Toy Safety Directive 2009/48/EC — An Explanatory Guidance Document (Rev 1.7)

Overview

This is the European Commission DG Enterprise and Industry guidance document (Rev 1.7, 13 December 2013) explaining the application of Directive 2009/48/EC on the safety of toys (the Toy Safety Directive, “TSD”). The guidance has no binding legal force on its own — the directive and its national transpositions are what bind — but it represents the consensus interpretation reached between Member State experts, European industry, European standardisation bodies, European consumer organisations, and Notified Bodies, and is the document Notified Bodies and market-surveillance authorities reference when applying the directive’s chemical-safety provisions. The chemical-properties content relevant to heavy-metal limits is concentrated in Section III of Annex II, particularly Points 1, 3-7 (CMR provisions and food-contact-material derogation) and Point 13 (the 19-element migration-limit table for three toy-material categories).

Key numbers

Annex II, Part III, Point 13 — migration limits for 19 elements (mg/kg of toy material)

Without prejudice to Points 3, 4 and 5 (the CMR provisions), the following migration limits from toys or components of toys must not be exceeded. Limits apply in addition to the CMR provisions, and where the two requirements conflict, the stricter prevails. Limit values do not apply to toys or components which, due to their accessibility, function, volume or mass, clearly exclude any hazard due to sucking, licking, swallowing or prolonged skin contact when used as specified in Article 10(2) first subparagraph (p. 107-108):

Element	Dry, brittle, powder-like or pliable toy material (mg/kg)	Liquid or sticky toy material (mg/kg)	Scraped-off toy material (mg/kg)
Aluminium	5 625	1 406	70 000
Antimony	45	11.3	560
Arsenic	3.8	0.9	47
Barium	1 500	375	18 750
Boron	1 200	300	15 000
Cadmium	1.3	0.3	17
Chromium (III)	37.5	9.4	460
Chromium (VI)	0.02	0.005	0.2
Cobalt	10.5	2.6	130
Copper	622.5	156	7 700
Lead	13.5	3.4	160
Manganese	1 200	300	15 000
Mercury	7.5	1.9	94
Nickel	75	18.8	930
Selenium	37.5	9.4	460
Strontium	4 500	1 125	56 000
Tin	15 000	3 750	180 000
Organic tin	0.9	0.2	12
Zinc	3 750	938	46 000

(Page 107-108. The directive uses comma as decimal separator throughout; reproduced here as decimal point for unit-discipline consistency with the rest of the wiki. The heading “Element” in the source is used loosely — some entries are compound categories, notably “Organic tin,” which the guidance clarifies “should apply to the sum of all organotin substances, as they are all toxic and have an additive effect (although some are more potent than others)” (p. 114).)

Daily-ingestion exposure assumptions underpinning the limits (p. 109-110)

Dry, brittle, powder-like or pliable toy material: assumed ingestion 100 mg/day. Examples: compressed paint tablets (dry), chalk and crayons (brittle), plaster of Paris (powder-like), magic sand / modelling compounds / plasticine / oven-hardened PVC modelling compounds / bouncing putty (pliable).
Liquid or sticky toy material: assumed ingestion 400 mg/day. Examples: bubble solution, poster paints, finger paints (liquid); liquid adhesives, glue sticks, slimes (sticky).
Scraped-off toy material: assumed ingestion 8 mg/day. Material classes: surface coatings (paints, varnish, electroplating, vacuum-deposited metals); hard polymers (polystyrene, ABS, uPVC, polypropylene); soft polymers (EVA foam, rubber, PVC, elastomers, leatherette); other materials (leather, bone, natural sponge, paper/card); wood (fibreboards, chipboard, plywood); textiles (fuzzy felts, cotton wool, polyester staple fibres, plush fabrics); glass and ceramics (marbles, fibre glass); metals and alloys (steel, nickel-silver).

Derivation principle for the six “particularly toxic” elements

The limit values for arsenic, cadmium, chromium (VI), lead, mercury and organic tin “are set at levels that are half of those considered safe according to the criteria of the relevant Scientific Committee, in order to ensure that only traces that are compatible with good manufacturing practice will be present” (p. 108-109). For the remaining 13 elements the limit corresponds to the level considered safe by the relevant Scientific Committee. The “considered safe” baseline derives from the RIVM 2008 study Chemicals in Toys. A general methodology for assessment of chemical safety of toys with a focus on elements (RIVM report 320003001), referenced in the guidance.

Allergenic-fragrance numerical limits (Annex II Part III Point 11; pp. 101-106)

55 allergenic fragrances prohibited (substances 1-55 in the first list). The first 40 are those already prohibited under the Cosmetics Directive; substances 41-55 are additional toy-specific prohibitions extending those that were merely labelling-required in cosmetics.
Traces tolerance: technically unavoidable presence under good manufacturing practice is allowed up to 100 mg/kg per fragrance substance.
A second list of 11 allergenic fragrances must be labelled on the toy, on an affixed label, on the packaging, or in an accompanying leaflet, when added at concentrations exceeding 100 mg/kg of the toy or its components.

