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Toy Safety Directive (TSD) In force

Overview

Jurisdiction
European Union
Topic
Product Safety
Instrument type
Directive
Reference number
2009/48/EC
Valid from
2009-07-20
Valid to
2026-08-06
Modified date
2009-06-18
Listed at
2026-08-06
Withdrawn at
-
Description
Sets harmonised safety requirements for toys made available on the EU market. It regulates, in particular, requirements for design, physical and mechanical properties, flammability, chemical and electrical properties, hygiene and radioactivity, as well as obligations of manufacturers, authorised representatives, importers and distributors, conformity assessment, technical documentation, the EC declaration of conformity, CE marking, warnings and market surveillance.

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Sources

Source URL Crawler Publish date
https://publications.europa.eu/resource/celex/32009L0048 Schokolade

Logs

Type Status Started at Finished at
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Rule sets

Label Effective
Toy manufacturers placing toys on the EU market 2011-07-20 — 9999-12-31
Applies from milestone:
Repeal (2011-07-20)
Expires at milestone:
-
Conditions:
  • Activities contains No Linked Attribute Value “manufactures toys” “has toys designed or manufactured” “markets toys under its name or trademark”
Importers placing toys from third countries on the EU market 2011-07-20 — 9999-12-31
Applies from milestone:
Repeal (2011-07-20)
Expires at milestone:
-
Conditions:
  • Activities contains No Linked Attribute Value “places toys from third countries on the EU market”
Distributors making toys available on the market 2011-07-20 — 9999-12-31
Applies from milestone:
Repeal (2011-07-20)
Expires at milestone:
-
Conditions:
  • Activities contains No Linked Attribute Value “makes toys available on the market”
Importers and distributors treated as manufacturers 2011-07-20 — 9999-12-31
Applies from milestone:
Repeal (2011-07-20)
Expires at milestone:
-
Conditions:
  • Activities contains No Linked Attribute Value “places a toy on the market under its own name or trademark” “modifies a toy in a way that may affect compliance”
Authorised representatives of toy manufacturers 2011-07-20 — 9999-12-31
Applies from milestone:
Repeal (2011-07-20)
Expires at milestone:
-
Conditions:
  • Activities contains No Linked Attribute Value “acts as authorised representative for a toy manufacturer”
Conformity assessment bodies seeking notification for toys 2011-07-20 — 9999-12-31
Applies from milestone:
Repeal (2011-07-20)
Expires at milestone:
-
Conditions:
  • Activities contains No Linked Attribute Value “performs third-party conformity assessment for toys”

Questions this regulation asks

Attributes only this regulation asks about — criteria no general attribute expresses. A company answers each once.

This regulation asks no questions of its own — every condition uses a general attribute.

