrical transformer of a toy shall not be an integral part of the toy.

10.

Electric toys with batteries that constitute small parts shall be designed andmanufactured in such a way as to ensure that access to the battery is prevented byrequiring the use of a tool. Where the size or nature of the toy so requires, a
rechargeable battery may instead be made inaccessible, and removable or replaceable
only by independent professionals.

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Part V Hygiene
1.

Toys shall be designed and manufactured in such a way with regards to their hygiene andcleanliness that they do not present any risk of infection, sickness or contamination.

2.

A toy intended for use by children under 36 months shall be designed and manufactured insuch a way that it can be cleaned. A textile toy shall, to this end, be washable, except if it
contains a mechanism that may be damaged if soak washed. The toy shall fulfil the safety
requirements also after having been cleaned in accordance with this point and the
manufacturer’s instructions.

3.

Toys with accessible aqueous materials shall be designed and manufactured in such a way
as to ensure that they do not present a microbiological risk.

Part VI Radioactivity
Toys shall comply with all relevant measures adopted under Chapter III of the Treaty establishing
the European Atomic Energy Community.

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Appendix
Specific conditions for the presence of certain chemical substances or mixtures in toys
Part A. Substances subject to specific limit values
1.

The following migration limits, from toys, components of toys or micro-structurally
distinct parts of toys, shall not be exceeded:

Element
Aluminium
Antimony
Arsenic
BariumBoron
Cadmium
Chromium(III)
Chromium(VI)
CobaltCopper
Lead
Manganese
Mercury
NickelSelenium
Strontium
Tin
Organic tin
Zinc

mg/kg in dry, brittle, powderlike or pliable toy material
2250
45
3,8
1 500
1 200
1,3
37,5

mg/kg in liquid or
sticky toy material
560
11,3
0,9
375
300
0,3
9,4

mg/kg in scrapedoff toy material
28130
560
47
18750
15 000
17
460

0,02

0,005

0,053

10,5
622,5
2,0
1 200
7,5
75
37,5
4 500
15 000
0,9
3 750

2,6
156
0,5
300
1,9
18,8
9,4
1 125
3 750
0,2
938

130
7 700
23
15 00094930
460
56 000180 000
12
46 000

These limit values shall not apply to toys or components of toys or micro-structurally
distinct parts of toys which, due to their accessibility, function, volume or mass, clearlyexclude any risk due to sucking, licking, swallowing or prolonged contact with skin whenused as specified in Article 5(2), first subparagraph.

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2.

NitrosaminesN-nitrosamines and nitrosableN-nitrosatable substances are prohibited in
the following toys intended for use by children under 36 months or in other toys intended
to be placed in the mouth where the migration of those substances is equal to or higher
than 0,01 mg/kg for nitrosamines and 0,1 mg/kg for nitrosable substances.:
N-nitrosamines

N-nitrosatable

mg/kg

substances
mg/kga) toys intended for use by children
under 36 months and intended or likely
to be placed into the mouth

0,01

0,1

b) toys intended for use by children under 36 months not covered by a)

0,05

1

c) toys intended for use by children of 36
months and over and intended to beplaced into the mouth

0,05

1

d) balloons

0,05

1

e) finger paints, slimes and putties

0,02

1

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3.

The following limit values, in toys or components of toys or micro-structurally distinct partsof toys, shall not be exceeded:
Substance

CAS
No

Limit value
application

andconditions

for

TCEP

11596-8

5 mg/kg (content limit)

TCPP

13674- 5 mg/kg (content limit)
84-5

TDCP

13674- 5 mg/kg (content limit)
87-8

Formamide75-12- 20 μg/m3 (emission limit) after a maximum
7of 28 days from the start of the emission
testing of foam toy materials containing
more than 200 mg/kg (cut-off limit based oncontent)

1,2-benzisothiazol-3(2H)-one

263433-5

5 mg/kg (content limit) in aqueous toy
materials, in accordance with the methods
laid down in EN 71-10:2005 and EN 7111:2005

Reaction mass of: 5-chloro-2- methyl-4- 55965- 1 mg/kg (content limit) in aqueous toy
isothiazolin-3-one [EC no. 247-500-7] 84-9
materials
and 2-methyl-2H -isothiazol-3-one [EC
no. 220-239-6] (3:1)
5-Chloro-2-methyl-isothiazolin-3(2H)- 26172- 0,75 mg/kg (content limit) in aqueous toyone
55-4
materials
2-methylisothiazolin-3(2H)-one

268220-4

0,25 mg/kg (content limit) in aqueous toy
materials

Phenol10895-2

5 mg/l (migration limit) in polymericmaterials in accordance with the methods
laid down in EN 71-10:2005 and EN 7111:2005.
10 mg/kg (content limit) as a preservative inaccordance with the methods laid down in
EN 71-10:2005 and EN 71-11:2005.

Formaldehyde

50-00- 1,5 mg/l (migration limit) in polymeric toy
0material
0,062 mg/m3 (emission limit) in wood toy
material
30 mg/kg (content limit) in textile toy

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30 mg/kg (content limit) in leather toy
material
30 mg/kg (content limit) in paper toy
material
10 mg/kg (content limit) in water-based toy
material
Aniline30 mg/kg (content limit) after reductive
cleavage in textile toy material and leather
62-53- toy material
3
10 mg/kg (content limit) as free aniline infinger paints
30 mg/kg (content limit) after reductive
cleavage in finger paints
0,77 mg/l (migration limit) in polymeric
toy materials

Styrene10042-5

Bisphenol A

80-05- 0,005 mg/l (migration limit)
7

Acrylonitrile

10713-1

0,01 mg/l (migration limit) in polymeric
toy materials

Butadiene

10699-0

0,07 mg/l (migration limit) in polymeric
toy materials

Vinyl chloride

75-01- 0,01 mg/l (migration limit) in polymeric
toy materials
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4.

Toys shall not contain the following fragrance allergens unless their presence in the toy istechnically unavoidable under good manufacturing practice and does not exceed 10010 mg/kg:
No

Name
of
the
fragranceChemical nameallergenic Common name(1)

Alanroot oil (Inula helenium) L.)

