Comparative Testing: Baby Pacifier and Sippy Cups

Overview

This Malaysian Association of Standards Users (Standards Users) comparative consumer-testing report documents the survey of eight infant-contact products (six pacifiers/soothers, one sippy cup, one 3-in-1 nursing cup) purchased from Malaysian retail in 2016 and submitted to two accredited laboratories for bisphenol A (BPA), six phthalate esters, and ten N-nitrosamine compounds. All three analyte classes were reported as Not Detected across all eight samples at the laboratories’ stated limits of reference (BPA limit of detection 0.5 ng/mL; phthalates limit of reference 0.5 and 5 mg/kg; nitrosamines limit of reference 0.5 and 1 mg/kg). The report does not test heavy metals in the eight samples. Heavy metals enter the report only as regulatory context: Tables 1 and 2 transcribe the soluble-element migration limits from Denmark (based on EN 71-3, applied to soothers) and from Malaysian standard MS 1156:1989 (Specification for Babies’ Pacifiers), and the body discusses the absence of Malaysian regulatory coverage for pacifiers, sippy cups, replacement nipples, teethers, and infant-food receptacles for nitrosamine/phthalate/BPA content. The HMI value of this source is therefore (i) a B-tier confirmation of zero BPA/phthalate/nitrosamine detections in an eight-product Malaysian retail sample of pacifiers and sippy cups (relevant to infant-contact product context, though outside the HMI analyte panel), and (ii) a regulatory-context transcription of the Danish EN 71-3 and Malaysian MS 1156:1989 element-migration limits relevant to pacifier and soother heavy-metals regulation.

Key numbers

Sample frame

• Products purchased and tested: 8 (Section 3.3, Table 4 p. 10-11, Table 5 p. 13-14).
• Pacifiers/soothers: 6 (samples No. 1-6; Section 3.3, Table 4).
• Sippy cup: 1 (sample No. 7; Section 3.3, Table 4).
• 3-in-1 nursing cup: 1 (sample No. 8; Section 3.3, Table 4).
• Unit price range: RM 2.70 (Silicone Soother with Cover, sample No. 5) to RM 7.60 (3-in-1 Nursing Cup, sample No. 8) (Table 4 p. 10-11).
• Laboratory assignment: two laboratories; one for phthalates and nitrosamines (named-but-redacted), one for bisphenol A (named as “Centre for Xenobiotics Studies”, with parent institution redacted) (Section 4, p. 12).
• Stated limitation: “The samples collected do not represent the amount of these products sold or available in the market. Budget constraints allow only a very small fraction of what is available in the market to be tested.” (Section 3.2, p. 5).

Test results (Table 5, p. 13-14)

All eight samples returned Not Detected (ND) for all three analyte classes:

Phthalate analyte panel (Figure 1, p. 12)

USEPA Method 3570 (extraction) and USEPA Method 8270 C (GC-MS determination) applied to six phthalate esters:

(The report frames this as “phthalates” without using the DEHP/DBP/BBP/DMP/DEP/DnOP shorthand nomenclature in the body text outside Figure 1.)

Nitrosamine analyte panel (Figure 1, p. 12)

USEPA Method 3570 (extraction) and USEPA Method 8270 C (GC-MS determination) applied to ten compounds reported in the nitrosamine block:

Regulatory context transcribed in the report

Table 1 — Danish soother element-migration limits, based on EN 71-3 (Section 2.4, p. 3):

Report note: “The analytical method specified in EN 71-3 has been applied in this standard to soothers. The limits set account for the prolonged sucking of a teat in the mouth.”

Companion Danish nitrosamine limits (Section 2.4, p. 3):

Table 2 — Malaysian Standard MS 1156:1989 (Specification for Babies’ Pacifiers) soluble-element limits (Section 2.5, p. 3):

Malaysian volatile-nitrosamine limit (Section 2.5, p. 4; ref. MS 1312:1993 dichloromethane extraction method): “all rubber pacifiers or rubber component parts of pacifiers including any filling in the teat shall not contain in excess of 30 ppb total volatile nitrosamine content, neither shall the contain in excess of 15 ppb of any one volatile nitrosamine.”

US CPSC nitrosamine limit (Section 2.4, p. 3): “the limit for nitrosamines in nipple not exceeding 20 ppb of total nitrosamines.”

Table 3 — Status of regulations and standards across jurisdictions (Section 2.6, p. 4): Malaysia (MS 1156:1989 and MS 1312:1993, status: “Not regulated”), Australia (AS 2432-2009 Baby Dummies, status: Mandatory), New Zealand (information not available), Canada (Hazardous Products (Pacifiers) Regulations, status: Mandatory), Denmark (EN 12868 nitrosamine method, EN 14060 soothers, DS/EN 1400-3 chemical requirements, status: Mandatory), Fiji (Trade Standards and Quality Control Decree banning phthalate plasticizers in toys and childcare items, status: Mandatory), United States (ASTM F1313-90(2011) volatile N-nitrosamine specification for rubber nipples on pacifiers, status: Mandatory).

