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Your regular update for technical and industry information

EU: New Version of Explanatory Guidance Document for Toys is Now Available

OCTOBER 2021 -  TOYS AND CHILDREN'S PRODUCTS

On 22 September 2021, the European Commission (EC) revised1 the explanatory guidance document for the Toy Safety Directive (TSD) to Rev 1.10. In addition to updating standard and regulatory references, noticeable topics like second-hand toys, online selling, water balloons, material categorisation of squishy toys and test methods for formamide are also addressed.

Highlights of the revision are summarised below.

Section(s)

Title

Updates

1.2.3

Article 2 Scope

How to deal with second-hand toys is explained.

Newly added:
“The placing on the market is understood as the first making available on the EU market for distribution or use. If toys have already been placed on the EU market and are then, after use, made available in the course of a commercial activity as second-hand toys, these second-hand toys are no longer considered as being placed on the market. Measures against second-hand toys can therefore be taken under the General Product Safety Directive (GPSD) on a national basis.”

2.1.1

Article 4 Obligations of manufacturers

Clarified regarding Article 4(7) that instructions and safety information on the web cannot replace those that have to accompany the toy on the packaging, in a leaflet or notice.

Newly added: 
“Manufacturers may also choose to upload instructions and safety information on their webpages. However, this should be regarded only as an additional channel to provide instructions and safety information and does not replace the instructions and safety information that have to accompany the toy (to be provided on the packaging, in a leaflet or notice).”

2.1.4

Article 7 Obligations of distributors

Clarified that instructions and safety information on the web are not sufficient.

3.2.7

fArticle 11 Warnings

Indicated in Article 11(3) that harmonised standard EN 71-1:2014+A1:2018 provides good practice for visibility and legibility of warnings, markings and instructions for use (Clause A.33).

3.6.2

Article 15 EC Declaration of Conformity

Article 15(2) now refers an EC declaration of conformity and any information inserted may be multilingual and can contain all official languages of the European Community or a selection of these depending on the Member State(s) in which the toy is placed or made available. 

6.2

8.2

Article 40 General obligation to organise market surveillance

Article 49 Transparency and confidentiality

Now clarifies that Regulation (EC) No 765/2008 was amended by Regulation (EU) 2019/1020.

10.1.1
10.1.2.3

Annex I list of products that, in particular, are not considered as toys within the meaning of this directive (article 2(1)).

Point 1 of Annex I, decorative objects for festivals and celebrations, folk dolls, decorative dolls and other similar articles, now also refers to Guidance document No. 202 on decorative products and products for collectors.

10.1.2

Point 2 of Annex I now refers to Guidance document No. 6 on the treatment of “grey zone” products - criteria for differentiating dolls for adult collectors from toys

10.1.17

Point 17 of Annex I now clarifies the Low Voltage Directive (LVD) is applicable to child-appealing luminaries and they are not toys.

11.1.19

Annex II particular safety requirements, I physical and mechanical properties

Point 11 of Annex II, Part I clarifies that activity toys shall fulfill also other applicable requirements in the EN 71-series of standards.

11.3.8

Annex II particular safety requirements, III chemical properties

Point 8 of Annex II, Part III now clarifies that also water balloons are intended to be placed in the mouth.

11.3.11

Point 11 of Annex II, Part III: 3 allergenic substances3 that will be prohibited as of 5 July 2022 added to the table and explanatory text adapted.

Point 11 of Annex II, Part III: 61 allergenic substances added to the table that will have to be labelled as of 5 July 2022 and explanatory text adapted.

11.3.13

Point 13 of Annex II, Part III:

  • Updating of the limit values for aluminium, lead and chromium VI;
  • Squishy toy is added as an example for pliable toy material in the table on “Dry, brittle, powder-like or pliable toy material” (Category I under EN 71-3).
11.4.9

The text on toys with LEDs is updated to “The revised EN 62115 contains specific requirements for lasers and LEDs in toys.”

11.9

Appendix C of Annex II regarding specific limit values for chemicals used in toys intended for children under 36 months or in other toys intended to be placed in the mouth

  • Updated in Appendix C the substance list by including bisphenol A (revised limit), formamide, BIT, CMI, MI, phenol, formaldehyde, aniline.
  • Newly added test methods for formamide:

Emission test
The test for formamide should be carried out in accordance with ISO 16000-6 and ISO 16000-9, with the required parameters and decision-making process for the restriction. The selection of test samples should be representative of the whole toy.

Content test
This test method is interim guidance to be considered until a harmonised referenced standard is in place.

This method was written by French SCL laboratories with experience in the measurement of chemicals in toy materials and in particular the formamide content of puzzle mats.

It is possible to use this test method for checking compliance with the cut-off value. It should be adapted, where necessary, to the specific laboratory equipment available.

14.2.1

Annex V Warnings

Addition of references to age-related sources of information:

  • Guidance document No 11 on the classification of toys intended for children under 3 years of age;
  • EN ISO/TR 8124-8:2016 Age determination guidelines (ISO/TR 8124-8:2016).

16

Explanation I – Obligations of economic operators

The table summarising the obligations of economic operators and the link to national language requirements for warnings, information and documentation are updated.

17

Explanation II – Clearly visible and easily legible warnings

References added to guidance on the visibility and legibility of warnings, markings and instructions for use.

  • Transparent carrier material may equally make warnings difficult to read, thus transparent carrier material should normally be avoided.
  • Standard EN 71-1:2014+A1:2018, cited in the Official Journal of the European Union (OJEU), provides in its informative annex A, part A.33, information on good practice for visibility and legibility of warnings, markings and instructions for use.
  • Further information may also be taken, as appropriate and following adaptation to toys, from 
  • CEN TR 13387-5:2018 Child care articles - General safety guidelines - Part 5: Product information;
  • ISO/IEC Guide 14:2018 Products and related services - Information for consumers;
  • IEC/IEEE 82079-1:2019 Preparation of information for use of products

 

[1]  TSD explanatory guidance document Rev 1.10

[2]  EU: EC published new toy guidance document for decorative products, May 2021

[3]  EU: TSD recent updates on allergic fragrances, December 2020

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