97676-35-2(2)AllylisothiocyanateAllyl isothiocyanate

57-06-7(3)

Benzyl cyanide

140-29-4(4)

4 -tert-Butylphenol

98-54-4(5)

Chenopodium ambrosioides L. (essential Chenopodium oil
oil)

8006-99-3(6)

Cyclamen alcohol4756-19-8(7)Diethyl maleate

141-05-9(8)

3,4-Dihydrocoumarin

119-84-6(9)2,4-Dihydroxy-3-methylbenzaldehyde

6248-20-0(10) 3,7-Dimethyl-2-octen-1-ol
Dihydrogeraniol)

CAS
number40607-48-5(6,7-(11) 4,6-Dimethyl-8-tert-butylcoumarin

17874-34-9(12) Dimethyl citraconate

617-54-9(13) 7,11-Dimethyl-4.,6,10-dodecatrien-3-one

Pseudomethyl-ionone

26651-96-7(14) 6,10-Dimethyl-3.,5,9-undecatrien-2-one

Pseudoionone

141-10-6(15) Diphenylamine

122-39-4(16) Ethyl acrylate

140-88-5(17) Fig leaf, fresh and preparations absolute(Ficus carica L.)

68916-52-9(18) trans-2-Heptenal18829-55-5(19) trans-2-Hexenal diethyl acetal

67746-30-9(20) trans-2-Hexenal dimethyl acetal

18318-83-7(21) Hydroabietyl alcohol

13393-93-6(22) 4-Benzyloxyphenol and 4-Ethoxy-phenol

103-16-2;
622-62-8

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(23) 6-lsopropyl-2-decahydronaphthalenol

34131-99-2(24) 7-Methoxycoumarin

531-59-9(25) 4-MethoxyphenolHydroquinone
methylether;Mequinolp-Hydroxyanisol

150-76-5(26) 4-(p4-Methoxyphenyl)-3-butene-2-one

Anisylidene Acetone

943-88-4(27) 1-(p4-Methoxyphenyl)-1-penten-3-one

alphaMethylanisylideneacetone104-27-8(28) Methyl trans-2-butenoate

623-43-8(29) 6-Methylcoumarin

92-48-8(30) 7-Methylcoumarin2445-83-2(31) 5-Methyl-2,3-hexanedione

13706-86-0

Acetyl isovaleryl(32) Costus root oil (Saussurea lappa Clarke)

8023-88-9(33) 7-Ethoxy-4-methylcoumarin

87-05-8(34) Hexahydrocoumarin

700-82-3(35) Peru balsam, crude ( Exudation of
Myroxylon pereirae (Royle) Klotzsch(Peru balsam, crude)8007-00-9(36) 2-Pentylidene-cyclohexanone

25677-40-1(37) 3.,6,10-Trimethyl-3.,5,9-undecatrien-2-one

Pseudo-Isomethyl ionone

1117-41-5(38) Verbena oilessential oils (Lippia citriodora
Kunth) and derivatives other thanabsolute8024-12-2(39) Musk ambrette (4-tert-Butyl-3-methoxy- Musk ambrette
2,6-dinitrotoluene)

83-66-9(40) 4-PhenylPhenylbut-3-butenen-2-one

Benzylidene acetone122-57-6(41) 2-BenzylideneheptanalAmyl cinnamal

Amyl cinnamal

122-40-7(42) 2-Pentyl-3-phenylprop-2-en-1-ol
Amylcinnamyl alcohol

Amylcinnamyl alcohol

101-85-9(43) Benzyl alcohol

100-51-6(44) Benzyl salicylate

118-58-1(45) Cinnamyl alcohol

104-54-1(46) 2-Propenal, 3-phenyl-Cinnamal
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104-55-2

Cinnamal
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(47) 3,7-Dimethyl-2,6-octadienalCitral

Citral5392-40-5(48) 2H-1-Benzopyran-2-oneCoumarin

Coumarin

91-64-5(49) Phenol,
Eugenol

2-methoxy-4-(2-propenyl) Eugenol

97-53-0(50) 2,6-Octadien-1-ol, 3,7-dimethyl-, (2E)- Geraniol
Geraniol

106-24-1(51) 7-Hydroxy-citronellal

107-75-5

Hydroxycitronellal(52) HydroxyHICC
methylpentylcyclohexenecarboxaldehyde3and
4-(4-Hydroxy-4-methylpentyl)
cyclohex-3-ene-1-carbaldehyde

51414-25-6;
31906-04-4(53) Phenol,
Isoeugenol

97-54-1

2-methoxy-4-(1-propenyl) Isoeugenol(54) Oakmoss extractsextract

Evernia prunastri extract

90028-68-5(55) Treemoss extractsextract

Evernia furfuracea extract

90028-67-4(56) Atranol(2,6-Dihydroxy-4-methyl- Atranol
benzaldehyde)526-37-4(57) Chloroatranol (3-Chloro-2,6-Dihydroxy- Chloratranol
4-methyl-benzaldehyde)

57074-21-2(58) Methyl Oct-2-ynoate (Methyl heptine Methyl 2-Octynoate
carbonate)111-12-6(59) 2-(4-tert-butylbenzyl) propionaldehyde

80-54-6

9740/1/24 REV 1
ANNEX

Lilial

TM/nm
COMPET.1

145

EN

Part B. Substances subject to specific labelling requirements
1.

The names of the following fragrance allergens shall be listed on the toy, on an affixedlabel, on the packaging or in an accompanying leaflet, as well as in the digital productpassport, if those allergens are added to a toy, where they are present in the toy or any
component thereof at concentrations exceeding 10010 mg/kg:
The information mentioned shall be expressed by using the common ingredient name ora term as contained in a generally accepted nomenclature.

No

Name of the allergenic fragranceCchemical Common name
name

CAS number(1)

4-Methoxybenzyl alcoholAnisyle alcohol

Anise alcohol

105-13-5(2)

Benzyl benzoate

Benzyl benzoate

120-51-4(3)

2-Propenoic acid, 3-phenyl-, phenylmethyl Benzyl cinnamate
ester

103-41-3

Benzyl cinnamate(4)

Citronellol3,7-Dimethyl-6- octen-1-ol

106-22-9;26489-01-0;
1117-61-9;
7540-51-4

Citronellol(3R)-3,7dimethyloct-6-en-1Citronellol)

ol

(D-

(3S)-3,7dimethyloct-6-en-1Citronellol)

ol

(L-

(5)

2,6,10-Dodecatrien-1-ol,
Farnesol(6)2-Benzylide-neoctanal Hexyl cinnamaldehyde(7)

Lilial(8)d-Limonene1-methyl-4-prop-1cyclohexene;

4602-84-0

3,7,11-trimethyl Farnesol
Hexyl cinnamaldehyde

101-86-0
80-54-6

en-2-yl- Limonene

138-86-3;
7705-14-8;
5989-27-5;
5989-54-8

dl-limonene (racemic);
Dipentene(R)-p-mentha-1,8- diene; (d-limonene)(S)-p-mentha-1,8- diene; (l-limonene)(9)1,6-Octadien-3-ol,3,7-dimethyl Linalool(10) 3-methyl-4-(2.6,6-trimethyl-2-cyclohexen-19740/1/24 REV 1
ANNEX