Obligations

Title Kind Rule set
Design and manufacture toys in compliance with safety requirements Other -
Description:
Manufacturers must ensure that toys are designed and manufactured in accordance with the general and particular safety requirements.
Frequency:
Continuous
Check frequency:
Event-triggered
Products/Services:
All toys made available on the market
Checking responsibility:
Manufacturer; national market surveillance authorities
Check method:
Market surveillance and testing against Article 10 and Annex II
Rule set:
-
Source reference:
Article 4(1) and Article 10
Source excerpt:
When placing their toys on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements set out in Article 10 and Annex II.
Carry out safety assessment before placing a toy on the market Due Diligence -
Description:
Manufacturers must analyse chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards and assess potential exposure.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Toys before being placed on the market
Checking responsibility:
Manufacturer
Check method:
Safety assessment retained in technical documentation
Rule set:
-
Source reference:
Article 18
Source excerpt:
Manufacturers shall, before placing a toy on the market, carry out an analysis of the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that the toy may present, as well as an assessment of the potential exposure to such hazards.
Carry out the applicable conformity assessment procedure Approval -
Description:
Manufacturers must use the applicable conformity assessment procedure to demonstrate compliance with the safety requirements.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
All toys before being placed on the market
Checking responsibility:
Manufacturer; notified body where required
Check method:
Documented conformity assessment; EC-type examination where applicable
Rule set:
-
Source reference:
Article 19(1)
Source excerpt:
Before placing a toy on the market, manufacturers shall use the conformity assessment procedures referred to in paragraphs 2 and 3 to demonstrate that the toy complies with the requirements set out in Article 10 and Annex II.
Draw up the EC declaration of conformity and affix the CE marking Reporting -
Description:
After demonstrating conformity, manufacturers must draw up, continuously update and translate the EC declaration of conformity and affix the CE marking.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Compliant toys
Checking responsibility:
Manufacturer
Check method:
Verification of the declaration and CE marking
Rule set:
-
Source reference:
Article 4(2), Article 15 and Article 17(1)
Source excerpt:
Where compliance of a toy with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EC declaration of conformity, as referred to in Article 15, and affix the CE marking, as set out in Article 17(1).
Identify suppliers and customers in the supply chain Record Keeping -
Description:
Economic operators must identify suppliers and customers on request and be able to present that information for ten years.
Frequency:
Continuous
Check frequency:
Event-triggered
Products/Services:
All toys in the supply chain
Checking responsibility:
All economic operators
Check method:
Provision of traceability information upon request
Rule set:
-
Source reference:
Article 9
Source excerpt:
Economic operators shall, on request, identify the following to the market surveillance authorities: (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 first paragraph 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, in the case of other economic operators.
Retain technical documentation and declaration of conformity for ten years Record Keeping -
Description:
Manufacturers must retain the technical documentation and EC declaration of conformity for ten years after the toy has been placed on the market.
Frequency:
Continuous
Check frequency:
Event-triggered
Products/Services:
Technical documentation and EC declaration of conformity for all toys placed on the market
Checking responsibility:
Manufacturer
Check method:
Provision upon a reasoned request from the competent authority; retention check
Rule set:
-
Source reference:
Article 4(3)
Source excerpt:
Manufacturers shall keep the technical documentation and the EC declaration of conformity for a period of 10 years after the toy has been placed on the market.
Monitor series production and record complaints and recalls Due Diligence -
Description:
Manufacturers must establish procedures to maintain conformity in series production and, where appropriate with regard to risk, conduct sample testing, investigations and maintain registers.
Frequency:
Continuous
Check frequency:
Continuous
Products/Services:
Series-produced toys
Checking responsibility:
Manufacturer
Check method:
Production controls, sample testing and complaint or recall registers where appropriate with regard to risk
Rule set:
-
Source reference:
Article 4(4)
Source excerpt:
Manufacturers shall ensure that procedures are in place for series production to remain in conformity. Changes in toy design or characteristics and changes in the harmonised standards by reference to which conformity of a toy is declared shall be adequately taken into account. When deemed appropriate with regard to the risks presented by a toy, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of marketed toys, investigate, and, if necessary, keep a register of complaints, of non-conforming toys and toy recalls, and shall keep distributors informed of any such monitoring.
Identify toys Record Keeping -
Description:
Manufacturers must affix an identifying type, batch, serial or model number or other identification element to the toy, or, where this is not possible, to its packaging or an accompanying document.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
All manufacturer toys
Checking responsibility:
Manufacturer
Check method:
Inspection of product marking and accompanying documents
Rule set:
-
Source reference:
Article 4(5)
Source excerpt:
Manufacturers shall ensure that their toys bear a type, batch, serial or model number or other element 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.
Provide manufacturer and contact details Other -
Description:
Manufacturers must indicate their name or registered trade name or trade mark and a contact address.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
All manufacturer toys
Checking responsibility:
Manufacturer
Check method:
Inspection of manufacturer details on the toy, packaging or accompanying document
Rule set:
-
Source reference:
Article 4(6)
Source excerpt:
Manufacturers shall indicate their name, registered trade name or registered trade mark and the 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.
Provide instructions and safety information Other -
Description:
Manufacturers must ensure that toys are accompanied by instructions and safety information in the language or languages easily understood by consumers as determined by the relevant Member State.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
All manufacturer toys
Checking responsibility:
Manufacturer
Check method:
Review of the language of instructions and safety information
Rule set:
-
Source reference:
Article 4(7)
Source excerpt:
Manufacturers shall ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers, as determined by the Member State concerned.
Take corrective action and notify authorities for non-compliance Other -
Description:
Manufacturers must immediately take corrective action where non-compliance is suspected and inform the competent national authorities where the toy presents a risk.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Non-compliant or risky toys
Checking responsibility:
Manufacturer
Check method:
Immediate notification to competent authorities and review of corrective, withdrawal or recall measures
Rule set:
-
Source reference:
Article 4(8)
Source excerpt:
Manufacturers who consider or have reason to believe that a toy which they have placed on the market is not in conformity with the relevant Community harmonisation legislation shall immediately take the corrective measures necessary to bring that toy into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the toy presents a risk, manufactures 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, of the non-compliance and of any corrective measures taken.
Affix warnings Other -
Description:
Manufacturers must affix required warnings visibly, legibly, understandably and accurately and make purchase-relevant warnings visible before purchase.
Frequency:
Event-triggered
Check frequency:
Event-triggered
Products/Services:
Toys requiring warnings and safety-related use limitations
Checking responsibility:
Manufacturer
Check method:
Inspection of warnings on the toy, label, packaging and, where appropriate, instructions for use
Rule set:
-
Source reference:
Article 11(2)
Source excerpt:
The manufacturer shall mark the warnings in a clearly visible, easily legible and understandable 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.