Regulatory background discussed (Section 1, p. 1)

• US CPSC 2010-07-20 recall: 45,000 baby pacifiers recalled by the US Consumer Product Safety Commission for choking and aspiration hazard (nipple separation, oversize handle, undersize mouth guard, missing ventilation holes).
• November 2009 CPSC recall: an earlier branded infant pacifier recalled for similar design-flaw choking risk.
• Malaysian BPA ban context (Section 3, p. 5): Malaysia “recently imposed ban on BPA in plastic feeding bottles (which takes effect in March 2012)“. The report flags that the ban does not cover sippy cups used for children, motivating the BPA test scope.

Background literature cited

• Nitrosamines, baby bottle nipples and pacifiers (Section 2.2, p. 2, footnote 2): “Reduction in levels of volatile N-nitrosamines in rubber nipples for babies’ bottles,” Food and Chemical Toxicology Volume 23, Issue 11, November 1985, pages 991-993. Reported finding: “out of 16 samples of baby bottle nipples and children pacifiers tested, 81% of the products did not meet the Dutch standards which was based on aqueous extraction method. And if it was compare to the uranium (U).S regulations, 37.5% of the products would be banned.”
• Non-volatile nitrosamines (Section 2.2, p. 2, footnote 3): Sen NP, Seaman SW, Kushwaha SC — “Determination of non-volatile N-nitrosamines in baby bottle rubber nipples and pacifiers by high-performance liquid chromatography-thermal energy analysis”, PubMed. Reported finding: “Eighteen out of twenty four samples analyzed were found to contain varying levels of N-nitrosodibenzylamine,” a carcinogenic compound.

Methods (brief)

The report names two laboratories but redacts both lab identities in the published PDF:

• Laboratory 1 (named-but-redacted): phthalates and nitrosamines, USEPA Method 3570 (extraction) and USEPA Method 8270 C (GC-MS determination of semivolatile organics). Limits of reference 0.5 mg/kg for most compounds; 1 mg/kg for N-nitrosopyrrolidine; 5 mg/kg for bis(2-ethylhexyl) phthalate (DEHP).
• Laboratory 2: bisphenol A; reported as “Centre for Xenobiotics Studies” with parent-institution name redacted. Limit of detection 0.5 ng/mL.

Sample collection: eight retail-purchased products from Malaysian retail in 2016. The report does not describe sample preparation, replicate count, or QC procedures beyond identifying the methods and labs; per the report’s own Section 3.2 limitation, the sample is small and not representative.

No heavy metal analysis was performed on the eight samples. The element migration limit tables (Tables 1 and 2) are regulatory transcriptions, not measurements.

Implications

• HMTc audit implications. For HMTc work on Pacifiers and sucking/teething aids (Category 9, Row 4) and Sippy cups and toddler drinkware components (Category 9, Row 3), this source contributes the Danish EN 71-3-based element-migration regulatory ceiling (Sb 15, arsenic (As) 10, Ba 100, cadmium (Cd) 20, lead (Pb) 25, chromium (Cr) 10, mercury (Hg) 10, Se 100 ppm) and the Malaysian MS 1156:1989 soluble-element ceiling (Sb 250, As 100, Ba 500, Cd 100, Cr 250, Pb 100 ppm) as named regulatory inputs to the lowest-applicable-regulatory-cap test in the Standards Workbench. The Danish limits are substantially tighter than the Malaysian limits across the panel — by a factor of 4 (Pb), 5 (Cd, Cr), and 10 (Sb, As) — and EN 71-3 is the operative European reference for prolonged-sucking exposure on soothers. The source contributes no occurrence data on the eight samples for these metals; the samples were tested only for BPA, phthalates, and nitrosamines.

• Occurrence data contribution. Zero. The eight-sample retail survey did not measure heavy metals. The all-ND BPA/phthalate/nitrosamine finding is outside the HMI analyte panel and is recorded here as the paper’s primary finding for traceability but does not populate any metal contamination_profile.

• Regulatory landscape. Table 3 (Section 2.6) is a useful jurisdiction-level snapshot of pacifier/soother chemical regulation as of 2016: Mandatory in Australia, Canada, Denmark, Fiji, US (nitrosamine-specific); Not regulated in Malaysia (the report’s policy ask is for the Malaysian Department of Standards to revise MS 1156:1989 and for the Ministry of Health to extend the BPA ban to pacifiers, sippy cups, replacement nipples, teethers, and infant food receptacles).

• App. Not directly relevant to ingredient contamination_profile data. Relevant to a future infant-product screening surface that explains why pacifiers and sippy cups are a regulated category under EN 71-3 (Europe) and ASTM F1313 (US nitrosamines) but were unregulated for chemical migration in Malaysia as of the report’s publication.

• Courses. Useful as a worked example of NGO comparative consumer testing as a regulatory-advocacy lever: a small retail-purchased sample (n=8), accredited laboratory methods (USEPA 3570/8270 C), all-ND findings, and the report’s resulting policy recommendation to the Department of Standards Malaysia and the Ministry of Health.

• Microbiome. Not applicable.

Related evidence

• Lead
• Cadmium
• Arsenic, Total
• Antimony
• Chromium
• Mercury, Total
• Pacifiers and sucking/teething aids
• Sippy cups and toddler drinkware components

Update history

No substantive edit history is available in this build. The full commit record is available in git.