Linalool

78-70-6alpha-Isomethyl ionone

127-51-5

TM/nm
COMPET.1

146ENyl)-3-buten-2-one
3-Methyl-4-(2,6,6- trimethyl-2-cyclo-hexen1-yl)-3-buten-2-one(11) [3R(3α,3aβ,7β,8aα)]-1(2,3,4,7,8,8a- Acetyl Cedrene
hexahydro-3,6,8,8tetramethyl-1H-3a,7methanoazulen-5- yl)ethan-1-one Acetyl
cedrene32388-55-9(12) Pentyl-2-hydroxy-benzoateAmyl salicylate
1-propen-1-yl-benzene(13) 1-Methoxy-4-(1E)(trans-Anethole)trans-Anethole(14) Benzaldehyde
1,7,7-Trimethylbi(15) Bornan-2-one;
cyclo[2.2.1]-2-hept-anoneCamphor

Amyl Salicylate

2050-08-0

Anethole

104-46-1;
4180-23-8
100-52-7(16) Carvone2-methyl-5-(prop-1-en-2-yl)cyclohex2-en-1-one(5R)-2-Methyl-5-prop-1-en-2-ylcyclohex-2en-1- one(5S)-2-Methyl-5-prop-1-en-2-ylcyclohex-2en-1-one(17) beta-Caryophyllene (ox.) (1R,4E,9S)-4,11,11Trimethyl-8-methylenebi-cyclo[7.2.0]undec4-Ene(18) 1-(2,6,6-Trimethyl-cyclohexa-1,3-dien-1-yl)2-buten-1-one
Rose ketone-4 (Damascenone )(19) alpha-Damascone(TMCHB)
1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2buten-1-one

CarvoneBenzaldehyde

76-22-2;
21368-68-3;
464-49-3;
464-48-2
99-49-0;6485-40-1;
2244-16-8

Camphorbeta-Caryophyllene

87-44-5Roseketone-4 23696-85-7(Damascenone )alpha-Damascone;
cis-Rose ketone 1;
trans-Rose ketone 1

43052-87-5;
23726-94-5;
24720-09-0(20) cis-beta-Damascone (Z)-1-(2,6,6- Trimethyl- cis-Rose ketone 2 (cis- 23726-92-3
1-cyclohexen-1-yl)-2-buten-1-one
beta-Damascone)

(21)

(22)
(23)
(24)

(E)-1-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2buten-1-one
delta-Damascone
1-(2,6,6-Trimethyl-3cyclohexen-1-yl)-2-buten-1-one
1-(2,6,6-Trimethyl-3-cyclohexen-1-yl)2-buten-1-one
2-Methyl-1-phenyl-2-propyl acetate;
Dimethylbenzyl Carbinyl Acetate
Dimethylbenzyl carbinyl acetate (DMBCA)
Oxacycloheptadecan-2-one
Hexadecanolactone
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-

9740/1/24 REV 1
ANNEX

trans-Rose ketone 2 23726-91-2(trans-beta-Damascone)
Rose ketone 3 (delta- 57378-68-4
Damascone)trans-Rose ketone 371048-82-3
Dimethyl
Phenethyl 151-05-3
Acetate (DMBCA)
Hexadecanolactone

109-29-5

Hexamethylindanopyran1222-05-5

TM/nm
COMPET.1

147

ENhexamethylcyclopenta-γ-2-benzopyran
Hexamethylindanopyran(25) (DL)-Limonene(26) 3,7-Dimethyl octa-1,6-diene-3-yl acetate
Linayl acetate(27) Menthol dl-Menthol (Menthol racemic)
Mentholl-menthol (Levomenthol)d-menthol(28) Methyl 2-hydroxybenzoate Methyl salicylate(29) 3-Methyl-5-(2,2,3-trimethyl-3cyclopentenyl)pent-4-en-2-ol
Trimethylcyclopentenyl Methylisopentenol
3-Methyl-5-(2,2,3-trimethyl-3cyclopentelnyl)pent-4-en-2-ol(30) 2,6,6-Trimethylbicyclo[3.1.1]hept-2-ene(alpha-Pinene);138-86-3
Linayl acetate115-95-7

Menthol

1490-04-6;
89-78-1;
2216-51-5;
15356-60-2
119-36-8

Methyl salicylate
Trimethylcyclopentenyl
Methylisopentenol

67801-20-1

Pinene80-56-8;7785-70-8;
127-91-3;
18172-67-3

6,6-Dimethyl2Methylenebicyclo[3.1.1]heptane(betaPinene)alpha-Pinene(31) beta-Pinene
3-Propylidenephthalide(32) 3-Propylidene-1(3H)-isobenzofuranone
Propylidene phthalide
Salicylaldehyde(33) o-Hydroxy-benzaldehyde Salicylaldehyde
Santalol(34) alpha-Santalol5-(2,3Dimethyltricyclo[2.2.1.02,6]-hept-3-yl)-2methylpent-2-en-1-ol ;Alpha-Santalol;(1S-(1a,2a(Z),4a))-2-Methyl-5-(2-methyl-3methylenebicyclo[2.2.1]hept-2-yl)-2-penten1-ol (beta-Santalol)(35) beta-Santalol(36) Sclareol[1R-(1α)]-α-Ethenyldecahydro-2hydroxy-α,2,5,5,8a-pentamethyl-1naphthalenepropanol(37) alpha-Terpineol2-(4-methylcyclohex-3-en-1yl)propan-2-ol;

127-91-3
17369-59-4
90-02-811031-45-1;
115-71-9;
77-42-9

77-42-9
Sclareol

515-03-7

Terpineol

8000-41-7
10482-56-1;
98-55-5;
138-87-4;
586-81-2;

p-Menth-1-en-8-ol (alpha-Terpineol);
1-methyl-4-(1-methyl-vinyl)cyclohexan-1-ol(beta-Terpineol);
1-methyl-4-(1-methylethylidene)cyclohexan1-ol (gamma-Terpineol)

9740/1/24 REV 1
ANNEX

TM/nm
COMPET.1

148

EN

(38) Terpineol (mixture of isomers)(39) Terpinolene p-Mentha-1,4(8)-diene

8000-41-7
Terpinolene

586-62-9(40) Tetramethyl acetyloctahydro naphthalenes
1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8tetramethyl-2-naphthyl)ethan-1-one;
1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5tetramethyl-2-naphthyl)ethan-1-one;
1-(1,2,3,5,6,7,8,8aoctahydro-2,3,8,8tetramethyl-2-naphthyl)ethan-1-one;
1-(1,2,3,4,6,7,8,8aoctahydro-2,3,8,8tetramethyl-2-naphthyl)ethan-1-one(41) Trimethyl benzenepropanol (Majantol)
3-(2,2-Dimethyl-3-hydroxypropyl)toluene