Measures

No measures.

Penalties

Description Kind Rule set
Criminal sanctions may be provided for serious infringements of the national provisions by economic operators. Criminal Liability -
Responsible authority:
Member State authorities
Source reference:
Article 51
Source excerpt:
Member States shall lay down rules on penalties for economic operators, which may include criminal sanctions for serious infringements
If adequate corrective action is not taken, market surveillance authorities may prohibit or restrict making the toy available and order withdrawal or recall. Prohibition of Sales -
Responsible authority:
National market surveillance authorities
Source reference:
Article 42(4)
Source excerpt:
Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities 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.
Where formal non-compliance persists, the Member State may restrict or prohibit making the toy available or ensure its recall or withdrawal. Prohibition of Sales -
Responsible authority:
Member State authorities
Source reference:
Article 45(2)
Source excerpt:
Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take appropriate measures to restrict or prohibit the toy being made available on the market, or shall ensure that it is recalled or withdrawn from the market.
An EC-type examination certificate may be refused, restricted, suspended or withdrawn where the toy is non-compliant or corrective action is ineffective. Other Prohibitions and Exclusions -
Responsible authority:
Notified body
Source reference:
Article 20(4) and Article 35(3)-(5)
Source excerpt:
The EC-type examination certificate shall be withdrawn if the toy fails to comply with the requirements set out in Article 10 and Annex II. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any EC-type examination certificates, as appropriate.
Manufacturers and importers are liable for damages under Directive 85/374/EEC on liability for defective products. Private Action -
Responsible authority:
National courts
Source reference:
Recital 45 and Article 52(1)
Source excerpt:
Manufacturers and importers who have placed non-compliant toys on the Community market are liable for damages under that Directive.
Member States must provide effective, proportionate and dissuasive penalties for economic operators; penalties may be increased for repeat infringements and may include criminal sanctions for serious infringements. Monetary Fine -
Responsible authority:
Member State authorities
Source reference:
Article 51
Source excerpt:
Member States shall lay down rules on penalties for economic operators, which may include criminal sanctions for serious infringements, applicable to infringements of the national provisions adopted pursuant to this Directive, and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive and may be increased if the relevant economic operator has previously committed a similar infringement of this Directive.

