Toy Safety and Heavy Metals: EN 71-3, IS 9873 and Coloured Plastics

Toy safety standards do not limit what a pigment contains. They limit what can migrate out of the finished toy into a child’s digestive system. That distinction is the whole subject, and misunderstanding it is why manufacturers reject perfectly compliant pigments and approve non-compliant ones.

If you make or import toys in India, or export them, this is what governs the colour in the plastic.

The two frameworks that matter

India: the Toys (Quality Control) Order. Toys sold in India require BIS certification and must carry the ISI mark, tested against the IS 9873 series, which is aligned with the international ISO 8124 series. The parts that matter most:

– IS 9873 Part 1 – mechanical and physical properties – IS 9873 Part 2 – flammability – IS 9873 Part 3 – migration of certain elements – IS 9873 Part 9 – certain phthalate esters

Europe: EN 71. The equivalent European series, with EN 71-3 covering migration of certain elements. Anyone exporting to the EU works to this.

For a colourant, Part 3 is the one that decides everything.

What EN 71-3 and IS 9873-3 actually do

The test does not analyse the plastic’s composition. It simulates what happens if a child swallows a piece.

The sample is placed in dilute hydrochloric acid at approximately pH 1.5, held at 37°C – the conditions of a child’s stomach – for a defined period. The solution is then analysed for the elements of concern, and the result is compared against migration limits.

Nineteen elements are covered in the current framework, including aluminium, antimony, arsenic, barium, boron, cadmium, chromium (III and VI separately), cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium, tin, organic tin and zinc.

Limits are set by material category, because different materials present different exposure:

Category	Material type	Relative limits
Category I	Dry, brittle, powder-like or pliable materials	Lowest limits
Category II	Liquid or sticky materials	Intermediate
Category III	Scraped-off materials, including coatings and surface layers	Highest limits, smallest sample mass

Most rigid moulded toy plastic falls under Category III as a scraped-off material, but the category is determined by the material and how it is presented, not by an assumption – and getting it wrong invalidates the assessment.

The practical implication: a pigment containing a restricted element is not automatically prohibited, and a pigment free of restricted elements is not automatically safe. What matters is whether the element migrates under those test conditions, at that loading, from that polymer.

Why insolubility is the whole game

Two pigments can contain the same element and behave completely differently.

Soluble compounds release their metal readily in acid. Lead chromate, cadmium salts and similar chemistries dissolve at pH 1.5 and put the element straight into solution. These are excluded from toy applications and, in most cases, from far wider use.

Highly insoluble complex inorganic pigments do not. Certain mixed-metal oxides are so chemically stable that the metal is locked in a crystal lattice and does not dissolve in gastric acid at a measurable rate. Some of these pass migration testing comfortably despite containing an element on the list.

Ultramarine blue is a useful illustration of the principle: it is a complex aluminosilicate, and its stability in the intended application is a matter of the specific grade and how it behaves under test, not of its element list.

This is precisely why you test the finished part rather than reasoning from a raw material datasheet. A supplier declaration on a pigment is evidence; it is not a compliance result.

The compliance chain

Migration is a property of the finished toy at its actual pigment loading in its actual polymer. That has consequences for how you buy.

What a masterbatch supplier can give you: – A declaration of the pigments used and their restricted-substance status – Test data on the masterbatch or on a standard plaque at a stated loading – RoHS and REACH declarations where relevant – Confirmation that the formulation was designed for toy applications

What only you can establish: – That the finished toy passes, at your loading, in your polymer, with your regrind, from your process

Do not accept a masterbatch certificate as certification of your toy. It is a necessary input and not a sufficient one. Equally, do not ask a colourant supplier to certify a toy they have never seen.

Beyond heavy metals

Colour is not the only material question in a toy.

Phthalates. IS 9873 Part 9 and equivalent regulations restrict certain phthalate esters. Relevant mainly to plasticised PVC, but any additive carrying a phthalate plasticiser is in scope.

Total lead content, separate from migration, is limited under some regimes – notably in the United States.

Azo colourants that can release certain aromatic amines are restricted under REACH. Relevant to textile and coated toy components more than to bulk moulded plastic, but relevant.

Small parts, sharp edges, cords, flammability – the mechanical and flammability parts of the standard. Nothing to do with colour, and they fail more toys than migration does.

Practical decisions for toy plastics

Choose your pigment class deliberately. For toy applications, formulations are normally built on organic pigments and highly insoluble inorganic pigments with a documented compliance history. The economics of trying to qualify an unusual pigment for a toy are rarely worth it.

Watch the recycled content question. Recyclate carries an unknown history, and unknown history is incompatible with element migration limits. Toy applications overwhelmingly use virgin material, and where recycled content is required for other reasons, the traceability burden rises sharply.

Keep the formulation stable. A compliance test result applies to the formulation tested. If your masterbatch supplier substitutes a pigment for supply reasons and does not tell you, your certification no longer describes what you are making. Put change notification into the purchase agreement – it costs nothing and it protects the certification you paid for.

Bright is harder than muted. Toys want saturated reds, yellows and oranges, and those are historically the shades where the highest-performing pigments were the restricted ones. Modern compliant alternatives exist across the range, but expect to pay more for a brilliant compliant red than for an industrial one, and expect it to have different lightfastness.

Talk to us

Life Color Pigments & Masterbatches supplies colour masterbatch for toy and juvenile product applications, manufactured under ISO 9001:2015, with RoHS and REACH declarations available where the application requires them.

Tell us your polymer, the standard you certify to – IS 9873, EN 71 or another – and your shade references, and we will formulate from a pigment set chosen for that requirement rather than one that happens to hit the shade.

Related: toys, household, delta E and colour tolerance, what is masterbatch.

FAQs

What does EN 71-3 test? Migration of certain elements from toy materials. The sample is held in dilute hydrochloric acid at around pH 1.5 at 37 degrees Celsius, simulating stomach conditions, and the solution is analysed for nineteen elements against category-specific migration limits.

Is EN 71-3 the same as IS 9873 Part 3? They cover the same subject – migration of certain elements – under different standards frameworks. IS 9873 is the Indian series aligned with ISO 8124 and is what BIS certification for toys sold in India is assessed against. EN 71 is the European series.

Do toys need BIS certification in India? Yes. Under the Toys (Quality Control) Order, toys sold in India require BIS certification and must carry the ISI mark, tested against the IS 9873 series covering mechanical properties, flammability, element migration and phthalates.

Can a pigment containing a heavy metal be used in toys? Possibly, because the standard limits migration rather than content. A highly insoluble complex inorganic pigment can lock a metal in a stable crystal lattice so that it does not dissolve measurably in gastric acid. Soluble compounds such as lead chromate cannot be used.

Does a masterbatch compliance certificate certify my toy? No. Migration is a property of the finished toy at your pigment loading, in your polymer, with your regrind and your process. A supplier declaration is a necessary input to your compliance file, not a substitute for testing the finished article.

What are the three material categories in EN 71-3? Category I covers dry, brittle, powder-like or pliable materials and carries the lowest limits. Category II covers liquid or sticky materials. Category III covers scraped-off materials including coatings, with the highest limits and the smallest sample mass.

Can recycled plastic be used in toys? Rarely, and with difficulty. Recyclate carries an unknown contamination history, which is fundamentally incompatible with element migration limits. Toy applications use virgin material almost exclusively.

What happens if my supplier changes a pigment? Your compliance test result describes the formulation that was tested, so a substitution can invalidate it. Require written change notification in the purchase agreement so that any reformulation triggers a review before it reaches production.