Tetramethyl
acetyloctahydronaphthalenes

54464-57-2;
54464-59-4;
68155-66-8;
68155-67-9

Trimethyl
benzenepropanol

103694-68-4(42) Vanillin4-Hydroxy-3-methoxybenzaldehyde(43) Cananga odorata flower oil and extract;

Vanillin

121-33-5

Cananga
Odorata
Flower Extract;
Ylang Ylang flower oil and extractCananga Cananga
Odorataodorata and Ylang-ylang oil
Flower Oil
Cedrusatlanticabarkoil
Cedrus Atlantica Bark
(44)
Cedrus atlantica oil and extract
Extract;
Cedrus Atlantica Bark
Oil;
Cedrus Atlantica Bark
Water;
Cedrus Atlantica Leaf
Extract;
Cedrus Atlantica Wood
Extract;
Cedrus Atlantica Wood
Oil(45) Cinnamomum cassia leaf oil(46) Cinnamomum zeylanicum bark oil(47) Citrus aurantium amara dulcis flower oil
Citrus aurantium dulcis peel oil

8007-80-5;
84961-46-6
84649-98-9;
8015-91-6
Citrus aurantium dulcis 8016-38-4;
flower oil
8028-48-6
Citrus aurantium dulcis 97766-30-8peel oil8028-48-6(48) Citrus aurantium amara peel flower oil
Citrus aurantium amara peel peel oil

9740/1/24 REV 1
ANNEX

83863-30-3;
8006-81-3;
68606-83-7;
93686-30-7
92201-55-3;
8023-85-6
8000-27-9

Citrus Sinensis
8008-57-9
Peel Oil
Citrus aurantium amara 72968-50-4
flower oil
Citrus aurantium amara 68916-04-1
peel peel oil
72968-50-4
TM/nm

COMPET.1

149

EN

(49) Citrus aurantium bergamia peel oil expressed

Citrus limonum peel oil(50) Citrus limon oil
Citrus limonum peel oil expressed(51) Citrus sinensis (syn.: Aurantium dulcis) peel oil
expressed

89957-91-5;
8007-75-8;68648-33-9;
8007-75-8;
85049-52-1
84929-31-7;
8008-56-8
97766-30-8;
8028-48-6(52) Cymbopogon Schoenanthus Oil
Cymbopogon Flexuosus Oil
Cymbopogon
Citratus
OilCymbopogon
citratus / schoenanthus oils

89998-14-1;
8007-02-01;
89998-16-3;
91844-92-7(53)92502-70-0;
97926-40-4;
8000-48-4

(54)

(55)

(56)
(57)

CitrusAurantium
Bergamia Peel Oil

Cymbopogon
Schoenanthus Oil;
Cymbopogon Flexuosus
Oil;
Cymbopogon
Citratus
Leaf Oil
Eucalyptus Globulus Oil
Eucalyptus
Globulus
Eucalyptus spp. leaf oil
Leaf Oil;
Eucalyptus
Globulus
Leaf/Twig Oil
Eugenia Caryophyllus Oil
Eugenia
Caryophyllus
Eugenia caryophyllus leaf / flower oil
Leaf Oil;
Eugenia
Caryophyllus
Flower Oil;
Eugenia
Caryophyllus
Stem oil;
Eugenia
Caryophyllus
Bud oil
Jasminum Grandiflorum /Officinale Oil and Jasminum Grandiflorum
ExtractJasminum grandiflorum / officinale
Flower Extract;
Jasminum Officinale Oil;
Jasminum
Officinale
FlowerExtractJasminum
Juniperus Virginiana Oil
Juniperus Virginiana Oil
Juniperus virginiana
Juniperus
Virginiana
Wood Oil
Laurus nobilis fruit oil
Laurus nobilis fruit leafoil(58) Laurus nobilis leaf oil(59) Laurus nobilis seed oil

84776-64-7;
90045-94-6;
8022-96-6;
8024-43-9;90045-94-6
8000-27-9;
85085-41-2
8007-48-5;
8002-41-3;
84603-73-6
8002-41-3
84603-73-6(60) Lavandula Hybrida Oil/Extract;

Lavandula Hybrida Oil
LavandulaHybridaExtract;
LavandulaHybridaFlower Extract;

Lavandula Intermedia Oil/Extract;
9740/1/24 REV 1
ANNEX

8000-34-8;
8015-97-2;
84961-50-2
84961-50-2
84961-50-2
84961-50-2

TM/nm
COMPET.1

91722-69-9;
8022-15-9;93455-96-0;93455-97-1;
92623-76-2;
150ENLavandula Intermedia
Flower/Leaf/Stem
Extract;
Lavandula Intermedia
Flower/Leaf/Stem Oil;
Lavandula Intermedia
Lavandula Angustifolia Oil ExtractLavandula Oil;hybridaLavandula Angustifolia
Oil;
Lavandula Angustifolia
Flower/Leaf/Stem
Extract
Lavandula
officinalis(61)(62) Mentha piperita oil
(63)
(64)

(65)
(66)
(67)
(68)
(69)

(70)
(71)

84776-65-8;
8000-28-0;
90063-37-9;84776-65-8;
8000-28-0;
90063-37-9

84776-65-8

8006-90-4;
84082-70-2
Mentha spicata
Mentha Viridis Leaf Oil 84696-51-5;
Mentha spicata oil (spearmint oil)
8008-79-5
Narcissus Poeticus Extract
Narcissus
Poeticus 90064-26-9;/ Pseudonarcissus
Extract
68917-12-4/ Jonquilla / Tazetta Extract Narcissus spp.
Narcissus
90064-27-0
Pseudonarcissus Flower 90064-25-8
diverseExtract
Narcissus
Jonquilla
Extract
Narcissus
Tazetta
Extract
Pelargonium graveolens oil
Pelargonium graveolens 90082-51-2;
8000-46-2
flower oil
90082-72-7
Pinus Mugo Leaf Oil; Pinus Mugo Twig Leaf
Extract; Pinus Mugo Twig OilPinus mugo
97676-05-6
Pinus Pumila Needle Extract; Pinus Pumila
Twig Leaf Extract; Pinus Pumila Twig Leaf
OilPinus pumila
Pogostemon cablin oil
8014-09-03;
84238-39-1
Rosa Damascena Flower Oil; Rosa
8007-01-0;
Damascena Flower Extract;
90106-38-0
Rosa Alba Flower Oil; Rosa Alba Flower
93334-48-6
Extract;
84696-47-9;
Rosa Canina Flower Oil; Rosa Centifolia
84604-12-6;
Flower Oil; Rosa Centifolia Flower Extract;84604-13-7;
Rosa Gallica Flower Oil;
92347-25-6
DiverseRosa Moschata Flower Oil; Rosa Rugosa
Flower Oil Rose flower oil (Rosa spp.)
Santalum album oil
84787-70-2;
8006-87-9
8006-64-2;
Turpentine gum (Pinus spp.);
Turpentine
9005-90-7;
Turpentine oil and rectified oil;
8052-14-0
Turpentine, steam distilled (Pinus

9740/1/24 REV 1
ANNEX

TM/nm
COMPET.1

151

ENspp.)Turpentine (oil)9740/1/24 REV 1
ANNEX

TM/nm
COMPET.1

152

EN

2.

