What Allergen Information Must Be in a Toy Digital Product Passport?
What allergen data must a Toy DPP contain under EU Regulation 2025/2509? See specified fragrance allergens, the 10 mg/kg threshold and key exclusions.
Navigate this page
- Direct answer
- When does the Toy DPP apply?
- What allergen-related information is in the Toy DPP?
- The 10 mg/kg threshold
- Not all allergenic fragrances are treated the same way
- What this does not mean
- Toy DPP versus technical documentation
- DPP versus full chemical or material composition
- Model-level context
- Is the allergen information public?
- What product-data teams should prepare
- Common misconceptions
- Direct questions
- Sources and legal basis
Direct answer
Yes. The adopted EU Toy Safety Regulation requires allergen-related information in the Digital Product Passport, but it is a narrow fragrance-allergen requirement, not a universal allergen, chemical or material disclosure rule.
Annex VI Part I requires the Toy DPP to contain a list of allergenic fragrances that are present in the toy and are subject to the specific labelling requirements in Part B, point 1, of the Appendix to Annex II.1
Those labelling rules apply when the specified fragrance allergen is present in the toy or a component of the toy at a concentration above 10 mg/kg. Its name must then appear in the required product information and in the DPP.1
That does not mean the Toy DPP must list:
- every allergen
- every fragrance substance
- every hazardous chemical
- every material
- the full product composition.
The Toy Safety Regulation does require broader material, substance, Safety Data Sheet and manufacturing information in the technical documentation. That is a separate regulatory layer and should not be silently copied into the mandatory DPP dataset.
The Toy Safety Regulation generally applies from 1 August 2030. The DPP corresponds to a specific toy model, unless another applicable Union law requires a batch-level passport.1
Legal basis: Regulation (EU) 2025/2509, particularly Articles 19 to 23, Article 49, Article 59, Annex V, Annex VI and the Appendix to Annex II.1
When does the Toy DPP apply?
Regulation (EU) 2025/2509 is adopted law. Its main provisions, including the new Toy DPP regime, generally apply from 1 August 2030.1
Some institutional and implementing provisions apply earlier. That does not turn the earlier dates into the general Toy DPP application date.
The useful public conclusion is:
The Toy DPP is adopted, but its general application date is 1 August 2030.
This is not a proposal or a Commission study. The mandatory dataset already appears in Annex VI of the Regulation.
For the full category position, see Toy Digital Product Passport Requirements.
The 10 mg/kg threshold
The Appendix to Annex II distinguishes different fragrance controls.
For the fragrances listed under Part B, point 1, the name must be shown when the substance is present in the toy or any component at a concentration above 10 mg/kg.1
Because Annex VI Part I(l) points specifically to those labelling requirements, the same set of triggered fragrance-allergen names becomes mandatory DPP information.
The DPP therefore needs controlled logic, not a generic yes/no "contains allergens" flag.
A product-data model should be able to establish at least:
- which listed fragrance is present
- the relevant evidence for its presence
- whether the legal concentration trigger is crossed
- which toy model or component the result relates to
- whether another fragrance restriction makes the substance impermissible rather than merely disclosable.
The last point is important because not every allergenic-fragrance rule in the Regulation is a disclosure rule.
Not all allergenic fragrances are treated the same way
The Toy Safety Regulation separates different categories of fragrance restrictions.
Part B point 1 fragrances
These are the fragrances tied to the specific labelling rule and, through Annex VI Part I(l), to the mandatory DPP allergen field.1
Prohibited allergenic fragrances
Other parts of the Appendix prohibit specified allergenic fragrances, subject to tightly framed unavoidable-trace conditions. Their existence in the Regulation does not mean the Toy DPP must contain one universal list of every prohibited fragrance.
Toys for children under 36 months or intended to be placed in the mouth
The Regulation is stricter for these products. The Part B point 1 fragrance allergens must not be present above the relevant unavoidable-trace level.1
That means a business should not read the DPP disclosure rule as permission to use a fragrance simply because it can be named in the passport.
A DPP disclosure obligation and a product safety restriction are different legal functions.
