Mapping of TSD 2009/48/EC

To implement the requirements of TSD 2009/48/EC in a transparent and structured way, the regulatory assessment process can be represented using a Structured Assessment Logic (SAL). This logic ensures that all regulatory requirements are systematically evaluated and that compliance is supported by documented evidence.

The SAL translates the complex structure of toy safety law into a repeatable engineering and compliance workflow.

1. Product qualification – Is the product a “toy” under the Directive?

2. Risk assessment – Identification of all relevant requirements (Annex II + Article 10)

   The risk assessment is required not only to evaluate and mitigate hazards, but also to identify which of the Annex II requirments are relevant to the specific toy, based on its design, intended use, and reasonably foreseeable conditions of use.

3. Harmonised standards & gap analysis – Which standards cover the requirements, and where are there gaps?

4. Selection of the conformity assessment procedure – Self-assessment or EU Type- Examination

   Unlike many other product directives, the TSD does not offer multiple modules in a free choice model.

   Instead, two routes exist:

   •         Internal production control (Module A / self-verification)

   •          EC-type examination + conformity to type (Notified Body involvement)

   The selection depends strictly on whether harmonised standards fully cover all relevant hazards.

5. Technical documentation – Which records demonstrate compliance?

6. Warnings & information requirements

7. Series Production – How is ongoing conformity ensured?

   Conformity is not limited to design and initial assessment; it must also be maintained throughout ongoing production. In practice, this means identifying and controlling those product and process characteristics whose deviation could compromise compliance with the relevant Annex II + Article 10 requirements.

8. EU Declaration of Conformity & CE marking – Official confirmation of compliance, ready for the EU market.

Note: SAL is not an end in itself. It provides a repeatable methodology that translates regulatory principles into a clear, structured assessment logic.

This diagram illustrates the SAL workflow visually:

Product qualification

↓

Hazard-based risk assessment (Annex II + Article 10)

↓

Harmonised standards & gap analysis

↓

Conformity assessment decision (Module A vs. NB route)

↓

Technical documentation↓Warnings & user information

↓

Series production control

↓

CE marking & EU Declaration of Conformity

Parallel applicability of legislation / Norm hierarchy and conflict of laws

Other Union harmonisation legislation may need to be taken into account. As part of the applicability assessment, it must be determined whether such acts apply in parallel or whether, due to rules of precedence and lex specialis principles, individual requirements or an entire harmonisation act is displaced in favour of another. Where no normative conflict exists, the respective requirements apply in parallel and cumulatively.

Overview: Directive 2009/48/EC

• Number: 2009/48/EC

• Title: Safety of Toys

• Publication: OJ L 170, 30.6.2009, p. 1

• Purpose: Ensure high level of child safety in toys placed on EU market

• Public interest: Product safety

• Guidelines on TSD 2009/48/EC:

  • TSD explanatory guidance document

  • Guidance on Toy Safety

Scope

A toy is defined as any product designed or intended, whether or not exclusively, for use in play by children under 14 years of age.

However, certain products are explicitly excluded (Annex I), such as:

• Playground equipment for public use

• Coin-operated public amusement machines

• Toy vehicles with combustion engines

• Toy steam engines

• Slings and catapults

  
  

Risk assessment – Identification of all relevant requirements (Annex II + Article 10)

A structured safety assessment must be performed before placing the toy on the market.

This includes:

• Physical & mechanical hazards

• Flammability risks

• Electrical safety

• Chemical hazards (including migration limits)

• Hygiene risks

• Radioactivity risks

A key SAL principle applies:

The assessment is hazard-driven, not checklist-driven. Only hazards that are reasonably present in the toy must be addressed in design and control.

Special consideration must be given to:

• Children under 36 months

• Foreseeable misuse based on child behaviour

  
  

Harmonised standards & gap analysis

• Technical specifications facilitating compliance

• Use provides a presumption of conformity

• Developed by recognised European standardisation organisations

• Referenced in the Official Journal of the EU

• Summary of references of harmonised standards published in the OJEU – Directive 2009/48/EC

This step determines whether:

• Self-verification is sufficient, or

• Third-party verification is required

Chemical Safety Interpretation Layer (SAL Rule)

At this stage of the SAL, particular attention must be given to chemical safety, as the applicability of harmonised standards and risk-based justification requires a differentiated interpretation approach.

A distinction must be made between:

1. General safety requirements (Annex II Parts I, II, IV, V, VI)

• Apply only if relevant hazards exist

• If no hazard is present → requirement is not operationally triggered

2. Chemical requirements (Annex II Part III and specific points)

• Always formally applicable

• However: testing and verification depend on risk-based presence analysis

Key SAL principle:

Even if a chemical requirement always “exists in law”,it does not always require testing or NB involvement if:

• The substance is demonstrably absent, or

• Exposure pathways are not reasonably foreseeable

This introduces a risk-based applicability filter inside a formally absolute requirement framework.

Selection of conformity assessment route (Article 19 logic)

A) Internal production control (Module A) applies if:

• Harmonised standards cover all relevant safety requirements 

• No restrictions apply

• No unaddressed hazards remain

• 
  

B) EC-type examination is required if:

• No harmonised standards exist

• Standards are not fully applied

• Standards are restricted

• Product design introduces new or unaddressed hazards

• Manufacturer opts for third-party verification

Notified Bodies perform model evaluation and issue EC-type certificates.

Technical documentation

Manufacturers must compile and retain technical documentation for 10 years.

This includes:

• Product design and drawings

• Risk assessment file

• Applied standards list

• Test reports (chemical, mechanical, electrical, etc.)

• Conformity assessment evidence

• Production control procedures

Warnings & information requirements

Toys must be accompanied by clear and visible safety information.

This includes:

• General warnings (Annex V Part A)

• Category-specific warnings (Annex V Part B)

• Age restrictions and usage limitations

• Instructions for safe use

Key requirements:

• Must be clearly visible, legible, understandable

• Must be preceded by “Warning” or “Warnings”

• Must be language-appropriate for the target market

  
  

Series production – maintaining conformity over time

Conformity is not a one-time event. The requirement for ongoing conformity is implemented in practice by ensuring that manufacturers identify and keep under control those product and process characteristics whose deviation could jeopardize compliance with the legal requirements.

This requires a systematic management of safety- and compliance-critical characteristics, defining how these characteristics are identified, monitored, controlled, and protected against unintended change.

8. EU Declaration of Conformity & CE marking

Final compliance step:

EU Declaration of Conformity

• Legally binding declaration by manufacturer

• Confirms full compliance with TSD

• Must be retained and updated where necessary

CE marking

• Mandatory before placing toy on EU market

• Must be visible, legible and indelible

• If Notified Body involved → NB identification number must be added

Conclusion

The SAL for the Toy Safety Directive transforms a highly detailed and hazard-specific legal framework into a structured engineering logic.

It ensures:

• Clear product scope determination

• Hazard-driven safety evaluation

• Standard-based conformity mapping

• Controlled decision between self-verification and Notified Body involvement

• Lifecycle conformity through production

• Transparent CE marking and declaration process

In practice, SAL acts as a regulatory “system architecture” that aligns legal requirements with design, testing, and manufacturing control.