The use of fragrances referred to in entries 41 to 51 and 53 to 55 in the table in Part A, point

4, and of fragrances referred to in points 1 to 109 in the table in point 1 of this Part shall be allowedin olfactory board games, cosmetic kits and gustative games, under the following conditions:(a)the fragrances are clearly labelled on the packaging of the toy, and the
packaging contains the warning referred to in point 11 of Annex III;(b)where applicable, the resulting products made by the child in accordance withthe manufacturer’s instructions comply with Regulation (EC) No 1223/2009;
and

(c)

where applicable, the fragrances comply with the relevant Union legislationlaw
on food.

Such olfactory board games, cosmetic kits and gustative games shall not be used bychildren under 36 months and shall comply with point 2 of Annex III.

9740/1/24 REV 1
ANNEX

TM/nm
COMPET.1

153

EN

Part C. Permitted usespresence of substances subject to generic prohibitions under Part III,
point 4, of Annex II
Substance

Classification

Permitted use

NickelCarc 2

In toys and toy components
made of stainless steel.
In toy components which areintended to conduct anelectric current.

CobaltCarc 1B, Muta 2, Repr 1B

In metal toy components
intended to conduct electric
current.
[In metal toy componentsthat serve a function otherthan electrical conductancesuch as metal toys, toy
jewellery, fidget spinners,
magnets.]1

Titanium Dioxide

1
2

[…]2

Carc 2The permitted use will be adapted at a later stage, following Chemicals Working
Group Meeting.
The permitted use will be adapted at a later stage, following Chemicals Working
Group Meeting.

9740/1/24 REV 1
ANNEX

TM/nm
COMPET.1

154

EN

ANNEX IIIWARNINGS AND INDICATIONS OF PRECAUTIONS TO BE TAKEN WHEN USINGCERTAIN CATEGORIES OF TOYS
1. General rules - presentation
All warnings shall be preceded by the word ‘Warning’ or, alternatively, by a in the form offollowing generic pictogram such as the following, without the obligation to repeat it before
each warning:

The pictogram size should be at least 10 mm in black triangle, yellow background and black
exclamation mark.

9740/1/24 REV 1
ANNEX

TM/nm
COMPET.1

155

EN

2. Toys not intended for use by children under 36 months
Toys which might be dangerous for children under 36 months shall bear a warning such as ‘Not
suitable for children under 36 months’ or ‘Not suitable for children under three years’ or a warningin the form of the following pictogram:

The pictogram size should be at least 10 mm, with a red circle and stroke, white backgroundand black age range and face.
These warnings shall be accompanied by a brief indication, which may appear in the instructions foruse, of the specific hazard calling for this precaution.
This point shall not apply to toys which, on account of their function, dimensions, characteristics orproperties, or on other cogent grounds, are manifestly unsuitable for children under 36 months.
3. Activity toys
Activity toys shall bear the following warning:‘Only for domestic use’.
Activity toys attached to a crossbeam as well as other activity toys, where appropriate, shall beaccompanied by instructions drawing attention to the need to carry out checks and maintenance ofthe main parts (suspensions, fixings, anchorages, etc.) at certain intervals, and pointing out that the
toy may cause a fall or overturn if such checks are not carried out.
Instructions shall also be given as to the correct assembly of the toy, indicating those parts which
can present a danger if incorrectly assembled. Specific information regarding a suitable surface on
which to place the toy shall be given.

9740/1/24 REV 1
ANNEX

TM/nm
COMPET.1

156

EN

4. Functional toys
Functional toys shall bear the following warning:‘To be used under the direct supervision of an adult’.
In addition, functional toys shall be accompanied by directions giving working instructions as wellas the precautions to be taken by the user, with the warning that failure to follow such working
instructions or take such precautions will expose the user to the hazards normally associated withthe appliance or product of which the toy is a scale model or imitation. Those hazards shall be
specified in the warning. It shall also be indicated that the toy is to be kept out of the reach ofchildren under a certain age, which shall be specified by the manufacturer.
5. Chemical toys
Without prejudice to the application of the provisions laid down in applicable Union legislation on
the classification, packaging and labelling of certain substances or mixtures, the instructions for useof toys containing inherently dangeroushazardous substances or mixtures shall bear a warning of
the dangeroushazardous nature of those substances or mixtures and an indication of the precautions
to be taken by the user in order to avoid hazards associated with them. These precautions shall be
specified concisely and shall relate to the type of toy. The first aid to be given in the event ofserious accidents resulting from the use of the relevant type of toy shall also be mentioned. It shallalso be stated that the toy is to be kept out of reach of children under a certain age, which shall be
specified by the manufacturer.
In addition to the instructions referred to in the first subparagraph, chemical toys shall bear thefollowing warning on their packaging:‘Not suitable for children under …1 years. For use under adult supervision’.

1

Age to be specified by the manufacturer.

9740/1/24 REV 1
ANNEX

TM/nm
COMPET.1

157

EN

6. Skates, roller skates, inline skates, skateboards, scooters and toy bicycles
Where skates, roller skates, inline skates, skateboards, scooters and toy bicycles are offered for saleas toys, they shall bear the following warning:‘Protective equipment should be worn. Not to be used in traffic’.
The instructions for use shall contain a reminder that the toy is to be used with caution, since it
requires great skill, so as to avoid falls or collisions causing injury to the user or third parties.
Indications shall also be given as to recommended protective equipment (helmets, gloves, kneepads, elbow-pads, etc.).
7. Aquatic toys
Aquatic toys shall bear the following warning:‘Only to be used in water in which the child is within his or herits depth and under adultsupervision’.
8. Toys in foodToysThe following warning for toys contained in food or co-mingled with food shall bear thefollowing warning be visible before the purchase:‘Toy inside. Adult supervision recommended’.

