Baby Toys and Teethers in Malaysia: Why "Goes in the Mouth" Makes Compliance Stricter

If you sell teethers, teething rings, cloth books, rattles, comforter blankets or baby activity gyms in Malaysia, remember one thing first: legally they are all "toys," governed by the Consumer Protection (Safety Standards for Toys) Regulations 2009 (P.U.(A) 275, issued under the Consumer Protection Act 1999). The competent authority is the Ministry of Domestic Trade and Cost of Living (KPDN), and testing and certification are carried out by accredited laboratories such as SIRIM QAS International. Any toy intended for children under 14 must, before going to market, be tested to the MS ISO 8124 series, obtain a Certificate of Conformity (COC), and bear the Malaysia conformity mark (MC Mark) on the product or packaging. And because infant products are put in the mouth and bitten and mouthed for long periods, their mechanical and chemical safety thresholds are higher than for general toys.

Is a teether actually a toy?

This is the most common sticking point. The key to the decision is "design intent":

In other words, "for the baby" does not mean everything follows the same rules. Teethers and comfort toys are toys; pacifiers and feeding bottles are feeding utensils, outside the reach of the Toy Regulations. When the boundary is unclear, it is advisable to confirm the product classification with KPDN or the testing body first, then decide which set of tests to submit, to avoid getting a whole batch tested in the wrong direction.

Mechanical safety: small parts and structure (MS ISO 8124-1)

MS ISO 8124-1 covers mechanical and physical safety. For baby toys, the most fatal risk is choking, so the checks are especially strict:

• Small parts: toys for babies under 36 months must in principle not contain detachable small objects that can pass through the "small parts cylinder"; beads, eyes, bells, etc. on a rattle must withstand tension testing without coming off.
• Structural strength: after drop, twist, tension and compression testing, there must be no sharp points, sharp edges, or cracking that exposes stuffing and small parts.
• Cords and loops: the length of cords and straps on comfort toys and hanging toys is restricted to avoid neck entanglement and strangulation.
• Liquid-filled teethers: chill-type teethers containing gel or liquid must have a bite-resistant shell that does not rupture or leak.

Chemical safety: heavy metals and phthalates

Because babies bite and mouth them with saliva, chemical safety is paramount. MS ISO 8124-3 sets the maximum migration limits for eight heavy metals in coatings and materials, including antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium; MS ISO 8124-6 targets phthalates (plasticisers). Under internationally prevailing standards, DEHP, DBP and BBP must not exceed 0.1% in any toy, while DINP, DIDP and DNOP must not exceed 0.1% in toys and childcare articles that "can be placed in the mouth" — teethers and teething rings are exactly the typical "mouthable" items and almost inevitably fall under this stricter limit. Soft PVC, scented materials and coloured coatings are high-risk sources of plasticisers and heavy metals, so material selection and supplier control should be done early.

Labelling, warnings and import/local differences

After passing the tests, the toy must bear the MC mark (no smaller than 5 mm × 5 mm, clear and indelible), with the KPDN-issued registration number marked beside it, and must state the name and address of the manufacturer/importer/distributor; where necessary, the applicable age and warnings are added. It is worth noting that the MS ISO 8124-1 "not suitable for children under 36 months" small-parts warning should not be used on a teether that is by design meant for babies — that would be self-contradictory. The correct approach is to design the toy itself to be free of small-parts risk.

Imports and local manufacturing follow the same testing standards and MC mark requirements; the difference lies in who applies: imported goods are registered with KPDN by the Malaysian importer or agent on the basis of test reports from an ILAC/APLAC mutual-recognition laboratory, obtaining the COC, with the label bearing importer information; local manufacturing is applied for by the manufacturer itself. Either way, without a COC and MC mark, the product may not be sold in the market (including physical and e-commerce channels).

Frequently asked questions (FAQ)

Q: Do teethers definitely need SIRIM certification? Yes. A teether is a toy and must be tested to MS ISO 8124, obtain a Certificate of Conformity (COC) and bear the MC mark before it can be sold in Malaysia; without certification it is non-compliant.

Q: Do pacifiers and feeding bottles also count as toys? No. Pacifiers, feeding bottles and trainer cups are feeding/childcare utensils and do not fall under the Toy Regulations; teethers, rattles and comfort toys are toys. When classification is uncertain, confirm with KPDN or the testing body first.

Q: Do baby toys need to be labelled "not suitable for under 3s"? A toy designed for babies should not carry this warning — that would imply the product itself has a small-parts risk. The correct approach is to pass the small-parts and tension tests, designing the risk out, rather than using a warning to evade it.

Q: Which chemical items most need attention for teethers? Heavy metal migration (the eight in MS ISO 8124-3) and phthalates (MS ISO 8124-6). Because they can be placed in the mouth, DINP/DIDP/DNOP must also meet the stricter 0.1% limit, with soft PVC and scented materials posing the highest risk.

Q: I already have overseas EN71 or ASTM reports — can I use them directly? MS ISO 8124 aligns closely with EN71 and ASTM F963, and KPDN accepts reports issued by ILAC/APLAC mutual-recognition laboratories as a basis for submission, but you must still complete COC registration and the MC mark in Malaysia — you cannot list a product on overseas reports alone.

Self-check checklist

• [ ] Confirmed the product is a "toy" rather than a pacifier/feeding utensil
• [ ] Passed MS ISO 8124-1 small-parts, tension, cord and structural testing
• [ ] Heavy metals (Part 3) and phthalates (Part 6, including the mouthable 0.1% limit) pass
• [ ] Obtained the COC and affixed the MC mark (≥5 mm) + KPDN registration number
• [ ] Label states the manufacturer/importer name and address and necessary warnings
• [ ] Baby toys not mislabelled "not suitable for under 3s"

Summary: The compliance logic for baby toys and teethers is "stricter because it goes in the mouth." First confirm that it is a toy, then fully address the three gates of small parts, heavy metals and phthalates, and finally complete the MC mark and importer labelling. Designing safety into the product is more reliable than adding warnings afterward.

Run a free label check now

Further reading: Malaysia toy safety certification and labelling guide (SIRIM, MS ISO 8124), how to label toy applicable age and choking warnings, toy safety test items: MS ISO 8124 and the 8 heavy metals.

This article is compiled from official sources for reference only; actual compliance is subject to the latest official text and review by the competent authority.