Nitrosamine and nitrosatable-substance limits (Annex II Part III Point 8; p. 100)

For toys intended for use by children under 36 months or other toys intended to be placed in the mouth, prohibited if migration is equal to or above:

0.05 mg/kg for N-nitrosamines
1 mg/kg for N-nitrosatable substances

The “intended to be placed in the mouth” qualifier limits nitrosamine relevance to materials such as balloons, finger paints, and rubber components; plastics like polyethylene and PVC do not normally contain amines and therefore would not normally contain nitrosamines.

Nickel-in-stainless-steel derogation (Annex II Part III Point 6; p. 99)

The CMR provisions in Points 3, 4 and 5 do not apply to nickel in stainless steel, “because its safety has been proven.” The derogation does not apply to nickel in coatings (p. 99). The general nickel migration limits in Point 13 still apply, as does the EU nickel directive (now Annex XVII of REACH) for articles intended for direct and prolonged contact with skin; the TSD addresses ingestion whereas the nickel directive addresses contact allergy, so there is no duplication (p. 114).

Food-contact-materials derogation (Annex II Part III Point 7; p. 99)

CMR provisions in Points 3, 4 and 5 do not apply to materials covered by and complying with Regulation (EC) No 1935/2004 on food-contact materials and its specific measures. Pending TSD-specific provisions (which were to be laid down within 8 years of entry into force of the directive — i.e., by 20 July 2017), this exemption applies provisionally. The Food-Contact Materials Regulation scope (Article 1.2 of 1935/2004) covers materials intended to be brought into contact with food, materials already in contact with food and intended for that purpose, and materials that can reasonably be expected to be brought into contact with food.

Scope of “toy” and the structural-distinctness principle (Annex II Part III Point 3; pp. 95-96)

Concentration limits for CMR substances in toys apply to all “microstructurally distinct parts,” a term the guidance treats as similar in meaning to the “homogeneous material” concept in RoHS Decision 2005/618/EC. The intent is that a paint coating on a base material is itself a microstructurally distinct part even if the coating is microscopically thin; both substrate and coating must meet the CMR limits independently. “Structurally distinct” parts (with a wider meaning than “part”) have a well-defined boundary visible by visual delineation; the example given is that a bicycle saddle’s metal and plastic regions are structurally distinct parts of the saddle part.

Methods (brief)

Regulatory guidance document, not a measurement study. Compiled by the relevant services of the DG Enterprise and Industry of the European Commission in consultation with Member States, European industry, European standardisation bodies, European consumer organisations, and Notified Bodies (p. 2). The migration limit values in Point 13 are derived (via the RIVM 2008 methodology) from a tolerable-daily-intake (TDI) framework: child body weight × TDI × allocation fraction ÷ assumed daily ingestion of the relevant material category = mg/kg limit in the material. The “half of considered safe” rule for the six particularly toxic elements (As, cadmium (Cd), hexavalent chromium (Cr-VI), lead (Pb), mercury (Hg), organic Sn) reflects the policy choice that intentional addition of these elements should not be allowed and only good-manufacturing-practice trace levels should be tolerated. The harmonised test method for migration is EN 71-3 (referenced in this guidance via the implementing standards list in Section 15).

The directive itself is silent on which analytical instruments are required; the guidance defers to harmonised standards. The RIVM 2008 methodology underpinning the daily-ingestion assumptions (100 mg, 400 mg, 8 mg per day) is cited explicitly on p. 109. The Scientific Committee on Health and Environmental Risks (SCHER) 2010 opinion evaluating these limits — including its recommendation to use a uniform 10% TDI allocation, its proposed updated TDIs for Cd, Pb, and arsenic (As), and its recommendation for physiologically-based extraction media in place of EN 71-3’s 0.07 M HCl — is the companion scientific document and is captured separately as Evaluation of the Migration Limits for Chemical Elements in Toys (SCHER Opinion).

Implications

Certification (HMTc): Primary regulatory anchor for EU toy-related migration limits across the full 19-element panel. The TSD migration values are referenced by HMTc Category 21 (toys) work where dermal, mouthing, or oral migration is the exposure model. The half-of-considered-safe principle for the six particularly toxic elements provides a precedent for the wiki/HMTc question of how a regulatory ceiling relates to a safety-anchored threshold.
Crosswalk: Establishes the EU’s three-material-category framework (dry/brittle/powder-like/pliable; liquid/sticky; scraped-off) with assumed daily ingestions (100, 400, 8 mg/day) that differ from the U.S. ASTM F 963 / CPSIA single-substrate paint limit of 90 ppm and from the ISO 8124-3 international consensus baseline. Pages comparing these regulatory regimes should cite the Annex II Part III Point 13 table for the EU baseline.
Courses: Foundational regulatory-affairs reference for any EU children’s-product safety teaching module. The document also lays out the CMR-derogation logic (Points 4 and 5), the nickel-in-stainless-steel exception (Point 6), and the food-contact-materials derogation (Point 7), each of which is a worked example of how a horizontal EU regulation interacts with a sector-specific directive.
App: Not directly relevant to ingredient contamination_profile values (the TSD addresses toy materials, not foods). Useful for product-page regulatory crosswalk fields where a toy product has both an EU TSD migration limit and an HMTc threshold.

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