9740/1/24 REV 1
ANNEX

TM/nm
COMPET.1

158

EN

9. Imitations of protective masks and helmets
Where imitations of protective masks and helmets are offered for sale as toys, they shall bear thefollowing warning:‘This toy does not provide protection’.
10. Toys intended to be strung across a cradle, cot or perambulator by means of strings,
cords, elastics or straps
For toys intended to be strung across a cradle, cot or perambulator by means of strings, cords,
elastics or straps, the following warning shall be given on the packaging of the toy and shall bepermanently marked on the toy:
‘To prevent possible injury by entanglement, remove this toy when the child starts trying to get up
on its hands and knees in a crawling position’’.
11. Packaging for fragrances in olfactory board games, cosmetic kits and gustative games
Packaging for fragrances in olfactory board games, cosmetic kits and gustative games that containfragrances referred to in entries 41 to 51 and 53 to 55 in the table in Part A, point 4, of the
Appendix to Annex II and of fragrances referred to in entries 1 to 109 in the table in Part B, point 1,of that Appendix shall contain the following warning:‘Contains fragrances that may cause allergies’.

9740/1/24 REV 1
ANNEX

TM/nm
COMPET.1

159

EN

ANNEX IV
CONFORMITY ASSESSMENT PROCEDURES
Part I - Module A: Internal production control
1.

Internal production control is the conformity assessment procedure whereby the
manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures anddeclares, on the manufacturer’s sole responsibility, that the toy satisfies the requirements ofthis Regulation.

2.

Technical documentation
The manufacturer shall establish the technical documentation. The documentation shallmake it possible to assess the product's conformity to the relevant requirements, and shall
include an adequate analysis and assessment of the risk(s). The technical documentation
shall specify the applicable requirements and cover, to the extent relevant for theassessment, the design, manufacture and operation of the toy. The technical documentation
shall contain at least the elements set out in Annex V.

3.

Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process andits monitoring ensure compliance of the manufactured products with the technicaldocumentation referred to in point 2 and with the requirements of this Regulation.

9740/1/24 REV 1
ANNEX

TM/nm
COMPET.1

160

EN

4.

CE marking and digital product passport

4.1.

The manufacturer shall affix the CE marking to each individual toy that satisfies theapplicable requirements of this Regulation.

4.2.

The manufacturer shall draw upcreate the digital product passport for a toy model andensure that together with the technical documentation, it remains available for 10 years
after the product has been placed on the market. The digital product passport shall identify
the toy for which it has been drawn upcreated.

5.

Authorised representative
The manufacturer's obligations set out in point 4 may be fulfilled by the manufacturer’s
authorised representative, on the manufacturer’s behalf and under the manufacturer’s
responsibility, provided that they are specified in the mandate.

9740/1/24 REV 1
ANNEX

TM/nm
COMPET.1

161

EN

Part II - Module B : EU-type examination
1.

EU-type examination is the part of a conformity assessment procedure in which a notified
body examines the technical design of a toy and verifies and attests that the technicaldesign of the toy meets the requirements of this Regulation.

2.

EU-type examination may be carried out in any of the following manners:(a)examination of a specimen, representative of the production envisaged, of thecomplete toy (production type),(b)assessment of the adequacy of the technical design of the toy through an examinationof the technical documentation and supporting evidence referred to in point 3, plus
examination of specimens, representative of the production envisaged, of one ormore critical parts of the toy (combination of production type and design type),(c)assessment of the adequacy of the technical design of the toy through an examinationof the technical documentation and supporting evidence referred to in point 3,
without examination of a specimen (design type).

3.

The manufacturer shall lodge an application for EU-type examination with a single notified
body of the manufacturer’s choice.
The application shall include:(a)the name and address of the manufacturer and, if the application is lodged by theauthorised representative, as well as the name and address of that representative,(b)a written declaration that the same application has not been lodged with any othernotified body,

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(c)

the technical documentation, which is to make it possible to assess the product's
conformity with the applicable requirements of this Regulation and is to include anadequate analysis and assessment of the risk(s), including the safety assessment
referred to in Article 21; it is to specify the applicable requirements and cover, to theextent relevant for the assessment, the design, manufacture and operation of the toy;
and it is to contain at least the elements set out in Annex V,(d)the specimens representative of the production envisaged. The notified body may
request further specimens if needed for carrying out the test programme,(e)the supporting evidence for the adequacy of the technical design solution; it is tomention any documents that have been used, in particular where the relevant
harmonised standards and/or technical specifications have not been applied in full;and it is to include, where necessary, the results of tests carried out by the appropriate
laboratory of the manufacturer, or by another testing laboratory on the
manufacturer’s behalf and under the manufacturer’s responsibility.

4.

The notified body shall:
For the toy:

4.1.

examine the technical documentation and supporting evidence to assess the adequacy of its
technical design;
For the specimen:

4.2.

verify that the specimen has been manufactured in conformity with the technicaldocumentation, and identify the elements which have been designed in accordance with theapplicable provisions of the relevant harmonised standards and/or common specifications,as well as the elements which have been designed without applying the relevant provisionsof those standards and/or common specifications;

4.3.

carry out appropriate examinations and tests, or have them carried out, to check whether,where the manufacturer has chosen to apply the solutions in the relevant harmonised
standards and/or common specifications, these have been applied correctly;

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4.4.

carry out appropriate examinations and tests, or have them carried out, to check whether,where the solutions in the relevant harmonised standards and/or common specifications
have not been applied, the solutions adopted by the manufacturer meet the corresponding
essential safety requirements of the legislative instrument;

4.5.

agree with the manufacturer on a location where the examinations and tests will be carried
out.

5.

The notified body shall draw up an evaluation report that records the activities undertakenin accordance with point 4 as well as their results. Without prejudice to its obligations vis-à
vis the notifying authorities, the notified body shall release the content of that report, in fullor in part, only with the agreement of the manufacturer.

6.

Where the type meets the requirements of this Regulation, the notified body shall issue an
EU-type examination certificate to the manufacturer. The EU type examination certificate
shall include a reference to this Regulation, a colour image, a clear description of the toy,
including its dimensions, and a list of the tests performed, together with a reference of therelevant test report. The certificate shall contain the name and address of the manufacturer,
an indication of the place of manufacture, the conclusions of the examination, theconditions (if any) for its validity and the necessary data for identification of the approved
type. The certificate may have annexes attached.
The certificate and the annexes thereto shall contain all relevant information to allow theconformity of manufactured products with the examined type to be evaluated and to allow
for in-service control.
Where the type does not satisfy the applicable requirements of this Regulation, the notified
body shall refuse to issue an EU-type examination certificate and shall inform the applicant
accordingly, giving detailed reasons for its refusal.