What this does not mean
The phrase "allergen information in the Toy DPP" can easily be over-expanded.
It does not mean every allergen
Annex VI does not create a universal field for every substance capable of causing an allergic reaction.
It does not mean every chemical
The Regulation contains extensive chemical safety controls, but the mandatory DPP dataset does not become a complete chemical inventory because those controls exist.
It does not mean every material
The full list of components and materials is part of the technical documentation under Annex V, not the mandatory Annex VI Part I DPP dataset.1
It does not mean every Safety Data Sheet belongs in the passport
Annex V requires the technical documentation to include a list of substances and mixtures and the Safety Data Sheets obtained from chemical suppliers. That is a technical-file requirement, not a command to expose those SDSs as mandatory DPP fields.1
It does not mean factory information is a DPP field
Manufacturing and storage addresses appear in the technical documentation requirements. They are not listed in Annex VI Part I as mandatory Toy DPP data.1
Toy DPP versus technical documentation
Toy safety information exists in several layers.
The Digital Product Passport is one of them.
Mandatory DPP data
Annex VI Part I includes product identity, manufacturer and responsible economic operator information, traceability, conformity references, standards or common specifications, notified-body or certificate details where applicable, CE marking, the specified fragrance-allergen list and other defined passport infrastructure information.1
Optional DPP data
Annex VI Part II allows safety information, warnings and instructions for use to be included in the passport.1
The fact that these can be included does not make them mandatory Part I data.
Technical documentation
Annex V requires a much broader evidence set. It includes, among other things:
- detailed design and manufacture information
- a list of components and materials
- a list of substances and mixtures used
- supplier Safety Data Sheets
- safety assessments
- conformity evidence
- manufacturing and storage addresses
- test reports and supporting documentation.1
Those are essential to the toy's regulatory evidence system. They are not automatically the mandatory DPP dataset.
A useful implementation principle is therefore:
Keep the product safety evidence graph connected to the DPP, but do not make every technical-file record a passport field.
DPP versus full chemical or material composition
The distinction can be stated simply.
DPP REQUIREMENT List the specified allergenic fragrances when the linked labelling requirement applies.
REQUIRED / AVAILABLE UNDER ANOTHER LEGAL INFORMATION SYSTEM Broader components, materials, substances, mixtures, supplier SDSs, safety assessments and manufacturing evidence in the toy technical documentation.
This prevents two opposite mistakes.
The first is under-collecting product safety evidence because "it is not in the DPP".
The second is over-publishing the entire technical file because "it is required by the Toy Safety Regulation".
Both confuse the passport with the wider compliance system.
Model-level context
Article 19 says the DPP corresponds to a specific toy model.1
That is the normal Toy DPP level.
Where another Union law applying to the same toy requires a DPP at batch level, the Toy Safety Regulation allows the combined passport to be issued at that level. But the Toy regime itself is another adopted example showing that Digital Product Passports are not universally individual-item records.
For allergen data, that means the controlled fragrance assessment needs to map cleanly to the model covered by the passport and to any relevant components or variants that could change the legal result.
Is the allergen information public?
The Regulation gives consumers and other end users free access to the DPP and says they cannot be required to register or provide a password.1
At the same time, Article 49 empowers the Commission to set detailed actor-by-data access rights for Toy DPP information.1
So the safe current position is:
- a consumer-accessible DPP architecture is adopted
- no registration or password can be required for consumer/end-user access
- the detailed allocation of actors to individual data fields is an implementation detail under Article 49.
Do not assume that every technical or sensitive product record is public simply because the DPP is consumer accessible.
See Who Can See What in a Digital Product Passport for the cross-category access model.
What product-data teams should prepare
The allergen field is narrow, but it still creates a serious product-data requirement.
Prepare a controlled fragrance reference
Do not rely on one free-text "fragrance" field. Maintain a controlled mapping to the substances listed in the relevant Annex II Part B point 1 list.
Keep concentration evidence
The legal threshold matters. The system should retain evidence strong enough to determine whether the 10 mg/kg trigger is crossed.