Milestones

Date Type Description
2009-06-18 Adopted Directive 2009/48/EC on the safety of toys adopted
Source reference:
Preamble / Done at Brussels
Source excerpt:
of 18 June 2009 on the safety of toys
2009-07-20 Entry into Force The Directive enters into force on the 20th day following its publication in the Official Journal of the European Union
Source reference:
Article 56
Source excerpt:
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
2011-01-20 Transposition Deadline Deadline for Member States to bring the necessary national implementing measures into force
Source reference:
Article 54
Source excerpt:
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 January 2011.
2011-07-20 Application Start National implementing measures begin to apply
Source reference:
Article 54
Source excerpt:
They shall apply those measures with effect from 20 July 2011.
2011-07-20 Other Deadline for notifying national penalty rules to the Commission
Source reference:
Article 51
Source excerpt:
The Member States shall notify the Commission of those rules by 20 July 2011, and shall notify it without delay of any subsequent amendment to them.
2011-07-20 Other Deadline for notifying national penalty rules to the Commission
Source reference:
Article 51
Source excerpt:
The Member States shall notify the Commission of those rules by 20 July 2011, and shall notify it without delay of any subsequent amendment to them.
2011-07-20 Repeal Directive 88/378/EEC is generally repealed
Source reference:
Article 55
Source excerpt:
Directive 88/378/EEC, except Article 2(1) and Part 3 of Annex II, is repealed with effect from 20 July 2011.
2013-07-20 Other End of the transitional rule for certain chemical requirements
Source reference:
Article 53(2)
Source excerpt:
Member States shall not impede the making available on the market of toys which are in accordance with the requirements of this Directive, except those set out in Part III of Annex II, provided that such toys meet the requirements set out in Part 3 of Annex II to Directive 88/378/EEC and were placed on the market before 20 July 2013.
2013-07-20 Repeal Article 2(1) and Part 3 of Annex II to Directive 88/378/EEC are repealed
Source reference:
Article 55
Source excerpt:
Article 2(1) thereof and Part 3 of Annex II thereto are repealed with effect from 20 July 2013.
2014-07-20 Other First Member State report to the Commission on application of the Directive; every five years thereafter
Source reference:
Article 48
Source excerpt:
By 20 July 2014 and every five years thereafter, Member States shall send the Commission a report on the application of this Directive.
2015-06-01 Other New classification criteria under Regulation (EC) No 1272/2008 apply to substances and mixtures in toys
Source reference:
Annex II Appendix B, point 1.B
Source excerpt:
Criteria to be applied from 1 June 2015:
2017-07-20 Other End of the latest transitional period for relying on food-contact-material provisions
Source reference:
Annex II Part III, point 7
Source excerpt:
or, until such provisions have been laid down, but not later than 20 July 2017, to materials covered by and complying with the provisions for food contact materials set out in Regulation (EC) No 1935/2004

Linked regulations

Type Regulation
Repeals Council Directive 88/378/EEC on the approximation of the laws of the Member States concerning the safety of toys
Supersedes Council Directive 88/378/EEC
Cites Directive 2001/95/EC of the European Parliament and of the Council on general product safety
Cites Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products
Cites Decision No 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products
Cites Directive 98/34/EC of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services
Cites REACH Regulation
Cites Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food
Cites Directive 2002/95/EC of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment
Cites Directive 2002/96/EC of the European Parliament and of the Council on waste electrical and electronic equipment
Cites Directive 2006/12/EC of the European Parliament and of the Council
Cites Directive 2006/66/EC of the European Parliament and of the Council
Cites Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission
Cites Packaging and Packaging Waste Directive
Cites Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances
Cites Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations
Cites Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures
Cites Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products
Cites Council Directive 85/374/EEC on the approximation of laws, regulations and administrative provisions of the Member States concerning liability for defective products
Cites Directive 94/62/EC of the European Parliament and of the Council