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7.

The notified body shall keep itself apprised of any changes in the generally acknowledged
state of the art which indicate that the approved type might no longer comply with thisRegulation, and shall determine whether such changes require further investigation. If so,
the notified body shall inform the manufacturer accordingly.
The manufacturer shall inform the notified body that holds the technical documentation
relating to the EU-type examination certificate of all modifications to the approved typethat may affect the conformity of the toy with the essential safety requirements of thisRegulation or the conditions for validity of the certificate. Such modifications shall require
additional approval in the form of an addition to the original EU-type examination
certificate.

8.

Each notified body shall inform its notifying authorities of the EU-type examination
certificates and/or any additions thereto which it has issued or withdrawn, and shall,periodically or upon request, make available to its notifying authorities the list ofcertificates and/or any additions thereto refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies of the EU-type examination
certificates and/or any additions thereto which it has refused, withdrawn, suspended orotherwise restricted, and, upon request, concerning the certificates and/or additions thereto
which it has issued.
Member States, the Commission and the other notified bodies may, on request, obtain acopy of the EU-type examination certificates and/or additions thereto. On request, Member
States and the Commission may obtain a copy of the technical documentation and theresults of the examinations carried out by the notified body. The notified body shall keep a
copy of the EU-type examination certificate, its annexes and additions, as well as thetechnical file including the documentation submitted by the manufacturer, until the expiryof the validity of the certificate.

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9.

The manufacturer shall keep a copy of the EU-type examination certificate, its annexes andadditions together with the technical documentation at the disposal of the national
authorities for 10 years after the toy has been placed on the market.

10.

The manufacturer's authorised representative may lodge the application referred to in point
3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the
mandate.

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Part III- Conformity to type based on internal production control (module C)
1.

Conformity to type based on internal production control is the part of a conformity
assessment procedure whereby the manufacturer fulfils the obligations laid down in points
2 and 3, and ensures and declares that the products concerned are in conformity with thetype described in the EU-type examination certificate and satisfy the requirements of thelegislative instrument that apply to them.

2.

Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process andits monitoring ensure conformity of the manufactured products with the approved typedescribed in the EU-type examination certificate and with the requirements of thelegislative instrument that apply to them.

3.

CE marking and digital product passport

3.1.

The manufacturer shall affix the CE marking to each individual product that is inconformity with the type described in the EU-type examination certificate and satisfies theapplicable requirements of the legislative instrument.

3.2.

The manufacturer shall create a digital product passport for a toy model and ensure that itremains available for 10 years after the toy has been placed on the market. The digitalproduct passport shall identify the toy for which it has been drawn upcreated.

4.

Authorised representative
The manufacturer's obligations set out in point 3 may be fulfilled by the manufacturer’s
authorised representative, on the manufacturer’s behalf and under the manufacturer’s
responsibility, provided that they are specified in the mandate.

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ANNEX V
ELEMENTS TO BE INCLUDED IN THE TECHNICAL DOCUMENTATION(as referred to in Article 23)(1)

A detailed description of the design and manufacture, including a list of components andmaterials used in the toy as well as the safety data sheets on substances and mixtures used,
to be obtained from the chemical suppliers;(2)

The safety assessment(s) carried out in accordance with Article 21;(3)

A description of the conformity assessment procedure followed;(4)

The addresses of the places of manufacture and storage;(5)

Copies of documents that the manufacturer has submitted to any notified body,(6)

Test reports and description of the means whereby the manufacturer ensured conformity of
production with the harmonised standards or common specifications, if the manufacturer
followed the internal production control procedure referred to in Article 22(2); and(7)a copy of the EU-type examination certificate, a description of the means whereby the
manufacturer ensured conformity of the production with the product type as described in
the EU-type examination certificate, and copies of the documents that the manufacturer
submitted to the notified body, if the manufacturer submitted the toy to EU-type
examination and followed the conformity to type procedure referred to in Article 22(3).

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ANNEX VI
DIGITAL PRODUCT PASSPORTPart I – Information to be included in the digital product passport(a)unique product identifier of the toy;(b)

name and address of the manufacturer orand, when applicable, of the
manufacturer’s authorised representative, as well as the unique operator identifier;(c)name and address of the economic operator responsible for carrying out the tasks set
out in Article 4 of Regulation (EU) 2019/1020, as well as the unique operator
identifier;(ca) the mention that this passport is issued under the sole responsibility of the
manufacturer;(d)object of the passport (identification of toy allowing traceability, including a colour
image of sufficient clarity to enable the identification of the toy;);(e)the commodity code, as defined in Council Regulation (EEC) No 2658/8731 underwhich the toy is classified at the moment the passport is created, as set out in Council
Regulation (EEC) No 2658/8732;(f)references to all Union legislationlaw that the toy complies with;(g)references to the relevant harmonised standards used, or references to common
specifications in relation to which conformity is declared;(h)where applicable: the notified body name and number which has intervened in theconformity assessment procedure and issued a certificate, as well as the reference tothe certificate;

(i)
31
32

the CE marking;Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statisticalnomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).
Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statisticalnomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

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(j)

a list of allergenic fragrances that are present in the toy and that are subject tospecific labelling requirements as set out in Part B, point 1, of the Appendix toAnnex II;(k)any substance of concern that is present in the toy. at a concentration exceeding
1000 mg/kg;(l)

the reference of the digital product passport service provider hosting the backup copy of the digital product passport.

Part II – Information that may be included in the digital product passport(a)safety information and warnings;(b)

instructions of use.

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ENANNEX VII
LIST OF COMMODITY CODES AND PRODUCT DESCRIPTIONS FOR THE PURPOSES
OF ARTICLE 20(8)1ex 3604; pyrotechnic toys2

ex 61, ex 62 Fancy dresses for children under 14 years of age, excluding goods
classified under 6111, 6112, 6115, 6116, 6209, 6211, 6212, 6213, 6216

3

ex 8711, ex 8712, ex 8714 Children's cycles, whether or not motorised, and parts
thereof.