That evidence does not have to become a consumer-facing concentration field in the DPP unless another rule requires it.
Link evidence to the model and component
The rule applies to a fragrance present in the toy or a component. Evidence should therefore be attributable to the right product model and, where relevant, the right component.
Keep technical documentation distinct
Materials, chemicals, SDSs, safety assessments and factory/storage information should remain available to the technical file without being mislabelled as mandatory passport fields.
Keep conformity records structured
The Toy DPP is safety and conformity oriented. CE marking, applicable Union law, standards/common specifications and notified-body/certificate references are part of the mandatory Part I architecture where applicable.1
Retain provenance
For every DPP field, keep the source, version, date, scope and owner of the evidence used to populate it.
See Passport Evidence: How We Know, and What a Blank Means and Is Your Product Data Ready for a DPP? for the wider evidence and readiness disciplines.
Common misconceptions
"The Toy DPP lists every allergen"
No. The mandatory allergen field is the specified set of allergenic fragrances linked to the Part B point 1 labelling rule.
"The Toy DPP lists every chemical in the toy"
No. Broader substances and mixtures are part of the technical documentation architecture, not a universal mandatory DPP chemical inventory.
"A 10 mg/kg threshold means any fragrance under it is always permitted"
No. Different fragrance restrictions apply to different lists and toy categories. Some uses are prohibited or tightly limited. The threshold used for the Part B labelling/DPP rule should not be treated as a universal safety permission.
"Factory information is part of the Toy DPP"
Not as a mandatory Annex VI Part I field. Manufacturing and storage addresses belong to the technical documentation layer.
"All safety warnings are mandatory DPP fields"
No. Annex VI Part II allows safety information, warnings and instructions for use to be included as optional passport information.
Direct questions
Does the Toy DPP contain allergen information?
Yes. It must include the specified allergenic fragrances that are present and subject to the linked labelling requirement.
Does it list every allergen?
No. The mandatory field is specifically tied to the fragrance allergens in Annex II Appendix Part B point 1.
Does it list every chemical?
No. Broader chemical and material information exists in the technical documentation but is not automatically mandatory DPP data.
Are fragrance allergens mandatory in the DPP?
Yes, when they fall within the specified Part B point 1 list and the legal labelling condition is triggered, generally above 10 mg/kg in the toy or a component.
Is full toy composition required in the DPP?
No. A component and material list is required in the technical documentation, not as a universal mandatory Annex VI Part I passport field.
Is factory information part of the Toy DPP?
Not as a mandatory Annex VI Part I field. Manufacturing and storage addresses are technical-documentation information.
When does the Toy DPP apply?
The Toy Safety Regulation generally applies from 1 August 2030.
What would change this page?
Re-check this resource if the Commission adopts the Toy DPP delegated act under Article 49 setting detailed technical and actor-by-data access rules, or if Annex VI or the allergenic-fragrance lists and thresholds in Annex II are amended.
This is a regulatory information resource, not personalised legal advice. Product scope, toy age/use category and applicable safety obligations should be checked against the law applying to the specific product and operator.
Keep exploring
The questions this page usually raises next.
- Related questionCross-category referenceWhy is the Toy DPP model-level?A direct next question arising from the answer on the source page.
- Broader questionCategory requirementsWhat are the full Toy DPP requirements?A direct next question arising from the answer on the source page.
- Related questionCross-category referenceIf factory addresses are in the technical file, are they DPP fields?A direct next question arising from the answer on the source page.
Does this reach your products?
Give ActivateDigital one product and it works out which obligations apply from the product's own character, and says which it cannot decide.
Help someone else make sense of product passports.
Sources and legal basis
Primary source
-
Commission Implementing Regulation (EU) 2026/1778 on the Digital Product Passport Registry. Canonical context - Toy Digital Product Passport Requirements - Digital Product Passport Requirements by Product Category - Who Can See What in a Digital Product Passport - Is Your Product Data Ready for a DPP? - Passport Evidence: How We Know, and What a Blank Means
https://eur-lex.europa.eu/eli/reg_impl/2026/1778/oj
Canonical context