4

ex 9503 Tricycles, scooters, pedal cars and similar wheeled toys; dolls' carriages;
dolls; other toys; reduced-size ('scale') models and similar recreational models,
working or not; puzzles of all kinds

4aex 9504 Video game consoles and machines, table or parlour games, including
pintables, billiards

5

ex 9505 Festive, carnival or other entertainment articles, including conjuring tricks
and novelty jokes

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ANNEX VIII
CORRELATION TABLE
Directive 2009/48/EC

This Regulation

Article 1

Article 1

Article 2(1)Article 2(1)Article 2(2)Article 2(2)Article 3(1)Article 3(1)Article 3(2)Article 3(2)Article 3(3)Article 3(3)Article 3(4)Article 3(4)Article 3(5)Article 3(5)Article 3(6)Article 3(6)Article 3(7)Article 3(8)Article 3(8)Article 3(10)-Article 3(9)Article 3(10)Article 3(22)Article 3(11)Article 3(20)Article 3(12)Article 3(21)Article 3(13)Article 3(26)Article 3(14)Article 3(27)Article 3(15)-Article 3(16)Article 3(12)Article 3(17)-Article 3(18)Article 3(29)Article 3(19)Article 3(30)Article 3(20)-9740/1/24 REV 1
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Article 3(21)Article 3(31)Article 3(22)Article 3(32)Article 3(23)Article 3(33)Article 3(24)Article 3(34)Article 3(25)Article 3(35)Article 3(26)-Article 3(27)Article 3(24)Article 3(28)Article 3(25)Article 3(29)-Article 4(1)Article 7(1)Article 4(2)Article 7(2)Article 4(3)Article 7(3)Article 4(4)Article 7(4)Article 4(5)Article 7(5)Article 4(6)Article 7(6)Article 4(7)Article 7(7)Article 4(8)Article 7(8)Article 4(9)Article 7(9)Article 5(1)Article 8(1)Article 5(2)Article 8(2)Article 5(3)Article 8(3)Article 6(1)Article 9(1)Article 6(2)Article 9(2)Article 6(3)Article 9(3)Article 6(4)Article 9(2)(b)Article 6(5)Article 9(4)9740/1/24 REV 1
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Article 6(6)Article 9(5)Article 6(7)Article 9(6)Article 6(8)Article 9(7)Article 6(9)Article 9(8)Article 7(1)Article 10(1)Article 7(2)Article 10(2)Article 7(3)Article 10(3)Article 7(4)Article 10(4)Article 7(5)Article 10(5)Article 8

Article 11

Article 9

Article 12

Article 10(1)Article 5(1)Article 10(2)Article 5(2)Article 10(3)Article 5(3)Article 11(1) first subparagraphArticle 6(1)Article 11(1) second subparagraphArticle 6(2)Article 11(2)Article 6(3)Article 11(3)-Article 12

Article 4(1)Article 13

Article 13

Article 14-

Article 15-

Article 16(1)Article 15 first subparagraphArticle 16(2)Article 15 second subparagraphArticle 16(3)-Article 16(4)Article 4(2)9740/1/24 REV 1
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Article 17(1)Article 16(1)Article 17(2)Article 16(2)(3)

Article 18

Article 21

Article 19(1)Article 22(1)Article 19(2)Article 22(2)Article 19(3)Article 22(3)Article 20-

Article 21(1)Article 23(1)Article 21(2)Article 23(2)Article 21(3)Article 23(3)Article 21(4)Article 23(4)Article 22

Article 24

Article 23(1)Article 25(1)Article 23(2)Article 25(2)Article 23(3)Article 25(3)Article 23(4)Article 25(4)Article 24(1)Article 26(1)Article 24(2)Article 26(2)Article 24(3)Article 26(3)Article 24(4)Article 26(4)Article 24(5)Article 26(5)Article 24(6)Article 26(6)Article 25

Article 27

Article 26(1)Article 28(1)Article 26(2)Article 28(2)Article 26(3)Article 28(3)9740/1/24 REV 1
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Article 26(4)Article 28(4)Article 26(5)Article 28(5)Article 26(6)Article 28(6)Article 26(7)Article 28(7)Article 26(8)Article 28(8)Article 26(9)Article 28(9)Article 26(10)Article 28(10)Article 26(11)Article 28(11)Article 27

Article 29

Article 28-

Article 29(1)Article 30(1)Article 29(2)Article 30(2)Article 29(3)Article 30(4)Article 29(4)Article 30(5)Article 30(1)Article 31(1)Article 30(2)Article 31(2)Article 30(3)-Article 31(1)Article 32(1)Article 31(2)Article 32(2)Article 31(3)Article 32(3)Article 31(4)-Article 31(5)Article 32(4)Article 31(6)Article 32(5)Article 32(1)Article 33(1)Article 32(2)Article 33(2)Article 33(1)Article 34(1)9740/1/24 REV 1
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Article 33(2)Article 34(2)Article 34(1)Article 35(1)Article 34(2)Article 35(2)Article 34(3)Article 35(3)Article 34(4)Article 35(4)Article 35(1)Article 36(1)Article 35(2)Article 36(2)Article 35(3)Article 36(3)Article 35(4)Article 36(4)Article 35(5)Article 36(5)Article 36(1)Article 38(1)Article 36(2)Article 38(2)Article 37

Article 39

Article 38

Article 40

Article 39-

Article 40-

Article 41(1)Article 38(1)Article 41(2)(3)-

Article 42(1)Article 41(1)Article 42(2)Article 41(2)Article 42(3)Article 41(3)Article 42(4)Article 41(4)Article 42(5)Article 41(5)Article 42(6)Article 41(6)Article 42(7)Article 41(7)Article 42(8)Article 41(8)9740/1/24 REV 1
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Article 43(1)Article 42(1)Article 43(2)Article 42(2)Article 43(3)Article 42(3)Article 44-

Article 45(1)Article 43(1)Article 45(2)Article 43(2)Article 46-

Article 47(1)Article 47(1)Article 47(2)-Article 48-

Article 49

Article 51

Article 50-

Article 51

Article 52

Annex I

Annex I

Annex II Part I

Annex II Part I

Annex II Part II

Annex II Part II

Annex II Part III, 1-2

Annex II, Part III, 1-2

Annex II Part III, 3

Annex II, Part III4

Annex II, Part III, 6

Appendix to Annex II, part C

Annex II Part III, 7-

Annex II, Part III, 8

Appendix to Annex II, part A, point 2

Annex II, Part III, 9

Article 46(8)Annex II, Part III, 10

Annex II, Part III, 8

Annex II, Part III, 11

Appendix to Annex II, Part A, point 4 andPart B, point 1

Annex II, Part III, 12

Appendix to Annex II, Part B, point 2

Annex II, Part III, 13

Appendix to Annex II, Part A, point 1

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Annex II, Part IV

Annex II, Part IV

Annex II, Part V

Annex II, Part V

Annex II, Part VI

Annex II, Part VI

Appendix A

Appendix to Annex II, Part C

Appendix B-

Appendix C

Appendix to Annex II, Part A, point 3

Annex III-

Annex IV

Annex V

Annex V

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